Vol. 76 Thursday, No. 218 November 10, 2011

Pages 70037–70320

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 76, No. 218

Thursday, November 10, 2011

Agriculture Department NOTICES See Animal and Plant Health Inspection Service Agency Information Collection Activities; Proposals, See National Agricultural Statistics Service Submissions, and Approvals, 70109–70110 NOTICES Agency Information Collection Activities; Proposals, Consumer Product Safety Commission Submissions, and Approvals, 70107–70108 NOTICES Meetings; Sunshine Act, 70117 Animal and Plant Health Inspection Service RULES Defense Acquisition Regulations System Importation of Live Swine, Swine Semen, Pork, and Pork PROPOSED RULES Products from Liechtenstein and Switzerland, 70037– Defense Federal Acquisition Regulation Supplements: 70040 Safeguarding Unclassified DoD Information; Meeting Cancellation, 70106 Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Defense Department See Defense Acquisition Regulations System Bureau of Ocean Energy Management, Regulation and See Navy Department NOTICES Enforcement Intents to Grant Exclusive Licenses: NOTICES Voltage Networking, LLC, 70117–70118 Draft Programmatic Environmental Impact Study: Department of Transportation Five-Year Outer Continental Shelf Oil and Gas Leasing See Pipeline and Hazardous Materials Safety Program for 2012–2017, 70156 Administration Five-Year Outer Continental Shelf Oil and Gas Leasing Program for 2012–2017, 70156–70160 Education Department NOTICES Centers for Medicare & Medicaid Services Agency Information Collection Activities; Proposals, RULES Submissions, and Approvals, 70120 Medicare Programs: End-Stage Renal Disease Prospective Payment System Energy Department and Quality Incentive Program; Ambulance Fee See Energy Information Administration Schedule; Durable Medical Equipment; and See Western Area Power Administration Competitive Acquisition of Certain Durable Medical NOTICES Equipment, Prosthetics, Orthotics and Supplies, Meetings: 70228–70316 Environmental Management Site-Specific Advisory NOTICES Board, Northern New Mexico, 70120–70121 Agency Information Collection Activities; Proposals, Environmental Management Site-Specific Advisory Submissions, and Approvals, 70148 Board, Portsmouth, 70121 Plan for Conduct of 2012 Electric Transmission Congestion Children and Families Administration Study, 70122–70123 NOTICES Statements of Organization, Functions, and Delegations of Energy Information Administration Authority: NOTICES Office of Refugee Resettlement, 70149–70150 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 70123–70125 Civil Rights Commission NOTICES Environmental Protection Agency Meetings: RULES Colorado Advisory Committee, 70109 National Oil and Hazardous Substance Pollution Contingency Plans; National Priorities List: Coast Guard Partial Deletion of Tar Lake Superfund Site, 70057–70061 RULES PROPOSED RULES Lifesaving Equipment: Approvals and Promulgations of Implementation Plans and Production Testing and Harmonization with International Designations of Areas for Air Quality Planning Standards, 70062 Purposes: Alabama; Redesignation of Birmingham 1997 Annual Commerce Department Fine Particulate Matter Nonattainment Area to See Foreign-Trade Zones Board Attainment, 70078–70091 See Industry and Security Bureau Alabama; Redesignation of Birmingham 2006 24-Hour See International Trade Administration Fine Particulate Matter Nonattainment Area to See National Oceanic and Atmospheric Administration Attainment, 70091–70105

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National Oil and Hazardous Substance Pollution Reissuance, 70145 Contingency Plans; National Priorities List: Revocation, 70145 Partial Deletion of Tar Lake Superfund Site, 70105–70106 NOTICES Federal Motor Carrier Safety Administration Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals: Qualifications of Drivers: NSPS for Municipal Waste Combustors (Renewal), Exemption Applications; Vision, 70210–70216 70127–70128 California State Motor Vehicle Pollution Control Standards: Federal Reserve System Amendments to the California Heavy-Duty Engine On- NOTICES Board Diagnostic Regulation; Waiver Request, 70128– Agency Information Collection Activities; Proposals, 70130 Submissions, and Approvals, 70146–70147 Environmental Impact Statements; Availability, etc.: Weekly Receipt, 70130 Fish and Wildlife Service Meetings: NOTICES Interagency Steering Committee on Radiation Standards, Endangered Species Recovery Permit Applications, 70160– 70130–70131 70162 Senior Executive Service Performance Review Board Membership, 70131 Food and Drug Administration NOTICES Equal Employment Opportunity Commission Draft Guidance for Industry and Staff; Availability: NOTICES Investigational Device Exemptions for Early Feasibility Meetings; Sunshine Act, 70131–70132 Medical Device Clinical Studies, Including Certain First in Human Studies, 70150–70151 Executive Office of the President Draft Guidance for Industry, Clinical Investigators, See Management and Budget Office Institutional Review Boards, and Staff; Availability: See Presidential Documents Decisions for Investigational Device Exemption Clinical See Science and Technology Policy Office Investigations, 70151–70152 Pilot Program for Early Feasibility Study Investigational Federal Aviation Administration Device Exemption Applications, 70152–70154 RULES Airworthiness Directives: Foreign-Trade Zones Board ATR – GIE Avions de Transport Regional Airplanes, NOTICES 70044–70046 Applications for Reorganization and Expansion under Eurocopter France Model AS350B, B1, B2, B3, BA, C, D, Alternative Site Framework: and D1; and AS355E, F, F1, F2, N, and NP Foreign-Trade Zone 109, County of Jefferson, NY, 70110 Helicopters, 70046–70051 Gulfstream Aerospace LP (Type Certificate Previously Health and Human Services Department Held by Israel Aircraft Industries, Ltd.) Airplanes, 70040–70042 See Centers for Medicare & Medicaid Services Pacific Aerospace Limited Airplanes, 70042–70044 See Children and Families Administration Establishments of Class D and Amendments of Class E See Food and Drug Administration Airspace: See National Institutes of Health NOTICES Los Angeles, CA, 70051–70053 Determinations Concerning Petitions to Add Class of Standard Instrument Approach Procedures, and Takeoff Employees to Special Exposure Cohort, 70147–70148 Minimums and Obstacle Departure Procedures, 70053– 70056 Homeland Security Department Federal Deposit Insurance Corporation See Coast Guard NOTICES Meetings; Sunshine Act, 70132 Housing and Urban Development Department NOTICES Federal Election Commission Federal Properties Suitable as Facilities to Assist Homeless, NOTICES 70155–70156 Meetings; Sunshine Act, 70132 Industry and Security Bureau Federal Housing Finance Agency NOTICES PROPOSED RULES Agency Information Collection Activities; Proposals, Federal Home Loan Bank Community Support Submissions, and Approvals: Amendments, 70069–70075 Miscellaneous Short Supply Activities, 70110–70111 NOTICES Request for Investigation Under Section 232 of the Trade Federal Home Loan Bank Members Selected for Community Expansion Act, 70111 Support Review, 70132–70145 Interior Department Federal Maritime Commission See Bureau of Ocean Energy Management, Regulation and NOTICES Enforcement Ocean Transportation Intermediary Licenses: See Fish and Wildlife Service Applicants, 70145–70146 See Land Management Bureau

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Internal Revenue Service Mine Safety and Health Administration RULES PROPOSED RULES Extending Religious and Family Member FICA and FUTA Proximity Detection Systems for Continuous Mining Exceptions to Disregarded Entities: Machines in Underground Coal Mines, 70075–70076 Correction, 70057 NOTICES National Agricultural Statistics Service Meetings: NOTICES Advisory Council to the Internal Revenue Service, 70225 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 70108–70109 International Trade Administration NOTICES National Foundation on the Arts and the Humanities Antidumping Duty Administrative Reviews; Results, NOTICES Amendments, Extensions, etc.: Meetings: Certain Frozen Fish Fillets from the Socialist Republic of Humanities Panel, 70168 Vietnam, 70111–70112 Certain Preserved Mushrooms from the People’s Republic National Institutes of Health of China, 70112–70113 NOTICES Executive-Led Medical Trade Missions to India; Mumbai, Meetings: New Delhi and Hyderabad March 2–8, 2012, 70113– Advisory Committee to Director, 70155 70116 National Cancer Institute, 70154–70155 National Heart, Lung, and Blood Institute, 70154 International Trade Commission National Institute of Allergy and Infectious Diseases, NOTICES 70155 Complaints: National Institute of General Medical Sciences, 70155 Certain Devices with Secure Communication Capabilities, etc., 70164 National Oceanic and Atmospheric Administration RULES Justice Department Atlantic Highly Migratory Species: See Justice Programs Office Update to Information on Effective Date of Smoothhound NOTICES Shark Fishery Management Measures, 70064–70066 Lodgings of Consent Decrees under CERCLA, 70164–70165 Fraser River Sockeye and Pink Salmon Fisheries; Inseason Orders, 70062–70064 Justice Programs Office NOTICES NOTICES Meetings: Ballistic-Resistant Body Armor Standard Workshop, 70165 National Climate Assessment and Development Advisory Committee; Time Changes, 70116–70117 Labor Department See Labor Statistics Bureau National Science Foundation See Mine Safety and Health Administration NOTICES See Occupational Safety and Health Administration Meetings; Sunshine Act, 70168 Labor Statistics Bureau National Transportation Safety Board NOTICES NOTICES Agency Information Collection Activities; Proposals, SES Performance Review Board Members, 70169 Submissions, and Approvals, 70165–70166 Navy Department Land Management Bureau NOTICES NOTICES Environmental Impact Statements; Availability, etc.: Environmental Assessments; Availability, etc.: Basing of MV–22 and H–1 Aircraft in Support of III Land Use Plan Amendment to Provide for a Proposed Marine Expeditionary Force Elements in Hawaii, Direct Land Sale in Blaine County, ID, 70162–70163 70118–70120 Filings of Plats of Surveys: Montana, 70163 Nuclear Regulatory Commission Meetings: PROPOSED RULES BLM–Alaska Resource Advisory Council; Correction, Environmental Impacts of Severe Reactor and Spent Fuel 70163 Pool Accidents, 70067–70069 Eastern Montana Resource Advisory Council, 70163– NOTICES 70164 Final Environmental Statements: Operation of Watts Bar Nuclear Plant, Unit 2, Tennessee Management and Budget Office Valley Authority, 70169–70170 RULES Proposed Alternative Soils Standards for Uravan, CO OMB Circulars, OFPP Policy Letters, and CASB Cost Uranium Mill, 70170–70173 Accounting Standards Included in Semiannual Agenda of Federal Activities; Withdrawal, 70037 Occupational Safety and Health Administration NOTICES Maritime Administration Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals: Administrative Waivers of Coastwise Trade Laws: Electrical Standards for Construction and General Vessel REEL ATTITUDE, 70216–70217 Industry, 70166–70168

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Office of Management and Budget Transportation Department See Management and Budget Office See Federal Aviation Administration See Federal Motor Carrier Safety Administration Pipeline and Hazardous Materials Safety Administration See Maritime Administration NOTICES See Pipeline and Hazardous Materials Safety Agency Information Collection Activities; Proposals, Administration Submissions, and Approvals, 70217–70220 See Surface Transportation Board Determinations: NOTICES New Jersey Regulations on Transportation of Regulated Agency Information Collection Activities; Proposals, Medical Waste, 70220–70223 Submissions, and Approvals: New Requirements and Procedures for Grant Payment Postal Regulatory Commission Request Submission, 70209–70210 NOTICES Applications for Certificates of Public Convenience and Post Office Closings, 70173–70176 Necessity and Foreign Air Carrier Permits, 70210 Presidential Documents ADMINISTRATIVE ORDERS Treasury Department Weapons of Mass Destruction; Continuation of National See Internal Revenue Service Emergency (Notice of November 9, 2011), 70317–70319 NOTICES Agency Information Collection Activities; Proposals, Science and Technology Policy Office Submissions, and Approvals, 70224–70225 NOTICES Requests for Information: Public Access to Digital Data Resulting from Federally Veterans Affairs Department Funded Scientific Research; Correction, 70176–70178 PROPOSED RULES Required Assessment Tool for State Nursing Homes: Securities and Exchange Commission Technical Revisions to Update Reference, 70076–70078 NOTICES Cancellations of Registrations: Western Area Power Administration Creative Investment Research, Inc., 70178 NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Environmental Impact Statements; Availability, etc.: BATS Exchange, Inc., 70192–70195 Proposed Solar Reserve LLC Quartzsite Solar Energy Chicago Board Options Exchange, Inc., 70198–70199 Project, La Paz County, AZ, etc., 70125–70127 EDGA Exchange, Inc., 70183–70184, 70202–70204 EDGX Exchange, Inc., 70204–70206 Financial Industry Regulatory Authority, Inc., 70190– 70192, 70195–70198 Separate Parts In This Issue ICE Clear Credit LLC, 70206–70207 International Securities Exchange, LLC, 70178–70183 Municipal Securities Rulemaking Board, 70207–70209 Part II NASDAQ OMX BX, Inc., 70184–70187 Health and Human Services Department, Centers for NASDAQ OMX PHLX LLC, 70187–70190 Medicare & Medicaid Services, 70228–70316 NASDAQ Stock Market LLC, 70199–70202 Part III State Department Presidential Documents, 70317–70319 NOTICES Delegations of Authority, 70209

Statistical Reporting Service Reader Aids See National Agricultural Statistics Service Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, Surface Transportation Board and notice of recently enacted public laws. NOTICES Abandonment Exemptions: To subscribe to the Federal Register Table of Contents CSX Transportation, Inc, Monroe County, AL, 70223 LISTSERV electronic mailing list, go to http:// Operation Exemptions: listserv.access.gpo.gov and select Online mailing list Saratoga and North Creek Railway, LLC for Tahawus archives, FEDREGTOC-L, Join or leave the list (or change Line, 70223–70224 settings); then follow the instructions.

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CFR PARTS AFFECTED IN THIS ISSUE

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

3 CFR Adminstrative Orders: Notices: Notice of November 9, 2011 ...... 70319 5 CFR Ch. III ...... 70037 9 CFR 93...... 70037 94...... 70037 98...... 70037 10 CFR Proposed Rules: 51...... 70067 12 CFR Proposed Rules: 1290...... 70069 14 CFR 39 (4 documents) ...... 70040, 70042, 70044, 70046 71...... 70051 97 (2 documents) ...... 70053, 70055 26 CFR 301...... 70057 30 CFR Proposed Rules: 75...... 70075 38 CFR Proposed Rules: 51...... 70076 40 CFR 300...... 70057 Proposed Rules: 52 (2 documents) ...... 70078, 70091 81 (2 documents) ...... 70078, 70091 300...... 70105 42 CFR 413...... 70228 414...... 70228 46 CFR 160...... 70062 180...... 70062 199...... 70062 48 CFR Ch. 1 ...... 70037 Proposed Rules: 204...... 70106 252...... 70106 50 CFR 300...... 70062 635...... 70064

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Rules and Regulations Federal Register Vol. 76, No. 218

Thursday, November 10, 2011

This section of the FEDERAL REGISTER DEPARTMENT OF AGRICULTURE vesicular disease (SVD), foot-and-mouth contains regulatory documents having general disease (FMD), and rinderpest. These applicability and legal effect, most of which Animal and Plant Health Inspection are dangerous and destructive are keyed to and codified in the Code of Service communicable diseases of ruminants Federal Regulations, which is published under and swine. 50 titles pursuant to 44 U.S.C. 1510. 9 CFR Parts 93, 94, and 98 Sections 94.9 and 94.10 of the The Code of Federal Regulations is sold by [Docket No. APHIS–2009–0093] regulations list regions of the world that the Superintendent of Documents. Prices of are declared free of or low-risk for CSF. new books are listed in the first FEDERAL Importation of Live Swine, Swine Sections 94.24 and 98.38 specify REGISTER issue of each week. Semen, Pork, and Pork Products From restrictions necessary to mitigate the Liechtenstein and Switzerland risk of introducing CSF into the United States via the importation of pork, pork OFFICE OF MANAGEMENT AND AGENCY: Animal and Plant Health products, live swine, and swine semen BUDGET Inspection Service, USDA. from the region of Europe that we ACTION: Final rule. recognize as low risk for CSF (currently, 5 CFR Chapter III 19 Member States of the European SUMMARY: We are amending the Union (EU)). Section 94.12 of the 48 CFR Chapter 1 regulations governing the importation of regulations lists regions that are animals and animal products to add Federal Regulations; OMB Circulars, declared free of SVD. Section 94.13 of Liechtenstein and Switzerland to the the regulations lists regions that have OFPP Policy Letters, and CASB Cost region of Europe that we recognize as Accounting Standards Included in the been determined to be free of SVD, but low risk for classical swine fever (CSF). that are subject to certain restrictions Semiannual Agenda of Federal We are also adding Liechtenstein to the Activities; Withdrawal because of their proximity to or trading list of regions we consider free from relationships with SVD-affected regions. swine vesicular disease (SVD) and to the Section 94.1 of the regulations lists AGENCY: Office of Management and list of regions considered free from foot- Budget. regions of the world that are declared and-mouth disease (FMD) and free of rinderpest or free of both ACTION: Withdrawal. rinderpest. These actions will relieve rinderpest and FMD. Section 94.11 of some restrictions on the importation the regulations lists regions that have SUMMARY: The Office of Management into the United States of certain animals and Budget (OMB) is announcing the been determined to be free of rinderpest and animal products from those regions, and FMD, but that are subject to certain withdrawal of its semiannual agenda of while continuing to protect against the upcoming activities for Federal restrictions because of their proximity to introduction of CSF, SVD, FMD, and or trading relationships with rinderpest- regulations, OMB Circulars, Office of rinderpest into the United States. Federal Procurement Policy (OFPP) or FMD-affected regions. DATES: Effective Date: November 25, On May 19, 2011, we published in the Policy Letters, and Cost Accounting 2011. Standards Board (CASB) Cost Federal Register (76 FR 28910–28913, Accounting Standards. FOR FURTHER INFORMATION CONTACT: Dr. Docket No. APHIS–2009–0093) a Kelly Rhodes, Regionalization proposed rule 1 to add Liechtenstein and DATES: The withdrawal is effective Evaluation Services, Import, Sanitary Switzerland to the region of Europe that October 14, 2011. Trade Issues Team, National Center for we recognize as low risk for CSF and to FOR FURTHER INFORMATION CONTACT: See Import and Export, VS, APHIS, 4700 add Liechtenstein to the lists of regions agency person listed for each entry in River Road Unit 38, Riverdale, MD we consider free from SVD and from the agenda, c/o Office of Management 20737; (301) 734–4356. FMD and rinderpest. and Budget, Washington, DC 20503. On SUPPLEMENTARY INFORMATION: We solicited comments concerning the overall agenda, contact Kevin F. our proposal for 60 days ending July 18, Neyland, (202) 395–5897, at the above Background 2011. address. The Animal and Plant Health We received three comments by that Inspection Service (APHIS) of the date. They were from an individual and SUPPLEMENTARY INFORMATION: In a from two organizations representing document published in the Federal United States Department of Agriculture (USDA) regulates the importation of pork producers. The comments are Register of September 29, 2011 (77 FR discussed below. 60357), OMB published its semiannual animals and animal products into the United States to guard against the With respect to our proposal to add regulatory agenda. That document is Switzerland to the region of Europe that being withdrawn because the agenda introduction of animal diseases not currently present or prevalent in this we recognize as low risk for CSF, one was prematurely and improperly commenter asked about Switzerland’s published. country. The regulations in 9 CFR parts 93, 94 and 98 (referred to below as the current practice regarding the feeding of Dated: October 11, 2011. regulations) prohibit or restrict the catering waste to pigs in that country. If Kevin F. Neyland, importation of specified animals and Switzerland allows this practice, the Deputy Administrator, Office of Information animal products to prevent the and Regulatory Affairs. 1 To view the proposed rule, supporting introduction into the United States of documents, and the comments we received, go to [FR Doc. 2011–27637 Filed 11–9–11; 8:45 am] various animal diseases, including http://www.regulations.gov/ BILLING CODE P classical swine fever (CSF), swine #!docketDetail;D=APHIS-2009-0093.

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commenter wanted APHIS to explain its live swine that are imported, and provisions of 5 U.S.C. 553, may be made decision that the level of CSF risk in essentially prohibit transit across either effective less than 30 days after Switzerland is equivalent to, or less country, the risk of CSF introduction by publication in the Federal Register. than, the CSF risk in that portion of the this pathway is negligible. This rule adds Liechtenstein and EU that APHIS currently recognizes as Passive surveillance in wild boar is Switzerland to the region of Europe that low risk for CSF. The commenter stated ongoing through hunter submissions. we recognize as low-risk for CSF. This that the EU (which does not include Hunters are required by law to report rule also adds Liechtenstein to the list Switzerland) bans the feeding of any wild boar found dead to an official of regions we consider free from swine catering waste to farm animals other veterinarian, who retrieves the carcass vesicular disease and to the list of than fur animals to reduce disease risk and submits it for pathology and CSF regions we consider free from FMD and to swine. testing. Some cantons—including rinderpest. These changes will allow Dr. Lukas Perler, head of animal Ticino and the northern cantons of breeding swine, swine semen, and pork health, Swiss Federal Veterinary Office, Zu¨ rich, Basel, and Aargau—require CSF and pork products to be imported into has confirmed that Switzerland began testing of all hunted wild boar. the United States from these countries enforcing a prohibition on feeding The Swiss Veterinary Service is subject to certain conditions. We have catering waste to pigs on July 1, 2011. enhancing passive surveillance for CSF determined that approximately 2 weeks Two commenters noted that our CSF through training and outreach activities are needed to ensure that APHIS and risk evaluations for Switzerland and focused on producers and private Department of Homeland Security, Liechtenstein indicated those countries veterinarians. The emergency response Bureau of Customs and Border rely on passive surveillance and a small plan includes provisions for CSF- Protection, personnel at ports of entry amount of serological surveillance in specific training and outreach for receive official notice of this change in domestic swine and wild boar to detect veterinary professionals, animal the regulations. Therefore, the an outbreak. One commenter urged keepers, the hunting community, and Administrator of the Animal and Plant APHIS to require Switzerland and the general public. Health Inspection Service has Liechtenstein to implement and enforce In addition, Switzerland tests 700– determined that this rule should be an active surveillance program, to be 1,000 swine each year for CSF, effective 15 days after publication in the verified by APHIS, before allowing the primarily for import or export of Federal Register. countries to export meat to the United domestic swine, or for boars entering States under conditions applicable to artificial insemination centers. Executive Order 12866 and Regulatory regions recognized as low risk for CSF. We believe the level of surveillance Flexibility Act The other commenter wanted APHIS to for CSF is adequate and that the facts This final rule is subject to Executive explain its decision that the level of CSF support our determination that level of Order 12866. However, for this action, risk in Switzerland and Liechtenstein is CSF risk in Switzerland and the Office of Management and Budget equivalent to, or less than, the CSF risk Liechtenstein is equivalent to, or less has waived its review under Executive in that portion of the EU that APHIS than, the CSF risk in that portion of the Order 12866. currently recognizes as low risk for CSF, EU that APHIS currently recognizes as In accordance with the Regulatory when Switzerland and Liechtenstein do low risk for CSF. Flexibility Act, we have analyzed the not have a national surveillance plan for Finally, one commenter expressed potential economic effects of this action CSF that is equivalent to other EU general concern about the effect of on small entities. Copies of the full countries or the United States. imports on American farmers. The analysis are available by contacting the Our risk assessment found no Office of the United States Trade person listed under FOR FURTHER evidence that CSF virus currently exists Representative (USTR) calls trade INFORMATION CONTACT or on the in Switzerland or Liechtenstein and no critical to America’s prosperity—fueling Regulations.gov Web site (see footnote 1 immediate and significant risks economic growth, supporting good jobs above for instructions for accessing associated with this hazard. The last at home, raising living standards, and Regulations.gov). CSF cases in Switzerland occurred in helping Americans provide for their Our analysis identifies U.S. swine 1993 in domestic swine and 1999 in families with affordable goods and producers as the small entities wild boar; Liechtenstein has never services. Both imports and exports potentially affected by the provisions of reported a CSF outbreak. contribute to the U.S. economy. While the rule, but also notes that Switzerland CSF infection in free-ranging wild exports raise productivity and incomes, and Liechtenstein have, historically, boar is not an immediate concern for imports increase consumer choices and exported a minimal amount of swine or introduction of the disease into purchasing power. As provided by the swine products. Switzerland or Liechtenstein, since the Animal Health Protection Act, APHIS Under these circumstances, the closest known infected population is regulates the importation of animals and Administrator of the Animal and Plant located over 150 kilometers from the animal products only to the extent Health Service has determined that this Swiss border, in Germany. necessary to protect against the action will not have a significant Switzerland and Liechtenstein have introduction of livestock diseases and economic impact on a substantial adopted import and trade regulations pests that could harm U.S. agriculture. number of small entities. concerning live animals and animal USDA places a high priority on Executive Order 12988 products that are equivalent to the removing unnecessary trade barriers on European Commission regulations that both imports and exports. This rule has been reviewed under apply to all EU Member States. Therefore, for the reasons given in the Executive Order 12988, Civil Justice Consequently, the baseline risk of CSF proposed rule and in this document, we Reform. This rule: (1) Preempts all State introduction into Switzerland or are adopting the proposed rule as a final and local laws and regulations that are Liechtenstein through import or trade is rule, without change. inconsistent with this rule; (2) has no similar to that of an EU Member State. retroactive effect; and (3) does not Since Switzerland and Liechtenstein Effective Date require administrative proceedings import very few live swine, require This is a substantive rule that relieves before parties may file suit in court substantial veterinary oversight of the restrictions and, pursuant to the challenging this rule.

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Paperwork Reduction Act PART 94—RINDERPEST, FOOT-AND- § 94.13 [Amended] MOUTH DISEASE, EXOTIC ■ This final rule contains no 11. In § 94.13, in the introductory text, NEWCASTLE DISEASE, AFRICAN the first sentence is amended by adding information collection or recordkeeping SWINE FEVER, CLASSICAL SWINE requirements under the Paperwork the word ‘‘Liechtenstein,’’ immediately FEVER, SWINE VESICULAR DISEASE, after the word ‘‘Latvia,’’. Reduction Act of 1995 (44 U.S.C. 3501 AND BOVINE SPONGIFORM et seq.). ENCEPHALOPATHY: PROHIBITED § 94.24 [Amended] List of Subjects AND RESTRICTED IMPORTATIONS ■ 12. Section 94.24 is amended as follows: 9 CFR Part 93 ■ 4. The authority citation for part 94 ■ a. In the section heading, by removing continues to read as follows: Animal diseases, Imports, Livestock, the words ‘‘APHIS-defined EU CSF Poultry and poultry products, Authority: 7 U.S.C. 450, 7701–7772, 7781– region’’ and adding the words ‘‘APHIS- Quarantine, Reporting and 7786, and 8301–8317; 21 U.S.C. 136 and defined European CSF region’’ in their recordkeeping requirements. 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and place. 371.4. ■ b. In paragraph (a) introductory text 9 CFR Part 94 ■ 5. In § 94.0, the definition of APHIS- and paragraph (a)(1)(i), by removing the words ‘‘APHIS-defined EU CSF region’’ Animal diseases, Imports, Livestock, defined EU CSF region is removed and each time they appear and adding the Meat and meat products, Milk, Poultry a definition of APHIS-defined European words ‘‘APHIS-defined European CSF and poultry products, Reporting and CSF region is added, in alphabetical region’’ in their place. recordkeeping requirements. order, to read as follows: ■ c. In paragraphs (a)(1)(ii) and 9 CFR Part 98 § 94.0 Definitions. (a)(1)(iii), by removing the words * * * * * ‘‘APHIS-defined EU CSF region’’ each Animal diseases, Imports. APHIS-defined European CSF region. time they appear and adding the words Accordingly, we are amending 9 CFR The regions of Austria, Belgium, the ‘‘APHIS-defined European CSF region’’ parts 93, 94, and 98 as follows: Czech Republic, Denmark, Finland, in their place, and by removing the France, Germany, Greece, Italy, Latvia, words ‘‘of the Member State’’ each time PART 93—IMPORTATION OF CERTAIN Liechtenstein, Lithuania, Luxembourg, they appear. ANIMALS, BIRDS, FISH, AND the Netherlands, Poland, Portugal, ■ d. In paragraph (a)(5), by removing the POULTRY, AND CERTAIN ANIMAL, Republic of Ireland, Spain, Sweden, words ‘‘of the APHIS-defined EU CSF BIRD, AND POULTRY PRODUCTS; Switzerland, and the United Kingdom region Member State’’. REQUIREMENTS FOR MEANS OF (England, Scotland, Wales, the Isle of ■ e. In paragraph (b) introductory text CONVEYANCE AND SHIPPING Man, and Northern Ireland). and paragraph (b)(2)(i), by removing the CONTAINERS * * * * * words ‘‘APHIS-defined EU CSF region’’ each time they appear and adding the ■ 1. The authority citation for part 93 § 94.1 [Amended] words ‘‘APHIS-defined European CSF continues to read as follows: ■ 6. In § 94.1, paragraph (a)(2) is region’’ in their place. ■ f. In paragraph (b)(2)(ii) and (b)(2)(iii), Authority: 7 U.S.C. 1622 and 8301–8317; amended by adding the word 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 ‘‘Liechtenstein,’’ immediately after the by removing the words ‘‘the APHIS- CFR 2.22, 2.80, and 371.4. word ‘‘Latvia,’’. defined EU CSF region’’ each time they appear and adding the words ‘‘the ■ 2. In § 93.500, the definition of § 94.9 [Amended] APHIS-defined European CSF region’’ in their place, and by removing the APHIS-defined EU CSF region is ■ 7. In § 94.9, paragraphs (b) and (c) words ‘‘of the Member State’’ each time removed and a definition of APHIS- introductory text, the words ‘‘APHIS- they appear. defined European CSF region is added, defined EU CSF region’’ are removed ■ g. In paragraph (b)(6), by removing the in alphabetical order, to read as follows: each time they appear and the words words ‘‘of the APHIS-defined EU CSF ‘‘APHIS-defined European CSF region’’ § 93.500 Definitions. region Member State’’. are added in their place. * * * * * § 94.10 [Amended] PART 98—IMPORTATION OF CERTAIN APHIS-defined European CSF region. ANIMAL EMBRYOS AND ANIMAL The regions of Austria, Belgium, the ■ 8. In § 94.10, paragraphs (b) and (c), SEMEN Czech Republic, Denmark, Finland, the words ‘‘APHIS-defined EU CSF France, Germany, Greece, Italy, Latvia, region’’ are removed each time they ■ 13. The authority citation for part 98 Liechtenstein, Lithuania, Luxembourg, appear and the words ‘‘APHIS-defined continues to read as follows: the Netherlands, Poland, Portugal, European CSF region’’ are added in Authority: 7 U.S.C. 1622 and 8301–8317; Republic of Ireland, Spain, Sweden, their place. 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 Switzerland, and the United Kingdom CFR 2.22, 2.80, and 371.4. (England, Scotland, Wales, the Isle of § 94.11 [Amended] ■ 14. In § 98.30, the definition of Man, and Northern Ireland). ■ 9. In § 94.11, paragraph (a) is amended APHIS-defined EU CSF region is * * * * * by adding the word ‘‘Liechtenstein,’’ removed and a definition of APHIS- immediately after the word ‘‘Latvia,’’. § 93.505 [Amended] defined European CSF region is added, § 94.12 [Amended] in alphabetical order, to read as follows: 3. In § 93.505, paragraph (a), the words ‘‘APHIS-defined EU CSF region’’ ■ 10. In § 94.12, paragraph (a) is § 98.30 Definitions. are removed and the words ‘‘APHIS- amended by adding the word * * * * * defined European CSF region’’ are ‘‘Liechtenstein,’’ immediately after the APHIS-defined European CSF region. added in their place. word ‘‘Latvia,’’. The regions of Austria, Belgium, the

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Czech Republic, Denmark, Finland, SUMMARY: We are adopting a new aircraft during a routine scheduled France, Germany, Greece, Italy, Latvia, airworthiness directive (AD) for certain maintenance inspection. This centering Liechtenstein, Lithuania, Luxembourg, Gulfstream Aerospace LP (type spring rod is common to all Gulfstream Mid the Netherlands, Poland, Portugal, certificate previously held by Israel Cabin model (G100, G150 and G200) aileron control servo actuators and the G200 elevator Republic of Ireland, Spain, Sweden, Aircraft Industries, Ltd.) Model Galaxy control servo actuator too. The function of Switzerland, and the United Kingdom and Gulfstream G150 airplanes; and the centering spring rod is to maintain the (England, Scotland, Wales, the Isle of Gulfstream Aerospace LP Model affected servo actuator and its associated Man, and Northern Ireland). Gulfstream 200 airplanes. This AD flight control surface in a centered position * * * * * results from mandatory continuing in the event of a disconnect of the normal airworthiness information (MCAI) mechanical control system input from the § 98.38 [Amended] originated by an aviation authority of flight crew to the same servo actuator. This ■ 15. Section 98.38 is amended as another country to identify and correct latent failure of a centering spring rod, if not detected and corrected, in conjunction with follows: an unsafe condition on an aviation ■ the disconnection of the normal mechanical a. In the section heading, by removing product. The MCAI describes the unsafe control system of the same servo actuator the words ‘‘APHIS-defined EU CSF condition as: would lead to loss [of] control of the flight region’’ and adding the words ‘‘APHIS- A broken aileron servo actuator centering control surface/aileron. This condition would defined European CSF region’’ in their spring rod was discovered on a model G100 reduce the control capability of the airplane place. aircraft during a routine scheduled and imposes a higher workload on the flight ■ b. In the introductory text, by maintenance inspection. * * * This latent crew reducing their ability to cope with removing the words ‘‘APHIS-defined EU failure of a centering spring rod, if not adverse operating conditions. CSF region’’ and adding the words detected and corrected, in conjunction with The required actions include a detailed ‘‘APHIS-defined European CSF region’’ the disconnection of the normal mechanical inspection of the servo actuator in their place. control system of the same servo actuator centering spring rods for the aileron and ■ would lead to loss [of] control of the flight c. In paragraph (a), by removing the elevator to detect fractured or broken words ‘‘of the APHIS-defined EU CSF control surface [aileron or elevator]. This condition would reduce the control rods, and replacing the rods if region Member State’’. necessary. You may obtain further ■ capability of the airplane and imposes a d. In paragraph (b)(1), by removing the information by examining the MCAI in words ‘‘APHIS-defined EU CSF region’’ higher workload on the flight crew reducing their ability to cope with adverse operating the AD docket. and adding the words ‘‘APHIS-defined conditions. European CSF region’’ in their place. Comments ■ We are issuing this AD to require e. In paragraphs (b)(2) and (b)(3), by We gave the public the opportunity to actions to correct the unsafe condition removing the words ‘‘APHIS-defined EU participate in developing this AD. We on these products. CSF region’’ each time they appear and received no comments on the NPRM adding the words ‘‘APHIS-defined DATES: This AD becomes effective (July 14, 2011 (76 FR 41432)) or on the European CSF region’’ in their place, December 15, 2011. determination of the cost to the public. and by removing the words ‘‘of the The Director of the Federal Register Member State’’ each time they appear. approved the incorporation by reference Conclusion ■ f. In paragraph (i), by removing the of certain publications listed in this AD We reviewed the available data and words ‘‘of the APHIS-defined EU CSF as of December 15, 2011. determined that air safety and the region Member State’’. ADDRESSES: You may examine the AD public interest require adopting the AD Done in Washington, DC, this 4th day of docket on the Internet at http:// as proposed. November 2011. www.regulations.gov or in person at the Differences Between This AD and the Kevin Shea, U.S. Department of Transportation, MCAI or Service Information Acting Administrator, Animal and Plant Docket Operations, M–30, West Health Inspection Service. Building Ground Floor, Room W12–140, We have reviewed the MCAI and [FR Doc. 2011–29133 Filed 11–9–11; 8:45 am] 1200 New Jersey Avenue SE., related service information and, in BILLING CODE 3410–34–P Washington, DC. general, agree with their substance. But we might have found it necessary to use FOR FURTHER INFORMATION CONTACT: Mike Borfitz, Aerospace Engineer, different words from those in the MCAI DEPARTMENT OF TRANSPORTATION International Branch, ANM–116, to ensure the AD is clear for U.S. Transport Airplane Directorate, FAA, operators and is enforceable. In making Federal Aviation Administration 1601 Lind Avenue SW., Renton, these changes, we do not intend to differ Washington 98057–3356; telephone substantively from the information 14 CFR Part 39 (425) 227–2677; fax (425) 227–1149. provided in the MCAI and related service information. [Docket No. FAA–2011–0716; Directorate SUPPLEMENTARY INFORMATION: We might also have required different Identifier 2011–NM–013–AD; Amendment 39–16858; AD 2011–23–07] Discussion actions in this AD from those in the MCAI in order to follow our FAA RIN 2120–AA64 We issued a notice of proposed policies. Any such differences are rulemaking (NPRM) to amend 14 CFR highlighted in a NOTE within the AD. Airworthiness Directives; Gulfstream part 39 to include an AD that would Aerospace LP (Type Certificate apply to the specified products. That Costs of Compliance Previously Held by Israel Aircraft NPRM was published in the Federal We estimate that this AD will affect Industries, Ltd.) Airplanes Register on July 14, 2011 (76 FR 41432). about 200 products of U.S. registry. We That NPRM proposed to correct an AGENCY: Federal Aviation also estimate that it will take about 19 unsafe condition for the specified work-hours per product to comply with Administration (FAA), Department of products. The MCAI states: Transportation (DOT). the basic requirements of this AD. The average labor rate is $85 per work-hour. ACTION: Final rule. A broken aileron servo actuator centering spring rod was discovered on a model G100 Based on these figures, we estimate the

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cost of this AD to the U.S. operators to Examining the AD Docket Reason be $323,000, or $1,615 per product. (e) The mandatory continuing You may examine the AD docket on In addition, we estimate that any airworthiness information (MCAI) states: the Internet at http:// necessary follow-on actions would take A broken aileron servo actuator centering www.regulations.gov; or in person at the up to 20 work-hours and require parts spring rod was discovered on a model G100 Docket Operations office between 9 a.m. costing $0, for a cost of $1,700 per aircraft during a routine scheduled and 5 p.m., Monday through Friday, product. We have no way of maintenance inspection. * * * This latent except Federal holidays. The AD docket determining the number of products failure of a centering spring rod, if not contains the NPRM (July 14, 2011 (76 detected and corrected, in conjunction with that may need these actions. Where the FR 41432)), the regulatory evaluation, the disconnection of the normal mechanical service information lists required parts any comments received, and other control system of the same servo actuator costs that are covered under warranty, information. The street address for the would lead to loss [of] control of the flight we have assumed that there will be no Docket Operations office (telephone control surface [aileron or elevator]. This charge for these costs. As we do not condition would reduce the control (800) 647–5527) is in the ADDRESSES control warranty coverage for affected capability of the airplane and imposes a section. Comments will be available in parties, some parties may incur costs higher workload on the flight crew reducing the AD docket shortly after receipt. higher than estimated here. their ability to cope with adverse operating List of Subjects in 14 CFR Part 39 conditions. Authority for This Rulemaking Compliance Air transportation, Aircraft, Aviation Title 49 of the United States Code (f) You are responsible for having the specifies the FAA’s authority to issue safety, Incorporation by reference, Safety. actions required by this AD performed within rules on aviation safety. Subtitle I, the compliance times specified, unless the section 106, describes the authority of Adoption of the Amendment actions have already been done. the FAA Administrator. ‘‘Subtitle VII: Inspection Aviation Programs,’’ describes in more Accordingly, under the authority detail the scope of the Agency’s delegated to me by the Administrator, (g) Within 12 months after the effective date of this AD, do the actions specified by authority. the FAA amends 14 CFR part 39 as follows: paragraph (g)(1) or (g)(2) of this AD, as We are issuing this rulemaking under applicable. the authority described in ‘‘Subtitle VII, PART 39—AIRWORTHINESS (1) For Model Gulfstream G150 airplanes: Part A, Subpart III, Section 44701: DIRECTIVES Do a one-time detailed inspection of the General requirements.’’ Under that aileron control servo actuators to detect section, Congress charges the FAA with fractured or broken centering spring rods, in ■ 1. The authority citation for part 39 promoting safe flight of civil aircraft in accordance with the Accomplishment continues to read as follows: air commerce by prescribing regulations Instructions of Gulfstream Service Bulletin for practices, methods, and procedures Authority: 49 U.S.C. 106(g), 40113, 44701. 150–27–123, Revision 1, dated January 27, 2011. the Administrator finds necessary for § 39.13 [Amended] (2) For Model Galaxy and Gulfstream 200 safety in air commerce. This regulation airplanes: Do a one-time detailed inspection is within the scope of that authority ■ 2. The FAA amends § 39.13 by adding of the aileron and elevator control servo because it addresses an unsafe condition the following new AD: actuators to detect fractured or broken centering spring rods, in accordance with the that is likely to exist or develop on 2011–23–07 Gulfstream Aerospace LP Accomplishment Instructions of Gulfstream products identified in this rulemaking (Type Certificate Previously Held by action. Israel Aircraft Industries, Ltd.): Service Bulletin 200–27–374, Revision 1, dated January 27, 2011. Regulatory Findings Amendment 39–16858. Docket No. FAA–2011–0716; Directorate Identifier Corrective Actions 2011–NM–013–AD. We determined that this AD will not (h) If any centering spring rod is found have federalism implications under Effective Date fractured or broken during any inspection Executive Order 13132. This AD will (a) This airworthiness directive (AD) required by this AD: Before further flight, not have a substantial direct effect on becomes effective December 15, 2011. replace the centering spring rod in the States, on the relationship between accordance with a method approved by the the national government and the States, Affected ADs Manager, International Branch, ANM 116, or on the distribution of power and (b) None. Transport Airplane Directorate, FAA, or the Civil Aviation Authority of Israel (CAAI) (or responsibilities among the various Applicability levels of government. its delegated agent). (c) This AD applies to the products Credit for Actions Accomplished in For the reasons discussed above, I identified in paragraphs (c)(1) and (c)(2) of certify this AD: Accordance With Previous Service this AD, certificated in any category. Information 1. Is not a ’’significant regulatory (1) Gulfstream Aerospace LP (Type action’’ under Executive Order 12866; Certificate previously held by Israel Aircraft (i) Actions done before the effective date of this AD in accordance with Gulfstream 2. Is not a ’’significant rule’’ under the Industries, Ltd.) Model Gulfstream G150 airplanes, serial numbers 201 through 286 Service Bulletin 150–27–123 or 200–27–374, DOT Regulatory Policies and Procedures inclusive. both dated October 27, 2010, as applicable, (44 FR 11034, February 26, 1979); and (2) Gulfstream Aerospace LP (Type are considered acceptable for the actions 3. Will not have a significant Certificate previously held by Israel Aircraft required by paragraph (g) of this AD. economic impact, positive or negative, Industries, Ltd.) Model Galaxy airplanes; and FAA AD Differences on a substantial number of small entities Gulfstream Aerospace LP Model Gulfstream under the criteria of the Regulatory 200 airplanes; serial numbers 004 through Note 1: This AD differs from the MCAI Flexibility Act. 231 inclusive. and/or service information as follows: The MCAI AD does not specify a corrective We prepared a regulatory evaluation Subject action for fractured or broken rods; however, of the estimated costs to comply with (d) Air Transport Association (ATA) of paragraph (h) of this AD requires corrective this AD and placed it in the AD docket. America Code 27: Flight controls. action.

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Other FAA AD Provisions reference at the National Archives and New Jersey Avenue SE., Washington, (j) The following provisions also apply to Records Administration (NARA). For DC 20590. information on the availability of this this AD: FOR FURTHER INFORMATION CONTACT: Karl (1) Alternative Methods of Compliance material at NARA, call (202) 741–6030, or go _ Schletzbaum, Aerospace Engineer, FAA, (AMOCs): The Manager, International to: http://www.archives.gov/federal register/ _ _ _ Branch, ANM–116, Transport Airplane code of federal regulations/ Small Airplane Directorate, 901 Locust, _ Directorate, FAA, has the authority to ibr locations.html. Room 301, Kansas City, Missouri 64106; approve AMOCs for this AD, if requested Issued in Renton, Washington, on October telephone: (816) 329–4146; fax: (816) using the procedures found in 14 CFR 39.19. 20, 2011. 329–4090; email: In accordance with 14 CFR 39.19, send your Kalene C. Yanamura, [email protected]. request to your principal inspector or local Flight Standards District Office, as Acting Manager, Transport Airplane SUPPLEMENTARY INFORMATION: Directorate, Aircraft Certification Service. appropriate. If sending information directly Discussion to the International Branch, send it to ATTN: [FR Doc. 2011–28572 Filed 11–9–11; 8:45 a.m.] Mike Borfitz, Aerospace Engineer, BILLING CODE 4910–13–P We issued a notice of proposed International Branch, ANM–116, Transport rulemaking (NPRM) to amend 14 CFR Airplane Directorate, FAA, 1601 Lind part 39 to include an AD that would Avenue SW., Renton, Washington 98057– DEPARTMENT OF TRANSPORTATION apply to the specified products. That 3356; telephone (425) 227–2677; fax (425) NPRM was published in the Federal 227–1149. Information may be emailed to: Federal Aviation Administration [email protected]. Register on September 8, 2011 (76 FR Before using any approved AMOC, notify 55614). That NPRM proposed to correct your appropriate principal inspector, or 14 CFR Part 39 an unsafe condition for the specified lacking a principal inspector, the manager of products. The MCAI states: [Docket No. FAA–2011–0971; Directorate the local flight standards district office/ Identifier 2011–CE–030–AD; Amendment Investigation of a recent Cresco 08–600 certificate holding district office. The AMOC 39–16862; AD 2011–23–11] accident identified a risk of the hopper lid approval letter must specifically reference interfering with the opening of the canopy in this AD. RIN 2120–AA64 the event of an emergency landing. The pilot (2) Airworthy Product: For any requirement was prevented from opening the canopy by in this AD to obtain corrective actions from Airworthiness Directives; Pacific the hopper lid in the fully forward open a manufacturer or other source, use these position. This AD is issued due to the fact actions if they are FAA-approved. Corrective Aerospace Limited Airplanes that the hopper lid installation on the actions are considered FAA-approved if they AGENCY: Federal Aviation accident aircraft was an unapproved are approved by the State of Design Authority modification and the Fletcher FU24 hopper (or their delegated agent). You are required Administration (FAA), Department of installation is a similar design to the Cresco to assure the product is airworthy before it Transportation (DOT). 08–600. is returned to service. ACTION: Final rule. Related Information The MCAI requires reviewing the SUMMARY: We are adopting a new aircraft records, doing a conformity (k) Refer to MCAI Israeli Airworthiness airworthiness directive (AD) for Pacific inspection for an approved design Directives 27–10–11–03, dated December 6, Aerospace Limited Model FU24 2010, and 27–10–12–29, dated January 4, hopper lid installation, and removing Airplanes. This AD results from the hopper lid installation, if not an 2011; and Gulfstream Service Bulletins 150– mandatory continuing airworthiness 27–123 and 200–27–374, both Revision 1, approved design. You may obtain both dated January 27, 2011; for related information (MCAI) issued by an further information by examining the information. aviation authority of another country to MCAI in the AD docket. identify and correct an unsafe condition Material Incorporated by Reference on an aviation product. The MCAI Comments (l) You must use Gulfstream Service describes the unsafe condition as: We gave the public the opportunity to Bulletin 150–27–123, Revision 1, dated January 27, 2011; or Gulfstream Service Investigation of a recent Cresco 08–600 participate in developing this AD. We Bulletin 200–27–374, Revision 1, dated accident identified a risk of the hopper lid received no comments on the NPRM (76 January 27, 2011; as applicable; to do the interfering with the opening of the canopy in FR 55614, September 8, 2011) or on the actions required by this AD, unless the AD the event of an emergency landing. The pilot determination of the cost to the public. specifies otherwise. was prevented from opening the canopy by (1) The Director of the Federal Register the hopper lid in the fully forward open Conclusion approved the incorporation by reference of position. This AD is issued due to the fact that the hopper lid installation on the We reviewed the available data and this service information under 5 U.S.C. determined that air safety and the 552(a) and 1 CFR part 51. accident aircraft was an unapproved modification and the Fletcher FU24 hopper public interest require adopting the AD (2) For service information identified in as proposed. this AD, contact Gulfstream Aerospace installation is a similar design to the Cresco 08–600. Corporation, P.O. Box 2206, Mail Station Differences Between This AD and the D–25, Savannah, Georgia 31402–2206; We are issuing this AD to require MCAI or Service Information telephone (800) 810–4853; fax (912) 965– actions to correct the unsafe condition 3520; email [email protected]; Internet on these products. We have reviewed the MCAI and http://www.gulfstream.com/ related service information and, in product_support/technical_pubs/pubs/ DATES: This AD is effective December general, agree with their substance. But index.htm. 15, 2011. we might have found it necessary to use (3) You may review copies of the service ADDRESSES: You may examine the AD different words from those in the MCAI information at the FAA, Transport Airplane docket on the Internet at http:// to ensure the AD is clear for U.S. Directorate, 1601 Lind Avenue SW., Renton, Washington. For information on the www.regulations.gov or in person at operators and is enforceable. In making availability of this material at the FAA, call Document Management Facility, U.S. these changes, we do not intend to differ (425) 227–1221. Department of Transportation, Docket substantively from the information (4) You may also review copies of the Operations, M–30, West Building provided in the MCAI and related service information that is incorporated by Ground Floor, Room W12–140, 1200 service information.

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We might also have required different (3) Will not have a significant Investigation of a recent Cresco 08–600 actions in this AD from those in the economic impact, positive or negative, accident identified a risk of the hopper lid MCAI in order to follow FAA policies. on a substantial number of small entities interfering with the opening of the canopy in Any such differences are highlighted in under the criteria of the Regulatory the event of an emergency landing. The pilot was prevented from opening the canopy by a NOTE within the AD. Flexibility Act. the hopper lid in the fully forward open We prepared a regulatory evaluation Costs of Compliance position. This AD is issued due to the fact of the estimated costs to comply with that the hopper lid installation on the We estimate that this AD will affect 1 this AD and placed it in the AD Docket. accident aircraft was an unapproved modification and the Fletcher FU24 hopper product of U.S. registry. We also Examining the AD Docket estimate that it would take about 1 installation is a similar design to the Cresco work-hours per product to comply with You may examine the AD docket on 08–600. the basic requirements of this AD. The the Internet at http:// The MCAI requires reviewing the aircraft average labor rate is $85 per work-hour. www.regulations.gov; or in person at the records, doing a conformity inspection for an Required parts would cost about $0 per Docket Management Facility between approved design hopper lid installation, and 9 a.m. and 5 p.m., Monday through removing the hopper lid installation, if not product. an approved design. Based on these figures, we estimate Friday, except Federal holidays. The AD the cost of the AD on U.S. operators to docket contains the NPRM (76 FR (f) Actions and Compliance be $85, or $85 per product. 55614, September 8, 2011), the Unless already done, do the following In addition, we estimate that any regulatory evaluation, any comments actions within 150 hours time-in-service necessary follow-on actions would take received, and other information. The (TIS) after December 15, 2011 (the effective street address for the Docket Office date of this AD) or within 12 calendar about 6 work-hours and require parts months after December 15, 2011 (the effective costing $0, for a cost of $510 per (telephone (800) 647–5527) is in the ADDRESSES section. Comments will be date of this AD), whichever occurs first: product. We have no way of (1) Review the aircraft records and determining the number of products available in the AD docket shortly after determine whether a hopper lid modification that may need these actions. receipt. has been recorded. If a hopper lid List of Subjects in 14 CFR Part 39 modification has been recorded, determine Authority for This Rulemaking whether the aircraft was certified for release Air transportation, Aircraft, Aviation Title 49 of the United States Code to service after completion of the safety, Incorporation by reference, specifies the FAA’s authority to issue modification and whether the applicable Safety. approved technical data (supplemental type rules on aviation safety. Subtitle I, certificate (STC) or field approval) is section 106, describes the authority of Adoption of the Amendment referenced. Visually inspect for an the FAA Administrator. ‘‘Subtitle VII: Accordingly, under the authority unapproved hopper lid modification. Aviation Programs,’’ describes in more delegated to me by the Administrator, (2) If the hopper lid modification is an detail the scope of the Agency’s the FAA amends 14 CFR part 39 as approved design, do a conformity inspection and determine whether the hopper lid authority. follows: We are issuing this rulemaking under modification conforms to the applicable approved technical data (supplemental type the authority described in ‘‘Subtitle VII, PART 39—AIRWORTHINESS certificate (STC) or field approval). Part A, Subpart III, Section 44701: DIRECTIVES (3) If the hopper lid modification is not an General requirements.’’ Under that ■ approved design (STC or field approval), section, Congress charges the FAA with 1. The authority citation for part 39 before further flight, remove the hopper lid promoting safe flight of civil aircraft in continues to read as follows: installation. air commerce by prescribing regulations Authority: 49 U.S.C. 106(g), 40113, 44701. Note 1: The Frontier-Aerospace for practices, methods, and procedures Incorporated Models Fletcher FU–24 and the Administrator finds necessary for § 39.13 [Amended] Fletcher FU–24A airplanes do not have this safety in air commerce. This regulation ■ 2. The FAA amends § 39.13 by adding unsafe condition and are not affected by this is within the scope of that authority the following new AD: AD. because it addresses an unsafe condition 2011–23–11 Pacific Aerospace Limited: Note 2: The basic hopper installation for that is likely to exist or develop on Amendment 39–16862; Docket No. the Pacific Aerospace Limited Model FU24– products identified in this rulemaking FAA–2011–0971; Directorate Identifier 954 airplane does not include a hopper lid action. 2011–CE–030–AD. due to the canopy sliding partly over the hopper inlet. A separate approval must be Regulatory Findings (a) Effective Date obtained to install a hopper lid. This airworthiness directive (AD) becomes We determined that this AD will not effective December 15, 2011. FAA AD Differences have federalism implications under Executive Order 13132. This AD will (b) Affected ADs Note 3: This AD differs from the MCAI and/or service information as follows: No not have a substantial direct effect on None. differences. the States, on the relationship between (c) Applicability the national government and the States, (g) Other FAA AD Provisions or on the distribution of power and This AD applies to Pacific Aerospace Limited Models FU24–954 and FU24A–954 The following provisions also apply to this responsibilities among the various airplanes, all serial numbers, certificated in AD: levels of government. any category. (1) Alternative Methods of Compliance For the reasons discussed above, I (AMOCs): The Manager, Standards Office, certify this AD: (d) Subject FAA, has the authority to approve AMOCs (1) Is not a ‘‘significant regulatory Air Transport Association of America for this AD, if requested using the procedures (ATA) Code 52: Doors. found in 14 CFR 39.19. Send information to action’’ under Executive Order 12866; ATTN: Karl Schletzbaum, Aerospace (2) Is not a ‘‘significant rule’’ under (e) Reason Engineer, FAA, Small Airplane Directorate, DOT Regulatory Policies and Procedures The mandatory continuing airworthiness 901 Locust, Room 301, Kansas City, Missouri (44 FR 11034, February 26, 1979); and information (MCAI) states: 64106; telephone: (816) 329–4146; fax: (816)

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329–4090; email: [email protected]. DEPARTMENT OF TRANSPORTATION Washington 98057–3356; telephone Before using any approved AMOC on any (425) 227–1137; fax (425) 227–1149. airplane to which the AMOC applies, notify Federal Aviation Administration SUPPLEMENTARY INFORMATION: your appropriate principal inspector (PI) in the FAA Flight Standards District Office 14 CFR Part 39 Discussion (FSDO), or lacking a PI, your local FSDO. We issued a notice of proposed (2) Airworthy Product: For any requirement [Docket No. FAA–2011–0721; Directorate Identifier 2010–NM–217–AD; Amendment rulemaking (NPRM) to amend 14 CFR in this AD to obtain corrective actions from 39–16861; AD 2011–23–10] part 39 to include an AD that would a manufacturer or other source, use these apply to the specified products. That actions if they are FAA-approved. Corrective RIN 2120–AA64 NPRM was published in the Federal actions are considered FAA-approved if they Register on August 5, 2011 (76 FR are approved by the State of Design Authority Airworthiness Directives; ATR–GIE 47520). That NPRM proposed to correct (or their delegated agent). You are required Avions de Transport Re´gional an unsafe condition for the specified to assure the product is airworthy before it Airplanes products. The MCAI states: is returned to service. (3) Reporting Requirements: For any AGENCY: Federal Aviation One ATR operator has experienced in- reporting requirement in this AD, a federal Administration (FAA), Department of flight elevator travel limitations with unusual effort being necessary on pitch axis to control agency may not conduct or sponsor, and a Transportation (DOT). the aeroplane, while the ‘‘pitch mistrim’’ ACTION: Final rule. person is not required to respond to, nor message appeared on the ADU display. The shall a person be subject to a penalty for SUMMARY: We are adopting a new elevators seemed to be jammed. failure to comply with a collection of During the post-flight inspection, it was information subject to the requirements of airworthiness directive (AD) for certain discovered that the LH elevator lower stop the Paperwork Reduction Act unless that Model ATR42 and ATR72 airplanes. assembly was broken at the level of the collection of information displays a current This AD results from mandatory angles, which may have prevented the valid OMB Control Number. The OMB continuing airworthiness information elevator to respond normally to the flight Control Number for this information (MCAI) originated by an aviation control input. collection is 2120–0056. Public reporting for authority of another country to identify This condition, if not detected and this collection of information is estimated to and correct an unsafe condition on an corrected, could lead to reduced control of the aeroplane. be approximately 5 minutes per response, aviation product. The MCAI describes the unsafe condition as: For the reasons described above, and as a including the time for reviewing instructions, precautionary measure, this [EASA] AD completing and reviewing the collection of One ATR operator has experienced in- requires a one-time [general visual and information. All responses to this collection flight elevator travel limitations with unusual detailed] inspection [for damaged angles] of of information are mandatory. Comments effort being necessary on pitch axis to control the elevator hinge fittings and the reporting concerning the accuracy of this burden and the aeroplane, while the ‘‘pitch mistrim’’ of all findings. Depending on the results, suggestions for reducing the burden should message appeared on the ADU [advisory further action may be considered. be directed to the FAA at: 800 Independence display unit] display. The elevators seemed to be jammed. Corrective actions also include Ave. SW., Washington, DC 20591, Attn: replacement of damaged angles with Information Collection Clearance Officer, During the post-flight inspection, it was discovered that the LH [left-hand] elevator serviceable parts; and a detailed AES–200. lower stop assembly was broken at the level inspection of adjacent areas for damage, (h) Related Information of the angles, which may have prevented the and repair if necessary. You may obtain elevator to respond normally to the flight MCAI Civil Aviation Authority (CAA) AD further information by examining the control input. MCAI in the AD docket. DCA/FU24/180, dated July 28, 2011, for This condition, if not detected and related information. You may review copies corrected, could lead to reduced control of Comments of the referenced service information at the the aeroplane. We gave the public the opportunity to FAA, Small Airplane Directorate, 901 Locust, * * * * * Kansas City, Missouri 64106. For information participate in developing this AD. We on the availability of this material at the We are issuing this AD to require received no comments on the NPRM (76 FAA, call (816) 329–4148. actions to correct the unsafe condition FR 47520), August 5, 2011) or on the on these products. determination of the cost to the public. (i) Material Incorporated by Reference DATES: This AD becomes effective Conclusion None. December 15, 2011. We reviewed the available data and The Director of the Federal Register Issued in Kansas City, Missouri, on determined that air safety and the approved the incorporation by reference November 2, 2011. public interest require adopting the AD of certain publications listed in this AD John Colomy, as proposed. as of December 15, 2011. Acting Manager, Small Airplane Directorate, Aircraft Certification Service. ADDRESSES: You may examine the AD Differences Between This AD and the MCAI or Service Information [FR Doc. 2011–29045 Filed 11–9–11; 8:45 am] docket on the Internet at http:// www.regulations.gov or in person at the BILLING CODE 4910–13–P We have reviewed the MCAI and U.S. Department of Transportation, related service information and, in Docket Operations, M–30, West general, agree with their substance. But Building Ground Floor, Room W12–140, we might have found it necessary to use 1200 New Jersey Avenue SE., different words from those in the MCAI Washington, DC. to ensure the AD is clear for U.S. FOR FURTHER INFORMATION CONTACT: Tom operators and is enforceable. In making Rodriguez, Aerospace Engineer, these changes, we do not intend to differ International Branch, ANM–116, substantively from the information Transport Airplane Directorate, FAA, provided in the MCAI and related 1601 Lind Avenue SW., Renton, service information.

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We might also have required different under the criteria of the Regulatory One ATR operator has experienced in- actions in this AD from those in the Flexibility Act. flight elevator travel limitations with unusual MCAI in order to follow our FAA We prepared a regulatory evaluation effort being necessary on pitch axis to control policies. Any such differences are of the estimated costs to comply with the aeroplane, while the ‘‘pitch mistrim’’ message appeared on the ADU [advisory highlighted in a NOTE within the AD. this AD and placed it in the AD docket. display unit] display. The elevators seemed Costs of Compliance Examining the AD Docket to be jammed. During the post-flight inspection, it was We estimate that this AD will affect You may examine the AD docket on discovered that the LH [left-hand] elevator 86 products of U.S. registry. We also the Internet at http:// lower stop assembly was broken at the level estimate that it will take about 4 work- www.regulations.gov; or in person at the of the angles, which may have prevented the hours per product to comply with the Docket Operations office between 9 a.m. elevator to respond normally to the flight basic requirements of this AD. The and 5 p.m., Monday through Friday, control input. average labor rate is $85 per work-hour. except Federal holidays. The AD docket This condition, if not detected and contains the NPRM (76 FR 47520, corrected, could lead to reduced control of Based on these figures, we estimate the the aeroplane. cost of this AD to the U.S. operators to August 5, 2011), the regulatory be $29,240, or $340 per product. evaluation, any comments received, and * * * * * In addition, we estimate that any other information. The street address for Compliance necessary follow-on actions would take the Docket Operations office (telephone (f) You are responsible for having the about 60 work-hours and require parts (800) 647–5527) is in the ADDRESSES actions required by this AD performed within costing $960, for a cost of $6,060 per section. Comments will be available in the compliance times specified, unless the product. We have no way of the AD docket shortly after receipt. actions have already been done. determining the number of products List of Subjects in 14 CFR Part 39 Actions that may need these actions. Air transportation, Aircraft, Aviation (g) Within 6 months after the effective date Authority for This Rulemaking safety, Incorporation by reference, of this AD, perform a general visual inspection of the inboard hinge fitting area Title 49 of the United States Code Safety. and a detailed inspection of lower stop specifies the FAA’s authority to issue Adoption of the Amendment angles of the inboard hinge fittings on both rules on aviation safety. Subtitle I, LH and right-hand (RH) elevators, in section 106, describes the authority of Accordingly, under the authority accordance with the Accomplishment the FAA Administrator. ‘‘Subtitle VII: delegated to me by the Administrator, Instructions of Avions de Transport Re´gional Aviation Programs,’’ describes in more the FAA amends 14 CFR part 39 as Service Bulletin ATR42–55–0014, dated May detail the scope of the Agency’s follows: 11, 2010; or Avions de Transport Re´gional authority. Service Bulletin ATR72–55–1006, dated May We are issuing this rulemaking under PART 39—AIRWORTHINESS 11, 2010; as applicable. DIRECTIVES (1) If any damaged angle is found during the authority described in ‘‘Subtitle VII, the inspection required by paragraph (g) of Part A, Subpart III, Section 44701: ■ 1. The authority citation for part 39 this AD, before further flight, replace the General requirements.’’ Under that continues to read as follows: damaged angles with serviceable parts and section, Congress charges the FAA with accomplish a detailed inspection of the promoting safe flight of civil aircraft in Authority: 49 U.S.C. 106(g), 40113, 44701. adjacent areas to detect any damage, in accordance with the Accomplishment air commerce by prescribing regulations § 39.13 [Amended] for practices, methods, and procedures Instructions of Avions de Transport Re´gional ■ the Administrator finds necessary for 2. The FAA amends § 39.13 by adding Service Bulletin ATR42–55–0014, dated May ´ safety in air commerce. This regulation the following new AD: 11, 2010; or Avions de Transport Regional Service Bulletin ATR72–55–1006, dated May is within the scope of that authority 2011–23–10 ATR–GIE Avions de Transport 11, 2010; as applicable. ´ because it addresses an unsafe condition Regional: Amendment 39–16861. Docket (2) If any damage is detected in adjacent that is likely to exist or develop on No. FAA–2011–0721; Directorate areas during the inspection required by products identified in this rulemaking Identifier 2010–NM–217–AD. paragraph (g)(1) of this AD, before further action. Effective Date flight, repair the damage using a method approved by either the Manager, (a) This airworthiness directive (AD) Regulatory Findings International Branch, ANM–116, Transport becomes effective December 15, 2011. We determined that this AD will not Airplane Directorate, FAA; or European have federalism implications under Affected ADs Aviation Safety Agency (EASA) (or its Executive Order 13132. This AD will (b) None. delegated agent). (h) Submit a report of the findings not have a substantial direct effect on Applicability (damaged angles found on the LH and RH the States, on the relationship between (c) This AD applies to ATR–GIE Avions de side elevator) of the inspection required by the national government and the States, Transport Re´gional Model ATR42–200, –300, paragraph (g) of this AD to ATR Engineering, or on the distribution of power and –320, and –500 airplanes, all manufacturer Service Bulletin Group, 1 Allee Pierre Nadot, responsibilities among the various serial numbers (MSN) up to MSN 643 31712 Blagnac Cedex, France, at the levels of government. inclusive; and Model ATR72–101, –102, applicable time specified in paragraph (h)(1) For the reasons discussed above, I –201, –202, –211, –212, and –212A airplanes, or (h)(2) of this AD. The report must include certify this AD: all MSNs up to MSN 728 inclusive; the MSN, accomplishment date, registration 1. Is not a ‘‘significant regulatory certificated in any category. number, number of flights, flight hours, inspection results, and performed actions. In action’’ under Executive Order 12866; Subject 2. Is not a ‘‘significant rule’’ under the addition, return any damaged lower stop angles to ATR Engineering, Service Bulletin DOT Regulatory Policies and Procedures (d) Air Transport Association (ATA) of America Code 55: Stabilizers. Group, 1 Allee Pierre Nadot, 31712 Blagnac (44 FR 11034, February 26, 1979); and Cedex, France. 3. Will not have a significant Reason (1) If the inspection was done on or after economic impact, positive or negative, (e) The mandatory continuing the effective date of this AD: Submit the on a substantial number of small entities airworthiness information (MCAI) states: report within 30 days after the inspection.

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(2) If the inspection was done before the Service Bulletin ATR72–55–1006, dated May tail rotor pitch control rods installed. effective date of this AD: Submit the report 11, 2010; for related information. That AD requires a daily check of the within 30 days after the effective date of this tail rotor (T/R) pitch control rod (control AD. Material Incorporated by Reference (k) You must use Avions de Transport rod) outboard spherical bearing FAA AD Differences Re´gional Service Bulletin ATR42–55–0014, (bearing) for play. If play exists, that AD Note 1: This AD differs from the MCAI dated May 11, 2010; or Avions de Transport requires measuring the bearing’s radial and/or service information as follows: No Re´gional Service Bulletin ATR72–55–1006, and axial play. Since that AD was differences. dated May 11, 2010; as applicable; to do the issued, an incident occurred where the actions required by this AD, unless the AD pilot of a Model AS350 helicopter felt Other FAA AD Provisions specifies otherwise. vibrations in the anti-torque pedal in (i) The following provisions also apply to (1) The Director of the Federal Register flight, resulting in a precautionary this AD: approved the incorporation by reference of landing. An investigation determined (1) Alternative Methods of Compliance this service information under 5 U.S.C. 552(a) and 1 CFR part 51. that the control rod showed extensive (AMOCs): The Manager, International wear on the ball-joint. This superseding Branch, ANM–116, has the authority to (2) For service information identified in approve AMOCs for this AD, if requested this AD, contact ATR—GIE Avions de AD maintains the requirements of the using the procedures found in 14 CFR 39.19. Transport Re´gional, 1, Alle´e Pierre Nadot, existing AD, and expands the In accordance with 14 CFR 39.19, send your 31712 Blagnac Cedex, France; telephone +33 applicability to include the Model request to your principal inspector or local (0) 5 62 21 62 21; fax +33 (0) 5 62 21 67 18; AS355NP helicopter and additional Flight Standards District Office, as email [email protected]; part-numbered control rods. The actions appropriate. If sending information directly Internet http://www.aerochain.com. specified by this AD are intended to to the International Branch, send it to ATTN: (3) You may review copies of the service prevent failure of a control rod, loss of information at the FAA, Transport Airplane Tom Rodriguez, Aerospace Engineer, T/R control, and subsequent loss of International Branch, ANM–116, Transport Directorate, 1601 Lind Avenue SW., Renton, Airplane Directorate, FAA, 1601 Lind Washington. For information on the control of the helicopter. Avenue SW., Renton, Washington 98057– availability of this material at the FAA, call DATES: Effective November 25, 2011. 3356; telephone (425) 227–1137; fax (425) (425) 227–1221. Comments for inclusion in the Rules 227–1149. Information may be emailed to: (4) You may also review copies of the Docket must be received on or before [email protected]. service information that is incorporated by January 9, 2012. Before using any approved AMOC, notify reference at the National Archives and your appropriate principal inspector, or Records Administration (NARA). For ADDRESSES: Use one of the following lacking a principal inspector, the manager of information on the availability of this addresses to submit comments on this the local flight standards district office/ material at NARA, call (202) 741–6030, or go AD: certificate holding district office. The AMOC to: http://www.archives.gov/federal_register/ • Federal eRulemaking Portal: Go to approval letter must specifically reference code_of_federal_regulations/ http://www.regulations.gov. Follow the this AD. ibr_locations.html. instructions for submitting comments. • (2) Airworthy Product: For any requirement Issued in Renton, Washington, on October Fax: (202) 493–2251. in this AD to obtain corrective actions from 27, 2011. • Mail: U.S. Department of a manufacturer or other source, use these Kalene C. Yanamura, Transportation, Docket Operations, actions if they are FAA-approved. Corrective M–30, West Building Ground Floor, actions are considered FAA-approved if they Acting Manager, Transport Airplane are approved by the State of Design Authority Directorate, Aircraft Certification Service. Room W12–140, 1200 New Jersey (or their delegated agent). You are required [FR Doc. 2011–28752 Filed 11–9–11; 8:45 am] Avenue SE., Washington, DC 20590. • Hand Delivery: U.S. Department of to assure the product is airworthy before it BILLING CODE 4910–13–P is returned to service. Transportation, Docket Operations, (3) Reporting Requirements: A federal M–30, West Building Ground Floor, agency may not conduct or sponsor, and a DEPARTMENT OF TRANSPORTATION Room W12–140, 1200 New Jersey person is not required to respond to, nor Avenue SE., Washington, DC 20590, shall a person be subject to a penalty for Federal Aviation Administration between 9 a.m. and 5 p.m., Monday failure to comply with a collection of through Friday, except Federal holidays. information subject to the requirements of the Paperwork Reduction Act unless that 14 CFR Part 39 You may get the service information identified in this AD from American collection of information displays a current [Docket No. FAA–2011–1158; Directorate valid OMB Control Number. The OMB Identifier 2010–SW–018–AD; Amendment Eurocopter Corporation, 2701 N. Forum Control Number for this information 39–16847; AD 2011–22–05] Drive, Grand Prairie, TX 75052, collection is 2120–0056. Public reporting for telephone (972) 641–0000 or (800) 232– this collection of information is estimated to RIN 2120–AA64 0323, fax (972) 641–3775, or at http:// be approximately 5 minutes per response, www.eurocopter.com/techpub. including the time for reviewing instructions, Airworthiness Directives; Eurocopter Examining the Docket: You may completing and reviewing the collection of France Model AS350B, B1, B2, B3, BA, examine the docket that contains the information. All responses to this collection C, D, and D1; and AS355E, F, F1, F2, AD, any comments, and other of information are mandatory. Comments N, and NP Helicopters concerning the accuracy of this burden and information on the Internet at http:// suggestions for reducing the burden should AGENCY: Federal Aviation www.regulations.gov, or in person at the be directed to the FAA at: 800 Independence Administration (FAA), DOT. Docket Operations office between 9 a.m. Ave. SW., Washington, DC 20591, Attn: ACTION: Final rule; request for and 5 p.m., Monday through Friday, Information Collection Clearance Officer, comments. except Federal holidays. The Docket AES–200. Operations office (telephone (800) 647– Related Information SUMMARY: This amendment supersedes 5527) is located in Room W12–140 on (j) Refer to MCAI EASA Airworthiness an existing airworthiness directive (AD) the ground floor of the West Building at Directive 2010–0138, dated July 1, 2010; for the Eurocopter France (Eurocopter) the street address stated in the Avions de Transport Re´gional Service Model AS350B, B1, B2, B3, BA, C, D, ADDRESSES section. Comments will be Bulletin ATR42–55–0014, dated May 11, and D1 helicopters; and Model AS355E, available in the AD docket shortly after 2010; and Avions de Transport Re´gional F, F1, F2, and N helicopters with certain receipt.

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FOR FURTHER INFORMATION CONTACT: Jim AS350B, B1, B2, B3, BA, BB, and D helicopter. This AD requires the Grigg, Manager, FAA, Rotorcraft helicopters; and Model AS355E, F, F1, following actions: Directorate, Safety Management Group, F2, and N, and NP helicopters with • Before the first flight of each day, 2601 Meacham Blvd., Fort Worth, TX control rods, P/N 350A33–2100–00, –01, check the control rod bearing for play 76137, telephone (817) 222–5126, fax –02, –03, or –04; P/N 350A33–2121–00, on the helicopter, by observation and (817) 222–5961. –01, or –02; P/N 350A33–2143–00; or P/ feel, by slightly moving the TR blade in SUPPLEMENTARY INFORMATION: N 350A33–2145–00 or –01. EASA the flapping axis while monitoring the advises that a pilot of a Eurocopter bearing for movement. This action may Discussion Model AS350 helicopter felt slight be performed by an owner/operator On October 22, 2003, the FAA issued vibrations in the pedal unit in flight. A (pilot) holding at least a private pilot AD 2003–22–06, Amendment 39–13354 few minutes later, the vibration level certificate, and must be entered into the (68 FR 61608, October 29, 2003), Docket increased and the pilot carried out a helicopter maintenance records in 2000–SW–12–AD (AD 2003–22–06), for precautionary autorotation landing. accordance with 14 CFR 43.9(a)(1)–(4) Eurocopter Model AS350B, B1, B2, B3, After landing, it was discovered that one and 91.417(a)(2)(v). A pilot may perform BA, C, D, and D1; and Model AS355E, TR pitch-change link was damaged, the this check because it involves only a F, F1, F2, and N helicopters with tailboom cone was missing, and there visual and physical check of the control control rods, part-number (P/N) was an impact mark on the tailboom. rod for play, and can be performed 350A33–2145–00 or 350A33–2145–01, Further investigation revealed the equally well by a pilot or a mechanic. which superseded AD 98–24–35, affected TR pitch-change link showed If play is detected, a mechanic must Amendment 39–10921 (63 FR 66418, extensive wear on the ball-joint. EASA remove the control rod from the December 2, 1998), Docket 98–SW–41– advises that this condition, if not helicopter, and using a dial indicator, AD, issued November 19, 1998 (AD 98– detected and corrected, could lead to measure the control rod bearing wear. If 24–35). AD 98–24–35 required a loss of the anti-torque function and the radial play exceeds 0.008 inch or recurring inspection to measure the possible loss of control of the helicopter. axial play exceeds 0.016 inch, the control rod bearing for radial and axial In addition, after further review of the control rod must be replaced with an play. That action was prompted by an language used to describe the unsafe airworthy control rod before further accident and separate incident condition addressed in AD 2003–22–06 flight. involving Model AS350B2 helicopters, (68 FR 61608, October 29, 2003), it has • Thereafter, at recurring intervals not and investigations revealed a broken been determined that changes are to exceed 30 hours time-in-service (TIS), needed in terminology to more control rod on the helicopter that was remove the control rod and measure the accurately describe the unsafe condition involved in the accident, and a severely bearing wear using a dial indicator. If that this AD is intending to correct. worn control rod on the helicopter the radial play exceeds 0.008 inch or involved in the incident. There were Related Service Information axial play exceeds 0.016 inch, replace two other unconfirmed incidents cited the control rod with an airworthy by the National Transportation Safety Eurocopter has issued Alert Service control rod before further flight. Board (based on the manufacturer’s Bulletin (ASB) No. 05.00.60 for the The short compliance time involved, reports) involving the same control rod, Model AS350 series helicopters, and before the first flight of each day, is P/N 350A33–2145–01. AD 2003–22–06 ASB No. 05.00.56 for the Model AS355 superseded AD 98–24–35, and requires series helicopters, both dated December required because the previously a daily check of the control rod bearing, 9, 2009. These ASBs specify performing described critical unsafe condition can allows a larger axial play limit, and an initial and recurring check for play adversely affect the controllability of the requires a more frequent inspection in the pitch-change links. If axial play helicopter. Therefore, this AD must be interval once play is found in the in the ball-joint is detectable, the ASBs issued immediately. Since a situation control rod bearing during a daily specify removing the pitch-change link exists that requires the immediate check. AD 2003–22–06 also added the and measuring the bearing wear using a adoption of this regulation, it is found Eurocopter Model AS350B3 helicopter dial indicator. The EASA classified that notice and opportunity for prior and another part-numbered control rod these ASBs as mandatory and issued public comment hereon are to the applicability. AD 2003–22–06 was EASA AD No. 2010–0006 to ensure the impracticable, and that good cause prompted by a review of additional continued airworthiness of these exists for making this amendment service information and public helicopters. effective in less than 30 days. comments regarding the requirements of FAA’s Determination and Requirements Differences Between This AD and the AD 98–24–35. The actions specified by of This AD EASA AD AD 2003–22–06 are intended to prevent separation of the bearing ball from its These helicopters have been approved This AD differs from the EASA AD as outer race, rubbing of the body of the by the aviation authority of France and follows: • control rod against the tail rotor blade are approved for operation in the United This AD includes the Model pitch horn clevis, failure of a control States. Pursuant to our bilateral AS350C and AS350D1 helicopters, as rod, loss of T/R control, and subsequent agreement with France, EASA, their they may have the same control rod; this loss of control of the helicopter. technical representative, has notified us AD does not include the Model of the unsafe condition described in the AS350BB because it does not have an Actions Since Issuing Previous AD EASA AD. We are issuing this AD FAA-issued type certificate. Since issuing AD 2003–22–06 (68 FR because we evaluated all information • This AD uses the term ‘‘T/R pitch 61608, October 29, 2003), the European provided by EASA and determined the control rod’’ and the EASA AD uses the Aviation Safety Agency (EASA), which unsafe condition exists and is likely to term ‘‘T/R pitch change link’’ to is the Technical Agent for the Member exist or develop on other helicopters of describe the same part. States of the European Union, has these same type designs. Therefore, this • This AD uses the term ‘‘loss of issued EASA AD No. 2010–0006, dated AD is being issued to prevent failure of T/R control’’ to describe the unsafe January 7, 2010, to correct an unsafe a control rod, loss of tail rotor control, condition, and the EASA AD uses the condition for the Eurocopter Model and subsequent loss of control of the term ‘‘loss of anti-torque control.’’

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• This AD uses the term ‘‘hours TIS’’ you can find and read the comments to List of Subjects in 14 CFR Part 39 to describe compliance times, and the any of our dockets, including the name Air transportation, Aircraft, Aviation EASA AD uses the term ‘‘flight hours.’’ of the individual who sent the • safety, Incorporation by reference, This AD requires either a pilot/ comment. You may review the DOT’s Safety. operator or mechanic, before the first complete Privacy Act Statement in the flight of each day, to perform a check or Federal Register published on April 11, Adoption of the Amendment inspection of the bearing for play. If 2000 (65 FR 19476). Accordingly, under the authority play is found, a mechanic must, before Regulatory Findings delegated to me by the Administrator, further flight, measure the bearing play, the FAA amends 14 CFR part 39 as and thereafter measure the bearing play We have determined that this AD will follows: at intervals not to exceed 30 hours TIS. not have federalism implications under The EASA AD requires a mechanic, Executive Order 13132. This AD will PART 39—AIRWORTHINESS within 30 flight hours, to perform an not have a substantial direct effect on DIRECTIVES initial inspection to measure the bearing the States, on the relationship between play, and thereafter, at intervals not to the national Government and the States, ■ 1. The authority citation for part 39 exceed 30 flight hours. The EASA AD or on the distribution of power and continues to read as follows: does not require a daily check. responsibilities among the various Authority: 49 U.S.C. 106(g), 40113, 44701. levels of government. Costs of Compliance For the reasons discussed above, I § 39.13 [Amended] We estimate that this AD will affect certify that the regulation: ■ 2. The FAA amends § 39.13 by about 733 helicopters of U.S. registry. 1. Is not a ‘‘significant regulatory removing Amendment 39–13354 (68 FR We estimate, per helicopter, it will take action’’ under Executive Order 12866; 61608; October 29, 2003), and adding minimal work-hours to do the daily 2. Is not a ‘‘significant rule’’ under the the following new Airworthiness check, 1 work-hour to do the recurring DOT Regulatory Policies and Procedures Directive (AD): inspection, and 1 work-hour to replace (44 FR 11034, February 26, 1979); 1 control rod. The average labor rate is 2011–22–05 EUROCOPTER FRANCE $85 per work-hour. Required parts will 3. Will not affect intrastate aviation in (EUROCOPTER): Amendment 39–16847; Alaska to the extent that it justifies Docket No. FAA–2011–1158; Directorate cost about $1,724 to replace a control Identifier 2010–SW–018–AD; supersedes rod per helicopter. Based on these making a regulatory distinction; and 4. Will not have a significant AD 2003–22–06, issued October 22, 2003 figures, we estimate the cost of this AD (68 FR 61608; October 29, 2003), on U.S. operators is $1,949,047 per year, economic impact, positive or negative, Amendment 39–13354, Docket No. assuming 10 recurring inspections per on a substantial number of small entities 2000–SW–12–AD. year per helicopter, and assuming 1 under the criteria of the Regulatory Applicability: Eurocopter Model AS350B, control rod is replaced per year per Flexibility Act. B1, B2, B3, BA, C, D, D1; and Model AS355E, helicopter. We prepared an economic evaluation F, F1, F2, N, and NP helicopters; with tail of the estimated costs to comply with rotor (T/R) pitch control rod (control rod), Comments Invited this AD. See the AD docket to examine part number (P/N) 350A33–2100–00, –01, This AD is a final rule that involves the economic evaluation. –02, –03, –04; P/N 350A33–2121–00, –01, requirements that affect flight safety and –02; P/N 350A33–2143–00; or P/N 350A33– Authority for This Rulemaking 2145–00 or –01, installed; certificated in any was not preceded by notice and an category. opportunity for public comment; Title 49 of the United States Code Compliance: Required as indicated. however, we invite you to submit any specifies the FAA’s authority to issue To prevent failure of a T/R control rod, loss written data, views, or arguments rules on aviation safety. Subtitle I, of T/R control, and subsequent loss of control regarding this AD. Send your comments Section 106, describes the authority of of the helicopter, accomplish the following: to an address listed under ADDRESSES. the FAA Administrator. Subtitle VII, (a) Before the first flight of each day, place Include ‘‘Docket No. FAA–2011–1158; Aviation Programs, describes in more the T/R pedals in the neutral position. If the Directorate Identifier 2010–SW–018– detail the scope of the Agency’s helicopter is fitted with a T/R load AD’’ at the beginning of your comments. authority. compensator, discharge the accumulator as described in the rotorcraft flight manual. We specifically invite comments on the We are issuing this rulemaking under Check the control rod bearing (bearing) for overall regulatory, economic, the authority described in Subtitle VII, play on the helicopter, by observation and environmental, and energy aspects of Part A, Subpart III, Section 44701, feel, by slightly moving the T/R blade in the this AD. We will consider all comments ‘‘General requirements.’’ Under that flapping axis while monitoring the bearing received by the closing date and may section, Congress charges the FAA with for movement. See the following Figure 1 of amend this AD because of those promoting safe flight of civil aircraft in this AD. The actions required by this comments. air commerce by prescribing regulations paragraph may be performed by the owner/ We will post all comments we for practices, methods, and procedures operator (pilot) holding at least a private pilot receive, without change, to http:// the Administrator finds necessary for certificate, and must be entered into the helicopter maintenance records showing www.regulations.gov, including any safety in air commerce. This regulation compliance with this AD in accordance with personal information you provide. We is within the scope of that authority 14 CFR 43.9(a)(1)–(4) and 14 CFR will also post a report summarizing each because it addresses an unsafe condition 91.417(a)(2)(v). The record must be substantive verbal contact with FAA that is likely to exist or develop on maintained as required by 14 CFR 91.173, personnel concerning this AD. Using the products identified in this rulemaking 121.380, or 135.439. search function of the docket Web site, action. BILLING CODE 4910–13–P

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(b) If the Teflon cloth is coming out of its replace the control rod with an airworthy the helicopter, and using a dial indicator, normal position within the bearing, totally or control rod. measure the bearing wear according to the partially, or if there is discoloration or (c) If a pilot or mechanic detects play, a following and as shown in Figures 2 and 3 scoring on the bearing, before further flight, mechanic must remove the control rod from of this AD:

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BILLING CODE 4910–13–C 39.19. Contact the Manager, Safety DEPARTMENT OF TRANSPORTATION (1) Remove the control rod from the Management Group, DOT/FAA, ATTN: Jim helicopter. Grigg, Manager, Rotorcraft Directorate, 2601 Federal Aviation Administration (2) Mount the control rod in a vise as Meacham Blvd., Fort Worth, TX 76137, shown in Figure 2 of this AD. telephone (817) 222–5126, fax (817) 222– (3) Using a dial indicator, take axial play 14 CFR Part 71 readings by moving the spherical bearing in 5961, for information about previously the direction F (up and down) as shown in approved alternative methods of compliance. [Docket No. FAA–2011–0496; Airspace Figure 2 of this AD. (e) The Joint Aircraft System/Component Docket No. 11–AWP–6] (4) Install a bolt through the bearing and Code is 6720: Tail rotor control system. secure it with a washer and nut to provide (f) This amendment becomes effective on Establishment of Class D and a clamping surface when the bearing is November 25, 2011. Amendment of Class E Airspace; Los Angeles, CA clamped in a vise. Note: The subject of this AD is addressed (5) Mount the control rod and bearing in in European Aviation Safety Agency (France) a vise as shown in Figure 3 of this AD. AGENCY: Federal Aviation (6) Using a dial indicator, take radial play AD No. 2010–0006, dated January 7, 2010. Administration (FAA), DOT. measurements by moving the control rod in Issued in Fort Worth, Texas, on October 12, ACTION: Final rule. the direction F as shown in Figure 3 of this 2011. AD. SUMMARY: This action establishes Class (7) Record the hours of operation on each Lance T. Gant, D airspace at Los Angeles International control rod. Acting Manager, Rotorcraft Directorate, Airport, Los Angeles, CA. Controlled (8) If the radial play exceeds 0.008 inch or Aircraft Certification Service. airspace is necessary to contain axial play exceeds 0.016 inch, replace the [FR Doc. 2011–27774 Filed 11–9–11; 8:45 am] control rod with an airworthy control rod potential missed approaches at Los before further flight. BILLING CODE 4910–13–P Angeles International Airport. This (9) If the radial and axial play are within action enhances the safety and limits, reinstall the control rod. management of aircraft operations at the (10) Thereafter, at intervals not to exceed airport. This action also edits Class E 30 hours time-in-service, remove the control airspace by adding the geographic rod and measure the bearing play with a dial coordinates and the airport name to the indicator in accordance with paragraph (c) of airspace designation. this AD. (d) To request a different method of DATES: Effective date, 0901 UTC, compliance or a different compliance time December 15, 2011. The Director of the for this AD, follow the procedures in 14 CFR Federal Register approves this

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incorporation by reference action under address aircraft containment issues. The 33°56’33’’ N., long. 118°24’26’’ W.’’ to 1 CFR part 51, subject to the annual Class D proposal has been designed to the airspace designation. revision of FAA Order 7400.9 and address specific safety concerns The FAA has determined this publication of conforming amendments. involving large turbojet aircraft regulation only involves an established FOR FURTHER INFORMATION CONTACT: operations in Class E airspace adjacent body of technical regulations for which Eldon Taylor, Federal Aviation to Los Angles International Airport. frequent and routine amendments are Administration, Operations Support Currently, non-participating aircraft necessary to keep them operationally Group, Western Service Center, 1601 may fly in close proximity to arriving current. Therefore, this regulation: (1) Is Lind Avenue SW., Renton, WA 98057; and departing Instrument Flight Rules not a ‘‘significant regulatory action’’ telephone (425) 203–4537. (IFR) aircraft in this Class E airspace. under Executive Order 12866; (2) is not SUPPLEMENTARY INFORMATION: The establishment of the Los Angeles a ‘‘significant rule’’ under DOT International Airport Class D airspace Regulatory Policies and Procedures (44 History area may be incorporated into the future FR 11034; February 26, 1979); and (3) On June 17, 2011, the FAA published Los Angeles Class B airspace design does not warrant preparation of a in the Federal Register a notice of proposal. regulatory evaluation as the anticipated proposed rulemaking to amend Another concern was frequency impact is so minimal. Since this is a controlled airspace at Los Angeles, CA congestion. The FAA found that pilot, routine matter that will only affect air (76 FR 35369). Interested parties were controller workload and frequency traffic procedures and air navigation, it invited to participate in this rulemaking congestion are not impacted by this is certified this rule, when promulgated, effort by submitting written comments proposal as all alternate missed will not have a significant economic on the proposal to the FAA. The FAA approach instructions currently require impact on a substantial number of small received four comments. this communication. Also of concern entities under the criteria of the One commenter had concerns about was that the FAA pursues a full review, Regulatory Flexibility Act. The FAA’s losing their hang gliding training area. including a redesign of the Los Angeles authority to issue rules regarding While there is no change to existing Class B airspace. The FAA agrees that a aviation safety is found in Title 49 of the hang gliding operations, a Letter of redesign of the Los Angeles Class B U.S. Code. Subtitle 1, Section 106 Agreement between Los Angeles Air airspace area may provide a unified discusses the authority of the FAA Traffic Control Tower and hang gliding airspace utilization solution in the Los Administrator. Subtitle VII, Aviation operators will be initiated once the rule Angeles Basin. This redesign will be Programs, describes in more detail the is adopted. pursued in accordance with Joint Order scope of the agency’s authority. This Two commenters are opposed in (JO) 7400.2H, Procedures for Handling rulemaking is promulgated under the general to the establishment of Class D Airspace Matters, as part of the ongoing authority described in Subtitle VII, Part airspace adjacent to Los Angeles Class B Los Angeles Basin airspace review. A, Subpart I, Section 40103. Under that airspace. As proposed, the Class D This action also amends Class E section, the FAA is charged with design area is intended to minimize the airspace to include the airport name and prescribing regulations to assign the use airspace reclassified, yet contain geographic coordinates in the airspace of airspace necessary to ensure the potential operations at Los Angeles designation. With the exception of safety of aircraft and the efficient use of International Airport, and is of editorial changes, this rule is the same airspace. This regulation is within the sufficient size to allow for safe and as that proposed in the NPRM. scope of that authority as it establishes efficient handling of these operations. Class D and Class E airspace additional controlled airspace at Los One commenter had several concerns designations are published in Angeles International Airport, Los and suggestions; one suggestion was to paragraphs 5000 and 6005, respectively, Angeles, CA. pursue non-rulemaking alternatives. of FAA Order 7400.9V dated August 9, List of Subjects in 14 CFR Part 71 Two concerns were that published 2011, and effective September 15, 2011, missed approach procedures are not which is incorporated by reference in 14 Airspace, Incorporation by reference, used because they conflict with other CFR 71.1. The Class D and Class E Navigation (air). aircraft and operations; and alternate airspace designations listed in this Adoption of the Amendment missed approach procedures are ‘‘ad- document will be published In consideration of the foregoing, the hoc’’ procedures. Firstly, the FAA subsequently in that Order. Federal Aviation Administration considered non-rulemaking solutions The Rule amends 14 CFR part 71 as follows: but found they did not provide the equivalent level of safety as would Class This action amends Title 14 Code of PART 71—DESIGNATION OF CLASS A, D airspace. Secondly, both standard and Federal Regulations (14 CFR) Part 71 by B, C, D AND E AIRSPACE AREAS; AIR alternate missed approach procedures establishing Class D airspace at Los TRAFFIC SERVICE ROUTES; AND are used as appropriate to ensure the Angeles International Airport, Los REPORTING POINTS safety of arriving and departing aircraft. Angeles, CA, for containment of Alternate missed approach instructions potential missed approaches at Los ■ 1. The authority citation for 14 CFR may be required in addition to Angeles International Airport. This part 71 continues to read as follows: action is based on the results of a study published missed approach procedures Authority: 49 U.S.C. 106(g), 40103, 40113, to ensure that during unplanned missed conducted by the Los Angeles VFR Task 40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959– approaches or unusual traffic situations, Force, and the Los Angeles Class B 1963 Comp., p. 389. aircraft remain safely separated. Workgroup. This action further The commenter was also concerned enhances the safety and management of § 71.1 [Amended] that the proposal does not address all aircraft operations at the airport. This ■ 2. The incorporation by reference in Los Angeles International Airport Class action also amends Class E airspace 14 CFR 71.1 of the Federal Aviation B airspace containment issues. The Los extending upward from 700 feet above Administration Order 7400.9V, Airspace Angeles Class B airspace area is the surface by adding ‘‘Los Angeles Designations and Reporting Points, currently under review to specifically International Airport, CA’’ and ‘‘lat. dated August 9, 2011, and effective

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September 15, 2011 is amended as Issued in Seattle, Washington, on 4. The National Archives and Records follows: November 2, 2011. Administration (NARA). For Robert Henry, Paragraph 5000 Class D airspace. information on the availability of this Acting Manager, Operations Support Group, material at NARA, call (202) 741–6030, * * * * * Western Service Center or go to: http://www.archives.gov/ AWP CA D Los Angeles, CA [New] [FR Doc. 2011–29122 Filed 11–9–11; 8:45 am] federal_register/code_of_federal_ Los Angeles International Airport, CA BILLING CODE 4910–13–P regulations/ibr_locations.html. (Lat. 33°56′33″ N., long. 118°24′26″ W.) Availability—All SIAPs and Takeoff Santa Monica Municipal Airport, CA Minimums and ODPs are available ° ′ ″ ° ′ ″ (Lat. 34 00 57 N., long. 118 27 05 W.) DEPARTMENT OF TRANSPORTATION online free of charge. Visit http://www. That airspace extending upward from the nfdc.faa.gov to register. Additionally, surface to and including 2,700 feet MSL Federal Aviation Administration individual SIAP and Takeoff Minimums bounded by a line beginning at lat. 33°57′42″ and ODP copies may be obtained from: N., long. 118°27′23″ W.; to lat. 33°58′18″ N., 14 CFR Part 97 long. 118°26′24″ W.; then via the 2.7-mile 1. FAA Public Inquiry Center (APA– radius of the Santa Monica Municipal [Docket No. 30810; Amdt. No. 3450] 200), FAA Headquarters Building, 800 Airport counterclockwise to lat. 34°00′00″ N., Independence Avenue SW., long. 118°24′02″ W.; to lat. 34°00′00″ N., Standard Instrument Approach Washington, DC 20591; or ° ′ ″ ° ′ ″ long. 118 22 58 W.; to lat. 33 57 42 N., Procedures, and Takeoff Minimums 2. The FAA Regional Office of the long. 118°22′10″ W., thence to the point of and Obstacle Departure Procedures; region in which the affected airport is beginning. That airspace extending upward Miscellaneous Amendments from the surface to and including 2,500 feet located. MSL bounded by a line beginning at lat. AGENCY: ° ′ ″ ° ′ ″ Federal Aviation FOR FURTHER INFORMATION CONTACT: 33 55 50 N., long. 118 22 06 W.; to lat. Administration (FAA), DOT. 33°54′16″ N., long. 118°24′17″ W.; to lat. Richard A. Dunham III, Flight Procedure 33°52′47″ N., long. 118°26′22″ W.; to lat. ACTION: Final rule. Standards Branch (AFS–420), Flight 33°55′51″ N., long. 118°26′05″ W., thence to Technologies and Programs Divisions, the point of beginning. This Class D airspace SUMMARY: This rule establishes, amends, Flight Standards Service, Federal area is effective during the specific dates and suspends, or revokes Standard Aviation Administration, Mike times established in advance by a Notice to Instrument Approach Procedures Monroney Aeronautical Center, 6500 Airmen. The effective date and time will (SIAPs) and associated Takeoff South MacArthur Blvd., Oklahoma City, thereafter be continuously published in the Minimums and Obstacle Departure Airport/Facility Directory. OK 73169 (Mail Address: P.O. Box Procedures for operations at certain 25082, Oklahoma City, OK 73125) Paragraph 6005 Class E airspace areas airports. These regulatory actions are Telephone: (405) 954–4164. extending upward from 700 feet or more needed because of the adoption of new SUPPLEMENTARY INFORMATION: This rule above the surface of the earth. or revised criteria, or because of changes amends Title 14 of the Code of Federal * * * * * occurring in the National Airspace Regulations, Part 97 (14 CFR part 97), by System, such as the commissioning of AWP CA E5 Los Angeles, CA [Amended] establishing, amending, suspending, or new navigational facilities, adding new Los Angeles International Airport, CA revoking SIAPS, Takeoff Minimums obstacles, or changing air traffic (Lat. 33°56′33″ N., long. 118°24′26″W.) and/or ODPS. The complete regulators requirements. These changes are That airspace extending upward from 700 description of each SIAP and its designed to provide safe and efficient feet above the surface bounded by a line associated Takeoff Minimums or ODP use of the navigable airspace and to beginning at lat. 34°05′00″ N., long. for an identified airport is listed on FAA ° ′ ″ ° ′ ″ promote safe flight operations under 118 33 03 W.; to lat. 34 05 00 N., long. form documents which are incorporated 118°15′03″ W.; to lat. 34°00′00″ N., long. instrument flight rules at the affected by reference in this amendment under 5 118°15′03″ W.; to lat. 34°00′00″ N., long. airports. 118°07′03″ W.; to lat. 33°56′00″ N., long. U.S.C. 552(a), 1 CFR part 51, and 14 118°07′03″ W.; to lat. 33°56′00″ N., long. DATES: This rule is effective November CFR 97.20. The applicable FAA Forms 117°53′03″ W.; to lat. 33°46′00″ N., long. 10, 2011. The compliance date for each are FAA Forms 8260–3, 8260–4, 8260– 117°45′03″ W.; to lat. 33°39′00″ N., long. SIAP, associated Takeoff Minimums, 5, 8260–15A, and 8260–15B when 117°30′03″ W.; to lat. 33°30′00″ N., long. and ODP is specified in the amendatory required by an entry on 8260–15A. 117°30′03″ W.; to lat. 33°30′00″ N., long. provisions. ° ′ ″ ° ′ ″ The large number of SIAPs, Takeoff 117 45 03 W.; to lat. 33 42 00 N., long. The incorporation by reference of 118°09′03″ W.; to lat. 33°42′00″ N., long. Minimums and ODPs, in addition to 118°26′03″ W.; to lat. 33°48′00″ N., long. certain publications listed in the their complex nature and the need for 118°26′03″ W.; to lat. 33°53′00″ N., long. regulations is approved by the Director a special format make publication in the 118°33′03″ W., thence to the point of of the Federal Register as of November Federal Register expensive and beginning. That airspace extending upward 10, 2011. impractical. Furthermore, airmen do not from 1,200 feet above the surface bounded by ADDRESSES: ° ′ ″ Availability of matters use the regulatory text of the SIAPs, a line beginning at lat. 34 00 00 N., long. incorporated by reference in the Takeoff Minimums or ODPs, but instead 119°05′03″ W.; to lat. 34°00′00″ N., long. 118°33′03″ W.; to lat. 34°05′00″ N., long. amendment is as follows: refer to their depiction on charts printed 118°33′03″ W.; to lat. 34°05′00″ N., long. For examination— by publishers of aeronautical materials. 117°59′03″ W.; to lat. 33°56′00″ N., long. 1. FAA Rules Docket, FAA The advantages of incorporation by 117°59′03″ W.; to lat. 33°56′00″ N., long. Headquarters Building, 800 reference are realized and publication of 117°53′03″ W.; to lat. 33°46′00″ N., long. Independence Avenue SW., the complete description of each SIAP, 117°45′03″ W.; to lat. 33°39′00″ N., long. Washington, DC 20591; Takeoff Minimums and ODP listed on 117°30′03″ W.; to lat. 33°30′00″ N., long. ° ′ ″ ° ′ ″ 2. The FAA Regional Office of the FAA forms is unnecessary. This 117 30 03 W.; to lat. 33 30 00 N., long. region in which the affected airport is amendment provides the affected CFR 118°34′03″ W.; to lat. 33°28′30″ N., long. 118°34′03″ W.; to lat. 33°28′30″ N., long. located; sections and specifies the types of SIAPs 119°07′03″ W.; to lat. 33°52′03″ N., long. 3. The National Flight Procedures and the effective dates of the, associated 119°07′02″ W., thence to the point of Office, 6500 South MacArthur Blvd., Takeoff Minimums and ODPs. This beginning. Oklahoma City, OK 73169 or amendment also identifies the airport

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and its location, the procedure, and the List of Subjects in 14 CFR Part 97 Nahunta, GA, Brantley County, RNAV (GPS) amendment number. Y RWY 1, Orig Air traffic control, Airports, Nahunta, GA, Brantley County, RNAV (GPS) The Rule Incorporation by reference, and Y RWY 19, Orig Navigation (air). Nahunta, GA, Brantley County, RNAV (GPS) This amendment to 14 CFR part 97 is Issued in Washington, DC, on October 28, Z RWY 1, Orig effective upon publication of each 2011. Nahunta, GA, Brantley County, RNAV (GPS) separate SIAP, Takeoff Minimums and Z RWY 19, Orig John McGraw, Driggs, ID, Driggs-Reed Memorial, LAMON ODP as contained in the transmittal. Deputy Director, Flight Standards Service. ONE Graphic DP Some SIAP and Takeoff Minimums and Adoption of the Amendment Driggs, ID, Driggs-Reed Memorial, LAMON textual ODP amendments may have TWO Graphic DP, CANCELLED been issued previously by the FAA in a Accordingly, pursuant to the Driggs, ID, Driggs-Reed Memorial, RNAV Flight Data Center (FDC) Notice to authority delegated to me, Title 14, (GPS) RWY 3, Amdt 1 Airmen (NOTAM) as an emergency Code of Federal Regulations, Part 97 Driggs, ID, Driggs-Reed Memorial, Takeoff (14 CFR part 97) is amended by Minimums & Obstacle DP, Amdt 3 action of immediate flight safety relating Battle Creek, MI, W K Kellog, VOR OR directly to published aeronautical establishing, amending, suspending, or TACAN RWY 5, Amdt 19A, CANCELLED charts. The circumstances which revoking Standard Instrument Approach Hancock, MI, Houghton County Memorial, created the need for some SIAP and Procedures and/or Takeoff Minimums Takeoff Minimums and Obstacle DP, Amdt Takeoff Minimums and ODP and/or Obstacle Departure Procedures 3 effective at 0902 UTC on the dates Lansing, MI, Capital Region Intl, ILS OR LOC amendments may require making them specified, as follows: RWY 10R, Amdt 10 effective in less than 30 days. For the Three Rivers, MI, Three Rivers Muni Dr. remaining SIAPS and Takeoff PART 97—STANDARD INSTRUMENT Haines, Takeoff Minimums and Obstacle Minimums and ODPS, an effective date APPROACH PROCEDURES DP, Orig at least 30 days after publication is Brainerd, MN, Brainerd Lakes Rgnl, ILS OR provided. ■ 1. The authority citation for part 97 LOC/DME RWY 34, Amdt 1 continues to read as follows: Park Rapids, MN, Park Rapids Muni-Konshok Further, the SIAPs and Takeoff Field, NDB RWY 31, Amdt 2 Minimums and ODPS contained in this Authority: 49 U.S.C. 106(g), 40103, 40106, Park Rapids, MN, Park Rapids Muni-Konshok amendment are based on the criteria 40113, 40114, 40120, 44502, 44514, 44701, Field, RNAV (GPS) RWY 13, Orig 44719, 44721–44722. Park Rapids, MN, Park Rapids Muni-Konshok contained in the U.S. Standard for ■ 2. Part 97 is amended to read as Field, RNAV (GPS) RWY 31, Orig Terminal Instrument Procedures Park Rapids, MN, Park Rapids Muni-Konshok (TERPS). In developing these SIAPS and follows: Field, VOR RWY 31, Amdt 14 Takeoff Minimums and ODPs, the Effective 15 DEC 2011 Park Rapids, MN, Park Rapids Muni-Konshok TERPS criteria were applied to the McGrath, AK, McGrath, RNAV (GPS) RWY Field, VOR/DME RWY 13, Amdt 9 conditions existing or anticipated at the 16, Amdt 1 Red Wing, MN, Red Wing Rgnl, ILS OR LOC McGehee, AR, McGehee Muni, RNAV (GPS) RWY 9, Amdt 1 affected airports. Because of the close Red Wing, MN, Red Wing Rgnl, RNAV (GPS) and immediate relationship between RWY 18, Orig McGehee, AR, McGehee Muni, RNAV (GPS) RWY 9, Amdt 1 these SIAPs, Takeoff Minimums and RWY 36, Orig St Paul, MN, St Paul Downtown Holman Fld, ODPs, and safety in air commerce, I find McGehee, AR, McGehee Muni, VOR/DME–A, Takeoff Minimums and Obstacle DP, Amdt that notice and public procedures before Amdt 3 8 adopting these SIAPS, Takeoff Phoenix, AZ, Phoenix-Mesa Gateway, RNAV Branson West, MO, Branson West Muni- (GPS) RWY 12R, Amdt 1 Emerson Field, Takeoff Minimums and Minimums and ODPs are impracticable Obstacle DP, Orig and contrary to the public interest and, Phoenix, AZ, Phoenix-Mesa Gateway, RNAV (GPS) RWY 30L, Amdt 1 Fort Leonard Wood, MO, Waynesville-St. where applicable, that good cause exists Blythe, CA, Blythe, RNAV (GPS) RWY 26, Robert Rgnl Forney Fld, Takeoff for making some SIAPs effective in less Amdt 1 Minimums and Obstacle DP, Orig than 30 days. Cloverdale, CA, Cloverdale Muni, Takeoff Manteo, NC, Dare County Rgnl, GPS RWY 5, Minimums and Obstacle DP, Amdt 1 Orig, CANCELLED Conclusion Davis/Woodland/Winters, CA, Yolo County, Manteo, NC, Dare County Rgnl, GPS RWY 17, RNAV (GPS) RWY 16, Amdt 2 Orig, CANCELLED The FAA has determined that this Oxnard, CA, Oxnard, ILS OR LOC RWY 25, Manteo, NC, Dare County Rgnl, GPS RWY 23, regulation only involves an established Amdt 13 Orig, CANCELLED body of technical regulations for which Oxnard, CA, Oxnard, LOC RWY 25, Orig, Manteo, NC, Dare County Rgnl, NDB RWY frequent and routine amendments are CANCELLED 17, Amdt 6 Manteo, NC, Dare County Rgnl, RNAV (GPS) necessary to keep them operationally Oxnard, CA, Oxnard, RNAV (GPS) RWY 25, Amdt 1 RWY 5, Orig current. It, therefore—(1) Is not a Oxnard, CA, Oxnard, VOR RWY 25, Amdt 10 Manteo, NC, Dare County Rgnl, RNAV (GPS) ‘‘significant regulatory action’’ under Stockton, CA, Stockton Metropolitan, ILS OR RWY 17, Orig Executive Order 12866; (2) is not a LOC RWY 29R, Amdt 20 Manteo, NC, Dare County Rgnl, RNAV (GPS) ‘‘significant rule’’ under DOT Stockton, CA, Stockton Metropolitan, NDB RWY 23, Orig Regulatory Policies and Procedures (44 RWY 29R, Amdt 14E, CANCELLED Manteo, NC, Dare County Rgnl, Takeoff Holyoke, CO, Holyoke, Takeoff Minimums & Minimums and Obstacle DP, Amdt 2 FR 11034; February 26,1979); and (3) Obstacle DP, Amdt 1 Morganton, NC, Foothills Rgnl, LOC RWY 3, does not warrant preparation of a Bonifay, FL, Tri-County, NDB–A, Amdt 2 Amdt 2 regulatory evaluation as the anticipated Bonifay, FL, Tri-County, RNAV (GPS) RWY Kimball, NE., Kimball Muni/Robert E Arraj impact is so minimal. For the same 19, Orig Field, RNAV (GPS) RWY 10, Amdt 1 reason, the FAA certifies that this Donalsonville, GA, Donalsonville Muni, Kimball, NE., Kimball Muni/Robert E Arraj Field, RNAV (GPS) RWY 28, Amdt 1 amendment will not have a significant RNAV (GPS) RWY 18, Amdt 1 Donalsonville, GA, Donalsonville Muni, Carlsbad, NM, Cavern City Air Terminal, economic impact on a substantial RNAV (GPS) RWY 36, Amdt 1 RNAV (GPS) RWY 32L, Amdt 1 number of small entities under the Jasper, GA, Pickens County, RNAV (GPS) Ely, NV, Ely Arpt/Yelland Fld, RNAV (GPS) criteria of the Regulatory Flexibility Act. RWY 16, Amdt 1 RWY 18, Amdt 1

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Minden, NV, Minden-Tahoe, MINDEN TWO obstacles, or changing air traffic SIAP is listed on the appropriate FAA Graphic DP requirements. These changes are Form 8260, as modified by the National Minden, NV, Minden-Tahoe, Takeoff designed to provide safe and efficient Flight Data Center (FDC)/Permanent Minimums and Obstacle DP, Amdt 2 use of the navigable airspace and to Notice to Airmen (P–NOTAM), and is Cleveland, OH, Cleveland-Hopkins Intl, ILS OR LOC RWY 28, Amdt 24 promote safe flight operations under incorporated by reference in the Cleveland, OH, Cleveland-Hopkins Intl, instrument flight rules at the affected amendment under 5 U.S.C. 552(a), 1 RNAV (GPS) RWY 10, Amdt 3 airports. CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations. Cleveland, OH, Cleveland-Hopkins Intl, DATES: This rule is effective November RNAV (GPS) RWY 28, Amdt 2 The large number of SIAPs, their 10, 2011. The compliance date for each North Bend, OR, Southwest Oregon Rgnl, ILS complex nature, and the need for a OR LOC RWY 4, Amdt 7A SIAP, associated Takeoff Minimums, special format make their verbatim North Bend, OR, Southwest Oregon Rgnl, and ODP is specified in the amendatory publication in the Federal Register VOR/DME RWY 4, Amdt 10 provisions. expensive and impractical. Further, Wilkes-Barre/Scranton, PA, Wilkes-Barre/ The incorporation by reference of airmen do not use the regulatory text of Scranton Intl, NDB–A, Amdt 17A, certain publications listed in the the SIAPs, but refer to their graphic CANCELLED regulations is approved by the Director Paris, TN, Henry County, ILS OR LOC/NDB depiction on charts printed by of the Federal Register as of November publishers of aeronautical materials. RWY 2, Amdt 1, CANCELLED 10, 2011. Abilene, TX, Abilene Rgnl, VOR RWY 22, Thus, the advantages of incorporation Amdt 4, CANCELLED ADDRESSES: Availability of matter by reference are realized and Gruver, TX, Gruver Muni, RNAV (GPS) RWY incorporated by reference in the publication of the complete description 2, Orig amendment is as follows: of each SIAP contained in FAA form Gruver, TX, Gruver Muni, RNAV (GPS) RWY For examination— documents is unnecessary. This 20, Orig 1. FAA Rules Docket, FAA amendment provides the affected CFR Gruver, TX, Gruver Muni, VOR/DME OR Headquarters Building, 800 sections and specifies the types of SIAP GPS–B, Orig, CANCELLED Independence Avenue SW., Lamesa, TX, Lamesa Muni, Takeoff and the corresponding effective dates. Minimums and Obstacle DP, Orig Washington, DC 20591; This amendment also identifies the Brigham City, UT, Brigham City, RNAV 2. The FAA Regional Office of the airport and its location, the procedure (GPS) RWY 35, Amdt 2 region in which the affected airport is and the amendment number. Provo, UT, Provo Muni, ILS OR LOC/DME located; RWY 13, Amdt 2 3. The National Flight Procedures The Rule Provo, UT, Provo Muni, RNAV (GPS) RWY Office, 6500 South MacArthur Blvd., This amendment to 14 CFR part 97 is 13, Amdt 2 Oklahoma City, OK 73169 or effective upon publication of each Gordonsville, VA, Gordonsville Muni, RNAV 4. The National Archives and Records separate SIAP as amended in the (GPS) RWY 5, Orig Administration (NARA). For transmittal. For safety and timeliness of Gordonsville, VA, Gordonsville Muni, RNAV (GPS) RWY 23, Orig information on the availability of this change considerations, this amendment Gordonsville, VA, Gordonsville Muni, material at NARA, call (202) 741–6030, incorporates only specific changes Takeoff Minimums and Obstacle DP, Orig or go to: http://www.archives.gov/ contained for each SIAP as modified by _ [FR Doc. 2011–28929 Filed 11–9–11; 8:45 am] federal register/ FDC/P–NOTAMs. code_of_federal_regulations/ The SIAPs, as modified by FDC BILLING CODE 4910–13–P ibr_locations.html. P–NOTAM, and contained in this Availability—All SIAPs are available amendment are based on the criteria DEPARTMENT OF TRANSPORTATION online free of charge. Visit nfdc.faa.gov contained in the U.S. Standard for to register. Additionally, individual Terminal Instrument Procedures Federal Aviation Administration SIAP and Takeoff Minimums and ODP (TERPS). In developing these changes to copies may be obtained from: SIAPs, the TERPS criteria were applied 14 CFR Part 97 1. FAA Public Inquiry Center (APA– only to specific conditions existing at 200), FAA Headquarters Building, 800 the affected airports. All SIAP [Docket No. 30811; Amdt. No. 3451] Independence Avenue SW., amendments in this rule have been Standard Instrument Approach Washington, DC 20591; or previously issued by the FAA in a FDC Procedures, and Takeoff Minimums 2. The FAA Regional Office of the NOTAM as an emergency action of and Obstacle Departure Procedures; region in which the affected airport is immediate flight safety relating directly Miscellaneous Amendments located. to published aeronautical charts. The circumstances which created the need FOR FURTHER INFORMATION CONTACT: AGENCY: Federal Aviation for all these SIAP amendments require Richard A. Dunham III, Flight Procedure Administration (FAA), DOT. making them effective in less than 30 Standards Branch (AFS–420) Flight ACTION: Final rule. days. Technologies and Programs Division, Because of the close and immediate SUMMARY: This rule establishes, amends, Flight Standards Service, Federal relationship between these SIAPs and suspends, or revokes Standard Aviation Administration, Mike safety in air commerce, I find that notice Instrument Approach Procedures Monroney Aeronautical Center, 6500 and public procedure before adopting (SIAPs) and associated Takeoff South MacArthur Blvd., Oklahoma City, these SIAPs are impracticable and Minimums and Obstacle Departure OK 73169 (Mail Address: P.O. Box contrary to the public interest and, Procedures for operations at certain 25082 Oklahoma City, OK. 73125) where applicable, that good cause exists airports. These regulatory actions are telephone: (405) 954–4164. for making these SIAPs effective in less needed because of the adoption of new SUPPLEMENTARY INFORMATION: This rule than 30 days. or revised criteria, or because of changes amends Title 14, Code of Federal occurring in the National Airspace Regulations, Part 97 (14 CFR part 97) by Conclusion System, such as the commissioning of amending the referenced SIAPs. The The FAA has determined that this new navigational facilities, adding new complete regulatory description of each regulation only involves an established

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body of technical regulations for which Issued in Washington, DC, on October 28, §§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, frequent and routine amendments are 2011. 97.35 [Amended] necessary to keep them operationally John McGraw, ■ 2. Part 97 is amended to read as current. It, therefore—(1) Is not a Deputy Director, Flight Standards Service. follows: ‘‘significant regulatory action’’ under Adoption of the Amendment Executive Order 12866; (2) is not a By amending: § 97.23 VOR, VOR/ ‘‘significant rule’’ under DOT regulatory Accordingly, pursuant to the DME, VOR or TACAN, and VOR/DME Policies and Procedures (44 FR 11034; authority delegated to me, Title 14, or TACAN; § 97.25 LOC, LOC/DME, February 26, 1979); and (3) does not Code of Federal regulations, part 97, 14 LDA, LDA/DME, SDF, SDF/DME; warrant preparation of a regulatory CFR part 97, is amended by amending § 97.27 NDB, NDB/DME; § 97.29 ILS, evaluation as the anticipated impact is Standard Instrument Approach ILS/DME, MLS, MLS/DME, MLS/RNAV; so minimal. For the same reason, the Procedures, effective at 0901 UTC on § 97.31 RADAR SIAPs; § 97.33 RNAV FAA certifies that this amendment will the dates specified, as follows: SIAPs; and § 97.35 COPTER SIAPs, not have a significant economic impact Identified as follows: on a substantial number of small entities PART 97—STANDARD INSTRUMENT under the criteria of the Regulatory APPROACH PROCEDURES * * * Effective Upon Publication Flexibility Act. ■ 1. The authority citation for part 97 List of Subjects in 14 CFR Part 97 continues to read as follows: Air traffic control, Airports, Authority: 49 U.S.C. 106(g), 40103, 40106, Incorporation by reference, and 40113, 40114, 40120, 44502, 44514, 44701, Navigation (air). 44719, 44721–44722.

AIRAC date State City Airport FDC No. FDC date Subject

15–Dec–11 ... UT Brigham City ...... Brigham City ...... 1/0187 10/4/11 Takeoff Minimums and Obstacle DP, Amdt 6 15–Dec–11 ... CQ Agana ...... Guam Intl ...... 1/0544 10/4/11 RNAV (RNP) Z RWY 24R, Orig- B 15–Dec–11 ... CQ Agana ...... Guam Intl ...... 1/0545 10/4/11 RNAV (RNP) Z RWY 6L, Orig-C 15–Dec–11 ... CQ Agana ...... Guam Intl ...... 1/0546 10/4/11 RNAV (RNP) Z RWY 6R, Orig-B 15–Dec–11 ... CQ Agana ...... Guam Intl ...... 1/0547 10/4/11 RNAV (RNP) Z RWY 24L, Orig-D 15–Dec–11 ... CA Oakland ...... Metropolitan Oakland Intl ...... 1/0581 10/24/11 RNAV (RNP) Z RWY 27R, Orig 15–Dec–11 ... CA Oakland ...... Metropolitan Oakland Intl ...... 1/0582 10/24/11 RNAV (RNP) Z RWY 29, Orig 15–Dec–11 ... CA Oakland ...... Metropolitan Oakland Intl ...... 1/0583 10/24/11 RNAV (RNP) Z RWY 27L, Orig 15–Dec–11 ... FL Tallahassee ...... Tallahassee Rgnl...... 1/1455 9/26/11 ILS OR LOC/DME RWY 36, Amdt 24A 15–Dec–11 ... FL Tallahassee ...... Tallahassee Rgnl ...... 1/1457 9/26/11 RNAV (GPS) RWY 9, Amdt 1 15–Dec–11 ... FL Tallahassee ...... Tallahassee Rgnl ...... 1/1458 9/26/11 RNAV (GPS) RWY 36, Orig 15–Dec–11 ... MI Benton Harbor ...... Southwest Michigan Rgnl ...... 1/2285 9/30/11 NDB RWY 28, Amdt 10 15–Dec–11 ... MI Benton Harbor ...... Southwest Michigan Rgnl ...... 1/2286 9/30/11 VOR RWY 10, Amdt 10 15–Dec–11 ... MI Benton Harbor ...... Southwest Michigan Rgnl ...... 1/2287 9/30/11 VOR RWY 28, Amdt 19 15–Dec–11 ... CQ Agana ...... Guam Intl ...... 1/3566 9/30/11 VOR A, Orig-D 15–Dec–11 ... CQ Agana ...... Guam Intl ...... 1/3567 9/30/11 VOR/DME OR TACAN RWY 6L, Orig-D 15–Dec–11 ... WI Sheboygan ...... Sheboygan County Memorial .. 1/5783 10/24/11 VOR RWY 21, Amdt 8A 15–Dec–11 ... WI Green Bay ...... Austin Straubel Intl ...... 1/6812 10/24/11 RNAV (GPS) RWY 18, Amdt 1 15–Dec–11 ... WI Hayward ...... Sawyer County ...... 1/8001 10/24/11 Takeoff Minimums and Obstacle DP, Amdt 4 15–Dec–11 ... FL Brooksville ...... Hernando County ...... 1/8352 10/24/11 RNAV (GPS) RWY 3, Amdt 1 15–Dec–11 ... FL Brooksville ...... Hernando County ...... 1/8353 10/24/11 RNAV (GPS) RWY 21, Amdt 1 15–Dec–11 ... FL Brooksville ...... Hernando County ...... 1/8354 10/24/11 ILS OR LOC RWY 9, Amdt 2B 15–Dec–11 ... FL Brooksville ...... Hernando County ...... 1/8355 10/24/11 RNAV (GPS) RWY 9, Amdt 1 15–Dec–11 ... GA Canon ...... Franklin County ...... 1/8356 10/24/11 RNAV (GPS) RWY 8, Orig 15–Dec–11 ... FL Brooksville ...... Hernando County ...... 1/8357 10/24/11 RNAV (GPS) RWY 27, Amdt 1 15–Dec–11 ... GA Canon ...... Franklin County ...... 1/8358 10/24/11 RNAV (GPS) RWY 26, Orig 15–Dec– 11 .. PA Palmyra ...... Reigle Field ...... 1/8359 10/24/11 Takeoff Minimums and Obstacle DP, Orig

[FR Doc. 2011–28932 Filed 11–9–11; 8:45 am] BILLING CODE 4910–13–P

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DEPARTMENT OF THE TREASURY On page 67366, column 1, under an soils, structures and groundwater within amendatory instruction, the language the boundaries of these parcels. In 2005, Internal Revenue Service ‘‘Par. 9. Section 301.7701–2T is revised the ETA, approximately 45.49 acres in to read as follows:’’ is removed and is the northeastern part of the Site, was 26 CFR Part 301 replaced with the new language ‘‘Par. 9. deleted from the NPL when EPA [TD 9554] Section 301.7701–2T is added to read as determined that the ETA was acceptable follows:’’ in its place. for unrestricted use and unlimited RIN 1545–BJ07 exposure (UU/UE). The two parcels LaNita Van Dyke, being proposed for deletion are adjacent Extending Religious and Family Chief, Publications and Regulations Branch, to and south of the ETA. The remaining Member FICA and FUTA Exceptions to Legal Processing Division, Associate Chief areas of the Site will remain on the NPL Disregarded Entities; Correction Counsel, Procedure and Administration. and are not being considered for [FR Doc. 2011–29087 Filed 11–9–11; 8:45 am] AGENCY: Internal Revenue Service (IRS), deletion as part of this action. BILLING CODE 4830–01–P Treasury. DATES: This direct final partial deletion ACTION: Correction to final and is effective January 9, 2012 unless EPA temporary regulations. receives adverse comments by ENVIRONMENTAL PROTECTION December 12, 2011. If adverse AGENCY SUMMARY: This document describes a comments are received, EPA will correction to final and temporary 40 CFR Part 300 publish a timely withdrawal of the regulations (TD 9554) extending the direct final partial deletion in the exceptions from taxes under the Federal [EPA–HQ–SFUND–1983–0002; FRL–9488–7] Federal Register informing the public Insurance Contributions Act (‘‘FICA’’) that the partial deletion will not take and the Federal Unemployment Tax Act National Oil and Hazardous Substance effect. (‘‘FUTA’’) under sections 3121(b)(3) Pollution Contingency Plan; National (concerning individuals who work for Priorities List: Partial Deletion of the ADDRESSES: Submit your comments, certain family members), 3127 Tar Lake Superfund Site identified by Docket ID No. EPA–HQ– (concerning members of religious SFUND–1983–0002, by one of the faiths), and 3306(c)(5) (concerning AGENCY: Environmental Protection following methods: persons employed by children and Agency (EPA). • Email: Karen Cibulskis, Remedial spouses and children under 21 ACTION: Direct final rule. Project Manager, at employed by their parents) of the [email protected] or Megan Internal Revenue Code (‘‘Code’’) to SUMMARY: The U.S. Environmental McSeveney, Community Involvement entities that are disregarded as separate Protection Agency (EPA) Region 5 is Coordinator, at from their owners for Federal tax publishing a direct final Notice of [email protected]. purposes. The temporary regulations Partial Deletion of the following two • Fax: Gladys Beard, Deletion Process also clarify the existing rule that the parcels of the Tar Lake Superfund Site Manager, at (312) 697–2077. • owners of disregarded entities, except (Site) located in Mancelona, Michigan Mail: Karen Cibulskis, Remedial for qualified subchapter S subsidiaries, from the National Priorities List (NPL): Project Manager, U.S. Environmental are responsible for backup withholding The non-East Tailings Area (ETA) part Protection Agency, Region 5 (SR–6J), 77 and related information reporting of property PIN 05–11–129–006–00 West Jackson Boulevard, Chicago, IL requirements under section 3406. These (41.4 acres); and the non-ETA part of 60604, (312) 886–1843; or Megan regulations were published in the property PIN 05–11–129–007–00 (33.63 McSeveney, Community Involvement Federal Register on Tuesday, November acres). Refer to Figures 1 to 3 in the Coordinator, U.S. Environmental 1, 2011 (76 FR 67363). deletion docket to view the location of Protection Agency (SI–7J), 77 West DATES: This correction is effective on the two parcels being proposed for Jackson Boulevard, Chicago, IL 60604, deletion. The NPL, promulgated (312) 886–1972 or (800) 621–8431. November 10, 2011, and is applicable • on November 1, 2011. pursuant to section 105 of the Hand delivery: Megan McSeveney, Comprehensive Environmental Community Involvement Coordinator, FOR FURTHER INFORMATION CONTACT: Response, Compensation and Liability U.S. Environmental Protection Agency, Joseph Perera, (202) 622–6040 (not a Act (CERCLA) of 1980, as amended, is toll-free number). (SI–7J), 77 West Jackson Boulevard, an appendix to the National Oil and Chicago, IL 60604. Such deliveries are SUPPLEMENTARY INFORMATION: Hazardous Substances Pollution only accepted during the docket’s Background Contingency Plan (NCP). This direct normal hours of operation and special The correction notice that is the final partial deletion is being published arrangements should be made for subject of this document is under by EPA with the concurrence of the deliveries of boxed information. The section 7701 of the Internal Revenue State of Michigan, through the Michigan normal business hours are Monday Code. Department of Environmental Quality through Friday, 8:30 a.m. to 4:30 p.m., (MDEQ), because EPA has determined excluding Federal holidays. Need for Correction that all appropriate response actions at Instruction: Direct your comments to As published, final and temporary these two parcels under CERCLA, other Docket ID No. EPA–HQ–SFUND–1983– regulations (TD 9554) contain an error than operation, maintenance and five- 0002. EPA’s policy is that all comments that may prove to be misleading and is year reviews, have been completed. received will be included in the public in need of clarification. However, this partial deletion does not docket without change and may be preclude future actions under made available online at http:// Correction of Publication Superfund. www.regulations.gov, including any Accordingly, the publication of final This partial deletion pertains only to personal information provided, unless and temporary regulations (TD 9554), the two property PINs listed above. The the comment includes information which was the subject of FR Doc. 2011– deletion of these two parcels from the claimed to be Confidential Business 28176, is corrected as follows: Site affects all surface soils, subsurface Information (CBI) or other information

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whose disclosure is restricted by statute. I. Introduction partially delete these two parcels of the Do not submit information that you EPA Region 5 is publishing this direct Site from the NPL unless adverse consider to be CBI or otherwise final Notice of Partial Deletion to delete comments are received during the protected through http:// two parcels of the Tar Lake Superfund public comment period. www.regulations.gov or email. The Site from the NPL. This partial deletion II. NPL Partial Deletion Criteria http://www.regulations.gov Web site is pertains to all surface soils, subsurface The NCP establishes the criteria that an ‘‘anonymous access’’ system, which soils, structures and groundwater within EPA uses to delete sites from the NPL. means EPA will not know your identity the boundaries of the non-ETA part of In accordance with 40 CFR 300.425(e), or contact information unless you PIN 05–11–129–006–00 (41.4 acres) and sites may be deleted from the NPL provide it in the body of your comment. the non-ETA part of PIN 05–11–129– where no further response is If you send an email comment directly 007–00 (33.63 acres). The NPL appropriate. In making such a to EPA without going through http:// constitutes Appendix B of 40 CFR part determination pursuant to 40 CFR www.regulations.gov, your email 300, which is the National Oil and 300.425(e), EPA will consider, in address will be automatically captured Hazardous Substances Pollution consultation with the state, whether any and included as part of the comment Contingency Plan (NCP), which EPA of the following criteria have been met: that is placed in the public docket and promulgated pursuant to section 105 of made available on the Internet. If you i. Responsible parties or other persons the Comprehensive Environmental have implemented all appropriate submit an electronic comment, EPA Response, Compensation and Liability recommends that you include your response actions required; Act (CERCLA) of 1980, as amended. ii. All appropriate Fund-financed name and other contact information in EPA maintains the NPL as the list of the body of your comment with any disk response under CERCLA has been sites that appear to present a significant implemented and no further response or CD–ROM you submit. If EPA cannot risk to public health, welfare, or the read your comment due to technical action by responsible parties is environment. Sites on the NPL may be appropriate; or difficulties and cannot contact you for the subject of remedial actions financed clarification, EPA may not be able to iii. The remedial investigation has by the Hazardous Substance Superfund shown that the release poses no consider your comment. Electronic files (Fund). This partial deletion of the Tar should avoid the use of special significant threat to public health or the Lake Superfund Site is proposed in environment and, therefore, the taking characters, any form of encryption, and accordance with 40 CFR 300.425(e) and be free of any defects or viruses. of remedial measures is not appropriate. is consistent with the Notice of Policy Pursuant to CERCLA section 121(c) Docket Change: Partial Deletion of Sites Listed and the NCP, EPA conducts five-year on the National Priorities List, 60 FR reviews to ensure the continued All documents in the docket are listed 55466 (Nov. 1, 1995). As described in protectiveness of remedial actions in the http://www.regulations.gov index. section 300.425(e)(3) of the NCP, a where hazardous substances, pollutants Although listed in the index, some portion of a site deleted from the NPL or contaminants remain at a site above information is not publicly available, remains eligible for Fund-financed levels that allow for UU/UE. EPA e.g., CBI or other information whose remedial action if future conditions conducts such five-year reviews even if disclosure is restricted by statute. warrant such actions. a site is deleted from the NPL. EPA may Certain other material, such as Because EPA considers this action to initiate further action to ensure copyrighted material, will be publicly be noncontroversial and routine, this continued protectiveness at a deleted available only in the hard copy. Publicly action will be effective January 9, 2012 site if new information becomes available docket materials are available unless EPA receives adverse comments available that indicates it is appropriate. either electronically at http:// by December 12, 2011. Along with this Whenever there is a significant release www.regulations.gov or in hard copy at: direct final Notice of Partial Deletion, • from a site deleted from the NPL, the U.S. Environmental Protection EPA is co-publishing a Notice of Intent deleted site may be restored to the NPL Agency-Region 5, 77 West Jackson to Delete in the ‘‘Proposed Rules’’ without application of the hazard Boulevard, Chicago, IL 60604, Hours: section of the Federal Register. If ranking system. Monday through Friday, 8:30 a.m. to adverse comments are received within 4:30 p.m., excluding Federal holidays. the 30-day public comment period on III. Partial Deletion Procedures • Mancelona Public Library, 202 West this deletion action, EPA will publish a The following procedures apply to State Street, Mancelona, MI 49659, timely withdrawal of this direct final this partial deletion of the Tar Lake Phone: (231) 587–9451, Hours: Monday Notice of Partial Deletion before the Superfund Site: through Thursday, 9 a.m. to 8 p.m.; effective date of the partial deletion and (1) EPA consulted with the State of Friday 12 p.m. to 6 p.m. and Saturday the partial deletion will not take effect. Michigan on this partial deletion prior 9 a.m. to 5 p.m. EPA will, as appropriate, prepare a to developing this direct final Notice of FOR FURTHER INFORMATION CONTACT: response to comments and continue Partial Deletion and the Notice of Intent Karen Cibulskis, Remedial Project with the deletion process on the basis of to Delete co-published today in the Manager, U.S. Environmental Protection the Notice of Intent for Partial Deletion ‘‘Proposed Rules’’ section of the Federal Agency, (SR–6J), 77 West Jackson and the comments already received. Register. Boulevard, Chicago, IL 60604, (312) There will be no additional opportunity (2) EPA provided the State with 30 886–1843, [email protected]. to comment. working days for review of this notice Section II of this document explains and the parallel Notice of Intent for SUPPLEMENTARY INFORMATION: the criteria for deleting sites from the Partial Deletion prior to their Table of Contents NPL. Section III discusses procedures publication today; and the State, I. Introduction that EPA is using for this action. Section through MDEQ, concurred on the partial II. NPL Deletion Criteria IV discusses the two parcels of the Tar deletion of the Site from the NPL. III. Deletion Procedures Lake Superfund Site and demonstrates (3) Concurrently with the publication IV. Basis for Site Deletion how they meet the deletion criteria. of this direct final Notice of Partial V. Deletion Action Section V discusses EPA’s action to Deletion, a notice of the availability of

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the parallel Notice of Intent for Partial be placed on the NPL on December 30, shallow unconfined aquifer beneath the Deletion is being published in a major 1982 (47 FR 58476); and was placed on 4-acre Tar Lake depression was local newspaper, The Antrim Review, in the NPL on September 8, 1983 (48 FR contaminated with benzene and 2,4- Bellarie, Michigan. The newspaper 40658). dimethylphenol above maximum notice announces the 30-day public The Site was separated into two contaminant levels (MCLs) and state comment period concerning the Notice operable units (OUs): The first operable drinking water standards. EPA also of Intent for Partial Deletion of the Site unit (OU1) included the tar concluded that on-site groundwater from the NPL. contamination in the 4-acre depression collected from groundwater monitoring (4) EPA placed copies of documents in the northwest corner of the Site and wells and off-site groundwater collected supporting the proposed partial deletion the second operable unit (OU2), from residential wells in the shallow in the deletion docket and made these comprised the remaining contamination drinking water aquifer were items available for public inspection beneath the 4-acre Tar Lake depression contaminated with iron and manganese and copying at the Site information and any additional contaminated at concentrations above the State of repositories identified above. groundwater and soil within the Site. Michigan’s Secondary Drinking Water (5) If adverse comments are received On November 25, 2005 EPA partially Standards, but not at concentrations within the 30-day public comment deleted the ETA component of OU2. At above EPA’s health-based risk levels. period on this partial deletion action, this time, all surface soils, subsurface Therefore, the 2002 Record of Decision EPA will publish a timely notice of soils, structures and groundwater within (ROD) determined that iron and withdrawal of this direct final Notice for the boundaries of the non-ETA part of manganese were not chemicals of Partial Deletion before its effective date PIN 05–11–129–006–00 (41.4 acres) and concern for the CERCLA remedy. and will prepare a response to the non-ETA part of PIN 05–11–129– Groundwater samples collected up comments and continue with the 007–00 (33.63 acres) proposed for gradient and between the 4-acre deletion process on the basis of the deletion are part of OU2. All of OU1 and depression and the two parcels Notice of Intent for Partial Deletion and the remaining sections of OU2 will proposed for deletion did not contain the comments already received. remain on the NPL (please refer to benzene, 2,4-dimethylphenol or iron Deletion of a portion of a site from the Figures 1 to 3). This partial deletion above MCLs or risk-based levels during NPL does not in itself create, alter, or notice will focus on the activities the RI. The RI and FS were completed revoke any individual’s rights or conducted at the two parcels in OU2 on August 7, 2000. obligations. Deletion of a portion of a subject to this notice. site from the NPL does not in any way Ownership of the Site changed several Selected Remedy alter EPA’s right to take enforcement times during the succeeding years after A ROD for OU2 was signed on actions, as appropriate. The NPL is 1945, and in 2009 Mancelona Private February 25, 2002 to address the soil designed primarily for informational Power Producers (MP3) of Traverse City, and groundwater. The OU2 ROD listed purposes and to assist EPA Michigan, purchased the two parcels the following site-wide remedial action management. Section 300.425(e)(3) of that are the subject of this partial objectives: deletion and are the current owners of the NCP states that the partial deletion a. Prevent human exposure through this property. MP3 is an energy of a site from the NPL does not preclude contact, ingestion, or inhalation of company planning to build and operate eligibility for future response actions contaminated tarry-like waste residue a $140,000,000 biomass energy plant on should future conditions warrant such (surface tar) in the Creosote Area. these two parcels and the already- actions. b. Prevent potential ecological deleted ETA section of the Site. IV. Basis for Site Deletions impacts from exposure to surface tar. The following information provides Remedial Investigation and Feasibility c. Control potential erosion and off- EPA’s rationale for deleting the non- Study (RI/FS) site transport of tar to nearby Nelson ETA part of PIN 05–11–129–006–00 In June 1999, EPA commenced the Lake. (41.4 acres) and the non-ETA part of PIN Remedial Investigation (RI) field work d. Prevent leaching of contaminants 05–11–129–007–00 (33.63 acres) of the for OU2. The overall objective of the RI from the 4-acre depression or ‘‘rind’’ Site from the NPL. for OU2 was to characterize what into soil and from soil into groundwater. effects, if any, the former iron e. Remediate on-site contaminated Site Background and History manufacturing processes had on the groundwater in the shallow unconfined The Site (EPA ID: MID980794655) Site, including determining the lateral aquifer to concentrations below MCLs or originally consisted of approximately and vertical extent of any risk-based Michigan PA 451 Part 201 234 acres of land located just east of contamination; understanding the Generic Cleanup Criteria for Highway 131, north and south of Elder potential risk to human health and the Groundwater within a reasonable time Road, and south of the Village of environment; and developing sufficient frame. Groundwater down gradient of Mancelona in the north central part of data to perform a feasibility study (FS). the site is used for drinking water the lower peninsula of Michigan. The As part of the RI/FS for OU2, EPA purposes and therefore a rapid John Otis Charcoal Iron Furnace conducted a baseline risk assessment to restoration of on-site groundwater Company manufactured iron at the Site determine the current and future effects should be considered. from 1882 to 1886, and the Antrim Iron of contaminants on human health and f. Minimize potential for future Works Company took over the Site in the environment. Initially, the Site was releases of contaminated on-site 1886 and continued to manufacture iron anticipated to have only industrial reuse groundwater to off-site groundwater. there until 1945. From approximately potential. The RI for OU2 originally The parcels identified for deletion are 1910 to 1944, a tar-like residue from quantified only industrial reuse risks, up gradient of both the sources of Antrim Iron Works’ charcoal production but was expanded to apply address contamination and the contaminated process was discharged into an on-site industrial, commercial, recreational, groundwater plume being addressed in depression south of Elder Road (also and residential uses. the ROD for OU2. The elements of the known as ‘‘Tar Lake’’) that covered four During the RI, EPA determined that selected remedy pertaining to the two acres of land. The Site was proposed to an on-site plume of groundwater in the parcels are:

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a. Institutional controls (ICs), EPA’s remedy. The proposal must also Volatile Organic Compounds (SVOCs) including recording legal notices on certify that non-potable wells will not prior to the well going dry. MDEQ has property deeds to restrict on-site land be used for potable use and for drinking been conducting annual and semi- and groundwater use; and water wells, and the property owner annual groundwater monitoring since b. Long-term monitoring to assess must submit four consecutive sampling 2004 at a groundwater monitoring well groundwater conditions over time. events at a monitoring well installed at cluster located between the area of The ICs would indicate that only each proposed well location, indicating groundwater contamination that is being industrial, commercial and recreational that groundwater contaminants do not remediated as part of OU2 and the two land use would be allowed until risks exceed applicable MCLs, MDEQ parcels that are being deleted. Benzene, associated with residential use had been drinking water criteria, and other 2,4-dimethylphenol, methylphenols or assessed. In addition, EPA would ensure applicable or relevant and appropriate iron have not been detected in these that the current property owners place criteria. wells above applicable criteria, language in their property deed to including MDEQ’s health-based Response Actions explain that no groundwater wells drinking water standard for iron, which should be installed until on-site Institutional controls are necessary for is currently 2,000 mg/L. This data, along groundwater in the shallow drinking the non-ETA part of PIN 05–11–129– with the data collected from MW–16 water aquifer is below the MCL for 006–00 (41.4 acres) and the non-ETA and subsequent groundwater data benzene (5 parts per billion (ppb)) and part of PIN 05–11–129–007–00 (33.63 collected by the current property owner below the state drinking water standard acres) to restrict residential land use for their Baseline Environmental for 2,4-dimethylphenol (370 ppb). When because the ROD, and subsequent Assessment and Due Care Plan, groundwater monitoring indicates that investigations, assumed future provides assurance that the on-site groundwater is below MCLs and commercial, industrial or recreational contaminated groundwater plume being state drinking water standards during land use. In addition, ICs are necessary remediated as part of OU2 has not four consecutive sampling events, there for groundwater to prevent drinking impacted the groundwater beneath these would no longer be restrictions on water wells or non-potable use wells two parcels. groundwater. from being installed and to protect the Two Explanation of Significant integrity of the ongoing biosparge Cleanup Goals Differences (ESDs) were written, in 2002 remedy, unless property owners provide EPA determined and documented in a and 2004, for the Site; however neither assurances that groundwater use does June 22, 2010 memo to the file that all one impacted the areas currently not impact the ongoing groundwater remedy components pertaining to these proposed for deletion. In 2009, property remedy or provide an unacceptable risk. two parcels have been implemented. owners redeveloping a portion of the On April 16, 2010 and June 10, 2010 There were no cleanup standards Site requested clarification of the MP3 recorded two Declarations of associated with remedial actions taken groundwater institutional controls. The Restrictive Covenants for the non-ETA at these parcels. Groundwater 2002 ROD did not clarify whether part of PIN 05–11–129–006–00 (41.4 monitoring results obtained during the groundwater use was prohibited on the acres), and the non-ETA part of PIN 05– RI and during the operation of the entire site until the groundwater 11–129–007–00 (33.63 acres), groundwater remedy demonstrate that contamination is cleaned up, even if respectively. These Declarations are MCLs and MDEQ Residency Drinking groundwater sampling at a specific consistent with the land and Water Criteria (RDWC) for benzene (5 property indicates chemical groundwater use restrictions required in mg/L), 2,4-dimethylphenol (370 mg/L), concentrations are below MCLs and EPA’s 2002 ROD and 2009 ESD. These methylphenols (370 mg/L) or iron (2,000 MDEQ criteria at that property. Also, the restrictive covenants were approved by mg/L) have not been exceeded in the requirements for groundwater use both EPA and the state before being groundwater underlying these parcels referenced in the 2002 ROD are drinking recorded. These two parcels are proposed for deletion. water standards. On September 14, 2009 facilities as that term is defined in part EPA issued an ESD clarifying that 201 (Environmental Remediation) of the Operation and Maintenance groundwater at the Site may be used for State of Michigan’s Natural Resources The selected remedy in the 2002 ROD either drinking water or non-potable and Environmental Protection Act, 1994 did not specify any ongoing operation purposes before the biosparge PA 451, as amended (NREPA). MDEQ and maintenance on the two parcels groundwater treatment cleanup is makes no warranty as to the fitness of being proposed for deletion, other than complete, provided the use of the these two parcels for any general or ensuring compliance with the recorded groundwater does not negatively impact specific use, and prospective purchasers ICs and conducting monitoring to EPA’s selected remedy for the site, or users are advised to conduct due ensure groundwater is not being including, but not limited to, the diligence prior to acquiring or using any impacted by the benzene contaminated biosparge system and groundwater portion of these two parcels and to groundwater beneath Tar Lake. monitoring wells, or pose an undertake appropriate actions to comply unacceptable risk to human health. The with the requirements of section 20107a Five-Year Review restrictive covenants or other of the NREPA. EPA conducted a five-year review of institutional controls to be implemented As noted in the RI, groundwater the Site in 2009 and determined that the at the Site will state that groundwater at sampling conducted up gradient and remedy selected in the 2002 ROD was the Site may be used for drinking water between the 4-acre depression and the protective in the short-term. The five- or non-potable purposes provided the two parcels proposed for deletion did year review did not recommend any property owner submits a proposal to not contain benzene, 2,4- modifications to the selected remedy for EPA and MDEQ, showing the proposed dimethylphenol or iron above MCLs or the two parcels being proposed for depth, location and pumping rate of EPA risk-based levels. Sampling during deletion. To achieve long-term each proposed non-potable well, the RI at MW–16, located within the protectiveness, the five-year review including an evaluation demonstrating parcels proposed for deletion, also recommended implementation of proper that the expected use of the proposed resulted in non-detects for Volatile restrictive covenants on all Site well(s) should not negatively impact Organic Compounds (VOCs) and Semi- properties now in place for these two

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parcels proposed for deletion, as well as that all appropriate response actions and it will not take effect. EPA will additional data collection and under CERCLA, other than five-year prepare a response to comments and evaluation activities in some areas of the reviews, have been completed on the continue with the deletion process on Site to evaluate iron concentrations in non-ETA part of PIN 05–11–129–006–00 the basis of the Notice of Intent for groundwater. These evaluations being (41.4 acres) and the non-ETA part of PIN Partial Deletion and the comments conducted are outside the boundaries of 05–11–129–007–00 (33.63 acres). already received. There will be no these two parcels and do not affect these Therefore, these two parcels meet the additional opportunity to comment. two parcels. Five-year reviews will criteria of 40 CFR 300.425(e) may be List of Subjects in 40 CFR Part 300 continue because waste was left in place deleted from the NPL. The State of in other areas of the Site above levels Michigan, through MDEQ, concurred on Environmental protection, Air that allow for unrestricted use/ this proposed deletion by letter dated pollution control, Chemicals, Hazardous unrestricted exposure (UU/UE). These May 10, 2011. waste, Hazardous substances, two parcels proposed for deletion will Intergovernmental relations, Penalties, Deletion Action be reviewed during the Site-wide FYR Reporting and recordkeeping to ensure compliance with the EPA, with concurrence of the State of requirements, Superfund, Water institutional controls. The next five-year Michigan through MDEQ, has pollution control, Water supply. review will be conducted in 2014. determined that all appropriate Dated: October 24, 2011. response actions under CERCLA, other Susan Hedman, Community Involvement than operation, maintenance, Regional Administrator, Region 5. Public participation activities have monitoring and five-year reviews, have been satisfied as required by section been completed. Therefore, EPA is For the reasons set out in this 113(k) of CERCLA, 42 U.S.C. 9613(k), deleting all surface soils, subsurface document, 40 CFR part 300 is amended and CERCLA section 117, 42 U.S.C. soils, structures and groundwater within as follows: 9617. Documents in the deletion docket the boundaries of the non-ETA part of PART 300—[AMENDED] which EPA relied on for determining PIN 05–11–129–006–00 (41.4 acres) and that the parcels listed herein meet the the non-ETA part of PIN 05–11–129– ■ 1. The authority citation for part 300 criteria for deletion from the NPL are 007–00 (33.63 acres) parcels of the Tar continues to read as follows: available to the public in the Lake Site from the NPL. information repositories listed above in Because EPA considers this action to Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. the Docket section and at http://www. be noncontroversial and routine, EPA is 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, regulations.gov. taking it without prior publication. This 3 CFR, 1987 Comp., p. 193. action will be effective January 9, 2012 Determination That the Criteria for unless EPA receives adverse comments Appendix B—[Amended] Deletion Have Been Met by December 12, 2011. If adverse ■ 2. Table 1 of Appendix B to part 300 The NCP (40 CFR 300.425(e)) states comments are received within the 30- is amended by revising the entry under that a site may be deleted from the NPL day public comment period, EPA will ‘‘Tar Lake’’, ‘‘MI ’’ to read as follows: when no further response action is publish a timely withdrawal of this appropriate. EPA, in consultation with direct final Notice for Partial Deletion Appendix B to Part 300—National the State of Michigan, has determined before the effective date of the deletion, Priorities List

TABLE 1—GENERAL SUPERFUND SECTION

State Site name City/County Notes a

******* MI Tar Lake Antrim P

******* a *** P = Sites with partial deletion(s).

[FR Doc. 2011–29069 Filed 11–9–11; 8:45 am] BILLING CODE 6560–50–P

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DEPARTMENT OF HOMELAND Atmospheric Administration (NOAA), of individual orders is impractical. SECURITY Commerce. Therefore, the 2011 orders are being ACTION: Temporary orders; inseason published in this single document to Coast Guard orders. avoid fragmentation. 46 CFR Parts 160, 180, and 199 SUMMARY: NMFS publishes Fraser River Inseason Orders salmon inseason orders to regulate The following inseason orders were [Docket No. USCG–2010–0048] treaty and non-treaty (all citizen) adopted by the Panel and issued for U.S. RIN 1625–AB46 commercial salmon fisheries in U.S. fisheries by NMFS during the 2011 waters. The orders were issued by the fishing season. Each of the following Lifesaving Equipment: Production Fraser River Panel (Panel) of the Pacific inseason actions was effective upon Testing and Harmonization With Salmon Commission (Commission) and announcement on telephone hotline International Standards subsequently approved and issued by numbers as specified at 50 CFR NMFS during the 2011 salmon fisheries 300.97(b)(1) and in 76 FR 25246 (May 4, Correction within the U.S. Fraser River Panel Area. 2011); those dates and times are listed In rule document 2011–25035, These orders established fishing dates, herein. The times listed are local times, appearing on pages 62962–63015 in the times, and areas for the gear types of and the areas designated are Puget issue of Monday, October 11, 2011, U.S. treaty Indian and all citizen Sound Management and Catch make the following corrections: commercial fisheries during the period Reporting Areas as defined in the the Panel exercised jurisdiction over Washington State Administrative Code § 160.051–1 [Corrected] these fisheries. at Chapter 220–22. ■ 1. On page 62975, in the second DATES: The effective dates for the Order Number 2011–01: Issued 12:30 column, in § 160.051–1(b), in the fifth inseason orders are set out in this p.m., July 26, 2011 through seventh lines, ‘‘[INSERT DATE document under the heading Inseason 30 DAYS AFTER DATE OF Orders. Treaty Indian Fisheries PUBLICATION OF INTERIM RULE]’’ FOR FURTHER INFORMATION CONTACT: Areas 4B, 5, and 6C: Open to drift should read ‘‘November 10, 2011’’. Peggy Mundy at (206) 526–4323. gillnets from 6 p.m., Tuesday, July 26, § 160.151–1 [Corrected] SUPPLEMENTARY INFORMATION: The 2011 to 12 p.m. (noon), Saturday, July Treaty between the Government of the 30, 2011. ■ 2. On page 62996, in the second United States of America and the column, in § 160.151–1, in the sixth Order Number 2011–02: Issued 11:30 Government of Canada concerning through eighth lines, ‘‘[INSERT DATE a.m., July 29, 2011 Pacific Salmon was signed at Ottawa on 30 DAYS AFTER DATE OF January 28, 1985, and subsequently was Treaty Indian Fisheries PUBLICATION OF INTERIM RULE]’’ given effect in the United States by the should read ‘‘November 10, 2011’’. Areas 4B, 5, and 6C: Open to drift Pacific Salmon Treaty Act (Act) at 16 gillnets, extended from 12 p.m. (noon), § 180.150 [Corrected] U.S.C. 3631–3644. Saturday, July 30, 2011 to 12 p.m. Under authority of the Act, Federal ■ (noon), Wednesday, August 3, 2011. 3. On page 63015, in the third column, regulations at 50 CFR part 300, subpart in § 180.150(c)(2), in the second through F provide a framework for the Order Number 2011–03: Issued 12:30 fourth lines, ‘‘[INSERT DATE 30 DAYS implementation of certain regulations of p.m., August 2, 2011 AFTER DATE OF PUBLICATION OF the Commission and inseason orders of Treaty Indian Fisheries INTERIM RULE]’’ should read the Commission’s Fraser River Panel for ‘‘November 10, 2011’’. U.S. sockeye and pink salmon fisheries Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon), § 199.150 [Corrected] in the Fraser River Panel Area. The regulations close the U.S. portion Wednesday, August 3, 2011, to 12 p.m. ■ 4. On page 63015, in the third column, of the Fraser River Panel Area to U.S. (noon), Thursday, August 4, 2011. in § 199.150(a)(2)(ii), in the second sockeye and pink salmon Tribal and through fourth lines, ‘‘[INSERT DATE Order Number 2011–04: Issued 11:45 non-Tribal commercial fishing unless a.m., August 3, 2011 30 DAYS AFTER DATE OF opened by Panel orders that are given PUBLICATION OF INTERIM RULE]’’ effect by inseason regulations published Treaty Indian Fisheries should read ‘‘November 10, 2011’’. by NMFS. During the fishing season, Areas 4B, 5, and 6C: Extend for drift [FR Doc. C1–2011–25035 Filed 11–9–11; 8:45 am] NMFS may issue regulations that gillnets from 12 p.m. (noon) Thursday, BILLING CODE 1505–01–D establish fishing times and areas August 4, 2011 to 12 p.m. (noon) consistent with the Commission Saturday, August 6, 2011. agreements and inseason orders of the Areas 6, 7, and 7A: Open to net DEPARTMENT OF COMMERCE Panel. Such orders must be consistent fishing from 5 a.m. Thursday, August 4, with domestic legal obligations and are 2011 to 9 a.m. Friday, August 5, 2011. National Oceanic and Atmospheric issued by Regional Administrator, Administration Northwest Region, NMFS. Official All Citizen Fisheries notification of these inseason actions is Areas 7 and 7A: Open to gillnets from 50 CFR Part 300 provided by two telephone hotline 2 p.m. to 11:59 p.m. (midnight) Friday, numbers described at 50 CFR August 5, 2011. RIN 0648–XA803 300.97(b)(1) and in 76 FR 25246 (May 4, Areas 7 and 7A: Open to purse seines Fraser River Sockeye and Pink Salmon 2011). The inseason orders are from 9 a.m. to 7 p.m. Friday, August 5, Fisheries; Inseason Orders published in the Federal Register as 2011. soon as practicable after they are issued. Areas 7 and 7A: Open to reefnets from AGENCY: National Marine Fisheries Due to the frequency with which 5 a.m. to 3 p.m. Saturday, August 6, Service (NMFS), National Oceanic and inseason orders are issued, publication 2011.

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Order Number 2011–05: Issued 1:30 Order Number 2011–09: Issued 2:25 Areas 6, 7, and 7A: Open to net p.m., August 5, 2011 p.m., August 15, 2011 fishing from 5 a.m. until 11:59 p.m. (midnight) Tuesday, August 30, 2011. Treaty Indian Fisheries Treaty Indian Fisheries All Citizen Fisheries Areas 4B, 5, and 6C: Extend for drift Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon), Saturday, gillnets from 12 p.m. (noon) Tuesday, Areas 7 and 7A: Open to gillnets with August 6, 2011, to 12 p.m. (noon), August 16, 2011, through 12 p.m. (noon) non-retention of sockeye from 8 a.m. to Tuesday, August 9, 2011. Wednesday, August 17, 2011. 11:59 p.m. (midnight) Wednesday, August 31, 2011. Areas 6, 7, and 7A: Open to net Order Number 2011–10: Issued 1:15 Areas 7 and 7A: Open to purse seines fishing from 5 a.m. Saturday, August 6, p.m., August 19, 2011 with non-retention of sockeye from 5 2011 to 11:59 p.m. Saturday, August 6, Treaty Indian Fisheries a.m. to 9 p.m. Wednesday, August 31, 2011. 2011. Areas 4B, 5, and 6C: Open for drift Areas 7 and 7A: Open to reefnets with Order Number 2011–06: Issued 3 p.m., gillnets from 12 p.m. (noon) Saturday, non-retention of sockeye from 5 a.m. to August 8, 2011 August 20 through 12 p.m. (noon) 9 p.m. Tuesday, August 30, 2011, Wednesday, August 24, 2011. Treaty Indian Fisheries Wednesday, August 31, 2011 and Areas 6, 7, and 7A: Open to net Thursday, September 1, 2011. Areas 4B, 5, and 6C: Extend for drift fishing from 5 a.m. Monday, August 22, gillnets from 12 p.m. (noon), Tuesday, 2011 through 9 a.m. Tuesday, August Order Number 2011–14: Issued 1:30 August 9, 2011, through 12 p.m. (noon) 23, 2011. p.m., September 1, 2011 Wednesday, August 10, 2011. Order Number 2011–11: Issued 1:30 Treaty Indian Fisheries Order Number 2011–07: Issued 12:30 p.m., August 23, 2011 Areas 4B, 5, and 6C: Extend for drift p.m., August 9, 2011 Treaty Indian Fisheries gillnets from 12 p.m. (noon) Friday, Treaty Indian Fisheries September 2, 2011 through 12 p.m. Areas 4B, 5, and 6C: Extend for drift (noon) Wednesday, September 7, 2011. Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon) Areas 6, 7, and 7A: Open to net gillnets from 12 p.m. (noon) Wednesday, August 24, 2011 through 12 fishing from 5 a.m. Friday, September 2, Wednesday, August 10, 2011 through 12 p.m. (noon) Saturday, August 27, 2011. 2011 until 11 a.m. Sunday, September 4, p.m. (noon) Saturday, August 13, 2011. Areas 6, 7, and 7A: Open to net 2011, in the area southerly and easterly fishing from 5 a.m. Thursday, August Areas 6, 7, and 7A: Open to net of a straight line drawn from Iwersen’s 25, 2011 through 11:59 p.m. (midnight) fishing from 5 a.m. to 11:59 p.m. dock on Point Roberts in the State of Friday, August 26, 2011. (midnight) Wednesday, August 10, Washington to the Georgina Point Light 2011. All Citizen Fisheries at the entrance to Active Pass in the Province of British Columbia. All Citizen Fisheries Areas 7 and 7A: Open to gillnets from 8 a.m. to 11:59 p.m. (midnight) All Citizen Fisheries Areas 7 and 7A: Open to gillnets from Wednesday, August 24, 2011. Areas 7 and 7A: Open to gillnets with 8 a.m. to 11:59 p.m. (midnight) Areas 7 and 7A: Open to purse seines Thursday, August 11, 2011. non-retention of sockeye from 11 a.m. to from 5 a.m. to 9 p.m. Wednesday, 11:59 p.m. (midnight) Sunday, Areas 7 and 7A: Open to purse seines August 24, 2011. September 4, 2011, in the area southerly from 9 a.m. to 5 p.m. Thursday, August Areas 7 and 7A: Open to reefnets from and easterly of a straight line drawn 11, 2011. 5 a.m. to 9 p.m. Wednesday, August 24, from Iwersen’s dock on Point Roberts in Areas 7 and 7A: Open to reefnets from 2011, Thursday, August 25, 2011, and the State of Washington to the Georgina 5 a.m. to 9 p.m. Thursday, August 11, Friday August 26, 2011. Point Light at the entrance to Active 2011. Order Number 2011–12: Issued 1:45 Pass in the Province of British Order Number 2011–08: Issued 1:40 p.m., August 26, 2011 Columbia. p.m., August 12. 2011 Areas 7 and 7A: Open to purse seines Treaty Indian Fisheries with non-retention of sockeye from 11 Treaty Indian Fisheries Areas 4B, 5, and 6C: Extend for drift a.m. to 9 p.m. Sunday, September 4, gillnets from 12 p.m. (noon) Saturday, 2011, in the area southerly and easterly Areas 4B, 5, and 6C: Extend for drift August 27, 2011 through 12 p.m. (noon) of a straight line drawn from Iwersen’s gillnets from 12 p.m. (noon) Saturday, Tuesday, August 30, 2011. dock on Point Roberts in the State of August 13, 2011 through 12 p.m. (noon) Washington to the Georgina Point Light All Citizen Fisheries Tuesday, August 16, 2011. at the entrance to Active Pass in the All Citizen Fisheries Areas 7 and 7A: Open to reefnets with Province of British Columbia. non-retention of sockeye from 5 a.m. to Areas 7 and 7A: Open to reefnets with Areas 7 and 7A: Open to gillnets from 9 p.m. Saturday, August 27, 2011, non-retention of sockeye daily from 5 12 p.m. (noon) to 11:59 p.m. (midnight) Sunday, August 28, 2011, and Monday a.m. to 9 p.m. Friday, September 2, 2011 Sunday, August 14, 2011. August 29, 2011. through Tuesday, September 6, 2011. Areas 7 and 7A: Open to purse seines Order Number 2022–13: Issued 1 p.m., Order Number 2011–15: Issued 11:30 from 10 a.m. to 4 p.m. Monday, August August 29, 2011 a.m., September 2, 2011 15, 2011. Areas 7 and 7A: Open to reefnets from Treaty Indian Fisheries Treaty Indian Fisheries 12 p.m. (noon) to 8 p.m. Saturday, Areas 4B, 5, and 6C: Extend for drift Areas 6, 7, and 7A: Open to net August 13, 2011, and from 12 p.m. gillnets from 12 p.m. (noon) Tuesday, fishing from 5 a.m. Monday, September (noon) to 8 p.m. Sunday, August 14, August 30, 2011 through 12 p.m. (noon) 5, 2011 until 9 a.m. Tuesday, September 2011. Friday, September 2, 2011. 6, 2011, in the area southerly and

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easterly of a straight line drawn from Order Number 2011–18: Issued 9 a.m., DEPARTMENT OF COMMERCE Iwersen’s dock on Point Roberts in the September 19, 2011 State of Washington to the Georgina National Oceanic and Atmospheric Point Light at the entrance to Active Areas 6 and 7: Relinquish regulatory Administration Pass in the Province of British control effective 11:59 p.m. (midnight), Columbia. Saturday, September 24, 2011. 50 CFR Part 635 All Citizen Fisheries Area 7A: The area easterly of the [Docket No. 110912579–1627–01] Eastpoint Light line will be relinquished Areas 7 and 7A: Open to gillnets with as scheduled at 11:59 p.m. (midnight) RIN 0648–BB43 non-retention of sockeye from 8:15 a.m. on Saturday, October 1, 2011. The to 11:59 p.m. (midnight) Tuesday, Atlantic Highly Migratory Species; remainder of Area 7A (westerly of the September 6, 2011, in the area southerly Update to Information on the Effective Eastpoint Light line) will be and easterly of a straight line drawn Date of Atlantic Smoothhound Shark from Iwersen’s dock on Point Roberts in relinquished as scheduled at 11:59 p.m. Fishery Management Measures the State of Washington to the Georgina (midnight) on Saturday, October 8, Point Light at the entrance to Active 2011. AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Pass in the Province of British Classification Columbia. Atmospheric Administration (NOAA), Areas 7 and 7A: Open to purse seines The Assistant Administrator for Commerce. with non-retention of sockeye from 5 Fisheries NOAA (AA), finds that good ACTION: Final rule. a.m. to 9 p.m. Tuesday, September 6, cause exists for the inseason orders to be SUMMARY: NMFS is updating the 2011, in the area southerly and easterly issued without affording the public anticipated effective date of of a straight line drawn from Iwersen’s prior notice and opportunity for smoothhound shark management dock on Point Roberts in the State of comment under 5 U.S.C. 553(b)(B) as Washington to the Georgina Point Light measures implemented in the Final Rule such prior notice and opportunity for for Amendment 3 to the 2006 at the entrance to Active Pass in the comments is impracticable and contrary Province of British Columbia. Consolidated Highly Migratory Species to the public interest. Prior notice and (HMS) Fishery Management Plan (FMP) Order Number 2011–16: Issued 12:30 opportunity for public comment is that published on June 1, 2010, and p.m., September 6, 2011 impracticable because NMFS has were corrected on August 17, 2010. insufficient time to allow for prior Treaty Indian Fisheries These measures originally were to be notice and opportunity for public effective around April 2012, before the Areas 4B, 5, and 6C: Extend for drift comment between the time the stock beginning of the 2012 fishing year. gillnets from 12 p.m. (noon) abundance information is available to However, the recently enacted Shark Wednesday, September 7, 2011 through determine how much fishing can be Conservation Act of 2010 requires 9 a.m. Friday, September 9, 2011. allowed and the time the fishery must NMFS to re-evaluate its shark Areas 6, 7, and 7A: Open to net open and close in order to harvest the management measures. The effective fishing from 5 a.m. Wednesday, appropriate amount of fish while they date will therefore be later than September 7, 2011 until 9 a.m. Friday, are available. originally thought to fully consider the September 9, 2011, in the area southerly Shark Conservation Act implications The AA also finds good cause to and easterly of a straight line drawn and to allow time for the Section 7 waive the 30-day delay in the effective from Iwersen’s dock on Point Roberts in consultation under the Endangered date, required under 5 U.S.C. 553(d)(3), the State of Washington to the Georgina Species Act (ESA) to be completed. This Point Light at the entrance to Active of the inseason orders. A delay in the rule also removes and reserves the Pass in the Province of British effective date of the inseason orders smoothhound shark regulations. These Columbia. would not allow fishers appropriately sections will be returned, with controlled access to the available fish at All Citizen Fisheries amendments as needed, in a final rule that time they are available. that implements both the smoothhound Areas 7 and 7A: Open to reefnets with shark sections of the Shark Conservation non-retention of sockeye from 5 a.m. to This action is authorized by 50 CFR Act and any requirements of the Section 9 p.m. Wednesday, September 7, 2011 300.97, and is exempt from review 7 consultation regarding smoothhound and Thursday, September 8, 2011. under Executive Order 12866. sharks. Authority: 16 U.S.C. 3636(b). Order Number 2011–17: Issued 1 p.m., DATES: The rule is effective December Dated: November 4, 2011. September 12, 2011 12, 2011. The amendments to Treaty Indian Fisheries Steven Thur, § 635.21(e)(3)(i), § 635.24(a)(7), and Acting Director, Office of Sustainable § 635.71(d)(18), published at 76 FR Areas 4B, 5, and 6C: Open for drift Fisheries, National Marine Fisheries Service. gillnets from 5 a.m. until 11:59 p.m. 49379, August 10, 2011, are withdrawn, [FR Doc. 2011–29192 Filed 11–9–11; 8:45 am] (midnight) Tuesday, September 13, effective November 10, 2011. 2011. BILLING CODE 3510–22–P FOR FURTHER INFORMATION CONTACT: Areas 6, 7, and 7A: Open to net Steve Durkee at (202) 670–6637 or Karyl fishing from 5 a.m. until 11:59 p.m. Brewster-Geisz at (301) 427–8503; (fax) (midnight) Tuesday, September 13, (301) 713–1917. 2011, in the area southerly and easterly SUPPLEMENTARY INFORMATION: The of a straight line drawn from Iwersen’s Atlantic shark fisheries are managed dock on Point Roberts in the State of under the 2006 Consolidated Atlantic Washington to the Georgina Point Light Highly Migratory Species (HMS) Fishery at the entrance to Active Pass in the Management Plan (FMP), its Province of British Columbia. amendments, and its implementing

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regulations found at 50 CFR part 635, perform outreach to a new set of effective date of the measures in the issued under authority of the constituents and to implement a new forthcoming final rule to implement Magnuson-Stevens Fishery commercial smoothhound fishing 2010 Shark Conservation Act Conservation and Management Act (16 permit (including Office of Management smoothhound provisions, and only after U.S.C. 1801 et seq.). and Budget approval). In the final rule ESA Section 7 consultation is The regulatory identification number implementing Amendment 3, NMFS completed. Notice of the effective date (RIN) for Amendment 3 to the 2006 stated that a document would be will be provided to the public and Consolidated HMS FMP was published in the Federal Register interested parties through publication in prematurely closed. The RIN for this announcing the effective date of those the Federal Register and through other action is formally tied to the closed RIN provisions once the Office of outreach channels, including for Amendment 3, 0648–AW65. Management and Budget (OMB) constituent phone calls and listserve Amendment 3 (75 FR 30484, June 1, approved information collection 2010; corrected by 75 FR 50715, August requirements, as required under the notices. This rule also removes and 17, 2010) will bring smoothhound Paperwork Reduction Act (PRA). reserves the smoothhound shark sharks under Federal management. The Furthermore, NMFS stated that the regulations in the Code of Federal smoothhound shark complex consists of effective date would likely be before the Regulations. These sections will be smooth dogfish (Mustelus canis) and the start of the 2012 fishing season for returned, with amendments as needed, Florida smoothhound (Mustelus norrisi). smoothhounds (approximately April 1, in a final rule that implements both the In Amendment 3, NMFS determined 2012). smoothhound shark sections of the that smoothhound sharks are oceanic Since publication of the final rule Shark Conservation Act and any sharks that should be managed under implementing Amendment 3, the Shark requirements of the Section 7 the Secretary’s authority because of Conservation Act of 2010 (Pub. L. 111– consultation regarding smoothhound their wide distribution and because 348) became law. This legislation sharks. their range extends into the jurisdictions directly impacts the smoothhound shark of more than one of the five Atlantic fishery. Specifically, it amended the Classification fishery management councils. NMFS Magnuson-Stevens Fishery The NMFS AA has determined that noted that, based on existing data, the Conservation and Management Act this final action is necessary for the smoothhound shark fishery was (Magnuson-Stevens Act) to provide substantial, with average annual greater protection for sharks landed in conservation and management of the landings of 431 mt dw, which would or imported into the United States. HMS fishery, and that it is consistent rank among the highest for any species Among the provisions are two with the Magnuson-Stevens Act, the of shark managed by NMFS. requirements that affect domestic shark 2006 Consolidated Atlantic HMS FMP Accordingly, NMFS determined that management. One provision amends the and its amendments, ATCA, and other sound, science-based conservation and Magnuson-Stevens Act to require that applicable law. management was necessary to provide all sharks landed in the United States be This final rule has been determined to for the long-term sustainable yield of the maintained with the fins naturally- be not significant for purposes of stock. attached to the carcass through Executive Order 12866. Most smoothhound shark catch offloading. The second provision is occurs with gillnet and trawl gear. In labeled as a ‘‘savings clause’’ and reads: Pursuant to 5 U.S.C. 553(b)(B), there Amendment 3, NMFS stated that ‘‘The amendments made by subsection is good cause to waive prior notice and managing the species using uniform (a) do not apply to an individual an opportunity for public comment on conservation and management measures engaged in commercial fishing for this action, as notice and comment is developed and implemented through an smooth dogfish (Mustelus canis) in that unnecessary. This action does not FMP in accordance with the procedures area of the waters of the United States amend prior regulations, but merely set forth in the Magnuson-Stevens Act located shoreward of a line drawn in provides updated information on the would better engage fishermen in such a manner that each point on it is anticipated timing of future rulemaking developing conservation measures 50 nautical miles from the baseline of a to implement Amendment 3. Indeed, affecting the fishery. It would become State from which the territorial sea is NMFS is not proposing any particular increasingly difficult for NMFS to measured, if the individual holds a rulemaking action upon which the determine if prescriptive conservation valid State commercial fishing license, public could comment, but is instead and management measures, through unless the total weight of smooth delaying the anticipated effective date of future FMP amendments and/or dogfish fins landed or found on board a regulation to allow NMFS to assess the regulatory changes, were needed a vessel to which this subsection applies impact of the 2010 Shark Conservation without initial smoothhound exceeds 12 percent of the total weight of Act on the original rulemaking. For the management measures in place to smooth dogfish carcasses landed or same reasons, there is good cause under collect critical data through Amendment found on board.’’ 5 U.S.C. 553(d)(3) to waive the 30-day 3. Since NMFS needs to complete ESA The final rule implementing consultation for the measures proposed delay in effective date. Amendment 3 published in June 2010, for smoothhound sharks, and because Because prior notice and opportunity but the effective date for all the Agency needs to consider and for public comment are not required for smoothhound shark management implement congressionally-mandated this rule by 5 U.S.C. 553, or any other measures was delayed to provide time smoothhound fishery management law, the analytical requirements of the for the NMFS Southeast Regional Office measures, NMFS is postponing the Regulatory Flexibility Act, 5 U.S.C. 601 of Protected Resources to finalize a anticipated effective date of the et seq., are inapplicable. Biological Opinion (BiOp) on the Amendment 3 smoothhound proposed Amendment 3 measures for management measures. The Agency no List of Subjects in 50 CFR Part 635 smoothhound effects on ESA-listed longer anticipates an effective date of Fisheries, Fishing, Fishing vessels, turtles and the northern right whale. April 1, 2012. Instead, NMFS Permits, Quota, Smoothhound shark. Time was also needed for NMFS to anticipates the date will fall on the

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Dated: November 7, 2011. Authority: 16 U.S.C. 971 et seq.; 16 U.S.C. § 635.22 [Amended] 1801 et seq. Samuel D. Rauch III, ■ 5. In § 635.22, paragraph (c)(6) is Deputy Assistant Administrator for § 635.2 [Amended] removed and reserved. Regulatory Programs, National Marine Fisheries Service. ■ 2. In § 635.2, the definition of § 635.27 [Amended] For the reasons set out in the ‘‘smoothhound shark’’ is removed. ■ 6. In § 635.27, paragraphs (b)(1)(vii) preamble, 50 CFR part 635 is amended § 635.4 [Amended] and (b)(2)(iv) are removed and reserved. as follows: Appendix A to Part 635 [Amended] ■ 3. In § 635.4, paragraph (e)(4) is PART 635—ATLANTIC HIGHLY removed and reserved. ■ 7. In Table 1 of Appendix A to part MIGRATORY SPECIES 635, the heading and text for the entry § 635.20 [Amended] E is removed and reserved. ■ 1. The authority citation for part 635 ■ 4. In § 635.20, paragraph (e)(4) is [FR Doc. 2011–29180 Filed 11–9–11; 8:45 am] continues to read as follows: removed and reserved. BILLING CODE 3510–22–P

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Proposed Rules Federal Register Vol. 76, No. 218

Thursday, November 10, 2011

This section of the FEDERAL REGISTER regulations that preclude considerations (301) 415–4737, or by email to contains notices to the public of the proposed of those issues in individual licensing [email protected]. For the ADAMS issuance of rules and regulations. The proceedings. The petitioners also accession numbers for the documents purpose of these notices is to give interested request the NRC to suspend multiple related to the 15 PRMs, see Section I, persons an opportunity to participate in the ongoing licensing proceedings while the Procedural Processing, of this rule making prior to the adoption of the final rules. NRC considers these petitions and the document. environmental issues raised in the • Federal Rulemaking Web Site: Fukushima Task Force Report. The NRC Supporting materials related to the 15 NUCLEAR REGULATORY is not instituting a public comment petitions for rulemaking can be found at COMMISSION period for these PRMs at this time. http://www.regulations.gov by searching ADDRESSES: You can access publicly on Docket ID NRC–2011–0189. Address 10 CFR Part 51 available documents related to the 15 questions about NRC dockets to Carol [Docket Nos. PRM–51–14, et al.; NRC–2011– petitions for rulemaking, using the Gallagher; telephone: (301) 492–3668; 0189] following methods: email: [email protected]. • NRC’s Public Document Room FOR FURTHER INFORMATION CONTACT: Taxpayers and Ratepayers United, et (PDR): The public may examine and Cindy Bladey, Chief, Rules, al.; Environmental Impacts of Severe have copies made, for a fee, publicly Announcements, and Directives Branch, Reactor and Spent Fuel Pool Accidents available documents at the NRC’s PDR, Division of Administrative Services, AGENCY: Nuclear Regulatory Room O1–F21, One White Flint North, Office of Administration, U.S. Nuclear Commission. 11555 Rockville Pike, Rockville, Regulatory Commission, Washington, Maryland 20852. DC 20555–0001, telephone: (301) 492– ACTION: Petitions for rulemaking; notice • 3667, email: [email protected]. of receipt. NRC’s Agencywide Documents Access and Management System SUPPLEMENTARY INFORMATION: SUMMARY: The U.S. Nuclear Regulatory (ADAMS): Publicly available documents Commission (NRC or the Commission) created or received at the NRC are I. Procedural Processing has received 15 petitions for rulemaking available online in the NRC Library at The petitions for rulemaking were (PRMs), each dated August 10, August http://www.nrc.gov/reading-rm/ docketed by the NRC on September 20, 11, or August 12, 2011, from the adams.html. From this page, the public 2011, and have been assigned the multiple petitioners listed in Section I, can gain entry into ADAMS, which Docket Numbers identified in the Procedural Processing, of this provides text and image files of the following table. The following table also document. The petitioners request that NRC’s public documents. If you do not identifies the ADAMS accession the NRC rescind its regulations that have access to ADAMS or if there are numbers for each PRM. In addition, the allow generic conclusions about the problems in accessing the documents following table provides the specific environmental impacts of severe reactor located in ADAMS, contact the NRC’s licensing proceedings that each and spent fuel pool accidents and its PDR reference staff at 1 (800) 397–4209, petitioner requests the NRC to suspend.

Licensing pro- Petitioner Docket Nos. ADAMS Accession No. ceeding affected

Gene Stilp, on behalf of Taxpayers and Ratepayers United ...... PRM–51–14 ..... ML112430559 ...... Bell Bend. Diane Curran, on behalf of San Luis Obispo Mothers for Peace ...... PRM–51–15 ...... ML11236A322 ...... Diablo Canyon. Diane Curran, on behalf of Southern Alliance for Clean Energy ...... PRM–51–16 ...... ML11223A291 ...... Watts Bar. Mindy Goldstein, on behalf of Center for a Sustainable Coast, Geor- PRM–51–17 ...... ML11223A043 ...... Vogtle. gia Women’s Action for New Directions f/k/a/ Atlanta Women’s Ac- tion for New Directions, and Southern Alliance for Clean Energy. Mindy Goldstein, on behalf of Southern Alliance for Clean Energy, PRM–51–18 ...... ML11223A044 ...... Turkey Point. National Parks Conservation Association, Dan Kipnis, and Mark Oncavage. Deborah Brancato, on behalf of Riverkeeper, Inc. & Hudson River PRM–51–19 ..... ML11229A712 ...... Indian Point. Sloop Clearwater, Inc. Paul Gunter, on behalf of Beyond Nuclear, Seacoast Anti-Pollution PRM–51–20 ...... ML11223A371 ...... Seabrook. League and Sierra Club of New Hampshire. Michael Mariotte, on behalf of Nuclear Information and Resource PRM–51–21 ...... ML11223A344 ...... Calvert Cliffs. Service, Beyond Nuclear, Public Citizen, and SOMDCARES. Raymond Shadis, on behalf of Friends of the Coast and New Eng- PRM–51–22 ...... ML11223A465 (PRM) ...... Seabrook. land Coalition. ML11223A443 (Motion to Admit). ML11223A444 (Contention). ML11223A446 (Declaration). Robert V. Eye, on behalf of Intervenors in South Texas Project Nu- PRM–51–23 ...... ML11223A472 ...... South Texas. clear Operating Co., Application for Units 3 and 4 Combined Oper- ating License. Robert V. Eye, on behalf of Intervenors in Luminant Generation Com- PRM–51–24 ...... ML11223A477 ...... Comanche pany, LCC, Application for Comanche Peak Nuclear Power Plant Peak. Combined License.

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Licensing pro- Petitioner Docket Nos. ADAMS Accession No. ceeding affected

Mary Olson, on behalf of the Ecology Party of Florida, Nuclear Infor- PRM–51–25 ..... ML11224A074 ...... Levy. mation and Resource Service Southeast Office, and the Green Party of Florida. Terry Lodge, on behalf of Beyond Nuclear, Citizens Environment Alli- PRM–51–26 ...... ML112450527 ...... Davis-Besse. ance of Southwestern Ontario, Don’t Waste Michigan, and the Green Party of Ohio. Terry Lodge, on behalf of Beyond Nuclear, Citizens for Alternatives to PRM–51–27 ...... ML112450528 ...... Fermi. Chemical Contamination, Citizens Environmental Alliance of South- western Ontario, Don’t Waste Michigan, Sierra Club, Keith Gunter, Edward McArdle, Henry Newman, Derek Coronado, Sandra Bihn, Harold L. Stokes, Michael J. Keegan, Richard Coronado, George Steinman, Marilyn R. Timmer, Leonard Mandeville, Frank Mantei, Marcee Meyers, and Shirley Steinman. Barry White, on behalf of Citizens Allied for Safe Energy, Inc ...... PRM–51–28 ...... ML11224A232 ...... Turkey Point.

Each submission separately cites the II. Petitioners The petitioners assert that the Fukushima Task Force Report and the ‘‘Recommendations for Enhancing Each petitioner is an intervener group Declaration demonstrate that the Reactor Safety in the 21st Century: The that has filed PRMs and contentions to ‘‘Fukushima accident has significant Near-Term Task Force Review of suspend licensing proceedings while regulatory implications with respect to Insights from the Fukushima Dai-ichi the NRC considers the environmental both severe reactor accidents and spent Accident’’ (Fukushima Task Force impacts of each licensing proceeding fuel pool accidents, because the Task Report, ADAMS Accession No. and the environmental implications in Force Report recommends that ML111861807), dated July 12, 2011, as the Fukushima Task Force Report. rationale for the petitions for mitigative measures for both of these rulemaking. The Commission has III. Petitions types of accidents, which are not currently included in the design basis recently directed staff to engage All 15 PRMs cite the Fukushima Task for nuclear reactors, should be added to Force Report dated July 12, 2011, promptly with stakeholders to review the design basis and subject to and assess the recommendations of the currently under review by the mandatory safety regulation.’’ Fukushima Task Force Report for the Commission, as rationale for the Primarily, the petitioners request that purpose of providing the Commission petitions for rulemaking. The the NRC rescind all regulations in Title with fully-informed options and Fukushima Task Force was a group of 10 of the Code of Federal Regulations recommendations. See U.S. Nuclear NRC staff experts specifically selected to (10 CFR) part 51 (including 51.45, 51.53, Regulatory Commission, ‘‘Near-Term review the Fukushima Dai-ichi Accident and 51.95 and Appendix B to 10 CFR Report and Recommendations for and make recommendations applicable part 51) that ‘‘reach generic conclusions Agency Actions Following the Events in to power reactors in the United States. about the environmental impacts of Japan,’’ Staff Requirements In addition to the Fukushima Task severe reactor and/or spent fuel pool Memorandum SECY–11–0093, August Force Report, each petitioner cites the accidents and therefore prohibit 19, 2011 (ADAMS Accession No. Declaration of Dr. Arjun Makhijani (the consideration of those impacts’’ in ML112310021) and U.S. Nuclear Declaration, ADAMS Accession No. reactor licensing proceedings. ML11223A446) as rationale for their Regulatory Commission, ‘‘Engagement Specifically, the petitioners request contentions and PRMs. Dr. Makhijani is of Stakeholders Regarding the Events in rescission of ‘‘any NRC regulations that the President of the Institute for Energy Japan,’’ Staff Requirements would prevent the NRC from complying and Environmental Research (IEER) in with its obligation under the National Memorandum COMWDM–11–0001/ Takoma Park, Maryland. The IEER Environmental Policy Act (NEPA).’’ The COMWCO–11–0001, August 22, 2011 provides scientific information and petitioners also request rescission of (ADAMS Accession No. ML112340693). analyses to advocacy groups and policy NRC regulations that would impede The NRC will consider the issues raised makers on a wide range of technical consideration of ‘‘the environmental by these PRMs through the process the topics such as energy and implications of new and significant Commission has established for environmental issues. Dr. Makhijani information discussed in the Fukushima addressing the recommendations from declares that the Fukushima Task Force Task Force Report regarding the the Fukushima Task Force Report, and Report ‘‘provides further support for regulatory implications of the is not providing a separate opportunity [his] opinions that the Fukushima Fukushima Dai-ichi nuclear accident’’ for public comment on the PRMs at this accident presents new and significant in the licensing proceedings. time. information regarding the risks to public In support of their requests to On September 9, 2011, the health and safety and the environment suspend licensing proceedings, the Commission issued a Memorandum and posed by the operation of nuclear petitioners quoted Robertson v. Methow Order, Union Electric Company D/B/A/ reactors and that the integration of this Valley Citizens Council, 490 U.S. 332, Ameren Missouri et al. (Callaway Plant, new information into the NRC’s 350 (1989) which states that ‘‘NEPA licensing process could affect the requires that agencies consider the Unit, et al.), CLI–11–05, __ NRC __ outcome of safety and environmental environmental impacts of their actions (Sept. 9, 2011) (slip op. at 41) which analyses for reactor licensing and before they are taken, in order to ensure declined the petitioners’ request to relicensing decisions and the NRC’s that ‘important effects [of the licensing suspend any of the licensing or evaluation of the fitness of new reactor decision] will not be overlooked or rulemaking proceedings pending designs for certification.’’ See page 2 in underestimated only to be discovered resolution of these rulemaking petitions. the Declaration. after resources have been committed or

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the die otherwise cast.’ ’’ The petitioners biennial community support statements Telecommunications Device for the assert that the ‘‘NRC’s obligation to containing their most recent CRA Hearing Impaired is (800) 877–8339. comply with NEPA in this respect is evaluations. Instead, the Banks would SUPPLEMENTARY INFORMATION: independent of and in addition to the verify a member’s CRA rating from NRC’s responsibilities under the Atomic publicly-available information from the I. Comments Energy Act, and must be enforced to the Federal Financial Institutions FHFA invites comments on all aspects ‘fullest extent possible.’ ’’ Thus, the Examination Council (FFIEC) or the of the proposed rule, and will revise the petitioners argue that the ‘‘NRC has a member’s primary Federal banking language of the proposed rule as non-discretionary duty to suspend’’ the regulatory agency. In addition, the appropriate after taking all comments subject licensing proceedings ‘‘while it Banks would be responsible for into consideration. Copies of all considers the environmental impacts of overseeing members’ compliance with comments will be posted without that decision, including the first-time homebuyer requirements. change, including any personal environmental implications of the Task DATES: Written comments must be information you provide, such as your Force Report with respect to severe received on or before February 8, 2012. name and address, on the FHFA Internet Web site at http://www.fhfa.gov. In reactor and spent fuel pool accidents.’’ ADDRESSES: You may submit your addition, copies of all comments comments, identified by regulatory IV. Conclusion received will be available for information number (RIN) 2590–AA38, examination by the public on business The Commission is currently by any of the following methods: reviewing the Fukushima Task Force • Email: Comments to Alfred M. days between the hours of 10 a.m. and Report, including the issues presented Pollard, General Counsel, may be sent 3 p.m., at the Federal Housing Finance Agency, Fourth Floor, 1700 G Street in the 15 petitions for rulemaking. The by email to [email protected]. NW., Washington, DC 20552. To make petitioners specifically cite the Please include ‘‘RIN 2590–AA38’’ in the an appointment to inspect comments, Fukushima Task Force Report as subject line of the message. rationale for the PRMs. The NRC will • Federal eRulemaking Portal: http:// please call the Office of General Counsel consider the issues raised by these www.regulations.gov. Follow the at (202) 414–6924. PRMs through the process the instructions for submitting comments. If II. Background Commission has established for you submit your comment to the addressing the recommendations from Section 10(g) of the Federal Home Federal eRulemaking Portal, please also Loan Bank Act of 1932 (Bank Act), as the Fukushima Task Force Report and is send it by email to FHFA at not providing a separate opportunity for amended by the Financial Institutions [email protected] to ensure Reform, Recovery and Enforcement Act public comment on the PRMs at this timely receipt by the Agency. Please time. of 1989 (FIRREA), requires FHFA to include ‘‘RIN 2590–AA38’’ in the adopt regulations establishing standards Dated at Rockville, Maryland, this 2nd day subject line of the message. • of community investment or service for of November 2011. Hand Delivered/Courier: The hand members of Banks to maintain access to For the Nuclear Regulatory Commission. delivery address is: Alfred M. Pollard, long-term advances. See 12 U.S.C. Andrew L. Bates, General Counsel, Attention: Comments/ 1430(g). Section 10(g) further states that Acting Secretary of the Commission. RIN 2590–AA38, Federal Housing such regulations ‘‘shall take into [FR Doc. 2011–29158 Filed 11–9–11; 8:45 am] Finance Agency, Fourth Floor, 1700 G account factors such as a member’s Street NW., Washington, DC 20552. The BILLING CODE 7590–01–P performance under the Community package should be logged in at the Reinvestment Act of 1977 and the Guard Desk, First Floor, on business member’s record of lending to first-time days between 9 a.m. and 5 p.m. homebuyers.’’ Id. FEDERAL HOUSING FINANCE • U.S. Mail, United Parcel Service, AGENCY Regulations implementing these Federal Express, or Other Mail Service: community support requirements were 12 CFR Part 1290 The mailing address for comments is: first published on November 21, 1991. Alfred M. Pollard, General Counsel, See 56 FR 58639 (Nov. 21, 1991). The RIN 2590–AA38 Attention: Comments/RIN 2590–AA38, original regulation required members to Federal Housing Finance Agency, submit to FHFA community support Federal Home Loan Bank Community Fourth Floor, 1700 G Street NW., Support Amendments statements comprising CRA evaluation Washington, DC 20552. reports and other supporting AGENCY: Federal Housing Finance FOR FURTHER INFORMATION CONTACT: documentation. Members not subject to Agency. Charles E. McLean, Associate Director, the CRA were required to submit ACTION: Proposed rule; request for (202) 408–2537, or Rafe R. Ellison, documentation evidencing that they comments. Senior Program Analyst, (202) 408– engaged in activities related to 2968, Brian Doherty, Manager, (202) community support. The community SUMMARY: The Federal Housing Finance 408–2991, Office of Housing and support regulation was substantially Agency (FHFA) is proposing to amend Regulatory Policy, 1625 Eye Street NW., amended to its current form by a final its community support regulation by Washington, DC 20006. (These are not rule published on May 29, 1997. See 62 requiring the Federal Home Loan Banks toll-free numbers.) For legal matters, FR 28983. The amendments streamlined (Banks) to monitor and assess the contact Kevin Sheehan, Assistant the regulatory mandate by requiring eligibility of each Bank member for General Counsel, (202) 414–8952, or members to submit one-page access to long-term advances through Sharon Like, Managing Associate community support statements, a compliance with the regulation’s General Counsel, (202) 414–8950, Office significant reduction to the Community Reinvestment Act of 1977 of General Counsel, Federal Housing documentation standards of the original (CRA) and first-time homebuyer Finance Agency, Fourth Floor, 1700 G regulation. Under the community standards. The proposed rule would Street NW., Washington, DC 20552. support regulation in effect today, FHFA also replace the current practice in (These are not toll-free numbers.) The generally reviews, on a biennial basis, which members submit to FHFA telephone number for the each member’s CRA performance and

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record of lending to first-time currently defined in § 1290.1 would B. Bank Community Support Program— homebuyers, to evaluate the member’s remain substantially unchanged, Proposed § 1290.2 compliance with the community including the definitions of ‘‘Advisory 1. Community Support Program support standards and determine Council,’’ ‘‘appropriate Federal banking ongoing eligibility for access to long- agency,’’ ‘‘appropriate State regulator,’’ Proposed § 1290.2(a) would set forth term Bank advances. See 12 CFR part ‘‘Bank,’’ ‘‘CDFI Fund,’’ ‘‘community requirements that appear in current 1290. A long-term advance is defined as development financial institution or § 1290.6 related to the Bank’s community support program, including an advance with a term to maturity CDFI,’’ ‘‘CRA,’’ ‘‘CRA evaluation,’’ greater than one year. 12 CFR 1290.1. In that each Bank’s program: Provide ‘‘FHFA,’’ ‘‘long-term advance,’’ and technical assistance to members; addition, FHFA requires each Bank to ‘‘targeted community lending.’’ The establish and maintain a community promote and expand affordable housing term ‘‘restriction on access to long-term support program that provides technical finance; and include an annual Targeted assistance to its members and promotes advances’’ would no longer be a Community Lending Plan. See also 12 and expands affordable housing finance. separately defined term because the CFR 952.4. The proposed rule would 12 CFR 1290.6. substance of the existing definition add a new paragraph (a)(1) requiring would be incorporated into proposed each Bank to establish policies and III. Analysis of Proposed Rule § 1290.3(a). procedures for the Bank’s evaluation The proposed rule would revise the Section 1290.1 currently defines and determination of community current community support regulation ‘‘first-time homebuyer’’ to include support compliance by its members to require the Banks, as part of their individuals who have not owned a under its community support program. community support programs, to principal residence during the three- Each Bank’s community support evaluate and determine members’ year period prior to purchasing a home. program policies would be required to compliance with the community include a CRA standard and a first-time The definition includes displaced support requirements and whether homebuyer standard, as further homemakers and single parents that members maintain access to long-term discussed below. In addition, the Bank’s Bank advances. The Banks would be would meet this criterion but for prior community support program policies required to establish policies and ownership of a home with a spouse or and procedures would include policies procedures for evaluating and residence in a home owned by a spouse. and procedures for verifying members’ determining their members’ community The current definition was based on the compliance with the two community support compliance under their definition of ‘‘first-time homebuyer’’ support standards through collection community support programs. under section 104 of the Cranston- and review of members’ CRA ratings The Banks currently are required to Gonzalez National Affordable Housing and their first-time homebuyer support adopt Member Product Policies Act. See 42 U.S.C. 12704. This statutory statements, as well as any other addressing the Banks’ management of definition was subsequently amended to appropriate information. their advances and other products include individuals whose previous 2. Evaluation and Determination of offered to members, and are responsible home was either a manufactured home Compliance for determining the terms and not permanently affixed to a permanent conditions under which they will make foundation or a substandard home that Proposed § 1290.2(b) would require advances to their members. See § 917.4 could not be brought into compliance each Bank to evaluate and determine its of this title, part 1266 of this chapter. with relevant building codes for less members’ compliance with the first-time Requiring the Banks to adopt policies than the cost of constructing a homebuyer standard and the CRA and procedures for community support permanent structure. The current standard, as applicable, pursuant to the Bank’s community support program evaluations, to conduct the evaluations, definition of ‘‘first-time homebuyer’’ in policies and procedures and the and to make decisions on any § 1290.1 does not reflect those requirements of the regulation. restrictions on access to long-term amendments. advances, would be consistent with 3. Public Comments their general advances underwriting Proposed § 1290.1 would remove the responsibilities. definition of ‘‘first-time homebuyer’’ in Under current § 1290.2, FHFA notifies While FHFA would no longer be order to be consistent with FHFA’s the applicable Bank and the public by directly involved in determining Affordable Housing Program (AHP) Federal Register notice of specific members’ community support regulation. The AHP regulation does not members selected for community compliance, FHFA would exercise its define the term, leaving the definition to support review. The Bank is also general regulatory authority to oversee be determined at the discretion of each required to provide written notice to the the Banks’ compliance with their Bank. See 12 CFR 1291.1. Accordingly, members selected for community community support program policies the terms ‘‘displaced homemaker’’ and support review, its Advisory Council, and procedures and the community ‘‘single parent,’’ which appear only in and to nonprofit housing developers, community groups, and other interested support regulation, consistent with how the ‘‘first-time homebuyer’’ definition, parties in its district of the name and FHFA regularly performs its oversight would also be removed. FHFA responsibilities with respect to the address of each member within its specifically requests comment on district that has to submit a Community Banks’ other mission-related activities. whether the definition of ‘‘first-time The specific provisions of the Support Statement Form during the homebuyer’’ should be removed, proposed rule are discussed further calendar quarter. In reviewing a whether the definition should be below. member’s Community Support maintained in its current form, or Statement Form for evidence of the A. Definitions—Proposed § 1290.1 whether the definition should be member’s compliance with the Proposed § 1290.1 would continue to revised to reflect the statutory community support requirements, set forth definitions applicable to the amendment that addressed previous FHFA is required to take into community support requirements in ownership of manufactured or consideration any public comments part 1290. A number of terms that are substandard housing. received concerning members of all 12

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Banks. In the previous two calendar with the community support standards this provision, see the final rule entitled years, FHFA has received only a small is eligible again for long-term advances ‘‘Federal Home Loan Bank Membership number of public comments concerning and the long-term advance restriction for Community Development Financial the community support programs and shall be removed. The Bank would be Institutions,’’ 75 FR 678, 689–690 (Jan. activities of members of the 12 Banks. required to develop policies and 5, 2010). Under the proposed rule, the Banks procedures that it determines are would be required to assess a member’s appropriate to ensure that it makes E. CRA Standard—Proposed § 1290.5 compliance with the community timely determinations and 1. Verification of CRA Rating support requirements by determining communicates with its members as Proposed § 1290.5(a) would provide whether a member received a CRA necessary. that for each member that is subject to rating of Satisfactory or above, and Current § 1290.5(d)(i) permits a the requirements of the CRA, the Bank determining whether the member member to seek from FHFA an shall, in accordance with its community engaged in eligible first-time homebuyer exception to a long-term advances support program policies and activities. Although the Banks do not restriction if the member’s appropriate procedures, verify the member’s rating publish in the Federal Register, Federal banking or State regulator in its most recent CRA evaluation with solicitation by the Banks of public determines that restricting the member’s comments on members’ community access to advances would adversely that member’s appropriate Federal support programs and activities could affect the member’s safety and banking agency or from information be implemented by the Banks posting soundness. Since, under the proposed made publicly available by FFIEC. As notices on their public Web sites. Under rule, the Banks would be determining under the current regulation, the Banks such a public notification process, each whether members should be subject to would not be required to evaluate the Bank would receive comments only long-term advances restrictions, compliance of credit unions and with respect to its own members. proposed § 1290.3(b) would provide that insurance companies under the CRA Accordingly, in view of the importance members may submit requests for safety standard, as they are not subject to the of public engagement, proposed and soundness exceptions to their Bank, CRA and are only subject to the first- § 1290.2(c) would require the Banks to rather than to FHFA, for decision. time homebuyer standard. include notices on their Web sites Consistent with the requirements of In complying with proposed inviting comments on any member’s the current regulation, the member’s § 1290.5(a), the Banks would be community support programs or written request shall contain a clear and required to routinely verify members’ activities, and to consider any concise statement of the basis for the CRA ratings, which would eliminate the comments received in determining the request, and a statement from the current gap in monitoring compliance member’s compliance. FHFA requests member’s appropriate Federal banking with the CRA standard. Under the comment on whether the public agency, or the member’s appropriate current regulation, FHFA reviews each comment process would be enhanced if State regulator for a member that is not member’s CRA rating once every two the Banks were required to give public subject to regulation or supervision by years. This existing practice enables a notice when specific members are a Federal regulator, that application of member to maintain access to long-term selected for community support review, the restriction may adversely affect the advances for up two years after or whether such notice should be at the safety and soundness of the member. receiving a rating of ‘‘Substantial discretion of each Bank. The Bank would be required to consider Noncompliance.’’ For example, if a each written request within 30 calendar member received a rating of C. Restrictions on Access to Long-Term days of receipt. ‘‘Satisfactory’’ on its July 2007 CRA Advances—Proposed § 1290.3 Consistent with the current evaluation and was notified that it Under current § 1290.5, if FHFA regulation, proposed § 1290.3(c) would needed to submit a community support determines that a member should be provide that any member that is statement in June 2009, the member placed on restriction from long-term ineligible for long-term advances due to could report to FHFA the results of the advances for failure to meet the a failure to meet the community support July 2007 CRA evaluation. However, if community support standards, FHFA requirements would also be ineligible to this same member then received a rating notifies the Bank and the member of its submit new applications under the of ‘‘Substantial Noncompliance’’ on its determination and the reasons, and Banks’ AHP under 12 CFR part 1291, or July 2009 CRA evaluation, it would not directs the Bank to deny the member’s under the Bank’s CICA programs offered have to report this information to FHFA requests for long-term advances. Such under 12 CFR part 952. until it is required to submit its next members would also be denied access to community support statement in June the AHP and the Community D. Exemption for CDFIs—Proposed 2011. During this period where the most Investment Cash Advances (CICA) § 1290.4 recent CRA rating is ‘‘Substantial Programs. If the member subsequently Section 1290.2(e) of the existing Noncompliance,’’ the member would complies with the community support regulation provides that a member that continue to have access to long-term standards, FHFA informs the Bank that has been certified as a community advances. the member’s access to long-term development financial institution FFIEC routinely publishes on its Web advances should be restored. (CDFI) by the CDFI Fund, other than a site the latest CRA ratings of financial Proposed § 1290.3(a) would replace member that also is an insured institutions supervised by the Federal § 1290.5 and would provide that a Bank depository institution or a CDFI credit Reserve Board, Office of the Comptroller shall not approve a member’s request for union (as defined in 12 CFR 1263.1), is of the Currency, Federal Deposit long-term advances unless the Bank has deemed to be in compliance with the Insurance Corporation, and Office of determined that the member is in community support standards by virtue Thrift Supervision. The Banks could compliance with the first-time of such certification and shall not be obtain CRA rating information from homebuyer standard and the CRA subject to community support review by FFIEC’s Web site to ensure that only standard, as applicable. A member any Bank. The proposed rule would members with ‘‘Satisfactory’’ or subject to a long-term advance relocate this provision unchanged to ‘‘Outstanding’’ ratings have access to restriction who subsequently complies § 1290.4. For additional discussion of long-term advances. The Banks should

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be able to readily and routinely obtain policy could restrict a member’s ability also requests comment on the degree of the necessary CRA ratings information to use long-term advances to address the discretion the Banks should have in from the FFIEC Web site. Under deficiencies that led to the ‘‘Needs to determining what first-time homebuyer proposed § 1290.2(a)(1), each Bank Improve’’ rating. FHFA specifically programs and activities should be would be required to establish policies requests comment on whether members eligible for purposes of meeting the first- and procedures for its review of its with a single CRA rating of ‘‘Needs to time homebuyer standard. For example, members’ CRA ratings. Improve’’ should be restricted from an alternative would be to allow each Bank at its discretion to determine all 2. Compliance With CRA Standard accessing long-term advances, or whether such members should be eligible first-time homebuyer programs Consistent with current § 1290.3(b), placed on probation, but maintain and activities, which may enable the proposed § 1290.5(b) would provide that access pending their next CRA rating, Bank to be more responsive to particular a member has met the CRA standard if similar to existing practice. housing needs in its district. FHFA also the member received a rating of requests comment on whether an ‘‘Outstanding’’ or ‘‘Satisfactory’’ in its F. First-Time Homebuyer Standard— alternative approach giving Banks more most recent CRA evaluation. The Proposed § 1290.6 discretion to determine eligible first- proposed rule would change the current 1. Eligible First-Time Homebuyer time homebuyer programs and activities regulation by requiring that the Banks Programs and Activities should include a requirement that a allow access to long-term advances only Bank consult with its Advisory Council Current § 1290.3(c)(1) and FHFA’s for members with ratings of in making such determination. ‘‘Satisfactory’’ or higher on their most existing Community Support Statement recent CRA evaluations. Form set forth the specific first-time 2. Compliance With First-Time Current § 1290.3(b)(2) provides that a homebuyer programs and activities that Homebuyer Standard member with a most recent CRA rating are eligible to meet the first-time As in the current regulation, proposed of ‘‘Needs to Improve’’ continues to homebuyer standard. Under proposed § 1290.6(b) would provide that a have access to long-term advances but is § 1290.6(a), the following substantially member that has received a rating in its placed on probation. If the member’s similar first-time homebuyer programs most recent CRA evaluation of subsequent CRA rating is ‘‘Satisfactory’’ and activities would be eligible for ‘‘Outstanding’’ would be deemed to or ‘‘Outstanding,’’ the member is purposes of meeting the first-time have satisfied the first-time homebuyer removed from probation. A member homebuyer standard: standard. with a CRA evaluation of ‘‘Substantial • Member’s established record of For those members with a CRA rating Noncompliance’’ on its most recent CRA lending to first-time homebuyers; below ‘‘Outstanding’’, the Bank would • evaluation, or with two consecutive In-house first-time homebuyer need to require the member to have CRA ratings of ‘‘Needs to Improve’’ on programs, such as marketing plans and engaged in one or more eligible first- its most recent two CRA evaluations, is outreach programs; time homebuyer programs or activities • required to be placed on restriction from Other in-house lending products in the period covered by the most recent access to long-term advances. Current that serve first-time homebuyers; first-time homebuyer support statement • § 1290.5(a) also requires FHFA to Underwriting standards that are to be eligible for a long-term advance. require that members that fail to submit appropriate for first-time homebuyers FHFA requests comment on whether complete community support and consistent with safe and sound a member should be required to engage statements be placed on restriction from lending practices; in more than one eligible first-time • access to long-term advances. In order Participation in non-governmental homebuyer program or activity in order for access to long-term advances to be first-time homebuyer programs; to be in compliance with the first-time • restored, a member must receive a CRA Participation in federal government homebuyer standard, and if so, how rating of ‘‘Satisfactory’’ or above on its programs that serve first-time many such programs or activities should homebuyers; next CRA evaluation and submit a • be required. FHFA also requests complete community support statement. Participation in state or local comment on whether the regulation FHFA has concluded that requiring at government programs targeted to first- should specify a particular number of least a ‘‘Satisfactory’’ rating on a time homebuyers; • such programs or activities, or whether member’s most recent CRA evaluation is Financial support or technical each Bank should have discretion to an appropriate standard to be eligible assistance to community groups or determine that number. for long-term advances because the organizations that assist first-time standard may provide additional homebuyers; 3. First-Time Homebuyer Support • incentive for members to consistently Participation in loan consortia that Statement make loans to first-time homebuyers; Under current § 1290.2(c), each meet the credit needs of the • communities they serve. Additionally, Participation in or support of member selected by FHFA for based on historical evaluation rating special counseling or homeownership community support review is required data, removing the probationary period education targeted to first-time to submit to FHFA a Community homebuyers; and Support Statement Form prescribed by for members rated less than • ‘‘Satisfactory’’ would likely affect or Participation in investments or FHFA that contains both the member’s have an impact on only a small loans that support first-time homebuyer CRA evaluation and identification of the percentage of members. Slightly more programs. member’s eligible first-time homebuyer than two percent of institutions that In addition, a Bank would have programs or activities from the list set were subject to CRA evaluations from discretion to determine other first-time forth in the Form. Under proposed 2008 to 2010 received ratings of ‘‘Needs homebuyer programs and activities as § 1290.6(c), members would submit to to Improve.’’ eligible to meet the first-time the Bank first-time homebuyer support Because the proposed rule would homebuyer standard. statements in which the member would prohibit Banks from making long-term FHFA requests comment on whether identify and describe the eligible first- advances to members after a single CRA the above list of programs and activities time homebuyer programs or activities rating of ‘‘Needs to Improve,’’ this should be revised in any way. FHFA in which it had engaged. Each Bank

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would prescribe the form of the first- proposed rule would not substantively Costs: FHFA estimates that there will time homebuyer support statement, or materially modify the approved be no annualized capital/start-up costs which would set forth all of the eligible information collection with respect to for the members to collect and submit first-time homebuyer programs and the members’ information collection the information. burden, although it would materially activities under proposed § 1290.6(a). C. Comment Request Each member would be required to decrease the time and hour burden on submit a completed first-time FHFA. FHFA will accept written comments homebuyer support statement to its Need for and proposed use of concerning the accuracy of the burden Bank at least once every two calendar information: Under the proposed rule, estimates and suggestions for reducing years, which is consistent with FHFA’s Bank members would be required to the burden at the address listed above. current biennial schedule for reviewing satisfy the community support Comments may also be submitted in members’ community support requirements in order to maintain writing to OMB (please also submit compliance. As in the current continued access to long-term advances. comments to FHFA for timely receipt regulation, the accuracy of the first-time The proposed collection of information and review) at the following address: homebuyer support statement would be from each Bank member is necessary to Attention: Desk Officer for Federal required to be certified by a senior enable the Banks to determine whether Housing Finance Agency, Office of officer of the member. their members satisfy those community Information and Regulatory Affairs, Room 10102, New Executive Office G. Reports—Proposed § 1290.7 support requirements. Members may also find it necessary to submit Building, 725 17th Street NW., The proposed rule would add a information to the Banks to request the Washington, DC 20503. Written comments are requested on: requirement for each Bank to submit a removal of restrictions on the members’ (1) Whether the proposed collection of report annually by May 1 to FHFA that access to long-term advances. The information is necessary for the proper identifies the results of the Bank’s collection of information contained in community support compliance performance of FHFA functions, part 1290 of the proposed rule is including whether the information has determinations for that year, including described more fully in part III of the whether any members are subject to practical utility; (2) The accuracy of SUPPLEMENTARY INFORMATION. FHFA estimates of the burdens of the restrictions on access to long-term Respondents: Likely respondents are advances. collection of information; (3) Ways to institutions that are members of a Bank. enhance the quality, utility, and clarity IV. Paperwork Reduction Act B. Burden Estimate of the information collected; and (4) Ways to minimize the burden of the A. Summary of Proposed Information FHFA estimates the total annualized Collection proposed collection of information on hour burden for all members of the members, including through the use of FHFA has submitted an analysis of proposed information collection to be automated collection techniques or the revisions to the currently approved 4,115 hours. This estimate includes the other forms of information technology. collection of information contained in biennial submission of first-time this proposed rule to the Office of homebuyer support statements by all V. Regulatory Flexibility Act Management and Budget (OMB) for members, as well as any requests by The Regulatory Flexibility Act (5 review in accordance with the members for removal of restrictions on U.S.C. 601 et seq.) requires that a Paperwork Reduction Act of 1995. See access to long-term advances. FHFA regulation that has a significant 44 U.S.C. 3507(d). Potential respondents estimates that an average of 4,100 economic impact on a substantial are not required to respond to the members will submit responses each number of small entities, small collection of information unless the year regarding their first-time businesses or small organizations must regulation collecting the information homebuyer programs and activities. include an initial regulatory flexibility displays a currently valid control FHFA estimates each response will take analysis describing the regulation’s number assigned by OMB. See 44 U.S.C. an average of .75 hours to prepare and impact on small entities. Such an 3512(a). process, for an annual total of 3,075 analysis need not be undertaken if the FHFA currently collects information hours (4,100 member responses × .75 agency has certified that the regulation biennially from Bank members hours = 3,075 hours). FHFA estimates will not have a significant economic regarding their compliance with the that the responses, on average, will take impact on a substantial number of small community support standards under an additional .25 hours for review and entities. 5 U.S.C. 605(b). FHFA has existing part 1290. Existing part 1290 certification by an appropriate senior considered the impact of the proposed also permits Bank members whose officer, for an annual total of 1,025 rule under the Regulatory Flexibility access to long-term advances has been hours (4,100 member responses × .25 Act. The General Counsel of FHFA restricted for failure to meet the hours = 1,025 hours). certifies that the proposed rule, if community support standards to apply FHFA estimates that an average of 15 adopted as a final rule, is not likely to directly to FHFA to remove the members each year will submit requests have a significant economic impact on restriction under certain circumstances. to remove restrictions on access to long- a substantial number of small business The current collection of information term advances. FHFA estimates that entities because the regulation is has been approved by OMB, and the these requests, on average, will take .75 applicable only to the Banks, which are control number, OMB No. 2590–0005, hours to prepare and process, for an not small entities for purposes of the will expire on October 31, 2012. The annual total of 11.25 hours (15 member Regulatory Flexibility Act. proposed rule would amend the requests × .75 hours = 11.25 hours). community support requirements in FHFA estimates that the requests, on List of Subjects in 12 CFR Part 1290 part 1290 and require the Banks to average, will take an additional .25 Credit, Federal home loan banks, collect compliance information from hours for review by an appropriate Housing, Mortgages, Reporting and their members and process requests to senior officer, for an annual total of 3.75 recordkeeping requirements. remove restrictions on members’ access hours (15 member requests × .25 hours Accordingly, for the reasons stated in to advances. The changes in the = 3.75 hours). the SUPPLEMENTARY INFORMATION, FHFA

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proposes to amend title 12, chapter XII, Targeted community lending means informing the public of the opportunity of the Code of Federal Regulations to providing financing for economic to submit comments on the community read as follows: development projects for targeted support programs and activities of Bank beneficiaries, as defined in part 952 of members and explaining how to submit PART 1290—COMMUNITY SUPPORT this title. such comments. In determining the REQUIREMENTS community support compliance of a § 1290.2 Bank community support Sec. program. member, a Bank shall take into 1290.1 Definitions. consideration any public comments it (a) Requirement. Consistent with the has received concerning the member. 1290.2 Bank community support program. safe and sound operation of the Bank, 1290.3 Restrictions on access to long-term each Bank shall establish and maintain § 1290.3 Restrictions on access to long- advances. term advances. 1290.4 Exemption for CDFIs. a community support program. A Bank 1290.5 CRA standard. shall, under its community support (a) Restriction on access to long-term 1290.6 First-time homebuyer standard. program: advances. A Bank shall not approve a 1290.7 Reports. (1) Establish policies and procedures member’s request for a long-term for the Bank’s evaluation and Authority: 12 U.S.C. 1430(g), 4511, 4513, advance, including renewal of a 4526. determination of community support maturing advance for a term to maturity compliance by the Bank’s members; greater than one year, unless the Bank § 1290.1 Definitions. (2) Provide technical assistance to has determined that the member is in For purposes of this part: members; compliance with the first-time Advisory Council means the Advisory (3) Promote and expand affordable homebuyer standard and the CRA Council each Bank is required to housing financing and financing for standard, as applicable. establish pursuant to section 10(j)(11) of first-time homebuyers; (b) Safety and soundness exception. A the Federal Home Loan Bank Act, as (4) Identify opportunities for members Bank may remove restrictions on a amended (12 U.S.C. 1421 through 1449), to expand financial and credit services member’s access to long-term advances and part 1291 of this chapter. in underserved neighborhoods and imposed under this section if the Bank Appropriate Federal banking agency communities; determines that application of the (5) Encourage members to increase has the meaning set forth in section 3(q) restriction may adversely affect the their targeted community lending and of the Federal Deposit Insurance Act (12 safety and soundness of the member. A affordable housing finance activities by U.S.C. 1813(q)) and, for federally providing incentives such as awards or member that seeks removal from insured credit unions, means the technical assistance to nonprofit restriction must submit a written National Credit Union Administration. housing developers or community request to the Bank to remove the Appropriate State regulator means groups with outstanding records of restriction under this paragraph (b). any State officer, agency, supervisor, or participation in targeted community Such written request shall contain a other entity that has regulatory authority lending or affordable housing finance clear and concise statement of the basis over, or is empowered to institute partnerships with members; and for the request, and a statement from the enforcement action against, a particular (6) Include an annual Targeted member’s appropriate Federal banking institution. Community Lending Plan, as required agency, or the member’s appropriate Bank means a Federal Home Loan by § 952.4 of this title, approved by the State regulator for a member that is not Bank established under section 12 of the Bank’s board of directors and subject to subject to regulation or supervision by Federal Home Loan Bank Act, as modification, which shall require the a Federal regulator, that application of amended (12 U.S.C. 1421 through 1449). Bank to— the restriction may adversely affect the CDFI Fund means the Community (i) Conduct market research in the safety and soundness of the member. Development Financial Institutions Bank’s district; The Bank shall consider each written Fund established under section 104(a) (ii) Describe how the Bank will request within 30 calendar days of of the Community Development address identified credit needs and receipt. Banking and Financial Institutions Act market opportunities in the Bank’s (c) Affordable Housing Program of 1994 (12 U.S.C. 4703(a)). district for targeted community lending; (AHP) and Community Investment Cash Community development financial (iii) Consult with its Advisory Council Advance (CICA) programs. A member institution or CDFI means an institution and with members, housing associates, that is restricted from access to long- that is certified as a community and public and private economic term advances under this part is not development financial institution by the development organizations in the eligible to participate in the AHP under CDFI Fund under the Community Bank’s district in developing and part 1291 of this chapter, or in any CICA Development Banking and Financial implementing its Targeted Community program offered under part 952 of this Institutions Act of 1994 (12 U.S.C. 4701 Lending Plan; and title. The restriction in this paragraph et seq.). (iv) Establish quantitative targeted (c) does not apply to AHP or CICA CRA means the Community community lending performance goals. applications or funding approved before Reinvestment Act of 1977, as amended (b) Bank evaluation and the date the restriction is imposed. (12 U.S.C. 2901 et seq.). determination of community support CRA evaluation means the public compliance. Pursuant to the Bank’s § 1290.4 Exemption for CDFIs. disclosure portion of the CRA community support program policies A member that has been certified as performance evaluation provided by a and procedures and the requirements of a CDFI by the CDFI Fund, other than a Bank member’s appropriate Federal this part, each Bank shall evaluate and member that also is an insured banking agency. determine compliance of each of its depository institution or a CDFI credit FHFA means Federal Housing members with the first-time homebuyer union (as defined in § 1263.1 of this Finance Agency. standard and the CRA standard, as chapter), is deemed to be in compliance Long-term advance means an advance applicable. with the community support standards with an original term to maturity greater (c) Public comments. Each Bank shall under this part by virtue of such than one year. include a notice on its Web site certification and shall not be subject to

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community support review by any Bank homebuyer standard if the member has Health Administration (MSHA) is under this part. engaged in one or more eligible first- extending the comment period on the time homebuyer programs or activities proposed rule addressing Proximity § 1290.5 CRA standard. in the period covered by the most recent Detection Systems for Continuous (a) Verification of CRA rating. For first-time homebuyer support statement. Mining Machines in Underground Coal each member that is subject to the A member that has received a rating in Mines. This extension gives commenters requirements of the CRA, the Bank its most recent CRA evaluation of additional time to comment on the shall, in accordance with its community ‘‘Outstanding’’ shall be deemed to be in proposed rule. The proposal was support program policies and compliance with the first-time published on August 31, 2011. procedures, verify the rating in the homebuyer standard. DATES: All comments must be received member’s most recent CRA evaluation (c) First-time homebuyer support or postmarked by midnight Eastern with that member’s appropriate Federal statement. Each Bank shall prescribe the Standard Time on November 28, 2011. banking agency or from information form of the first-time homebuyer ADDRESSES: Comments must be made publicly available by the Federal support statement to be completed by its identified with ‘‘RIN 1219–AB65’’ and Financial Institutions Examination members, which shall set forth all of the may be sent by any of the following Council. eligible first-time homebuyer programs methods: (b) Compliance with CRA standard. A and activities under paragraph (a) of this (1) Federal e-Rulemaking Portal: member shall be in compliance with the section. The Bank shall require http://www.regulations.gov. Follow the CRA standard if the member received a members to submit a completed first- instructions for submitting comments. rating of ‘‘Outstanding’’ or time homebuyer support statement to (2) Facsimile: (202) 693–9441. Include ‘‘Satisfactory’’ in its most recent CRA the Bank at least once every two ‘‘RIN 1219–AB65’’ in the subject line of evaluation. calendar years. The Bank shall require the message. each member to identify and describe § 1290.6 First-time homebuyer standard. (3) Regular Mail: MSHA, Office of the eligible first-time homebuyer Standards, Regulations, and Variances, (a) Eligible first-time homebuyer programs or activities engaged in by the 1100 Wilson Boulevard, Room 2350, programs and activities. The following member on the first-time homebuyer Arlington, Virginia 22209–3939. programs and activities are eligible first- support statement. The accuracy of the (4) Mail or Hand Delivery: MSHA, time homebuyer programs and activities first-time homebuyer support statement Office of Standards, Regulations, and for purposes of determining Bank shall be certified by a senior officer of Variances, 1100 Wilson Boulevard, members’ compliance with the first-time the member. A member that has Room 2350, Arlington, Virginia. Sign in homebuyer standard: received a rating in its most recent CRA at the receptionist’s desk on the 21st (1) An established record of lending to evaluation of ‘‘Outstanding’’ shall not be floor. first-time homebuyers; required to submit a first-time MSHA will post all comments (2) In-house first-time homebuyer homebuyer support statement. without change, including any personal programs, such as marketing plans and information provided. Access comments outreach programs; § 1290.7 Reports. electronically on http:// (3) Other in-house lending products Each Bank shall submit a report www.regulations.gov and on MSHA’s that serve first-time homebuyers; annually by May 1 to FHFA that Web site at http://www.msha.gov/ (4) Underwriting standards that are identifies the results of the Bank’s currentcomments.asp. Review appropriate for first-time homebuyers community support compliance comments in person at the Office of and consistent with safe and sound determinations for that year, including Standards, Regulations, and Variances, lending practices; whether any members are subject to (5) Participation in non-governmental long-term advances restrictions. 1100 Wilson Boulevard, Room 2350, Arlington, Virginia. Sign in at the first-time homebuyer programs; Dated: November 4, 2011. (6) Participation in federal receptionist’s desk on the 21st floor. Edward J. DeMarco, MSHA maintains a list that enables government programs that serve first- Acting Director, Federal Housing Finance subscribers to receive email notification time homebuyers; Agency. (7) Participation in state or local when the Agency publishes rulemaking [FR Doc. 2011–29159 Filed 11–9–11; 8:45 am] government programs targeted to first- documents in the Federal Register. To time homebuyers; BILLING CODE 8070–01–P subscribe, go to http://www.msha.gov/ (8) Financial support or technical subscriptions/subscribe.aspx. assistance to community groups or FOR FURTHER INFORMATION CONTACT: organizations that assist first-time DEPARTMENT OF LABOR Roslyn B. Fontaine, Acting Director, Office of Standards, Regulations and homebuyers; Mine Safety and Health Administration (9) Participation in loan consortia that Variances, MSHA, at [email protected] (Email), (202) make loans to first-time homebuyers; 30 CFR Part 75 (10) Participation in or support of 693–9440 (Voice), or (202) 693–9441 special counseling or homeownership RIN 1219–AB65 (Fax). education targeted to first-time SUPPLEMENTARY INFORMATION: homebuyers; Proximity Detection Systems for (11) Participation in investments or Continuous Mining Machines in Extension of Comment Period loans that support first-time homebuyer Underground Coal Mines On August 31, 2011 (76 FR 54163), programs; and AGENCY: Mine Safety and Health MSHA published a proposed rule, (12) Other first-time homebuyer Administration, Labor. Proximity Detection Systems for programs or activities, as determined by ACTION: Proposed rule; extension of Continuous Mining Machines in a Bank in its discretion. comment period. Underground Coal Mines. MSHA (b) Compliance with first-time conducted hearings on October 18, homebuyer standard. A member shall be SUMMARY: In response to requests from October 20, October 25, and October 27 in compliance with the first-time interested parties, the Mine Safety and of 2011. In response to commenters,

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MSHA is providing additional time for Room 1063B, between the hours of receiving per diem to provide long term interested parties to comment on the 8 a.m. and 4:30 p.m., Monday through care to veterans use the most up to date proposed rule. MSHA is extending the Friday (except holidays). Please call version of MDS as well. This will ensure comment period from November 14, (202) 461–4902 (this is not a toll-free that the most comprehensive assessment 2011 to November 28, 2011. All number) for an appointment. In is performed for all veterans in State comments and supporting addition, during the comment period, homes receiving per diem, and thereby documentation must be received or comments may be viewed online that the highest standard of care is postmarked by November 28, 2011. through the Federal Docket Management provided for those veterans. Indeed, if Dated: November 7, 2011. System at http://www.regulations.gov. veterans are assessed under the former Joseph A. Main, FOR FURTHER INFORMATION CONTACT: 2.0 standard, VA would essentially permit State homes to care for veterans Assistant Secretary of Labor for Mine Safety Nancy Quest, Chief, State Veterans and Health. Home Clinical & Survey Oversight, using a lower assessment standard than that afforded other Federally funded [FR Doc. 2011–29128 Filed 11–9–11; 8:45 am] Geriatrics and Extended Care Services (114), Veterans Health Administration, patients. BILLING CODE 4510–43–P Department of Veterans Affairs, 810 The most significant change in the Vermont Avenue NW., Washington, DC MDS 3.0 update requires that a direct 20420, (202) 461–6064. (This is not a interview be conducted with all DEPARTMENT OF VETERANS toll free number). residents who are able to be understood AFFAIRS SUPPLEMENTARY INFORMATION: On April, at least some of the time, such that staff 38 CFR Part 51 2009, VA published in the Federal must directly communicate with the Register a rule amending part 51 of title resident to complete certain sections of RIN 2900–AO02 38, Code of Federal Regulations, which the MDS. This is in contrast to staff relying on the medical record to Technical Revisions To Update set forth a mechanism for paying per complete certain MDS sections, as was Reference to the Required Assessment diem to State homes providing nursing permitted under MDS 2.0. The sections Tool for State Nursing Homes home care to eligible veterans. 74 FR in MDS 3.0 which now require a direct Receiving Per Diem Payments From 19426–01 (Apr. 29, 2009). This interview to complete relate to the VA regulation went into effect on May 29, 2009. 38 CFR 51.110. This proposed topics of cognition, mood, daily AGENCY: Department of Veterans Affairs. rule would amend 38 CFR part 51 to activities and preferences, and pain. For ACTION: Proposed rule. update reference to the required instance, a staff member providing resident assessment tool for State homes rehabilitation services to a resident can SUMMARY: The Department of Veterans providing nursing home care, The no longer rely on a previous entry of a Affairs (VA) proposes to amend its Centers for Medicare and Medicaid Registered Nurse in the medical record regulations to update the reference to Services (CMS) Resident Assessment regarding a resident’s level of pain to the required resident assessment tool for Instrument/Minimum Data Set (MDS). complete that staff member’s section of State homes that receive per diem from The MDS is a core set of screening, the MDS. Direct interviewing ensures VA for providing nursing home care to clinical, and functional status elements firsthand, real time monitoring in the veterans. The proposed rule would that form the foundation of the MDS, improving accuracy of the entered require State nursing homes receiving comprehensive assessment for all information. We agree with CMS’s per diem from VA to use the most recent residents of long term care facilities changes because we believe that MDS version of the Centers for Medicare and certified to participate in Medicare and 3.0 provides a more accurate assessment Medicaid Services (CMS) Resident Medicaid. While these certified facilities and will help ensure that the most Assessment Instrument/Minimum Data complete the MDS as a condition of comprehensive care plan is developed, Set (MDS), which is version 3.0. This receiving CMS payments for the and will help ensure that the highest will ensure that the standard used to provision of long term care to Medicare standard of care is provided. assess veterans is the same as the and Medicaid beneficiaries, the MDS is The MDS assessment process itself standard applicable to Medicare and the standardized assessment instrument generates Quality Indicators, Quality Medicaid beneficiaries. in long term care generally, and is Measures, and Resource Utilization DATES: Comments must be received by designed to identify the health care Groups (RUGs). The RUGs are used in VA on or before January 9, 2012. needs of residents and generate a plan nurse staffing methodology to determine ADDRESSES: Written comments may be of care regardless of source of payment resident case mix, or how residents may submitted through http:// for the individual resident. VA therefore be categorized so that resources are www.regulations.gov; by mail or hand requires State homes receiving per diem maximized to provide the highest delivery to the Director, Office of for the provision of long term care to standard of care. The MDS 3.0 update Regulation Policy and Management veterans to use the MDS, and to transmit has increased the number of RUGs from (02REG), Department of Veterans data from the MDS electronically to the 53 to 66. This increase reflects Affairs, 810 Vermont Avenue NW., VA Austin Information Technology technological advances in healthcare Room 1068, Washington, DC 20420; or Center (AITC), for the purpose of and changes in resident and staff mix, by fax to (202) 273–9026. Comments monitoring certain care indicators for as well as changes in healthcare should indicate that they are submitted the benefit of veterans. The MDS practice. For example, conditions and in response to ‘‘RIN 2900–AO02, version currently required by the services such as mood assessment and Technical Revisions to Update regulation is MDS 2.0. 38 CFR the pain interview have been added, Reference to the Required Assessment 51.110(b)(1)(i). and the behavior section has been Tool for State Nursing Homes Receiving On October 1, 2010, all CMS certified modified, which now ensures these Per Diem Payments From VA.’’ Copies long term care facilities were required to issues are considered in care planning. of comments received will be available update their assessment from MDS 2.0 Because this change should lead to for public inspection in the Office of to MDS 3.0. It is critical that VA improved long term care, we believe Regulation Policy and Management, mandate by regulation that State homes that it is appropriate to require the

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increased RUGS under our per diem rulemaking are State government State, local, or Tribal governments, in regulations. entities under the control of State the aggregate, or by the private sector, of Other important changes in the MDS governments. All State homes are $100 million or more (adjusted annually 3.0 update, which also ensure the most owned, operated, and managed by State for inflation) in any given year. This comprehensive assessment and that the governments except for a small number rule would have no such effect on State, highest standard of care is provided to that are operated by entities under local, or Tribal governments, or on the veterans, include the following contract with State governments. These private sector. requirements: documentation of a contractors are not small entities. significant change for any resident who Therefore, under 5 U.S.C. 605(b), this Catalog of Federal Domestic Assistance enrolls in a hospice program; proposed amendment is exempt from Numbers documentation of pressure ulcers the initial and final regulatory flexibility present on admission; documentation of analysis requirements of sections 603 The Catalog of Federal Domestic the type of injury sustained in a fall; and and 604. Assistance numbers and titles for the a resident assessment at discharge. The programs affected by this document are Executive Orders 12866 and 13563 following have been eliminated: the 64.005, Grants to States for Construction reverse staging of pressure ulcers to Executive Orders 12866 and 13563 of State Home Facilities; 64.009, document healing and documentation of direct agencies to assess the costs and Veterans Medical Care Benefits; 64.010, the use of a catheter to show a patient benefits of available regulatory Veterans Nursing Home Care; 64.015, is continent. Additionally, a section has alternatives and, when regulation is Veterans State Nursing Home Care; been included concerning the return of necessary, to select regulatory 64.018, Sharing Specialized Medical the resident to the community. approaches that maximize net benefits Resources; 64.019, Veterans We note that the vast majority of State (including potential economic, Rehabilitation, Alcohol and Drug homes receiving per diem from VA are environmental, public health and safety Dependence. CMS certified and receiving payments effects, and other advantages; from CMS for the provision of long term distributive impacts; and equity). Signing Authority care to Medicare and Medicaid Executive Order 13563 (Improving The Secretary of Veterans Affairs, or beneficiaries, and, therefore, are already Regulation and Regulatory Review) using MDS 3.0. These State homes do emphasizes the importance of designee, approved this document and not use the former MDS 2.0 to quantifying both costs and benefits, authorized the undersigned to sign and separately assess veterans whose long reducing costs, harmonizing rules, and submit the document to the Office of the term care is covered instead by per diem promoting flexibility. Executive Order Federal Register for publication payments from VA. This rulemaking 12866 (Regulatory Planning and electronically as an official document of will affect only those State homes that Review) defines a ‘‘significant the Department of Veterans Affairs. John are not CMS certified, do not receive regulatory action,’’ which requires R. Gingrich, Chief of Staff, Department CMS payments for the provision of long review by the Office of Management and of Veterans Affairs, approved this term care, and have not updated to MDS Budget (OMB), as ‘‘any regulatory action document on November 4, 2011, for 3.0. We estimate that this will affect that is likely to result in a rule that may: publication. only 56 out of the 140 State homes who (1) Have an annual effect on the List of Subjects in 38 CFR Part 51 receive per diem payments from VA. economy of $100 million or more or adversely affect in a material way the Administrative practice and Effect of Rulemaking economy, a sector of the economy, procedure, Claims, Government The Code of Federal Regulations, as productivity, competition, jobs, the contracts, Grant programs—health, revised by this proposed rulemaking, environment, public health or safety, or Grant programs—veterans, Health care, would represent the exclusive legal State, local, or Tribal governments or authority on this subject. No contrary communities; (2) Create a serious Health facilities, Health professions, rules or procedures would be inconsistency or otherwise interfere Health records, Mental health programs, authorized. All VA guidance would be with an action taken or planned by Nursing homes, Reporting and read to conform with this proposed another agency; (3) Materially alter the recordkeeping requirements, Travel and rulemaking if possible, or, if not budgetary impact of entitlements, transportation expenses, Veterans. possible, such guidance would be grants, user fees, or loan programs or the Dated: November 7, 2011. rights and obligations of recipients superseded by this rulemaking. Robert C. McFetridge, thereof; or (4) Raise novel legal or policy Paperwork Reduction Act issues arising out of legal mandates, the Director of Regulation Policy and This proposed rule contains no President’s priorities, or the principles Management, Office of the General Counsel, Department of Veterans Affairs. collections of information under the set forth in this Executive Order.’’ Paperwork Reduction Act (44 U.S.C. The economic, interagency, For the reasons stated in the 3501–3521). budgetary, legal, and policy preamble, the Department of Veterans implications of this regulatory action Regulatory Flexibility Act Affairs proposes to amend 38 CFR part have been examined and it has been 51 as follows: The Secretary hereby certifies that determined not to be a significant this proposed regulatory amendment regulatory action under Executive Order PART 51—PER DIEM FOR NURSING would not have a significant economic 12866. HOME CARE OF VETERANS IN STATE impact on a substantial number of small HOMES entities as they are defined in the Unfunded Mandates Regulatory Flexibility Act, 5 U.S.C. 601– The Unfunded Mandates Reform Act 1. The authority citation for part 51 612. The reason for this certification is requires, at 2 U.S.C. 1532, that agencies continues to read as follows: that these amendments would not prepare an assessment of anticipated directly affect any small entities, as the costs and benefits before issuing any Authority: 38 U.S.C. 101, 501, 1710, 1720, State homes that are subject to this rule that may result in expenditure by 1741–1743; and as stated in specific sections.

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2. Amend § 51.110(b)(1)(i) by 2. Email: [email protected]. www.regulations.gov index. Although removing the phrase ‘‘Version 2.0’’ and 3. Fax: (404) 562–9019. listed in the index, some information is adding, in its place, ‘‘Version 3.0’’. 4. Mail: EPA–R04–OAR–2011–0316, not publicly available, i.e., CBI or other [FR Doc. 2011–29157 Filed 11–9–11; 8:45 am] Regulatory Development Section, Air information whose disclosure is Planning Branch, Air, Pesticides and BILLING CODE 8320–01–P restricted by statute. Certain other Toxics Management Division, U.S. material, such as copyrighted material, Environmental Protection Agency, is not placed on the Internet and will be Region 4, 61 Forsyth Street SW., publicly available only in hard copy ENVIRONMENTAL PROTECTION Atlanta, Georgia 30303–8960. AGENCY form. Publicly available docket 5. Hand Delivery or Courier: Ms. materials are available either Lynorae Benjamin, Chief, Regulatory 40 CFR Parts 52 and 81 electronically in www.regulations.gov or Development Section, Air Planning in hard copy at the Regulatory [EPA–R04–OAR–2011–0316–201156; FRL– Branch, Air, Pesticides and Toxics Development Section, Air Planning 9489–7] Management Division, U.S. Branch, Air, Pesticides and Toxics Environmental Protection Agency, Approval and Promulgation of Management Division, U.S. Region 4, 61 Forsyth Street SW., Environmental Protection Agency, Implementation Plans and Designation Atlanta, Georgia 30303–8960. Such of Areas for Air Quality Planning Region 4, 61 Forsyth Street SW., deliveries are only accepted during the Atlanta, Georgia 30303–8960. EPA Purposes; Alabama; Redesignation of Regional Office’s normal hours of the Birmingham 1997 Annual Fine requests that if at all possible, you operation. The Regional Office’s official contact the person listed in the FOR Particulate Matter Nonattainment Area hours of business are Monday through to Attainment FURTHER INFORMATION CONTACT section to Friday, 8:30 to 4:30, excluding Federal schedule your inspection. The Regional AGENCY: Environmental Protection holidays. Office’s official hours of business are Instructions: Direct your comments to Agency (EPA). Monday through Friday, 8:30 to 4:30, Docket ID No. EPA–R04–OAR–2011– excluding Federal holidays. ACTION: Proposed rule. 0316. EPA’s policy is that all comments received will be included in the public FOR FURTHER INFORMATION CONTACT: Joel SUMMARY: On May 2, 2011, the State of Huey of the Regulatory Development Alabama, through the Alabama docket without change and may be made available online at Section, in the Air Planning Branch, Department of Environmental Air, Pesticides and Toxics Management Management (ADEM), Air Division, www.regulations.gov, including any personal information provided, unless Division, U.S. Environmental Protection submitted a request for EPA to Agency, Region 4, 61 Forsyth Street redesignate the Birmingham fine the comment includes information claimed to be Confidential Business SW., Atlanta, Georgia 30303–8960. Joel particulate matter (PM2.5) nonattainment Huey may be reached by phone at (404) area (hereafter referred to as the Information (CBI) or other information whose disclosure is restricted by statute. 562–9104, or via electronic mail at ‘‘Birmingham Area’’ or ‘‘Area’’) to Do not submit through [email protected]. attainment for the 1997 Annual PM2.5 www.regulations.gov or email, SUPPLEMENTARY INFORMATION: National Ambient Air Quality Standards information that you consider to be CBI (NAAQS); and to approve a State or otherwise protected. The Table of Content Implementation Plan (SIP) revision www.regulations.gov Web site is an I. What are the actions EPA is proposing to containing a maintenance plan for the ‘‘anonymous access’’ system, which take? Area. The Birmingham 1997 Annual means EPA will not know your identity II. What is the background for EPA’s PM nonattainment area is comprised 2.5 or contact information unless you proposed actions? of Jefferson and Shelby Counties in their III. What are the criteria for redesignation? provide it in the body of your comment. entireties and a portion of Walker IV. Why is EPA proposing these actions? If you send an email comment directly V. What is EPA’s analysis of the request? County. EPA is proposing to approve to EPA without going through the redesignation request for the VI. What is EPA’s analysis of Alabama’s www.regulations.gov, your email proposed NOX and PM2.5 MVEBs for the Birmingham Area, along with the address will be automatically captured Birmingham area? related SIP revision, including and included as part of the comment VII. What is the status of EPA’s adequacy Alabama’s 2009 emissions inventory for that is placed in the public docket and determination for the proposed NOX and the Area and Alabama’s plan for made available on the Internet. If you PM2.5 MVEBs for 2024 for the Birmingham area? maintaining attainment of the PM2.5 submit an electronic comment, EPA standard in the Area. EPA is also VIII. What is EPA’s analysis of the proposed recommends that you include your 2009 base year emissions inventory for proposing to approve the motor vehicle name and other contact information in emission budgets (MVEBs) for nitrogen the Birmingham area? the body of your comment and with any IX. Proposed Action on the Redesignation oxides (NOX) and PM2.5 for the year disk or CD–ROM you submit. If EPA Request and Maintenance Plan SIP 2024 for the Birmingham Area. These cannot read your comment due to Revision Including Proposed Approval actions are being proposed pursuant to technical difficulties and cannot contact of the 2024 NOX and PM2.5 MVEBs for the Birmingham Area the Clean Air Act (CAA or Act) and its you for clarification, EPA may not be implementing regulations. X. What is the effect of EPA’s proposed able to consider your comment. actions? DATES: Comments must be received on Electronic files should avoid the use of XI. Statutory and Executive Order Reviews or before December 12, 2011. special characters, any form of ADDRESSES: Submit your comments, encryption, and be free of any defects or I. What are the actions EPA is identified by Docket ID No. EPA–R04– viruses. For additional information proposing to take? OAR–2011–0316, by one of the about EPA’s public docket visit the EPA EPA is proposing to take the following following methods: Docket Center homepage at http:// three separate but related actions, some 1. www.regulations.gov: Follow the www.epa.gov/epahome/dockets.htm. of which involve multiple elements: (1) on-line instructions for submitting Docket: All documents in the To redesignate the Birmingham Area to comments. electronic docket are listed in the attainment for the 1997 Annual PM2.5

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NAAQS, provided EPA approves the EPA is proposing to approve (into the retained the annual average NAAQS at emissions inventory submitted with the Alabama SIP) the 2024 MVEBs that are 15.0 mg/m3 but revised the 24-hour maintenance plan; (2) to approve, under included as part of Alabama’s NAAQS to 35 mg/m3, based again on the CAA section 172(c)(3), the emissions maintenance plan for the 1997 Annual 3-year average of the 98th percentile of 2 inventory submitted with the PM2.5 NAAQS. 24-hour concentrations. Under EPA maintenance plan; and (3) to approve On a matter related to this third regulations at 40 CFR part 50, the into the Alabama SIP, under section action, EPA is also notifying the public primary and secondary 1997 Annual 175A of the CAA, Alabama’s 1997 of the status of EPA’s adequacy process PM2.5 NAAQS are attained when the Annual PM2.5 NAAQS maintenance for the newly established NOX and annual arithmetic mean concentration, plan, including the associated MVEBs PM2.5 MVEBs for 2024 for the as determined in accordance with 40 (EPA is also notifying the public of the Birmingham Area. The Adequacy CFR part 50, Appendix N, is less than status of EPA’s adequacy determination comment period for the Birmingham or equal to 15.0 mg/m3 at all relevant for the Birmingham Area MVEBs for the Area 2024 MVEBs began on March 24, monitoring sites in the subject area over PM2.5 NAAQS). These actions are 2011, with EPA’s posting of the a 3-year period. summarized below and described in availability of this submittal on EPA’s On January 5, 2005, at 70 FR 944, and greater detail throughout this notice of Adequacy Web site (http:// supplemented on April 14, 2005, at 70 proposed rulemaking. www.epa.gov/otaq/stateresources/ FR 19844, EPA designated the First, EPA proposes to determine that, transconf/currsips.htm). The Adequacy Birmingham Area as nonattainment for if EPA finalizes approval of the 2009 comment period for these MVEBs closed the 1997 PM2.5 NAAQS based upon air baseline emissions inventory for the on April 25, 2011. No adverse quality data for calendar years 2001– Birmingham Area, the Area has met the comments were received during the 2003. In that action, EPA defined the requirements for redesignation under Adequacy public comment period. 1997 PM2.5 Birmingham nonattainment section 107(d)(3)(E) of the CAA. In this Please see section VII of this proposed area to include Jefferson and Shelby action, EPA is proposing to approve a rulemaking for further explanation of Counties in their entireties and a request to change the legal designation this process and for more details on the portion Walker County. On November of Jefferson and Shelby Counties in their MVEBs. 13, 2009, at 74 FR 58688, EPA entireties and the designated portion of Today’s notice of proposed promulgated designations for the 2006 Walker County in the Birmingham Area rulemaking is in response to Alabama’s PM2.5 NAAQS, designating the from nonattainment to attainment for May 2, 2011, SIP submittal. That Birmingham Area (with the same document addresses the specific issues boundaries as for the 1997 PM2.5 the 1997 Annual PM2.5 NAAQS. As discussed below, the emissions summarized above and the necessary nonattainment area) as nonattainment inventory is being proposed for elements described in section for the 2006 24-hour PM2.5 NAAQS approval today. 107(d)(3)(E) of the CAA for based upon air quality data for calendar Second, EPA is proposing to approve redesignation of the Birmingham Area years 2006–2008. That action also Alabama’s 2009 emissions inventory for to attainment of the 1997 Annual PM2.5 clarified that the Birmingham Area was the Birmingham Area (under CAA NAAQS. classified unclassifiable/attainment for section 172(c)(3)). Alabama selected II. What is the background for EPA’s the 1997 24-hour PM2.5 NAAQS. EPA 2009 as the attainment emissions proposed actions? did not promulgate designations for the annual average NAAQS promulgated in inventory year for the Birmingham Area. Fine particle pollution can be emitted This attainment inventory identifies a 2006 since that NAAQS was essentially directly or formed secondarily in the identical to the 1997 Annual PM2.5 level of emissions in the Area that is atmosphere. The main precursors of sufficient to attain the 1997 Annual NAAQS. Therefore, the Birmingham PM2.5 are sulfur dioxide (SO2), NOX, Area is designated nonattainment for PM2.5 NAAQS and is a current, ammonia and volatile organic comprehensive inventory that meets the the Annual NAAQS promulgated in compounds (VOCs). Unless otherwise 1997 and for the 24-hour NAAQS requirements of section 172(c)(3). noted by the State or EPA, ammonia and Third, EPA is proposing to approve promulgated in 2006. Today’s action VOCs are presumed to be insignificant only addresses the designation for the Alabama’s 1997 Annual PM2.5 NAAQS contributors to PM formation, maintenance plan for the Birmingham 2.5 Annual NAAQS promulgated in 1997. whereas SO2 and NOX are presumed to All 1997 PM2.5 NAAQS areas were Area as meeting the requirements of be significant contributors to PM section 175A (such approval being one 2.5 designated under subpart 1 of title I, formation. Sulfates are a type of part D, of the CAA. Subpart 1 contains of the CAA criteria for redesignation to secondary particle formed from SO attainment status). The recently 2 the general requirements for emissions of power plants and nonattainment areas for any pollutant promulgated Cross State Air Pollution industrial facilities. Nitrates, another Rule (CSAPR) 1 requires reductions of governed by a NAAQS and is less common type of secondary particle, are prescriptive than the other subparts of NOX and SO2 associated with power formed from NOX emissions of power title I, part D. On April 25, 2007 (72 FR plants to be permanent and enforceable. plants, automobiles, and other The maintenance plan is designed to 20664), EPA promulgated its PM2.5 combustion sources. implementation rule, codified at 40 CFR help keep the Birmingham Area in On July 18, 1997, EPA promulgated attainment of the 1997 Annual PM2.5 the first air quality standards for PM2.5. 2 In response to legal challenges of the annual NAAQS through 2024. Consistent with EPA promulgated an annual standard at standard promulgated in 2006, the United States the CAA, the maintenance plan that a level of 15.0 micrograms per cubic Court of Appeals for the District of Columbia EPA is proposing to approve today also m 3 Circuit (D.C. Circuit) remanded this NAAQS to EPA meter ( g/m ), based on a 3-year average for further consideration. See American Farm includes NOX and PM2.5 MVEBs for the of annual mean PM2.5 concentrations. In Bureau Federation and National Pork Producers year 2024 for the Birmingham Area. the same rulemaking, EPA promulgated Council, et al. v. EPA. 559 F.3d 512 (D.C. Circuit a 24-hour standard of 65 mg/m3, based 2009). However, given that the 1997 and 2006 1 See ‘‘Federal Implementation Plans to Reduce Annual NAAQS are essentially identical, Interstate Transport of Fine Particulate Matter and on a 3-year average of the 98th attainment of the 1997 Annual NAAQS would also Ozone in 27 States; Correction of SIP Approvals for percentile of 24-hour concentrations. On indicate attainment of the remanded 2006 Annual 22 States’’ (76 FR 48208, August 8, 2011). October 17, 2006, at 71 FR 61144, EPA NAAQS.

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part 51, subpart Z, in which the Agency improvement that would be expected to criteria are met: (1) The Administrator provided guidance for state and Tribal result from full implementation of determines that the area has attained the plans to implement the PM2.5 NAAQS. CSAPR) may also be considered to be applicable NAAQS; (2) the This rule, at 40 CFR 51.1004(c), permanent and enforceable. EPA Administrator has fully approved the specifies some of the regulatory impacts proposes that the requirement in section applicable implementation plan for the of attaining the NAAQS, as discussed 107(d)(3)(E)(iii) has now been met area under section 110(k); (3) the below. because the emission reduction Administrator determines that the On May 12, 2005, EPA published the requirements of CAIR address emissions improvement in air quality is due to Clean Air Interstate Rule (CAIR), which through 2011 and EPA has now permanent and enforceable reductions addressed the interstate transport promulgated CSAPR, which requires in emissions resulting from requirements of the CAA and required similar or greater reductions in the implementation of the applicable SIP states to significantly reduce SO2 and relevant areas in 2012 and beyond. and applicable Federal air pollutant NOX emissions from power plants (70 Because the emission reduction control regulations and other permanent FR 25162). The associated Federal requirements of CAIR are enforceable and enforceable reductions; (4) the Implementation Plans (FIPs) were through the 2011 control period, and Administrator has fully approved a published on April 28, 2006 (71 FR because CSAPR has now been maintenance plan for the area as 25328). However, on July 11, 2008, the promulgated to address the meeting the requirements of section D.C. Circuit Court issued its decision to requirements previously addressed by 175A; and (5) the state containing such vacate and remand both CAIR and the CAIR and gets similar or greater area has met all requirements applicable associated CAIR FIPs in their entirety reductions in the relevant areas in 2012 to the area under section 110 and part (North Carolina v. EPA, 531 F.3d 836 and beyond, EPA is proposing to (D.C. Cir., 2008)). EPA petitioned for determine that the pollutant transport D of title I of the CAA. rehearing, and the Court issued an order part of the reductions that led to EPA has provided guidance on remanding CAIR to EPA without attainment in the Birmingham Area can redesignation in the General Preamble vacating either CAIR or the CAIR FIPs now be considered permanent and for the Implementation of title I of the (North Carolina v. EPA, 550 F.3d 1176 enforceable. Therefore, EPA proposes to CAA Amendments of 1990 (April 16, (D.C. Cir., 2008)). The Court left CAIR in find that the transport requirement of 1992, 57 FR 13498, and supplemented place to ‘‘temporarily preserve the CAA section 107(d)(3)(E)(iii) has been on April 28, 1992, 57 FR 18070) and has environmental values covered by CAIR’’ met for the Birmingham Area. provided further guidance on processing until EPA replaces it with a rule The 3-year ambient air quality data for redesignation requests in the following consistent with the Court’s opinion. Id. 2008–2010 indicated no violations of documents: at 1178. The Court directed EPA to the 1997 PM2.5 NAAQS for the ‘‘remedy CAIR’s flaws’’ consistent with Birmingham Area. As a result, on May 1. ‘‘Procedures for Processing Requests to Redesignate Areas to Attainment,’’ its July 11, 2008, opinion but declined 2, 2011, Alabama requested Memorandum from John Calcagni, to impose a schedule on EPA for redesignation of the Birmingham Area Director, Air Quality Management completing that action. Id. As a result of to attainment for the 1997 Annual PM 2.5 Division, September 4, 1992 (hereafter these court rulings, the power plant NAAQS. The redesignation request referred to as the ‘‘Calcagni emission reductions that resulted solely included three years of complete, Memorandum’’); from the development, promulgation, quality-assured ambient air quality data 2. ‘‘State Implementation Plan (SIP) Actions and implementation of CAIR, and the for the 1997 Annual PM NAAQS for 2.5 Submitted in Response to Clean Air Act associated contribution to air quality 2008–2010, indicating that the 1997 (CAA) Deadlines,’’ Memorandum from improvement that occurred solely as a Annual PM2.5 NAAQS had been John Calcagni, Director, Air Quality result of CAIR in the Birmingham Area achieved for the Birmingham Area. Management Division, October 28, 1992; could not be considered to be Under the CAA, nonattainment areas and permanent. may be redesignated to attainment if 3. ‘‘Part D New Source Review (Part D NSR) On August 8, 2011, EPA published sufficient, complete, quality-assured Requirements for Areas Requesting CSAPR in the Federal Register under data is available for the Administrator to Redesignation to Attainment,’’ the title, ‘‘Federal Implementation Plans determine that the area has attained the Memorandum from Mary D. Nichols, to Reduce Interstate Transport of Fine standard and the area meets the other Assistant Administrator for Air and Particulate Matter and Ozone in 27 CAA redesignation requirements in Radiation, States; Correction of SIP Approvals for section 107(d)(3)(E). From 2008 through October 14, 1994. 22 States’’ (76 FR 48208, August 8, the present, the annual PM2.5 design 2011) to address interstate transport of values for the Birmingham Area have IV. Why is EPA proposing these emissions and resulting secondary air declined. While annual PM2.5 actions? pollutants and to replace CAIR. The concentrations are dependent on a CAIR emission reduction requirements variety of conditions, the overall On May 2, 2011, the State of Alabama, through ADEM, requested the limit emissions in Alabama and states downtrend in PM2.5 concentrations in upwind of Alabama through 2011, and the Birmingham Area can be attributed redesignation of the Birmingham Area CSAPR requires similar or greater to the reduction of emissions, as will be to attainment for the 1997 Annual PM2.5 reductions in the relevant areas in 2012 discussed in more detail in section V of NAAQS. EPA’s evaluation indicates that and beyond. The emission reductions this proposed rulemaking. the Birmingham Area has attained the that CSAPR mandates may be 1997 Annual PM2.5 NAAQS and meets considered to be permanent and III. What are the criteria for the requirements for redesignation set enforceable. In turn, the air quality redesignation? forth in section 107(d)(3)(E), including improvement in the Birmingham Area The CAA provides the requirements the maintenance plan requirements that has resulted from electric for redesignating a nonattainment area under section 175A of the CAA. As a generating units (EGUs) emission to attainment. Specifically, section result, EPA is proposing to take the reductions associated with CAIR (as 107(d)(3)(E) of the CAA allows for three related actions summarized in well as the additional air quality redesignation providing the following section I of this notice.

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V. What is EPA’s analysis of the Criteria (1)—The Birmingham Area Has accordance with 40 CFR part 58 and request? Attained the 1997 Annual PM2.5 NAAQS recorded in the EPA Air Quality System As stated above, in accordance with For redesignating a nonattainment (AQS). The monitors generally should the CAA, EPA proposes in today’s area to attainment, the CAA requires have remained at the same location for action to: (1) Redesignate the EPA to determine that the area has the duration of the monitoring period Birmingham Area to attainment for the attained the applicable NAAQS (CAA required for demonstrating attainment. 1997 Annual PM2.5 NAAQS; (2) approve section 107(d)(3)(E)(i)). EPA is On June 29, 2011, at 76 FR 38023, the Birmingham Area emissions proposing to determine that the EPA determined that the Birmingham inventory submitted with the Birmingham Area continues to attain Area was attaining the 1997 Annual maintenance plan; and (3) approve into the 1997 Annual PM2.5 NAAQS. For PM NAAQS. For that action EPA the Alabama SIP Birmingham’s 1997 PM , an area may be considered to be 2.5 2.5 reviewed PM monitoring data from Annual PM NAAQS maintenance attaining the 1997 Annual PM 2.5 2.5 2.5 monitoring stations in the Birmingham plan, including the associated MVEBs. NAAQS if it meets the 1997 Annual Area for the 1997 Annual PM2.5 NAAQS These actions are based upon EPA’s PM2.5 NAAQS, as determined in determination that the Birmingham accordance with 40 CFR 50.13 and for 2008–2010. These data have been Area continues to attain the 1997 Appendix N of part 50, based on three quality-assured and are recorded in AQS. EPA has reviewed more recent Annual PM2.5 NAAQS and that all other complete, consecutive calendar years of redesignation criteria have been met for quality-assured air quality monitoring data which indicates that the the Birmingham Area, provided EPA data. To attain these NAAQS, the Birmingham Area continues to attain approves the emissions inventory annual arithmetic mean concentration, the 1997 Annual PM2.5 NAAQS beyond submitted with the maintenance plan. as determined in accordance with 40 the submitted 3-year attainment period The five redesignation criteria provided CFR part 50, Appendix N, is less than of 2008–2010. The annual arithmetic under CAA section 107(d)(3)(E) are or equal to 15.0 mg/m3 at all relevant mean of the PM2.5 concentrations for discussed in greater detail for the Area monitoring sites in the subject area over 2008–2010 and the 3-year average of in the following paragraphs of this a 3-year period. The relevant data must these values (i.e., design values) are section. be collected and quality-assured in summarized in Table 1.

TABLE 1—DESIGN VALUE CONCENTRATIONS FOR THE BIRMINGHAM 1997 ANNUAL PM2.5 AREA [μg/m3]

Annual arithmetic mean 3-Year concentrations design Location County Monitor ID values 2008 2009 2010 2008– 2010

North Birmingham...... Jefferson ...... 01–073–0023 15.5 11.7 13.8 13.7 McAdory ...... Jefferson ...... 01–073–1005 12.2 10.4 11.8 11.5 Bruce Shaw Road (Providence) ...... Jefferson ...... 01–073–1009 10.8 9.6 10.1 10.2 Asheville Road (Leeds) ...... Jefferson ...... 01–073–1010 13.2 10.3 12.1 11.9 Wylam ...... Jefferson ...... 01–073–2003 14.4 11.3 12.4 12.7 Hoover ...... Jefferson ...... 01–073–2006 12.1 10.3 11.8 11.4 Pinson High School ...... Jefferson ...... 01–073–5002 11.9 9.9 11.0 10.9 Corner School Road ...... Jefferson ...... 01–073–5003 11.5 9.7 10.7 10.6 Pelham High School ...... Shelby ...... 01–117–0006 11.6 9.8 13.9 10.9 Highland Avenue (Walker Co.) ...... Walker ...... 01–127–0002 11.7 10.1 11.3 11.0

The 3-year design value for 2008– discussed in more detail below, the applicable SIP requirements for the 2010 submitted by Alabama for State of Alabama has committed to Birmingham Area under section 110 of redesignation of the Birmingham Area is continue monitoring in this Area in the CAA (general SIP requirements) for 13.7 mg/m3, which meets the NAAQS as accordance with 40 CFR part 58. purposes of redesignation. Additionally, described above. Data available to date EPA proposes to find that the Alabama Criteria (5)—Alabama Has Met All SIP satisfies the criterion that it meet in AQS for 2011, which have not yet Applicable Requirements Under Section applicable SIP requirements for been certified, indicate the Birmingham 110 and Part D of Title I of the CAA; purposes of redesignation under part D Area continues to attain the 1997 and Criteria (2)—Alabama Has a Fully of title I of the CAA (requirements Annual PM2.5 NAAQS and that ambient Approved SIP Under Section 110(k) for specific to 1997 Annual PM annual concentrations of PM2.5 continue the Birmingham Area 2.5 to decline. As mentioned above, on June nonattainment areas) in accordance 29, 2011 (76 FR 38023) EPA published For redesignating a nonattainment with section 107(d)(3)(E)(v). Further, a clean data determination for the area to attainment, the CAA requires EPA proposes to determine that the SIP Birmingham Area for the 1997 Annual EPA to determine that the state has met is fully approved with respect to all PM2.5 NAAQS. In today’s action, EPA is all applicable requirements under requirements applicable for purposes of proposing to determine that the Area is section 110 and part D of title I of the redesignation in accordance with continuing to attain the 1997 PM2.5 CAA (CAA section 107(d)(3)(E)(v)) and section 107(d)(3)(E)(ii). In making these NAAQS. EPA will not go forward with that the state has a fully approved SIP determinations, EPA ascertained which the redesignation if the Area does not under section 110(k) for the area (CAA requirements are applicable to the Area continue to attain until the time that section 107(d)(3)(E)(ii)). EPA proposes and, if applicable, that they are fully EPA finalizes the redesignation. As to find that Alabama has met all approved under section 110(k). SIPs

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must be fully approved only with CSAPR). The section 110(a)(2)(D) of the nonattainment status of the respect to requirements that were requirements for a state are not linked Birmingham Area. As stated above, EPA applicable prior to submittal of the with a particular nonattainment area’s believes that section 110 elements not complete redesignation request. designation and classification in that linked to an area’s nonattainment status state. EPA believes that the are not applicable for purposes of a. The Birmingham Area Has Met All requirements linked with a particular redesignation. Therefore, Applicable Requirements Under Section nonattainment area’s designation and notwithstanding the fact that EPA has 110 and part D of the CAA classifications are the relevant measures not yet completed rulemaking on General SIP requirements. Section to evaluate in reviewing a redesignation Alabama’s submittal for the PM2.5 110(a)(2) of title I of the CAA delineates request. The transport SIP submittal infrastructure SIP elements of section the general requirements for a SIP, requirements, where applicable, 110(a)(2), EPA believes it has approved which include enforceable emissions continue to apply to a state regardless of all SIP elements under section 110 that limitations and other control measures, the designation of any one particular must be approved as a prerequisite for means, or techniques; provisions for the area in the state. Thus, EPA does not redesignating the Birmingham Area to establishment and operation of believe that the CAA’s interstate attainment. appropriate devices necessary to collect transport requirements should be Title I, Part D requirements. EPA data on ambient air quality; and construed to be applicable requirements proposes that if EPA approves programs to enforce the limitations. for purposes of redesignation. However, Alabama’s base year emissions General SIP elements and requirements as discussed later in this notice, inventory, which is part of the are delineated in section 110(a)(2) of addressing pollutant transport from maintenance plan submittal, the title I, part A of the CAA. These other states is an important part of an Alabama SIP will meet applicable SIP requirements include, but are not area’s maintenance demonstration. requirements under part D of the CAA. limited to, the following: submittal of a In addition, EPA believes other As discussed in greater detail below, SIP that has been adopted by the state section 110 elements that are neither EPA believes the emissions inventory is after reasonable public notice and connected with nonattainment plan approvable because the 2009 direct hearing; provisions for establishment submissions nor linked with an area’s PM2.5, SO2, and NOX emissions for and operation of appropriate procedures attainment status are applicable Alabama were developed consistent needed to monitor ambient air quality; requirements for purposes of with EPA guidance for emissions implementation of a source permit redesignation. The area will still be inventories and represent a program; provisions for the subject to these requirements after the comprehensive, accurate and current implementation of part C requirements area is redesignated. The section 110 inventory as required by CAA section (Prevention of Significant Deterioration and part D requirements which are 172(c)(3). (PSD)) and provisions for the linked with a particular area’s Part D, subpart 1 applicable SIP implementation of part D requirements designation and classification are the requirements. EPA has determined that (New Source Review (NSR) permit relevant measures to evaluate in if the approval of the base year programs); provisions for air pollution reviewing a redesignation request. This emissions inventory, discussed in modeling; and provisions for public and approach is consistent with EPA’s section VIII of this rulemaking, is local agency participation in planning existing policy on applicability (i.e., for finalized, the Alabama SIP will meet the and emission control rule development. redesignations) of conformity and applicable SIP requirements for the Section 110(a)(2)(D) requires that SIPs oxygenated fuels requirements, as well Birmingham Area for purposes of contain certain measures to prevent as with section 184 ozone transport redesignation under title I, part D of the sources in a state from significantly requirements. See Reading, CAA. Subpart 1 of part D sets forth the contributing to air quality problems in Pennsylvania, proposed and final basic nonattainment requirements another state. To implement this rulemakings (61 FR 53174–53176, applicable to all nonattainment areas. provision, EPA has required certain October 10, 1996), (62 FR 24826, May 7, All areas that were designated states to establish programs to address 1997); Cleveland-Akron-Lorain, Ohio, nonattainment for the 1997 Annual the interstate transport of air pollutants final rulemaking (61 FR 20458, May 7, PM2.5 NAAQS were designated under 3 4 this subpart of the CAA and the (e.g., NOX SIP Call, CAIR, and 1996); and Tampa, Florida, final rulemaking at (60 FR 62748, December requirements applicable to them are 3 On October 27, 1998 (63 FR 57356), EPA issued 7, 1995). See also the discussion on this contained in sections 172 and 176. a NOX SIP Call requiring the District of Columbia issue in the Cincinnati, Ohio, For purposes of evaluating this and 22 states to reduce emissions of NOX in order redesignation (65 FR 37890, June 19, redesignation request, the applicable to reduce the transport of ozone and ozone 2000), and in the Pittsburgh, part D, subpart 1 SIP requirements for precursors. In compliance with EPA’s NOX SIP Call, all nonattainment areas are contained in Alabama developed rules governing the control of Pennsylvania, redesignation (66 FR NOX emissions from EGUs, major non-EGU 50399, October 19, 2001). sections 172(c)(1)–(9) and in section industrial boilers, major cement kilns, and internal EPA has not yet completed 176. A thorough discussion of the combustion engines. On December 27, 2002, EPA rulemaking on a submittal from requirements contained in section 172 approved Alabama’s rules as fulfilling Phase I (67 can be found in the General Preamble FR 78987). Alabama dated September 23, 2009, 4 On May 12, 2005 (70 FR 25162), EPA addressing ‘‘infrastructure SIP’’ for Implementation of title I (57 FR promulgated CAIR, which required 28 upwind elements required under CAA section 13498, April 16, 1992). States and the District of Columbia to revise their 110(a)(2). However, these are statewide Subpart 1 Section 172 Requirements. SIPs to include control measures that would reduce requirements that are not a consequence Section 172(c)(1) requires the plans for emissions of SO2 and NOX. Various aspects of CAIR rule were petitioned in court and on December 23, all nonattainment areas to provide for 2008, the U.S. Court of Appeals for the District of directed EPA to remedy various areas of the rule the implementation of all Reasonable Columbia Circuit remanded CAIR to EPA (see that were petitioned consistent with its July 11, Available Control Measures (RACM) as Alabama v. EPA, 550 F.3d 1176 (DC Circuit, 2008 (see Alabama v. EPA, 531 F.3d 836 (DC expeditiously as practicable and to December 23, 2008)), which left CAIR in place to Circuit, July 11, 2008)), opinion, but declined to ‘‘temporarily preserve the environmental values impose a schedule on EPA for completing that provide for attainment of the national covered by CAIR’’ until EPA replaces it with a rule action. Id. Therefore, CAIR is currently in effect in primary ambient air quality standards. consistent with the Court’s ruling. The Court Alabama. EPA interprets this requirement to

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impose a duty on all nonattainment redesignation request for the Transit Act (transportation conformity) areas to consider all available control Birmingham Area, Alabama submitted a as well as to all other federally measures and to adopt and implement 2009 base year emissions inventory. As supported or funded projects (general such measures as are reasonably discussed below in section VIII, EPA is conformity). State transportation available for implementation in each proposing to approve the 2009 base year conformity SIP revisions must be area as components of the area’s inventory submitted with the consistent with Federal conformity attainment demonstration. Under redesignation request as meeting the regulations relating to consultation, section 172, states with nonattainment section 172(c)(3) emissions inventory enforcement and enforceability that EPA areas must submit plans providing for requirement. promulgated pursuant to its authority timely attainment and meeting a variety Section 172(c)(4) requires the under the CAA. of other requirements. However, identification and quantification of EPA interprets the conformity SIP pursuant to 40 CFR 51.1004(c), EPA’s emissions for major new and modified requirements5 as not applying for June 29, 2011, determination that the stationary sources to be allowed in an purposes of evaluating a redesignation Birmingham area was attaining the area, and section 172(c)(5) requires request under section 107(d) because Annual PM2.5 standard suspended source permits for the construction and state conformity rules are still required Alabama’s obligation to submit most of operation of new and modified major after redesignation and Federal the attainment planning requirements stationary sources anywhere in the conformity rules apply where state rules that would otherwise apply. nonattainment area. EPA has have not been approved. See Wall v. Specifically, the determination of determined that, since PSD EPA, 265 F.3d 426 (6th Cir. 2001) attainment suspended Alabama’s requirements will apply after (upholding this interpretation); see also obligation to submit an attainment redesignation, areas being redesignated 60 FR 62748 (December 7, 1995) demonstration and planning SIPs to need not comply with the requirement (redesignation of Tampa, Florida). Thus, provide for reasonable further progress that an NSR program be approved prior the Birmingham Area has satisfied all (RFP), RACM, and contingency to redesignation, provided that the area applicable requirements for purposes of measures under section 172(c)(9). demonstrates maintenance of the redesignation under section 110 and The General Preamble for NAAQS without part D NSR. A more part D of title I of the CAA. Implementation of Title I (57 FR 13498, detailed rationale for this view is b. The Birmingham Area Has a Fully April 16, 1992) also discusses the described in a memorandum from Mary evaluation of these requirements in the Nichols, Assistant Administrator for Air Approved Applicable SIP Under Section context of EPA’s consideration of a and Radiation, dated October 14, 1994, 110(k) of the CAA redesignation request. The General entitled, ‘‘Part D New Source Review If EPA issues a final approval of the Preamble sets forth EPA’s view of Requirements for Areas Requesting base year emissions inventory, EPA will applicable requirements for purposes of Redesignation to Attainment.’’ Alabama have fully approved the applicable evaluating redesignation requests when has demonstrated that the Birmingham Alabama SIP for the Birmingham 1997 an area is attaining a standard (General Area will be able to maintain the Annual PM2.5 nonattainment area under Preamble for Implementation of Title I NAAQS without part D NSR in effect, section 110(k) of the CAA for all (57 FR 13498, April 16, 1992)). and therefore Alabama need not have requirements applicable for purposes of Because attainment has been reached fully approved part D NSR programs redesignation. EPA may rely on prior in the Birmingham Area, no additional prior to approval of the redesignation SIP approvals in approving a measures are needed to provide for request. Nonetheless, Alabama currently redesignation request (see Calcagni attainment, and section 172(c)(1) has a fully approved part D NSR Memorandum at p. 3; Southwestern requirements for an attainment program in place. Alabama’s PSD Pennsylvania Growth Alliance v. demonstration and RACM are no longer program will become effective in the Browner, 144 F.3d 984, 989–90 (6th Cir. considered to be applicable for purposes Birmingham Area upon redesignation to 1998); Wall, 265 F.3d 426) plus any of redesignation as long as the Area attainment. Section 172(c)(6) requires additional measures it may approve in continues to attain the standard until the SIP to contain control measures conjunction with a redesignation action redesignation. See also 40 CFR necessary to provide for attainment of (see 68 FR 25426 (May 12, 2003) and 51.1004(c). the NAAQS. Because attainment has citations therein). Following passage of The RFP plan requirement under been reached, no additional measures the CAA of 1970, Alabama has adopted section 172(c)(2) is defined as progress are needed to provide for attainment. and submitted, and EPA has fully that must be made toward attainment. Section 172(c)(7) requires the SIP to approved at various times, provisions This requirement is not relevant for meet the applicable provisions of addressing the various 1997 Annual purposes of redesignation because EPA section 110(a)(2). As noted above, EPA PM2.5 NAAQS SIP elements applicable has determined that the Birmingham believes the Alabama SIP meets the in the Birmingham Area (May 31, 1972, Area has monitored attainment of the requirements of section 110(a)(2) 37 FR 10842; July 13, 2011, 76 FR 1997 Annual PM2.5 NAAQS. See applicable for purposes of 41100). General Preamble, 57 FR 13564. See also redesignation. As indicated above, EPA believes that 40 CFR 51.1004 (c). In addition, because Section 176 Conformity the section 110 elements that are neither the Birmingham Area has attained the Requirements. Section 176(c) of the connected with nonattainment plan 1997 Annual PM2.5 NAAQS and is no CAA requires states to establish criteria submissions nor linked to an area’s longer subject to an RFP requirement, and procedures to ensure that federally nonattainment status are not applicable the requirement to submit the section supported or funded projects conform to requirements for purposes of 172(c)(9) contingency measures is not the air quality planning goals in the applicable for purposes of applicable SIP. The requirement to 5 CAA Section 176(c)(4)(E) requires states to redesignation. Id. determine conformity applies to submit revisions to their SIPs to reflect certain Section 172(c)(3) requires submission transportation plans, programs and Federal criteria and procedures for determining transportation conformity. Transportation and approval of a comprehensive, projects that are developed, funded or conformity SIPs are different from the MVEBs that accurate, and current inventory of actual approved under title 23 of the United are established in control strategy SIPs and emissions. As part of Alabama’s States Code (U.S.C.) and the Federal maintenance plans.

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redesignation. In addition, EPA believes Criteria (3)—The Air Quality State, local and Federal measures that since the part D subpart 1 Improvement in the Birmingham 1997 enacted in recent years have resulted in requirements did not become due prior Annual PM2.5 NAAQS Nonattainment permanent emission reductions. Most of to submission of the redesignation Area Is Due to Permanent and these emission reductions are request, they are also not applicable Enforceable Reductions in Emissions enforceable through regulations. A few requirements for purposes of Resulting From Implementation of the non-regulatory measures also result in redesignation. Sierra Club v. EPA, 375 SIP and Applicable Federal Air emission reductions. F.3d 537 (7th Cir. 2004); 68 FR 25424, Pollution Control Regulations and Other Permanent and Enforceable Reductions The state and local measures that 25427 (May 12, 2003) (redesignation of have been implemented to date and the St. Louis-East St. Louis Area to For redesignating a nonattainment relied upon by Alabama to demonstrate attainment of the 1-hour ozone area to attainment, the CAA requires attainment and/or maintenance include EPA to determine that the air quality NAAQS). With the approval of the local NOX controls on cement plants in emissions inventory, EPA will have improvement in the area is due to the Area due to the 8-hour ozone approved all Part D subpart 1 permanent and enforceable reductions contingency plan, Jefferson and Shelby requirements applicable for purposes of in emissions resulting from County burn bans, and voluntary on- implementation of the SIP and this redesignation. road and off-road diesel retrofit projects. applicable Federal air pollution control regulations and other permanent and As shown in Table 2, below, enforceable reductions (CAA section reasonably available control technology 107(d)(3)(E)(iii)). EPA believes that (RACT) PM controls installed in the Alabama has demonstrated that the Birmingham Area have reduced direct observed air quality improvement in the PM2.5 emissions by approximately 62 Birmingham Area is due to permanent tons per year (tpy) as of the end of 2009. and enforceable reductions in emissions These controls are associated with the resulting from implementation of the Birmingham Annual PM2.5 Attainment SIP, Federal measures, and other state Demonstration SIP, submitted to EPA on adopted measures. March 13, 2009.

TABLE 2—SUMMARY OF RACT CONTROLS IN THE BIRMINGHAM AREA

PM2.5 Facility Source RACT Controls reduction Installation (tpy) date

W.J. Bullock ...... Crucible furnaces ...... Baghouse ...... 3 .891 2009 McWane Pipe ...... Charge handling area ...... Wet suppression ...... 0 .385 2008 Sloss Industries ...... Coal piles ...... Wet suppression ...... 0.398 2008 American Cast Iron Pipe ..... Charge make-up ...... Wet suppression ...... 11 .91 2008 Roads & process areas ...... Paving ...... 3.58 2007/2008 Cupola melting furnace ...... New Cupola/Bag house & spray suppression ...... 5 .84 2007/2008 Sand & cement silos ...... Baghouse ...... 0.09 2008 Nucor Steel ...... Meltshop fugitives ...... Baghouse & physical improvements ...... 28 .1 2008 U.S. Pipe ...... Cupola charge make-up ...... Wet suppression ...... 1 .818 2008 Sand & cement silos ...... Bin vents ...... 5 .93 2008

Total ...... 61 .942 ......

In addition, closures of certain RACT controls and facility closures Company’s (APC) Gorgas Plant in facilities have resulted in continued amount to reductions of greater than anticipation of CAIR. Selective catalytic reductions of local PM2.5 emissions in eight percent of direct PM2.5 point reduction (SCR) systems were installed the Birmingham Area. In late 2009, W.J. source emissions in Jefferson County. on units 3 and 4 at APC Miller Plant in Bullock and Sloss Mineral Wool in Furthermore, control equipment 2003 as a result of the NOX SIP Call, Jefferson County announced plans to installed at utilities in the Birmingham with a consent decree requiring year cease operations, resulting in additional Area have decreased emissions of NOX round operation beginning in 2008 in PM2.5 emission reductions of 0.13 tpy and SO2. These reductions, prompted by preparation for CAIR. The year round and 130 tpy, respectively. In March the NOX SIP Call and CAIR, are SCR operation requirements have been 2010, U.S. Pipe ceased production, summarized in Table 3 below. In 2007, incorporated into the facilities’ title V resulting in an additional emission flue gas desulfurization systems were operating permits and are thus reduction of 46 tpy of PM2.5. In total, the added to units 8–10 of Alabama Power enforceable.

TABLE 3—SUMMARY OF EMISSIONS AND CONTROLS AT UTILITIES IN THE BIRMINGHAM AREA 6

Date control installed Emissions reductions from 2006–2009 (tpy) Facility NOX SO2 NOX SO2 Percent

APC Miller Unit 3 ...... 2008 ...... 4,680 ...... 71 APC Miller Unit 4 ...... 2008 ...... 3,786 ...... 70 APC Gorgas Unit 8 ...... 2007 ...... 10,007 96 APC Gorgas Unit 9 ...... 2007 ...... 9,975 96

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TABLE 3—SUMMARY OF EMISSIONS AND CONTROLS AT UTILITIES IN THE BIRMINGHAM AREA 6—Continued

Date control installed Emissions reductions from 2006–2009 (tpy) Facility NOX SO2 NOX SO2 Percent

APC Gorgas Unit 10 ...... 2007 ...... 40,779 97 APC Gaston Unit 5 * ...... 2010 ...... 43,579 78

Total Reductions ...... 8,466 104,341 ...... * Gaston Unit 5 data reflects reductions from 2006–2010.

The Federal measures that have been Large nonroad diesel engine the final CSAPR on August 8, 2011. implemented include the following: standards. Promulgated in 2004, this CSAPR addresses the interstate Tier 2 vehicle standards. In addition rule is being phased in between 2008 transport requirements of the CAA with to requiring NOX controls, the Tier 2 and 2014. This rule will reduce sulfur respect to the 1997 ozone, 1997 PM2.5 rule reduced the allowable sulfur content in nonroad diesel fuel and, and 2006 PM2.5 NAAQS. As noted content of gasoline to 30 parts per when fully implemented, will reduce previously, the requirements of CAIR million (ppm) starting in January of NOX and direct PM2.5 emissions by over address emissions through the 2011 2006. Most gasoline sold in Alabama 90 percent from these engines. control period and CSAPR requires prior to this had a sulfur content of NOX SIP Call. On October 27, 1998 similar or greater emission reductions in approximately 300 ppm. (63 FR 57356), EPA issued a NOX SIP the relevant areas in 2012 and beyond. Heavy-duty gasoline and diesel Call requiring the District of Columbia highway vehicle standards. The second and 22 states to reduce emissions of Because PM2.5 concentrations in the Birmingham area are impacted by the phase of the standards and testing NOX. Affected states were required to procedures, which began in 2007, comply with Phase I of the SIP Call transport of sulfates and nitrates, the reduces particulate matter (PM) and beginning in 2004, and Phase II area’s air quality is affected by NOX from heavy-duty highway engines beginning in 2007. Emission reductions regulation of SO2 and NOX emissions and also reduces highway diesel fuel resulting from regulations developed in from upwind power plants. Table 4, sulfur content to 15 ppm. The total response to the NOX SIP Call are below, presents statewide EGU program is expected to achieve a 90 and permanent and enforceable. emissions data compiled by EPA’s Clean 95 percent reduction in PM and NOX CAIR and CSAPR. As previously Air Markets Division for the years 2002 emissions from heavy-duty highway discussed, the remanded CAIR, and 2009. Emissions for 2009 reflect engines, respectively. originally promulgated to reduce implementation of CAIR. Table 4 shows Nonroad spark-ignition engines and transported pollution, was left in place that Alabama and states impacting the recreational engines standards. Tier 1 of to ‘‘temporarily preserve the Birmingham Area for the Annual PM2.5 this standard, implemented in 2004, and environmental values covered by CAIR’’ NAAQS, as indicated in CSAPR, Tier 2, implemented in 2007, have until EPA replaced it with a rule reduced NOX and SO2 emissions from reduced and will continue to reduce PM consistent with the Court’s opinion. To EGUs by 995,606 tpy and 1,901,135 tpy, emissions. remedy CAIR’s flaws, EPA promulgated respectively, between 2002 and 2009.

TABLE 4—COMPARISON OF 2002 AND 2009 STATEWIDE EGU NOX AND SO2 EMISSIONS (TPY) FOR STATES IMPACTING 6 THE BIRMINGHAM AREA FOR THE ANNUAL PM2.5 NAAQS

NOX SO2 State Net change Net change 2002 2009 2002–2009 2002 2009 2002–2009

Alabama ...... 161,559 49,609 ¥111,950 448,248 277,972 ¥170,276 Georgia ...... 146,456 57,566 ¥88,890 512,654 262,258 ¥250,396 Illinois ...... 174,247 72,286 ¥101,961 353,699 229,364 ¥124,335 Indiana ...... 281,146 110,969 ¥170,177 778,868 413,726 ¥365,142 Kentucky ...... 198,599 78,767 ¥119,832 482,653 252,002 ¥230,651 Ohio ...... 370,497 95,785 ¥274,712 1,132,069 600,687 ¥531,382 Tennessee ...... 155,996 27,912 ¥128,084 336,995 108,042 ¥228,953

Total ...... 1,488,500 492,894 ¥995,606 4,045,186 2,144,051 ¥1,901,135

As was noted earlier, EPA improvement in the Birmingham Area. be replaced by CSAPR beginning in promulgated CSAPR to address CSAPR requires substantial reductions 2012. CSAPR requires reductions of interstate transport of emissions and of SO2 and NOX emissions from EGUs NOX and SO2 emissions to levels below resulting secondary air pollutants and to across most of the Eastern United States, the levels that led to attainment of the replace CAIR. CAIR, among other with implementation beginning on 1997 24-hour PM2.5 standard in the things, required emission reductions January 1, 2012. CAIR will continue to Birmingham Area. Given the remanded that contributed to the air quality be implemented through 2011, and will status of CAIR, air quality improvement

6 Data in Tables 3 and 4 reflect reported actual Database http://camddataandmaps.epa.gov/gdm/ emissions from the Clean Air Markets Division index.cfm?fuseaction=emissions.wizard.

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from the EGU reductions could not be maintenance plan must contain mobile. The future year emissions considered permanent at the time contingency measures as EPA deems inventories have been estimated using ADEM submitted its request for necessary to assure prompt correction of projected rates of growth in population, redesignation of the Birmingham Area. any future 1997 Annual PM2.5 traffic, economic activity, expected However, since that time CSAPR has violations. The Calcagni Memorandum control programs, and other parameters. been finalized, which mandates even provides further guidance on the Due to the remand of CAIR, ADEM did greater reductions than have already content of a maintenance plan, not include any emissions reductions occurred under CAIR and, more explaining that a maintenance plan expected under the rule past 2012. importantly, more reductions than are should address five requirements: the Promulgation of CSAPR ensured that needed to maintain the standard in the attainment emissions inventory, reductions expected under CAIR would Area. The reductions of EGU emissions maintenance demonstration, remain, thus EPA considers ADEM’s of SO2 and NOX contributed to the air monitoring, verification of continued projections to be conservative estimates. quality improvement in the Birmingham attainment, and a contingency plan. As Non-road mobile emissions estimates Area. Therefore, the final promulgation is discussed more fully below, EPA were based on the EPA’s of CSAPR, in combination with the finds that Alabama’s maintenance plan NONROAD2008a non-road mobile other measures cited by Alabama and includes all the necessary components model, with the exception of the described above, ensure that the and is thus proposing to approve it as railroad locomotives, commercial emission reductions that led the Area to a revision to the Alabama SIP. marine, and aircraft engine. These attain the 1997 Annual PM NAAQS emissions are estimated by taking 2.5 b. Attainment Emissions Inventory can be considered permanent and activity data, such as landings and enforceable for purposes of section The Birmingham Area attained the takeoffs, and multiplying by an 107(d)(3)(E)(iii). 1997 Annual PM2.5 NAAQS based on Economic Growth Analysis System monitoring data for the 3-year period (EGAS) emission factor. On-road mobile Criteria (4)—The Birmingham Area Has from 2008–2010. Alabama selected 2009 source emissions were calculated using a Fully Approved Maintenance Plan as the attainment emissions inventory EPA’s MOVES2010a mobile emission Pursuant to Section 175A of the CAA year. The attainment inventory factors model. The 2009 SO2, NOX and For redesignating a nonattainment identifies a level of emissions in the PM2.5 emissions for the Birmingham area to attainment, the CAA requires Area that is sufficient to attain the 1997 Area, as well as the emissions for other EPA to determine that the area has a Annual PM2.5 NAAQS. Alabama began years, were developed consistent with fully approved maintenance plan development of the attainment EPA guidance and are summarized in pursuant to section 175A of the CAA inventory by first generating a baseline Tables 5 through 8 of the following (CAA section 107(d)(3)(E)(iv)). In emissions inventory for the Birmingham subsection discussing the maintenance conjunction with its request to Area. As noted above, the year 2009 was demonstration. redesignate the Birmingham Area to chosen as the base year for developing c. Maintenance Demonstration attainment for the 1997 Annual PM2.5 a comprehensive emissions inventory NAAQS, ADEM submitted a SIP for direct PM2.5 and the primary PM2.5 The May 2, 2011, final submittal revision to provide for the maintenance precursors, SO2 and NOX, for which includes a maintenance plan for the of the 1997 Annual PM2.5 NAAQS for at projected emissions could be developed Birmingham nonattainment area. The least 10 years after the effective date of for 2012, 2015, 2018, 2021, and 2024. maintenance plan: redesignation to attainment. EPA ADEM used actual point source (i) Shows compliance with and believes this maintenance plan meets emissions data for 2009 for all sources maintenance of the Annual PM2.5 the requirements for approval under in Jefferson County and a majority of standard by providing information to section 175A of the CAA. sources in Shelby County. The Visibility support the demonstration that current Improvement—State and Tribal and future emissions of SO , NO and a. What is required in a maintenance 2 X Association of the Southeast (VISTAS) PM remain at or below 2009 plan? 2.5 projected 2009 emissions were used emissions levels. Section 175A of the CAA sets forth only where actual emissions were (ii) Uses 2009 as the attainment year the elements of a maintenance plan for unavailable. The projected inventory and includes future emissions inventory areas seeking redesignation from included with the maintenance plan projections for 2012, 2015, 2018, 2021, nonattainment to attainment. Under estimates emissions forward to 2024, and 2024. section 175A, the plan must which is beyond the 10-year interval (iii) Identifies an ‘‘out year’’ at least 10 demonstrate continued attainment of required in section 175A of the CAA. In years (and beyond) after the time the applicable NAAQS for at least 10 addition to comparing the final year of necessary for EPA to review and years after the Administrator approves a the plan, 2024, to the base year, 2009, approve the maintenance plan. Per 40 redesignation to attainment. Eight years Alabama compared interim years to the CFR part 93, NOX and PM2.5 MVEBs after the redesignation, the State must baseline to demonstrate that these years were established for the last year (2024) submit a revised maintenance plan are also expected to show continued of the maintenance plan (see section VI which demonstrates that attainment will maintenance of the Annual PM2.5 below). continue to be maintained for the 10 standard. (iv) Provides actual and projected years following the initial 10-year The emissions inventory is composed emissions inventories, in tpy, for the period. To address the possibility of of four major types of sources: point, Birmingham nonattainment area, as future NAAQS violations, the area, on-road mobile and non-road shown in Tables 5 through 8 below.

TABLE 5—ACTUAL AND PROJECTED ANNUAL PM2.5 EMISSIONS (TPY) FOR THE BIRMINGHAM AREA

Sector 2009 2012 2015 2018 2021 2024

Point ...... 4,095.30 3,558.75 3,755.85 3,971.20 4,186.55 4,416.50 Area ...... 4,507.75 4,445.70 4,515.05 4,588.05 4,664.70 4,737.70

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TABLE 5—ACTUAL AND PROJECTED ANNUAL PM2.5 EMISSIONS (TPY) FOR THE BIRMINGHAM AREA—Continued

Sector 2009 2012 2015 2018 2021 2024

Nonroad ...... 584.00 543.85 481.80 419.75 383.25 365.00 Mobile ...... 819.80 663.50 507.24 450.06 392.88 335.70

Total ...... 10,006.85 9,211.80 9,259.94 9,429.06 9,627.38 9,854.90

TABLE 6—ACTUAL AND PROJECTED ANNUAL NOX EMISSIONS (TPY) FOR THE BIRMINGHAM AREA

Sector 2009 2012 2015 2018 2021 2024

Point ...... 35,131.25 35,189.65 35,773.65 36,375.90 37,102.25 37,846.85 Area ...... 4,102.60 4,168.30 4,230.35 4,296.05 4,358.10 4,423.80 Nonroad ...... 9,968.15 8,979.00 7,935.10 7,172.25 7,004.35 7,088.30 Mobile ...... 24,991.13 19,980.14 14,969.14 12,892.21 10,815.28 8,738.39

Total ...... 74,193.13 68,317.09 62,908.24 60,736.41 59,279.98 58,097.34

TABLE 7—ACTUAL AND PROJECTED ANNUAL SO2 EMISSIONS (TPY) FOR THE BIRMINGHAM AREA

Sector 2009 2012 2015 2018 2021 2024

Point ...... 180,094.65 74,354.15 74,609.65 74,887.05 75,131.97 75,525.80 Area ...... 386.90 397.85 405.15 416.10 423.40 434.35 Nonroad ...... 182.50 73.00 69.35 69.35 69.35 73.00 Mobile ...... 149.08 121.57 94.09 94.62 95.15 95.62

Total ...... 180,813.13 74,946.57 75,178.24 75,467.12 75,719.87 76,128.77

TABLE 8—EMISSION ESTIMATES FOR BIRMINGHAM AREA

Year PM2.5 (tpy) NOX (tpy) SO2 (tpy)

2009 ...... 10,006.85 74,193.13 180,813.13 2012 ...... 9,211.80 68,317.09 74,946.57 2015 ...... 9,259.94 62,908.24 75,178.24 2018 ...... 9,429.06 60,736.41 75,467.12 2021 ...... 9,627.38 59,279.98 75,719.87 2024 ...... 9,854.90 58,097.34 76,128.77 Difference from 2009 to 2024 ...... ¥151.95 ¥16095.79 ¥104,684.36

Tables 5 through 8 summarize the level of emissions during one of the operation of the monitors in the 2009 and future projected emissions of years in which the area met the NAAQS. Birmingham Area in compliance with direct PM2.5 and precursors from the Alabama selected 2009 as the 40 CFR part 58 and have thus addressed counties in the Birmingham Area. In attainment emissions inventory year for the requirement for monitoring. EPA situations where local emissions are the the Birmingham Area. Alabama approved Alabama’s 2010 monitoring primary contributor to nonattainment, calculated the safety margins in its plan on October 8, 2010. submittal as 16,095.79 tpy for NOx and the ambient air quality standard should e. Verification of Continued Attainment not be violated in the future as long as 151.95 tpy for PM2.5. The State has emissions from within the decided to allocate 7,243.11 tpy of the The State of Alabama, through ADEM, nonattainment area remain at or below available NOx safety margin and 106.37 has the legal authority to enforce and implement the requirements of the the baseline with which attainment was tpy of the available PM2.5 safety margin

achieved. Alabama has projected to the 2024 MVEBs for the Birmingham Birmingham Area 1997 Annual PM2.5 maintenance plan. This includes the emissions as described previously and Area. Therefore, the remaining safety authority to adopt, implement and determined that emissions in the margin for NOx will be 8852.68 tpy and enforce any subsequent emissions Birmingham Area will remain below the remaining safety margin for PM2.5 control contingency measures those in the attainment year inventory will be 45.58 tpy. This allocation and determined to be necessary to correct for the duration of the maintenance the resulting available safety margin for future PM attainment problems. plan. the Birmingham Area are discussed 2.5 further in section VI of this proposed ADEM will track the progress of the As discussed in section VI of this rulemaking. maintenance plan by performing future proposed rulemaking, a safety margin is reviews of triennial emissions the difference between the attainment d. Monitoring Network inventories for the Birmingham Area as level of emissions (from all sources) and There are currently ten monitors required in the Air Emissions Reporting the projected level of emissions (from measuring PM2.5 in the Birmingham Rule (AERR) and Consolidated all sources) in the maintenance plan. Area. The State of Alabama, through Emissions Reporting Rule (CERR). For The attainment level of emissions is the ADEM, has committed to continue these periodic inventories, ADEM will

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review the assumptions made for the PM2.5 NAAQS, as described in section II Demonstration SIP, which is included purpose of the maintenance above, are violated. Alabama commits to in the docket for this proposed demonstration concerning projected adopting, within 18 months of a rulemaking (EPA–R04–OAR–2011– growth of activity levels. If any of these certified violation of the Annual PM2.5 0316). Chapter 8 contains the detailed assumptions appear to have changed NAAQS, one or more of the control contingency measures for the Annual substantially, then ADEM will re-project measures discussed below. PM2.5 SIP and was referenced in the emissions for the Birmingham Area. Additionally, Alabama has identified a redesignation request and maintenance secondary trigger to occur when the plan for the Annual PM NAAQS. Also f. Contingency Measures in the 2.5 annual average PM concentrations in in the event that further reductions are Maintenance Plan 2.5 a year at any individual monitor in the needed, ADEM will consider the The contingency measures are nonattainment area records a reading of possibility of expanding the current designed to promptly correct a violation 15.0 mg/m3 or higher. In such a case, the voluntary diesel retrofit program of the NAAQS that occurs after state will evaluate existing controls currently in place in the Birmingham redesignation. Section 175A of the CAA measures and determine whether any Area. requires that a maintenance plan further emission reduction measures Once a primary trigger is initiated, include such contingency measures as should be implemented. ADEM will ADEM will commence analysis, EPA deems necessary to assure that the consider several factors in its evaluation including review of expected emissions state will promptly correct a violation of of the need for additional controls reductions from local and regional the NAAQS that occurs after measures in the event of a future year regulatory programs, air quality redesignation. The maintenance plan violation of the 1997 Annual PM2.5 modeling, and emissions inventory should identify the contingency NAAQS. Depending on the timing of the assessment to determine emission measures to be adopted, a schedule and future year violations, additional local control measures that will be required to procedure for adoption and and regional emissions reductions may attain or maintain the 1997 Annual implementation, and a time limit for still be planned. ADEM will evaluate PM2.5 NAAQS. All controls relied upon action by the State. A state should also the air quality impacts of those for contingency purposes are scheduled identify specific indicators to be used to regulatory programs in determining if to be installed in 2012 or later and are determine when the contingency further reductions are required to ensure therefore not already relied upon for measures need to be implemented. The continued maintenance of the Annual maintenance. At least one of the maintenance plan must include a PM2.5 NAAQS in the Birmingham following contingency measures will be requirement that a state will implement Maintenance Area. adopted and implemented upon a all measures with respect to control of In addition to the triggers indicated primary triggering event: the pollutant that were contained in the above, Alabama will monitor regional • Continued implementation of SIP before redesignation of the area to emissions through the CERR and AERR previously adopted controls which have attainment in accordance with section and compare them to the projected not yet been realized but are sufficient 175A(d). inventories and the attainment year to address the violation, including In the May 2, 2011, submittal, inventory. If the actual emissions from future year emission reductions from Alabama affirms that all programs these inventories are greater than ten Federal measures to address interstate instituted by the State and EPA will percent above the projected emissions pollutant transport and from the Georgia remain enforceable and that sources are presented in the maintenance plan, than multi-pollutant rule; prohibited from reducing emissions ADEM will evaluate whether additional • Additional controls of direct PM2.5 controls following the redesignation of planning or control measures are emissions from the list of ‘‘culpable the Area. The contingency plan needed to prevent the Area from sources’’ developed in the Annual PM2.5 included in the submittal includes a violating the NAAQS or to correct a attainment SIP; triggering mechanism to determine potential violation. • Expansion of the current voluntary when contingency measures are needed In the event that further reductions diesel retrofit program in the and a process of developing and are needed to ensure continued Birmingham Area; implementing appropriate control maintenance, the list of ‘‘culpable • Any additional controls deemed measures. The State of Alabama will use sources’’ developed by Alabama in the beneficial to address the violation at the actual ambient monitoring data as the State’s 2009 Birmingham Annual PM2.5 time of the trigger. triggering event to determine when Attainment Demonstration SIP, The schedule for implementation of contingency measures should be submitted to EPA on March 13, 2009, this plan and details of steps ADEM will implemented. will be evaluated for additional control take to bring the area back into Alabama has identified a primary of direct PM2.5 emissions. Those sources compliance are outlined in Table 9 trigger as occurring when the Annual are listed in Chapter 8 of the Attainment below.

TABLE 9—SCHEDULE FOR PERMIT REVISIONS AND/OR RULE REVISIONS FOR IMPLEMENTING CONTINGENCY MEASURES

Step Description of action Schedule

1 ...... Identify and quantify the emissions reductions expected to result from current and future state and Federal 3 months. regulatory programs. 2 ...... Use the best available air quality modeling to evaluate the air quality improvement expected from step 1 6 months. above. 3 ...... Draft any needed permit conditions or SIP regulations ...... 3 months. 4 ...... Complete rulemaking or permit revision process and submit to EPA ...... 6 months.

Maximum time required for completion ...... 18 months.

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EPA has concluded that the preamble to the November 24, 1993, Area are approved or found adequate maintenance plan adequately addresses Transportation Conformity Rule (58 FR (whichever is completed first), they the five basic components of a 62188). The preamble also describes must be used for future conformity maintenance plan: attainment how to establish the MVEB in the SIP determinations. After thorough review, inventory, monitoring network, and how to revise the MVEB. EPA has determined that the budgets verification of continued attainment, After interagency consultation with meet the adequacy criteria, as outlined and a contingency plan. Therefore, the the transportation partners for the in 40 CFR 93.118(e)(4), and is proposing maintenance plan SIP revision Birmingham Area, Alabama has elected to approve the budgets because they are submitted by the State of Alabama for to develop MVEBs for NOX and PM2.5 consistent with maintenance of the 1997 the Birmingham Area meets the for the entire nonattainment area Annual PM2.5 NAAQS through 2024. requirements of section 175A of the (Jefferson, Shelby, and the VII. What is the status of EPA’s CAA and is approvable. nonattainment portion of Walker adequacy determination for the Counties). Alabama is developing these VI. What is EPA’s analysis of proposed NOX and PM2.5 MVEBs for MVEBs, as required, for the last year of Alabama’s proposed NOX and PM2.5 2024 for the Birmingham Area? MVEBs for the Birmingham area? its maintenance plan, 2024. The MVEBs reflect the total on-road emissions for When reviewing submitted ‘‘control Under section 176(c) of the CAA, new 2024, plus an allocation from the strategy’’ SIPs or maintenance plans transportation plans, programs, and containing MVEBs, EPA may available NOX and PM2.5 safety margin. projects, such as the construction of Under 40 CFR 93.101, the term ‘‘safety affirmatively find the MVEB contained new highways, must ‘‘conform’’ to (i.e., margin’’ is the difference between the therein adequate for use in determining be consistent with) the part of the state’s attainment level (from all sources) and transportation conformity. Once EPA air quality plan that addresses pollution the projected level of emissions (from affirmatively finds the submitted MVEB from cars and trucks. Conformity to the all sources) in the maintenance plan. is adequate for transportation SIP means that transportation activities The safety margin can be allocated to conformity purposes, that MVEB must will not cause new air quality the transportation sector; however, the be used by state and Federal agencies in violations, worsen existing violations, or total emissions must remain below the determining whether proposed delay timely attainment of the NAAQS transportation projects conform to the attainment level. The NOX and PM2.5 or any interim milestones. If a MVEBs and allocation from the safety SIP as required by section 176(c) of the transportation plan does not conform, margin were developed in consultation CAA. EPA’s substantive criteria for most new projects that would expand with the transportation partners and the capacity of roadways cannot go determining adequacy of a MVEB are set were added to account for uncertainties forward. Regulations at 40 CFR part 93 out in 40 CFR 93.118(e)(4). The process in population growth, changes in model set forth EPA policy, criteria, and for determining adequacy consists of vehicle miles traveled and new procedures for demonstrating and three basic steps: Public notification of emission factor models. The NO and assuring conformity of such X a SIP submission, a public comment PM MVEBs for the Birmingham Area transportation activities to a SIP. The 2.5 period, and EPA’s adequacy are defined in Table 10 below. regional emissions analysis is one, but determination. This process for not the only, requirement for determining the adequacy of submitted TABLE 10—BIRMINGHAM AREA PM implementing transportation 2.5 MVEBs for transportation conformity conformity. Transportation conformity NOX MVEBS purposes was initially outlined in EPA’s is a requirement for nonattainment and [tpy] May 14, 1999, guidance, ‘‘Conformity maintenance areas. Maintenance areas Guidance on Implementation of March are areas that were previously PM2.5 NOX 2, 1999, Conformity Court Decision.’’ nonattainment for a particular NAAQS EPA adopted regulations to codify the 2024 On-road adequacy process in the Transportation but have since been redesignated to Mobile Emis- attainment with an approved sions (tpy) ..... 335.7 8,738.39 Conformity Rule Amendments for the maintenance plan for that NAAQS. Safety Margin ‘‘New 8-Hour Ozone and PM2.5 National Under the CAA, states are required to Allocated to Ambient Air Quality Standards and submit, at various times, control strategy MVEB ...... 106.37 7,243.11 Miscellaneous Revisions for Existing SIPs and maintenance plans for 2024 Conformity Areas; Transportation Conformity Rule nonattainment areas. These control MVEB ...... 442.07 15,981.50 Amendments—Response to Court strategy SIPs (including RFP and Decision and Additional Rule Change,’’ attainment demonstration) and As mentioned above, the Birmingham on July 1, 2004 (69 FR 40004). maintenance plans create MVEBs for Area has chosen to allocate a portion of Additional information on the adequacy criteria pollutants and/or their the available safety margin to the NOX process for transportation conformity precursors to address pollution from and PM2.5 MVEBs for 2024. This purposes is available in the proposed cars and trucks. Per 40 CFR part 93, a allocation is 7,243.11 tpy and 106.37 tpy rule entitled, ‘‘Transportation MVEB must be established for the last for NOX and PM2.5, respectively. Thus, Conformity Rule Amendments: year of the maintenance plan. A state the remaining safety margins for 2024 Response to Court Decision and may adopt MVEBs for other years as are 8,852.68 tpy and 45.58 tpy for NOX Additional Rule Changes,’’ 68 FR 38974, well. The MVEB is the portion of the and PM2.5, respectively. 38984 (June 30, 2003). total allowable emissions in the Through this rulemaking, EPA is As discussed earlier, Alabama’s maintenance demonstration that is proposing to approve the MVEBs for maintenance plan submission includes allocated to highway and transit vehicle NOX and PM2.5 for 2024 for the NOX and PM2.5 MVEBs for the use and emissions. See 40 CFR 93.101. Birmingham Area because EPA has Birmingham Area for 2024, the last year The MVEB serves as a ceiling on determined that the Area maintains the of the maintenance plan. EPA reviewed emissions from an area’s planned 1997 Annual PM2.5 NAAQS with the the NOX and PM2.5 MVEBs through the transportation system. The MVEB emissions at the levels of the budgets. adequacy process. The Alabama SIP concept is further explained in the Once the MVEBs for the Birmingham submission, including the Birmingham

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Area NOX and PM2.5 MVEBs, was open them, the new MVEBs for NOX and meet this requirement. Emissions for public comment on EPA’s adequacy PM2.5 must be used for future contained in the submittal cover the Web site on March 24, 2011, found at: transportation conformity general source categories of point http://www.epa.gov/otaq/ determinations. For required regional sources, area sources, on-road mobile stateresources/transconf/currsips.htm. emissions analysis years that involve sources, and non-road mobile sources. The EPA public comment period on 2024 or beyond, the applicable budgets All emission summaries were adequacy for the MVEBs for 2024 for will be the new 2024 MVEBs accompanied by source-specific Birmingham Area closed on April 25, established in the maintenance plan, as descriptions of emission calculation 2011. EPA did not receive any defined in section VI of this proposed procedures and sources of input data. comments on the adequacy of the rulemaking. Alabama’s submittal documents 2009 MVEBs, nor did EPA receive any emissions in the Birmingham Area in requests for the SIP submittal. VIII. What is EPA’s analysis of the EPA intends to make its proposed 2009 base year emissions units of tpy. Table 11, below, provides determination on the adequacy of the inventory for the Birmingham area? a summary of the 2009 emissions of 2024 MVEBs for the Birmingham Area As discussed above, section 172(c)(3) direct PM2.5, NOX, and SO2 for the for transportation conformity purposes of the CAA requires areas to submit a Birmingham Area. In today’s notice, in the near future by completing the base year emissions inventory. As part EPA is proposing to approve this 2009 adequacy process that was started on of Alabama’s request to redesignate the base year inventory as meeting the March 24, 2011. After EPA finds the Birmingham Area, the State submitted a section 172(c)(3) emissions inventory 2024 MVEBs adequate or approves 2009 base year emissions inventory to requirement.

TABLE 11—BIRMINGHAM AREA 2009 EMISSIONS FOR PM2.5, NOX, AND SO2 [tpy (percent total)]

Source PM2.5 NOX SO2

Point Source Total ...... 4,095.30 [40.9] 35,131.25 [47.4] 180,094.65 [99.6] Area Source Total ...... 4,507.75 [45.0] 4,102.60 [5.5] 386.90 [0.2] On-Road Mobile Source Total ...... 819.80 [8.2] 24,991.13 [33.7] 149.08 [0.1] Non-Road Mobile Source Total ...... 584.00 [5.8] 9,968.15 [13.4] 182.50 [0.1]

Total for all Sources ...... 10,006.85 74,193.13 180,813.13

IX. What is the effect of EPA’s proposed X. Proposed Actions on the inventory year for the Birmingham Area. actions? Redesignation Request and This attainment inventory identifies a EPA’s proposed actions establish the Maintenance Plan SIP Revisions level of emissions in the Area that is basis upon which EPA may take final Including Approval of the NOX and sufficient to attain the 1997 Annual action on the issues being proposed for PM2.5 MVEBs for 2024 for the PM2.5 NAAQS and also is a current, approval today. Approval of Alabama’s Birmingham Area comprehensive inventory that meets the redesignation request would change the EPA previously determined that the requirements of section 172(c)(3). legal designation of Jefferson and Shelby Birmingham Area was attaining the Third, EPA is proposing to approve Counties and the designated portion of 1997 Annual PM2.5 NAAQS on June 29, the maintenance plan for the Walker County in Alabama for the 1997 2011, at 76 FR 38023. EPA is now taking Birmingham Area, including the PM2.5 Annual PM2.5 NAAQS, found at 40 CFR three separate but related actions and NOX MVEBs for 2024, into the part 81, from nonattainment to regarding the Area’s redesignation and Alabama SIP (under CAA section 175A). attainment. Approval of Alabama’s maintenance of the 1997 Annual PM2.5 The maintenance plan demonstrates request would also incorporate a plan NAAQS. that the Area will continue to maintain for maintaining the 1997 Annual PM2.5 First, EPA is proposing to determine, the 1997 Annual PM2.5 NAAQS, and the NAAQS in the Birmingham Area based on complete, quality-assured and budgets meet all of the adequacy criteria through 2024 into the Alabama SIP. certified monitoring data for the 2008– contained in 40 CFR 93.118(e)(4) and This maintenance plan includes 2010 monitoring period, and after (5). Further, as part of today’s action, contingency measures to remedy any review of preliminary data in AQS for EPA is describing the status of its future violations of the 1997 Annual 2011, that the Birmingham Area adequacy determination for the PM2.5 PM2.5 NAAQS and procedures for continues to attain the 1997 Annual and NOX MVEBs for 2024 in accordance evaluation of potential violations. The PM2.5 NAAQS. EPA is proposing to with 40 CFR 93.118(f)(1). Within 24 maintenance plan also establishes NOX determine that the Birmingham Area months from the effective date of EPA’s and PM2.5 MVEBs for the Birmingham has met the criteria under CAA section adequacy determination for the MVEBs Area. The NOX and PM2.5 MVEBs for 107(d)(3)(E) for redesignation from or the effective date for the final rule for 2024 for the Birmingham Area are nonattainment to attainment for the this action, whichever is earlier, the 15,981.50 tpy and 442.07 tpy, 1997 Annual PM2.5 NAAQS. On this transportation partners will need to respectively. Final action would also basis, EPA is proposing to approve demonstrate conformity to the new NOX approve the Area’s emissions inventory Alabama’s redesignation request for the and PM2.5 MVEBs pursuant to 40 CFR under section 172(c)(3). Additionally, Birmingham Area. 93.104(e). EPA is notifying the public of the status Second, EPA is proposing to approve If finalized, approval of the of EPA’s adequacy determination for the Alabama’s 2009 emissions inventory for redesignation request would change the newly-established PM2.5 and NOX the Birmingham Area (under CAA official designation of Jefferson and MVEBs for 2024 for the Birmingham section 172(c)(3)). Alabama selected Shelby Counties in their entireties and Area. 2009 as the attainment emissions the nonattainment portion of Walker

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County in the Birmingham Area for the application of those requirements would Implementation Plan (SIP) revision 1997 Annual PM2.5 NAAQS, found at 40 be inconsistent with the CAA; and containing a maintenance plan for the CFR part 81, from nonattainment to • Do not provide EPA with the Area. The Birmingham 2006 24-hour attainment. discretionary authority to address, as PM2.5 nonattainment area is comprised of Jefferson and Shelby Counties in their XI. Statutory and Executive Order appropriate, disproportionate human entireties and a portion of Walker Reviews health or environmental effects, using practicable and legally permissible County. EPA is proposing to approve Under the CAA, redesignation of an methods, under Executive Order 12898 the redesignation request for the area to attainment and the (59 FR 7629, February 16, 1994). Birmingham Area, along with the accompanying approval of a In addition, this proposed rule does not related SIP revision, including maintenance plan under section have Tribal implications as specified by Alabama’s 2009 emissions inventory for 107(d)(3)(E) are actions that affect the Executive Order 13175 (65 FR 67249, the Area and Alabama’s plan for status of a geographical area and do not November 9, 2000), because the SIP is maintaining attainment of the PM2.5 impose any additional regulatory not approved to apply in Indian country standard in the Area. EPA is also requirements on sources beyond those located in the State, and EPA notes that proposing to approve the motor vehicle imposed by state law. A redesignation to it will not impose substantial direct emission budgets (MVEBs) for nitrogen attainment does not in and of itself costs on Tribal governments or preempt oxides (NOX) and PM2.5 for the year create any new requirements, but rather Tribal law. 2024 for the Birmingham Area. These results in the applicability of actions are being proposed pursuant to requirements contained in the CAA for List of Subjects the Clean Air Act (CAA or Act) and its areas that have been redesignated to 40 CFR Part 52 implementing regulations. attainment. Moreover, the Administrator Environmental protection, Air DATES: Comments must be received on is required to approve a SIP submission or before December 12, 2011. that complies with the provisions of the pollution control, Intergovernmental ADDRESSES: Submit your comments, Act and applicable Federal regulations. relations, Reporting and recordkeeping identified by Docket ID No. EPA–R04– 42 U.S.C. 7410(k); 40 CFR 52.02(a). requirements, and Particulate matter. OAR–2011–0043, by one of the Thus, in reviewing SIP submissions, 40 CFR Part 81 following methods: EPA’s role is to approve state choices, Environmental protection, Air 1. http://www.regulations.gov: Follow provided that they meet the criteria of pollution control. the on-line instructions for submitting the CAA. Accordingly, this proposed comments. action merely approves state law as Authority: 42 U.S.C. 7401 et seq. 2. Email: [email protected]. meeting Federal requirements and does Dated: November 2, 2011. 3. Fax: (404) 562–9019. not impose additional requirements Gwendolyn Keyes Fleming, 4. Mail: EPA–R04–OAR–2011–0043, beyond those imposed by state law. For Regional Administrator, Region 4. Regulatory Development Section, Air this reason, these proposed actions: [FR Doc. 2011–29176 Filed 11–9–11; 8:45 am] Planning Branch, Air, Pesticides and • Are not ‘‘significant regulatory BILLING CODE 6560–50–P Toxics Management Division, U.S. action[s]’’ subject to review by the Environmental Protection Agency, Office of Management and Budget under Region 4, 61 Forsyth Street SW., Executive Order 12866 (58 FR 51735, ENVIRONMENTAL PROTECTION Atlanta, Georgia 30303–8960. October 4, 1993); AGENCY • Do not impose an information 5. Hand Delivery or Courier: Ms. Lynorae Benjamin, Chief, Regulatory collection burden under the provisions 40 CFR Parts 52 and 81 of the Paperwork Reduction Act (44 Development Section, Air Planning U.S.C. 3501 et seq.); [EPA–R04–OAR–2011–0043–201110; FRL– Branch, Air, Pesticides and Toxics 9490–6] • Are certified as not having a Management Division, U.S. Environmental Protection Agency, significant economic impact on a Approval and Promulgation of substantial number of small entities Region 4, 61 Forsyth Street SW., Implementation Plans and Designation Atlanta, Georgia 30303–8960. Such under the Regulatory Flexibility Act of Areas for Air Quality Planning (5 U.S.C. 601 et seq.); deliveries are only accepted during the • Purposes; Alabama; Redesignation of Regional Office’s normal hours of Do not contain any unfunded the Birmingham 2006 24-Hour Fine mandate or significantly or uniquely operation. The Regional Office’s official Particulate Matter Nonattainment Area hours of business are Monday through affect small governments, as described to Attainment in the Unfunded Mandates Reform Act Friday, 8:30 to 4:30, excluding Federal of 1995 (Pub. L. 104–4); AGENCY: Environmental Protection holidays. • Do not have Federalism Agency (EPA). Instructions: Direct your comments to implications as specified in Executive ACTION: Proposed rule. Docket ID No. EPA–R04–OAR–2011– Order 13132 (64 FR 43255, August 10, 0043. EPA’s policy is that all comments 1999); SUMMARY: On June 17, 2010, the State of received will be included in the public • Are not economically significant Alabama, through the Alabama docket without change and may be regulatory actions based on health or Department of Environmental made available online at safety risks subject to Executive Order Management (ADEM), Air Division, www.regulations.gov, including any 13045 (62 FR 19885, April 23, 1997); submitted a request for EPA to personal information provided, unless • Are not significant regulatory redesignate the Birmingham fine the comment includes information actions subject to Executive Order particulate matter (PM2.5) nonattainment claimed to be Confidential Business 13211 (66 FR 28355, May 22, 2001); area (hereafter referred to as the Information (CBI) or other information • Are not subject to requirements of ‘‘Birmingham Area’’ or ‘‘Area’’) to whose disclosure is restricted by statute. Section 12(d) of the National attainment for the 2006 24-hour PM2.5 Do not submit through Technology Transfer and Advancement National Ambient Air Quality Standards www.regulations.gov or email, Act of 1995 (15 U.S.C. 272 note) because (NAAQS); and to approve a State information that you consider to be CBI

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or otherwise protected. The Table of Contents 2009 as the attainment emissions www.regulations.gov Web site is an I. What are the actions EPA is proposing to inventory year for the Birmingham Area. ‘‘anonymous access’’ system, which take? This attainment inventory identifies a means EPA will not know your identity II. What is the background for EPA’s level of emissions in the Area that is or contact information unless you proposed actions? sufficient to attain the 2006 24-hour provide it in the body of your comment. III. What are the criteria for redesignation? PM2.5 NAAQS and is a current, If you send an email comment directly IV. Why is EPA proposing these actions? comprehensive inventory that meets the to EPA without going through V. What is EPA’s analysis of the request? requirements of section 172(c)(3). www.regulations.gov, your email VI. What is EPA’s analysis of Alabama’s proposed NOX and PM2.5 MVEBs for the Third, EPA is proposing to approve address will be automatically captured Birmingham Area? Alabama’s 2006 24-hour PM2.5 NAAQS and included as part of the comment VII. What is the status of EPA’s adequacy maintenance plan for the Birmingham that is placed in the public docket and determination for the proposed NOX and Area as meeting the requirements of made available on the Internet. If you PM2.5 MVEBs for 2024 for the section 175A (such approval being one submit an electronic comment, EPA Birmingham area? of the CAA criteria for redesignation to VIII. What is EPA’s analysis of the proposed recommends that you include your attainment status). The recently name and other contact information in 2009 base year emissions inventory for the Birmingham area? promulgated Cross State Air Pollution the body of your comment and with any IX. Proposed Action on the Redesignation Rule (CSAPR),1 requires reductions of disk or CD–ROM you submit. If EPA Request and Maintenance Plan SIP NOX and SO2 associated with power cannot read your comment due to Revision Including Proposed Approval plants to be permanent and enforceable. technical difficulties and cannot contact of the 2024 NOX and PM2.5 MVEBs for The maintenance plan is designed to you for clarification, EPA may not be the Birmingham Area help keep the Birmingham Area in X. What is the effect of EPA’s proposed able to consider your comment. attainment of the 2006 24-hour PM2.5 Electronic files should avoid the use of actions? XI. Statutory and Executive Order Reviews NAAQS through 2024. Consistent with special characters, any form of the CAA, the maintenance plan that encryption, and be free of any defects or I. What are the actions EPA is EPA is proposing to approve today also viruses. For additional information proposing to take? includes NOX and PM2.5 MVEBs for the about EPA’s public docket visit the EPA EPA is proposing to take the following year 2024 for the Birmingham Area. Docket Center homepage at http:// three separate but related actions, some EPA is proposing to approve (into the www.epa.gov/epahome/dockets.htm. of which involve multiple elements: (1) Alabama SIP) the 2024 MVEBs that are Docket: All documents in the To redesignate the Birmingham Area to included as part of Alabama’s electronic docket are listed in the attainment for the 2006 24-hour PM2.5 maintenance plan for the 2006 24-hour www.regulations.gov index. Although NAAQS, provided EPA approves the PM2.5 NAAQS. listed in the index, some information is emissions inventory submitted with the On a matter related matter to this not publicly available, i.e., CBI or other maintenance plan; (2) to approve, under third action, EPA is also notifying the information whose disclosure is CAA section 172(c)(3), the emissions public of the status of EPA’s adequacy restricted by statute. Certain other inventory submitted with the process for the newly-established NOX material, such as copyrighted material, maintenance plan; and (3) to approve and PM2.5 MVEBs for 2024 for the is not placed on the Internet and will be into the Alabama SIP, under section Birmingham Area. ADEM submitted publicly available only in hard copy 175A of the CAA, Alabama’s 2006 24- MVEBs for NOX and PM2.5 in its original form. Publicly available docket hour PM2.5 NAAQS maintenance plan, June 17, 2010, redesignation request. On materials are available either including the associated MVEBs (EPA is May 2, 2011, ADEM submitted electronically in www.regulations.gov or also notifying the public of the status of additional revisions to the MVEBs for in hard copy at the Regulatory EPA’s adequacy determination for the the 24-hour redesignation request.2 The Development Section, Air Planning Birmingham Area MVEBs for the PM2.5 adequacy comment period for the new Branch, Air, Pesticides and Toxics NAAQS). These actions are summarized Birmingham Area 2024 MVEBs began Management Division, U.S. below and described in greater detail on March 24, 2011, with EPA’s posting Environmental Protection Agency, throughout this notice of proposed of the availability of this submittal on Region 4, 61 Forsyth Street SW., rulemaking. EPA’s Adequacy Web site (http:// Atlanta, Georgia 30303–8960. EPA First, EPA proposes to determine that, www.epa.gov/otaq/stateresources/ requests that if at all possible, you if EPA finalizes approval of the 2009 transconf/currsips.htm). The adequacy contact the person listed in the FOR baseline emissions inventory for the comment period for these MVEBs closed FURTHER INFORMATION CONTACT section to Birmingham Area, the Area has met the on April 25, 2011. No adverse schedule your inspection. The Regional requirements for redesignation under comments were received during the Office’s official hours of business are section 107(d)(3)(E) of the CAA. In this adequacy public comment period. Monday through Friday, 8:30 to 4:30, action, EPA is proposing to approve a Please see section VII of this proposed excluding Federal holidays. request to change the legal designation rulemaking for further explanation of FOR FURTHER INFORMATION CONTACT: Joel of Jefferson and Shelby Counties in their Huey of the Regulatory Development entireties and the designated portion of 1 See ‘‘Federal Implementation Plans to Reduce Section, in the Air Planning Branch, Walker County in the Birmingham Area Interstate Transport of Fine Particulate Matter and from nonattainment to attainment for Ozone in 27 States; Correction of SIP Approvals for Air, Pesticides and Toxics Management 22 States’’ (76 FR 48208, August 8, 2011). the 2006 24-hour PM2.5 NAAQS. As Division, U.S. Environmental Protection 2 discussed below, the emissions On March 2, 2011, ADEM submitted a proposed Agency, Region 4, 61 Forsyth Street revision to the 24-hour NOX and PM2.5 MVEBs SW., Atlanta, Georgia 30303–8960. Joel inventory is being proposed for originally submitted on June 17, 2010. The final approval today. MVEBs were submitted on May 2, 2011, with Huey may be reached by phone at (404) ADEM’s 1997 Annual PM NAAQS redesignation 562–9104, or via electronic mail at Second, EPA is proposing to approve 2.5 Alabama’s 2009 emissions inventory for submittal. A copy of the submittal is included in [email protected]. the docket for this proposed rulemaking (EPA–R04– the Birmingham Area (under CAA OAR–2011–0043) and can be obtained from the SUPPLEMENTARY INFORMATION: section 172(c)(3)). Alabama selected www.regulations.gov Web site.

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this process and for more details on the monitoring sites in the subject area over remanding CAIR to EPA without MVEBs. a 3-year period. vacating either CAIR or the CAIR FIPs Today’s notice of proposed On January 5, 2005, at 70 FR 944, and (North Carolina v. EPA, 550 F.3d 1176 rulemaking is in response to Alabama’s supplemented on April 14, 2005, at 70 (DC Cir., 2008)). The Court left CAIR in June 17, 2010, SIP submittal and FR 19844, EPA designated the place to ‘‘temporarily preserve the subsequent supplement of May 2, 2011. Birmingham Area as nonattainment for environmental values covered by CAIR’’ Those documents addresses the specific the 1997 PM2.5 NAAQS based upon air until EPA replaces it with a rule issues summarized above and the quality data for calendar years 2001– consistent with the Court’s opinion. Id. necessary elements described in section 2003. In that action, EPA defined the at 1178. The Court directed EPA to 107(d)(3)(E) of the CAA for 1997 PM2.5 Birmingham nonattainment ‘‘remedy CAIR’s flaws’’ consistent with redesignation of the Birmingham Area area to include Jefferson and Shelby its July 11, 2008, opinion but declined to attainment of the 2006 24-hour PM2.5 Counties in their entireties and a to impose a schedule on EPA for NAAQS. portion Walker County. On November completing that action. Id. As a result of 13, 2009, at 74 FR 58688, EPA these court rulings, the power plant II. What is the background for EPA’s promulgated designations for the 2006 emission reductions that resulted solely proposed actions? PM2.5 NAAQS, designating the from the development, promulgation, Fine particle pollution can be emitted Birmingham Area (with the same and implementation of CAIR, and the directly or formed secondarily in the boundaries as for the 1997 PM2.5 associated contribution to air quality atmosphere. The main precursors of nonattainment area) as nonattainment improvement that occurred solely as a for the 2006 24-hour PM2.5 NAAQS PM2.5 are sulfur dioxide (SO2), NOX, result of CAIR in the Birmingham Area ammonia and volatile organic based upon air quality data for calendar could not be considered to be compounds (VOC). Unless otherwise years 2006–2008. That action also permanent. clarified that the Birmingham Area was noted by the State or EPA, ammonia and On August 8, 2011, EPA published classified unclassifiable/attainment for VOCs are presumed to be insignificant CSAPR in the Federal Register under the 1997 24-hour PM2.5 NAAQS. EPA contributors to PM2.5 formation, the title, ‘‘Federal Implementation Plans did not promulgate designations for the whereas SO2 and NOX are presumed to to Reduce Interstate Transport of Fine annual average NAAQS promulgated in be significant contributors to PM2.5 Particulate Matter and Ozone in 27 2006 since that NAAQS was essentially formation. Sulfates are a type of States; Correction of SIP Approvals for secondary particle formed from SO identical to the 1997 annual PM2.5 2 NAAQS. Therefore, the Birmingham 22 States’’ (76 FR 48208, August 8, emissions of power plants and 2011) to address interstate transport of industrial facilities. Nitrates, another Area is designated nonattainment for the annual NAAQS promulgated in emissions and resulting secondary air common type of secondary particle, are pollutants and to replace CAIR. The formed from NO emissions of power 1997 and for the 24-hour NAAQS X promulgated in 2006. Today’s action CAIR emission reduction requirements plants, automobiles, and other limit emissions in Alabama and states combustion sources. only addresses the designation for the 24-hour NAAQS promulgated in 2006. upwind of Alabama through 2011, and On July 18, 1997, EPA promulgated CSAPR requires similar or greater All 2006 PM2.5 NAAQS areas were the first air quality standards for PM2.5. designated under subpart 1 of title I, reductions in the relevant areas in 2012 EPA promulgated an annual standard at part D, of the CAA. Subpart 1 contains and beyond. The emission reductions a level of 15 micrograms per cubic meter the general requirements for that CSAPR mandates may be 3 (mg/m ), based on a 3-year average of nonattainment areas for any pollutant considered to be permanent and annual mean PM2.5 concentrations. In governed by a NAAQS and is less enforceable. In turn, the air quality the same rulemaking, EPA promulgated prescriptive than the other subparts of improvement in the Birmingham Area 3 a 24-hour standard of 65 mg/m , based title I, part D. On April 25, 2007 (72 FR that has resulted from electric on a 3-year average of the 98th 20664), EPA promulgated its PM2.5 generating units (EGUs) emission percentile of 24-hour concentrations. On implementation rule, codified at 40 CFR reductions associated with CAIR (as October 17, 2006, at 71 FR 61144, EPA part 51, subpart Z, in which the Agency well as the additional air quality retained the annual average NAAQS at provided guidance for state and Tribal improvement that would be expected to m 3 15 g/m but revised the 24-hour plans to implement the PM2.5 NAAQS. result from full implementation of NAAQS to 35 mg/m3, based again on the This rule, at 40 CFR 51.1004(c), CSAPR) may also be considered to be 3-year average of the 98th percentile of specifies some of the regulatory impacts permanent and enforceable. EPA 24-hour concentrations.3 Under EPA of attaining the NAAQS, as discussed proposes that the requirement in section regulations at 40 CFR part 50, the below. 107(d)(3)(E)(iii) has now been met primary and secondary 2006 24-hour On May 12, 2005, EPA published the because the emission reduction PM2.5 NAAQS are attained when the Clean Air Interstate Rule (CAIR), which requirements of CAIR address emissions annual arithmetic mean concentration, addressed the interstate transport through 2011 and EPA has now as determined in accordance with 40 requirements of the CAA and required promulgated CSAPR which requires CFR part 50, Appendix N, is less than states to significantly reduce SO2 and similar or greater reductions in the 3 or equal to 35 mg/m at all relevant NOX emissions from power plants (70 relevant areas in 2012 and beyond. FR 25162). The associated Federal Because the emission reduction 3 In response to legal challenges of the annual Implementation Plans (FIPs) were requirements of CAIR are enforceable standard promulgated in 2006, the United States published on April 28, 2006 (71 FR through the 2011 control period, and Court of Appeals for the District of Columbia Circuit (DC Circuit) remanded this NAAQS to EPA 25328). However, on July 11, 2008, the because CSAPR has now been for further consideration. See American Farm DC Circuit Court issued its decision to promulgated to address the Bureau Federation and National Pork Producers vacate and remand both CAIR and the requirements previously addressed by Council, et al. v. EPA, 559 F.3d 512 (DC Circuit associated CAIR FIPs in their entirety CAIR and gets similar or greater 2009). However, given that the 1997 and 2006 annual NAAQS are essentially identical, attainment (North Carolina v. EPA, 531 F.3d 836 reductions in the relevant areas in 2012 of the 1997 Annual NAAQS would also indicate (DC Cir., 2008)). EPA petitioned for and beyond, EPA is proposing to attainment of the remanded 2006 Annual NAAQS. rehearing, and the Court issued an order determine that the pollutant transport

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part of the reductions that led to area has met all requirements applicable the Birmingham Area, provided EPA attainment in the Birmingham Area can to the area under section 110 and part approves the emissions inventory now be considered permanent and D of title I of the CAA. submitted with the maintenance plan. enforceable. Therefore, EPA proposes to EPA has provided guidance on The five redesignation criteria provided find that the transport requirement of redesignation in the General Preamble under CAA section 107(d)(3)(E) are CAA section 107(d)(3)(E)(iii) has been for the Implementation of title I of the discussed in greater detail for the Area met for the Birmingham Area. CAA Amendments of 1990 (April 16, in the following paragraphs of this The 3-year ambient air quality data for 1992, 57 FR 13498, and supplemented section. 2007–2009 indicated no violations of on April 28, 1992, 57 FR 18070) and has the 2006 PM2.5 NAAQS for the provided further guidance on processing Criteria (1)—The Birmingham Area has Birmingham Area. As a result, on June redesignation requests in the following attained the 2006 24-hour PM2.5 NAAQS 17, 2010, Alabama requested documents: For redesignating a nonattainment redesignation of the Birmingham Area 1. ‘‘Procedures for Processing Requests to area to attainment, the CAA requires to attainment for the 2006 24-hour PM 2.5 Redesignate Areas to Attainment,’’ EPA to determine that the area has NAAQS. The redesignation request Memorandum from John Calcagni, attained the applicable NAAQS (CAA included three years of complete, Director, Air Quality Management section 107(d)(3)(E)(i)). EPA is quality-assured ambient air quality data Division, September 4, 1992 (hereafter proposing to determine that the for the 2006 24-hour PM NAAQS for referred to as the ‘‘Calcagni 2.5 Birmingham Area continues to attain 2007–2009, indicating that the 2006 24- Memorandum’’); 2. ‘‘State Implementation Plan (SIP) Actions the 2006 24-hour PM NAAQS. For hour PM NAAQS had been achieved 2.5 2.5 Submitted in Response to Clean Air Act PM , an area may be considered to be for the Birmingham Area. Under the 2.5 (CAA) Deadlines,’’ Memorandum from attaining the 2006 24-hour PM CAA, nonattainment areas may be 2.5 John Calcagni, Director, Air Quality NAAQS if it meets the 2006 24-hour redesignated to attainment if sufficient, Management Division, October 28, 1992; PM NAAQS, as determined in complete, quality-assured data is and 2.5 accordance with 40 CFR 50.13 and available for the Administrator to 3. ‘‘Part D New Source Review (Part D NSR) Appendix N of part 50, based on three determine that the area has attained the Requirements for Areas Requesting Redesignation to Attainment,’’ complete, consecutive calendar years of standard and the area meets the other Memorandum from Mary D. Nichols, quality-assured air quality monitoring CAA redesignation requirements in Assistant Administrator for Air and data. To attain these NAAQS, the 98th section 107(d)(3)(E). From 2007 through Radiation, October 14, 1994. percentile 24-hour concentration, as the present, the 24-hour PM design 2.5 determined in accordance with 40 CFR values for the Birmingham Area have IV. Why is EPA proposing these part 50, Appendix N, is less than or declined. While 24-hour PM actions? 2.5 equal to 35 mg/m3 at all relevant concentrations are dependent on a On June 17, 2010, the State of monitoring sites in the subject area over variety of conditions, the overall Alabama, through ADEM, requested the a 3-year period. The relevant data must downtrend in PM concentrations in redesignation of the Birmingham Area 2.5 be collected and quality-assured in the Birmingham Area can be attributed to attainment for the 2006 24-hour PM2.5 accordance with 40 CFR part 58 and to the reduction of emissions, as will be NAAQS. EPA’s evaluation indicates that recorded in the EPA Air Quality System discussed in more detail in section V of the Birmingham Area has attained the (AQS). The monitors generally should this proposed rulemaking. 2006 24-hour PM2.5 NAAQS and meets have remained at the same location for the requirements for redesignation set III. What are the criteria for the duration of the monitoring period forth in section 107(d)(3)(E), including redesignation? required for demonstrating attainment. the maintenance plan requirements The CAA provides the requirements under section 175A of the CAA. As a On September 20, 2010, at 75 FR for redesignating a nonattainment area result, EPA is proposing to take the 57186, EPA determined that the to attainment. Specifically, section three related actions summarized in Birmingham Area was attaining the 107(d)(3)(E) of the CAA allows for section I of this notice. 2006 24-hour PM2.5 NAAQS. For that redesignation providing the following action EPA reviewed PM2.5 monitoring criteria are met: (1) The Administrator V. What is EPA’s analysis of the data from monitoring stations in the determines that the area has attained the request? Birmingham Area for the 2006 24-hour applicable NAAQS; (2) the As stated above, in accordance with PM2.5 NAAQS for 2007–2009. These Administrator has fully approved the the CAA, EPA proposes in today’s data have been quality-assured and are applicable implementation plan for the action to: (1) Redesignate the recorded in AQS. EPA has reviewed area under section 110(k); (3) the Birmingham Area to attainment for the more recent data which indicates that Administrator determines that the 2006 24-hour PM2.5 NAAQS; (2) the Birmingham Area continues to improvement in air quality is due to approve the Birmingham Area attain the 2006 24-hour PM2.5 NAAQS permanent and enforceable reductions emissions inventory submitted with the beyond the submitted 3-year attainment in emissions resulting from maintenance plan; and (3) approve into period of 2007–2009. The 98th implementation of the applicable SIP the Alabama SIP Birmingham’s 2006 24- percentiles of the PM2.5 concentrations and applicable Federal air pollutant hour PM2.5 NAAQS maintenance plan, for 2007–2010 and the 3-year average of control regulations and other permanent including the associated MVEBs. These these values (i.e., design values) are and enforceable reductions; (4) the actions are based upon EPA’s summarized in Table 1. Data available Administrator has fully approved a determination that the Birmingham to date in AQS for 2011, which have not maintenance plan for the area as Area continues to attain the 2006 24- yet been certified, indicate the meeting the requirements of section hour PM2.5 NAAQS and that all other Birmingham Area continues to attain 175A; and (5) the state containing such redesignation criteria have been met for the 2006 24-hour PM2.5 NAAQS.

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3 TABLE 1—DESIGN VALUE CONCENTRATIONS FOR THE BIRMINGHAM 2006 24-HOUR PM2.5 AREA (μG/M )

98th Percentile 24-hour concentrations 3-Year design values Location County Monitor ID 2007 2008 2009 2010 2007– 2008– 2009 2010

North Birmingham...... Jefferson ...... 01–073–0023 42.8 33.5 24.4 28.7 34 29 McAdory ...... Jefferson ...... 01–073–1005 30.9 25.8 21.3 22.7 26 23 Bruce Shaw Rd. (Provi- Jefferson ...... 01–073–1009 31.4 27.3 22.1 18.4 27 23 dence). Asheville Road (Leeds) ...... Jefferson ...... 01–073–1010 33.0 24.6 19.1 22.3 26 22 Wylam ...... Jefferson ...... 01–073–2003 37.7 33.5 25.2 25.4 32 28 Hoover ...... Jefferson ...... 01–073–2006 29.8 25.9 20.4 21.6 25 23 Pinson High School ...... Jefferson ...... 01–073–5002 34.2 26.4 21.3 20.0 27 23 Corner School Road ...... Jefferson ...... 01–073–5003 32.5 30.0 21.3 18.3 28 23 Pelham High School ...... Shelby ...... 01–117–0006 30.9 24.8 21.2 4 20.0 26 4 22 Highland Avenue (Walker Walker ...... 01–127–0002 30.9 24.3 22.1 18.8 26 22 Co.). 4 The Pelham High School site did not meet completeness criteria for the third quarter of 2010. However, the maximum third quarter value from 2008–2010 was 33.6 μg/m3 (which occurred in 2008). If this value were used as the 98th percentile 24-hour concentration for 2010, the 24- hour design value for the 2008–2010 period would be 27 μg/m3 and the 2010 design value for the Birmingham Area (from the North Birmingham site) would be unchanged at 29 μg/m3.

The 3-year design value for 2007– purposes of redesignation. Additionally, needed to monitor ambient air quality; 2009 submitted by Alabama for EPA proposes to find that the Alabama implementation of a source permit redesignation of the Birmingham Area is SIP satisfies the criterion that it meet program; provisions for the 34 mg/m3, which meets the NAAQS as applicable SIP requirements for implementation of part C requirements described above. Air quality data for purposes of redesignation under part D (Prevention of Significant Deterioration 2010 show that the Area continues to of title I of the CAA (requirements (PSD)) and provisions for the attain the PM2.5 NAAQS, with a 3-year specific to 2006 24-hour PM2.5 implementation of part D requirements design value of 29 mg/m3, and that nonattainment areas) in accordance (New Source Review (NSR) permit ambient 24-hour concentrations of PM2.5 with section 107(d)(3)(E)(v). Further, programs); provisions for air pollution continue to decline. As mentioned EPA proposes to determine that the SIP modeling; and provisions for public and above, on September 20, 2010 (75 FR is fully approved with respect to all local agency participation in planning 57186) EPA published a clean data requirements applicable for purposes of and emission control rule development. determination for the Birmingham Area redesignation in accordance with Section 110(a)(2)(D) requires that SIPs for the 2006 24-hour PM2.5 NAAQS. In section 107(d)(3)(E)(ii). In making these contain certain measures to prevent today’s action, EPA is proposing to determinations, EPA ascertained which sources in a state from significantly determine that the Area is continuing to requirements are applicable to the Area contributing to air quality problems in attain the 2006 PM2.5 NAAQS. EPA will and, if applicable, that they are fully another state. To implement this not go forward with the redesignation if approved under section 110(k). SIPs provision, EPA has required certain the Area does not continue to attain must be fully approved only with states to establish programs to address until the time that EPA finalizes the respect to requirements that were the interstate transport of air pollutants 5 6 redesignation. As discussed in more applicable prior to submittal of the (e.g., NOX SIP Call, CAIR, and detail below, the State of Alabama has complete redesignation request. committed to continue monitoring in 5 On October 27, 1998 (63 FR 57356), EPA issued a. The Birmingham Area Has Met All a NOX SIP Call requiring the District of Columbia this Area in accordance with 40 CFR Applicable Requirements Under Section and 22 states to reduce emissions of NOX in order part 58. 110 and Part D of the CAA to reduce the transport of ozone and ozone precursors. In compliance with EPA’s NOX SIP Call, Criteria (5)—Alabama Has Met All General SIP requirements. Section Alabama developed rules governing the control of Applicable Requirements Under Section 110(a)(2) of title I of the CAA delineates NOX emissions from EGUs, major non-EGU 110 and Part D of Title I of the CAA; industrial boilers, major cement kilns, and internal the general requirements for a SIP, combustion engines. On December 27, 2002, EPA and Criteria (2)—Alabama Has a Fully which include enforceable emissions approved Alabama’s rules as fulfilling Phase I (67 Approved SIP Under Aection 110(k) for limitations and other control measures, FR 78987). the Birmingham Area 6 On May 12, 2005 (70 FR 25162), EPA means, or techniques; provisions for the promulgated CAIR, which required 28 upwind For redesignating a nonattainment establishment and operation of States and the District of Columbia to revise their area to attainment, the CAA requires appropriate devices necessary to collect SIPs to include control measures that would reduce EPA to determine that the state has met data on ambient air quality; and emissions of SO2 and NOX. Various aspects of CAIR rule were petitioned in court and on December 23, all applicable requirements under programs to enforce the limitations. 2008, the U.S. Court of Appeals for the District of section 110 and part D of title I of the General SIP elements and requirements Columbia Circuit remanded CAIR to EPA (see CAA (CAA section 107(d)(3)(E)(v)) and are delineated in section 110(a)(2) of Alabama v. EPA, 550 F.3d 1176 (DC Circuit, that the state has a fully approved SIP title I, part A of the CAA. These December 23, 2008)), which left CAIR in place to ‘‘temporarily preserve the environmental values under section 110(k) for the area (CAA requirements include, but are not covered by CAIR’’ until EPA replaces it with a rule section 107(d)(3)(E)(ii)). EPA proposes limited to, the following: submittal of a consistent with the Court’s ruling. The Court to find that Alabama has met all SIP that has been adopted by the state directed EPA to remedy various areas of the rule applicable SIP requirements for the after reasonable public notice and that were petitioned consistent with its July 11, 2008 (see Alabama v. EPA, 531 F.3d 836 (DC Birmingham Area under section 110 of hearing; provisions for establishment Circuit, July 11, 2008)), opinion, but declined to the CAA (general SIP requirements) for and operation of appropriate procedures Continued

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CSAPR). The section 110(a)(2)(D) linked to an area’s nonattainment status such measures as are reasonably requirements for a state are not linked are not applicable for purposes of available for implementation in each with a particular nonattainment area’s redesignation. Therefore, area as components of the area’s designation and classification in that notwithstanding the fact that EPA has attainment demonstration. Under state. EPA believes that the not yet completed rulemaking on section 172, states with nonattainment requirements linked with a particular Alabama’s submittal for the PM2.5 areas must submit plans providing for nonattainment area’s designation and infrastructure SIP elements of section timely attainment and meeting a variety classifications are the relevant measures 110(a)(2), EPA believes it has approved of other requirements. However, to evaluate in reviewing a redesignation all SIP elements under section 110 that pursuant to 40 CFR 51.1004(c), EPA’s request. The transport SIP submittal must be approved as a prerequisite for September 20, 2010, determination that requirements, where applicable, redesignating the Birmingham Area to the Birmingham area was attaining the continue to apply to a state regardless of attainment. 24-hour PM2.5 standard suspended the designation of any one particular Title I, Part D requirements. EPA Alabama’s obligation to submit most of area in the state. Thus, EPA does not proposes that if EPA approves the attainment planning requirements believe that the CAA’s interstate Alabama’s base year emissions that would otherwise apply. transport requirements should be inventory, which is part of the Specifically, the determination of construed to be applicable requirements maintenance plan submittal, the attainment suspended Alabama’s for purposes of redesignation. However, Alabama SIP will meet applicable SIP obligation to submit an attainment as discussed later in this notice, requirements under part D of the CAA. demonstration and planning SIPs to addressing pollutant transport from As discussed in greater detail below, provide for reasonable further progress other states is an important part of an EPA believes the emissions inventory is (RFP), reasonable available control area’s maintenance demonstration. approvable because the 2009 direct measures, and contingency measures In addition, EPA believes other PM2.5, SO2, and NOX emissions for under section 172(c)(9). section 110 elements that are neither Alabama were developed consistent The General Preamble for connected with nonattainment plan with EPA guidance for emission Implementation of Title I (57 FR 13498, submissions nor linked with an area’s inventories and represent a April 16, 1992) also discusses the attainment status are applicable comprehensive, accurate and current evaluation of these requirements in the requirements for purposes of inventory as required by CAA section context of EPA’s consideration of a redesignation. The area will still be 172(c)(3). redesignation request. The General subject to these requirements after the Part D, subpart 1 applicable SIP Preamble sets forth EPA’s view of area is redesignated. The section 110 requirements. EPA has determined that applicable requirements for purposes of and part D requirements which are if the approval of the base year evaluating redesignation requests when linked with a particular area’s emissions inventory, discussed in an area is attaining a standard (General designation and classification are the section VIII of this rulemaking, is Preamble for Implementation of Title I relevant measures to evaluate in finalized, the Alabama SIP will meet the (57 FR 13498, April 16, 1992)). reviewing a redesignation request. This applicable SIP requirements for the Because attainment has been reached approach is consistent with EPA’s Birmingham Area for purposes of in the Birmingham Area, no additional existing policy on applicability (i.e., for redesignation under title I, part D of the measures are needed to provide for redesignations) of conformity and CAA. Subpart 1 of part D sets forth the attainment, and section 172(c)(1) oxygenated fuels requirements, as well basic nonattainment requirements requirements for an attainment as with section 184 ozone transport applicable to all nonattainment areas. demonstration and RACM are no longer requirements. See Reading, All areas that were designated considered to be applicable for purposes Pennsylvania, proposed and final nonattainment for the 1997 Annual of redesignation as long as the Area rulemakings (61 FR 53174–53176, PM2.5 NAAQS were designated under continues to attain the standard until October 10, 1996), (62 FR 24826, May 7, this subpart of the CAA and the redesignation. See also 40 CFR 1997); Cleveland-Akron-Loraine, Ohio, requirements applicable to them are 51.1004(c). final rulemaking (61 FR 20458, May 7, contained in sections 172 and 176. The RFP plan requirement under 1996); and Tampa, Florida, final For purposes of evaluating this section 172(c)(2) is defined as progress rulemaking at (60 FR 62748, December redesignation request, the applicable that must be made toward attainment. 7, 1995). See also the discussion on this part D, subpart 1 SIP requirements for This requirement is not relevant for issue in the Cincinnati, Ohio, all nonattainment areas are contained in purposes of redesignation because EPA redesignation (65 FR 37890, June 19, sections 172(c)(1)–(9) and in section has determined that the Birmingham 2000), and in the Pittsburgh, 176. A thorough discussion of the Area has monitored attainment of the Pennsylvania, redesignation (66 FR requirements contained in section 172 2006 24-hour PM2.5 NAAQS. See 50399, October 19, 2001). can be found in the General Preamble General Preamble, 57 FR 13564. See EPA has not yet completed for Implementation of title I (57 FR also 40 CFR 51.1004(c). In addition, rulemaking on a submittal from 13498, April 16, 1992). because the Birmingham Area has Alabama dated September 23, 2009, Subpart 1 Section 172 Requirements. attained the 2006 24-hour PM2.5 NAAQS addressing ‘‘infrastructure SIP’’ Section 172(c)(1) requires the plans for and is no longer subject to a RFP elements required under CAA section all nonattainment areas to provide for requirement, the requirement to submit 110(a)(2). However, these are statewide the implementation of all Reasonable the section 172(c)(9) contingency requirements that are not a consequence Available Control Measures (RACM) as measures is not applicable for purposes of the nonattainment status of the expeditiously as practicable and to of redesignation. Id. Birmingham Area. As stated above, EPA provide for attainment of the national Section 172(c)(3) requires submission believes that section 110 elements not primary ambient air quality standards. and approval of a comprehensive, EPA interprets this requirement to accurate, and current inventory of actual impose a schedule on EPA for completing that impose a duty on all nonattainment emissions. As part of Alabama’s action. Id. Therefore, CAIR is currently in effect in areas to consider all available control redesignation request for the Alabama. measures and to adopt and implement Birmingham Area, Alabama submitted a

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2009 base year emissions inventory. As approved under title 23 of the United that since the part D subpart 1 discussed below in section VIII, EPA is States Code (U.S.C.) and the Federal requirements did not become due prior proposing to approve the 2009 base year Transit Act (transportation conformity) to submission of the redesignation inventory submitted with the as well as to all other federally request, they are also not applicable redesignation request as meeting the supported or funded projects (general requirements for purposes of section 172(c)(3) emissions inventory conformity). State transportation redesignation. Sierra Club v. EPA, 375 requirement. conformity SIP revisions must be F.3d 537 (7th Cir. 2004); 68 FR 25424, Section 172(c)(4) requires the consistent with Federal conformity 25427 (May 12, 2003) (redesignation of identification and quantification of regulations relating to consultation, the St. Louis-East St. Louis Area to emissions for major new and modified enforcement and enforceability that EPA attainment of the 1-hour ozone stationary sources to be allowed in an promulgated pursuant to its authority NAAQS). With the approval of the area, and section 172(c)(5) requires under the CAA. emissions inventory, EPA will have source permits for the construction and EPA interprets the conformity SIP approved all part D subpart 1 operation of new and modified major requirements 7 as not applying for requirements applicable for purposes of stationary sources anywhere in the purposes of evaluating a redesignation this redesignation. nonattainment area. EPA has request under section 107(d) because determined that, since PSD state conformity rules are still required Criteria (3)—The Air Quality requirements will apply after after redesignation and Federal Improvement in the Birmingham 2006 redesignation, areas being redesignated conformity rules apply where state rules 24-Hour PM2.5 NAAQS Nonattainment need not comply with the requirement have not been approved. See Wall v. Area Is Due to Permanent and that a NSR program be approved prior EPA, 265 F.3d 426 (6th Cir. 2001) Enforceable Reductions in Emissions to redesignation, provided that the area (upholding this interpretation); see also Resulting From Implementation of the demonstrates maintenance of the 60 FR 62748 (December 7, 1995) SIP and Applicable Federal Air NAAQS without part D NSR. A more (redesignation of Tampa, Florida). Thus, Pollution Control Regulations and Other detailed rationale for this view is the Birmingham Area has satisfied all Permanent and Enforceable Reductions described in a memorandum from Mary applicable requirements for purposes of For redesignating a nonattainment Nichols, Assistant Administrator for Air redesignation under section 110 and area to attainment, the CAA requires and Radiation, dated October 14, 1994, part D of title I of the CAA. EPA to determine that the air quality entitled, ‘‘Part D New Source Review improvement in the area is due to Requirements for Areas Requesting b. The Birmingham Area Has a Fully permanent and enforceable reductions Redesignation to Attainment.’’ Alabama Approved Applicable SIP Under Section in emissions resulting from has demonstrated that the Birmingham 110(k) of the CAA implementation of the SIP and Area will be able to maintain the If EPA issues a final approval of the applicable Federal air pollution control NAAQS without part D NSR in effect, base year emissions inventory, EPA will regulations and other permanent and and therefore Alabama need not have have fully approved the applicable enforceable reductions (CAA section fully approved part D NSR programs Alabama SIP for the Birmingham 2006 107(d)(3)(E)(iii)). EPA believes that prior to approval of the redesignation 24-hour PM2.5 nonattainment area under Alabama has demonstrated that the request. Nonetheless, Alabama currently section 110(k) of the CAA for all observed air quality improvement in the has a fully-approved part D NSR requirements applicable for purposes of Birmingham Area is due to permanent program in place. Alabama’s PSD redesignation. EPA may rely on prior and enforceable reductions in emissions program will become effective in the SIP approvals in approving a resulting from implementation of the Birmingham Area upon redesignation to redesignation request (see Calcagni SIP, Federal measures, and other state attainment. Section 172(c)(6) requires Memorandum at p. 3; Southwestern adopted measures. the SIP to contain control measures Pennsylvania Growth Alliance v. State, local and Federal measures necessary to provide for attainment of Browner, 144 F.3d 984, 989–90 (6th Cir. enacted in recent years have resulted in the NAAQS. Because attainment has 1998); Wall, 265 F.3d 426) plus any permanent emission reductions. Most of been reached, no additional measures additional measures it may approve in these emission reductions are are needed to provide for attainment. conjunction with a redesignation action enforceable through regulations. A few Section 172(c)(7) requires the SIP to (see 68 FR 25426 (May 12, 2003) and non-regulatory measures also result in meet the applicable provisions of citations therein). Following passage of emission reductions. section 110(a)(2). As noted above, EPA the CAA of 1970, Alabama has adopted The state and local measures that believes the Alabama SIP meets the and submitted, and EPA has fully have been implemented to date and requirements of section 110(a)(2) approved at various times, provisions relied upon by Alabama to demonstrate applicable for purposes of addressing the various 2006 24-hour attainment and/or maintenance include redesignation. PM2.5 NAAQS SIP elements applicable local NOX controls on cement plants in Section 176 Conformity in the Birmingham Area (May 31, 1972, the Area due to the 8-hour ozone Requirements. Section 176(c) of the 37 FR 10842; July 13, 2011, 76 FR contingency plan, Jefferson and Shelby CAA requires states to establish criteria 41100). County burn bans, and voluntary on- and procedures to ensure that federally As indicated above, EPA believes that road and off-road diesel retrofit projects. supported or funded projects conform to the section 110 elements that are neither As shown in Table 2, local reasonably the air quality planning goals in the connected with nonattainment plan available control technology (RACT) PM applicable SIP. The requirement to submissions nor linked to an area’s controls installed in the Birmingham determine conformity applies to nonattainment status are not applicable Area have reduced direct PM2.5 transportation plans, programs and requirements for purposes of emissions by approximately 62 tons per projects that are developed, funded or redesignation. In addition, EPA believes year (tpy) as of the end of 2009. These

7 CAA section 176(c)(4)(E) requires states to transportation conformity. Transportation are established in control strategy SIPs and submit revisions to their SIPs to reflect certain conformity SIPs are different from the MVEBs that maintenance plans. Federal criteria and procedures for determining

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controls are associated with the Demonstration SIP, submitted to EPA on Birmingham Annual PM2.5 Attainment March 13, 2009.

TABLE 2—SUMMARY OF RACT CONTROLS IN THE BIRMINGHAM AREA

PM2.5 reduction Facility Source RACT controls (tpy) Installation date

W.J. Bullock ...... Crucible furnaces ...... Baghouse ...... 3 .891 2009 McWane Pipe ...... Charge handling area ...... Wet suppression ...... 0 .385 2008 Sloss Industries ...... Coal piles ...... Wet suppression ...... 0.398 2008 American Cast Iron Pipe ...... Charge make-up ...... Wet suppression ...... 11 .91 2008 Roads & process areas ...... Paving ...... 3.58 2007/2008 Cupola melting furnace ...... New Cupola/Bag house & spray 5 .84 2007/2008 suppression. Sand & cement silos ...... Baghouse ...... 0.09 2008 Nucor Steel...... Meltshop fugitives...... Baghouse & physical improve- 28 .1 2008 ments. U.S. Pipe ...... Cupola charge make-up ...... Wet suppression ...... 1 .818 2008 Sand & cement silos ...... Bin vents ...... 5.93 2008

Total ...... 61 .942 ......

In addition, closures of certain RACT controls and facility closures Company’s (APC) Gorgas Plant in facilities have resulted in continued amount to reductions of greater than anticipation of CAIR. Selective catalytic reductions of local PM2.5 emissions in eight percent of direct PM2.5 point reduction (SCR) systems were installed the Birmingham Area. In late 2009, W.J. source emissions in Jefferson County. on units 3 and 4 at APC Miller Plant in Bullock and Sloss Mineral Wool in Furthermore, control equipment 2003 as a result of the NOX SIP Call, Jefferson County announced plans to installed at utilities in the Birmingham with a consent decree requiring year cease operations, resulting in additional Area have decreased emissions of NOX round operation beginning in 2008 in PM2.5 emission reductions of 0.13 tpy and SO2. These reductions, prompted by preparation for CAIR. The year round and 130 tpy, respectively. In March the NOX SIP Call and CAIR, are SCR operation requirements have been 2010, U.S. Pipe ceased production, summarized in Table 3 below. In 2007, incorporated into the facilities’ title V resulting in an additional emission flue gas desulfurization systems were operating permits and are thus reduction of 46 tpy of PM2.5. In total, the added to units 8–10 of Alabama Power enforceable.

TABLE 3—SUMMARY OF EMISSIONS AND CONTROLS AT UTILITIES IN THE BIRMINGHAM AREA 8

Date control installed Emissions reductions from Facility 2006–2009 (tpy) NOX SO2 NOX SO2 Percent

APC Miller Unit 3 ...... 2008 ...... 4,680 ...... 71 APC Miller Unit 4 ...... 2008 ...... 3,786 ...... 70 APC Gorgas Unit 8 ...... 2007 ...... 10,007 96 APC Gorgas Unit 9 ...... 2007 ...... 9,975 96 APC Gorgas Unit 10 ...... 2007 ...... 40,779 97 APC Gaston Unit 5 * ...... 2010 ...... 43,579 78

Total Reductions ...... 8,466 104,341 ...... * Gaston Unit 5 data reflects reductions from 2006–2010.

The Federal measures that have been phase of the standards and testing Large nonroad diesel engine implemented include the following: procedures, which began in 2007, standards. Promulgated in 2004, this Tier 2 vehicle standards. In addition reduces particulate matter (PM) and rule is being phased in between 2008 to requiring NOX controls, the Tier 2 NOX from heavy-duty highway engines and 2014. This rule will reduce sulfur rule reduced the allowable sulfur and also reduces highway diesel fuel content in nonroad diesel fuel and, content of gasoline to 30 parts per sulfur content to 15 ppm. The total when fully implemented, will reduce million (ppm) starting in January of program is expected to achieve a 90 and NOX and direct PM2.5 emissions by over 2006. Most gasoline sold in North 95 percent reduction in PM and NOX 90 percent from these engines. Carolina prior to this had a sulfur emissions from heavy-duty highway NOX SIP Call. On October 27, 1998 content of approximately 300 ppm. engines, respectively. (63 FR 57356), EPA issued a NOX SIP Heavy-duty gasoline and diesel Nonroad spark-ignition engines and Call requiring the District of Columbia highway vehicle standards. The second recreational engines standards. Tier 1 of and 22 states to reduce emissions of this standard, implemented in 2004, and NOX. Affected states were required to 8 Data in Tables 3 and 4 reflect reported actual Tier 2, implemented in 2007, have comply with Phase I of the SIP Call emissions from the Clean Air Markets Division Database http://camddataandmaps.epa.gov/gdm/ reduced and will continue to reduce PM beginning in 2004, and Phase II index.cfm?fuseaction=emissions.wizard. emissions. beginning in 2007. Emission reductions

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resulting from regulations developed in transport requirements of the CAA with presents statewide EGU emissions data response to the NOX SIP Call are respect to the 1997 ozone, 1997 PM2.5 compiled by EPA’s Clean Air Markets permanent and enforceable. and 2006 PM2.5 NAAQS. As noted Division for the years 2002 and 2009. CAIR and CSAPR. As previously previously, the requirements of CAIR Emissions for 2009 reflect discussed, the remanded CAIR, address emissions through the 2011 implementation of CAIR. Table 4 shows originally promulgated to reduce control period and CSAPR requires that Alabama and states impacting the transported pollution, was left in place similar or greater emission reductions in Birmingham Area for the 24-hour PM2.5 to ‘‘temporarily preserve the the relevant areas in 2012 and beyond. NAAQS, as indicated in CSAPR, environmental values covered by CAIR’’ Because PM concentrations in the 2.5 reduced NO and SO emissions from until EPA replaced it with a rule Birmingham area are impacted by the X 2 EGUs by 1,173,566 tpy and 2,425,474 consistent with the Court’s opinion. To transport of sulfates and nitrates, the remedy CAIR’s flaws, EPA promulgated area’s air quality is affected by tpy, respectively, between 2002 and 2009. the final CSAPR on August 8, 2011. regulation of SO2 and NOX emissions CSAPR addresses the interstate from power plants. Table 4, below,

TABLE 4—COMPARISON OF 2002 AND 2009 STATEWIDE EGU NOX AND SO2 EMISSIONS (TPY) FOR STATES IMPACTING THE BIRMINGHAM AREA 8

NOX SO2 State Net change Net change 2002 2009 2002–2009 2002 2009 2002–2009

Alabama ...... 161,559 49,609 ¥111,950 448,248 277,972 ¥170,276 Georgia ...... 146,456 57,566 ¥88,890 512,654 262,258 ¥250,396 Indiana ...... 281,146 110,969 ¥170,177 778,868 413,726 ¥365,142 Kentucky ...... 198,599 78,767 ¥119,832 482,653 252,002 ¥230,651 Ohio ...... 370,497 95,785 ¥274,712 1,132,069 600,687 ¥531,382 Pennsylvania ...... 200,909 110,239 ¥90,670 889,766 573,619 ¥316,147 Tennessee ...... 155,996 27,912 ¥128,084 336,995 108,042 ¥228,953 West Virginia ...... 225,371 36,120 ¥189,251 507,110 174,583 ¥332,527

Total ...... 1,740,533 566,967 ¥1,173,566 5,088,363 2,662,889 ¥2,425,474

As was noted earlier, EPA with the other measures cited by section 175A, the plan must promulgated CSAPR to address Alabama and described above, ensure demonstrate continued attainment of interstate transport of emissions and that the emission reductions that led the the applicable NAAQS for at least 10 resulting secondary air pollutants and to Area to attain the 2006 24-hour PM2.5 years after the Administrator approves a replace CAIR. CAIR, among other NAAQS can be considered permanent redesignation to attainment. Eight years things, required emission reductions and enforceable for purposes of section after the redesignation, the State must that contributed to the air quality 107(d)(3)(E)(iii). submit a revised maintenance plan which demonstrates that attainment will improvement in the Birmingham Area. Criteria (4)—The Birmingham Area Has continue to be maintained for the 10 CSAPR requires substantial reductions a Fully Approved Maintenance Plan years following the initial 10-year of SO2 and NOX emissions from EGUs Pursuant to Section 175A of the CAA across most of the Eastern United States, period. To address the possibility of with implementation beginning on For redesignating a nonattainment future NAAQS violations, the January 1, 2012. CAIR will continue to area to attainment, the CAA requires maintenance plan must contain be implemented through 2011, and will EPA to determine that the area has a contingency measures as EPA deems be replaced by CSAPR beginning in fully approved maintenance plan necessary to assure prompt correction of 2012. CSAPR requires reductions of pursuant to section 175A of the CAA any future 2006 24-hour PM2.5 NOX and SO2 emissions to levels below (CAA section 107(d)(3)(E)(iv)). In violations. The Calcagni Memorandum the levels that led to attainment of the conjunction with its request to provides further guidance on the 1997 24-hour PM2.5 standard in the redesignate the Birmingham Area to content of a maintenance plan, Birmingham Area. Given the remanded attainment for the 2006 24-hour PM2.5 explaining that a maintenance plan status of CAIR, this air quality NAAQS, ADEM submitted a SIP should address five requirements: The improvement could not be considered revision to provide for the maintenance attainment emissions inventory, permanent at the time ADEM submitted of the 2006 24-hour PM2.5 NAAQS for at maintenance demonstration, its request for redesignation of the least 10 years after the effective date of monitoring, verification of continued Birmingham Area. However, since that redesignation to attainment. EPA attainment, and a contingency plan. As time CSAPR has been finalized, which believes this maintenance plan meets is discussed more fully below, EPA mandates even greater reductions than the requirements for approval under finds that Alabama’s maintenance plan have already occurred under CAIR and, section 175A of the CAA. includes all the necessary components more importantly, more reductions than and is thus proposing to approve it as a. What is required in a maintenance a revision to the Alabama SIP. are needed to maintain the standard in plan? the Area. The reductions of EGU b. Attainment Emissions Inventory emissions of SO2 and NOX contributed Section 175A of the CAA sets forth to the air quality improvement in the the elements of a maintenance plan for The Birmingham Area attained the Birmingham Area. Therefore, the final areas seeking redesignation from 2006 24-hour PM2.5 NAAQS based on promulgation of CSAPR in combination nonattainment to attainment. Under monitoring data for the 3-year period

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from 2007–2009. Alabama selected 2009 contains revisions to emissions data in PM2.5 emissions for the Birmingham as the attainment emissions inventory Tables 4.3–1, 4.3–2, and 4.3–3 of the Area, as well as the emissions for other year. The attainment inventory redesignation request to correct years, were developed consistent with identifies a level of emissions in the administrative errors and a clarification EPA guidance and are summarized in Area that is sufficient to attain the 2006 on how the 2009 point source inventory Tables 5 through 8 of the following 24-hour PM2.5 NAAQS. Alabama began was developed. A copy of the letter is subsection discussing the maintenance development of the attainment included in the docket for this proposed demonstration. inventory by first generating a baseline rulemaking (EPA–R04–OAR–2011– emissions inventory for the Birmingham 0043) and can be obtained from the c. Maintenance Demonstration Area. As noted above, the year 2009 was www.regulations.gov Web site. The June 17, 2010, final submittal The emissions inventory is composed chosen as the base year for developing includes a maintenance plan for the a comprehensive emissions inventory of four major types of sources: Point, Birmingham nonattainment area. The for direct PM and the primary PM area, on-road mobile and non-road 2.5 2.5 maintenance plan: precursors, SO2 and NOX, for which mobile. The future year emissions projected emissions could be developed inventories have been estimated using (i) Shows compliance with and for 2012, 2015, 2018, 2021, and 2024. projected rates of growth in population, maintenance of the 24-hour PM2.5 ADEM used actual point source traffic, economic activity, expected standard by providing information to emissions data for 2009 for all sources control programs, and other parameters. support the demonstration that current in Jefferson County and a majority of Due to the remand of CAIR, ADEM did and future emissions of SO2, NOX and sources in Shelby County. The Visibility not include any emissions reductions PM2.5 remain at or below 2009 Improvement—State and Tribal expected under the rule past 2012. The emissions levels. Association of the Southeast (VISTAS) promulgation of CSAPR ensured that (ii) Uses 2009 as the attainment year projected 2009 emissions were used reductions expected under CAIR would and includes future emissions inventory only where actual emissions were remain, thus EPA considers ADEM’s projections for 2012, 2015, 2018, 2021, unavailable. The projected inventory projections to be conservative estimates. and 2024. included with the maintenance plan Non-road mobile emissions estimates estimates emissions forward to 2024, were based on the EPA’s (iii) Identifies an ‘‘out year’’ at least 10 which is beyond the 10-year interval NONROAD2008a non-road mobile years (and beyond) after the time required in section 175A of the CAA. In model, with the exception of the necessary for EPA to review and addition to comparing the final year of railroad locomotives, commercial approve the maintenance plan. Per 40 the plan, 2024, to the base year, 2009, marine, and aircraft engine. These CFR part 93, NOX and PM2.5 MVEBs Alabama compared interim years to the emissions are estimated by taking were established for the last year (2024) baseline to demonstrate that these years activity data, such as landings and of the maintenance plan (see section VI are also expected to show continued takeoffs, and multiplying by an below). maintenance of the 24-hour PM2.5 Economic Growth Analysis System (iv) Provides actual and projected standard. On March 7, 2011, at the (EGAS) emission factor. On-road mobile emissions inventories, in tons per day request of EPA, ADEM submitted a source emissions were calculated using (tpd), for the Birmingham letter in support of the June 17, 2010, EPA’s MOVES2010 mobile emission nonattainment area, as shown in Tables redesignation request. The letter factors model. The 2009 SO2, NOX and 5 through 8 below.

TABLE 5—ACTUAL AND PROJECTED 24-HOUR PM2.5 EMISSIONS (TPD) FOR THE BIRMINGHAM AREA

Sector 2009 2012 2015 2018 2021 2024

Point ...... 11.22 9.75 10.29 10.88 11.47 12.10 Area ...... 12.35 12.18 12.37 12.57 12.78 12.98 Nonroad ...... 1.60 1.49 1.32 1.15 1.05 1.00 Mobile ...... 2.36 1.90 1.45 1.30 1.15 0.96

Total ...... 27.53 25.32 25.43 25.90 26.45 27.04

TABLE 6—ACTUAL AND PROJECTED 24-HOUR NOX EMISSIONS (TPD) FOR THE BIRMINGHAM AREA

Sector 2009 2012 2015 2018 2021 2024

Point ...... 96.25 96.41 98.01 99.66 101.65 103.69 Area ...... 11.24 11.42 11.59 11.77 11.94 12.12 Nonroad ...... 27.31 24.60 21.74 19.65 19.19 19.42 Mobile ...... 72.05 57.74 43.43 37.34 31.25 25.20

Total ...... 206.85 190.17 174.77 168.42 164.03 160.43

TABLE 7—ACTUAL AND PROJECTED 24-HOUR SO2 EMISSIONS (TPD) FOR THE BIRMINGHAM AREA

Sector 2009 2012 2015 2018 2021 2024

Point ...... 493.41 203.71 204.41 205.17 205.84 206.92 Area ...... 1.06 1.09 1.11 1.14 1.16 1.19 Nonroad ...... 0.50 0.20 0.19 0.19 0.19 0.20

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TABLE 7—ACTUAL AND PROJECTED 24-HOUR SO2 EMISSIONS (TPD) FOR THE BIRMINGHAM AREA—Continued

Sector 2009 2012 2015 2018 2021 2024

Mobile ...... 0.43 0.37 0.29 0.30 0.32 0.33

Total ...... 495.40 205.37 206.00 206.80 207.51 208.64

TABLE 8—EMISSION ESTIMATES FOR BIRMINGHAM AREA

Year PM2.5 (tpd) NOX (tpd) SO2 (tpd)

2009 ...... 27.53 206.85 495.40 2012 ...... 25.32 190.17 205.37 2015 ...... 25.43 174.77 206.00 2018 ...... 25.90 168.42 206.80 2021 ...... 26.45 164.03 207.51 2024 ...... 27.04 160.43 208.64 Difference from 2009 to 2024 ...... ¥0.49 ¥46.42 ¥286.76

Tables 5 through 8 summarize the d. Monitoring Network state will promptly correct a violation of 2009 and future projected emissions of There are currently ten monitors the NAAQS that occurs after redesignation. The maintenance plan direct PM2.5 and precursors from the measuring PM2.5 in the Birmingham counties in the Birmingham Area. In Area. The State of Alabama, through should identify the contingency situations where local emissions are the ADEM, has committed to continue measures to be adopted, a schedule and primary contributor to nonattainment, operation of the monitors in the procedure for adoption and the ambient air quality standard should Birmingham Area in compliance with implementation, and a time limit for not be violated in the future as long as 40 CFR part 58 and have thus addressed action by the State. A state should also emissions from within the the requirement for monitoring. EPA identify specific indicators to be used to nonattainment area remain at or below approved Alabama’s 2010 monitoring determine when the contingency the baseline with which attainment was plan on October 8, 2010. measures need to be implemented. The maintenance plan must include a achieved. Alabama has projected e. Verification of Continued Attainment requirement that a state will implement emissions as described previously and all measures with respect to control of determined that emissions in the The State of Alabama, through ADEM, has the legal authority to enforce and the pollutant that were contained in the Birmingham Area will remain below implement the requirements of the SIP before redesignation of the area to those in the attainment year inventory Birmingham Area 2006 24-hour PM attainment in accordance with section for the duration of the maintenance 2.5 maintenance plan. This includes the 175A(d). plan. authority to adopt, implement and In the June 17, 2010, submittal, As discussed in section VI of this enforce any subsequent emissions Alabama affirms that all programs proposed rulemaking, a safety margin is control contingency measures instituted by the State and EPA will the difference between the attainment determined to be necessary to correct remain enforceable and that sources are level of emissions (from all sources) and future PM2.5 attainment problems. prohibited from reducing emissions the projected level of emissions (from ADEM will track the progress of the controls following the redesignation of all sources) in the maintenance plan. maintenance plan by performing future the Area. The contingency plan The attainment level of emissions is the reviews of triennial emission included in the submittal includes a level of emissions during one of the inventories for the Birmingham Area as triggering mechanism to determine years in which the area met the NAAQS. required in the Air Emissions Reporting when contingency measures are needed and a process of developing and Alabama selected 2009 as the Rule (AERR) and Consolidated implementing appropriate control attainment emissions inventory year for Emissions Reporting Rule (CERR). For measures. The State of Alabama will use the Birmingham Area. Alabama these periodic inventories, ADEM will review the assumptions made for the actual ambient monitoring data as the calculated the safety margins in its purpose of the maintenance triggering event to determine when submittal as 46.42 tpd for NOX and 0.49 demonstration concerning projected contingency measures should be tpd for PM . The State has decided to 2.5 growth of activity levels. If any of these implemented.

allocate 23.21 tpd of the available NOX assumptions appear to have changed As previously mentioned, on March 7, safety margin and 0.245 tpd of the substantially, then ADEM will re-project 2011, at the request of EPA, ADEM available PM2.5 safety margin to the emissions for the Birmingham Area. submitted a letter in support of the June 2024 MVEBs for the Birmingham Area. 17, 2010, redesignation request. The Therefore, the remaining safety margin f. Contingency Measures in the letter contains clarifying information Maintenance Plan for NOX will be 23.21 tpd and the regarding the contingency measures remaining safety margin for PM2.5 will The contingency measures are included in the maintenance plan and be 0.245 tpd. This allocation and the designed to promptly correct a violation an additional emissions inventory-based resulting available safety margin for the of the NAAQS that occurs after contingency measure trigger. A copy of Birmingham Area are discussed further redesignation. Section 175A of the CAA the letter is included in the docket for in section VI of this proposed requires that a maintenance plan this proposed rulemaking (EPA–R04– rulemaking. include such contingency measures as OAR–2011–0043) and can be obtained EPA deems necessary to assure that the from the www.regulations.gov Web site.

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Alabama has identified a primary inventory. If the actual emissions from regulatory programs, air quality trigger as occurring when the 24-hour these inventories are greater than ten modeling, and emissions inventory PM2.5 NAAQS, as described in section II percent above the projected emissions assessment to determine emission above, are violated. Alabama commits to presented in the maintenance plan, than control measures that will be required to adopting, within 18 months of a ADEM will evaluate whether additional attain or maintain the 2006 24-hour certified violation of the 24-hour PM2.5 planning or control measures are PM2.5 NAAQS. All controls that will be NAAQS, one or more of the control needed to prevent the Area from relied upon for contingency purposes measures discussed below. violating the NAAQS or to correct a are scheduled to be installed in 2012 or Additionally, Alabama has identified a potential violation. later and are therefore not already relied secondary trigger to occur when the In the event that further reductions upon in for maintenance. The schedule 98th percentile 24-hour concentration are needed to ensure continued for implementation of this plan and for a single year at any monitor in the maintenance, the list of ‘‘culpable details of steps ADEM will take to bring nonattainment area records a sources’’ developed by Alabama in the the area back into compliance are concentration of 36 mg/m3 or greater. In State’s 2009 attainment demonstration outlined in Table 9. such a case, the state will evaluate for the Annual PM2.5 NAAQS will be At least one of the following existing controls measures and evaluated for additional control of direct contingency measures will be adopted determine whether any further emission PM2.5 emissions. As additional and implemented upon a primary reduction measures should be information, a copy of section 8.2 of the triggering event: implemented. ADEM will consider Birmingham Annual PM2.5 Attainment • Continued implementation of several factors in its evaluation of the Demonstration SIP, submitted to EPA on previously adopted controls which have need for additional controls measures in March 13, 2009, was included with the not yet been realized but are sufficient the event of a future year violation of March 7, 2011, letter to EPA, which is to address the violation, including the 2006 24-hour PM NAAQS. included in the docket for this proposed 2.5 future year emission reductions from Depending on the timing of the future rulemaking (EPA–R04–OAR–2011– Federal measures to address interstate year violations, additional local and 0043). This section contains the detailed pollutant transport and from the Georgia regional emissions reductions may still contingency measures for the annual multi-pollutant rule; be planned. ADEM will evaluate the air PM2.5 SIP and was referenced in the • quality impacts of those regulatory redesignation request and maintenance Additional controls of direct PM2.5 emissions from the list of ‘‘culpable programs in determining if further plan for the 24-hour PM2.5 NAAQS. In reductions are required to ensure addition, ADEM will consider the sources’’ developed in the PM2.5 annual continued maintenance of the 24-hour possibility of expanding the current attainment SIP and included in the March 7, 2011, letter; PM2.5 NAAQS in the Birmingham voluntary diesel retrofit program Maintenance Area. currently in place in the Birmingham • Expansion of the current voluntary In addition to the triggers indicated Area. diesel retrofit program in the above, Alabama will monitor regional Once a primary trigger is initiated, Birmingham Area; emissions through the CERR and AERR ADEM will commence analysis, • Any additional controls deemed and compare them to the projected including review of expected emissions beneficial to address the violation at the inventories and the attainment year reductions from local and regional time of the trigger.

TABLE 9—SCHEDULE FOR PERMIT REVISIONS AND/OR RULE REVISIONS FOR IMPLEMENTING CONTINGENCY MEASURES

Step Description of action Schedule

1 ...... Identify and quantify the emissions reductions expected to result from current and future state and Federal 3 months. regulatory programs. 2 ...... Use the best available air quality modeling to evaluate the air quality improvement expected from step 1 6 months. above. 3 ...... Draft any needed permit conditions or SIP regulations ...... 3 months. 4 ...... Complete rulemaking or permit revision process and submit to EPA ...... 6 months.

Maximum time required for completion 18 months.

EPA has concluded that the VI. What is EPA’s analysis of most new projects that would expand maintenance plan adequately addresses Alabama’s proposed NOX and PM2.5 the capacity of roadways cannot go the five basic components of a MVEBs for the Birmingham area? forward. Regulations at 40 CFR part 93 maintenance plan: Attainment Under section 176(c) of the CAA, new set forth EPA policy, criteria, and inventory, monitoring network, transportation plans, programs, and procedures for demonstrating and verification of continued attainment, projects, such as the construction of assuring conformity of such and a contingency plan. Therefore, the new highways, must ‘‘conform’’ to (i.e., transportation activities to a SIP. The maintenance plan SIP revision be consistent with) the part of the state’s regional emissions analysis is one, but submitted by the State of Alabama for air quality plan that addresses pollution not the only, requirement for the Birmingham Area meets the from cars and trucks. Conformity to the implementing transportation requirements of section 175A of the SIP means that transportation activities conformity. Transportation conformity CAA and is approvable. will not cause new air quality is a requirement for nonattainment and violations, worsen existing violations, or maintenance areas. Maintenance areas delay timely attainment of the NAAQS are areas that were previously or any interim milestones. If a nonattainment for a particular NAAQS transportation plan does not conform, but have since been redesignated to

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attainment with an approved TABLE 10—BIRMINGHAM AREA PM2.5 MVEBs for transportation conformity maintenance plan for that NAAQS. NOX MVEBS purposes was initially outlined in EPA’s Under the CAA, states are required to [tpd] May 14, 1999, guidance, ‘‘Conformity submit, at various times, control strategy Guidance on Implementation of March 2, 1999, Conformity Court Decision.’’ SIPs and maintenance plans for PM2.5 NOX EPA adopted regulations to codify the nonattainment areas. These control 2024 On-road Mo- adequacy process in the Transportation strategy SIPs (including RFP and bile Emissions Conformity Rule Amendments for the attainment demonstration) and (tpd) ...... 0 .96 25.20 ‘‘New 8-Hour Ozone and PM2.5 National maintenance plans create MVEBs for Safety Margin Allo- Ambient Air Quality Standards and criteria pollutants and/or their cated to MVEB .... 0.245 23.21 Miscellaneous Revisions for Existing precursors to address pollution from 2024 Conformity Areas; Transportation Conformity Rule MVEB ...... 1.21 48.41 cars and trucks. Per 40 CFR part 93, a Amendments—Response to Court MVEB must be established for the last Decision and Additional Rule Change,’’ As mentioned above, the Birmingham year of the maintenance plan. A state on July 1, 2004 (69 FR 40004). Area has chosen to allocate a portion of may adopt MVEBs for other years as Additional information on the adequacy the available safety margins to the NO well. The MVEB is the portion of the X process for transportation conformity and PM MVEBs for 2024. This 2.5 purposes is available in the proposed total allowable emissions in the allocation is 23.21 tpd and 0.245 tpd for rule entitled, ‘‘Transportation maintenance demonstration that is NO and PM , respectively. Therefore, X 2.5 Conformity Rule Amendments: allocated to highway and transit vehicle the remaining safety margins for 2024 use and emissions. See 40 CFR 93.101. Response to Court Decision and are 23.21 tpd and 0.245 tpd for NOX and Additional Rule Changes,’’ 68 FR 38974, The MVEB serves as a ceiling on PM2.5, respectively. emissions from an area’s planned 38984 (June 30, 2003). Through this rulemaking, EPA is As discussed earlier, Alabama’s transportation system. The MVEB proposing to approve the MVEBs for maintenance plan submission includes concept is further explained in the NOX and PM2.5 for 2024 for the NOX and PM2.5 MVEBs for the preamble to the November 24, 1993, Birmingham Area because EPA has Birmingham Area for 2024, the last year Transportation Conformity Rule (58 FR determined that the Area maintains the of the maintenance plan. EPA reviewed 62188). The preamble also describes 2006 24-hour PM2.5 NAAQS with the the NOX and PM2.5 MVEBs through the how to establish the MVEB in the SIP emissions at the levels of the budgets. adequacy process. The Alabama SIP and how to revise the MVEB. Once the MVEBs for the Birmingham submission, including the Birmingham Area are approved or found adequate After interagency consultation with Area NOX and PM2.5 MVEBs, was open the transportation partners for the (whichever is completed first), they for public comment on EPA’s adequacy must be used for future conformity Birmingham Area, Alabama has elected Web site on March 24, 2011, found at: determinations. After thorough review, to develop MVEBs for NO and PM http://www.epa.gov/otaq/state X 2.5 EPA has determined that the budgets for the entire nonattainment area resources/transconf/currsips.htm. The meet the adequacy criteria, as outlined EPA public comment period on (Jefferson, Shelby, and the in 40 CFR 93.118(e)(4), and is proposing nonattainment portion of Walker adequacy for the MVEBs for 2024 for to approve the budgets because they are Birmingham Area closed on April 25, Counties). Alabama is developing these consistent with maintenance of the 2006 2011. EPA did not receive any MVEBs, as required, for the last year of 24-hour PM2.5 NAAQS through 2024. comments on the adequacy of the its maintenance plan, 2024. The MVEBs MVEBs, nor did EPA receive any reflect the total on-road emissions for VII. What is the status of EPA’s adequacy determination for the requests for the SIP submittal. 2024, plus an allocation from the EPA intends to make its proposed NOX and PM2.5 MVEBs for available NOX and PM2.5 safety margin. 2024 for the Birmingham Area? determination on the adequacy of the Under 40 CFR 93.101, the term ‘‘safety 2024 MVEBs for the Birmingham Area margin’’ is the difference between the When reviewing submitted ‘‘control for transportation conformity purposes attainment level (from all sources) and strategy’’ SIPs or maintenance plans in the near future by completing the the projected level of emissions (from containing MVEBs, EPA may adequacy process that was started on all sources) in the maintenance plan. affirmatively find the MVEB contained March 24, 2011. After EPA finds the The safety margin can be allocated to therein adequate for use in determining 2024 MVEBs adequate or approves the transportation sector; however, the transportation conformity. Once EPA them, the new MVEBs for NOX and total emissions must remain below the affirmatively finds the submitted MVEB PM2.5 must be used for future is adequate for transportation attainment level. The NOX and PM2.5 transportation conformity MVEBs and allocation from the safety conformity purposes, that MVEB must determinations. For required regional be used by state and Federal agencies in margin were developed in consultation emissions analysis years that involve determining whether proposed with the transportation partners and 2024 or beyond, the applicable budgets transportation projects conform to the were added to account for uncertainties will be the new 2024 MVEBs SIP as required by section 176(c) of the established in the maintenance plan, as in population growth, changes in model CAA. vehicle miles traveled and new defined in section VI of this proposed EPA’s substantive criteria for rulemaking. emission factor models. The NOX and determining adequacy of a MVEB are set PM2.5 MVEBs for the Birmingham Area out in 40 CFR 93.118(e)(4). The process VIII. What is EPA’s analysis of the are defined in Table 10 below. for determining adequacy consists of proposed 2009 base year emissions three basic steps: public notification of inventory for the Birmingham area? a SIP submission, a public comment As discussed above, section 172(c)(3) period, and EPA’s adequacy of the CAA requires areas to submit a determination. This process for base year emissions inventory. As part determining the adequacy of submitted of Alabama’s request to redesignate the

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Birmingham Area, the State submitted a All emission summaries were summary of the 2009 emissions of direct 2009 base year emissions inventory to accompanied by source-specific PM2.5, NOX, and SO2 for the meet this requirement. Emissions descriptions of emission calculation Birmingham Area. In today’s notice, contained in the submittal cover the procedures and sources of input data. EPA is proposing to approve this 2009 general source categories of point Alabama’s submittal documents 2009 base year inventory as meeting the sources, area sources, on-road mobile emissions in the Birmingham Area in section 172(c)(3) emissions inventory sources, and non-road mobile sources. units of tpd. Table 11 below provides a requirement.

TABLE 11—BIRMINGHAM AREA 2009 EMISSIONS FOR PM2.5, NOX, AND SO2 [tpd (percent total)]

Source PM2.5 NOX SO2

Point Source Total ...... 11.22 [40.8] 96.25 [46.5] 493.41 [99.6] Area Source Total ...... 12.35 [44.9] 11.24 [5.4] 1.06 [0.2] On-Road Mobile Source Total ...... 2.36 [8.6] 72.05 [34.8] 0.43 [0.1] Non-Road Mobile Source Total ...... 1.60 [5.8] 27.31 [13.2] 0.50 [0.1]

Total for all Sources ...... 27.53 ...... 206.85 ...... 495.40 ......

IX. What is the effect of EPA’s proposed redesignation and maintenance of the this action, whichever is earlier, the actions? 2006 24-hour PM2.5 NAAQS. transportation partners will need to First, EPA is proposing to determine, demonstrate conformity to the new NO EPA’s proposed actions establish the X based on complete, quality-assured and and PM2.5 MVEBs pursuant to 40 CFR basis upon which EPA may take final certified monitoring data for the 2007– 93.104(e). action on the issues being proposed for 2009 monitoring period, and after If finalized, approval of the approval today. Approval of Alabama’s review of preliminary data in AQS for redesignation request would change the redesignation request would change the 2008–2010, that the Birmingham Area official designation of Jefferson and legal designation of Jefferson and Shelby continues to attain the 2006 24-hour Shelby Counties in their entireties and Counties and the designated portion of PM2.5 NAAQS. EPA is proposing to the nonattainment portion of Walker Walker County in Alabama for the 2006 determine that the Birmingham Area County in the Birmingham Area for the 24-hour PM2.5 NAAQS, found at 40 CFR has met the criteria under CAA section 2006 24-hour PM2.5 NAAQS, found at 40 part 81, from nonattainment to 107(d)(3)(E) for redesignation from CFR part 81, from nonattainment to attainment. Approval of Alabama’s nonattainment to attainment for the attainment. request would also incorporate a plan 2006 24-hour PM NAAQS. On this 2.5 XI. Statutory and Executive Order for maintaining the 2006 24-hour PM2.5 basis, EPA is proposing to approve NAAQS in the Birmingham Area Alabama’s redesignation request for the Reviews through 2024 into the Alabama SIP. Birmingham Area. Under the CAA, redesignation of an This maintenance plan includes Second, EPA is proposing to approve area to attainment and the contingency measures to remedy any Alabama’s 2009 emissions inventory for accompanying approval of a future violations of the 2006 24-hour the Birmingham Area (under CAA maintenance plan under section PM2.5 NAAQS and procedures for section 172(c)(3)). Alabama selected 107(d)(3)(E) are actions that affect the evaluation of potential violations. The 2009 as the attainment emissions status of a geographical area and do not maintenance plan also establishes NOX inventory year for the Birmingham Area. impose any additional regulatory and PM2.5 MVEBs for the Birmingham This attainment inventory identifies a requirements on sources beyond those Area. The NOX and PM2.5 MVEBs for level of emissions in the Area that is imposed by state law. A redesignation to 2024 for the Birmingham Area are 48.41 sufficient to attain the 2006 24-hour attainment does not in and of itself tpd and 1.21 tpd, respectively. Final PM2.5 NAAQS and also is a current, create any new requirements, but rather action would also approve the Area’s comprehensive inventory that meets the results in the applicability of emissions inventory under CAA section requirements of section 172(c)(3). requirements contained in the CAA for 172(c)(3). Additionally, EPA is notifying Third, EPA is proposing to approve areas that have been redesignated to the public of the status of EPA’s the maintenance plan for the attainment. Moreover, the Administrator adequacy determination for the newly- Birmingham Area, including the PM2.5 is required to approve a SIP submission established PM2.5 and NOX MVEBs for and NOX MVEBs for 2024, into the that complies with the provisions of the 2024 for the Birmingham Area. Alabama SIP (under CAA section 175A). Act and applicable Federal regulations. X. Proposed Actions on the The maintenance plan demonstrates 42 U.S.C. 7410(k); 40 CFR 52.02(a). Redesignation Request and that the Area will continue to maintain Thus, in reviewing SIP submissions, Maintenance Plan SIP Revisions the 2006 24-hour PM2.5 NAAQS, and the EPA’s role is to approve state choices, budgets meet all of the adequacy criteria provided that they meet the criteria of Including Approval of the NOX and contained in 40 CFR 93.118(e)(4) and the CAA. Accordingly, this proposed PM2.5 MVEBs for 2024 for the Birmingham Area (5). Further, as part of today’s action, action merely approves state law as EPA is describing the status of its meeting Federal requirements and does EPA previously determined that the adequacy determination for the PM2.5 not impose additional requirements Birmingham Area was attaining the and NOX MVEBs for 2024 in accordance beyond those imposed by state law. For 2006 24-hour PM2.5 NAAQS on with 40 CFR 93.118(f)(1). Within 24 this reason, these proposed actions: September 20, 2010, at 75 FR 57186. months from the effective date of EPA’s • Are not ‘‘significant regulatory EPA is now taking three separate but adequacy determination for the MVEBs action[s]’’ subject to review by the related actions regarding the Area’s or the effective date for the final rule for Office of Management and Budget under

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Executive Order 12866 (58 FR 51735, ENVIRONMENTAL PROTECTION • http://www.regulations.gov: Follow October 4, 1993); AGENCY on-line instructions for submitting • Do not impose an information comments. collection burden under the provisions 40 CFR Part 300 • Email: Karen Cibulskis, Remedial of the Paperwork Reduction Act (44 Project Manager, at U.S.C. 3501 et seq.); [EPA–HQ–SFUND–1983–0002; FRL–9488–6] [email protected] or Megan • Are certified as not having a McSeveney, Community Involvement significant economic impact on a National Oil and Hazardous Substance Coordinator, at Pollution Contingency Plan National [email protected]. substantial number of small entities • under the Regulatory Flexibility Act Priorities List: Partial Deletion of the Fax: Gladys Beard, Deletion Process (5 U.S.C. 601 et seq.); Tar Lake Superfund Site Manager, at (312) 697–2077. • Mail: Karen Cibulskis, Remedial • Do not contain any unfunded AGENCY: Environmental Protection Project Manager, U.S. Environmental mandate or significantly or uniquely Agency (EPA). Protection Agency (SR–6J), 77 West affect small governments, as described ACTION: Proposed rule. Jackson Boulevard, Chicago, IL 60604, in the Unfunded Mandates Reform Act (312) 886–1843, or Megan McSeveney, of 1995 (Pub. L. 104–4); SUMMARY: The Environmental Protection • Community Involvement Coordinator, Do not have Federalism Agency (EPA) Region 5 is issuing a U.S. Environmental Protection Agency implications as specified in Executive Notice of intent of Partial Deletion of the (SI–7J), 77 West Jackson Boulevard, Order 13132 (64 FR 43255, August 10, following two parcels of the Tar Lake Chicago, IL 60604, (312) 886–1972 or 1999); Site Superfund (Site) located in (800) 621–8431. • Are not economically significant Mancelona, Michigan from the National • Hand delivery: Megan McSeveney, regulatory actions based on health or Priorities List (NPL): the non-East Community Involvement Coordinator, safety risks subject to Executive Order Tailings Area (ETA) part of property PIN U.S. Environmental Protection Agency, 13045 (62 FR 19885, April 23, 1997); 05–11–129–006–00 (41.4 acres); and the Region 5 (SI–7J), 77 West Jackson • Are not significant regulatory non-ETA part of property PIN 05–11– Boulevard, Chicago, IL 60604. Such actions subject to Executive Order 129–007–00 (33.63 acres) and requests deliveries are only accepted during the 13211 (66 FR 28355, May 22, 2001); public comments on this proposed docket’s normal hours of operations, • Are not subject to requirements of action. The NPL, promulgated pursuant and special arrangements should be Section 12(d) of the National to section 105 of the Comprehensive made for deliveries of boxed Technology Transfer and Advancement Environmental Response, information. The normal business hours Act of 1995 (15 U.S.C. 272 note) because Compensation, and Liability Act are Monday through Friday, 8:30 a.m. to application of those requirements would (CERCLA) of 1980, as amended, is an 4:30 p.m., excluding Federal holidays. be inconsistent with the CAA; and appendix of the National Oil and Instructions: Direct your comments to • Do not provide EPA with the Hazardous Substances Pollution Docket ID No. EPA–HQ–SFUND–1983– discretionary authority to address, as Contingency Plan (NCP). EPA and the 0002. EPA’s policy is that all comments appropriate, disproportionate human State of Michigan, through the Michigan received will be included in the public health or environmental effects, using Department of Environmental Quality, docket without change and may be practicable and legally permissible have determined that all appropriate made available online at http:// methods, under Executive Order 12898 response actions at these two parcels www.regulations.gov, including any (59 FR 7629, February 16, 1994). under CERCLA have been completed. personal information provided, unless the comment includes information In addition, this proposed rule does not However, this deletion does not preclude future actions under claimed to be Confidential Business have Tribal implications as specified by Information (CBI) or other information Executive Order 13175 (65 FR 67249, Superfund. This partial deletion pertains only to whose disclosure is restricted by statute. November 9, 2000), because the SIP is Do not submit information that you not approved to apply in Indian country the two property PINs listed above. The deletion of these two parcels from the consider to be CBI or otherwise located in the State, and EPA notes that protected through http:// it will not impose substantial direct Site affects all surface soils, subsurface soils, structures and groundwater within www.regulations.gov or email. The costs on Tribal governments or preempt http://www.regulations.gov Web site is Tribal law. the boundaries of these parcels. In 2005, the ETA, approximately 45.49 acres, in an ‘‘anonymous access’’ system, which List of Subjects the northeastern part of the Site, was means EPA will not know your identity or contact information unless you 40 CFR Part 52 deleted from the NPL when EPA determined that the ETA was acceptable provide it in the body of your comment. Environmental protection, Air for unrestricted use and unlimited If you send an email comment directly pollution control, Intergovernmental exposure (UU/UE). The two parcels to EPA without going through http:// relations, Reporting and recordkeeping being proposed for deletion are adjacent www.regulations.gov, your email requirements, and Particulate matter. to and south of the ETA. The current address will be automatically captured and included as part of the comment 40 CFR Part 81 remaining areas of the Site will remain on the NPL and are not being that is placed in the public docket and Environmental protection, Air considered for deletion as part of this made available on the Internet. If you pollution control. action. submit an electronic comment, EPA Authority: 42 U.S.C. 7401 et seq. recommends that you include your DATES: Comments must be received by name and other contact information in Dated: November 2, 2011. December 12, 2011. the body of your comment and with any Gwendolyn Keyes Fleming, ADDRESSES: Submit your comments, disk or CD–ROM you submit. If EPA Regional Administrator, Region 4. identified by Docket ID No. EPA–HQ– cannot read your comment due to [FR Doc. 2011–29183 Filed 11–9–11; 8:45 am] SFUND–1983–0002, by one of the technical difficulties and cannot contact BILLING CODE 6560–50–P following methods: you for clarification, EPA may not be

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able to consider your comment. will not take effect. We will, as and evaluation of public comments Electronic files should avoid the use of appropriate, address all public received. Public comments should still special characters, any form of comments in a subsequent final Notice be submitted by December 16, 2011 encryption, and be free of any defects or of Partial Deletion regarding these using one of the methods discussed viruses. parcels, based on this Notice of Intent under the section below titled To Delete. We will not institute a ADDRESSES. Docket second comment period on this Notice DATES: Submission of Comments: All documents in the docket are listed of Intent To Delete. Any parties Comments on the proposed rule should in the http://www.regulations.gov index. interested in commenting must do so at be submitted in writing to the address Although listed in the index, some this time. shown below on or before December 16, information is not publicly available, For additional information, see the 2011, to be considered in the formation e.g., CBI or other information whose direct final Notice of Partial Deletion of the rule. disclosure is restricted by statute. regarding these parcels which is located Certain other material, such as in the Rules and Regulations section of ADDRESSES: Submission of Comments: copyrighted material, will be publicly this Federal Register. You may submit written comments, available only in the hard copy. Publicly identified by DFARS Case 2011–D039, available docket materials are available List of Subjects in 40 CFR Part 300 using any of the following methods: • either electronically at http:// Environmental protection, Air Regulations.gov: http:// www.regulations.gov or in hard copy at: pollution control, Chemicals, Hazardous www.regulations.gov. Submit comments U.S. Environmental Protection waste, Hazardous substances, via the Federal eRulemaking portal by Agency—Region 5, 77 West Jackson Intergovernmental relations, Penalties, inputting ‘‘DFARS Case 2011–D039’’ Boulevard, Chicago, IL 60604. Reporting and recordkeeping under the heading ‘‘Enter keyword or Hours: Monday through Friday, requirements, Superfund, Water ID’’ and selecting ‘‘Search.’’ Select the 8:30 a.m. to 4:30 p.m., excluding pollution control, Water supply. link ‘‘Submit a Comment’’ that Federal holidays. corresponds with ‘‘DFARS Case 2011– Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. D039.’’ Follow the instructions provided Mancelona Public Library, 202 West 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, State Street, Mancelona, MI 49659, (231) 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; at the ‘‘Submit a Comment’’ screen. 587–9451. 3 CFR, 1987 Comp., p. 193. Please include your name, company Hours: Monday through Thursday, name (if any), and ‘‘DFARS Case 2011– Dated: October 24, 2011. D039’’ on your attached document. 9 a.m. to 8 p.m.; Friday 12 p.m. to 6 Susan Hedman, • p.m.; and Saturday 9 a.m. to 5 p.m. Email: [email protected]. Include Regional Administrator, Region 5. DFARS Case 2011–D039 in the subject FOR FURTHER INFORMATION CONTACT: [FR Doc. 2011–29070 Filed 11–9–11; 8:45 am] line of the message. Karen Cibulskis, Remedial Project BILLING CODE 6560–50–P • Fax: (703) 602–0350. Manager, U.S. Environmental Protection • Mail: Defense Acquisition Agency (SR–6J), 77 West Jackson Blvd.; Regulations System, Attn: Mr. Julian Chicago, IL 60604, (312) 886–1843, Thrash, OUSD (AT&L) DPAP (DARS), [email protected]. DEPARTMENT OF DEFENSE Room 3B855, 3060 Defense Pentagon, SUPPLEMENTARY INFORMATION: Defense Acquisition Regulations Washington, DC 20301–3060. In the ‘‘Rules and Regulations’’ System Comments received generally will be section of today’s Federal Register, we posted without change to http:// are publishing a direct final notice of 48 CFR Parts 204 and 252 www.regulations.gov, including any Partial Deletion of two parcels of the Tar personal information provided. To RIN 0750–AG47 Lake Superfund Site from the NPL, the confirm receipt of your comment, please non-ETA part of PIN 05–129–006–00 Defense Federal Acquisition check http://www.regulations.gov (41.4 acres) and the non-ETA part of PIN Regulation Supplement; Safeguarding approximately two to three days after 05–11–129–007–00 (33.63 acres), Unclassified DoD Information (DFARS submission to verify posting (except without prior notice of intent to delete Case 2011–D039) allow 30 days for posting of comments because we view this as a submitted by mail). noncontroversial revision and anticipate AGENCY: Defense Acquisition FOR FURTHER INFORMATION CONTACT: Mr. no adverse comments. We have Regulations System, Department of Julian E. Thrash, telephone (703) 602– explained our reasons for these partial Defense (DoD). 0310. deletions in the preamble to the direct ACTION: Notice of meeting cancellation. final notice of Partial Deletion, and List of Subjects in 48 CFR Parts 204 and those reasons are incorporated herein. If SUMMARY: On October 28, 2011 (76 FR 252 we receive no adverse comments on this 66889), DoD gave notice of a public Government procurement. partial deletion action, we will not take meeting to be held on November 15, further action on this Notice of Intent To 2011, from 9:30 a.m. to 12 p.m. EST at Mary Overstreet, Delete for these two parcels. If we the General Services Administration Editor, Defense Acquisition Regulations receive adverse comments, we will (GSA), Central Office Auditorium. This System. withdraw the direct final Notice of meeting has been cancelled and may be [FR Doc. 2011–29132 Filed 11–9–11; 8:45 am] Partial Deletion of these parcels, and it rescheduled at a later date after review BILLING CODE 5001–06–P

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Notices Federal Register Vol. 76, No. 218

Thursday, November 10, 2011

This section of the FEDERAL REGISTER the collection of information unless it ensure that the poultry meat or poultry contains documents other than rules or displays a currently valid OMB control products from Sinaloa and Sonora pose proposed rules that are applicable to the number. the most negligible risk possible for public. Notices of hearings and investigations, introducing exotic Newcastle disease Animal & Plant Health Inspection committee meetings, agency decisions and into the United States. rulings, delegations of authority, filing of Service Description of Respondents: Business petitions and applications and agency Title: Importation of Poultry Meat and statements of organization and functions are or other for-profit; Federal Government. examples of documents appearing in this Other Poultry Products from Sinaloa Number of Respondents: 280. section. and Sonora, Mexico. Frequency of Responses: Reporting: OMB Control Number: 0579–0144. On occasion. Summary Of Collection: The Animal Total Burden Hours: 280. DEPARTMENT OF AGRICULTURE Health Protection Act of 2002 (Title X, Subtitle E, Sec. 10401–18 of Pub. L. Animal and Plant Health Inspection Service Submission for OMB Review; 107–171) is the primary Federal law Comment Request governing the protection of animal Title: Foot-and-Mouth Disease; health. Veterinary Services, a program Prohibition on Importation of Farm November 4, 2011. within USDA’s Animal and Plant Health Equipment. The Department of Agriculture has Inspection Service (APHIS), is OMB Control Number: 0579–0195. submitted the following information responsible for administering Summary of Collection: The Animal collection requirement(s) to OMB for regulations intended to prevent the Health Protection Act of 2002 is the review and clearance under the introduction of animal diseases, such as primary Federal law governing the Paperwork Reduction Act of 1995, exotic Newcastle disease (END) into the protection of animal health. Regulations Public Law 104–13. Comments United States. APHIS currently has contained in 9 CFR chapter 1, regarding (a) whether the collection of regulations in place that restrict the subchapter D, parts 92 through 98 information is necessary for the proper importation of poultry meat and other prohibits the importation of used farm performance of the functions of the poultry products from Mexico due to equipment into the United States from agency, including whether the the presence of exotic Newcastle disease regions in which foot-and-mouth information will have practical utility; in the country. However, APHIS does disease or rinderpest exist, unless the (b) the accuracy of the agency’s estimate allow the importation of poultry meat equipment has been stream-cleaned of burden including the validity of the and poultry products from the Mexican prior to export to the United States so methodology and assumptions used; (c) States of Sinaloa and Sonora because that it is free of exposed dirt and other ways to enhance the quality, utility and APHIS has determined that poultry particulate matter. Disease prevention is clarity of the information to be meat and products from these two the most effective method for collected; (d) ways to minimize the Mexican States pose a negligible risk of maintaining a healthy animal burden of the collection of information introducing exotic Newcastle disease population and enhancing the Animal on those who are to respond, including into the United States. To ensure that and Plant Health Inspection Service through the use of appropriate these items are safe for importation, (APHIS) ability to compete in exporting automated, electronic, mechanical, or APHIS requires that certain data appear animals and animal products. other technological collection on the foreign meat inspection Need and Use of the Information: techniques or other forms of information certificate that accompanies the poultry APHIS will collect information through technology should be addressed to: Desk meat and other poultry products from the use of a certification statement Officer for Agriculture, Office of Sinaloa and Sonora to the United States. completed by the farm equipment Information and Regulatory Affairs, APHIS also requires that serial exporter and signed by an authorized Office of Management and Budget numbered seals be applied to containers official of the national animal health (OMB), carrying the poultry meat and other service of the region of origin, stating [email protected] or poultry products. that the steam-cleaning of the fax (202) 395–5806 and to Departmental Need and Use of the Information: equipment has been done. This is Clearance Office, USDA, OCIO, Mail APHIS will collect information to certify necessary to help prevent the Stop 7602, Washington, DC 20250– that the poultry meat or other poultry introduction of food-and-mouth disease 7602. Comments regarding these products were (1) derived from poultry into the United States. If the information information collections are best assured born and raised in commercial breeding were not collected APHIS would be of having their full effect if received establishments in Sinaloa and Sonora; forced to discontinue the importation of within 30 days of this notification. (2) derived from poultry that were any used farm equipment from FMD Copies of the submission(s) may be slaughtered in Sinaloa or Sonora in a regions, a development that could have obtained by calling (202) 720–8958. Federally-inspected slaughter plant a damaging financial impact on An agency may not conduct or approved to export these commodities exporters and importers of this sponsor a collection of information to the United States in accordance with equipment. unless the collection of information Food Safety & Inspection regulations; (3) Description of Respondents: Business displays a currently valid OMB control processed at a Federally inspected or other for-profit; State, Local or Tribal number and the agency informs processing plant in Sinaloa or Sonora; Government. potential persons who are to respond to and (4) kept out of contact with poultry Number of Respondents: 150. the collection of information that such from any other State within Mexico. Frequency of Responses: Reporting: persons are not required to respond to APHIS will also collect information to On occasion.

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Total Burden Hours: 200. DEPARTMENT OF AGRICULTURE management practices, as well as the Census of Agriculture. The Milk and Animal Plant and Health Inspection National Agricultural Statistics Service Milk Products Surveys obtain basic Service agricultural statistics on milk Notice of Intent To Request Approval production and manufactured dairy Title: Interstate Movement of Sheep To Revise and Extend an Information and Goats. products from farmers and processing Collection plants throughout the nation. Data are OMB Control Number: 0579–0258. AGENCY: National Agricultural Statistics gathered for milk production, dairy Summary of Collection: The Animal Service, USDA. products, evaporated and condensed milk, manufactured dry milk, and Health Protection Act (AHPA) of 2002 is ACTION: Notice and request for manufactured whey products. Milk the primary Federal law governing the comments. protection of animal health. The law production and manufactured dairy gives the Secretary of Agriculture broad SUMMARY: In accordance with the products statistics are used by the U.S. authority to detect, control, or eradicate Paperwork Reduction Act of 1995, this Department of Agriculture (USDA) to pests or diseases of livestock or poultry. notice announces the intention of the help administer Federal programs and by the dairy industry in planning, Disease prevention is the most effective National Agricultural Statistics Service pricing, and projecting supplies of milk method for maintaining a healthy (NASS) to request approval to revise and milk products. Included in this animal population and enhancing the and extend a currently approved information collection, the Milk and approval request are several changes to ability of the Animal and Plant Health this group of surveys. The monthly Milk Inspection Service (APHIS) to help U.S. Milk Products Surveys. Revision to burden hours will be needed due to Production Survey will now be producers compete in the world market changes in the size of the target conducted quarterly (January, April, of animal and animal product trade. The population, sample design, and/or July, and October) instead of monthly. Veterinary Services (VS) program of questionnaire length. Monthly estimates for the non-quarterly APHIS is the unit responsible for months will still be published for total DATES: Comments on this notice must be carrying out the disease prevention received by January 9, 2012 to be number of dairy cows, the number of mission. One of the APHIS disease assured of consideration. cows milked, and the total milk eradication programs addresses scrapie. produced. Estimates for the non-survey ADDRESSES: You may submit comments, Scrapie is a progressive, degenerative, months will be generated by using a identified by docket number 0535–0020, and eventually fatal disease affecting the combination of administrative data, by any of the following methods: regression modeling, and historic data. central nervous system of sheep and • Email: [email protected]. goats. In the spring of 2012 NASS also plans Include docket number above in the to discontinue the collection of Dairy Need and Use of the Information: In subject line of the message. Product Prices. This data will be • Fax: (202) 720–6396. order for APHIS’ scrapie eradication collected by the Agricultural Marketing • Mail: Mail any paper, disk, or CD– program to be effective, its animal Service (AMS) in compliance with the ROM submissions to: David Hancock, identification, recordkeeping, and other Mandatory Price Reporting Act of 2010, NASS Clearance Officer, U.S. requirements must be carried out at and the amended section 273(d) of the Department of Agriculture, Room 5336 livestock facilities that handle sheep Agricultural Marketing Act of 1946. and goats moving in interstate South Building, 1400 Independence Authority: Voluntary dairy commerce. The individual legally Avenue SW., Washington, DC 20250– information reporting is conducted responsible for the day-to-day operation 2024. under authority of 7 U.S.C. 2204(a). • Hand Delivery/Courier: Hand of the facility must execute an Approval Individually identifiable data collected deliver to: David Hancock, NASS of Livestock Facilities Agreement with under this authority are governed by Clearance Officer, U.S. Department of section 1770 of the Food Security Act of APHIS. The information restricts the Agriculture, Room 5336 South Building, interstate movement of livestock within 1985 (7 U.S.C. 2276), which requires 1400 Independence Avenue SW., USDA to afford strict confidentiality to the United States to control diseases of Washington, DC 20250–2024. concern and approve livestock facilities non-aggregated data provided by FOR FURTHER INFORMATION CONTACT: that handle sheep and goats moving in respondents. Joseph T. Reilly, Associate Mandatory dairy product information interstate commerce. Administrator, National Agricultural reporting is based on the Agricultural Description of Respondents: Business Statistics Service, U.S. Department of Marketing Act of 1946, as amended by or other for-profit; State, Local or Tribal Agriculture, (202) 720–4333. the Dairy Market Enhancement Act of Government. SUPPLEMENTARY INFORMATION: Title: Milk 2000 and the Farm Security and Rural Number of Respondents: 200. and Milk Products Surveys. Development Act of 2002 (U.S.C. 1637– OMB Control Number: 0535–0020. 1637b). This program requires each Frequency of Responses: Expiration Date of Approval: March manufacturer to report to USDA the Recordkeeping; Reporting: On occasion. 31, 2012. price, quantity, and moisture content of Total Burden Hours: 237. Type of Request: To revise and extend dairy products sold and each entity a currently approved information storing dairy products to report Charlene Parker, collection for a period of three years. information on the quantity of dairy Departmental Information Collection Abstract: The primary objective of the products stored. Any manufacturer that Clearance Officer. National Agricultural Statistics Service processes, markets, or stores less than [FR Doc. 2011–29093 Filed 11–9–11; 8:45 am] (NASS) is to collect, prepare and issue 1,000,000 pounds of dairy products per BILLING CODE 3410–34–P State and national estimates of crop and year is exempt. USDA is required to livestock production, prices and maintain information, statistics, or disposition as well as economic documents obtained under these Acts in statistics, farm numbers, land values, a manner that ensures that on-farm pesticide usage, pest crop confidentiality is preserved regarding

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the identity of persons and proprietary COMMISSION ON CIVIL RIGHTS Dated in Washington, DC, on November 4, business information, subject to 2011. verification by the Agricultural Agenda and Notice of Public Meeting Peter Minarik, Marketing Service (AMS) under Public of the Colorado Advisory Committee Acting Chief, Regional Programs Law No. 106–532. This Notice is Coordination Unit. submitted in accordance with the Notice is hereby given, pursuant to [FR Doc. 2011–29115 Filed 11–9–11; 8:45 am] the provisions of the rules and Paperwork Reduction Act of 1995, BILLING CODE 6335–01–P Public Law 104–13 (44 U.S.C. 3501, et regulations of the U.S. Commission on seq.) and Office of Management and Civil Rights (Commission), and the Federal Advisory Committee Act Budget regulations at 5 CFR part 1320. DEPARTMENT OF COMMERCE NASS also complies with OMB (FACA), that a planning meeting of the Implementation Guidance, Colorado Advisory Committee to the Submission for OMB Review; ‘‘Implementation Guidance for Title V Commission will convene by Comment Request of the E–Government Act, Confidential teleconference at 10 a.m. (MDT) on Information Protection and Statistical Tuesday, November 22, 2011. The The Department of Commerce will Efficiency Act of 2002 (CIPSEA),’’ purpose of the meeting is to discuss submit to the Office of Management and Federal Register, Vol. 72, No. 115, June next steps after project selection. Budget (OMB) for clearance the 15, 2007, p. 33362. This meeting is available to the public following proposal for collection of Estimate of Burden: Public reporting through the following toll-free call-in information under the provisions of the burden for this collection of information number: (800) 516–9896. Conference ID: Paperwork Reduction Act (44 U.S.C. is estimated to average 8 minutes per 8334. Any interested member of the chapter 35). response. This average is based on the public may call this number and listen Agency: National Institute of 12 different surveys in the information to the meeting. Callers can expect to Standards and Technology (NIST). collection: 4 weekly, 2 monthly, 4 incur charges for calls they initiate over Title: Evacuation Movement and quarterly, and 2 annual. The estimated wireless lines, and the Commission will Behavior Questionnaire. total number of responses is 64,500 not refund any incurred charges. Callers OMB Control Number: 0693–0051. Type of Request: Regular. annually, with an average annual will incur no charge for calls they Burden Hours: 3,334. frequency of 3.64 responses per initiate over land-line connections to Number of Respondents: 20,000. respondent. the toll-free telephone number. Persons Average Hours per Response: 10 Respondents: Farms and businesses. with hearing impairments may also Estimated Number of Respondents: follow the proceedings by first dialing minutes. Needs and Uses: The NIST’s 15,000. Dial 711 for relay services and enter 1– Engineering Laboratory, formally the Estimated Total Annual Burden on (800) 516–9896, followed by Conference Building and Fire Research Laboratory, Respondents: 8,350 hours. ID: 8334. To ensure that the has established project efforts to better Copies of this information collection Commission secures an appropriate understand occupant egress from high- and related instructions can be obtained number of telephone lines for the rise buildings. Buildings of interest without charge from NASS Clearance public, persons are asked to contact the include varying heights, and of varying Officer, at (202) 720–2248 or at Rocky Mountain Regional Office 10 occupancy types, e.g., residential, office, [email protected]. days before the meeting date either by and assembly occupancies. Data will be Comments: Comments are invited on: email at [email protected], or by phone collected via questionnaires on (a) Whether the proposed collection of at (303) 866–1040. occupant behavior during regularly information is necessary for the proper Members of the public are entitled to performance of the functions of the scheduled evacuation drills from high- submit written comments; the rise building across the United States. agency, including whether the comments must be received in the information will have practical utility; All of these evacuation drills will be regional office by December 22, 2011. conducted regardless of whether NIST (b) the accuracy of the agency’s estimate Comments may be mailed to the Rocky of the burden of the proposed collection data collection takes place. The Mountain Regional Office, U.S. occupant behavioral data requested will of information including the validity of Commission on Civil Rights, 999–18th the methodology and assumptions used; involve the occupants’ knowledge of the Street, Suite 1380 South, Denver, CO procedure, their awareness of the event, (c) ways to enhance the quality, utility, 80202, faxed to (303) 866–1050, or and clarity of the information to be and their behavior during the emailed to [email protected]. Persons evacuation. This data will be used to collected; and (d) ways to minimize the who desire additional information may burden of the collection of information improve egress designs for buildings, contact the Rocky Mountain Regional safety assessment models, and occupant on those who are to respond, through Office by email at [email protected] or the use of appropriate automated, training and education about what to do by phone at (303) 866–1040. in an emergency. electronic, mechanical, technological or Records generated from this meeting other forms of information technology Affected Public: Individuals or may be inspected and reproduced at the households (selected individuals who collection methods. Rocky Mountain Regional Office, as All responses to this notice will have evacuated high-rise buildings in they become available, both before and become a matter of public record and be cities across the U.S. during scheduled after the meeting. Persons interested in summarized in the request for OMB evacuation drills). the work of this advisory committee are approval. Frequency: Annually. directed to the Commission’s Web site, Respondent’s Obligation: Voluntary. Signed at Washington, DC on October 4, http://www.usccr.gov, or may contact OMB Desk Officer: Jasmeet Seehra, 2011. the Rocky Mountain Regional Office at (202) 395–3123. Joseph T. Reilly, the above email or street address. Copies of the above information Associate Administrator. The meeting will be conducted collection proposal can be obtained by [FR Doc. 2011–28886 Filed 11–9–11; 8:45 am] pursuant to the rules and regulations of calling or writing Diana Hynek, BILLING CODE 3410–20–P the Commission and FACA. Departmental Paperwork Clearance

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Officer, (202) 482–0266, Department of Jefferson, New York, as described in the DEPARTMENT OF COMMERCE Commerce, Room 6616, 14th and application. If approved, the grantee Constitution Avenue, NW., Washington, would be able to serve sites throughout Bureau of Industry and Security DC 20230 (or via the Internet at the service area based on companies’ [email protected]). needs for FTZ designation. The Proposed Information Collection; Written comments and proposed service area is within and Comment Request; Miscellaneous recommendations for the proposed adjacent to the Alexandria Bay Customs Short Supply Activities information collection should be sent and Border Protection port of entry. AGENCY: Bureau of Industry and within 30 days of publication of this The applicant is requesting authority Security, Commerce. notice to Jasmeet Seehra, OMB Desk to reorganize and expand its existing ACTION: Notice. Officer, FAX number (202) 395–5167 or zone project to include existing Site 1 as via the Internet at a ‘‘magnet’’ site and to remove existing SUMMARY: The Department of [email protected]. Site 2. The applicant has also requested Commerce, as part of its continuing Dated: November 4, 2011. that Site 1 be expanded to include an effort to reduce paperwork and additional 95 acres. In addition, the respondent burden, invites the general Gwellnar Banks, applicant is requesting approval of the public and other Federal agencies to Management Analyst, Office of the Chief following new ‘‘magnet’’ sites: Proposed take this opportunity to comment on Information Officer. Site 3 (122 acres), City Central Industrial proposed and/or continuing information [FR Doc. 2011–29101 Filed 11–9–11; 8:45 am] Park, Bellew Avenue South, Watertown; collections, as required by the BILLING CODE 3510–13–P and, Proposed Site 4 (1,059 acres) Paperwork Reduction Act of 1995. located at the Corporate Park at DATES: Written comments must be Watertown International Airport, NYS DEPARTMENT OF COMMERCE submitted on or before January 9, 2012. Route 12F, 22529 Airport Drive, Dexter. ADDRESSES: Direct all written comments Foreign-Trade Zones Board The ASF allows for the possible to Diana Hynek, Departmental exemption of one magnet site from the Paperwork Clearance Officer, [Docket 70–2011] ‘‘sunset’’ time limits that generally Department of Commerce, Room 6616, apply to sites under the ASF, and the 14th and Constitution Avenue NW., Foreign-Trade Zone 109—County of applicant proposes that Site 1 be so Jefferson, NY; Application for Washington, DC 20230 (or via the exempted. No usage-driven sites are Internet at [email protected]). Reorganization and Expansion Under being requested at this time. Because the Alternative Site Framework FOR FURTHER INFORMATION CONTACT: ASF only pertains to establishing or Requests for additional information or An application has been submitted to reorganizing a general-purpose zone, the copies of the information collection the Foreign-Trade Zones (FTZ) Board application would have no impact on instrument and instructions should be (the Board) by the County of Jefferson, FTZ 109’s authorized subzone. directed to Larry Hall, BIS ICB Liaison, In accordance with the Board’s grantee of FTZ 109, requesting authority (202) 482–4895, [email protected]. regulations, Kathleen Boyce of the FTZ to reorganize and expand the zone gov. Staff is designated examiner to evaluate under the alternative site framework and analyze the facts and information SUPPLEMENTARY INFORMATION: (ASF) adopted by the Board (74 FR presented in the application and case 1170, 1/12/09 (correction 74 FR 3987, I. Abstract record and to report findings and 1/22/09); 75 FR 71069–71070, This information collection is recommendations to the Board. 11/22/10). The ASF is an option for comprised of two rarely used short Public comment is invited from grantees for the establishment or supply activities: ‘‘Registration of U.S. interested parties. Submissions (original reorganization of general-purpose zones Agricultural Commodities for and 3 copies) shall be addressed to the and can permit significantly greater Exemption from Short Supply Board’s Executive Secretary at the flexibility in the designation of new Limitations on Export’’ (USAG), and address below. The closing period for ‘‘usage-driven’’ FTZ sites for operators/ ‘‘Petitions for the Imposition of their receipt is January 9, 2012. Rebuttal users located within a grantee’s ‘‘service Monitoring or Controls on Recyclable comments in response to material area’’ in the context of the Board’s Metallic Materials (Petitions); Public submitted during the foregoing period standard 2,000-acre activation limit for Hearings.’’ These activities are statutory may be submitted during the subsequent a general-purpose zone project. The in nature and, therefore, must remain a 15-day period to January 24, 2012. application was submitted pursuant to A copy of the application will be part of BIS’s active information the Foreign-Trade Zones Act, as available for public inspection at the collections. amended (19 U.S.C. 81a–81u), and the Office of the Executive Secretary, II. Method of Collection regulations of the Board (15 CFR part Foreign-Trade Zones Board, Room 2111, Submitted electronically or on paper. 400). It was formally filed on November U.S. Department of Commerce, 1401 7, 2011. Constitution Avenue NW., Washington, III. Data FTZ 109 was approved by the Board DC 20230–0002, and in the ‘‘Reading on November 5, 1984 (Board Order 278, OMB Control Number: 0694–0102. Room’’ section of the Board’s Web site, Form Number(s): None. 49 FR 44937, 11/13/84). which is accessible via www.trade.gov/ Type of Review: Regular submission. The current zone project includes the ftz. For further information, contact Affected Public: Business or other for- following sites: Site 1 (115 acres)— Kathleen Boyce at Kathleen.Boyce@ profit organizations. Jefferson County Industrial Park, trade.gov or (202) 482–1346. Estimated Number of Respondents: 2. junction of I–81 and Coffeen Street, Estimated Time per Response: USAG, Dated: November 7, 2011. Watertown; and, Site 2 (16 acres)— 30 minutes; and Petitions, 100 hours. Dexter Sulphite Mill, 349 Lakeview Dr. Andrew McGilvray, Estimated Total Annual Burden & Stockton Avenue, Dexter. Executive Secretary. Hours: 201. The grantee’s proposed service area [FR Doc. 2011–29178 Filed 11–9–11; 8:45 am] Estimated Total Annual Cost to under the ASF would be the County of BILLING CODE P Public: $0.

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IV. Request for Comments (202) 482–4895, DEPARTMENT OF COMMERCE Comments are invited on: (a) Whether [email protected]. International Trade Administration the proposed collection of information SUPPLEMENTARY INFORMATION: is necessary for the proper performance [A–552–801] of the functions of the agency, including I. Abstract whether the information shall have Upon request, BIS will initiate an Certain Frozen Fish Fillets from the practical utility; (b) the accuracy of the investigation to determine the effects of Socialist Republic of Vietnam: agency’s estimate of the burden imports of specific commodities on the Extension of Deadline for Preliminary (including hours and cost) of the national security, and will make the Results of the New Shipper Review proposed collection of information; (c) findings known to the President for AGENCY: Import Administration, ways to enhance the quality, utility, and possible adjustments to imports through International Trade Administration, clarity of the information to be tariffs. The findings are made publicly Department of Commerce. collected; and (d) ways to minimize the available and are reported to Congress. DATES: Effective Date: November 10, burden of the collection of information The purpose of this collection is to 2011 on respondents, including through the account for the public burden associated use of automated collection techniques with the surveys distributed to FOR FURTHER INFORMATION CONTACT: or other forms of information determine the impact on national Emeka Chukwudebe, AD/CVD technology. security. Operations, Office 9, Import Comments submitted in response to Administration, International Trade this notice will be summarized and/or II. Method of Collection Administration, U.S. Department of included in the request for OMB Submitted electronically or on paper. Commerce, 14th Street and Constitution approval of this information collection; Avenue NW., Washington, DC 20230; they also will become a matter of public III. Data telephone: (202) 482–0219. record. OMB Control Number: 0694–0120. Background Dated: November 4, 2011. Form Number(s): None. On August 12, 2003, the Department Gwellnar Banks, Type of Review: Regular submission. of Commerce (‘‘Department’’) published Management Analyst, Office of the Chief Affected Public: Business or other for- in the Federal Register, the Information Officer. profit organizations. antidumping duty order on certain [FR Doc. 2011–29097 Filed 11–9–11; 8:45 am] Estimated Number of Respondents: frozen fish fillets from the Socialist 1 BILLING CODE 3510–33–P 400. Republic of Vietnam (‘‘Vietnam’’). On Estimated Time per Response: 7 hours March 31, 2011, the Department and 30 minutes. published a notice of initiation of a new DEPARTMENT OF COMMERCE Estimated Total Annual Burden shipper review with respect to Thuan Hours: 3,000. An Production Trading & Services Co., Bureau of Industry and Security Estimated Total Annual Cost to Ltd. (‘‘TAFISHCO’’) covering the period Public: $0. August 1, 2010, through January 31, Proposed Information Collection; 2011.2 On September 27, 2011, the IV. Request for Comments Comment Request; Request for Department published a notice of an Investigation Under Section 232 of the Comments are invited on: (a) Whether extension of the time period for the Trade Expansion Act the proposed collection of information preliminary results of this new shipper AGENCY: Bureau of Industry and is necessary for the proper performance review by 45 days, to November 4, 3 Security, Commerce. of the functions of the agency, including 2011. whether the information shall have ACTION: Notice. Extension of Time Limits for practical utility; (b) the accuracy of the Preliminary Results SUMMARY: The Department of agency’s estimate of the burden Commerce, as part of its continuing (including hours and cost) of the Section 751(a)(2)(B)(iv) of the Act and effort to reduce paperwork and proposed collection of information; (c) 19 CFR 351.214(i)(1), requires the respondent burden, invites the general ways to enhance the quality, utility, and Department to issue the preliminary public and other Federal agencies to clarity of the information to be results in a new shipper review of an take this opportunity to comment on collected; and (d) ways to minimize the antidumping duty order 180 days after proposed and/or continuing information burden of the collection of information the date on which the new shipper collections, as required by the on respondents, including through the review was initiated. The Department Paperwork Reduction Act of 1995. use of automated collection techniques may however, extend the deadline for or other forms of information completion of the preliminary results of DATES: Written comments must be a new shipper review to 300 days if it submitted on or before January 9, 2012. technology. Comments submitted in response to determines that the case is ADDRESSES: Direct all written comments this notice will be summarized and/or extraordinarily complicated. See 19 CFR to Diana Hynek, Departmental 351.214(i)(2). Paperwork Clearance Officer, included in the request for OMB approval of this information collection; Department of Commerce, Room 6616, 1 they also will become a matter of public See Notice of Antidumping Duty Order: Certain 14th and Constitution Avenue NW., Frozen Fish Fillets from the Socialist Republic of Washington, DC 20230 (or via the record. Vietnam, 68 FR 47909 (August 12, 2003). Dated: November 4, 2011. 2 See Certain Frozen Fish Fillets From the Internet at [email protected]). Socialist Republic of Vietnam: Initiation of FOR FURTHER INFORMATION CONTACT: Gwellnar Banks, Antidumping Duty New Shipper Review, 76 FR Requests for additional information or Management Analyst, Office of the Chief 17837 (March 31, 2011). copies of the information collection Information Officer. 3 See Certain Frozen Fish Fillets From the Socialist Republic of Vietnam: Extension of Time instrument and instructions should be [FR Doc. 2011–29098 Filed 11–9–11; 8:45 am] Limit for Preliminary Results of the New Shipper directed to Larry Hall, BIS ICB Liaison, BILLING CODE 3510–33–P Review, 76 FR 59658 (September 27, 2011).

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The Department determines that this telephone: (202) 482–2924, (202) 482– ‘‘errors in addition, subtraction, or other new shipper review involves 4947 or (202) 482–0649, respectively. arithmetic function, clerical errors extraordinarily complicated SUPPLEMENTARY INFORMATION: resulting from inaccurate copying, methodological issues. Interested parties duplication, or the like, and any other have submitted voluminous surrogate Background type of unintentional error with the country comments and surrogate value 19 CFR 351.224(c)(2) states that a administering authority considers data, and thus, the Department requires party to an antidumping duty ministerial.’’ 1 In this review, interested additional time to analyze these data. proceeding must file comments parties have alleged a total of four We are, therefore, further extending the concerning ministerial errors within five ministerial errors. time for the completion of the days after the earlier of the date on Æ Blue Field alleges that the preliminary results of this new shipper which the Secretary released documents Department erred in its normal value review by 31 days to December 5, 2011. to that party or held a disclosure calculation by applying incorrect The final results continue to be due 90 meeting with that party. We released programming language regarding the days after the publication of the disclosure documents to Blue Field cost of metal lids for tin can products. Æ preliminary results. (Sichuan) Food Industrial Co., Ltd. XITIC alleges that the Department This notice is published in (‘‘Blue Field’’) and Zhejiang Iceman erred in failing to value labor using the accordance with sections Group, Co., Ltd. (‘‘Iceman Group’’) on methodology announced in 751(a)(2)(B)(iv) of the Act. September 7, 2011. On September 12, Antidumping Methodologies in 2011, Blue Field filed a timely Proceedings Involving Non-Market Dated: November 4, 2011. allegation of a ministerial error with the Economics: Valuing the Factor of Gary Taverman, Department. On September 14, 2011, the Production: Labor, 76 FR 36092 (June Acting Deputy Assistant Secretary for Department released disclosure 21, 2011). Antidumping and Countervailing Duty documents to Xiamen International Æ XITIC also alleges the Department Operations. Trade & Industrial Co., Ltd. (‘‘XITIC’’), used an incorrect surrogate value for its [FR Doc. 2011–29172 Filed 11–9–11; 8:45 am] thus establishing the deadline for lime input. BILLING CODE 3510–DS–P XITIC’s ministerial error comments as Æ Iceman Group alleges the September 19, 2011. On September 19, Department made a clerical error by 2011, XITIC and Iceman Group filed including Iceman Group in the DEPARTMENT OF COMMERCE allegations of ministerial errors with the proceedings. No interested party commented on International Trade Administration Department. On September 26, 2011, Monterey Mushrooms, Inc. (petitioner) Blue Field’s allegation. After analyzing filed rebuttal comments in response to Blue Field’s allegation, we find, in [A–570–851] the filings from XITIC and Iceman accordance with section 751(h) of the Group. Act and 19 CFR 351.224(f), that the Certain Preserved Mushrooms From On October 5, 2011, the Department Department made a ministerial error in the People’s Republic of China: rejected from the record Iceman Group’s its normal value calculation by applying Amended Final Results of September 19, 2011, submission incorrect programming language Antidumping Duty Administrative because it was untimely given that the regarding the cost of metal lids for tin Review Department released all disclosure can products.. Therefore, in accordance AGENCY: Import Administration, materials to it on September 7, 2011. On with section 751(h) of the Act and 19 International Trade Administration, October 7, 2011, Iceman Group CFR 351.224(e), we are amending the Department of Commerce. submitted a letter arguing that its Final Results for Blue Field and the September 19, 2011, submission was not weighted-average margin for companies DATES: Effective Date: November 10, untimely because, inter alia, it actually that applied for separate-rate status. For 2011. had not received all disclosure materials details, see Memorandum from Scott SUMMARY: On September 14, 2011, the on September 7, 2011. Specifically, Hoefke to the File, Subject: ‘‘Analysis of Department of Commerce (the Iceman Group claimed that it had not Data Submitted by Blue Field (Sichuan) Department) published in the Federal received the computation of the rate for Food Industrial Co., Ltd. (Blue Field) in Register the final results of the separate-rate respondents. The the Amended Final Results of administrative review of the Department subsequently determined Administrative Review of the antidumping duty order on certain that it had indeed failed to release to Antidumping Duty Order on Certain preserved mushrooms from the People’s interested parties the computation of the Preserved Mushrooms from the People’s Republic of China (PRC). See Certain rate for the separate-rate respondents. Republic of China,’’ dated concurrently Preserved Mushrooms From the People’s Therefore, on October 18, 2011, the with this notice. Republic of China: Final Results of Department released this computation With respect to both of XITIC’s Antidumping Duty Administrative to all interested parties and also invited allegations, petitioners argue that they Review and Rescission in Part, 76 FR Iceman Group to resubmit its September constitute methodological issues, and 56732 (September 14, 2011) (Final 19, 2011, submission. not ministerial errors. Results). The period of review is No interested parties submitted After analyzing the interested parties’ February 1, 2009, through January 31, ministerial error allegations with respect allegations and reply comments 2010. We are amending our final results to the computation of the rate for the regarding XITIC, we find, in accordance to correct a ministerial error. separate-rate respondents. Iceman with section 751(h) of the Act, that the FOR FURTHER INFORMATION CONTACT: Fred Group resubmitted its ministerial error allegations made by XITIC challenge Baker, Scott Hoefke, or Robert James, allegation on October 25, 2011. methodological determinations in the AD/CVD Operations, Office 7, Import final results, rather than any clerical Administration, International Trade Ministerial Errors errors made in carrying out its Administration, U.S. Department of A ministerial error as defined in intentions. XITIC cited no record Commerce, 14th Street and Constitution section 751(h) of the Tariff Act of 1930, Avenue NW., Washington, DC 20230; as amended (‘‘the Act’’), includes 1 See also 19 CFR 351.224(f).

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evidence in its ministerial error separate rate certification filed by previously investigated or reviewed PRC allegation that it was the Department’s Iceman Group lists the company Web and non-PRC exporters that have intention in preparing the final results site as www.icemanfood.com and the separate rates whose rate has not to use either the labor rate methodology company email address as changed as a result of these amended announced on June 21, 2011, or to value ‘‘[email protected];’’ and (4) final results, the cash deposit rate will lime using any surrogate value other Iceman Group did not comment on the continue to be the exporter-specific rate than the one it used in the final results. Preliminary Results, which specifically published for the most recent period. Thus, XITIC’s allegations do not fall list Iceman Group as preliminarily For all PRC exporters of subject under the definition of a ministerial receiving a separate rate. Therefore, the merchandise which have not been error set forth in 751(h) of the Act and Department correctly and reasonably found to be entitled to a separate rate, 19 CFR 351.224(f). Therefore, the assigned a separate rate to Iceman the cash deposit rate will be the PRC- Department has not amended the final Group as a result of counsel’s wide rate of 198.63 percent. For all non- results with respect to XITIC’s representation of Iceman Group and PRC exporters of subject merchandise allegations. Iceman Food, and the party’s own which have not received their own rate, Finally, Iceman Group argues that the actions before the Department the cash deposit will be the rate Department made a clerical error by indicating that the two names apply to applicable to the PRC exporters that including Iceman Group in the the same company which is subject to supplied that non-PRC exporter. These proceedings. Iceman Group claims that the review. Thus, the Department will deposit requirements shall remain in no party requested a review of Iceman not amend the Final Results for Iceman effect until further notice. Group, and that the Department did not Group other than to account for These amended final results are initiate an administrative review of adjustments to the weighted-average published in accordance with sections shipments by Iceman Group. Instead, margin for companies that applied for 751(h) and 777(i)(1) of the Act. Iceman Group argues, petitioners separate-rates status as described above. requested a review of Zhejiang Iceman Dated: November 4, 2011. Food, Co., Ltd. (‘‘Iceman Food’’), and it Amended Final Results of the Review Paul Piquado, was on this entity that the Department The Department has determined that Assistant Secretary for Import initiated an administrative review. the following amended margins exist for Administration. Petitioner argues the Department the period February 1, 2009, through [FR Doc. 2011–29175 Filed 11–9–11; 8:45 am] should reject Iceman Group’s argument January 31, 2010. BILLING CODE 3510–DS–P for three reasons: (1) Iceman Group actively participated in the Weighted- DEPARTMENT OF COMMERCE administrative proceedings before the Exporter average Department (submitting a separate rate margin certification) and its counsel filed an (percent) International Trade Administration entry of appearance on behalf of Iceman Blue Field (Sichuan) Food Executive-Led Medical Trade Mission Food; (2) the Department’s Preliminary Industrial Co., Ltd ...... 2.17 to India Mumbai, New Delhi and Results 2 specifically identified Iceman Ayecue (Liaocheng) Food- Hyderabad March 2–8, 2012 Group as an entity preliminarily eligible stuff Co., Ltd ...... 76.12 for a separate rate; and (3) Iceman Fujian Golden Banyan Food- AGENCY: International Trade Group’s attempt to raise this issue as a stuffs Industrial Co., Ltd .... 76.12 Administration, Commerce. Shandong Jiufa Edible Fun- clerical error—rather than having raised ACTION: Notice. it during the Department’s on-going gus Corporation, Ltd ...... 76.12 proceedings—is an inappropriate use of Zheijiang Iceman Group Co., Ltd ...... 76.12 Mission Description the clerical error provision in the Department’s regulations. The United States Department of After analyzing the interested parties’ Assessment Rates Commerce, International Trade allegations and reply comments Pursuant to section 751(a)(2)(A) of the Administration, U.S. and Foreign regarding Iceman Group, in accordance Act and 19 CFR 351.212(b), the Commercial Service (CS) is organizing with section 751(h) of the Act and 19 Department shall determine, and U.S. an Executive-Led Medical Trade CFR 351.224(e), we find that the Customs and Border Protection (CBP) Mission to India from March 2–8, 2012. Department did not err by including shall assess, antidumping duties on all The Medical Trade Mission to India is Iceman Group in the proceedings. First, appropriate entries. The Department intended to include representatives the allegations made by Iceman Group intends to issue assessment instructions from a variety of U.S. medical/ do not fall under the definition of to CBP that are related to the amended healthcare industry manufacturers ‘‘ministerial error’’ set forth in 751(h) of final results 15 days after the of (equipment/devices, laboratory the Act and 19 CFR 351.224(f). publication of the amended final results equipments, emergency equipment, Additionally, four reasons support of review. diagnostic, physiotherapy and equating Iceman Group with the entity orthopedic, healthcare information Iceman Food: (1) Counsel filed an entry Cash Deposit Requirements technology, and other allied sectors), of appearance on behalf of Iceman Food Cash deposit requirements related to service providers, and associations and on April 5, 2010; (2) Iceman Group, the amended final results will be trade organizations. The mission will which never filed a separate notice of effective retroactively for all shipments introduce the participants to the appearance, filed a certification for a of the subject merchandise entered, or government bodies, end-users and separate rate on April 29, 2010; (3) the withdrawn from warehouse, for prospective partners whose needs and consumption on or after the publication capabilities are best suited to each U.S. 2 See Certain Preserved Mushrooms From the date of the final results, as provided by participant’s strengths. Participating in People’s Republic of China: Preliminary Results of section 751(a)(2)(C) of the Act. The cash an official U.S. industry delegation, Antidumping Duty Administrative Review, Recission in Part, and Intent to Rescind in Part, 76 deposit rates for companies whose rate rather than traveling to India on their FR 12704 (March 8, 2011) (Preliminary Results) was corrected are noted above. For own, will enhance the participants’

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ability to secure meetings in India. The expected to reach over $75 billion by following measures to promote this delegates will meet with government 2012. There is a growing demand for industry: officials to obtain first-hand information quality healthcare service. The Indian • 100 per cent foreign direct about the regulations, policies and population of 1 billion people is investment (FDI) is permitted for health procedures in the healthcare industry. It growing at a rate of 1.6 percent per year. and medical services under the will be an opportunity for participants The growth in affluence in India, which automatic route. (FDI in sectors/ to visit healthcare facilities to get now has over 400 million middle- activities to the extent permitted under acquainted with the functioning of income consumers, is creating demand automatic route does not require any hospitals in India and the varied for a higher standard of healthcare. The prior approval either by the Government standards. Market forces, such as type of healthcare serviced required or Reserve Bank of India (RBI). The medical tourism, insurance and have changed due to the change in the investors are only required to notify the corporate sector have accelerated the demographic profile of India and the Regional Office concerned of RBI within demand for quality in healthcare rise of lifestyle-related diseases such as 30 days of receipt of inward remittances services. As a result, there is a growing diabetes, cardiovascular diseases, and and file the required documents with demand from consumers for better diseases of the central nervous system. that office within 30 days of issue of healthcare as the lack of quality The number of individuals covered by shares of foreign investors. assurance mechanisms limits their health plans is estimated at 20 million • The National Rural Health Mission access to appropriate health services. presently, leaving a large portion of the (NRHM) has allocated US$ 10.15 billion The Healthcare industry is now Indian population uninsured. The for the up-grading and capacity proactively creating standards for the potential market for healthcare services, enhancement of healthcare facilities. medical tourism industry with the help including healthcare information and • Moreover, in order to meet the of credit rating agencies, insurance management systems, is expected to revised cost of construction, in March companies and others involved in the grow at a faster pace as hospitals strive 2010 the Government of India (GOI) self regulation of the sector. The to improve operational efficiencies in allocated an additional US$ 1.2 billion National Accreditation Board for managing patient records and other key for the construction of six All India Hospitals (NABH) has been set-up to systems. Institute of Medical Sciences (AIIMS)- Currently, the medical infrastructure establish and operate accreditation like institutes and up- grade of 13 in India is far from adequate with programs for healthcare organizations. existing Government Medical Colleges. Some private hospitals are also applying demand for hospitals and beds far Medical tourism is one of the major for accreditation from bodies such as the surpassing availability. The problem is external drivers of growth of the Indian Joint Commission International (JCI). most acute in rural India, which healthcare sector. The cost of major The mission will include appointments accounts for over half of India’s surgeries in India remains relatively and briefings in Mumbai, New Delhi population; about 80 percent of low. Government and private sector and Hyderabad, India’s major healthcare available hospital beds are located in estimates the value of this segment of industry hubs. Trade mission the urban centers, leaving only 20 the industry will reach $1.5 billion by participants will have the opportunity percent for the larger rural population. to interact extensively with Embassy/ Both the Indian government and the 2012. The healthcare industry is now Consulate Officials and Commercial private sector are striving to bring about proactively creating standards for the Service (CS) India healthcare specialists, rapid growth in the industry to manage medical tourism industry with the help to discuss industry developments, the increased demand for high quality of credit rating agencies, insurance opportunities, and sales strategies. service. Construction of several new companies and others involved in the There is an option in the mission to hospitals as well as upgrades of existing self regulation of the sector. The participate in Medical Fair India. The hospitals is planned. Healthcare is National Accreditation Board for Medical Fair India is the 18th provided through primary care facilities, Hospitals (NABH) has been set-up to International Exhibition and Conference secondary and tertiary care hospitals. establish and operate accreditation on Diagnostic, Medical Technology, While the first two categories are fully programs for healthcare organizations. Rehabilitation, Medical Equipment and managed by the government, tertiary Some private hospitals are also applying Components. MEDICAL FAIR INDIA care hospitals are owned and managed for accreditation from bodies such as the offers a new platform for technology and either by government or private sector. Joint Commission International (JCI). service solutions for use in the medical The growth in medical infrastructure The growth in this industry makes it engineering industry—from new is accompanied by increased demand very attractive for U.S. companies, both materials, components, intermediate for medical equipment/devices. The large companies already doing business products, packaging and services all the medical equipment segment is growing in the market but also and especially way over to more complex micro system at an impressive rate of 15 percent. The small- and medium- sized enterprises technology and nanotechnology. For demand for the medical equipment is (SMEs), and new-to-market (NTM) more information on Medical Fair India, expected to reach $5 billion by 2012, companies. please visit http://www.medicalfair- reflecting significant growth from the Mission Goals india.com/. For the last three years the current figure of $2.7 billion. The new U.S. Department of Commerce has specialty and super-specialty hospital The goal of the Medical Trade certified the Medical Fair India. facilities depend on the import of high- Mission to India is to (1) familiarize the end medical equipment, which accounts participants with the current healthcare Commercial Setting for over 65 percent of the entire situation as well as the developments The Indian healthcare industry is healthcare market. The demand is taking place in India (2) introduce experiencing a rapid transformation and primarily for high-tech devices. Most participants to government officials in emerging to be a promising market for Indian healthcare institutes use foreign India to learn about various regulatory U.S. suppliers of high end products medical equipment for the purpose of procedures and policies in the seeking partnership opportunities. The diagnosis, treatment and surgery. The healthcare sector (3) introduce Indian healthcare industry is estimated government has identified healthcare as participants to Indian companies for at $50 billion industry in India and is a priority sector and has taken the potential partnerships.

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Mission Scenario members will learn about policies, • Embassy/Consulate briefings on the procedures and opportunities in the business climate, political scenario, The first stop on the mission itinerary country’s healthcare industry. medical/healthcare industry scenario; is Mumbai, the financial capital of These three cities are each regional • India, located in western India. New Industry briefings ‘‘Doing business hubs for the medical/healthcare in India—focus sector medical/ Delhi and Hyderabad are the second and industry. The end-users of the third stops of the mission and are healthcare’’; healthcare industry often prefer to be • located in northern and western India. Pre-scheduled meetings with serviced by regional distributors/agents potential partners, distributors, end Several corporate hospital chains have rather than country-wide distributors. their headquarters in these cities. These users, or local industry contacts in Thus, medical equipment importers/ Mumbai, New Delhi and Hyderabad; include Max group and Medicity distributors are based in these cities to • Meetings with Indian Government Medanta in New Delhi, the Apollo supply and service the regions group in Hyderabad, Fortis and the Tata officials in New Delhi; surrounding each of the cities. The three • Research in Mumbai. cities will serve as good locations for Tour of hospitals and interaction In all three cities the delegates will business one-on-one matchmaking with senior hospital staff and attend Embassy and industry briefings, meetings and networking. procurement head (all the three stops); networking events and take part in U.S. participants will be counseled and business matchmaking appointments before and after the mission by U.S. • Networking receptions in three with private-sector organizations. As Export Assistance Center trade cities of the trade mission. New Delhi is the capital city and home specialists, primarily by members of the Proposed Timetable to Central (Federal) Government, the Global Healthcare Team. Participation participants will have an opportunity in in the mission will include the Mission participants will be New Delhi to meet the representatives of following: encouraged to arrive Thursday, March 1, the Ministry of Health, Drugs Controller • Pre-travel briefings/Webinar on 2012 to allow time to adjust to their new Generals Office, and Department of subjects ranging from business practices surroundings before the mission Pharmaceutical. The U.S. mission in India to security; program begins on Friday, March 2.

Friday, March 2 ...... Mumbai. Morning: Consulate & Industry briefing by U.S. Department of Commerce at the hotel. Noon/Afternoon: Option I—Trade Mission. One-on-One business matchmaking appointments at the hotel. Lunch—private lunch. Option II—participate/exhibit in Medical Fair 2012 by Messe Dusseldorf. Evening: Networking reception at the hotel. Saturday, March 3 ...... Mumbai/New Delhi. Option I— Morning: One-on-One business matchmaking appointments at the hotel. Late afternoon: Check-out of the hotel & depart for Mumbai airport. Travel to New Delhi. Evening: Arrive New Delhi. Option II—participate/exhibit in Medical Fair 2012 by Messe Dusseldorf. Delegates in Option 2 depart for New Delhi on Sunday, March 4, 2011. Sunday, March 4 ...... New Delhi. Free day for the delegates in Option 1/Travel Day for the Delegates in Option II. Monday, March 5 ...... New Delhi. Morning: Breakfast briefing by the U.S. Commercial Service at hotel. Meetings with the Government of India Ministries. Lunch: Private lunch. Afternoon: One-on-one matchmaking meeting at the hotel Evening: Networking reception. Tuesday, March 6 ...... New Delhi/Hyderabad. Morning: One-on-one matchmaking meeting at the hotel. Lunch on own. Late afternoon: Check-out of the hotel & depart for New Delhi airport. Travel to Hyderabad. Evening: Arrive Hyderabad. Wednesday, March 7 ...... Hyderabad. Morning: One-on-One business matchmaking appointments at the hotel. Private lunch. Afternoon: One-on-One business matchmaking appointments at the hotel. Evening: Networking reception. Thursday, March 8 ...... Hyderabad. Hospital chain visit and meeting with senior management. Lunch on own. Evening: Check-out of the hotel. Depart for Hyderabad International airport for onward travel.

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Participation Requirements application and supplemental media, direct mail, broadcast fax, All parties interested in participating application materials, including notices by industry trade associations in the India Medical Trade Mission adequate information on the company’s and other multiplier groups, and must complete and submit an products and/or services (or in the case publicity at industry meetings, application for consideration by the of a trade association or trade symposia, conferences, and trade shows. Department of Commerce. All organization, information on the Recruitment for the mission will applicants will be evaluated on their products and/or services of the begin immediately and conclude no ability to meet certain conditions and companies to be represented on the later than December 22, 2011. The U.S. best satisfy the selection criteria as trade mission), primary market Department of Commerce will review outlined below. A minimum of 15 and objectives, and goals for participation. If applications and make selection a maximum of 20 companies will be the Department of Commerce receives decisions on a rolling basis. We will selected to participate in the mission an incomplete application, the inform all applicants of selection from the applicant pool. U.S. companies Department may reject the application, decisions as soon as possible after the already doing business in India as well request additional information, or take applications are reviewed. Applications as U.S. companies seeking to enter the the lack of information into account received after the December 22 deadline Indian market for the first may apply. when evaluating the applications. will be considered only if space and • Each applicant must also certify scheduling constraints permit. Fees and Expenses that the products and services it seeks Contacts After a company or organization has to export through the mission are either been selected to participate on the produced in the United States, or, if not, U.S. Commercial Service mission, a payment to the Department of marketed under the name of a U.S. firm Ms. September Secrist, Healthcare Commerce in the form of a participation and have at least fifty-one percent U.S. Team: International Trade Specialist, fee is required. content. In the case of a trade U.S. Commercial Service, U.S. Option 1: The participation fee for the association or trade organization, the Department of Commerce, 2001 6th three city (Mumbai, New Delhi and applicant must certify that, for each Avenue, Suite 2610, Seattle, WA Hyderabad) Trade Mission will be company to be represented by the trade 98121, Phone: (206) 553–5615x229, $4537.00 for a small or medium-sized association or trade organization, the Fax: (206) 553–7253. enterprise (SME),* or trade organization, products and services the represented and $5225.00 for large firms. The fee for company seeks to export are either U.S. Commercial Service in India each additional firm representative produced in the United States, or, if not, Ms. Ruma Chatterjee, U.S. Commercial (large firm or SME/trade organization) is marketed under the name of a U.S. firm Service Mumbai, Ph: 91–22–2265 $500. and have at least fifty-one percent U.S. 2511, Fax: 91–22–22652850, Option 2: Fee, for participants joining content. [email protected]. the Trade Mission in two-cities (Delhi and Hyderabad) will be $3,275.00 for Selection Criteria for Participation Mr. Sandeep Maini, U.S. Commercial SMEs or trade organizations, and Selection will be based on the Service New Delhi, Ph: 91–11– $3950.00 for large companies. The fee following criteria: 23472222, Fax: 91–11–2331 5172, for each additional firm representative • Suitability of a company’s (or, the [email protected]. (large firm or SME/trade organization) is case of a trade association or trade Elnora Moye, $500. Selecting option II * in Mumbai organization, representing companies’) Trade Program Assistant. products or services to the mission’s i.e. exhibiting in Medical Fair India * [FR Doc. 2011–28590 Filed 11–9–11; 8:45 am] will be approximately $3547.00 for 9 goals. • BILLING CODE 3510–FP–P sq.m. shell scheme space + $578.00 as Company’s (or, in the case of a trade registration fees (this will be billed in association or trade organization, Euros). represented companies’) potential for DEPARTMENT OF COMMERCE (* Fee for participating in the Medical business in India, including likelihood Fair 2012 is separate and will have to be of exports resulting from the trade National Oceanic and Atmospheric paid directly to the organizers Messe mission. Administration (NOAA) • Dusseldorf.) Consistency of the applicant’s goals Expenses for lodging, some meals, and objectives with the stated scope of National Climate Assessment and incidentals, and travel (except for the trade mission. Development Advisory Committee transportation to and from meetings) Referrals from political organizations (NCADAC) will be the responsibility of each and any documents containing AGENCY: mission participant. references to partisan political activities Office of Oceanic and (including political contributions) will Atmospheric Research (OAR), National Conditions for Participation be removed from an applicant’s Oceanic and Atmospheric • An applicant must submit a submission and not considered during Administration (NOAA), Department of completed and signed mission the selection process. Commerce (DOC). ACTION: Timeframe for Recruitment and Notice of time changes for * An SME is defined as a firm with 500 or fewer Applications public meeting and public comment employees or that otherwise qualifies as a small period. business under SBA regulations (see http:// Mission recruitment will be www.sba.gov/category/navigation-structure/ SUMMARY: contracting/contracting-officials/size-standards). conducted in an open and public The National Climate Parent companies, affiliates, and subsidiaries will manner, including publication in the Assessment and Development Advisory be considered when determining business size. The Federal Register (http:// Committee (NCADAC) was established dual pricing schedule reflects the Commercial www.gpoaccess.gov/fr), posting on ITA’s by the Secretary of Commerce under the Service’s user fee schedule that became effective trade mission calendar—www.trade.gov/ May 1, 2008 (for additional information see authority of the Global Change Research http://www.export.gov/newsletter/march2008/ trade-missions—and other Internet Web Act of 1990 to synthesize and initiatives.html). sites, press releases to general and trade summarize the science and information

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pertaining to current and future impacts Official, National Climate Assessment DEPARTMENT OF DEFENSE of climate. and Development Advisory Committee, Time and Date: The meeting will be NOAA OAR, R/SAB, 1315 East-West Office of the Secretary held November 16 from 8:30 a.m. to 3 Highway, Silver Spring, Maryland Notice of Intent To Grant an Exclusive p.m. and November 17, 2011, from 9 20910. (Phone: (301) 734–1156, Fax: License; Voltage Networking, LLC a.m. to 3 p.m. These times are subject (301) 713–1459, Email: to change. Please refer to the Web page [email protected]; or visit the AGENCY: National Security Agency, http://www.nesdis.noaa.gov/NCADAC/ NCADAC Web site at http:// index.html for changes and for the most Department of Defense (DoD). www.nesdis.noaa.gov/NCADAC/ up-to-date meeting agenda. index.html. ACTION: Notice. Federal Register Citation of Previous Announcement 76 65183 SUPPLEMENTARY INFORMATION: A ‘‘world SUMMARY: The National Security Agency cafe´’’ engagement exercise will be hereby gives notice of its intent to grant Date and Time of Previously demonstrated from 3:30—5:30 p.m. on Voltage Networking, LLC a revocable, Announced Meeting: November 16–17, November 16, 2011 at the same location non-assignable, exclusive, license to 2011, at the following times: November practice the following Government- 16, 2011, from 9 a.m. to 5 p.m.; as the meeting. The public is welcome to attend this event. Owned inventions as described in the November 17, 2011, from 9 a.m. to 3 following: Patent No. 6,835,581 entitled p.m. Public comment period November Dated: November 4, 2011. ‘‘Method of coating optical device facets 16, 2011 at 5 p.m. Mark E. Brown, with dielectric layer and device made Place: The meeting will be held at the therefrom’’; Patent No. 6,541,288 NOAA Earth System Research Chief Financial Officer/Chief Administrative Officer, Office of Oceanic and Atmospheric entitled ‘‘Method of determining Laboratory—David Skaggs Research Research, National Oceanic and Atmospheric semiconductor laser facet reflectivity Center (DSRC), 325 Broadway, Boulder, Administration. after facet reflectance modification’’; CO 80305–3337. Please check the Web [FR Doc. 2011–29091 Filed 11–9–11; 8:45 am] Patent No. 6,760,350 entitled ‘‘Method site http://www.nesdis.noaa.gov/ for measuring gain of photonic NCADAC/index.html for confirmation BILLING CODE 3510–KD–P inverters’’; Patent No. 7,010,187 entitled of the venue and for directions. Status: Seating will be available on a ‘‘Mode transition-discrimination first come, first serve basis. Members of photonic logic device’’; Patent No. the public must RSVP in order to attend CONSUMER PRODUCT SAFETY 7,599,594 entitled ‘‘Method of all or a portion of the meeting by COMMISSION fabricating waveguide using sacrificial contacting the NCADAC DFO spacer layer’’; Patent No. 7,442,577 ([email protected]) by Sunshine Act Meeting entitled ‘‘Method of fabricating a November 1, 2011. The meeting will be patterned device using sacrificial spacer open to public participation with a 30 TIME AND DATE: Wednesday, November layer’’; Patent No. 7,678,593 entitled minute public comment period on 16, 2011; 10 a.m.–11 a.m. ‘‘Method of fabricating optical device November 16 at 3:30 p.m. (check Web using multiple sacrificial spacer layers’’; PLACE: Hearing Room 420, Bethesda site to confirm time). The NCADAC Patent No. 7,611,914 entitled ‘‘Method Towers, 4330 East West Highway, expects that public statements presented of fabricating turning mirror using at its meetings will not be repetitive of Bethesda, Maryland. sacrificial spacer layer and device made previously submitted verbal or written STATUS: Closed to the Public. therefrom’’; Patent No. 7,833,828 statements. In general, each individual entitled ‘‘Method of fabricating a or group making a verbal presentation Matter To Be Considered patterned device using sacrificial spacer layer’’; Patent No. 7,595,221 entitled will be limited to a total time of five (5) Compliance Status Report minutes. Individuals or groups planning ‘‘Method of fabricating a patterned to make a verbal presentation should The Commission staff will brief the device using sacrificial spacer layer’’; contact the NCADAC DFO Commission on the status of compliance Patent No. 7,531,382 entitled ‘‘Method ([email protected]) by matters. of fabricating a patterned device using sacrificial spacer layer’’; Patent No. November 10, 2011 to schedule their For a recorded message containing the presentation. Written comments should 7,700,387 entitled ‘‘Method of latest agenda information, call (301) be received in the NCADAC DFO’s fabricating optical device using multiple 504–7948. Office by November 10, 2011 to provide sacrificial spacer layers’’; Patent No. sufficient time for NCADAC review. CONTACT PERSON FOR MORE INFORMATION: 7,700,391 entitled ‘‘Method of Written comments received by the Todd A. Stevenson, Office of the fabricating optical device using multiple NCADAC DFO after November 10, 2011 Secretary, U.S. Consumer Product sacrificial spacer layers’’; Patent No. will be distributed to the NCADAC, but Safety Commission, 4330 East West 7,741,136 entitled ‘‘Method of may not be reviewed prior to the Highway, Bethesda, MD 20814, (301) fabricating turning mirror using meeting date. 504–7923. sacrificial spacer layer and device made Special Accommodations: These therefrom’’; Patent No. 7,838,867 meetings are physically accessible to Dated: November 8, 2011. entitled ‘‘Method of fabricating turning people with disabilities. Requests for Todd A Stevenson, mirror using sacrificial spacer layer and sign language interpretation or other Secretary. device made therefrom’’; and Patent No. auxiliary aids should be directed to Dr. [FR Doc. 2011–29325 Filed 11–8–11; 4:15 pm] 7,838,866 entitled ‘‘Method of fabricating turning mirror using Cynthia Decker (301) 563–6162, BILLING CODE 6355–01–P ([email protected]) by sacrificial spacer layer and device made November 1, 2011. therefrom.’’ FOR FURTHER INFORMATION CONTACT: Dr. The above-mentioned inventions are Cynthia Decker, Designated Federal assigned to the United States

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Government as represented by the parties are encouraged to provide of the public record on the DEIS and National Security Agency. comments in person at any of the public will be addressed in the Final EIS. DATES: Anyone wishing to object to the comment meetings, or in writing Comments may also be submitted by grant of this license has fifteen (15) days anytime during the public comment U.S. mail or electronically, as described from the date of publication of this period. This Notice announces the dates below. notice to file written objections along and locations of the public meetings and The DEIS is available at the project with any supporting evidence, if any. provides supplementary information Web site, www.mcbh.usmc.mil/ ADDRESSES: Written objections are to be about the environmental planning effort. mv22h1eis [please note: 1, before ‘‘eis’’ filed with the National Security Agency Per 36 CFR part 800.8, the DoN is in the Web site address, is numeric], Technology Transfer Program, 9800 integrating the NEPA and National and at the libraries identified at the end Savage Road, Suite 6541, Fort George G. Historic Preservation Act (NHPA) public of this notice. Meade, MD 20755–6541. involvement processes. In addition to ADDRESSES: Comments on the DEIS can FOR FURTHER INFORMATION CONTACT: meeting NEPA public involvement be submitted via the project Web site or Marian T. Roche, Director, Technology requirements, the public meetings will submitted in writing to: Department of Transfer Program, 9800 Savage Road, provide opportunities for NHPA Section the Navy, Naval Facilities Engineering Suite 6541, Fort George G. Meade, MD 106 input regarding the identification Command, Pacific Division, Attn: EV21, 20755–6541, telephone (443) 479–9569. and treatment of historic properties. MV–22/H–1 EIS Project Manager, 258 Dated: November 4, 2011. DATES: The DEIS will be distributed to Makalapa Drive, Suite 100, Pearl Harbor, HI 96860–3134. Mailed Aaron Siegel, Federal, State, and local agencies, elected officials, and other interested comments must be postmarked no later Alternate OSD Federal Register Liaison than December 27, 2011, and electronic Officer, Department of Defense. parties on November 10, 2011, initiating the public comment period, which will comments must be submitted by [FR Doc. 2011–29064 Filed 11–9–11; 8:45 am] end on December 27, 2011. Each of the midnight, December 27, 2011, to be BILLING CODE 5001–06–P five public meetings will have specific considered in this environmental review times set aside for NHPA Section 106 process. DEPARTMENT OF DEFENSE public involvement and an FOR FURTHER INFORMATION CONTACT: informational open house. USMC and Naval Facilities Engineering Command, Department of the Navy DoN representatives will be available to Pacific Division, Attn: EV21, MV–22/H– clarify information related to the DEIS. 1 EIS Project Manager, 258 Makalapa Notice of Public Meetings for the Draft The public comment meetings will be Drive, Suite 100, Pearl Harbor, HI Environmental Impact Statement for held on the dates and at the times and 96860–3134. Basing of MV–22 and H–1 Aircraft in locations indicated below: SUPPLEMENTARY INFORMATION: A Notice Support of III Marine Expeditionary 1. Wednesday, November 30, 2011, of Intent for the EIS was published in Force Elements in Hawaii Waimea Elementary School Cafeteria, the Federal Register on August 6, 2010 AGENCY: Department of the Navy, DoD. 67–1225 Mamalahoa Hwy, Kamuela, HI, (Vol. 75, No. 151, pp. 47562–47564). 5:30–6:30 p.m.: NHPA Section 106 ACTION: Notice. input, 6:30–8:30 p.m.: Open house. Proposed Action SUMMARY: Pursuant to Section 2. Thursday, December 1, 2011, Hilo The Proposed Action includes: (1) (102)(2)(c) of the National Intermediate School Cafeteria, 587 Basing and operating up to two Marine Environmental Policy Act (NEPA) of Waianuenue Avenue, Hilo, HI, 4:30– Medium Tiltrotor Squadrons (VMM) 1969, and regulations implemented by 5:30 p.m.: NHPA Section 106 input, and one Marine Light Attack Helicopter the Council on Environmental Quality 5:30–7:30 p.m.: Open house. Squadron (HMLA) to service USMC (40 Code of Federal Regulations [CFR] 3. Tuesday, December 6, 2011, operations in Hawaii, and (2) Parts 1500–1508), Department of Navy Mililani Middle School Cafeteria, 95– conducting aviation training, readiness, (DoN) NEPA regulations (32 CFR part 1140 Lehiwa Drive, Mililani, HI, 5:30– and special exercise operations to attain 775), and U.S. Marine Corps (USMC) 6:30 p.m.: NHPA Section 106 input, and maintain proficiency in the NEPA directives (Marine Corps Order 6:30–8:30 p.m.: Open house. employment of the MV–22 and H–1 P5090.2A, change 2), DoN has prepared 4. Wednesday, December 7, 2011, (AH–1 and UH–1) aircraft at training and filed with the U.S. Environmental Waimanalo Elementary & Intermediate facilities statewide. Demolition, new Protection Agency a Draft School Cafeteria, 41–1330 Kalanianaole construction, and renovation are Environmental Impact Statement (DEIS) Highway, Waimanalo, HI, 5:30–6:30 proposed to develop basing facilities for that evaluates the potential p.m.: NHPA Section 106 input, 6:30– the VMM and HMLA squadrons. environmental consequences that may 8:30 p.m.: Open house. Specific activities would include: result from the basing of Osprey tiltrotor 5. Thursday, December 8, 2011, Castle Construction, demolition and (MV–22) and Cobra and Huey attack and High School Cafeteria, 45–386 Kaneohe renovation of hangars and other utility (H–1) aircraft in support of III Bay Drive, Kaneohe, HI, 5:30–6:30 p.m.: structures; taxiway and parking apron Marine Expeditionary Force (MEF) NHPA Section 106 input, 6:30–9 p.m.: improvements; construction of elements in Hawaii. The Department of Open house. additional bachelor enlisted quarters the Army (DoA) is a cooperating agency Attendees will be able to submit (BEQs); construction of Marine Aviation for this DEIS because the proposed written comments at the public Group 24 headquarters and parking squadrons would train on land currently meetings. DEIS team members will be structure; and expansion of Marine owned or controlled by the DoA. present to receive oral comments; Aviation Logistics Squadron 24 aircraft With the filing of the DEIS, the DoN however, to ensure the accuracy of the maintenance facilities. Existing facilities is initiating a 45-day public comment record, all statements should be would be used to the extent possible. period and has scheduled five public submitted in writing. Equal weight will comment meetings to receive oral and be given to oral and written statements. Purpose and Need written comments on the DEIS. Federal, All statements submitted during the The purpose of the Proposed Action state and local agencies and interested public review period will become part is to ensure that the Marine Air Ground

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Task Force (MAGTF) is capable of Molokai; and the Hawaii Army National With Alternative A or B, there is a supporting the needs of the III MEF Guard Facility on the island of Maui. potential for traffic impacts at MCB operational commander to carry out With the No Action Alternative, the Hawaii Kaneohe Bay. These would be legally mandated responsibilities in VMM and HMLA squadrons would not mitigated with improvements at three Hawaii. The need for the Proposed be based in Hawaii, and no facilities intersections and improvement of Action is to correct existing rotary-wing would be constructed at MCB Hawaii procedures at the entry gates for deficiencies of the MAGTF in Hawaii Kaneohe Bay or at the training areas to increased efficiency and capacity. and the need for ‘‘work-arounds’’ accommodate them. The No Action Impacts on the endangered Hawaiian through gap deployments from Alternative does not meet the purpose hoary bat (Lasiurus cinereus semotus) elsewhere (e.g., from the continental and need for the proposed action, but is are possible at the DoA training areas on U.S.). The purpose and need described included to provide a baseline against Oahu and at PTA on the island of here support the goals stated in the which the action alternatives may be Hawaii. DoN has submitted a biological FY2011 Aviation Plan: (1) Sustain compared. evaluation to the U.S. Fish & Wildlife wartime operational tempo while Potential impacts are evaluated in the Service with a determination of ‘‘may improving current readiness and DEIS under all alternatives for the affect but not likely to adversely affect,’’ effectiveness through efficient use of following resources/issues: Land use; in compliance with Section 7 of the existing resources; (2) execute planned airspace; air quality; noise; geology, Endangered Species Act. In addition, transition strategies from legacy soils, and topography; drainage, DoN has made ‘‘no effect’’ equipment to advanced capabilities of hydrology, and water quality; biological determinations for two endangered the next generation of equipment; and resources; cultural resources; safety and species at PTA, creeping mint (3) improve war-fighting integration environmental health; socioeconomics; (Stenogyne angustifolia) and nene or between the air, ground, and logistic infrastructure; and energy use. Hawaiian goose (Branta sandvicensis). elements of the MAGTF. The DEIS describes an array of Another possible impact during operations is erosion due to MV–22 Alternatives Considered in the DEIS conservation and construction measures and features of project design and rotor downwash at unpaved LZs where The DEIS evaluates the following planning that would avoid or minimize soils have high erosion potential facility alternatives at Marine Corps most potential impacts. The proposed (Schofield Barracks East Range and Base (MCB) Hawaii Kaneohe Bay: action would fully comply with parts of Kawailoa Training Area). Alternative A (preferred): regulatory requirements for the Conditions would be monitored at these Accommodate all aviation facilities on protection of environmental resources. landing zones. Should field the southeast side of the runway. Implementing Alternative A or B observations verify the occurrence of Alternative B: Accommodate MV–22 would have construction impacts on soil erosion, the USMC would work facilities on the northwest side of the cultural resources at MCB Hawaii with the range manager to implement runway at West Field, and Kaneohe Bay and at MCTAB, as well as appropriate repairs or other accommodate all other aviation facilities potential impacts from MV–22 rotor management actions. on the southeast side of the runway; downwash on archaeological sites in Schedule: The Notice of Availability construct a runway underpass for access some of the training areas. Impacts on publication in the Federal Register and to West Field. historic buildings and archaeological local print media starts the 45-day No Action Alternative: The following resources at MCB Hawaii Kaneohe Bay public comment period for the DEIS. elements would be the same under both would vary between the two alternatives The USMC will consider and respond to action alternatives: Number and type of due to the placement of some facilities all written and electronic comments, personnel added to MCB Hawaii on different sides of the runway, as well including email, submitted as described Kaneohe Bay, types of basing facilities as different options presented for BEQ above in preparing the Final EIS. DoN that are required, improvements at demolition and construction. Impacts intends to issue the Final EIS in 2012, training areas, and type and tempo of on archaeological resources at MCTAB at which time a Notice of Availability training operations. Both action would depend on the depth of ground- will be published in the Federal alternatives would involve demolition, disturbing activities during Register and local media. A Record of new construction, replacement, and construction. Impacts on archaeological Decision is expected in 2012. renovation of facilities at MCB Hawaii features at certain landing zones (LZs) Copies of the DEIS are available for Kaneohe Bay, and include in the Kahuku and Kawailoa Training public review at the following libraries improvements to existing facilities at Areas on the island of Oahu and at PTA within the State of Hawaii: 1. Island of Hawaii Libraries: Marine Corps Training Area Bellows on the island of Hawaii cannot currently Hilo: 300 Waianuenue Ave, Hilo, HI (MCTAB) on the island of Oahu, be assessed because archaeological 96720. Pohakuloa Training Area (PTA) on the surveys of those areas have not been Hilo: UH Hilo, 200 W. Kawili St, Hilo, island of Hawaii, and Molokai Training completed. The extent of impacts due to HI 96720. Support Facility (MTSF) on the island MV–22 rotor downwash would depend Kailua-Kona: 75–138 Hualalai Rd, of Molokai. on the location and depth of such Kailua-Kona, HI 96740. Under either Alternative A or B, the features. Surveys of these areas will be North Kohala: 54–3645 Akoni Pule VMM and HMLA squadrons would completed and any impacts evaluated Hwy, Kapaau, HI 96755. conduct training operations at: MCTAB; prior to use of the LZs by the MV–22 Thelma Parker: 67–1209 Mamalahoa the DoA’s Kahuku, Kawailoa, and squadrons (VMM). Any required Hwy, Kamuela, HI 96743. Schofield Barracks East Range Training avoidance or mitigation measures for 2. Island of Maui Libraries: Areas and Dillingham Military cultural resources impacts resulting Kahului: 90 School St, Kahului, HI Reservation on the island of Oahu; PTA from implementation of the proposed 96732. and Upolu Airport on the island of action would be documented in the Kahului: UH Maui College, 310 W. Hawaii; Pacific Missile Range Facility Programmatic Agreement being Kaahumanu Ave, Kahului, HI 96732. on the island of Kauai; MTSF and prepared as part of the NHPA Section Kihei: 35 Waimahaihai St, Kihei, HI Kalaupapa Airport on the island of 106 process. 96753.

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Wailuku: 251 High St, Wailuku, HI DC 20503, be faxed to (202) 395–5806 or institutional data (OMB# 1850–0666 96793. emailed to [email protected]. v.9). NPSAS:12 will also serve as the 3. Island of Kauai Libraries: gov with a cc: to [email protected]. base year study for the Beginning Lihue: 4344 Hardy St, Lihue, HI Please note that written comments Postsecondary Students Longitudinal 96766. received in response to this notice will Study (BPS) of first-time postsecondary Lihue: Kauai Community College, 3– be considered public records. students that will focus on issues of 1901 Kaumualii Hwy, Lihue, HI 96766. SUPPLEMENTARY INFORMATION: Section persistence, degree attainment, and Waimea: P.O. Box 397, Waimea, HI 3506 of the Paperwork Reduction Act of employment outcome. BPS will conduct 96796. 1995 (44 U.S.C. Chapter 35) requires follow-up studies in 2014 and 2017, 4. Island of Molokai Library: that the Office of Management and with revised strata for institution Kaunakakai: P.O. Box 395, Budget (OMB) provide interested sampling to reflect the recent growth in Kaunakakai, HI 96748. Federal agencies and the public an early enrollment in for-profit four-year 5. Island of Oahu Libraries: opportunity to comment on information institutions. Institution contacting for Honolulu: Hawaii State Library, 478 collection requests. The OMB is the full scale collection will begin in S. King St, Honolulu, HI 96813. particularly interested in comments September 2011, list collection will be Honolulu: UH Manoa—Hamilton which: (1) Evaluate whether the conducted January through June 2012, Library, 2550 McCarthy Mall, Honolulu, proposed collection of information is and student data collection will take HI 96822. necessary for the proper performance of place January through September 2012. Kahuku: 56–490 Kamehameha Hwy, the functions of the agency, including This submission requests approval for Kahuku, HI 96731. whether the information will have collecting student records, conducting Kailua: 239 Kuulei Rd, Kailua, HI practical utility; (2) Evaluate the student interviews, and post-data 96734. accuracy of the agency’s estimate of the collection administrative record Kaneohe: 45–829 Kamehameha Hwy, burden of the proposed collection of matching for the full-scale NPSAS:12. Kaneohe, HI 96744. information, including the validity of Copies of the information collection Kaneohe Windward Community the methodology and assumptions used; submission for OMB review may be College, 45–720 Keaahala Rd, Kaneohe, (3) Enhance the quality, utility, and accessed from the RegInfo.gov Web site HI 96744. clarity of the information to be at http://www.reginfo.gov/public/do/ Mililani: 95–450 Makaimoimo St, collected; and (4) Minimize the burden PRAMain or from the Department’s Web Mililani, HI 96789. of the collection of information on those site at http://edicsweb.ed.gov, by Wahiawa: 820 California Ave, who are to respond, including through selecting the ‘‘Browse Pending Wahiawa, HI 96786. the use of appropriate automated, Collections’’ link and by clicking on Waialua: P.O. Box 684, Waialua, HI electronic, mechanical, or other link number 4744. When you access the 96791. technological collection techniques or information collection, click on Waimanalo: 41–1320 Kalanianaole other forms of information technology. ‘‘Download Attachments’’ to view. Hwy, Waimanalo, HI 96795. Written requests for information should Dated: November 7, 2011. be addressed to U.S. Department of Dated: November 3, 2011. Darrin King, L. M. Senay, Education, 400 Maryland Avenue SW., Director, Information Collection Clearance LBJ, Washington, DC 20202–4537. Lieutenant, Office of the Judge Advocate Division, Privacy, Information and Records Requests may also be electronically General, U.S. Navy, Alternate Federal Register Management Services, Office of Management. Liaison Officer. mailed to the Internet address [email protected] or faxed to (202) [FR Doc. 2011–29119 Filed 11–9–11; 8:45 am] Institute of Education Sciences 401–0920. Please specify the complete BILLING CODE 3810–FF–P Type of Review: Revision. title of the information collection and Title of Collection: 2011–12 National OMB Control Number when making Postsecondary Student Aid Study your request. (NPSAS:12) Full Scale Student Data DEPARTMENT OF EDUCATION Individuals who use a Collection. telecommunications device for the deaf Notice of Submission for OMB Review OMB Control Number: 1850–0666. (TDD) may call the Federal Information Agency Form Number(s): N/A. AGENCY: Relay Service (FIRS) at 1–(800) 877– Department of Education. Frequency of Responses: Annually. 8339. ACTION: Comment Request. Affected Public: Individuals or Households; Not-for-Profit Institutions. [FR Doc. 2011–29145 Filed 11–9–11; 8:45 am] SUMMARY: The Director, Information Total Estimated Number of Annual BILLING CODE 4000–01–P Collection Clearance Division, Privacy, Responses: 89,631. Information and Records Management Total Estimated Annual Burden Services, Office of Management, invites Hours: 72,637. DEPARTMENT OF ENERGY comments on the submission for OMB Abstract: National Postsecondary review as required by the Paperwork Student Aid Study (NPSAS), a Environmental Management Site- Reduction Act of 1995 (Pub. L. 104–13). nationally representative study of how Specific Advisory Board, Northern New DATES: Interested persons are invited to students and their families finance Mexico submit comments on or before education beyond high school, was first AGENCY: Department of Energy. December 12, 2011. implemented by the National Center for ACTION: Notice of Open Meeting. ADDRESSES: Written comments should Education Statistics (NCES) in 1987 and be addressed to the Office of has been fielded every three to four SUMMARY: This notice announces a Information and Regulatory Affairs, years since. This submission is for meeting of the Environmental Attention: Education Desk Officer, collection of student data in the eighth Management Site-Specific Advisory Office of Management and Budget, 725 cycle in the series, NPSAS:12, and Board (EM SSAB), Northern New 17th Street NW., Room 10222, New supplements the recently obtained Mexico. The Federal Advisory Executive Office Building, Washington, approval for NPSAS:12 collection of Committee Act (Pub. L. 92–463, 86 Stat.

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770) requires that public notice of this needs. If you require special to make recommendations to DOE–EM meeting be announced in the Federal accommodations due to a disability, and site management in the areas of Register. please contact Menice Santistevan at environmental restoration, waste DATES: Wednesday, November 30, 2011, least seven days in advance of the management and related activities. meeting at the telephone number listed 1 p.m.–7 p.m. Tentative Agenda above. Written statements may be filed ADDRESSES: Ohkay Owingeh Conference with the Board either before or after the • Center, North Taos Highway 68, San Call to Order, Introductions, Review meeting. Individuals who wish to make of Agenda. Juan Pueblo, New Mexico 87566. oral statements pertaining to agenda • Approval of November Minutes. FOR FURTHER INFORMATION CONTACT: items should contact Menice • Menice Santistevan, Northern New Santistevan at the address or telephone Deputy Designated Federal Officer’s Mexico Citizens’ Advisory Board number listed above. Requests must be Comments. (NNMCAB), 1660 Old Pecos Trail, Suite received five days prior to the meeting • Federal Coordinator’s Comments. B, Santa Fe, NM 87505. Phone (505) and reasonable provision will be made • Liaisons’ Comments. 995–0393; Fax (505) 989–1752 or Email: to include the presentation in the • Presentation. [email protected]. agenda. The Deputy Designated Federal SUPPLEMENTARY INFORMATION: Officer is empowered to conduct the • FLUOR B&W Community Purpose of the Board: The purpose of meeting in a fashion that will facilitate Commitment Plan Update, Jerry the Board is to make recommendations the orderly conduct of business. Schneider. to DOE–EM and site management in the Individuals wishing to make public • Administrative Issues: areas of environmental restoration, comments will be provided a maximum Æ Subcommittee Updates. waste management, and related of five minutes to present their • activities. comments. Public Comments. Minutes: Minutes will be available by • Final Comments from the Board. Tentative Agenda writing or calling Menice Santistevan at • Adjourn. 1 p.m. Call to Order by Co-Deputy the address or phone number listed Public Participation: The meeting is Designated Federal Officers above. Minutes and other Board open to the public. The EM SSAB, (DDFO), Ed Worth and Lee Bishop. documents are on the Internet at: Portsmouth, welcomes the attendance of Establishment of a Quorum: Roll Call http://www.nnmcab.org/. and Excused Absences. the public at its advisory committee Issued at Washington, DC, on November 4, meetings and will make every effort to Welcome and Introductions, Ralph 2011. Phelps. accommodate persons with physical LaTanya R. Butler, Welcome to Ohkay Owingeh Pueblo, disabilities or special needs. If you Governor Ron Lovato (invited). Acting Deputy Committee Management require special accommodations due to Officer. Approval of Agenda and September a disability, please contact Joel 28, 2011, Meeting Minutes. [FR Doc. 2011–29143 Filed 11–9–11; 8:45 am] Bradburne at least seven days in 1:30 p.m. Public Comment Period. BILLING CODE 6405–01–P advance of the meeting at the phone 1:45 p.m. Old Business: number listed above. Written statements • Written Reports. may be filed with the Board either DEPARTMENT OF ENERGY • Other Items. before or after the meeting. Individuals who wish to make oral statements 2 p.m. New Business: Environmental Management Site- • pertaining to agenda items should Consideration and Action on 2011 Specific Advisory Board, Portsmouth Self Evaluation, Carlos Valdez. contact Joel Bradburne at the address or • Other items. AGENCY: Department of Energy (DOE). telephone number listed above. 2:30 p.m. Items from DDFOs, Ed ACTION: Notice of Open Meeting. Requests must be received five days Worth and Lee Bishop. prior to the meeting and reasonable 3 p.m. Break. SUMMARY: This notice announces a provision will be made to include the 3:15 p.m. ‘‘Possible Impacts of WIPP meeting of the Environmental presentation in the agenda. The Deputy Expansion Proposals on LANL Management Site-Specific Advisory Designated Federal Officer is Cleanup and the Consent Order,’’ Board (EM SSAB), Portsmouth. The empowered to conduct the meeting in a Scott Kovak, Nuclear Watch NM. Federal Advisory Committee Act (Pub. fashion that will facilitate the orderly 4 p.m. Presentation on Waste Disposal, L. 92–463, 86 Stat. 770) requires that conduct of business. Individuals Robert Neill. public notice of this meeting be wishing to make public comments will 5 p.m. Dinner Break. announced in the Federal Register. be provided a maximum of five minutes 6 p.m. Public Comment Period. DATES: Thursday, December 1, 2011, to present their comments. 6:15 p.m. Consideration and Action on 6 p.m. Minutes: Minutes will be available by Draft Recommendations to the DOE, ADDRESSES: Ohio State University, writing or calling Joel Bradburne at the Ralph Phelps. Endeavor Center, 1862 Shyville Road, address and phone number listed above. 6:45 p.m. Wrap up and Comments Piketon, Ohio 45661. Minutes will also be available at the from Board Members. FOR FURTHER INFORMATION CONTACT: Joel following Web site: http://www.ports- 7 p.m. Adjourn, Lee Bishop and Ed Bradburne, Deputy Designated Federal ssab.energy.gov/. Worth. Officer, Department of Energy Issued at Washington, DC, on November 7, Public Participation: The EM SSAB, Portsmouth/Paducah Project Office, Post 2011. Northern New Mexico, welcomes the Office Box 700, Piketon, Ohio 45661, LaTanya R. Butler, attendance of the public at its advisory (740) 897–3822, Joel.Bradburne@lex. Acting Deputy Committee Management committee meetings and will make doe.gov. Officer. every effort to accommodate persons SUPPLEMENTARY INFORMATION: Purpose of [FR Doc. 2011–29148 Filed 11–9–11; 8:45 am] with physical disabilities or special the Board: The purpose of the Board is BILLING CODE 6450–01–P

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DEPARTMENT OF ENERGY final determination concerning transmission organizations (RTOs) and disclosure or nondisclosure of independent system operators (ISOs), Plan for Conduct of 2012 Electric information submitted to DOE and for and regional planning groups. Unlike Transmission Congestion Study treating it in accordance with the DOE’s the 2006 Congestion Study, the AGENCY: Office of Electricity Delivery Freedom of Information regulations (10 Department did not conduct or support and Energy Reliability, Department of CFR 1004.11). All comments received studies of projected congestion for the Energy (DOE). by DOE regarding the 2012 Congestion 2009 Congestion Study. The Department Study will be posted on http:// did, however, direct the first study of ACTION: Notice of regional workshops energy.gov/oe/congestion-study-2012 for and request for written comments. publicly available historic congestion public review. data in the Eastern Interconnection. As SUMMARY: Section 216(a)(1) of the Note: Delivery of the U.S. Postal Service part of the data gathering, the Federal Power Act (FPA) requires the mail to DOE continues to be delayed by Department held six public Regional Department of Energy (Department or several weeks due to security screening. DOE Workshops and one public Technical DOE) to complete a study of electric therefore encourages those wishing to Conference. DOE issued the 2009 transmission congestion every three comment to submit their comments Congestion Study in 2010 and requested years. DOE issued its first ‘‘National electronically by email. If comments are comments within 60 days. Electric Transmission Congestion submitted by regular mail, the Department requests that they be accompanied by a CD The 2009 Congestion Study reviewed Study’’ (Congestion Study) in August or diskette containing electronic files of the congestion areas from the 2006 2006 and the second early in 2010. The submission. Congestion Study. The two ‘‘Critical Department is now initiating Congestion Areas’’ (i.e., areas where the preparations for the 2012 Congestion FOR FURTHER INFORMATION CONTACT: current and/or projected effects of Study, and seeks comments on what David Meyer, DOE Office of Electricity congestion are especially broad and publicly-available data and information Delivery and Energy Reliability, (202) severe) identified in 2006 were still should be considered, and what types of 586–1411, [email protected]. determined to be areas of critical analysis should be performed to identify SUPPLEMENTARY INFORMATION: and understand the significance and congestion: The Atlantic coastal area I. Background character of transmission congestion. from metropolitan New York through DOE will host four regional pre-study The Energy Policy Act of 2005 (Pub. northern Virginia (the Mid-Atlantic workshops in early December 2011 to L. 109–58) (EPAct) added several new Critical Congestion Area), and southern receive input and suggestions provisions to the Federal Power Act California (the Southern California concerning the study. DOE expects to (16 U.S.C. 824p) (FPA), including FPA Critical Congestion Area). Two of the release a draft of the study in 2012 for section 216. FPA section 216(a) requires ‘‘Congestion Areas of Concern’’ (i.e., a 60-day comment period. After the Secretary of Energy to conduct a areas where a large-scale congestion reviewing and considering the study of electric transmission problem exists or may be emerging but comments received, DOE will publish a congestion within one year from the more information and analysis appear to final version of the study. Interested date of enactment of EPAct and every be needed to determine the magnitude persons may submit comments in three years thereafter. The 2006 and of the problem) identified in 2006 also response to this notice in the manner 2009 Congestion Studies reviewed remain areas of concern: The San indicated in the ADDRESSES section. congestion nationwide except for the Francisco Peninsula and the Seattle- DATES: See SUPPLEMENTARY INFORMATION portion of Texas covered by the Portland area. Two Congested Areas of section III. Pre-Study Workshops for Electricity Reliability Council of Texas, Concern areas, New England and the workshop dates and locations. DOE to which FPA section 216 does not Phoenix-Tucson areas, were found to recognizes that some commenters may apply. The 2012 Congestion Study will have alleviated or made significant wish to draw upon or direct us to be of a similar scope. FPA section 216(a) progress on alleviating congestion; studies or analyses that are now in requires the congestion study be therefore, the 2009 Congestion Study process. DOE requests that commenters conducted in consultation with affected did not identify these areas as submit such materials as they become States. Also, in exercising its Congestion Areas of Concern. The 2009 available, but no later than January 31, responsibilities under Section 216, DOE Congestion Study identified Conditional 2012. is required to consult regularly with the Constraint Areas focused on areas of Federal Energy Regulatory Commission potential renewable generation to satisfy ADDRESSES: You may submit written (FERC), any appropriate regional entity comments to http://energy.gov/oe/ requirements of the American referred to in FPA section 215, i.e., the congestion-study-2012, or by mail to the Reinvestment and Recovery Act. regional electric reliability Office of Electricity Delivery and Energy Conditional Constraint Areas were organizations,1 and Regional Reliability, OE–20, U.S. Department of identified in a large area of the Western Transmission Organizations approved Energy, 1000 Independence Avenue and Eastern Interconnections that could by FERC. SW., Washington, DC 20585. The support wind (Midwest), solar In preparing the 2009 Congestion following electronic file formats are (Southwest) and geothermal (Nevada- Study, the Department gathered acceptable: Microsoft Word (.doc), Corel Oregon-Idaho-Utah) generation, and historical congestion data obtained from Word Perfect (.wpd), Adobe Acrobat areas pertaining to off-shore wind on existing studies prepared by regional (.pdf), Rich Text Format (.rtf), plain text both the east and west coasts, the Gulf reliability councils, regional (.txt), Microsoft Excel (.xls), and of Mexico and on the Great Lakes. Microsoft PowerPoint (.ppt). The 1 The regional reliability organizations under FPA II. Plan for the 2012 Congestion Study Department intends to use only data section 215 are the Florida Reliability Coordinating that is publicly available for this study. Council, the Midwest Reliability Organization, the The 2012 study will draw upon many Accordingly, please do not submit Northeast Power Coordinating Council, Reliability of the same kinds of data, analyses and First Corporation, SERC Reliability Corporation, the information as the earlier studies, with information that you believe is or Southwest Power Pool, the Texas Regional Entity should be protected from public (TRE), and the Western Electricity Coordinating some additions. These sources may disclosure. DOE is responsible for the Council. include, but are not limited to:

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Æ Electricity market analyses, Marina, 1380 Harbor Island Drive, San related transmission constraints. Special including locational marginal price Diego, CA 92101. attention should be given to the (LMP) patterns. Additional details about the question of how to gauge the magnitude Æ Reliability analyses and actions, workshops are available at http:// or significance of congestion using including transmission loading relief energy.gov/oe/congestion-study-2012. publicly available data, including FERC (TLR) actions. Public Participation: The workshops 890 filings. In addition, DOE is Æ Historic energy flows. will be open to the public, and will be particularly interested in comments that Æ Current and projected electric simulcast over the Internet. Advance speak to the most appropriate and supply and generation plans. registration for the Webcasts is required effective methods for distinguishing Æ Recent, current and planned by visiting http://www.iian.ibeam.com/ between the effects of technical limits transmission and interconnection events/ener001/26552/. A complete on line loadings and possible queues. archive of each event will be on this contractual limits on the use of those Æ Current and forecast electricity Web site soon after the conclusion of the same lines. loads, including energy efficiency, event, and will be downloadable in distributed generation (DG) and demand Issued in Washington, DC, on November 4, podcast format. 2011. response (DR) plans and policies. Members of the public interested in Æ The location of renewable resources offering oral comments at a pre-study Patricia A. Hoffman, and state and regional policies with workshop may do so on the day of the Assistant Secretary, Office of Electricity respect to renewable development. workshop, subject to the time available. Delivery and Energy Reliability. Æ Projected impacts of current or Approximately one-half hour will be [FR Doc. 2011–29189 Filed 11–9–11; 8:45 am] pending environmental regulation on reserved for public comments. Time BILLING CODE 6450–01–P generation availability. allotted per speaker will depend on the Æ Effects of recent or projected number who wish to speak but is not DEPARTMENT OF ENERGY economic conditions on demand and expected to exceed three minutes. congestion. Anyone who is not able to attend the Æ Energy Information Administration Analytic results from the eastern workshop or has had insufficient time to and western interconnection-level present material is invited to submit a Agency Information Collection planning studies undertaken with DOE written statement in the manner Activities: Proposed Collection; support. indicated in the ADDRESSES section of Æ Comment Request Filings under FERC Order 890. this notice. DOE intends to release a draft version of AGENCY: U.S. Energy Information Note: The Department will consult with Administration (EIA), Department of the 2012 Congestion Study in 2012 for the States and regional reliability a 60-day comment period. After organizations in the preparation of the 2012 Energy (DOE). reviewing and considering the Congestion Study. DOE recognizes that in ACTION: Agency Information Collection comments received, DOE will issue a addition to (or as an alternative to) Activities: Proposed Collection; final version of the study. participating in the regional pre-study Comment Request. workshops, some States or other III. Pre-Study Workshops organizations may wish to discuss congestion SUMMARY: The EIA is soliciting In December 2011, DOE will host four matters with the Department on a bilateral comments on the proposed 3-year regional half-day pre-study workshops basis. DOE will reserve time at the sites of extension of EIA Form EIA–914 Monthly to receive and discuss input relevant to the regional workshops for such bilateral Natural Gas Production Report. discussions, and it invites interested States or the 2012 Congestion Study, including other organizations to contact the Department DATES: Comments must be filed by comments on what publicly-available to identify mutually convenient times. In January 9, 2012. If you anticipate data should be considered to identify addition, the Department will maintain an difficulty in submitting comments and understand the significance and ‘‘open door’’ policy, and will schedule within that period, contact the person character of transmission congestion. congestion meetings at DOE headquarters listed below as soon as possible. Each workshop will consist of panels of upon request with States, reliability ADDRESSES: Send comments to Mr. organizations, Regional Transmission invited speakers who will present their Jeffrey Little. The mailing address is views, followed by a discussion among Organizations, Independent System Operators, utilities, and other stakeholders. Jeffrey Little, EI–24, Forrestal Building, the panelists led by DOE staff. Each U.S. Department of Energy, 1000 workshop will begin at 9 a.m. and end IV. Comments in Response to This Independence Ave. SW., Washington, by 12:30 p.m. Notice DC 20585. To ensure receipt of the Workshops: The cities, dates, and comments by the due date, submission All comments filed in response to locations for the technical workshops by email ([email protected]) is today’s notice should be marked ‘‘Re are: recommended. Alternatively, Mr. Little Preparation of the 2012 Congestion 1. Philadelphia, PA, December 6, may be contacted by telephone at (202) Study,’’ and sent to the Department in 2011, at the Philadelphia Airport Hilton, 586–6284. 4509 Island Avenue, Philadelphia, PA the manner indicated in the ADDRESSES FOR FURTHER INFORMATION CONTACT: 19153. section of this notice. In written Requests for additional information or 2. St. Louis, MO, December 8, 2011, comments in response to this notice and copies of any forms and instructions at the St. Louis Airport Hilton, 10330 at the regional workshops, DOE requests should be directed to Mr. Jeffrey Little Natural Bridge Road, St. Louis, MO States, utilities, regional transmission at the contact information listed above. 63134. organizations (RTOs), independent 3. Portland, OR, December 13, 2011, system operators (ISOs), and other The proposed forms and instructions are at the Sheraton Portland Airport Hotel, stakeholders to describe changes in their also available on the Internet at: http://www.eia.doe.gov/oil_gas/natural_ 8235 Northeast Airport Way, Portland, respective areas since 2009 that affect _ _ _ OR 97220. the location, duration, frequency, gas/survey forms/nat survey forms. 4. San Diego, CA, December 15, 2011, magnitude, and significance of html. at the Sheraton San Diego Hotel & transmission congestion, including SUPPLEMENTARY INFORMATION:

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I. Background evaluation of energy policy and following guidelines are provided to II. Current Actions legislation. Data are disseminated assist in the preparation of comments. III. Request for Comments through the EIA Natural Gas Monthly, As a Potential Respondent to the Monthly Natural Gas Gross Production I. Background Request for Information Report, and EIA Natural Gas Annual The Federal Energy Administration Web site. Secondary publications that A. Is the proposed collection of Act of 1974 (Pub. L. 93–275, 15 U.S.C. information necessary for the proper 761 et seq.) and the DOE Organization use the data include EIA’s Short-Term Energy Outlook, Annual Energy performance of the functions of the Act (Pub. L. 95–91, 42 U.S.C. 7101 et agency and does the information have seq.) require the EIA to carry out a Outlook, Monthly Energy Review, and Annual Energy Review. practical utility? centralized, comprehensive, and unified B. What actions could be taken to energy information program. This II. Current Actions help ensure and maximize the quality, program collects, evaluates, assembles, This section contains the following objectivity, utility, and integrity of the analyzes, and disseminates information information to be collected? on energy resource reserves, production, information about the energy information collection submitted to C. Are the instructions and definitions demand, technology, and related clear and sufficient? If not, which economic and statistical information. OMB for review: (1) The collection numbers and title; (2) the sponsor (i.e., instructions need clarification? This information is used to assess the D. Can the information be submitted adequacy of energy resources to meet the Department of Energy component); (3) the current OMB docket number (if by the respondent by the due date? near and longer-term domestic E. Public reporting burden for this demands. applicable); (4) the type of request (i.e., new, revision, extension, or collection is estimated to average 3 The EIA, as part of its effort to comply hours per response. The estimated with the Paperwork Reduction Act of reinstatement); (5) response obligation (i.e., mandatory, voluntary, or required burden includes the total time necessary 1995 (Pub. L. 104–13, 44 U.S.C. chapter to provide the requested information. In 35), provides the general public and to obtain or retain benefits); (6) a description of the need for and your opinion, how accurate is this other Federal agencies with estimate? opportunities to comment on collections proposed use of the information; (7) an estimate of the number of respondents; F. The agency estimates that the only of energy information conducted by or cost to a respondent is for the time it in conjunction with the EIA. Any (8) an estimate of the total annual responses; (9) an estimate of the total will take to complete the collection. comments received help the EIA to Will a respondent incur any start-up prepare data requests that maximize the annual reporting burden; (10) an estimate of reporting and recordkeeping costs for reporting, or any recurring utility of the information collected, and annual costs for operation, maintenance, to assess the impact of collection costs. 1. Information Collection Request and purchase of services associated with requirements on the public. Also, the the information collection? EIA will later seek approval by the Title: Form EIA–914, ‘‘Monthly Natural Gas Production Report’’. G. What additional actions could be Office of Management and Budget taken to minimize the burden of this (OMB) under Section 3507(a) of the 2. Agency: U.S. Energy Information Administration. collection of information? Such actions Paperwork Reduction Act of 1995. may involve the use of automated, 3. OMB Control Number: 1905–0205. Currently there are 243 respondents, a electronic, mechanical, or other 4. Type of review: Three-year sample of operators of natural gas wells technological collection techniques or extension. report on the Form EIA–914. From a other forms of information technology. universe of about 9,300 active operators, 5. Type of collection: Mandatory. H. Does any other Federal, State, or a cut-off sample is selected of the largest 6. The purpose of the survey is to local agency collect similar information? natural gas producers by State or area, collect monthly data on the production If so, specify the agency, the data known to have produced at least 20 of natural gas in seven geographical element(s), and the methods of million cubic feet (10 million cubic feet areas (Texas (including State offshore), collection. in Oklahoma) of natural gas per day. Louisiana (including State offshore), Using information collected on Form Oklahoma, New Mexico, Wyoming, As a Potential User of the Information EIA–914, EIA estimates and Federal Gulf of Mexico offshore and To Be Collected disseminates timely and reliable Other States (defined as all remaining A. Is the proposed collection of monthly natural gas production data for states, except Alaska, in which the information necessary for the proper Texas (onshore and offshore) and operator produced natural gas during performance of the functions of the Louisiana (onshore and offshore), New the report month)). Data will be used to agency and does the information have Mexico, Oklahoma, Wyoming, the monitor natural gas supplies. Survey practical utility? Federal Offshore Gulf of Mexico, Other respondents would be a sample of well B. What actions could be taken to States (onshore and offshore for the operators. help ensure and maximize the quality, remaining gas producing States with 7. Annual Estimated Number of objectivity, utility, and integrity of the Alaska excluded), and the lower 48 Respondents: 243. information disseminated? States. This collection is essential to the 8. Annual Estimated Number of Total C. Is the information useful at the mission of the DOE in general and the Responses: 2,916. levels of detail to be collected? EIA in particular because of the 9. Annual Estimated Number of D. For what purpose(s) would the increasing demand for natural gas in the Burden Hours: 8,748. information be used? Be specific. United States and the requirement for 10. Annual Estimated Reporting and E. Are there alternate sources for the accurate and timely natural gas Recordkeeping Cost Burden: $0. information and are they useful? If so, production information necessary to what are their weaknesses and/or III. Request for Comment monitor the United States natural gas strengths? supply and demand balance. These Prospective respondents and other Comments submitted in response to estimates are essential to the interested parties should comment on this notice will be summarized and/or development, implementation, and the actions discussed in item II. The included in the request for OMB

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approval of the form. They also will Office of Survey Development and Issued in Washington, DC, on November 2, become a matter of public record. Statistical Integration (EI–21), Forrestal 2011. Statutory Authority: Section 13(b) of the Building, U.S. Department of Energy, Stephanie Brown, Federal Energy Administration Act of 1974, 1000 Independence Ave. SW., Director, Office of Survey Development and Pub. L. 93–275, codified at 15 U.S.C. 772(b). Washington, DC 20585–0670. Mr. Statistical Integration, U.S. Energy Information Administration. Issued in Washington, DC, on November 2, Worrall may be contacted by telephone 2011. at (202) 586–6075. [FR Doc. 2011–29147 Filed 11–9–11; 8:45 am] Stephanie Brown, SUPPLEMENTARY INFORMATION: This BILLING CODE 6450–01–P Director, Office of Survey Development and section contains the following Statistical Integration, U.S. Energy information about the energy Information Administration. information collections submitted to DEPARTMENT OF ENERGY OMB for review: (1) The collection [FR Doc. 2011–29187 Filed 11–9–11; 8:45 am] Western Area Power Administration BILLING CODE 6450–01–P numbers and title; (2) the sponsor (i.e., the Department of Energy component); Notice of Availability of the Draft (3) the current OMB docket number (if Environmental Impact Statement for DEPARTMENT OF ENERGY applicable); (4) the type of request (i.e, the Proposed Solar Reserve LLC new, revision, extension, or Quartzsite Solar Energy Project, La Energy Information Administration reinstatement); (5) response obligation Paz County, AZ (DOE/EIS—0440) and (i.e., mandatory, voluntary, or required Agency Information Collection the proposed Amendment to the to obtain or retain benefits); (6) a Bureau of Land Management Yuma Activities: Submission for OMB description of the need for and Review; Comment Request Field Office Resource Management proposed use of the information; (7) a Plan AGENCY: U. S. Energy Information categorical description of the likely Administration (EIA), Department of respondents; (8) estimated number of AGENCY: Western Area Power Energy (DOE). respondents annually; (9) an estimate of Administration, DOE. ACTION: Agency Information Collection the total annual reporting burden in ACTION: Notice of Availability. Activities: Submission for OMB Review; hours (i.e., the estimated number of Comment Request. likely respondents times the proposed SUMMARY: In accordance with the frequency of response per year times the National Environmental Policy Act SUMMARY: The EIA has submitted the average hours per response); and (10) an (NEPA) of 1969, as amended, and the U.S. Energy Information estimate of the total annual reporting Federal Land Policy and Management Administration’s Monthly Biodiesel and recordkeeping cost burden (in Act (FLPMA) of 1976, as amended, Production Survey to the Office of thousands of dollars). Western Area Power Administration Management and Budget (OMB) for 1. EIA–22M, ‘‘Monthly Biodiesel (Western) and the Bureau of Land revision and a three-year extension Production Survey.’’ Management (BLM) have prepared a under section 3507(h)(1) of the 2. U.S. Energy Information Draft Environmental Impact Statement Paperwork Reduction Act of 1995 (Pub. Administration. (DEIS) for the proposed Quartzsite Solar L. 104–13) (44 U.S.C. 3501 et seq). 3. OMB Number 1905–0207. Energy Project (Project), in La Paz DATES: Comments must be filed by 4. Three-year extension. County, Arizona, and the proposed December 12, 2011. If you anticipate 5. Mandatory. amendment to the Yuma Field Office that you will be submitting comments 6. The purpose of the survey is to (Yuma) Resource Management Plan but find it difficult to do so within that collect information from biodiesel (RMP), and by this notice are period, you should contact the OMB producers regarding the following: Plant announcing the opening of the public Desk Officer for DOE listed below as location, capacity, and operating status; comment period. Western is the lead soon as possible. Biodiesel and co-product production; Federal agency for purposes of Inputs to production; Sales for end-use ADDRESSES: Send comments to OMB satisfying the NEPA requirements with and resale; Sales revenue; and Biodiesel Desk Officer for DOE, Office of the BLM acting as a cooperating agency. stocks. DATES: Information and Regulatory Affairs, 7. Business or other for-profit. The public is invited to submit Office of Management and Budget. To 8. 150 Respondents comments on the DEIS for the proposed ensure receipt of the comments by the 9. Annual total of 5400, hours, Project and the proposed RMP due date, submission by Fax at (202) collected 12 times per year, three hours amendment during the public comment 395–7285 or email to per response. period. To ensure that comments will be [email protected] is 10. Annual total of $0. considered, Western or BLM must recommended. The mailing address is Please refer to the supporting receive written comments on the DEIS/ 725 17th Street NW., Washington, DC statement as well as the proposed forms proposed RMP amendment within 90 20503. The OMB DOE Desk Officer may and instructions for more information days following the date the be telephoned at (202) 395–4718. (A about the purpose, who must report, Environmental Protection Agency copy of your comments should also be when to report, where to submit, the publishes its Notice of Availability in provided to EIA’s Office of Survey elements to be reported, detailed the Federal Register. Oral comments Development and Statistical Integration instructions, provisions for will be taken at a public hearing, which at the address below.) confidentiality, and uses (including will be announced at least 15 days in FOR FURTHER INFORMATION CONTACT: possible nonstatistical uses) of the advance through public notices, media Requests for additional information information. For instructions on releases, and/or mailings. should be directed to Jason Worrall. To obtaining materials, see the FOR FURTHER ADDRESSES: Written comments on the ensure receipt of the comments by the INFORMATION CONTACT section. Project may be sent to Ms. Liana Reilly, due date, submission by email Statutory Authority: Section 13(b) of the NEPA Document Manager, Western ([email protected]) is also Federal Energy Administration Act of 1974, Area Power Administration, P.O. Box recommended. The mailing address is P.L. 93–275, codified at 15 U.S.C. 772(b). 281213, Lakewood, CO 80228–8213 or

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sent by email to The formal scoping period for the Proposed Agency Actions [email protected]. Copies of proposed RMP amendment closed on the DEIS and proposed RMP April 29, 2011. Comments received Western’s proposed action is to amendment are available on the during the scoping periods were interconnect the proposed Project to Western and BLM Project Web sites: considered in preparing the DEIS. Western’s existing Bouse-Kofa 161-kV http://www.wapa.gov/transmission/ transmission line. As part of Western’s quartzsitesolar.htm and http:// Proposed Project proposed action, Western would also construct, operate and maintain the new www.blm.gov/az/st/en/prog/energy/ The proposed Project is a 100- _ _ switchyard and would establish either a solar/quartzsite solar energy.html. megawatt solar electric power plant that Copies of the document are also would use concentrating solar power fiber optic or microwave available at the BLM Yuma Field Office, technology to capture the sun’s heat to telecommunications point. In addition 2555 East Gila Ridge Road, Yuma, AZ make steam, which would power to responding to the project ROW 85365 and at the BLM Arizona State traditional steam turbine generators. applications analyzed in the EIS, BLM Office, One North Central Avenue, The solar generation facility would is also considering amending the Yuma Phoenix, AZ 85004. contain the central receiver or tower, a RMP. The Yuma RMP recognizes the Before including your address, phone compatibility of solar generation number, or email address in your solar field consisting of mirrors or heliostats to reflect the sun’s energy to facilities on public lands, but requires comment, you should be aware that that such activities conform to your entire comment may be made the central tower, a conventional steam turbine generator, insulated storage designated visual resource management publicly available at any time. While (VRM) classes. you can ask us in your comment to tanks for hot and cold liquid salt, withhold your information from public ancillary tanks, evaporation ponds, a Alternatives review, we cannot guarantee that we temporary construction laydown area, will be able to do so. technical and non-technical buildings, The DEIS analyzes two Project alternatives, a dry-cooling technology FOR FURTHER INFORMATION CONTACT: For transformers and a 161/230-kilovolt (kV) information on the proposed Project, the electrical substation, roads, and water and a hybrid cooling technology. The EIS and general information about wells. All Project components would be DEIS also analyzes the proposed RMP Western’s transmission system, contact located on BLM-managed land. amendment to change approximately Ms. Liana Reilly, Western NEPA Quartzsite Solar Energy, LLC (QSE) has 6,800 acres of VRM Class III to VRM Document Manager, at (720) 962–7253 applied to Western to interconnect the Class IV with a project approval, the or the address provided above. Parties proposed Project to Western’s proposed plan amendment without wishing to be placed on the Project transmission system. A new 1.5-mile project approval, and a no action mailing list for future information and long 161/230-kV generator tie-line alternative. For the proposed to receive copies of the document would extend from the southern amendment, BLM’s preferred alternative should also contact Ms. Reilly. For boundary of the solar facility boundary is to amend the Yuma RMP. BLM has general information on the DOE NEPA to a new switchyard to be constructed not identified a preferred alternative for process, please contact Ms. Carol M. adjacent to Western’s existing Bouse- the proposed project. Borgstrom, Director, Office of NEPA Kofa 161-kV transmission line. The As required under NEPA, the DEIS Policy and Compliance (GC–54), U.S. switchyard would be on BLM-managed analyzes the following no action land and would be owned and operated Department of Energy, 1000 alternatives: Western would deny the by Western. Independence Avenue SW., interconnection request and the BLM Washington, DC 20585, telephone (202) QSE has submitted a right-of-way would either (1) decline to amend the 586–4600 or (800) 472–2756. For (ROW) application to the BLM for the Yuma RMP and deny the project information on BLM’s role with the Project. The ROW application is for a proposal; or (2) amend the Yuma RMP Project or the proposed RMP total of 26,273 acres, of which 1,675 to change the VRM management Amendment, contact Mr. Eddie Arreola, acres would be utilized for the final classification but deny the project Supervisory Project Manager, (602) 417– Project ROW if approved. The Project proposal. 9505, One North Central Avenue, site is in an undeveloped area in La Paz Phoenix, AZ 85004 or County, Arizona, east of State Route For purposes of NEPA compliance, [email protected]. (SR) 95, approximately 10 miles north of Western is serving as the lead Federal agency with BLM acting as a SUPPLEMENTARY INFORMATION: A Notice Quartzsite, Arizona, on lands managed by the BLM. cooperating agency. The DEIS analyzes of Intent (NOI) to Prepare an EIS for the site-specific impacts on air quality, proposed Project in La Paz County was Agency Purpose and Need biological resources, recreation, cultural published in the Federal Register on resources, water resources, geological January 14, 2010 (75 FR 2133). Western Western’s purpose and need for the resources and hazards, hazardous and BLM held public scoping meetings Project is to respond to QSE’s materials handling, land use, noise, in Yuma, Arizona, on January 26, 2010, interconnection request in accordance paleontological resources, public health, in Parker, Arizona, on January 27, 2010 with Western’s Open Access socioeconomics, soils, traffic and and in Quartzsite, Arizona, on January Transmission Tariff. The BLM’s purpose transportation, visual resources, waste 28, 2010. The formal scoping period and need for the Project is to respond to management, and worker safety and fire ended February 16, 2010. A NOI for the QSE’s application for a ROW under proposed RMP amendment was Title V of FLPMA (43 U.S.C. 1761) to protection, as well as facility design published in the Federal Register on construct, operate, and decommission engineering, efficiency, reliability, March 30, 2011 (76 FR 17668). Scoping the solar facility, 161/230-kV collector transmission system engineering, and meetings for the proposed RMP line and access road, and also to transmission line safety and nuisance. amendment were held by BLM in Yuma, respond to Western’s application for a Western and BLM welcome public Arizona, on April 18, 2011, and in switchyard, and fiber optic line on comments on the DEIS and proposed Quartzsite, Arizona, on April 19, 2011. public lands administered by the BLM. RMP amendment.

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Dated: October 19, 2011. On May 9, 2011 (76 FR 26900), EPA of any startup, shutdown, or Timothy J. Meeks, sought comments on this ICR pursuant malfunction in the operation of an Administrator. to 5 CFR 1320.8(d). EPA received no affected facility, or any period during [FR Doc. 2011–29146 Filed 11–9–11; 8:45 am] comments. Any additional comments on which the monitoring system is BILLING CODE 6450–01–P this ICR should be submitted to both inoperative. The pollutants of concern EPA and OMB within 30 days of this for subpart Ea are metals, municipal notice. waste combustor (MWC) organics, MWC EPA has established a public docket ENVIRONMENTAL PROTECTION acid gases, and nitrogen oxides. In for this ICR under docket ID number AGENCY subpart Eb, the additional pollutants of EPA–HQ–OECA–2011–0210, which is concern are cadmium (Cd), lead (Pb), [EPA–HQ–OECA–2011–0210; FRL–9490–4] available for public viewing online at and mercury (Hg). Subparts Ea and Eb http://www.regulations.gov, or in person require owners and operators with unit Agency Information Collection viewing at the Enforcement and capacity above 225 megagrams per day Activities; Submission to OMB for Compliance Docket in the EPA Docket to notify the Agency of intent to Review and Approval; Comment Center (EPA/DC), EPA West, Room construct and initiate operation of a Request; NSPS for Municipal Waste 3334, 1301 Constitution Avenue NW., new, modified, or reconstructed MWC. Combustors (Renewal) Washington, DC The EPA Docket Center The notification must contain Public Reading Room is open from 8:30 AGENCY: Environmental Protection supporting information regarding unit Agency (EPA). a.m. to 4:30 p.m., Monday through design capacity, the calculations used to Friday, excluding legal holidays. The determine capacity, and estimated ACTION: Notice. telephone number for the Reading Room startup dates. SUMMARY: In compliance with the is (202) 566–1744, and the telephone Owners and operators must submit Paperwork Reduction Act (44 U.S.C. number for the Enforcement and semiannual and annual compliance 3501 et seq.), this document announces Compliance Docket is (202) 566–1752. reports. In addition, facilities subject to that an Information Collection Request Use EPA’s electronic docket and subpart Eb are required to keep records (ICR) has been forwarded to the Office comment system at http:// of the weekly amount of carbon used for of Management and Budget (OMB) for www.regulations.gov to submit or view activated carbon injection and to review and approval. This is a request public comments, access the index calculate the estimated hourly carbon to renew an existing approved listing of the contents of the docket and injection rate for hours of operation as collection. The ICR which is abstracted to either access those documents in the a means of determining continuous below describes the nature of the docket that are available electronically. compliance for Hg. Annual reports of Once in the system, select ‘‘docket collection and the estimated burden and excess emissions are required under search,’’ then key in the docket ID cost. subpart Ea, while semiannual reports of number identified above. Please note excess emissions are required under DATES: Additional comments may be that EPA’s policy is that public subpart Eb. These notifications, reports, submitted on or before December 12, comments, whether submitted and records are essential in determining 2011. electronically or in paper, will be made compliance and are required, in general, ADDRESSES: Submit your comments, available for public viewing at http:// of all sources subject to the standard. referencing docket ID number EPA–HQ– www.regulations.gov as EPA receives Any owner or operator subject to OECA–2011–0210, to (1) EPA online them and without change, unless the subpart Ea will maintain a file of these using www.regulations.gov (our comment contains copyrighted material, measurements, and retain the file for at preferred method), or by email to Confidential Business Information (CBI), least two years. For those facilities [email protected], or by mail to: EPA or other information whose public subject to subpart Eb, all records are Docket Center (EPA/DC), Environmental disclosure is restricted by statute. For required to be maintained at the source Protection Agency, Enforcement and further information about the electronic for a period of five years. Compliance Docket and Information docket, go to www.regulations.gov. Notifications are used to inform the Center, mail code 2822IT, 1200 Title: NSPS for Municipal Waste Agency or delegated authority when a Pennsylvania Avenue NW., Washington, Combustors (Renewal). source becomes subject to the standard. DC 20460; and (2) OMB at: Office of ICR Numbers: EPA ICR Number The reviewing authority may then Information and Regulatory Affairs, 1506.12, OMB Control Number 2060– inspect the source to check if the Office of Management and Budget 0210. pollution control devices are properly (OMB), Attention: Desk Officer for EPA, ICR Status: This ICR is scheduled to installed and operated and that the 725 17th Street NW., Washington, DC expire on December 31, 2011. Under standard is being met. Performance test 20503. OMB regulations, the Agency may reports are needed as these are the continue to conduct or sponsor the Agency’s records of a source’s initial FOR FURTHER INFORMATION CONTACT: collection of information while this capability to comply with the emission Learia Williams, Monitoring, submission is pending at OMB. standards, and serve as a record of the Assistance, and Media Programs Abstract: The New Source operating conditions under which Division, Office of Compliance, Mail Performance Standards (NSPS) for compliance was achieved. The Code 2223A, Environmental Protection Municipal Waste Combustors apply to information generated by monitoring, Agency, 1200 Pennsylvania Avenue municipal waste combustors with unit recordkeeping, and reporting NW., Washington, DC 20460; telephone capacities greater than 225 megagrams requirements described in this ICR is number: (202) 564–4113; fax number: per day. Owners or operators of the used by the Agency to ensure that (202) 564–0050; email address: affected facilities must make one-time- facilities affected by the standard [email protected]. only notifications and reports and must continue to operate the control SUPPLEMENTARY INFORMATION: EPA has keep records of all facilities subject to equipment and achieve continuous submitted the following ICR to OMB for NSPS requirements. Owners or compliance with the regulation. review and approval according to the operators are also required to maintain All reports are sent to the delegated procedures prescribed in 5 CFR 1320.12. records of the occurrence and duration state or local authority. In the event that

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there is no such delegated authority, the currently identified in the OMB site for an update: http://www.epa.gov/ reports are sent directly to the EPA Inventory of approved Burdens. The otaq/cafr.htm. regional office. This information is increase is not due to any program Parties wishing to present oral being collected to assure compliance changes. The change in burden cost is testimony at the public hearing should with 40 CFR part 60, subparts Ea and due to the use of the most updated labor also provide written notice to David Eb, as authorized in section 112 and rates. Dickinson at the address noted below. If 114(a) of the Clean Air Act. The Since there are no changes in the EPA receives a request for a public required information consists of regulatory requirements and there is no hearing, that hearing will be held at emissions data and other information significant industry growth, the labor 1310 L St. NW., Washington, DC 20005. that have been determined to be private. hours from the previous ICR are used in If EPA does not receive a request for a An agency may not conduct or this ICR. public hearing, then EPA will not hold sponsor, and a person is not required to Dated: November 4, 2011. a hearing, and instead consider CARB’s respond to, a collection of information John Moses, request based on written submissions to unless it displays a currently valid OMB the docket. Any party may submit Director, Collection Strategies Division. Control Number. The OMB Control written comments by January 9, 2012. Numbers for the EPA regulations are [FR Doc. 2011–29186 Filed 11–9–11; 8:45 am] ADDRESSES: EPA will make available for BILLING CODE 6560–50–P listed in 40 CFR part 9 and 48 CFR public inspection materials submitted chapter 15, and are identified on the by CARB, written comments received form and/or instrument, if applicable. from interested parties, and any Burden Statement: The annual public ENVIRONMENTAL PROTECTION testimony given at the public hearing. reporting and recordkeeping burden for AGENCY Materials relevant to this proceeding are this collection of information is [AMS–FRL–9490–7] contained in the Air and Radiation estimated to average 198 hours per Docket and Information Center, response. Burden means the total time, California State Motor Vehicle maintained in Docket No. EPA–HQ– effort, or financial resources expended Pollution Control Standards; OAR–2011–0816. The docket is located by persons to generate, maintain, retain, Amendments to the California Heavy- at The Air Docket, Room 3334, 1301 or disclose or provide information to or Duty Engine On-Board Diagnostic Constitution Avenue NW., Washington, for a Federal agency. This includes the Regulation; Waiver Request; DC 20460, and may be viewed between time needed to review instructions; Opportunity for Public Hearing 8 a.m., and 5:30 p.m., Monday through develop, acquire, install, and utilize AGENCY: Friday. The telephone is (202) 566– technology and systems for the purposes Environmental Protection 1742. A reasonable fee may be charged of collecting, validating, and verifying Agency (EPA). by EPA for copying docket material. information, processing and ACTION: Notice of Opportunity for Public Additionally, an electronic version of maintaining information, and disclosing Hearing and Comment. the public docket is available through and providing information; adjust the SUMMARY: The California Air Resources the Federal government’s electronic existing ways to comply with any Board (CARB) has notified EPA that it public docket and comment system. previously applicable instructions and has adopted amendments to its You may access EPA dockets at http:// requirements which have subsequently regulations related to heavy-duty engine www.regulations.gov. After opening the changed; train personnel to be able to on-board diagnostic (HD OBD) in http://www.regulations.gov Web site, respond to a collection of information; California. By letter dated September 27, enter EPA–HQ–OAR–2011–0816 in search data sources; complete and 2010, CARB requested that EPA confirm ‘‘Search Documents’’ to view documents review the collection of information; that its amendments are within-the- in the record. Although a part of the and transmit or otherwise disclose the scope of a previous waiver of official docket, the public docket does information. preemption issued by EPA. In the Respondents/Affected Entities: not include Confidential Business alternative, CARB requested that EPA Municipal waste combustors. Information (CBI) or other information confirm that the amendments that relax Estimated Number of Respondents: whose disclosure is restricted by statute. and clarify the existing HD OBD 12. FOR FURTHER INFORMATION CONTACT: Frequency of Response: Initially, regulation are within-the-scope of a David Dickinson, Compliance Division quarterly, annually, and semiannually. previous waiver of preemption issued (6405J), U.S. Environmental Protection Estimated Total Annual Hour Burden: by EPA and that EPA grant a new Agency, 1200 Pennsylvania Ave. NW., 20,421. waiver of preemption for the remainder Washington, DC 20460. Telephone: Estimated Total Annual Cost: of CARB’s HD OBD amendments. This (202) 343–9256, Fax: (202) 343–2804, $1,916,503, which includes $1,757,811 notice announces that EPA has email address: in labor costs, $60,000 in capital/startup tentatively scheduled a public hearing [email protected]. costs, and $98,692 in operation and concerning California’s request and that SUPPLEMENTARY INFORMATION: maintenance (O&M) costs. EPA is accepting written comment on Changes in the Estimates: There is no the request. (A) Procedural History change in the labor hours or cost in this DATES: EPA has tentatively scheduled a CARB initially adopted the HD OBD ICR compared to the previous ICR. This public hearing concerning CARB’s requirements in December 2005, and is due to two considerations: (1) The request on December 12, 2011 at 10 a.m. EPA issued a waiver of preemption in regulations have not changed over the EPA will hold a hearing only if any August 2008.1 CARB’s HD OBD past three years and are not anticipated party notifies EPA by November 25, regulation, as initially adopted, required to change over the next three years; and 2011, expressing its interest in manufacturers to install a fully (2) the growth rate for the industry is presenting oral testimony. By December compliant HD OBD system on both very low, negative, or non-existent, so 1, 2011, any person who plans to attend there is no significant change in the the hearing may call David Dickinson at 1 The EPA decision was signed on August 13, overall burden. There is, however, an (202) 343–9256 to learn if a hearing will 2008 and published at 73 FR 52042 (September 8, increase in the estimated burden cost as be held or may check the following Web 2008).

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diesel and gasoline powered heavy-duty Section 209(b)(1) of the Act requires determination that its standards, in the engines (engines used in vehicles the Administrator, after notice and aggregate, are at least as protective of having a gross vehicle weight rating opportunity for public hearing, to waive pubic health and welfare as comparable greater than 14,000 pounds). The application of the prohibitions of Federal standards, (b) affect the requirements are phased in on a single section 209(a) for any state that has consistency of California’s requirements engine family for model years 2010 adopted standards (other than crankcase with section 202(a) of the Act, or (c) through 2012 before requiring emission standards) for the control of raise new issues affecting EPA’s manufacturers to incorporate fully emissions from new motor vehicles or previous waiver determinations? Please compliant HD OBD systems on all 2013 new motor vehicle engines prior to also provide comments to address the and later model year engines. March 30, 1966, if the state determines full waiver analysis, in the event that CARB adopted amendments to its HD that the state standards will be, in the EPA cannot confirm that CARB’s HD OBD regulation along with a new HD aggregate, at least as protective of public OBD amendments are within-the-scope OBD enforcement regulation on April 5, health and welfare as applicable Federal of previous waivers. The full waiver 2010.2 In amending the HD OBD standards. California is the only state analysis, which we are requesting regulation CARB, among other that is qualified to seek and receive a comment on, includes consideration of provisions, relaxed the malfunction waiver under section 209(b). The the following three criteria: Whether (a) thresholds until 2013 model year for Administrator must grant a waiver CARB’s determination that its three major emission controls: PM unless she finds that (A) the above- standards, in the aggregate, are at least filters, NOX catalysts, and NOX sensors. described ‘‘protectiveness’’ as protective of public health and The amendments also delay certain determination of the state is arbitrary welfare as applicable Federal standards monitoring requirements, including and capricious, (B) the state does not is arbitrary and capricious, (b) California those that apply to catalyst-based need the state standard to meet needs separate standards to meet components, until 2013. CARB further compelling and extraordinary compelling and extraordinary amended the regulation to expand the conditions, or (C) the state standards conditions, and (c) California’s monitoring requirements for EGR and and accompanying enforcement standards and accompanying boost control system strategies. procedures are not consistent with enforcement procedures are consistent By letter dated September 27, 2010, section 202(a) of the Act. EPA has with section 202(a) of the Act. CARB requested that EPA confirm that previously stated that ‘‘consistency with Procedures for Public Participation: In amendments to its HD OBD regulations section 202(a)’’ requires that California’s recognition that public hearings are are within-the-scope of a previous standards must be technologically designed to give interested parties an waiver of preemption issued by EPA.3 feasible within the lead time provided, opportunity to participate in this In the alternative, CARB requested that given due consideration of costs, and proceeding, there are no adverse parties EPA confirm that the amendments that that California and applicable Federal as such. Statements by participants will relax and clarify the existing HD OBD test procedures be consistent. not be subject to cross-examination by regulation (e.g. the major emission When EPA receives new waiver other participants without special control monitoring requirements noted requests from CARB, EPA traditionally approval by the presiding officer. The above) are within-the-scope of EPA’s publishes a notice of opportunity for presiding officer is authorized to strike previous HD OBD waiver of preemption. public hearing and comment and then, from the record statements that he or she deems irrelevant or repetitious and Under this alternative request, CARB after the comment period has closed, publishes a notice of its decision in the to impose reasonable time limits on the seeks a new waiver of preemption for Federal Register. In contrast, when EPA duration of the statement of any the remainder of CARB’s HD OBD receives within-the-scope waiver participant. amendments. requests from CARB, EPA usually If a hearing is held, the Agency will (B) Background and Discussion publishes a notice of its decision in the make a verbatim record of the proceedings. Interested parties may Section 209(a) of the Clean Air Act, as Federal Register and concurrently arrange with the reporter at the hearing amended (Act), 42 U.S.C. 7543(a), invites public comment if an interested to obtain a copy of the transcript at their provides: party is opposed to EPA’s decision. Although CARB has submitted a own expense. Regardless of whether a No state or any political subdivision within-the-scope waiver request for its pubic hearing is held, EPA will keep the thereof shall adopt or attempt to enforce any HD OBD amendments EPA invites record open until January 9, 2012. Upon standard relating to the control of emissions comment on the following issues. First, expiration of the comment period, the from new motor vehicles or new motor should California’s HD OBD Administrator will render a decision of vehicle engines subject to this part. No state shall require certification, inspection or any amendments be considered under the CARB’s request based on the record of other approval relating to the control of within-the-scope criteria or should they the public hearing, if any, relevant emissions from any new motor vehicle or be considered under the full waiver written submissions, and other new motor vehicle engine as condition criteria? Second, to the extent that not information that she deems pertinent. precedent to the initial retail sale, titling (if all of the HD OBD amendments should All information will be available for any), or registration of such motor vehicle, be considered under the within-the- inspection at the EPA Air Docket No. motor vehicle engine, or equipment. scope criteria, should the amendments EPA–HQ–OAR–2011–0816. identified by CARB (as part of its Persons with comments containing 2 The California Office of Administrative Law alternative request) be considered under proprietary information must approved the amendments and the new regulation the within-the-scope criteria? Third, to distinguish such information from other on May 18, 2010. The HD OBD requirements, as adopted in 2005, included detailed certification the extent that HD OBD amendments comments to the greatest possible extent requirements and production engine/vehicle should be considered as a within-the- and label it as ‘‘Confidential Business evaluation testing. The amended regulations, at 13 scope request, do such amendments Information’’ (CBI). If a person making CCR section 1971.5, includes additional in-use meet the criteria for EPA to grant a comments wants EPA to base its enforcement provisions. 3 CARB’s request letter can be found at EPA–HQ– within-the-scope confirmation? decision in part on a submission labeled OAR–2011–0816–0001. EPA’s previous waiver is at Specifically, do those amendments: (a) as CBI, then a non-confidential version 73 FR 52042 (September 8, 2008). Undermine California’s previous of the document that summarizes the

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key data or information should be Rebuilding Plan, Annual Catch 10/07/2011: Extending Comment submitted for the public docket. To Limits, Management Measures, Red Period from 11/21/2011 to 12/21/ ensure that proprietary information is Grouper—Annual Catch Limits, 2011. not inadvertently placed in the docket, Management Measures, Grouper Dated: November 7, 2011. Accountability Measures, Gulf of submissions containing such Cliff Rader, information should be sent directly to Mexico, Review Period Ends: 12/12/ 2011, Contact: Roy E. Crabtree (727) Acting Director, NEPA Compliance Division, the contact person listed above and not Office of Federal Activities. to the public docket. Information 824–5301. covered by a claim of confidentiality EIS No. 20110378, Draft EIS, FHWA, LA, [FR Doc. 2011–29188 Filed 11–9–11; 8:45 am] will be disclosed by EPA only to the Tier 1—Baton Rouge Loop Toll BILLING CODE 6560–50–P extent allowed and by the procedures Facility Project, Proposed as a 90 to set forth in 40 CFR part 2. If no claim 105 mile long Circumferential Controlled Access Free-Flow Toll ENVIRONMENTAL PROTECTION of confidentiality accompanies the AGENCY submission when EPA receives it, EPA Roadway with two new Mississippi will make it available to the public River Crossings, in Parishes of [FRL–9490–2] without further notice to the person Ascension, East Baton Rouge, making comments. Iberville, Livingston, and West Baton Notice of Public Meeting of the Rouge, LA, Comment Period Ends: Interagency Steering Committee on Dated: November 4, 2011. 01/09/2012, Contact: Cark N, Radiation Standards Margo Tsirigotis Oge, Highsmith (225) 757–7615. Director, Office of Transportation and Air EIS No. 20110379, Draft EIS, USN, HI, AGENCY: Environmental Protection Quality, Office of Air and Radiation. Basing of MV–22 and H–1 Aircraft in Agency. [FR Doc. 2011–29168 Filed 11–9–11; 8:45 am] Support of III Marine Expeditionary ACTION: Notice of Public Meeting. BILLING CODE 6560–50–P Force (MEF) Elements, Construction SUMMARY: and Renovation of Facilities to The Environmental Protection Accommodate and Maintain the Agency (EPA) will host a meeting of the ENVIRONMENTAL PROTECTION Squadrons, HI, Comment Period Ends: Interagency Steering Committee on AGENCY 12/27/2011, Contact: John Bigay (808) Radiation Standards (ISCORS) on November 14, 2011, in Washington, DC. [ER–FRL–8999–9] 472–1196. EIS No. 20110380, Second Draft The purpose of ISCORS is to foster early Environmental Impacts Statements; Supplement, NRC, TN, Related to the resolution and coordination of Notice of Availability Operation of Watts Bar Nuclear Plant regulatory issues associated with Units 2, New and Updated radiation standards. Agencies Responsible Agency: Office of Federal Information, Operating License, Rhea represented as members of ISCORS Activities, General Information (202) County, TN, Comment Period Ends: include the following: EPA; Nuclear 564–1399 or http://www.epa.gov/ 01/24/2012, Contact: Justin Poole Regulatory Commission; Department of compliance/nepa/. Weekly receipt of (301) 415–2048. Energy; Department of Defense; Environmental Impact Statements. Filed EIS No. 20110381, Draft EIS, WAPA, Department of Transportation; 10/31/2011 Through 11/04/2011 AZ, Quartzsite Solar Energy Project Department of Homeland Security; Pursuant to 40 CFR 1506.9. and Proposed Yuma Field Office Department of Labor’s Occupational Safety and Health Administration; and Notice Resource Management Plan Amendment, Implementation, Right- the Department of Health and Human Section 309(a) of the Clean Air Act of-Way Application to the BLM, La Services. ISCORS meeting observer requires that EPA make public its Paz County, AZ, Comment Period agencies include the Office of Science comments on EISs issued by other Ends: 02/08/2012, Contact: Liana and Technology Policy, Office of Federal agencies. EPA’s comment letters Reilly (720) 962–7253. Management and Budget, Defense on EIS are available at: http:// EIS No. 20110382, Draft EIS, DOI, 00, Nuclear Facilities Safety Board, as well www.epa.gov/compliance/nepa/ Programmatic EIS—Outer Continental as representatives from both the States eisdata.html. Shelf Oil and Gas Leasing Program— of Illinois and Pennsylvania. ISCORS EIS No. 20110375, Final EIS, USFS, AK, 2012–2017 in Six Planning Area, maintains several objectives: Facilitate a Coconino National Forest Travel Western, Central and Eastern Gulf of consensus on allowable levels of Management Project, Proposes to Mexico, Cook Inlet, the Beaufort Sea, radiation risk to the public and workers; Designate a System of Road and and the Chukchi Sea, Comment promote consistent and scientifically Motorized Travel, Implementation, Period Ends: 01/09/2012, Contact: sound risk assessment and risk Coconino and Yavapai County, AZ, James F. Bennett (703) 787–1660. management approaches in setting and Review Period Ends: 12/12/2011, implementing standards for Contact: Mike Dechter (928) 527– Amended Notices occupational and public protection from 3416. EIS No. 20110332, Draft Supplement, ionizing radiation; promote EIS No. 20110376, Final EIS, USFS, AZ, USFS, MT, Montanore Project, completeness and coherence of Federal Pinaleno Ecosystem Restoration Additional Information on standards for radiation protection; and Project, Proposed On-the-Ground Alternatives, Proposes to Construct a identify interagency radiation protection Treatments to Improve Forest Health Copper and Silver Underground Mine issues and coordinate their resolution. and Improve or Protect Red Squirrel and Associated Facilities, Including a ISCORS meetings include presentations Habitat, Coronado National Forest, New Transmission Line, Plan-of- by the chairs of the subcommittees and Graham County, AZ, Review Period Operation Permit, Kootenai National discussions of current radiation Ends: 12/12/2011, Contact: Craig Forest, Sanders County, MT, protection issues. Committee meetings Wilcox (928) 348–1961. Comment Period Ends: 12/21/2011, normally involve pre-decisional intra- EIS No. 20110377, Final EIS, NOAA, 00, Contact: Lynn Hagarty (406) 283– governmental discussions and, as such, Reef Fish Amendment 32, Gag— 7642, Revision to FR Notice Published are normally not open for observation

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by members of the public or media. This ACTION: Notice. Research Center, Office of Research and is the one ISCORS meeting out of four Development. held each year that is open to all SUMMARY: Notice is hereby given of the Ephraim King, Director, Office of interested members of the public. There membership of the Environmental Science and Technology, Office of will be time on the agenda for members Protection Agency Performance Review Water. of the public to provide comments. Board for 2011. Kimberly A. Lewis (Ex-Officio), Summaries of previous ISCORS FOR FURTHER INFORMATION CONTACT: Director, Office of Human Resources, meetings are available at the ISCORS Karen D. Higginbotham, Director, Office of Administration and Resources Web site, www.iscors.org. The final Executive Resources Division, 3606A, Management. agenda for the November 14th meeting Office of Human Resources, Office of Brenda Mallory, Principal Deputy will be posted on the Web site shortly Administration and Resources General Counsel, Office of General before the meeting. Management, Environmental Protection Counsel. DATES: The meeting will be held on Agency, 1200 Pennsylvania Avenue Suzanne Murray, Regional Counsel, November 14, 2011, from 1 p.m. to NW., Washington, DC 20460 (202) 564– Region 6, Office of Enforcement and 4 p.m. 7287. Compliance Assurance. ADDRESSES: The ISCORS meeting will SUPPLEMENTARY INFORMATION: Section Denise B. Sirmons, Deputy Director, be held in Room 152 at the EPA 4314(c)(1) through (5) of Title 5, U.S.C., Office of Grants and Debarment, Office building located at 1310 L Street NW., requires each agency to establish in of Administration and Resources in Washington, DC. Attendees are accordance with regulations prescribed Management. required to present a photo ID such as by the Office of Personnel Management, Cynthia Sonich-Mullin, Deputy a government agency photo one or more SES performance review Director, National Homeland Security identification badge or valid driver’s boards. This board shall review and Research Center—Cincinnati, Ohio, license. Visitors and their belongings evaluate the initial appraisal of a senior Office of Research and Development. will be screened by EPA security executive’s performance by the Michael M. Stahl, Deputy Assistant guards. Visitors must sign the visitors supervisor, along with any Administrator, Office of International log at the security desk and will be recommendations to the appointment and Tribal Affairs. issued a visitors badge by the security authority relative to the performance of Panagiotis E. Tsirigotis, Director, guards to gain access to the meeting. the senior executive. Sector Policies and Programs Division— FOR FURTHER INFORMATION CONTACT: Members of the 2011 EPA Research Triangle Park, Office of Air Marisa Savoy, Radiation Protection Performance Review Board are: and Radiation. Division, Office of Radiation and Indoor William H. Benson, Director, Gulf Dated: November 4, 2011. Air, Mailcode 6608J, Environmental Ecology Division, National Health and Craig E. Hooks, Protection Agency, 1200 Pennsylvania Environmental Effects Research Lab, Assistant Administrator, Administration and Avenue NW., Washington, DC 20460; Office of Research and Development. Resources Management. telephone (202) 343–9237; fax (202) Bruce Binder, Senior Associate [FR Doc. 2011–29185 Filed 11–9–11; 8:45 am] 343–2302; email address savoy.marisa@ Director for Grants Competition, Office BILLING CODE 6560–50–P epa.gov. of Grants and Debarment, Office of SUPPLEMENTARY INFORMATION: Pay Administration and Resources parking is available for visitors at the Management. EQUAL EMPLOYMENT OPPORTUNITY Colonial parking lot next door in the David Bloom, Director, Office of COMMISSSION garage of the Franklin Square building. Budget, Office of the Chief Financial Visitors can also ride metro to the Officer. Sunshine Act Notice McPherson Square (Blue and Orange Barry N. Breen, Principal Deputy Line) station and leave the station via Assistant Administrator, Office of Solid AGENCY HOLDING THE MEETING: Equal the 14th Street exit. Walk two blocks Waste and Emergency Response. Employment Opportunity Commission. north on 14th Street to L Street. Turn Jeanette Brown, Director, Office of DATE AND TIME: Wednesday, November right at the corner of 14th and L Streets. Small Business Programs, Office of the 16, 2011, 8:30 a.m. Eastern Time. EPA’s 1310 L Street building is on the Administrator. PLACE: Commission Meeting Room on right towards the end of the block. Visit Rafael DeLeon (Ex-Officio), Director, the First Floor of the EEOC Office, the ISCORS Web site, www.iscors.org, Office of Civil Rights, Office of the Building, 131 ‘‘M’’ Street NE., for more detailed information. Administrator. Washington, DC 20507. Dated: November 3, 2011. Carl E. Edlund, Director, Multimedia Planning and Permitting Division, STATUS: The meeting will be open to the Anna B. Duncan, public. Acting Director, Office of Radiation and Region 6. Indoor Air. Robin Gonzalez, Director, Office of Matters To Be Considered: Information Analysis and Access, Office [FR Doc. 2011–29182 Filed 11–9–11; 8:45 am] Open Session of Environmental Information. BILLING CODE 6560–50–P Joan Harrigan-Farrelly, Director, 1. Announcement of Notation Votes, Antimicrobials Division, Office of 2. Draft Final Regulation on Disparate ENVIRONMENTAL PROTECTION Chemical Safety and Pollution Impact and Reasonable Factors Other AGENCY Prevention. Than Age Under the Age Discrimination Karen D. Higginbotham (Ex-Officio), in Employment Act, and [FRL–9489–5] Director, Executive Resources Division, 3. Overcoming Barriers to the Employment of Veterans with Senior Executive Service Performance Office of Human Resources, Office of Disabilities. Review Board; Membership Administration and Resources Management. Note: In accordance with the Sunshine Act, AGENCY: Environmental Protection Peter Jutro, Deputy Director for the meeting will be open to public Agency. Policy, National Homeland Security observation of the Commission’s

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deliberations and voting. Seating is limited The meeting was held in the Board DATES: Bank members selected for the and it is suggested that visitors arrive 30 Room of the FDIC Building located at review cycle under the FHFA’s minutes before the meeting in order to be 550—17th Street NW., Washington, DC. community support requirements processed through security and escorted to regulation must submit completed the meeting room. (In addition to publishing Dated: November 8, 2011. Community Support Statements to notices on EEOC Commission meetings in the Robert E. Feldman, FHFA on or before December 27, 2011. Federal Register, the Commission also Executive Secretary, Federal Deposit provides information about Commission Insurance Corporation. ADDRESSES: Bank members selected for meetings on its Web site, eeoc.gov., and the 2010 fourth round review cycle [FR Doc. 2011–29280 Filed 11–8–11; 4:15 pm] provides a recorded announcement a week in under the FHFA’s community support advance on future Commission sessions.) BILLING CODE P requirements regulation must submit Please telephone (202) 663–7100 completed Community Support (voice) and (202) 663–4074 (TTY) at any Statements to FHFA either by hard-copy time for information on these meetings. FEDERAL ELECTION COMMISSION mail at the Federal Housing Finance Agency, Housing Mission and Goals, The EEOC provides sign language Sunshine Act Notice interpretation and Communication 1625 Eye Street NW., Washington, DC Access Realtime Translation (CART) AGENCY: Federal Election Commission. 20006, or by electronic mail at services at Commission meetings for the hmgcommunitysupportprogram@ DATE AND TIME: Tuesday, November 15, hearing impaired. Requests for other fhfa.gov. 2011 at 10 a.m. reasonable accommodations may be FOR FURTHER INFORMATION CONTACT: made by using the voice and TTY PLACE: 999 E Street, NW., Washington, DC Rona Richardson, Office Assistant, numbers listed above. Housing Mission and Goals, Federal CONTACT PERSON FOR MORE INFORMATION: STATUS: This Meeting will be Closed to Housing Finance Agency, by telephone Stephen Llewellyn, Executive Officer on the Public. at (202) 408–2945, by electronic mail at (202) 663–4070. Items To Be Discussed [email protected], or by hard-copy mail at the Federal Housing This notice issued November 7, 2011. Compliance matters pursuant to 2 Finance Agency, 1625 Eye Street NW., Stephen Llewellyn, U.S.C. 437g. Washington, DC 20006. Executive Officer, Executive Secretariat. Audits conducted pursuant to 2 U.S.C. SUPPLEMENTARY INFORMATION: [FR Doc. 2011–29262 Filed 11–8–11; 11:15 am] 437g, 438(b), and Title 26, U.S.C. BILLING CODE 6570–01–P Matters concerning participation in civil I. Selection for Community Support actions or proceedings or arbitration. Review Internal personnel rules and procedures Section 10(g)(1) of the Federal Home FEDERAL DEPOSIT INSURANCE or matters affecting a particular Loan Bank Act (Bank Act) requires CORPORATION employee. FHFA to promulgate regulations * * * * * Sunshine Act Meeting establishing standards of community PERSON TO CONTACT FOR INFORMATION: investment or service Bank members Pursuant to the provisions of the Judith Ingram, Press Officer. Telephone: must meet in order to maintain access ‘‘Government in the Sunshine Act’’ (5 (202) 694–1220. to long-term advances. See 12 U.S.C. U.S.C. 552b), notice is hereby given that 1430(g)(1). The regulations promulgated Shawn Woodhead Werth, at 10 a.m. on Tuesday, November 8, by FHFA must take into account factors 2011, the Board of Directors of the Secretary and Clerk of the Commission. such as the Bank member’s performance Federal Deposit Insurance Corporation [FR Doc. 2011–29345 Filed 11–8–11; 4:15 pm] under the Community Reinvestment Act met in closed session to consider BILLING CODE 6715–01–P of 1977 (CRA), 12 U.S.C. 2901 et seq., matters related to the Corporation’s and record of lending to first-time supervision, corporate, and resolution homebuyers. See 12 U.S.C. 1430(g)(2). activities. FEDERAL HOUSING FINANCE Pursuant to section 10(g) of the Bank In calling the meeting, the Board AGENCY Act, FHFA has promulgated a determined, on motion of Director community support requirements Thomas J. Curry (Appointive), seconded [No. 2011–N–12] regulation that establishes standards a by Director John G. Walsh (Acting Federal Home Loan Bank Members Bank member must meet in order to Comptroller of the Currency), and Selected for Community Support maintain access to long-term advances, concurred in by Acting Chairman Review and review criteria FHFA must apply in Martin J. Gruenberg, that Corporation evaluating a member’s community business required its consideration of AGENCY: Federal Housing Finance support performance. See 12 CFR part the matters which were to be the subject Agency. 1290. The regulation includes standards of this meeting on less than seven days’ ACTION: Notice. and criteria for the two statutory notice to the public; that no earlier factors—CRA performance and record of notice of the meeting was practicable; SUMMARY: The Federal Housing Finance lending to first-time homebuyers. 12 that the public interest did not require Agency (FHFA) is announcing the CFR 1290.3. Only members subject to consideration of the matters in a Federal Home Loan Bank (Bank) the CRA must meet the CRA standard. meeting open to public observation; and members it has selected for the 2010 12 CFR 1290.3(b). All members, that the matters could be considered in fourth round review cycle under the including those not subject to CRA, a closed meeting by authority of FHFA’s community support must meet the first-time homebuyer subsections (c)(4), (c)(6), (c)(8), requirements regulation. This notice standard. 12 CFR 1290.3(c). (c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the also prescribes the deadline by which Under the rule, FHFA selects ‘‘Government in the Sunshine Act’’ (5 Bank members selected for review must approximately one-eighth of the U.S.C. 552b(c)(4), (c)(6), (c)(8), submit Community Support Statements members in each Bank district for (c)(9)(A)(ii), (c)(9)(B), and (c)(10)). to FHFA. community support review each

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calendar quarter. 12 CFR 1290.2(a). FHFA by the December 27, 2011 Statement Form (OMB No. 2590–0005), FHFA will not review an institution’s deadline prescribed in this notice. 12 which also is available on the FHFA’s community support performance until it CFR 1290.2(b)(1)(ii) and (c). On or Web site: http://www.fhfa.gov/webfiles/ has been a Bank member for at least one before November 24, 2011, each Bank 2924/FHFAForm060.pdf. Upon request, year. Selection for review is not, nor will notify the members in its district the member’s Bank also will provide should it be construed as, any that have been selected for the 2010 assistance in completing the indication of either the financial fourth round community support review Community Support Statement. condition or the community support cycle that they must complete and performance of the member. submit to FHFA by the deadline a FHFA has selected the following Each Bank member selected for Community Support Statement. 12 CFR members for the 2010 fourth round review must complete a Community 1290.2(b)(2)(i). The member’s Bank will community support review cycle: Support Statement and submit it to provide a blank Community Support

Federal Home Loan Bank of Boston—District 1

Union Savings Bank ...... Danbury ...... Connecticut Jewett City Savings Bank ...... Jewett City ...... Connecticut Naugatuck Valley Savings and Loan ...... Naugatuck ...... Connecticut Newtown Savings Bank ...... Newtown ...... Connecticut Fairfield County Bank ...... Ridgefield ...... Connecticut First County Bank ...... Stamford ...... Connecticut Patriot National Bank ...... Stamford ...... Connecticut Dutch Point Credit Union ...... Wethersfield ...... Connecticut Windsor Locks Federal Credit Union ...... Windsor Locks ...... Connecticut Athol Credit Union ...... Athol ...... Massachusetts Crescent Credit Union ...... Brockton ...... Massachusetts Brookline Bank ...... Brookline ...... Massachusetts North Cambridge Co-Operative Bank ...... Cambridge ...... Massachusetts Cambridge Trust Company ...... Cambridge ...... Massachusetts Canton Co-Operative Bank ...... Canton ...... Massachusetts Meetinghouse Co-Operative Bank ...... Dorchester ...... Massachusetts Edgartown National Bank ...... Edgartown ...... Massachusetts Fidelity Co-Operative Bank ...... Fitchburg ...... Massachusetts Greenfield Co-Operative Bank ...... Greenfield ...... Massachusetts Haverhill Bank ...... Haverhill ...... Massachusetts Leominster Credit Union ...... Leominster ...... Massachusetts The Lowell Co-operative Bank ...... Lowell ...... Massachusetts Marlborough Savings Bank ...... Marlborough ...... Massachusetts Milford Federal Savings & Loan Association ...... Milford ...... Massachusetts Natick Federal Savings Bank ...... Natick ...... Massachusetts Institution Savings in Newburyport and its Vicinity ...... Newburyport ...... Massachusetts Rockland Federal Credit Union ...... Rockland ...... Massachusetts South Coastal Bank ...... Rockland ...... Massachusetts The Cooperative Bank ...... Roslindale ...... Massachusetts Salem Five Cents Savings Bank ...... Salem ...... Massachusetts TAUPA Lithuanian Federal Credit Union ...... Boston ...... Massachusetts Southbridge Credit Union ...... Southbridge ...... Massachusetts Stoneham Savings Bank ...... Stoneham ...... Massachusetts Country Bank for Savings ...... Ware ...... Massachusetts Wellesley Bank ...... Wellesley ...... Massachusetts Cape Cod Co-Operative Bank ...... Hyannis ...... Massachusetts Northeast Bank ...... Lewiston ...... Maine Bangor Savings Bank ...... Bangor ...... Maine Bangor Federal Credit Union ...... Bangor ...... Maine Bar Harbor Savings & Loan Association ...... Bar Harbor ...... Maine York County Federal Credit Union ...... Sanford ...... Maine Centrix Bank & Trust ...... Bedford ...... New Hampshire Northway Bank ...... Berlin ...... New Hampshire Profile Bank, FSB ...... Rochester ...... New Hampshire Holy Rosary Regional Credit Union ...... Rochester ...... New Hampshire BankNewport ...... Newport ...... Rhode Island Greenwood Credit Union ...... Warwick ...... Rhode Island The Brattleboro Savings and Loan Association ...... Brattleboro ...... Vermont

Federal Home Loan Bank of New York—District 2

Cape Bank ...... Cape May Court House ...... New Jersey United Roosevelt Savings Bank ...... Carteret ...... New Jersey Unity Bank ...... Clinton ...... New Jersey First Constitution Bank ...... Cranbury ...... New Jersey Delanco Federal Savings Bank ...... Delanco ...... New Jersey Pinnacle Federal Credit Union ...... Edison ...... New Jersey Columbia Bank ...... Fair Lawn ...... New Jersey

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Haven Savings Bank ...... Hoboken ...... New Jersey 1st Bank of Sea Isle City ...... Sea Isle City ...... New Jersey Union Center National Bank ...... Union ...... New Jersey Manasquan Savings Bank ...... Wall Township ...... New Jersey Wawel Savings Bank ...... Wallington ...... New Jersey Crest Savings Bank ...... Wildwood Crest ...... New Jersey The Bridgehampton National Bank ...... Bridgehampton ...... New York Atlas Bank ...... Brooklyn ...... New York Visions Federal Credit Union ...... Endicott ...... New York Tompkins Trust Company ...... Ithaca ...... New York First National Bank of Jeffersonville ...... Jeffersonville ...... New York The National Union Bank of Kinderhook ...... Kinderhook ...... New York Mid-Hudson Valley Federal Credit Union ...... Kingston ...... New York Medina Savings & Loan Association ...... Medina ...... New York Northeast Community Bank ...... New York ...... New York Israel Discount Bank of New York ...... New York ...... New York Emigrant Bank ...... New York ...... New York NBT Bank, N.A ...... Norwich ...... New York The Oneida Savings Bank ...... Oneida ...... New York Suffolk County National Bank of Riverhead ...... Riverhead ...... New York Sawyer Savings Bank ...... Saugerties ...... New York Adirondack Bank ...... Utica ...... New York Hometown Bank of the Hudson Valley ...... Walden ...... New York First Central Savings Bank ...... Whitestone ...... New York Banco Bilbao Vizcaya Argentaria Puerto Rico ...... San Juan ...... Puerto Rico

Federal Home Loan Bank of Pittsburgh—District 3

Ing Bank, FSB ...... Wilmington ...... Delaware First National Bank of Wyoming ...... Wyoming ...... Delaware American Bank ...... Allentown ...... Pennsylvania Iron Workers Bank ...... Aston ...... Pennsylvania National Penn Bank ...... Boyertown ...... Pennsylvania Union Building and Loan Savings Bank ...... Bridgewater ...... Pennsylvania Clearfield Bank & Trust ...... Clearfield ...... Pennsylvania Centric Bank ...... Harrisburg ...... Pennsylvania Indiana First Savings Bank ...... Indiana ...... Pennsylvania The Jim Thorpe National Bank ...... Jim Thorpe ...... Pennsylvania Manor Bank ...... Manor ...... Pennsylvania Union Community Bank ...... Marietta ...... Pennsylvania Riverview National Bank ...... Marysville ...... Pennsylvania Standard Bank, PASB ...... Murrysville ...... Pennsylvania Sb1 Federal Credit Union ...... Philadelphia ...... Pennsylvania American Heritage Federal Credit Union ...... Philadelphia ...... Pennsylvania Philadelphia Trust Company ...... Philadelphia ...... Pennsylvania Customers Bank ...... Phoenixville ...... Pennsylvania Brentwood Bank ...... Pittsburgh ...... Pennsylvania PNC Bank, N.A ...... Pittsburgh ...... Pennsylvania Allegheny Valley Bank of Pittsburgh ...... Pittsburgh ...... Pennsylvania Franklin Security Bank ...... Plains ...... Pennsylvania Somerset Trust Company ...... Somerset ...... Pennsylvania Univest Bank and Trust Company ...... Souderton ...... Pennsylvania Compass Savings Bank ...... Wilmerding ...... Pennsylvania Sovereign Bank ...... Wyomissing ...... Pennsylvania Hancock County Savings Bank, FSB ...... Chester ...... West Virginia Citizens Bank of West Virginia ...... Elkins ...... West Virginia MVB Bank, Inc ...... Fairmont ...... West Virginia Fayette County National Bank ...... Fayetteville ...... West Virginia The Bank of Romney ...... Romney ...... West Virginia Progressive Bank, N.A ...... Wheeling ...... West Virginia

Federal Home Loan Bank of Atlanta—District 4

America’s First Federal Credit Union ...... Birmingham ...... Alabama First Educators Credit Union ...... Birmingham ...... Alabama First Bank of Boaz ...... Boaz ...... Alabama Town-country National Bank ...... Camden ...... Alabama Coosa Pines Federal Credit Union ...... Childersburg ...... Alabama EvaBank ...... Eva ...... Alabama Escambia County Bank ...... Flomaton ...... Alabama First Federal Bank ...... Fort Payne ...... Alabama Traders & Farmers Bank ...... Haleyville ...... Alabama City Bank of Hartford ...... Hartford ...... Alabama Worthington Federal Bank ...... Huntsville ...... Alabama

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Pinnacle Bank ...... Jasper ...... Alabama Marion Bank and Trust Company ...... Marion ...... Alabama Bank of Pine Hill ...... Pine Hill ...... Alabama First Federal Bank, A FSB ...... Tuscaloosa ...... Alabama Alabama Credit Union ...... Tuscaloosa ...... Alabama AmeriFirst Bank ...... Union Springs ...... Alabama Small Town Bank ...... Wedowee ...... Alabama Bank of York ...... York ...... Alabama Independence Federal Savings Bank ...... Washington ...... District of Columbia Library of Congress Federal Credit Union ...... Washington ...... District of Columbia Bank of Delmarva ...... Seaford ...... Delaware First Southern Bank ...... Boca Raton ...... Florida Platinum Bank ...... Brandon ...... Florida Citizens Bank and Trust ...... Frostproof ...... Florida Columbia Bank ...... Lake City ...... Florida Pacific National Bank ...... Miami ...... Florida City National Bank of Florida ...... Miami ...... Florida Intercredit Bank, N.A ...... Miami ...... Florida Northern Trust, National Association ...... Miami ...... Florida Farmers and Merchants Bank ...... Monticello ...... Florida The First National Bank of Mount Dora ...... Mount Dora ...... Florida Fairwinds Credit Union ...... Orlando ...... Florida Community Credit Union of Florida ...... Rockledge ...... Florida Cornerstone Community Bank ...... St. Petersburg ...... Florida Valrico State Bank ...... Valrico ...... Florida Grand Bank & Trust of Florida ...... West Palm Beach ...... Florida The Perkins State Bank ...... Williston ...... Florida Albany Bank & Trust ...... Albany ...... Georgia SunTrust Bank, Atlanta ...... Atlanta ...... Georgia First Port City Bank ...... Bainbridge ...... Georgia Peoples State Bank and Trust ...... Baxley ...... Georgia Bank of Early ...... Blakely ...... Georgia Tippins Bank and Trust Company ...... Claxton ...... Georgia The Citizens Bank of Forsyth County ...... Cumming ...... Georgia First Bank of Dalton ...... Dalton ...... Georgia Alliance National Bank ...... Dalton ...... Georgia Decatur First Bank ...... Decatur ...... Georgia The Bank of Edison ...... Edison ...... Georgia Colony Bank ...... Fitzgerald ...... Georgia Community Banking Company of Fitzgerald ...... Fitzgerald ...... Georgia Commercial Banking Company ...... Hahira ...... Georgia Farmers State Bank ...... Lumpkin ...... Georgia The Security State Bank ...... McRae ...... Georgia First Bank of Coastal Georgia ...... Pembroke ...... Georgia First Peoples Bank ...... Pine Mountain ...... Georgia Citizens Bank of Washington County ...... Sandersville ...... Georgia Bank of Hancock County ...... Sparta ...... Georgia Thomas County Federal Savings & Loan Association ...... Thomasville ...... Georgia Stephens Federal Bank ...... Toccoa ...... Georgia Bank of Dade ...... Trenton ...... Georgia Altamaha Bank & Trust Company ...... Uvalda ...... Georgia Vidalia Federal Savings Bank ...... Vidalia ...... Georgia Bank of Dooly ...... Vienna ...... Georgia The Peoples Bank ...... Willacoochee ...... Georgia Talbot State Bank ...... Woodland ...... Georgia Harford Bank ...... Aberdeen ...... Maryland Chesapeake Bank of Maryland ...... Baltimore ...... Maryland Arundel Federal Savings Bank ...... Baltimore ...... Maryland Rosedale Federal Savings & Loan Association ...... Baltimore ...... Maryland Madison Square Federal Savings Bank ...... Baltimore ...... Maryland Fairmount Bank ...... Baltimore ...... Maryland Hopkins Federal Savings Bank ...... Baltimore ...... Maryland Municipal Employees Credit Union of Baltimore ...... Baltimore ...... Maryland Marriott Employees Federal Credit Union ...... Bethesda ...... Maryland U.S. Postal Service Federal Credit Union ...... Clinton ...... Maryland The Patapsco Bank ...... Dundalk ...... Maryland OBA Bank ...... Germantown ...... Maryland Community Bank of Tri-County ...... Waldorf ...... Maryland Woodsboro Bank ...... Woodsboro ...... Maryland Asheville Savings Bank ...... Asheville ...... North Carolina Crescent State Bank ...... Cary ...... North Carolina Charlotte Metro Credit Union ...... Charlotte ...... North Carolina First Trust Bank ...... Charlotte ...... North Carolina First Federal Bank ...... Dunn ...... North Carolina

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North Carolina Community Federal Credit Union ...... Goldsboro ...... North Carolina First FSB of Lincolnton ...... Lincolnton ...... North Carolina Lumbee Guaranty Bank ...... Pembroke ...... North Carolina N.C. Local Government Employees Federal Credit Union ...... Raleigh ...... North Carolina Roanoke Valley Savings Bank, SSB ...... Roanoke Rapids ...... North Carolina Roxboro Savings Bank, SSB ...... Roxboro ...... North Carolina First South Bank ...... Washington ...... North Carolina Truliant Federal Credit Union ...... Winston Salem ...... North Carolina Abbeville Savings and Loan Association ...... Abbeville ...... South Carolina The Conway National Bank ...... Conway ...... South Carolina First Piedmont Federal Savings & Loan Association of Gaffney ...... Gaffney ...... South Carolina South Carolina Telco Federal Credit Union ...... Greenville ...... South Carolina Mutual Savings Bank ...... Hartsville ...... South Carolina The Commercial Bank ...... Honea Path ...... South Carolina Founders Federal Credit Union ...... Lancaster ...... South Carolina First Community Bank, N.A ...... Lexington ...... South Carolina Pee Dee Federal Savings Bank ...... Marion ...... South Carolina South Carolina Federal Credit Union ...... North Charleston ...... South Carolina Family Trust Federal Credit Union ...... Rock Hill ...... South Carolina Oconee Federal Savings and Loan ...... Seneca ...... South Carolina Seneca National Bank ...... Seneca ...... South Carolina Community First Bank ...... Walhalla ...... South Carolina Bank of Walterboro ...... Walterboro ...... South Carolina Citizens Bank and Trust Company ...... Blackstone ...... Virginia Monarch Bank ...... Chesapeake ...... Virginia Cardinal Bank ...... Fairfax ...... Virginia Alliance Bank Corporation ...... Fairfax ...... Virginia Acacia Federal Savings Bank ...... Falls Church ...... Virginia Virginia Savings Bank, FSB ...... Front Royal ...... Virginia Virginia Community Bank ...... Louisa ...... Virginia Martinsville First Savings Bank ...... Martinsville ...... Virginia TowneBank ...... Portsmouth ...... Virginia Millennium Bank, NA ...... Reston ...... Virginia Partners Financial Federal Credit Union ...... Richmond ...... Virginia

Federal Home Loan Bank of Cincinnati—District 5

Home Federal Savings & Loan Association ...... Ashland ...... Kentucky Kentucky Federal Savings & Loan Association ...... Covington ...... Kentucky Casey County Bank ...... Liberty ...... Kentucky Louisville Community Development ...... Louisville ...... Kentucky Home Savings Bank, FSB ...... Ludlow ...... Kentucky First Guaranty Bank ...... Martin ...... Kentucky Bank of Maysville ...... Maysville ...... Kentucky Hart County Bank and Trust ...... Munfordville ...... Kentucky The Farmers Bank ...... Nicholasville ...... Kentucky Independence Bank of Kentucky ...... Owensboro ...... Kentucky First Security Bank of Owensboro ...... Owensboro ...... Kentucky Owingsville Banking Company ...... Owingsville ...... Kentucky Family Bank, FSB ...... Paintsville ...... Kentucky Community Trust Bank, Inc ...... Pikeville ...... Kentucky Madison Bank ...... Richmond ...... Kentucky Cumberland Security Bank ...... Somerset ...... Kentucky Citizens National Bank of Somerset ...... Somerset ...... Kentucky Commercial Bank ...... West Liberty ...... Kentucky Antwerp Exchange Bank ...... Antwerp ...... Ohio Hocking Valley Bank ...... Athens ...... Ohio Rockhold Brown & Company Bank ...... Bainbridge ...... Ohio Citizens Federal Savings & Loan Association ...... Bellefontaine ...... Ohio Citizens Bank Company ...... Beverly ...... Ohio Mercer Savings Bank ...... Celina ...... Ohio Cheviot Savings Bank ...... Cincinnati ...... Ohio Cincinnati Federal Savings & Loan Association ...... Cincinnati ...... Ohio The North Side Bank & Trust ...... Cincinnati ...... Ohio The Home Loan Savings Bank ...... Coshocton ...... Ohio The Covington Savings & Loan Association ...... Covington ...... Ohio The Citizens Bank of De Graff ...... De Graff ...... Ohio Midwest Community Federal Credit Union ...... Defiance ...... Ohio First National Bank of Germantown ...... Germantown ...... Ohio Chaco Credit Union, Incorporated ...... Hamilton ...... Ohio The Hicksville Bank ...... Hicksville ...... Ohio The Delaware County B&T Company ...... Lewis Center ...... Ohio The Home Builders Association ...... Lynchburg ...... Ohio The Bank of Magnolia Company ...... Magnolia ...... Ohio

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The Citizens Savings Bank ...... Martins Ferry ...... Ohio Peoples First Savings Bank ...... Mason ...... Ohio Western Reserve Bank ...... Medina ...... Ohio Bramble Savings Bank ...... Milford ...... Ohio The Commercial & Savings Bank ...... Millersburg ...... Ohio Peoples National Bank ...... New Lexington ...... Ohio The First National Bank of Pandora ...... Pandora ...... Ohio Century Bank, FSB ...... Parma ...... Ohio Farmers Bank & Savings Company ...... Pomeroy ...... Ohio The St. Henry Bank ...... Saint Henry ...... Ohio The Arlington Bank ...... Upper Arlington ...... Ohio The Commercial Savings Bank ...... Upper Sandusky ...... Ohio First Citizens N.B. of Upper Sandusky ...... Upper Sandusky ...... Ohio Versailles Savings and Loan Company ...... Versailles ...... Ohio First National Bank of Waverly ...... Waverly ...... Ohio Kemba Credit Union, Inc ...... West Chester ...... Ohio Spring Valley Bank ...... Wyoming ...... Ohio Home Savings and Loan Company ...... Youngstown ...... Ohio Athens Federal Community Bank ...... Athens ...... Tennessee People’s Bank & Trust Company of Pickett ...... Byrdstown ...... Tennessee Bank of Camden ...... Camden ...... Tennessee Legends Bank ...... Clarksville ...... Tennessee Fort Campbell Federal Credit Union ...... Clarksville ...... Tennessee Greenfield Banking Company ...... Greenfield ...... Tennessee First Peoples Bank of Tennessee ...... Jefferson City ...... Tennessee Lawrenceburg Federal Bank, FSB ...... Lawrenceburg ...... Tennessee Community Bank ...... Lexington ...... Tennessee Union Bank & Trust Company ...... Livingston ...... Tennessee BankTennessee ...... Memphis ...... Tennessee City of Memphis Credit Union ...... Memphis ...... Tennessee Farmers State Bank ...... Mountain City ...... Tennessee Tennessee Credit Union ...... Nashville ...... Tennessee Citizens Savings Bank & Trust Company ...... Nashville ...... Tennessee First Trust & Savings Bank ...... Oneida ...... Tennessee The First National Bank of Oneida ...... Oneida ...... Tennessee Citizens Bank & Trust Company ...... Rutledge ...... Tennessee The Bank of Waynesboro ...... Waynesboro ...... Tennessee

Federal Home Loan Bank of Indianapolis—District 6

Hoosier Heartland State Bank ...... Crawfordsville ...... Indiana The Elberfeld State Bank ...... Elberfeld ...... Indiana Forum Credit Union ...... Fishers ...... Indiana Mutual Savings Bank ...... Franklin ...... Indiana First Federal Savings & Loan Association of Hammond ...... Hammond ...... Indiana The Lafayette Life Insurance Company ...... Lafayette ...... Indiana Farmers State Bank ...... Lagrange ...... Indiana West End Savings Bank ...... Richmond ...... Indiana The Scott County State Bank ...... Scottsburg ...... Indiana Communitywide Federal Credit Union ...... South Bend ...... Indiana Indiana State University Federal Credit Union ...... Terre Haute ...... Indiana Encompass Credit Union ...... Tipton ...... Indiana Purdue Employees Federal Credit Union ...... West Lafayette ...... Indiana TLC Community Credit Union ...... Adrian ...... Michigan Sunrise Family Credit Union ...... Bay City ...... Michigan Fidelity Bank ...... Dearborn ...... Michigan First Independence Bank ...... Detroit ...... Michigan Communicating Arts Credit Union ...... Detroit ...... Michigan Michigan State University Federal Credit Union ...... East Lansing ...... Michigan Northern Michigan Bank ...... Escanaba ...... Michigan Citizens Bank ...... Flint ...... Michigan Mercantile Bank of Michigan ...... Grand Rapids ...... Michigan Lake Michigan Credit Union ...... Grand Rapids ...... Michigan Northpointe Bank ...... Grand Rapids ...... Michigan Mainstreet Savings Bank, FSB ...... Hastings ...... Michigan The Bank of Holland ...... Holland ...... Michigan Honor State Bank ...... Honor ...... Michigan First National Bank & Trust Company of Iron Mountain ...... Iron Mountain ...... Michigan Mayville State Bank ...... Mayville ...... Michigan Wolverine Federal Savings & Loan Association ...... Midland ...... Michigan Dow Chemical Employees Credit Union ...... Midland ...... Michigan Northland Area Federal Credit Union ...... Oscoda ...... Michigan Port Austin State Bank ...... Port Austin ...... Michigan Sturgis Bank & Trust Company, FSB ...... Sturgis ...... Michigan

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Federal Home Loan Bank of Chicago—District 7

Southeast National Bank ...... Moline ...... Illinois Citizens National Bank of Albion ...... Albion ...... Illinois Anna-Jonesboro National Bank ...... Anna ...... Illinois Arcola First Bank ...... Arcola ...... Illinois The First National Bank of Arenzville ...... Arenzville ...... Illinois Ben Franklin Bank of Illinois ...... Arlington Heights ...... Illinois West Central Bank ...... Ashland ...... Illinois The Atlanta National Bank ...... Atlanta ...... Illinois Scott State Bank ...... Bethany ...... Illinois First State Bank of Bloomington ...... Bloomington ...... Illinois Midland Federal Savings & Loan Association ...... Bridgeview ...... Illinois First National Bank of Brookfield ...... Brookfield ...... Illinois Farmers and Merchants State Bank of Bushnell ...... Bushnell ...... Illinois Byron Bank ...... Byron ...... Illinois First State Bank of Campbell Hill ...... Campbell Hill ...... Illinois Carrollton Bank ...... Carrollton ...... Illinois Bank of Chestnut ...... Chestnut ...... Illinois Second Federal Savings & Loan Association of Chicago ...... Chicago ...... Illinois Royal Savings Bank ...... Chicago ...... Illinois Hoyne Savings Bank ...... Chicago ...... Illinois Loomis Federal Savings & Loan Association ...... Chicago ...... Illinois North Side Federal Savings & Loan Association of Chicago ...... Chicago ...... Illinois Seaway Bank and Trust Company ...... Chicago ...... Illinois American Metro Bank ...... Chicago ...... Illinois Chicago Patrolmen’s Federal Credit Union ...... Chicago ...... Illinois MB Financial Bank, National Association ...... Chicago ...... Illinois Central Federal Savings & Loan Association ...... Cicero ...... Illinois Central State Bank ...... Clayton ...... Illinois De Witt Savings Bank ...... Clinton ...... Illinois First Collinsville Bank ...... Collinsville ...... Illinois First United Bank ...... Crete ...... Illinois Crystal Lake Bank & Trust Company, N.A ...... Crystal Lake ...... Illinois Soy Capital Bank and Trust Company ...... Decatur ...... Illinois Baxter Credit Union ...... Deerfield ...... Illinois Better Banks ...... Dunlap ...... Illinois Community First Bank ...... Fairview Heights ...... Illinois Bank of Farmington ...... Farmington ...... Illinois First State Bank of Forrest ...... Forrest ...... Illinois Community State Bank ...... Galva ...... Illinois The Gifford State Bank ...... Gifford ...... Illinois Harvard Savings Bank ...... Harvard ...... Illinois Premier Bank of Jacksonville ...... Jacksonville ...... Illinois Joy State Bank ...... Joy ...... Illinois First Trust Bank of Illinois ...... Kankakee ...... Illinois First National Bank of Lagrange ...... Lagrange ...... Illinois Exchange State Bank ...... Lanark ...... Illinois The Lemont National Bank ...... Lemont ...... Illinois State Bank of Lincoln ...... Lincoln ...... Illinois Prairie Community Bank ...... Marengo ...... Illinois The First National Bank ...... Mattoon ...... Illinois A J Smith Federal Savings Bank ...... Midlothian ...... Illinois Security Savings Bank ...... Monmouth ...... Illinois Farmers State Bank & Trust Company ...... Mount Sterling ...... Illinois First County Bank ...... New Baden ...... Illinois Warren-Boynton State Bank ...... New Berlin ...... Illinois The Peoples State Bank of Newton, Illinois ...... Newton ...... Illinois The Old Exchange N.B. of Okawville ...... Okawville ...... Illinois First Personal Bank ...... Orland Park ...... Illinois Ottawa Savings Bank ...... Ottawa ...... Illinois Peoples Bank & Trust ...... Pana ...... Illinois State Bank of Paw Paw, Illinois ...... Paw Paw ...... Illinois Farmers-Merchants National Bank of Paxton ...... Paxton ...... Illinois Town and Country Bank of Quincy ...... Quincy ...... Illinois Community State Bank of Rock Falls ...... Rock Falls ...... Illinois Alpine Bank of Illinois ...... Rockford ...... Illinois Rushville State Bank ...... Rushville ...... Illinois AmericaUnited Bank and Trust Company USA ...... Schaumburg ...... Illinois American Chartered Bank ...... Schaumburg ...... Illinois State Bank of Speer ...... Speer ...... Illinois Illini Bank ...... Springfield ...... Illinois Tuscola National Bank ...... Tuscola ...... Illinois Petefish, Skiles & Company ...... Virginia ...... Illinois

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Community Bank ...... Winslow ...... Illinois State Bank ...... Wonder Lake ...... Illinois Portage County Bank ...... Almond ...... Wisconsin Pioneer Bank ...... Auburndale ...... Wisconsin First Bank of Baldwin ...... Baldwin ...... Wisconsin Black River Country Bank ...... Black River Falls ...... Wisconsin Bonduel State Bank ...... Bonduel ...... Wisconsin Bank Mutual ...... Brown Deer ...... Wisconsin Bank of Cashton ...... Cashton ...... Wisconsin Farmers and Merchants Union Bank ...... Columbus ...... Wisconsin Wisconsin Community Bank ...... Cottage Grove ...... Wisconsin Cumberland Federal Bank, FSB ...... Cumberland ...... Wisconsin Town Bank ...... Delafield ...... Wisconsin Cornerstone Community Bank ...... Grafton ...... Wisconsin Bay Bank ...... Green Bay ...... Wisconsin Highland State Bank ...... Highland ...... Wisconsin Park Bank ...... Holmen ...... Wisconsin Security State Bank ...... Iron River ...... Wisconsin East Wisconsin Savings Bank, S.A ...... Kaukauna ...... Wisconsin The Greenwood’s State Bank ...... Lake Mills ...... Wisconsin First National Bank—Fox Valley ...... Menasha ...... Wisconsin Bank of Milton ...... Milton ...... Wisconsin Clare Bank, N.A ...... Platteville ...... Wisconsin Mound City Bank ...... Platteville ...... Wisconsin First National Bank of Platteville ...... Platteville ...... Wisconsin The First National Bank of River Falls ...... River Falls ...... Wisconsin Intercity State Bank ...... Schofield ...... Wisconsin Community Bank & Trust ...... Sheboygan ...... Wisconsin Bank of Sun Prairie ...... Sun Prairie ...... Wisconsin Walworth State Bank ...... Walworth ...... Wisconsin First Federal Savings Bank of Wisconsin ...... Waukesha ...... Wisconsin KeySavings Bank ...... Wisconsin Rapids ...... Wisconsin WoodTrust Bank, N.A ...... Wisconsin Rapids ...... Wisconsin River Cities Bank ...... Wisconsin Rapids ...... Wisconsin

Federal Home Loan Bank of Des Moines—District 8

Landmands Bank ...... Audubon ...... Iowa Commercial Savings Bank ...... Carroll ...... Iowa Page County State Bank ...... Clarinda ...... Iowa Linn County State Bank ...... Coggon ...... Iowa Farmers Savings Bank ...... Colesburg ...... Iowa Iowa Savings Bank ...... Carroll ...... Iowa Okey-Vernon First National Bank ...... Corning ...... Iowa Alliant Credit Union ...... Dubuque ...... Iowa First National Bank in Fairfield ...... Fairfield ...... Iowa Farmers Savings Bank ...... Fostoria ...... Iowa Grinnell Mutual Reinsurance Company ...... Grinnell ...... Iowa Security State Bank ...... Hubbard ...... Iowa First State Bank of Mapleton ...... Mapleton ...... Iowa Maxwell State Bank ...... Maxwell ...... Iowa Bridge Community Bank ...... Mount Vernon ...... Iowa State Bank & Trust Company ...... Nevada ...... Iowa First Newton National Bank ...... Newton ...... Iowa American State Bank ...... Osceola ...... Iowa Panora State Bank ...... Panora ...... Iowa Marion County State Bank ...... Pella ...... Iowa Savings Bank ...... Primghar ...... Iowa Readlyn Savings Bank ...... Readlyn ...... Iowa Premier Bank ...... Rock Valley ...... Iowa Home State Bank ...... Royal ...... Iowa Iowa State Bank ...... Sac City ...... Iowa Sanborn Savings Bank ...... Sanborn ...... Iowa The State Bank ...... Spirit Lake ...... Iowa The State Bank of Toledo ...... Toledo ...... Iowa Iowa State Bank ...... Wapello ...... Iowa Security State Bank ...... Waverly ...... Iowa First State Bank ...... Webster City ...... Iowa Freedom Financial Bank ...... West Des Moines ...... Iowa Union State Bank ...... Winterset ...... Iowa Farmers & Merchants State Bank ...... Winterset ...... Iowa Altura State Bank ...... Altura ...... Minnesota American National Bank of Minnesota ...... Baxter ...... Minnesota First State Bank and Trust ...... Bayport ...... Minnesota

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First National Bank Bemidji ...... Bemidji ...... Minnesota F & M Bank Minnesota ...... Clarkfield ...... Minnesota The First National Bank of Coleraine ...... Coleraine ...... Minnesota Woodland Bank ...... Remer ...... Minnesota Farmers State Bank of Dent ...... Dent ...... Minnesota Northwestern Bank, N.A ...... Dilworth ...... Minnesota Western National Bank ...... Duluth ...... Minnesota Fidelity Bank ...... Edina ...... Minnesota State Bank of Fairmont ...... Fairmont ...... Minnesota Franklin State Bank ...... Franklin ...... Minnesota Commerce Bank ...... Geneva ...... Minnesota The First National Bank of Gilbert ...... Gilbert ...... Minnesota Eagle Bank ...... Glenwood ...... Minnesota First Southeast Bank ...... Harmony ...... Minnesota Farmers State Bank of Hartland ...... Hartland ...... Minnesota First Community Bank Lester Prairie ...... Lester Prairie ...... Minnesota Center National Bank ...... Litchfield ...... Minnesota Exchange State Bank ...... Hills ...... Minnesota Northern Star Bank ...... Mankato ...... Minnesota CornerStone State Bank ...... Montgomery ...... Minnesota United Farmers & Merchants State Bank ...... Morris ...... Minnesota Citizens State Bank Norwood Young America ...... Norwood Young America ...... Minnesota Odin State Bank ...... Odin ...... Minnesota PrinsBank ...... Prinsburg ...... Minnesota Randall State Bank ...... Randall ...... Minnesota Home Federal Savings Bank ...... Rochester ...... Minnesota North Star Bank ...... Roseville ...... Minnesota Unity Bank ...... Rush City ...... Minnesota First State Bank Southwest ...... Pipestone ...... Minnesota First Community Bank Silver Lake ...... Silver Lake ...... Minnesota Integrity Bank Plus ...... Wabasso ...... Minnesota Citizens State Bank of Waverly, Inc ...... Waverly ...... Minnesota Wells Federal Bank, a Federal Savings Bank ...... Wells ...... Minnesota St. Paul Postal Employees Credit Union ...... Woodbury ...... Minnesota Worthington Federal Savings Bank, FSB ...... Worthington ...... Minnesota Community First Bank ...... Appleton City ...... Missouri First Missouri National Bank ...... Brookfield ...... Missouri Carroll County Trust Company ...... Carrollton ...... Missouri Investors National Bank ...... Chillicothe ...... Missouri Chillicothe State Bank ...... Chillicothe ...... Missouri Concordia Bank of Concordia ...... Concordia ...... Missouri Ozarks Federal Savings and Loan Association ...... Farmington ...... Missouri First State Community Bank ...... Farmington ...... Missouri The Callaway Bank ...... Fulton ...... Missouri Northland National Bank ...... Gladstone ...... Missouri Bank Northwest ...... Hamilton ...... Missouri HNB National Bank ...... Hannibal ...... Missouri Eagle Bank & Trust Company of Missouri ...... Hillsboro ...... Missouri Bank of Iberia ...... Iberia ...... Missouri Lamar Bank and Trust Company ...... Lamar ...... Missouri Summit Bank of Kansas City ...... Lee’s Summit ...... Missouri Legends Bank ...... Linn ...... Missouri First National Bank ...... Malden ...... Missouri Wood & Huston Bank ...... Marshall ...... Missouri Community Bank of Marshall ...... Marshall ...... Missouri The First National Bank of Audrain County ...... Mexico ...... Missouri Peoples Bank of the Ozarks ...... Nixa ...... Missouri First Midwest Bank of the Ozarks ...... Piedmont ...... Missouri Peoples Savings Bank of Rhineland ...... Rhineland ...... Missouri The State Bank ...... Richmond ...... Missouri First State Bank of St. Charles, Missouri ...... Saint Charles ...... Missouri Town & Country Bank ...... Salem ...... Missouri Farmers State Bank, SB ...... Schell City ...... Missouri Third National Bank ...... Sedalia ...... Missouri Senath State Bank ...... Senath ...... Missouri The Community Bank of Shell Knob ...... Shell Knob ...... Missouri Old Missouri Bank ...... Springfield ...... Missouri Midwest BankCentre ...... St. Louis ...... Missouri Bank of Thayer ...... Thayer ...... Missouri Quarry City Savings & Loan Association ...... Warrensburg ...... Missouri First State Bank of Cando ...... Cando ...... North Dakota Citizens State Bank—Midwest ...... Cavalier ...... North Dakota U.S. Bank National Association, North Dakota ...... Fargo ...... North Dakota Union State Bank of Fargo ...... Fargo ...... North Dakota

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State Bank & Trust of Kenmare ...... Kenmare ...... North Dakota Farmers and Merchants State Bank ...... Langdon ...... North Dakota First Western Bank & Trust ...... Minot ...... North Dakota Lakeside State Bank ...... New Town ...... North Dakota McKenzie County Bank ...... Watford City ...... North Dakota BankStar Financial ...... Elkton ...... South Dakota Dakotaland Federal Credit Union ...... Huron ...... South Dakota Home Federal Bank ...... Sioux Falls ...... South Dakota Great Western Bank ...... Sioux Falls ...... South Dakota First State Bank ...... Wilmot ...... South Dakota First National Bank South Dakota ...... Yankton ...... South Dakota

Federal Home Loan Bank of Dallas—District 9

First Community Bank ...... Batesville ...... Arkansas Farmers Bank & Trust Company ...... Blytheville ...... Arkansas Centennial Bank ...... Conway ...... Arkansas River Town Bank ...... Dardanelle ...... Arkansas First Financial Bank ...... El Dorado ...... Arkansas Fordyce Bank & Trust Company ...... Fordyce ...... Arkansas Forrest City Bank, N.A ...... Forrest City ...... Arkansas Benefit Bank ...... Ft. Smith ...... Arkansas First State Bank of Northwest Arkansas ...... Huntsville ...... Arkansas Simmons First Bank of South Arkansas ...... Lake Village ...... Arkansas Allied Bank ...... Mulberry ...... Arkansas First National Bank at Paris ...... Paris ...... Arkansas Delta Trust & Bank ...... Parkdale ...... Arkansas Pine Bluff National Bank ...... Pine Bluff ...... Arkansas Simmons First Bank of Northwest Arkansas ...... Rogers ...... Arkansas Red River Bank ...... Alexandria ...... Louisiana E Federal Credit Union ...... Baton Rouge ...... Louisiana Bank of Coushatta ...... Coushatta ...... Louisiana St. Tammany Homestead Association ...... Covington ...... Louisiana City Savings Bank & Trust Company ...... De Ridder ...... Louisiana Teche Federal Bank ...... Franklin ...... Louisiana Florida Parishes Bank ...... Hammond ...... Louisiana Synergy Bank ...... Houma ...... Louisiana Coastal Commerce Bank ...... Houma ...... Louisiana Mutual Savings and Loan Association ...... Metairie ...... Louisiana Eureka Homestead ...... Metairie ...... Louisiana Hibernia Homestead Bank ...... New Orleans ...... Louisiana Peoples Bank and Trust Company ...... New Roads ...... Louisiana American Gateway Bank ...... Port Allen ...... Louisiana Richland State Bank ...... Rayville ...... Louisiana Bank of Ringgold ...... Ringgold ...... Louisiana Bank of Ruston ...... Ruston ...... Louisiana Bank of St. Francisville ...... St. Francisville ...... Louisiana The Bank of Commerce ...... White Castle ...... Louisiana Amory Federal Savings & Loan Association ...... Amory ...... Mississippi Spirit Bank ...... Belmont ...... Mississippi The Peoples Bank ...... Biloxi ...... Mississippi Bank of Brookhaven ...... Brookhaven ...... Mississippi The Cleveland State Bank ...... Cleveland ...... Mississippi Commerce National Bank ...... Corinth ...... Mississippi Bank of Holly Springs ...... Holly Springs ...... Mississippi Britton & Koontz Bank, N.A ...... Natchez ...... Mississippi Sycamore Bank ...... Senatobia ...... Mississippi Mechanics Bank ...... Water Valley ...... Mississippi First National Bank ...... Alamogordo ...... New Mexico International Bank ...... Raton ...... New Mexico Tucumcari Federal Savings & Loan Association ...... Tucumcari ...... New Mexico First State Bank ...... Athens ...... Texas Community Resource Credit Union ...... Baytown ...... Texas Fannin Bank ...... Bonham ...... Texas Texas Heritage Bank ...... Cross Plains ...... Texas Zavala County Bank ...... Crystal City ...... Texas NexBank, SSB ...... Dallas ...... Texas Beal Bank, SSB ...... Dallas ...... Texas Credit Union of Texas ...... Dallas ...... Texas First United Bank ...... Dimmitt ...... Texas First National Bank of Dublin ...... Dublin ...... Texas Union State Bank ...... Florence ...... Texas OmniAmerican Bank ...... Fort Worth ...... Texas Security National Bank of Quanah ...... Frisco ...... Texas

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Community Bank ...... Granbury ...... Texas Community National Bank ...... Hondo ...... Texas MetroBank, N.A ...... Houston ...... Texas Central Bank ...... Houston ...... Texas Reliance Standard Life Insurance Company ...... Houston ...... Texas Southwestern National Bank ...... Houston ...... Texas Austin Bank, Texas N.A ...... Jacksonville ...... Texas Texas State Bank ...... Joaquin ...... Texas Pinnacle Bank ...... Keene ...... Texas First National Bank of Lake Jackson ...... Lake Jackson ...... Texas First Federal Bank Littlefield, Texas ...... Littlefield ...... Texas PlainsCapital Bank ...... Lubbock ...... Texas The Mason National Bank ...... Mason ...... Texas Mineola Community Bank, SSB ...... Mineola ...... Texas First Financial Bank, N.A ...... Mineral Wells ...... Texas The American National Bank Mt. Pleasant ...... Mount Pleasant ...... Texas Commercial Bank of Texas, N.A...... Nacogdoches ...... Texas Western National Bank ...... Odessa ...... Texas Security Bank ...... Odessa ...... Texas Orange Savings Bank, SSB ...... Orange ...... Texas Lone Star National Bank ...... Pharr ...... Texas South Padre Bank, N.A ...... South Padre ...... Texas First Financial Bank, N.A ...... Southlake ...... Texas Woodforest National Bank ...... The Woodlands ...... Texas First National Bank of Trinity ...... Trinity ...... Texas Citizens State Bank ...... Tyler ...... Texas First National Bank of Bosque County ...... Valley Mills ...... Texas First National Bank of Central Texas ...... Waco ...... Texas Extraco Banks, N.A ...... Waco ...... Texas Community Bank & Trust ...... Waco ...... Texas

Federal Home Loan Bank of Topeka—District 10

Premier Members Federal Credit Union ...... Boulder ...... Colorado First National Bank, Cortez ...... Cortez ...... Colorado Del Norte Savings & Loan Association ...... Del Norte ...... Colorado Premier Bank—Denver, Colorado ...... Denver ...... Colorado Citywide Banks—Aurora, Colorado ...... Denver ...... Colorado Rocky Mountain Law Enforcement Federal Credit Union ...... Denver ...... Colorado Bank of the San Juans ...... Durango ...... Colorado Fort Morgan State Bank ...... Fort Morgan ...... Colorado Points West Community Bank ...... Julesburg ...... Colorado Kit Carson State Bank ...... Kit Carson ...... Colorado The State Bank ...... La Junta ...... Colorado Home State Bank ...... Loveland ...... Colorado First Colorado National Bank ...... Paonia ...... Colorado Home Savings Bank ...... Chanute ...... Kansas Bank of Commerce ...... Chanute ...... Kansas Farmers & Merchants Bank of Colby ...... Colby ...... Kansas Legacy Bank ...... Colwich ...... Kansas The State Bank of Conway Springs ...... Conway Springs ...... Kansas Farmers and Drovers Bank ...... Council Grove ...... Kansas Citizens State Bank & Trust Company ...... Ellsworth ...... Kansas State Bank of Fredonia ...... Fredonia ...... Kansas Gardner Bank ...... Gardner ...... Kansas Community Bank of the Midwest ...... Great Bend ...... Kansas The Halstead Bank ...... Halstead ...... Kansas Security Bank of Kansas City ...... Kansas City ...... Kansas Douglas County Bank ...... Lawrence ...... Kansas National Bank of Kansas City ...... Leawood ...... Kansas The Lyons State Bank ...... Lyons ...... Kansas The Farmers State Bank ...... McPherson ...... Kansas The Mission Bank ...... Mission ...... Kansas Carson Bank ...... Mulvane ...... Kansas The Farmers State Bank of Oakley ...... Oakley ...... Kansas Valley View State Bank ...... Overland Park ...... Kansas Citizens State Bank ...... Paola ...... Kansas University Bank ...... Pittsburg ...... Kansas Alliant Bank ...... Sedgwick ...... Kansas TriCentury Bank ...... Simpson ...... Kansas First Bank ...... Sterling ...... Kansas The Valley State Bank ...... Syracuse ...... Kansas The Tampa State Bank ...... Tampa ...... Kansas Kaw Valley Bank ...... Topeka ...... Kansas

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Community Bank ...... Topeka ...... Kansas Chisholm Trail State Bank ...... Wichita ...... Kansas Intrust Bank, National Association ...... Wichita ...... Kansas Bank of the Valley ...... Bellwood ...... Nebraska Bank of Bennington ...... Bennington ...... Nebraska Washington County Bank ...... Blair ...... Nebraska Custer Federal Savings & Loan Association ...... Broken Bow ...... Nebraska First Central Bank ...... Cambridge ...... Nebraska Citizens State Bank ...... Carleton ...... Nebraska CerescoBank ...... Ceresco ...... Nebraska First Bank and Trust Company ...... Cozad ...... Nebraska Jefferson County Bank ...... Daykin ...... Nebraska First National Bank in Exeter ...... Exeter ...... Nebraska First State Bank ...... Farnam ...... Nebraska First State Bank and Trust ...... Fremont ...... Nebraska Gothenburg State Bank ...... Gothenburg ...... Nebraska Five Points Bank of Hastings ...... Hastings ...... Nebraska Henderson State Bank ...... Henderson ...... Nebraska Farmers State Bank ...... Maywood ...... Nebraska First Central Bank McCook, N.A ...... McCook ...... Nebraska Farmers and Merchants Bank ...... Milligan ...... Nebraska Centennial Bank ...... Omaha ...... Nebraska First National Bank of Omaha ...... Omaha ...... Nebraska The Potter State Bank of Potter ...... Potter ...... Nebraska Peoples-Webster County Bank ...... Red Cloud ...... Nebraska Citizens Bank of Ada ...... Ada ...... Oklahoma The First National Bank in Altus ...... Altus ...... Oklahoma The FNB and Trust Company of Broken Arrow ...... Broken Arrow ...... Oklahoma Farmers Exchange Bank ...... Cherokee ...... Oklahoma The First National Bank and Trust Company ...... Chickasha ...... Oklahoma 1st Bank Oklahoma ...... Claremore ...... Oklahoma Kirkpatrick Bank ...... Edmond ...... Oklahoma The Bank of Union ...... El Reno ...... Oklahoma Bank of Western Oklahoma ...... Elk City ...... Oklahoma Liberty Federal Savings Bank ...... Enid ...... Oklahoma Fairview Savings & Loan Association ...... Fairview ...... Oklahoma Stockmans Bank—Altus, OK ...... Gould ...... Oklahoma Oklahoma State Bank ...... Guthrie ...... Oklahoma The City NB&T Company of Guymon ...... Guymon ...... Oklahoma The Bank of Kremlin ...... Kremlin ...... Oklahoma Liberty National Bank ...... Lawton ...... Oklahoma The Morris State Bank ...... Morris ...... Oklahoma Oklahoma Educators Credit Union—Oklahoma ...... Oklahoma City ...... Oklahoma First Security Bank and Trust Company ...... Oklahoma City ...... Oklahoma Osage Federal Bank ...... Pawhuska ...... Oklahoma NBC Bank ...... Pawhuska ...... Oklahoma Exchange Bank and Trust Company ...... Perry ...... Oklahoma The Central National Bank of Poteau ...... Poteau ...... Oklahoma First Pryority Bank ...... Pryor ...... Oklahoma Peoples Bank & Trust Company ...... Ryan ...... Oklahoma InterBank ...... Sayre ...... Oklahoma Southwest State Bank ...... Sentinel ...... Oklahoma Advantage Bank ...... Spencer ...... Oklahoma Bank of Commerce ...... Stilwell ...... Oklahoma American Bank and Trust Company ...... Tulsa ...... Oklahoma Security Bank ...... Tulsa ...... Oklahoma Sooner State Bank ...... Tuttle ...... Oklahoma First State Bank ...... Valliant ...... Oklahoma First State Bank ...... Watonga ...... Oklahoma Peoples Bank ...... Westville ...... Oklahoma The Bank of Wyandotte ...... Wyandotte ...... Oklahoma The Yukon National Bank ...... Yukon ...... Oklahoma

Federal Home Loan Bank of San Francisco—District 11

Los Angeles National Bank ...... Buena Park ...... California Burbank City Federal Credit Union ...... Burbank ...... California Pacific Trust Bank ...... Chula Vista ...... California Financial Partners Credit Union ...... Downey ...... California Centennial Bank ...... Fountain Valley ...... California Murphy Bank ...... Fresno ...... California USC Credit Union ...... Los Angeles ...... California Heritage Oaks Bank ...... Paso Robles ...... California Provident Credit Union ...... Redwood Shores ...... California

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Provident Savings Bank ...... Riverside ...... California Five Star Bank ...... Rocklin ...... California First U.S. Community Credit Union ...... Sacramento ...... California Neighborhood National Bank ...... San Diego ...... California Bank of The Orient ...... San Francisco ...... California Pacific Coast Bankers’ Bank ...... San Francisco ...... California Meriwest Credit Union ...... San Jose ...... California Santa Cruz Community Credit Union ...... Santa Cruz ...... California Bank of Stockton ...... Stockton ...... California Universal Bank, FSB ...... West Covina ...... California First Republic Bank ...... San Francisco ...... California Pinnacle Bank (AZ) ...... Scottsdale ...... Arizona Professional Business Bank ...... Pasadena ...... California River City Bank ...... Sacramento ...... California Royal Business Bank ...... Los Angeles ...... California San Mateo Credit Union ...... Redwood City ...... California

Federal Home Loan Bank of Seattle—District 12

Credit Union 1 ...... Anchorage ...... Alaska ANZ Guam, Inc ...... Agana ...... Guam Panhandle State Bank ...... Sandpoint ...... Idaho First Citizens Bank of Butte ...... Butte ...... Montana Dutton State Bank ...... Dutton ...... Montana Valley Bank of Glasgow ...... Glasgow ...... Montana 1st Liberty Federal Credit Union ...... Great Falls ...... Montana Independence Bank ...... Havre ...... Montana Manhattan Bank ...... Manhattan ...... Montana First Security Bank of Missoula ...... Missoula ...... Montana Community Bank-Missoula, Inc ...... Missoula ...... Montana Community Bank, Inc...... Ronan ...... Montana Basin State Bank ...... Stanford ...... Montana Evergreen Federal Savings & Loan Association ...... Grants Pass ...... Oregon Bank of Eastern Oregon ...... Heppner ...... Oregon South Valley Bank & Trust ...... Klamath Falls ...... Oregon USU Charter Federal Credit Union ...... Logan ...... Utah Wells Fargo Bank Northwest, N.A ...... Salt Lake City ...... Utah Franklin Templeton Bank & Trust, FSB ...... Salt Lake City ...... Utah American Marine Bank ...... Bainbridge Island ...... Washington Riverview Community Bank ...... Camas ...... Washington The Bank of Washington ...... Edmonds ...... Washington Fife Commercial Bank ...... Fife ...... Washington Whidbey Island Bank ...... Oak Harbor ...... Washington Olympia Federal Savings & Loan Association ...... Olympia ...... Washington TwinStar Credit Union ...... Olympia ...... Washington First Federal Savings & Loan Association of Port Angeles ...... Port Angeles ...... Washington Seattle Bank ...... Seattle ...... Washington Our Community Credit Union ...... Shelton ...... Washington Western United Life Assurance Company ...... Spokane ...... Washington Yakima Federal Savings & Loan Association ...... Yakima ...... Washington Buffalo Federal Savings Bank ...... Buffalo ...... Wyoming Hilltop National Bank ...... Casper ...... Wyoming Tri-County Bank ...... Cheyenne ...... Wyoming Big Horn Federal Savings Bank ...... Greybull ...... Wyoming Oregon Trail Bank ...... Guernsey ...... Wyoming Rocky Mountain Bank ...... Rock Springs ...... Wyoming Rock Springs National Bank ...... Rock Springs ...... Wyoming Pinnacle Bank—Wyoming ...... Torrington ...... Wyoming

II. Public Comments 12 CFR 1290.2(b)(2)(ii). In reviewing a Federal Housing Finance Agency, member for community support Housing Mission and Goals, 1625 Eye To encourage the submission of compliance, FHFA will consider any Street NW., Washington, DC 20006, or public comments on the community public comments it has received by electronic mail to hmgcommunity support performance of Bank members, concerning the member. 12 CFR [email protected] on or before on or before November 24, 2011, each Bank will notify its Advisory Council 1290.2(d). To ensure consideration by the December 27, 2011 deadline for and nonprofit housing developers, FHFA, comments concerning the submission of Community Support community groups, and other interested community support performance of Statements. parties in its district of the members members selected for the 2010 fourth selected for community support review round review cycle must be delivered to in the 2010 fourth round review cycle. FHFA, either by hard-copy mail at the

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Dated: November 4, 2011. Transportation Intermediaries, 46 CFR FEDERAL MARITIME COMMISSION Edward J. DeMarco, part 515, effective on the corresponding Acting Director, Federal Housing Finance date shown below: Ocean Transportation Intermediary Agency. License Number: 004505NF. License; Reissuance [FR Doc. 2011–29164 Filed 11–9–11; 8:45 am] Name: Freight Masters Systems, BILLING CODE 8070–01–P International, Inc. Notice is hereby given that the Address: 2629 Waterfront Parkway following Ocean Transportation East Drive, Suite 300, Indianapolis, IN Intermediary licenses have been FEDERAL MARITIME COMMISSION 46214. reissued by the Federal Maritime Date Revoked: October 15, 2011. Commission pursuant to section 19 of Ocean Transportation Intermediary License Number: 020624N. the Shipping Act of 1984 (46 U.S.C. License; Revocation Name: OTA Logistic Inc. chapter 409) and the regulations of the Address: 7300 Alondra Blvd., Suite The Federal Maritime Commission Commission pertaining to the licensing 108, Paramount, CA 90723. of Ocean Transportation Intermediaries, hereby gives notice that the following Date Revoked: October 21, 2011. Ocean Transportation Intermediary 46 CFR part 515. licenses have been revoked pursuant to Sandra L. Kusumoto, section 19 of the Shipping Act of 1984 Director, Bureau of Certification and (46 U.S.C. chapter 409) and the Licensing. regulations of the Commission [FR Doc. 2011–29083 Filed 11–9–11; 8:45 am] pertaining to the licensing of Ocean BILLING CODE 6730–01–P

License No. Name/address Date reissued

002391F ...... Silva, Leonel dba Best Forwarders, 411 North Oak Street, Inglewood, CA 90302 ...... September 22, 2011. 019453N ...... La Onion Shipping Co., Inc., 1680 Jerome Avenue, Bronx, NY 10453 ...... October 2, 2011.

Sandra L. Kusumoto, Individual), Allaix Augustin, Acting Secretary. Application Type: Director, Bureau of Certification and Secretary. Application Type: QI New NVO & OFF License. Licensing. Change. I.T. Freight Corporation (NVO & OFF), [FR Doc. 2011–29085 Filed 11–9–11; 8:45 am] Enter To USA LLC (NVO & OFF), 1553 1970 NW 129 Avenue, Suite 105, BILLING CODE 6730–01–P NW 82nd Avenue, Miami, FL 33126. Miami, FL 33182. Officers: Nicolas I. Officers: Melissa O. Meier, Manager Cassis, Secretary (Qualifying (Qualifying Individual), Julio A. Individual), Jorge Zambrano, FEDERAL MARITIME COMMISSION Aniat, Manager. Application Type: President/Treasurer. Application New NVO & OFF License. Type: New NVO & OFF License. Ocean Transportation Intermediary Kamino International Transport, Inc. License; Applicants Forward System Logistics Inc. (NVO), 144–54 156th Street, Jamaica, NY dba Kamino Ocean (NVO & OFF), Notice is hereby given that the 11434. Officers: Victor Leung, 145th Avenue & Hook Creek Blvd., following applicants have filed with the Secretary (Qualifying Individual), Valley Stream, NY 11581. Officers: Federal Maritime Commission an Jerry Lo, President/Treasurer. Jeffrey Hudson, Vice President of application for a license as a Non- Application Type: QI Change. Operations (Qualifying Individual), Robert Snelson, CEO/Director. Vessel-Operating Common Carrier G J Cargo Corp (NVO & OFF), 2000 NW Application Type: QI Change. (NVO) and/or Ocean Freight Forwarder 84 Avenue, #228, Miami, FL 33122. Kin Services, Inc. (OFF), 2027 (OFF)—Ocean Transportation Officers: Carolina R. Jaramillo Saad, Winwright Court, Palatine, IL 60074. Intermediary (OTI) pursuant to section Vice President/Secretary (Qualifying Officers: Majetete Balanganayi, 19 of the Shipping Act of 1984 as Individual), German Jaramillo, President (Qualifying Individual), amended (46 U.S.C. chapter 409 and 46 President. Application Type: New Ngalula I. Balanganayi, Secretary. CFR 515). Notice is also hereby given of NVO & OFF License. the filing of applications to amend an Application Type: New OFF License. existing OTI license or the Qualifying Global Freight Express, L.L.C. (NVO), Linear Shipping, Inc. (NVO & OFF), Individual (QI) for a license. 8417 NW 68 Street, Miami, FL 33166. 5919 Ridgeway Drive, Grand Prairie, Interested persons may contact the Officers: Isidro A. Castro, Manager TX 75052. Officer: Syed S. Rabi-ul- Office of Transportation Intermediaries, (Qualifying Individual), Roza M. Hassan, President/Secretary/Treasurer Federal Maritime Commission, Castro, Manager. Application Type: (Qualifying Individual). Application Washington, DC 20573, by telephone at New NVO License. Type: License Transfer. (202) 523–5843 or by email at Green Line Shipping & Logistics Nunez Shipping Inc (NVO), 1388 NW [email protected]. Services Inc. (NVO & OFF), 16230 29th Street, Miami, FL 33142. Accurate Cargo Services (NVO), 141 Lake View Lane, Apple Valley, CA Officers: Emigdio O. Nunez, Vice South 2nd Street, Montebello, CA 92307. Officer: Monwar Hussain, President (Qualifying Individual), 91640. Officer: Stephanie L. Kong, President (Qualifying Individual). Osvaldo Nunez, President. President/Secretary/Treasurer Application Type: Name Change/Add Application Type: New NVO License. (Qualifying Individual). Application NVO Service. Priority Air Express, LLC dba Priority Type: New NVO License. Investment Logistic Solution Corp (NVO Marine Express dba Priority Solutions Alomar Transport, Inc. (NVO & OFF), & OFF), 6701 NW. 7th Street, #135, International (NVO & OFF), 11 150–30 132nd Avenue, Suite 303, Miami, FL 33126. Officers: Maria E. Technology Drive, Suite A, Jamaica, NY 11434. Officers: Patricia Arias, Vice President (Qualifying Swedesboro, NJ 08085. Officers: Irina A. Lally, President (Qualifying Individual), Enid Gonzalez, President/ Freidel, Vice President (Qualifying

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Individual), William Ciminello, information collection that has been 452–3829). Telecommunications Device Director/President. Application Type: extended, revised, or implemented on or for the Deaf (TDD) users may contact QI Change. after October 1, 1995, unless it displays (202) 263–4869, Board of Governors of Seafair USA, LLC. (NVO & OFF), 10813 a currently valid OMB control number. the Federal Reserve System, NW 30 Street, Miami, FL 33172. DATES: Comments must be submitted on Washington, DC 20551. Officers: Claudio R. Lopez, Managing or before January 9, 2012. SUPPLEMENTARY INFORMATION: Member (Qualifying Individual), Peter ADDRESSES: You may submit comments, Doeschner, Member. Application Request for Comment on Information identified by FR 2320 or FR Y–8 by any Collection Proposals Type: New NVO & OFF License. of the following methods: Tazmanian Freight Forwarding, Inc. • Agency Web Site: http:// The following information (NVO & OFF), 4949 Old Grayton www.federalreserve.gov. Follow the collections, which are being handled Road, Cleveland, OH 44135. Officers: instructions for submitting comments at under this delegated authority, have Jeffrey W. Schumacher, Vice http://www.federalreserve.gov/ received initial Board approval and are President of International (Qualifying generalinfo/foia/ProposedRegs.cfm. hereby published for comment. At the Individual), Robert D. Rossbach, Chief • Federal eRulemaking Portal: http:// end of the comment period, the Executive Officer. Application Type: www.regulations.gov. Follow the proposed information collections, along New NVO & OFF License. instructions for submitting comments. with an analysis of comments and Tecnoship Group, Corp. (NVO), 8233 • Email: regs.comments@ recommendations received, will be NW 68 Street, Miami, FL 33166. federalreserve.gov. Include docket submitted to the Board for final Officers: Karla S. Guevara, Director number in the subject line of the approval under OMB delegated (Qualifying Individual), Jose F. message. authority. Comments are invited on the Rodriguez, President. Application • Fax: (202) 452–3819 or (202) 452– following: Type: New NVO License. 3102. a. Whether the proposed collection of Yes Logistics Corporation (NVO & OFF), • Mail: Jennifer J. Johnson, Secretary, information is necessary for the proper 3675 E. Huntington Drive, Suite 210, Board of Governors of the Federal performance of the Federal Reserve’s Pasadena, CA 91107. Officers: John S. Reserve System, 20th Street and functions; including whether the Hsi, Assistant Vice President, Frank Constitution Avenue NW., Washington, information has practical utility; Chao, Director/President (Qualifying DC 20551. b. The accuracy of the Federal Individual). Application Type: QI All public comments are available Reserve’s estimate of the burden of the Change. from the Board’s Web site at proposed information collection, Dated: November 4, 2011. www.federalreserve.gov/generalinfo/ including the validity of the Karen V. Gregory, foia/ProposedRegs.cfm as submitted, methodology and assumptions used; c. Ways to enhance the quality, Secretary. unless modified for technical reasons. Accordingly, your comments will not be utility, and clarity of the information to [FR Doc. 2011–29086 Filed 11–9–11; 8:45 am] edited to remove any identifying or be collected; BILLING CODE 6730–01–P contact information. Public comments d. Ways to minimize the burden of may also be viewed electronically or in information collection on respondents, paper form in Room MP–500 of the including through the use of automated FEDERAL RESERVE SYSTEM Board’s Martin Building (20th and C collection techniques or other forms of information technology; and Proposed Agency Information Streets, NW.) between 9 a.m. and 5 p.m. on weekdays. e. Estimates of capital or start up costs Collection Activities; Comment and costs of operation, maintenance, Request Additionally, commenters should send a copy of their comments to the and purchase of services to provide AGENCY: Board of Governors of the OMB Desk Officer—Shagufta Ahmed— information. Federal Reserve System. Office of Information and Regulatory Proposal To Approve Under OMB SUMMARY: On June 15, 1984, the Office Affairs, Office of Management and Delegated Authority the of Management and Budget (OMB) Budget, New Executive Office Building, Implementation of the Following delegated to the Board of Governors of Room 10235, 725 17th Street NW., Report Washington, DC 20503 or by fax to (202) the Federal Reserve System (Board) its Report title: Quarterly Savings and 395–6974. approval authority under the Paperwork Loan Holding Company Report. Reduction Act (PRA), pursuant to 5 CFR FOR FURTHER INFORMATION CONTACT: A Agency form number: FR 2320. 1320.16, to approve of and assign OMB copy of the PRA OMB submission, OMB control number: 7100—to be control numbers to collection of including the proposed reporting form assigned. information requests and requirements and instructions, supporting statement, Frequency: Quarterly. conducted or sponsored by the Board and other documentation will be placed Reporters: Top and lower-tier savings under conditions set forth in 5 CFR into OMB’s public docket files, once and loan holding companies (SLHCs). 1320 Appendix A.1. Board-approved approved. These documents will also be Estimated annual reporting hours: collections of information are made available on the Federal Reserve 400 hours. incorporated into the official OMB Board’s public Web site at: http:// Estimated average hours per response: inventory of currently approved www.federalreserve.gov/boarddocs/ 2.5 hours. collections of information. Copies of the reportforms/review.cfm or may be Number of respondents: 40. Paperwork Reduction Act Submission, requested from the agency clearance General description of report: This supporting statements and approved officer, whose name appears below. information collection is mandatory collection of information instruments Federal Reserve Board Clearance pursuant to section 312 of the Dodd- are placed into OMB’s public docket Officer—Cynthia Ayouch—Division of Frank Act; and section 10 of the Home files. The Federal Reserve may not Research and Statistics, Board of Owners’ Loan Act (HOLA), as amended conduct or sponsor, and the respondent Governors of the Federal Reserve by section 369 of the Dodd-Frank Act is not required to respond to, an System, Washington, DC 20551, (202) authorizing the Federal Reserve to

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collect information on the FR 2320. structure data. The new report would be 31,294 hours; Institutions without Public Law 111–203, § 312(b)(1) and 12 effective as of the March 31, 2012, covered transactions, 18,204 hours. U.S.C. 1467a(b)(2), as amended by report date. The proposed FR 2320 Estimated average hours per response: Public Law 111–201, § 369(8). report would generally be filed by the Institutions with covered transactions, The Federal Reserve has determined top-tier SLHCs. However, in situations 7.8 hours; Institutions without covered that a few of the items that the Office where the top-tier SLHC is not the direct transactions, 1 hour. of Thrift Supervision (OTS) had deemed owner of the thrift or does not control Number of respondents: Institutions confidential—specifically, the FR 2320 the thrift, a lower tier SLHC may be with covered transactions, 1,003; counterparts to items HC850, HC855, required to file instead of the top-tier Institutions without covered and HC860 on Schedule HC of the Thrift SLHC. In addition, lower tier SLHCs transactions, 4,551. Financial Report (TFR; OMB No. 1557– may voluntarily file Schedule HC or General description of report: This 0255)—may be protected from may be required to file in addition to the information collection is mandatory disclosure under exemption 4 of the top-tier for safety and soundness pursuant to section 5(c) of the Bank Freedom of Information Act (FOIA), (5 purposes. Holding Company Act (12 U.S.C. U.S.C. 552(b)(4)). The proposed new report would be 1844(c)) and section 225.5(b) of With regard to the remaining items submitted quarterly as of the end of Regulation Y (12 CFR 225.5(b)). The the OTS had deemed confidential on March, June, September, and December. data are confidential pursuant to the Schedule HC, the SLHC may request, in If a SLHC has a quarter-end other than Freedom of Information Act (5 U.S.C. writing, confidential treatment of such a calendar quarter-end, data from the 552(b)(4)). Section (b)(4) exempts information under one or more of the fiscal quarter ending within the information deemed competitively exemptions in FOIA, 5 U.S.C. 552(b). calendar quarter may be used to sensitive from disclosure. All such requests for confidential complete the FR 2320.3 The filing Abstract: This reporting form collects treatment would be reviewed on a case- deadline would be 45 calendar days information on transactions between an by-case basis and in response to a after the March 31, June 30, September insured depository institution and its specific request for disclosure. 30, and December 31 as-of date. affiliates that are subject to section 23A Current actions: The Federal Reserve Respondents would be required to of the Federal Reserve Act. The primary proposes to implement the Quarterly submit all items of the proposed FR purpose of the data is to enhance the Savings and Loan Holding Company 2320 report, both financial and non- Federal Reserve’s ability to monitor Report (FR 2320) from SLHCs exempt financial, electronically using the bank exposures to affiliates and to from initially filing Federal Reserve Federal Reserve’s Internet Electronic ensure banks’ compliance with section regulatory reports.1 These data would be Submission (IESUB) application. The 23A of the Federal Reserve Act. Section the same as data previously collected on IESUB application would validate the 23A of the Federal Reserve Act is one Schedule HC of the TFR.2 Title III of the report data for mathematical and logical of the most important statutes on Dodd-Frank Act transferred all former consistency, calculate derived items, limiting exposures to individual OTS authorities (including rulemaking) and provide the reporting institution institutions and protecting against the related to SLHCs to the Federal Reserve with a confirmation receipt of its expansion of the federal safety net. on July 21, 2011. Consequently, the submission. Any respondent interested Board of Governors of the Federal Reserve Federal Reserve became responsible for in learning more about the IESUB System, November 4, 2011. the consolidated supervision of SLHCs application would be directed to the Robert deV. Frierson, beginning July 21, 2011. These data Federal Reserve Bank Services— Deputy Secretary of the Board. would assist the Federal Reserve in the Reporting Central Web site and their [FR Doc. 2011–29088 Filed 11–9–11; 8:45 am] evaluation of a diversified holding Federal Reserve Bank contact (http:// BILLING CODE 6210–01–P company and in determining whether www.frbservices.org/centralbank/ an SLHC is in compliance with reportingcentral/index.html). applicable laws and regulations. Data Proposal to approve under OMB DEPARTMENT OF HEALTH AND collected with the proposed FR 2320 delegated authority the extension for HUMAN SERVICES would contribute to the analyses of the three years, without revision, of the overall financial condition of exempt following report: Determination Concerning a Petition SLHCs to ensure safe and sound Report title: Bank Holding Company To Add a Class of Employees to the operations. Report of Insured Depository Special Exposure Cohort The proposed new FR 2320 would Institutions’ Section 23A Transactions collect parent only and consolidated with Affiliates. AGENCY: National Institute for financial data and organizational Agency form number: FR Y–8. Occupational Safety and Health OMB control number: 7100–0126. (NIOSH), Department of Health and 1 Under the current reporting proposal for SLHCs Frequency: Quarterly. Human Services (HHS). Reporters: Top-tier bank holding (76 FR 53129), an exempt SLHC meets one of the ACTION: Notice. following criteria (1) formed under section companies (BHCs), including financial 10(c)(9)(C) of the Home Owners’ Loan Act (HOLA) holding companies (FHCs), for all SUMMARY: HHS gives notice of a whose saving association subsidiaries’ consolidated assets make up less than 5 percent of the total insured depository institutions that are determination concerning a petition to consolidated assets of the SLHCs, or (2) its top-tier owned by the BHC and by foreign add a class of employees from the Piqua holding company is an insurance company that banking organizations (FBOs) that Organic Moderated Reactor, Piqua, only prepares financial statements using statutory directly own a U.S. subsidiary bank. Ohio, to the Special Exposure Cohort accounting principles. The definition of an exempt Estimated annual reporting hours: SLHC is subject to change, based on comments (SEC) under the Energy Employees received from the public during the comment Institutions with covered transactions, Occupational Illness Compensation period. Program Act of 2000 (EEOICPA), 42 2 Early in 2011, the Office of the Comptroller of 3 For example, if the SLHC’s fiscal year end is U.S.C. 7384q. On October 26, 2011, the the Currency, the Federal Reserve, Federal Deposit October, its fiscal quarter-ends are January, April, Insurance Corporation, and the Office of Thrift July, and October. Therefore, the fiscal quarter Secretary of HHS determined that the Supervision issued notice of the elimination of the ending January 31 would be reported for the March following class of employees does not TFR after the December 31, 2011, report date. 31 calendar quarter for the FR 2320. meet the statutory criteria for addition

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to the SEC as authorized under can also be submitted by email to meets the requirements set out in EEOICPA: [email protected]. Section 1311(d) of the Affordable Care Act. In order to ensure that a State All employees of the Department of John Howard, Energy, its predecessor agencies, and their seeking certification as a State Exchange Director, National Institute for Occupational meets all applicable requirements the contractors and subcontractors who worked Safety and Health. in any location at the Piqua Organic Secretary will require a State to submit Moderated Reactor during the operational [FR Doc. 2011–29173 Filed 11–9–11; 8:45 am] an application for approval during the period from January 1, 1963 through May 1, BILLING CODE 4163–19–P Fall of 2012 and to demonstrate 1966. operational readiness through virtual and on-site readiness review. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND Submission of this application may be Stuart L. Hinnefeld, Director, Division HUMAN SERVICES through various means including online of Compensation Analysis and Support, or by paper. This application may be National Institute for Occupational Centers for Medicare & Medicaid adjusted to reflect final rules. Form Safety and Health (NIOSH), 4676 Services Number: CMS–10415 (OCN: 0938–New) Columbia Parkway, MS C–46, [Document Identifier: CMS–10415] Frequency: Once; Affected Public: State, Cincinnati, OH 45226, Telephone Local, or Tribal governments; Number of 1–(877) 222–7570. Information requests Agency Information Collection Respondents: 56; Number of Responses: can also be submitted by email to Activities: Proposed Collection; 56; Total Annual Hours: 11,816. (For [email protected]. Comment Request policy questions regarding this John Howard, AGENCY: Centers for Medicare & collection, contact Sarah Summer (301) Director, National Institute for Occupational Medicaid Services, HHS. 492–4443. For all other issues call (410) Safety and Health. In compliance with the requirement 786–1326.) [FR Doc. 2011–29169 Filed 11–9–11; 8:45 am] of section 3506(c)(2)(A) of the To obtain copies of the supporting BILLING CODE 4163–19–P Paperwork Reduction Act of 1995, the statement and any related forms for the Centers for Medicare & Medicaid proposed paperwork collections Services (CMS) is publishing the referenced above, access CMS’ Web site DEPARTMENT OF HEALTH AND following summary of proposed at http://www.cms.gov/ HUMAN SERVICES collections for public comment. PaperworkReductionActof1995/PRAL/ Interested persons are invited to send list.asp#TopOfPage or email your Determination Concerning a Petition comments regarding this burden request, including your address, phone To Add a Class of Employees to the estimate or any other aspect of this number, OMB number, and CMS Special Exposure Cohort collection of information, including any document identifier, to of the following subjects: (1) The [email protected], or call the AGENCY: National Institute for necessity and utility of the proposed Reports Clearance Office at 410–786– Occupational Safety and Health information collection for the proper 1326. (NIOSH), Department of Health and performance of the agency’s functions; Human Services (HHS). In commenting on the proposed (2) the accuracy of the estimated information collections please reference ACTION: Notice. burden; (3) ways to enhance the quality, the document identifier or OMB control utility, and clarity of the information to number. To be assured consideration, SUMMARY: HHS gives notice of a be collected; and (4) the use of comments and recommendations must determination concerning a petition to automated collection techniques or be submitted in one of the following add a class of employees from the other forms of information technology to ways by January 9, 2012: Norton Co. (or a subsequent owner), minimize the information collection Worcester, Massachusetts, to the Special burden. 1. Electronically. You may submit Exposure Cohort (SEC) under the Energy 1. Type of Information Collection your comments electronically to http:// Employees Occupational Illness Request: New collection; Title of www.regulations.gov. Follow the Compensation Program Act of 2000 Information Collection: State Exchange instructions for ‘‘Comment or (EEOICPA), 42 U.S.C. 7384q. On Certification Application Use: All States Submission’’ or ‘‘More Search Options’’ October 26, 2011, the Secretary of HHS (including the 50 States, consortia of to find the information collection determined that the following class of States, and the District of Columbia document(s) accepting comments. employees does not meet the statutory herein referred to as States) have the 2. By regular mail. You may mail criteria for addition to the SEC as opportunity under Section 1311(b) of written comments to the following authorized under EEOICPA: the Affordable Care Act to establish an address: CMS, Office of Strategic Exchange no later than January 1, 2014. Operations and Regulatory Affairs, All Atomic Weapons Employees who Given the innovative nature of worked in any building or area at the facility Division of Regulations Development, Exchanges and the statutorily- owned by Norton Co. (or a subsequent Attention: Document Identifier/OMB owner) in Worcester, Massachusetts, from prescribed relationship between the Control Number, Room C4–26–05, 7500 October 11, 1962, through October 31, 2009. Secretary and States in their Security Boulevard, Baltimore, development and operation, it is critical Maryland 21244–1850. FOR FURTHER INFORMATION CONTACT: that the Secretary work closely with Stuart L. Hinnefeld, Director, Division States to provide necessary guidance Dated: November 7, 2011. of Compensation Analysis and Support, and technical assistance to ensure that Martique Jones, National Institute for Occupational States can meet the prescribed Director, Regulations Development Group, Safety and Health (NIOSH), 4676 timelines, federal requirements, and Division B, Office of Strategic Operations and Columbia Parkway, MS C–46, goals of the statute. Regulatory Affairs. Cincinnati, OH 45226, Telephone States seeking to establish an [FR Doc. 2011–29144 Filed 11–9–11; 8:45 am] 1–(877) 222–7570. Information requests Exchange must build an Exchange that BILLING CODE 4120–01–P

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DEPARTMENT OF HEALTH AND program policies, procedures and makes determinations of eligibility for HUMAN SERVICES interpretations to provide program the Unaccompanied Refugee Minors direction. The Office monitors and (URM) Program. Administration for Children and evaluates the performances of States and The Office prepares annual budget Families other public and private agencies in estimates and related materials; and administering these programs and develops regulations, legislative Office of Refugee Resettlement; supports actions to improve them. It proposals, and routine interpretations of Statement of Organization, Functions, provides leadership and direction in the policy as they relate to each of the and Delegations of Authority development and coordination of program areas. The Office performs allocation and tracking of funds for all AGENCY: Administration for Children national public and private programs and Families, HHS. that provide assistance to refugees, programs. The Office collects data and asylees, Cuban and Haitian entrants, performs analysis on the changing needs ACTION: Notice. and certain Amerasians and victims of of the refugee and entrant population; SUMMARY: Statement of Organizations, severe forms of trafficking in persons. provides leadership to identify data Functions, and Delegations of The Office is also responsible for the needs and sources, and formulates data Authority. The Administration for care and custody of unaccompanied and reporting requirements. Children and Families has reorganized alien children, the issuance of eligibility Within the Office, the Deputy Director the Office of Refugee Resettlement. This letters for victims of severe forms of assumes the Director’s responsibilities reorganization includes the organization trafficking in persons, the provision of in the absence of the Director and provides oversight to the Division of and its substructure components as specific consent in Special Immigrant Refugee Health, Division of Refugee listed in this document. This Juvenile status cases, and the policies, Services and the Division of Refugee reorganization establishes the Division procedures and interpretations needed Assistance. of Refugee Health. It renames the in these program areas. KR.10 Organization. The Office of The Associate Deputy Director Division of Community Resettlement to provides oversight to the Division of the Division of Refugee Services. It Refugee Resettlement (ORR) is headed by a Director who reports directly to the Children’s Services and the Division of renames the Division of Unaccompanied Anti-Trafficking in Persons. Assistant Secretary for Children and Children’s Services to the Division of B. Division of Refugee Assistance Families. Children’s Services. It deletes the represents ORR in coordinating services The Office is organized as follows: Division of Budget, Policy, and Data and capacity for refugees in a manner Analysis and moves the function to the Office of the Director (KRA); that helps refugees to become employed Office of the Director. The notice also Division of Refugee Assistance (KRE); and economically self-sufficient as soon serves to establish an Associate Deputy Division of Refugee Services (KRF); after their arrival in the United States. Director position. Division of Children’s Services (KRH); The Division monitors and provides FOR FURTHER INFORMATION CONTACT: Division of Anti-Trafficking in Persons technical assistances to the State- Eskinder Negash, Director, Office of (KRI); administered domestic assistance Refugee Resettlement, Administration Division of Refugee Health (KRJ). programs and Wilson/Fish projects. The for Children and Families, 901 D Street KR.20 Functions. A. The Office of the Division works closely with each state SW., Washington, DC 20447, (202) 401– Director is directly responsible to the in designing a resettlement program 9246. Assistant Secretary for Children and specific to the needs of incoming This notice amends Part K of the Families for carrying out ORR’s mission populations. The Division develops Statement of Mission, Organization, and providing guidance and general guidance and procedures for their Functions, and Delegations of Authority supervision to the components of ORR. implementation; manages special of the Department of Health and Human The Office provides direction in the initiatives to increase refugee self- Services (HHS), Administration for development of general supervision to sufficiency such as through state funded Children and Families (ACF) as follows: the components of ORR. The Office discretionary grants or pilot programs. Chapter KR, the Office of Refugee provides direction in the development The Division also assists public and Resettlement (ORR) (73 FR 5199), as last of program policy and budget and in the private agencies on data reporting and amended January 29, 2008. formulation of salaries and expense the resolution of reporting problems. Under Chapter KR, Office of Refugee budgets. Staff also provide The Division develops and supports the Resettlement, delete KR in its entirety administrative and personnel support flow of information on refugee profiles and replace with the following: services. and community resources in support of KR.00 Mission. The Office of Refugee The Office coordinates with the lead effective placement at the State and Resettlement (ORR) advises the refugee and entrant program offices of local level. The Division works closely Secretary, through the Assistant other Federal departments; provides with the Department of State to ensure Secretary for Children and Families, on leadership in representing refugee and effective and seamless orientation from matters relating to refugee resettlement, entrant programs, policies and overseas to local resettlement immigration, victims of severe forms of administration to a variety of community. The Division manages the trafficking in persons, victims of torture, governmental entities and other public effective allocation of formula social unaccompanied alien children and the and private interests; and acts as the services and targeted assistance in repatriation of U.S. citizens. The Office coordinator of the total refugee and support of newly arriving populations. plans, develops and directs entrant resettlement effort for ACF and The Division tracks all state costs implementation of a comprehensive the Department. The Office oversees the related to refugee assistance. program for domestic refugee and care and custody of unaccompanied C. Division of Refugee Services directs entrant resettlement assistance to alien children, grants specific consent and manages effective refugee include cash assistance, medical for those who wish to invoke the resettlement through the programmatic assistance and associated social services jurisdiction of a state court for a implementation of grants, contracts and in support of early self-sufficiency. It dependency order to seek Special special initiatives, such as the Match develops, recommends, and issues Immigrant Juvenile (SIJ) status and Grant Program. The Division oversees

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and monitors most ORR discretionary Division administers the pro bono legal Dated: November 1, 2011. grants; recommends grantee allocation; services and child advocate program George H. Sheldon, coordinates with the grants management and compiles a state-by-state list of Acting Assistant Secretary for Children and office to review the financial professionals or entities qualified to Families. expenditures under discretionary grant provide the children with a guardian [FR Doc. 2011–29075 Filed 11–9–11; 8:45 am] programs; provides data in support of and attorney representational services. BILLING CODE 4120–27–P apportionment requests; and provides technical assistance on discretionary E. Division of Anti-Trafficking in grants operations. The Division Persons is responsible for implementing DEPARTMENT OF HEALTH AND coordinates and provides liaison with certain provisions of the Trafficking HUMAN SERVICES the Department and other Federal Victims Protection Act. The Division agencies on discretionary grant coordinates the certification of, and Food and Drug Administration services to, victims of severe forms of operational issues and other activities as [Docket No. FDA–2011–D–0787] specified by the Director or required by trafficking, promotes public awareness Congressional mandate. The Division on human trafficking, and increases Draft Guidance for Industry and Food responds to unanticipated refugee and identification of potential victims of and Drug Administration Staff; entrant arrivals or significant increases severe forms of trafficking. The Division Investigational Device Exemptions for in arrivals to communities where manages these activities through grants Early Feasibility Medical Device adequate or appropriate services do not and contracts. It also coordinates with Clinical Studies, Including Certain First exist through supplemental initiatives. other Federal Government agencies on in Human Studies; Availability The Division works to promote certification activities and policy issues economic independence among refugees related to the trafficking laws. The AGENCY: Food and Drug Administration, through social services, educational Division certifies victims of severe HHS. services, and intensive case forms of trafficking following ACTION: Notice. management and community consultation with appropriate Federal development initiatives. SUMMARY: The Food and Drug D. Division of Children’s Services and State Government agencies and Administration (FDA) is announcing the supports services to unaccompanied social service agencies. The Division availability of a draft guidance entitled children, who are referred to ORR for coordinates with the appropriate ‘‘Investigational Device Exemptions care as refugees, asylees, Cuban and entities for the determination and (IDE) for Early Feasibility Medical Haitian entrants, children granted placement of identified and certified Device Clinical Studies, Including Special Immigrant Juvenile Visas and unaccompanied minor victims of Certain First in Human (FIH) Studies.’’ those pending immigration status or trafficking. It maintains statistical Through the approaches announced in identified as victims of trafficking. The information and data on each victim, this draft guidance, FDA intends to Division implements intake and including certification documentation facilitate early feasibility studies of placement decisions for all and services provided. The Division medical devices, using appropriate risk unaccompanied refugee and alien compiles an annual report, in mitigation strategies, under the IDE children. The Division supports coordination with other Federal requirements. Early feasibility studies specialized care through grants, agencies, on the number of certifications allow for limited early clinical contracts and state administered issued to and services accessed by evaluations of devices to provide proof unaccompanied minors programs. The identified victims. of principle and initial clinical safety Division conducts monitoring and data before the device design is F. Division of Refugee Health inspections of facilities and placement finalized. This draft guidance addresses provides direction for assuring that locations in which unaccompanied the information that should be provided children reside. The Division also refugees are provided medical to FDA in support of an early feasibility maintains statistical information and assistance and mental health services study IDE application and explains the data on each child and any actions through the State-administered program requirements applicable to concerning the child while the child is and alternative programs such as the modifications to the device design or under the Director’s care. Wilson/Fish projects. The Division clinical protocol during the early The Division ensures consideration of ensures the quality of medical screening feasibility study. This draft guidance is the child’s best interest in care and and initial medical treatment of refugees not final nor is it in effect at this time. custody decisions. The Division through its administration of grant DATES: Although you can comment on coordinates all decisions related to programs, technical assistance and any guidance at any time (see 21 CFR sponsor reunification, background interagency agreements in support of 10.115(g)(5)), to ensure that the Agency checks, home assessments, follow-up comprehensive medical and mental considers your comment on this draft services, medical assessment and health services. The Division supports guidance before it begins work on the treatment, sponsorship breakdowns, coordination of services to refugees final version of the guidance, submit repatriation and movement of children under the Affordable Care Act. The either electronic or written comments into the Unaccompanied Refugee Division also supports mental health on the draft guidance by February 8, Minors (URM) Program. services to victims of torture. The Division develops policy to 2012. ensure all children’s programs are The Division works closely with State ADDRESSES: Submit written requests for administered in a manner that ensures Refugee Health Coordinators in the single copies of the draft guidance the best interest of the child and that planning and provision of medical and document entitled ‘‘Investigational services are administered in a manner mental health services to meet the Device Exemptions (IDE) for Early that supports child welfare standards of individual needs of incoming Feasibility Medical Device Clinical care and services to include; training, populations. The Division tracks all Studies, Including Certain First in accreditation, legal services, assessment state costs related to refugee medical Human (FIH) Studies’’ to the Division of and trauma related initiatives. The assistance and screening. Small Manufacturers, International, and

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Consumer Assistance, Center for II. Significance of Guidance of Dockets Management between 9 a.m. Devices and Radiological Health, Food This draft guidance is being issued and 4 p.m., Monday through Friday. and Drug Administration, 10903 New consistent with FDA’s good guidance Dated: November 4, 2011. Hampshire Ave., Bldg. 66, rm. 4613, practices regulation (21 CFR 10.115). Leslie Kux, Silver Spring, MD 20993–0002. Send The draft guidance, when finalized, will Acting Assistant Commissioner for Policy. one self-addressed adhesive label to represent the Agency’s current thinking assist that office in processing your [FR Doc. 2011–29117 Filed 11–9–11; 8:45 am] on IDE for early feasibility studies. It BILLING CODE 4160–01–P request, or fax your request to (301) does not create or confer any rights for 847–8149. See the SUPPLEMENTARY or on any person and does not operate INFORMATION section for information on to bind FDA or the public. An DEPARTMENT OF HEALTH AND electronic access to the guidance. alternative approach may be used if HUMAN SERVICES Submit electronic comments on the such approach satisfies the draft guidance to http:// requirements of the applicable statute Food and Drug Administration www.regulations.gov. Submit written and regulations. [Docket No. FDA–2011–D–0790] comments to the Division of Dockets Elsewhere in this issue of the Federal Management (HFA–305), Food and Drug Register, FDA is announcing the Draft Guidance for Industry, Clinical Administration, 5630 Fishers Lane, rm. solicitation of nominations from Investigators, Institutional Review 1061, Rockville, MD 20852. Identify sponsors of innovative device Boards, and Food and Drug comments with the docket number technologies to participate in a pilot Administration Staff; Food and Drug found in brackets in the heading of this program for early feasibility study IDE Administration Decisions for document. applications, which implements the Investigational Device Exemption FOR FURTHER INFORMATION CONTACT: approaches announced in this draft Clinical Investigations; Availability Dorothy Abel, Center for Devices and guidance. The experience gained from Radiological Health, Food and Drug the pilot program will be used to inform AGENCY: Food and Drug Administration, Administration, 10903 New Hampshire the final version this draft guidance. HHS. ACTION: Notice. Ave., Bldg. 66, rm. 1204, Silver Spring, III. Electronic Access MD 20993–0002, (301) 796–6366. Persons interested in obtaining a copy SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: of the draft guidance may do so by using Administration (FDA) is announcing the I. Background the Internet. A search capability for all availability of the draft guidance CDRH guidance documents is available entitled ‘‘FDA Decisions for This draft guidance is intended to Investigational Device Exemption (IDE) provide assistance to FDA staff, at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Clinical Investigations.’’ This guidance clinicians, clinical innovators, and GuidanceDocuments/default.htm. document has been developed to industry on the development and Guidance documents are also available promote the initiation of clinical review of IDE applications (21 CFR at http://www.regulations.gov. investigations to evaluate medical 812.20) for early feasibility studies of You may either send an email request devices under FDA’s IDE regulations. In significant risk devices. Early feasibility to [email protected] to receive an an effort to promote timely clinical studies allow for early clinical electronic copy of this draft guidance or investigations in a manner that protects evaluation of devices to provide proof of send a fax request to (301) 847–8149 to study subjects, FDA has developed principle and initial clinical safety data receive a hard copy. Please use the methods to allow a clinical investigation in a limited number of subjects. During document number 1782 to identify the to begin under certain circumstances, these studies, iterative device guidance you are requesting. even when there are outstanding issues modifications are likely to be made regarding the IDE submission. These IV. Paperwork Reduction Act of 1995 based on clinical experience. Early mechanisms, including approval with feasibility studies may be appropriate This draft guidance refers to conditions, staged approval or staged early in device development when previously approved collections of approval with conditions, and nonclinical testing methods are not information found in FDA regulations. communication of outstanding issues available or adequate to provide the These collections of information are related to the IDE through future information needed to advance the subject to review by the Office of considerations, are described in this developmental process, and clinical Management and Budget (OMB) under guidance. experience is thus necessary. As with all the Paperwork Reduction Act of 1995 DATES: Although you can comment on clinical studies, initiation of an early (44 U.S.C. 3501–3520). The collections any guidance at any time (see 21 CFR feasibility study must be justified by an of information in 21 CFR part 812 have 10.115(g)(5)), to ensure that the Agency appropriate risk-benefit analysis and been approved under OMB control considers your comment on this draft adequate human subject protection number 0910–0078. measures. guidance before it begins work on the This draft guidance discusses the key V. Comments final version of the guidance, submit principles unique to the justification for, Interested persons may submit to the either electronic or written comments and design of, early feasibility studies, Division of Dockets Management (see on the draft guidance by February 8, as well as outlines the general ADDRESSES), either electronic or written 2012. principles for preparing and reviewing comments regarding this document. It is ADDRESSES: Submit written requests for early feasibility study IDE applications. only necessary to send one set of single copies of the draft guidance This draft guidance is not intended to comments. It is no longer necessary to document entitled ‘‘FDA Decisions for address all required elements of an IDE send two copies of mailed comments. Investigational Device Exemption (IDE) application generally or to provide a Identify comments with the docket Clinical Investigations’’ to the Division comprehensive tutorial on best clinical number found in brackets in the of Small Manufacturers, International practices for investigational medical heading of this document. Received and Consumer Assistance, Center for device studies. comments may be seen in the Division Devices and Radiological Health, Food

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and Drug Administration, 10903 New consider in preparation for a marketing receive an electronic copy of the Hampshire Ave., Bldg. 66, rm. 4613, application or a future clinical document or send a fax request to (301) Silver Spring, MD 20993–0002; or to the investigation. Future considerations are 847–8149 to receive a hard copy. Please Office of Communication, Outreach and intended to provide helpful advice to use the document number 1783 to Development (HFM–40), Center for sponsors regarding important elements identify the guidance you are Biologics Evaluation and Research of the future application that the IDE requesting. may not specifically address. (CBER), Food and Drug Administration, IV. Paperwork Reduction Act of 1995 1401 Rockville Pike, Rockville, MD In this guidance new mechanisms are 20852–1448. Send one self-addressed introduced, termed ‘‘stage approval’’ This draft guidance refers to adhesive label to assist that office in and ‘‘staged approval with conditions,’’ previously approved collections of processing your request, or fax your by which FDA may grant IDE approval information found in FDA regulations. request to (301) 847–8149. See the or approval with conditions, while These collections of information are SUPPLEMENTARY INFORMATION section for certain outstanding questions are being subject to review by the Office of information on electronic access to the answered in parallel with enrollment in Management and Budget (OMB) under guidance. the clinical investigation. Staged the Paperwork Reduction Act of 1995 Submit electronic comments on the approval and staged approval with (44 U.S.C. 3501–3520). The collections draft guidance to http:// conditions permit the clinical of information in 21 CFR part 812 have www.regulations.gov. Submit written investigation to begin in a timely been approved under OMB control comments to the Division of Dockets manner while maintaining appropriate number 0910–0078. Management (HFA–305), Food and Drug subject protections. Staged approval or V. Comments Administration, 5630 Fishers Lane, rm. staged approval with conditions is most 1061, Rockville, MD 20852. Identify common for pivotal studies in which Interested persons may submit to the comments with the docket number many subjects will be enrolled over an Division of Dockets Management (see found in brackets in the heading of this extended period of time, but may be ADDRESSES), either electronic or written document. applicable to other clinical comments regarding this document. It is only necessary to send one set of FOR FURTHER INFORMATION CONTACT: investigations as well. As a result of this draft guidance, comments. It is no longer necessary to Owen Faris, Center for Devices and FDA, where appropriate, seeks to offer send two copies of mailed comments. Radiological Health, Food and Drug flexibility in how outstanding issues can Identify comments with the docket Administration, 10903 New be addressed to allow clinical number found in brackets in the Hampshire Ave., Bldg. 66, rm. 1108, investigations to commence without heading of this document. Received Silver Spring, MD 20993–0002, (301) unnecessary delay, while ensuring that comments may be seen in the Division 796–6356; or human subjects are adequately of Dockets Management between 9 a.m. Stephen Ripley, Center for Biologics protected. and 4 p.m., Monday through Friday. Evaluation and Research (HFM–17), Dated: November 4, 2011. Food and Drug Administration, 1401 II. Significance of Guidance Leslie Kux, Rockville Pike, suite 200N, Rockville, This draft guidance is being issued MD 20852, (301) 827–6210. consistent with FDA’s good guidance Acting Assistant Commissioner for Policy. practices regulation (21 CFR 10.115). [FR Doc. 2011–29118 Filed 11–9–11; 8:45 am] I. Background The draft guidance, when finalized, will BILLING CODE 4160–01–P FDA approval of an IDE submission represent the Agency’s current thinking allows the initiation of a clinical on ‘‘FDA Decisions for Investigational DEPARTMENT OF HEALTH AND investigation of a significant risk device. Device Exemption (IDE) Clinical HUMAN SERVICES This guidance is intended to provide Investigations.’’ It does not create or clarification regarding the regulatory confer any rights for or on any person Food and Drug Administration implications of the decisions that FDA and does not operate to bind FDA or the may render based on review of an IDE public. An alternative approach may be [Docket No. FDA–2011–N–0788] and to provide a general explanation of used if such approach satisfies the Pilot Program for Early Feasibility the reasoning and implications of those requirements of the applicable statute Study Investigational Device decisions. FDA has traditionally and regulations. referred to IDE approvals that have Exemption Applications III. Electronic Access conditions as ‘‘Conditional Approvals.’’ AGENCY: Food and Drug Administration, FDA believes that the term ‘‘Approval Persons interested in obtaining a copy HHS. with Conditions’’ is more appropriate of the draft guidance may do so by using ACTION: Notice. because the term conveys that the IDE the Internet. A search capability for all has been approved and may begin CDRH guidance documents is available SUMMARY: The Food and Drug without awaiting further FDA review. at http://www.fda.gov/MedicalDevices/ Administration (FDA) is soliciting An IDE may be approved with DeviceRegulationandGuidance/ nominations from sponsors of conditions if FDA has determined, GuidanceDocuments/default.htm. innovative device technologies to despite outstanding issues, that the Guidance documents are also available participate in a pilot program for early information provided is sufficient to at http://www.regulations.gov or from feasibility study investigational device justify human clinical evaluation of the the CBER Internet site at http:// exemption (IDE) applications. The pilot device, and that the proposed study www.fda.gov/BiologicsBloodVaccines/ program will conform to the approaches design is generally acceptable. FDA may GuidanceComplianceRegulatory outlined in the draft guidance entitled now also include ‘‘future Information/default.htm. To receive ‘‘Investigational Device Exemptions considerations’’ in an approval or ‘‘FDA Decisions for Investigational (IDE) for Early Feasibility Medical approval with conditions letter, which Device Exemption (IDE) Clinical Device Clinical Studies, Including are issues and recommendations that Investigations’’ you may either send an Certain First in Human (FIH) Studies.’’ FDA believes the sponsor should email request to [email protected] to Under the pilot program, FDA’s review

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of IDE applications for an early learned and experiences gained from the C. Procedures feasibility study, including a first in pilot program will help inform the final human study, is expected to be based on guidance document. FDA has developed the following less nonclinical data than would be procedures to ensure adequate II. Early Feasibility Study IDE Pilot expected for a traditional feasibility or information to assess a candidate’s Program a pivotal study. The pilot will also suitability for the pilot program is involve new approaches to IDE review FDA has developed a pilot program provided to FDA without creating a to facilitate timely device and clinical that presents a streamlined process to burdensome new application process: protocol modifications during an early interested sponsors/requesters. This 1. Nomination feasibility study. notice outlines: (1) The guiding DATES: FDA will begin accepting principles underlying the pilot program, The sponsor/requester of an nominations for participation in the (2) appropriate candidates for the pilot innovative therapeutic or diagnostic voluntary pilot program on December program, and (3) the procedures FDA device may nominate their study for 12, 2011. intends to follow in the pilot program participation in the pilot program by submitting a nomination to the CDRH FOR FURTHER INFORMATION CONTACT: for early feasibility IDEs. Document Mail Center (Food and Drug Sheila Brown, Center for Devices and A. Guiding Principles Administration, Center for Devices and Radiological Health, Food and Drug Radiological Health, Document Mail Administration, 10903 New Hampshire The following basic principles Center, Bldg. 66, rm. G609, 10903 New Ave. Bldg. 66, rm. 1676, Sliver Spring, underline the early feasibility study IDE Hampshire Ave., Silver Spring, MD MD 20993–0002, (301) 796–5640. pilot program described in this notice. 20993–0002), with a duplicate copy sent SUPPLEMENTARY INFORMATION: FDA intends that these principles create a common understanding between the to the Investigational Device Exemption I. Background sponsor and FDA about the goals and Section (see FOR FURTHER INFORMATION CONTACT). FDA intends to acknowledge Early feasibility studies allow for parameters of the early feasibility study receipt of nominations via email. The early clinical evaluation of significant IDE application pilot program: following information will assist FDA in risk devices to provide proof of 1. FDA will not publicly disclose processing and responding to principle and initial clinical safety data. participation of a sponsor in the early nominations: During these studies, iterative device feasibility IDE pilot program, unless the modifications are likely to be made sponsor consents or has already made • Name of the sponsor/requester and based on clinical experience. Early this information public, or disclosure is relevant contact information, feasibility studies may be appropriate required by law. • Name of the product, early in the device development process 2. Participating in this pilot program • Succinct description of the in a limited number of subjects when does not guarantee approval of an IDE technology and disease or condition the nonclinical testing methods are not application, nor is a sponsor precluded device is intended to diagnose or treat, available or adequate to provide the from withdrawing from the pilot and information needed to advance the program and pursuing traditional IDE • A brief statement explaining why development process, making clinical review. the device is an appropriate candidate experience necessary. As with all 3. Due to FDA resource issues, FDA for the pilot program as described in clinical studies, the initiation of an early intends to limit the pilot program to this document in section B. Appropriate feasibility study must be justified by an nine candidates. Candidates. appropriate risk-benefit analysis and adequate human subject protection B. Appropriate Candidates 2. FDA Consideration measures. Because these studies are Appropriate candidates for the pilot FDA intends to consider each performed early in the device program are medical devices for which: development process before the device nomination within 30 days of receiving 1. The sponsor has not already design is finalized and are only the complete information described in submitted an IDE application. appropriate where additional this document in section C. Procedures. nonclinical testing is not available or 2. An application for premarket FDA may contact the sponsor/requester adequate to provide the information review or approval would require the to request supplemental information needed to advance device development, submission of clinical data. during the 30-day review period. the information included in the IDE 3. Limited clinical study of the device 3. Sponsor/Requester Notification application may vary from the (e.g., generally fewer than 10 initial information typically included in IDE subjects) is necessary because additional FDA intends to notify the sponsor/ applications for traditional feasibility or nonclinical testing is unlikely to requester whether or not the product is pivotal studies. To address the unique provide the insights necessary to further an appropriate candidate for the early challenge of early feasibility studies, the development of the device, or feasibility study IDE pilot program elsewhere in this issue of the Federal appropriate nonclinical tests are within 30 days from receiving the Register, FDA is announcing the unavailable. complete information described in this availability of the early feasibility study FDA encourages any interested document in section C. Procedures. draft guidance. sponsors who believe their device and/ 4. Acceptance Meeting The anticipated benefits of this pilot or study are appropriate candidates to program include facilitating contact FDA through the Center for If the nominee is deemed an development of innovative products in Devices and Radiological Health appropriate candidate, FDA intends to the United States and evaluating the (CDRH), Investigational Device meet with the product sponsor/ new approaches for modifications made Exemption Section at (301) 796–5640, requester, either in person or by during early feasibility studies, which before initiating the procedures telephone, within 30 days of notifying are outlined in the early feasibility referenced in this document in section the sponsor/requester that its nominee study draft guidance. The information C. Procedures. was accepted.

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5. FDA Review Dated: November 4, 2011. Place: Hyatt Regency Crystal City, 2799 Leslie Kux, Jefferson Davis Highway, Arlington, VA Under the pilot program, early 22202. Acting Assistant Commissioner for Policy. feasibility study IDE applications will Contact Person: Tony L Creazzo, Ph.D., be reviewed according to the [FR Doc. 2011–29116 Filed 11–9–11; 8:45 am] Scientific Review Officer. approaches outlined in the early BILLING CODE 4160–01–P (Catalogue of Federal Domestic Assistance feasibility study draft guidance. The Program Nos. 93.233, National Center for essential elements announced in the Sleep Disorders Research; 93.837, Heart and early feasibility study draft guidance DEPARTMENT OF HEALTH AND Vascular Diseases Research; 93.838, Lung are: HUMAN SERVICES Diseases Research; 93.839, Blood Diseases • FDA may approve an IDE and Resources Research, National Institutes application for an early feasibility study, National Institutes of Health of Health, HHS) Dated: November 4, 2011. including certain first in human studies, National Heart, Lung, and Blood based on less nonclinical data than Institute; Notice of Closed Meetings Jennifer S. Spaeth, would be expected for a traditional Director, Office of Federal Advisory feasibility or a pivotal study. This is Pursuant to section 10(d) of the Committee Policy. because early feasibility studies are only Federal Advisory Committee Act, as [FR Doc. 2011–29142 Filed 11–9–11; 8:45 am] appropriate where additional amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P nonclinical testing is not available or hereby given of the following meetings. adequate to provide the information The meetings will be closed to the needed to advance the developmental public in accordance with the DEPARTMENT OF HEALTH AND process. Identification of the data provisions set forth in sections HUMAN SERVICES necessary to support an early feasibility 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., study should be based on a thorough as amended. The grant applications and National Institutes of Health device evaluation strategy that describes the discussions could disclose the device and procedure-related confidential trade secrets or commercial National Cancer Institute; Notice of attributes and addresses the potential property such as patentable material, Closed Meeting failure modes. Appropriate human and personal information concerning Pursuant to section 10(d) of the subject protection measures and risk individuals associated with the grant Federal Advisory Committee Act, as mitigation strategies must also be applications, the disclosure of which amended (5 U.S.C. App.), notice is identified. This policy is intended to would constitute a clearly unwarranted hereby given of the following meeting. facilitate initiation of clinical studies in invasion of personal privacy. The meeting will be closed to the the United States earlier in the device Name of Committee: National Heart, Lung, public in accordance with the development process than has and Blood Institute Special Emphasis Panel, provisions set forth in sections historically occurred, when appropriate. Life after Linkage: The Future of Family 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., • New approaches that facilitate Studies. as amended. The grant applications and timely device and clinical protocol Date: December 1–2, 2011. the discussions could disclose modifications during an early feasibility Time: 8:30 a.m. to 5:30 p.m. confidential trade secrets or commercial study while still requiring compliance Agenda: To review and evaluate grant property such as patentable material, applications. with the IDE regulations in 21 CFR part and personal information concerning 812. Place: Hilton Garden Inn, 7301 Waverly Street, Bethesda, MD 20814. individuals associated with the grant FDA has provided additional Contact Person: YingYing Li-Smerin, MD, applications, the disclosure of which information regarding its expectations Ph.D., Scientific Review Officer, Office of would constitute a clearly unwarranted for early feasibility study IDE Scientific Review/DERA, National Heart, invasion of personal privacy. applications in the early feasibility Lung, and Blood Institute, 6701 Rockledge Name of Committee: National Cancer study draft guidance. Drive, Room 7184, Bethesda, MD 20892– Institute Special Emphasis Panel, Small 7924. (301) 435–0277. Grants Program for Cancer Epidemiology. D. Duration of the Pilot [email protected]. Date: November 17–18, 2011. FDA intends to accept requests for Name of Committee: National Heart, Lung, Time: 8:30 a.m. to 5 p.m. participation in the pilot program for and Blood Institute Special Emphasis Panel, Agenda: To review and evaluate grant 180 days from the date of publication of COPD Case Finding Methodology. applications. this notice. FDA may decide to Date: December 1, 2011. Place: Bethesda North Marriott Hotel & terminate the pilot program before the Time: 9 a.m. to 2 p.m. Conference Center, 5701 Marinelli Road, close of the 180-day period or extend Agenda: To review and evaluate grant Bethesda, MD 20852. applications. the pilot program beyond the 180-day Contact Person: Jeffrey E. DeClue, Ph.D., Place: Marriott Wardman Park Washington Scientific Review Officer, Special Review period. The decision to terminate or DC Hotel, 2660 Woodley Road NW., and Logistics Branch, Division of Extramural extend the pilot will be announced in Washington, DC 20008. Activities, National Cancer Institute, NIH, the Federal Register. FDA may also Contact Person: Stephanie J Webb, Ph.D., 6116 Executive Boulevard, Room 8059, decide to modify the pilot program Scientific Review Officer, Review Branch/ Bethesda, MD 20892–8329, (301) 496–7904, while it is in effect. Any modifications DERA, National Heart, Lung, and Blood [email protected]. will also be announced in the Federal Institute, 6701 Rockledge Drive, Room 7196, This notice is being published less than 15 Register. FDA intends to terminate the Bethesda, MD 20892. (301) 435–0291. days prior to the meeting due to scheduling [email protected]. pilot program when the early feasibility conflicts. Information is also available on the study draft guidance is finalized. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, Institute’s/Center’s home page: http:// E. Evaluation PPG Review: Endothelium and deainfo.nci.nih.gov/advisory/sep/sep.htm, cardiovascular function. where an agenda and any additional FDA intends to use the experience Date: December 2, 2011. information for the meeting will be posted gained from the pilot program to inform Time: 8:30 a.m. to 4:30 p.m. when available. the final version of the early feasibility Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance study draft guidance. applications. Program Nos. 93.392, Cancer Construction;

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93.393, Cancer Cause and Prevention DEPARTMENT OF HEALTH AND Building 1, Room 103, Bethesda, MD 20892. Research; 93.394, Cancer Detection and HUMAN SERVICES (301) 496–4272. [email protected]. Diagnosis Research; 93.395, Cancer Any interested person may file written Treatment Research; 93.396, Cancer Biology National Institutes of Health comments with the committee by forwarding Research; 93.397, Cancer Centers Support; the statement to the Contact Person listed on 93.398, Cancer Research Manpower; 93.399, National Institute of General Medical this notice. The statement should include the name, address, telephone number and, when Cancer Control, National Institutes of Health, Sciences; Amended Notice of Meeting HHS) applicable, the business or professional affiliation of the interested person. Dated: November 4, 2011. Notice is hereby given of a change in the meeting of the National Institute of In the interest of security, NIH has Jennifer S. Spaeth, instituted stringent procedures for entrance General Medical Sciences Special onto the NIH campus. All visitor vehicles, Director, Office of Federal Advisory Emphasis Panel, November 15, 2011, Committee Policy. including taxicabs, hotel, and airport shuttles 12 p.m. to November 15, 2011, 5 p.m., will be inspected before being allowed on [FR Doc. 2011–29141 Filed 11–9–11; 8:45 am] National Institutes of Health, Natcher campus. Visitors will be asked to show one BILLING CODE 4140–01–P Building, 45 Center Drive, Room form of identification (for example, a 3AN18A, Bethesda, MD 20892 which government-issued photo ID, driver’s license, was published in the Federal Register or passport) and to state the purpose of their visit. DEPARTMENT OF HEALTH AND on November 1, 2011, 76 FR 67467. HUMAN SERVICES Information is also available on the The meeting date and time have been Institute’s/Center’s home page: http:// changed to November 21, 2011, 2 p.m. National Institutes of Health acd.od.nih.gov, where an agenda and any to November 21, 2011, 5 p.m. additional information for the meeting will National Institute of Allergy and The meeting is closed to the public. be posted when available. Infectious Diseases; Notice of Closed Dated: November 4, 2011. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Meeting Jennifer S. Spaeth, Training Award; 93.22, Clinical Research Director, Office of Federal Advisory Loan Repayment Program for Individuals Pursuant to section 10(d) of the Committee Policy. from Disadvantaged Backgrounds; 93.232, Federal Advisory Committee Act, as [FR Doc. 2011–29140 Filed 11–9–11; 8:45 am] Loan Repayment Program for Research amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P Generally; 93.39, Academic Research hereby given of the following meeting. Enhancement Award; 93.936, NIH Acquired The meeting will be closed to the Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate public in accordance with the DEPARTMENT OF HEALTH AND HUMAN SERVICES Scholarship Program for Individuals from provisions set forth in sections Disadvantaged Backgrounds, National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Institutes of Health, HHS) as amended. The contract proposals and National Institutes of Health Dated: November 4, 2011. the discussions could disclose Office of the Director, National Jennifer S. Spaeth, confidential trade secrets or commercial Institutes of Health; Notice of Meeting property such as patentable material, Director, Office of Federal Advisory and personal information concerning Pursuant to section 10(a) of the Committee Policy. individuals associated with the contract Federal Advisory Committee Act, as [FR Doc. 2011–29138 Filed 11–9–11; 8:45 am] proposals, the disclosure of which amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P would constitute a clearly unwarranted hereby given of a meeting of the invasion of personal privacy. Advisory Committee to the Director, National Institutes of Health. DEPARTMENT OF HOUSING AND Name of Committee: National Institute of URBAN DEVELOPMENT Allergy and Infectious Diseases Special The meeting will be open to the Emphasis Panel, NIAID Contract Review. public, with attendance limited to space [Docket No. FR–5477–N–45] Date: December 5, 2011. available. Individuals who plan to Time: 8 a.m. to 6 p.m. attend and need special assistance, such Federal Property Suitable as Facilities Agenda: To review and evaluate contract as sign language interpretation or other To Assist the Homeless proposals. reasonable accommodations, should Place: Bethesda North Marriott Hotel & notify the Contact Person listed below AGENCY: Office of the Assistant Conference Center, 5701 Marinelli Road, in advance of the meeting. Secretary for Community Planning and Bethesda, MD 20852. Development, HUD. Name of Committee: Advisory Committee Contact Person: Brenda Lange-Gustafson, ACTION: Notice. Ph.D., Scientific Review Officer, NIAID/NIH/ to the Director, National Institutes of Health. DHHS, Scientific Review Program, Room Date: December 8–9, 2011. SUMMARY: This Notice identifies 3122, 6700–B Rockledge Drive, MSC–7616, Time: December 8, 2011, 9 a.m. to 4 p.m. unutilized, underutilized, excess, and Agenda: Report from NIH Director, various Bethesda, MD 20892–7616, (301) 451–3684, surplus Federal property reviewed by [email protected]. Working Group reports. Place: National Institutes of Health, HUD for suitability for possible use to (Catalogue of Federal Domestic Assistance Building 31, 31 Center Drive, Bethesda, MD assist the homeless. Program Nos. 93.855, Allergy, Immunology, 20892. FOR FURTHER INFORMATION CONTACT: and Transplantation Research; 93.856, Time: December 9, 2011, 8:30 a.m. to Juanita Perry, Department of Housing Microbiology and Infectious Diseases 12 p.m. Research, National Institutes of Health, HHS) and Urban Development, 451 Seventh Agenda: Report from NCI Director, various Street SW., Room 7262, Washington, DC Dated: November 4, 2011. Working Group reports. 20410; telephone (202) 708–1234; TTY Jennifer S. Spaeth, Place: National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD number for the hearing- and speech- Director, Office of Federal Advisory 20892. impaired (202) 708–2565, (these Committee Policy. Contact Person: Gretchen Wood, Staff telephone numbers are not toll-free), or [FR Doc. 2011–29137 Filed 11–9–11; 8:45 am] Assistant, National Institutes of Health, call the toll-free Title V information line BILLING CODE 4140–01–P Office of the Director, One Center Drive, at (800) 927–7588.

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SUPPLEMENTARY INFORMATION: In EIS Availability: Persons interested in locations: December 5, 2011, accordance with the December 12, 1988 reviewing the OCS Oil and Gas Leasing Wainwright at the R. James Community court order in National Coalition for the Program for 2012–2017 Draft Center; December 6, 2011, Nuiqsut at Homeless v. Veterans Administration, Programmatic Environmental Impact the Community Center, on; December 7, No. 88–2503–OG (D.D.C.), HUD Statement, OCS EIS/EA BOEM 2011– 2011, Katovik at the Community Center; publishes a Notice, on a weekly basis, 001 can locate it on the Internet at December 8, 2011, Fairbanks at the identifying unutilized, underutilized, http://www.boem.gov/5-year/2012-2017 Westmark Hotel and Conference Center, excess and surplus Federal buildings or you may contact Mr. James F. Bennett 813 Noble Street, Fairbanks, AK 99701; and real property that HUD has at the address listed above to request a December 9, 2011, Anchorage at the reviewed for suitability for use to assist copy, in hard copy or as a CD/ROM Wilda Marston Theatre, 3600 Denali the homeless. Today’s Notice is for the version. Please specify if you wish a CD Street, Anchorage, AK; December 12, purpose of announcing that no or paper copy. If neither is specified, a 2011, Kotzebue at the NW Arctic additional properties have been CD containing the Draft PEIS will be Borough Assembly Chamber, 163 determined suitable or unsuitable this forwarded. Lagoon Street, Kotzebue, AK 99752; week. Library Availability: The Draft PEIS December 13, 2011, Point Hope at the will also be available for review at City Qalgi Center; December 14, 2011, Dated: November 3, 2011. libraries in states near the proposed Mark R. Johnston, Point Lay at the Community Center; and lease sales. These libraries are listed at December 16, 2011, Barrow at the Deputy Assistant Secretary for Special Needs. the BOEM Web site at http:// Inupiat Heritage Center. [FR Doc. 2011–28941 Filed 11–9–11; 8:45 am] www.boem.gov/5-Year/2012-2017/ After the public hearings and written BILLING CODE 4210–67–P libraries or a list of libraries can be comments on the Draft PEIS have been provided by contacting the contact reviewed and analyzed, a Final PEIS person listed above. will be prepared. DEPARTMENT OF THE INTERIOR Written Comments: Comments may be submitted online at http:// Dated: October 26, 2011. Bureau of Ocean Energy Management www.boem.gov/5-year/2012-2017 or Rodney Cluck, letters may be sent to Mr. James F. Acting Chief Environmental Officer, Bureau Draft Programmatic Environmental Bennett at the address listed above. of Ocean Energy Management. Impact Study (PEIS) for Proposed Comments should be labeled ‘‘Attn: 5- [FR Doc. 2011–29152 Filed 11–9–11; 8:45 am] 5-Year Outer Continental Shelf (OCS) Year Program Draft PEIS.’’ BILLING CODE 4310–MR–P Oil and Gas Leasing Program for 2012– An individual commenter may ask 2017 that we withhold their name, home address, or both from the public record, DEPARTMENT OF THE INTERIOR AGENCY: Bureau of Ocean Energy and we will honor such a request to the Management, Interior. extent allowable by law. If you submit Bureau of Ocean Energy Management ACTION: Notice of availability. comments and wish us to withhold such Proposed 5-Year Outer Continental information, you must state so SUMMARY: Pursuant to the National Shelf (OCS) Oil and Gas Leasing prominently at the beginning of your Environmental Policy Act (NEPA), Program for 2012–2017 BOEM announces the availability of the submission. We will not consider OCS Oil and Gas Leasing Program 2012– anonymous comments. AGENCY: Bureau of Ocean Energy 2017 Draft PEIS prepared by BOEM to Public Hearings: Thirteen public Management, Interior. support the Proposed Outer Continental hearings on the 2012–2017 OCS Oil and ACTION: Notice of availability. Shelf Oil and Gas Leasing Program for Gas Leasing Program Draft PEIS will be SUMMARY: The Bureau of Ocean Energy 2012–2017. BOEM concurrently held December 5 through December 16, Management (BOEM) announces the requests comments and announces 2011. In the Gulf Region, the hearings availability of and requests comments public hearings. will be held from 1:00 to 4 p.m. and from 6 p.m. to 9 p.m. on the following on the Proposed 5-Year OCS Oil and DATES: Submit comments on or before dates and at the following locations: Gas Leasing Program for 2012–2017 January 9, 2012. See public hearing December 6, 2011, Houston, TX at the (‘‘Proposed Program’’). This is part of a dates in the SUPPLEMENTARY INFORMATION Marriott Houston Intercontinental at multi-step process required by law below. George Bush Intercontinental, 18700 before the Secretary of the Interior may FOR FURTHER INFORMATION CONTACT: John F. Kennedy Boulevard, Houston, approve a new 5-year program. BOEM is Bureau of Ocean Energy Management, TX 77032; December 7, 2011, Mobile, publishing a Notice of Availability of Headquarters, 381 Elden Street, AL at the Renaissance Mobile Riverview the 5-Year Draft Programmatic Herndon, VA 20170; Attention: Mr. Plaza Hotel, 64 South Water Street, Environmental Impact Statement (PEIS) James F. Bennett, Chief of the Division Mobile, AL 36602; and December 8, concurrently with this notice. of Environmental Assessment, 2011, New Orleans, LA at the DATES: Please submit comments and telephone: (703) 787–1660. Doubletree New Orleans Airport Hotel, information to BOEM no later than SUPPLEMENTARY INFORMATION: This draft 2150 Veterans Memorial Boulevard, February 8, 2012. PEIS assesses the scheduling for Kenner, LA 70062. proposed lease sales during the years In Washington, DC, the hearing will Public Comment Procedure 2012 to 2017 in six planning areas on be held from 1 p.m. to 5 p.m. on BOEM will accept comments in one of the OCS. These areas are the Western, December 6, 2011, at the Main two formats: By mail or via our Internet Central and Eastern Gulf of Mexico, Department of the Interior Building at commenting system. Please submit your Cook Inlet, the Beaufort Sea, and the 1849 C Street NW., Washington, DC comments using only one of these Chukchi Sea. Federal regulations (40 20240. formats, and include full names and CFR 1502.4(b)) recommend analyzing In Alaska, public hearings will be addresses. Comments submitted by effects of broad programs within a single held from 7 p.m. to 10 p.m. on the other means may not be considered. We programmatic EIS. following dates and at the following will not consider anonymous

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comments, and we will make available Section 18 of the Outer Continental The use of the acronym ‘‘BOEM’’ for inspection in their entirety all Shelf Lands Act (OCSLA) specifies a includes, within its meaning, BOEM’s comments submitted by organizations multi-step process of consultation and predecessor agencies, the Bureau of and businesses or by individuals analysis that must be completed before Ocean Energy Management, Regulation identifying themselves as the Secretary of the Interior may and Enforcement and the Minerals representatives of organizations and approve a new 5-year Program. The Management Service. businesses. required steps following this notice Summary of the Proposed Program Our practice is to make comments, include the development of a proposed including the names and home final program to be submitted to the The proposed program document addresses of respondents, available for Congress and the President, with analyzes the six planning areas public review. An individual Secretarial approval of a new program proposed for 2012–2017 leasing in the commenter may ask that we withhold no sooner than 60 days after such Proposed Program and reflects the his or her name, home address, or both submission. Pursuant to the National consideration of the analysis of all 12 from the public record, and we will Environmental Policy Act (NEPA), areas in the DPP. The Proposed Program honor such a request to the extent BOEM also is preparing a PEIS for the schedules a total of 15 OCS lease sales allowable by law. If you submit new 5-Year Program. The draft PEIS is in six areas (three areas off Alaska and comments and wish us to withhold such being issued with this Proposed three areas in the Gulf of Mexico). Maps information, you must so state Program and a final PEIS will be issued A and B show the areas proposed for prominently at the beginning of your with the Proposed Final Program. leasing. Table A lists the location and submission. BOEM requests comments from states, timing of the proposed lease sales in ADDRESSES: local governments, native groups, areas under consideration for leasing. By Mail—Mail comments and Tribes, the oil and gas industry, Federal information to: Steven Textoris, 5-Year agencies, environmental and other Alaska Region Program Manager, Bureau of Ocean interest organizations, and all other In the Alaska Region, the program Energy Management (MS–4010), Room interested parties, including the public, proposes one sale in the Beaufort Sea in 3120, 381 Elden Street, Herndon, to assist in the preparation of a 5-Year 2015, excluding at least two whaling Virginia 20170. Please label your OCS Oil and Gas Leasing Program for deferral areas from leasing comments and the packaging in which 2012–2017. consideration, as was done in the 2009 The Proposed Program document may they are submitted as ‘‘Comments on DPP. In the Chukchi Sea, the proposed be downloaded from the BOEM Web Proposed 5-Year Program for 2012– program schedules one sale in 2016, site at www.BOEM.gov. The document 2017.’’ If you submit any privileged or excluding at least a 25-mile buffer area proprietary information to be treated as also is available as part of our electronic along the coast, as presented in the 2009 confidential, please mark the envelope, commenting system noted above. Hard DPP. ‘‘Contains Confidential Information.’’ copies may be obtained by contacting By Internet—Federal eRulemaking the 5-Year Program Office at (703) 787– The Cook Inlet Planning Area is Portal: http://www.regulations.gov. 1215. included on the schedule as a special Under the tab ‘‘More Search Options,’’ Along with the proposed program, interest sale, which may occur as early click ‘‘Advanced Docket Search,’’ then three technical documents will be as 2013. Before BOEM proceeds with select ‘‘Bureau of Ocean Energy posted on http://www.BOEM.gov for the presale process, it will issue a Management’’ from the agency drop- public review and comment: (1) request for interest and comments and down menu, then click the submit Economic Analysis for the OCS 5-Year will move forward if there is sufficient button. In the Docket ID column, select Program 2012–2017: Theory and industry interest. If there is insufficient BOEM–2011–0119 to submit public Methodology (BOEM 050–2011), a paper interest, a request may be issued again comments and to view related materials containing a more detailed description the following year, and so on through available for the proposed program. of the methodology used for the Net the 5-year schedule, until the sale is Information on using Regulations.gov, Benefits analysis; (2) Energy held or the schedule expires. including instructions for accessing Alternatives and the Environment, Gulf of Mexico Region documents, submitting comments, and 2012–2017 (BOEM 051–2011), a paper viewing the docket after the close of the expanding upon the energy alternatives In the Central and Western Gulf of comment period, is available through likely to replace OCS oil and gas in the Mexico Planning Areas, which remain the site’s ‘‘User Tips’’ link. The BOEM absence of a new program; and (3) the the two areas of highest resource will post all comments. draft Revised Offshore Environmental potential and interest, the Proposed FOR FURTHER INFORMATION CONTACT: Cost Model (OECM): Guide to Cost and Program schedules annual areawide Steven Textoris, 5-Year Program Benefit Calculations, a document lease sales of all unleased available Manager, at (703) 787–1215. designed to provide decisionmakers acreage, starting in 2012 in the Western SUPPLEMENTARY INFORMATION: This is the with information about the relative Gulf and 2013 in the Central Gulf. There second proposal in the usual statutory environmental and social costs are two lease sales scheduled in the preparation process for a new program associated with having, or not having, portion of the Eastern Gulf of Mexico to succeed the current program, which an offshore leasing program absent a Planning Area that is not under expires on June 30, 2012. The first low probability, high impact event. This congressional moratorium, pursuant to proposal—the Draft Proposed Program— is relevant to weighing the costs and the Gulf of Mexico Energy Security Act was issued in January 2009, for a 60-day benefits of the Proposed Program. A of 2006 (GOMESA). The Proposed comment period that was extended by report documenting the final version of Program area includes the 2008 Sale 224 180 days and closed on September 21, the OECM will be published prior to the Area (mandated by GOMESA) and a 2009. Proposed Final Program. sliver to the southeast of that area.

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TABLE A—PROPOSED PROGRAM FOR 2012–2017—LEASE SALE SCHEDULE

Sale No. Area Year

229 ...... Western Gulf of Mexico ...... 2012 227 ...... Central Gulf of Mexico ...... 2013 244 ...... Cook Inlet ...... 2013 233 ...... Western Gulf of Mexico ...... 2013 231 ...... Central Gulf of Mexico ...... 2014 225 ...... Eastern Gulf of Mexico ...... 2014 238 ...... Western Gulf of Mexico ...... 2014 235 ...... Central Gulf of Mexico ...... 2015 242 ...... Beaufort Sea ...... 2015 246 ...... Western Gulf of Mexico ...... 2015 241 ...... Central Gulf of Mexico ...... 2016 226 ...... Eastern Gulf of Mexico ...... 2016 237 ...... Chukchi Sea ...... 2016 248 ...... Western Gulf of Mexico ...... 2016 247 ...... Central Gulf of Mexico ...... 2017

Assurance of Fair Market Value Information Requested submitted and mark it appropriately. On We request all interested and affected request, BOEM will treat such Section 18 of the OCSLA requires information as confidential from the receipt of fair market value for OCS oil parties to comment on the size, timing, and location of leasing and the time of its receipt until 5 years after and gas leases and the rights they procedures for assuring fair market approval of the new leasing program, convey. A series of decisions related to value that are included in the Proposed subject to the standards of the Freedom the timing of a lease sale, the leasing 5-Year OCS Oil and Gas Leasing of Information Act. BOEM will not treat framework, sale terms, and bid Program for 2012–2017. Respondents as confidential any aggregate summaries adequacy provide the foundation for who submitted information in response of privileged or proprietary information, ensuring receipt of fair market value. to previous requests for comments on the names of respondents, or any Under the Proposed Program, BOEM the preparation of this 5-year program comments not marked by the intends to use a two-phase post-sale bid may wish to reference that information, respondent as confidential. evaluation process that has been in as appropriate, rather than repeating it Next Steps in the Process effect since 1983, while studying and in their comments on the proposed evaluating refinements and alternative program. We also invite comments and BOEM plans to issue the proposed approaches throughout the 2012–2017 suggestions on how to proceed with the final program and final PEIS in the 5-Year Program. The flexibility section 18 analysis for the Proposed summer of 2012. Sixty days later, the incorporated into the Proposed Program Final Program. Secretary may approve the new 5-year allows BOEM to evaluate alternatives Section 18(g) of the OCSLA authorizes Program. with respect to delaying a sale area, confidential treatment of privileged or choosing a leasing framework, and proprietary information that is Dated: November 7, 2011. setting the fiscal terms and conditions submitted to BOEM. In order to protect Tommy P. Beaudreau, by individual lease sale, based on a the confidentiality of such information, Director, Bureau of Ocean Energy current assessment of market and respondents should include it as an Management. resource conditions. attachment to other comments BILLING CODE 4310–MR–P

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[FR Doc. 2011–29151 Filed 11–9–11; 8:45 am] ACTION: Notice of receipt of permit DATES: Comments on these permit BILLING CODE 4310–MR–C applications; request for comment. applications must be received on or before December 12, 2011. SUMMARY: We, the U.S. Fish and DEPARTMENT OF THE INTERIOR Wildlife Service, invite the public to ADDRESSES: Written data or comments comment on the following applications should be submitted to the U.S. Fish Fish and Wildlife Service to conduct certain activities with and Wildlife Service, Endangered endangered species. With some Species Program Manager, Region 8, [FWS–R8–ES–2011–N234; 80221–1113– exceptions, the Endangered Species Act 2800 Cottage Way, Room W–2606, 0000–F5] (Act) prohibits activities with Sacramento, CA 95825 (telephone: 916– 414–6464; fax: 916–414–6486). Please Endangered Species Recovery Permit endangered and threatened species refer to the respective permit number for Applications unless a Federal permit allows such activity. The Act also requires that we each application when submitting AGENCY: Fish and Wildlife Service, invite public comment before issuing comments. Interior. these permits.

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FOR FURTHER INFORMATION CONTACT: Permit No. TE–101743 nitratoides nitratoides), giant kangaroo Daniel Marquez, Fish and Wildlife Applicant: Daniel Edelstein, Novato, rat (Dipodomys ingens), Fresno Biologist; see ADDRESSES (telephone: California. kangaroo rat (Dipodomys nitratoides 760–431–9440; fax: 760–431–9624). exilis), Morro Bay kangaroo rat The applicant requests an amendment (Dipodomys heermanni morroensis), SUPPLEMENTARY INFORMATION: The to a permit to take (capture, handle, and Buena Vista lake shrew (Sorex ornatus following applicants have applied for release) the California tiger salamander scientific research permits to conduct relictus), riparian woodrat (Neotoma (Ambystoma californiense) in fuscipes riparia) and riparian brush certain activities with endangered conjunction with survey activities species under section 10(a)(1)(A) of the rabbit (Sylvilagus bachmani riparius); throughout the range of the species in • Take (survey, capture, handle, Act (16 U.S.C. 1531 et seq.). We seek California for the purpose of enhancing release, and use baited camera stations review and comment from local, State, the species’ survival. and baited hair snare traps) San Joaquin and Federal agencies and the public on kit fox (Vulpes macrotis mutica); the following permit requests. Permit No. TE–071216 • Take (survey, capture, handle, Applicant Applicant: Reed V. Smith, Ventura, photo document, and release) the Kern California. primrose sphinx moth (Euproserpinus Permit No. TE–126141 The applicant requests a permit to euterpe); and Applicant: Craig A. Stockwell, Fargo, take (survey, locate and monitor nests) • Remove and reduce to possession North Dakota. the California least tern (Sterna from lands under Federal jurisdiction antillarum browni) in conjunction with the following species: The applicant requests an amendment population monitoring activities within Caulanthus californicus (California to take (survey, trap, handle, capture, State Park Lands in Ventura County, jewel-flower), mark, collect biological samples, California, for the purpose of enhancing Chloropyron palmatum (palmate- release, transport, and sacrifice) the the species’ survival. bracted bird’s-beak), Pharump poolfish (Empetrichtys latos) Eremalche kernensis (Kern mallow), in conjunction with surveys, genetic Permit No. TE–148555 Monolopia (=Lembertia) congdonii research, mesocosm experiments, and Applicant: Phillip Brylski, Irvine, (San Joaquin wooly-threads), population monitoring activities California. Opuntia basilaris var. treeleasei throughout the range of the species in (Bakersfield cactus), Nevada, for the purpose of enhancing The applicant requests an amendment Orcuttia pilosa (hairy Orcutt grass), the species’ survival. to a permit to take (survey, capture, Pseudobahia bahiifolia (Hartweg’s handle, and release) the Fresno golden sunburst), Permit No. TE–787716 kangaroo rat (Dipodomys nitratoides Sidalcea keckii (Keck’s checker- Applicant: Scott B. Tremor, Santee, exilis), Tipton kangaroo rat (Dipodomys mallow), California. nitratoides nitratoides), giant kangaroo Sidalcea keckii (Green’s tuctoria). rat (Dipodomys ingens), Amargosa vole The applicant requests a permit to (Microtus californicus scirpensis), salt Permit No. TE–54614A–0 take (harass by survey, capture, handle, marsh harvest mouse (Reithrodontomys Applicant: California Department of and release) the Pacific pocket mouse raviventris), and riparian woodrat Fish and Game, Bishop, California (Perognathus longimembris pacificus) in (Neotoma fuscipes riparia) in The applicant requests a permit to conjunction with surveys and conjunction with survey activities take (capture, handle, mark, recapture, population monitoring activities throughout the range of each species in disease study, and release) the throughout the range of each species in California for the purpose of enhancing Amargosa vole (Microtus californicus California, for the purpose of enhancing the species’ survival. scirpensis) in conjunction with surveys, the species’ survival. Permit No. TE–54631A research and population monitoring Permit No. TE–50510A activities in Inyo County, California, for Applicant: California Department of the purpose of enhancing the species’ Applicant: Geoffrey D. Cline, Oakhurst, Fish and Game, Fresno, California. survival. California. The applicant requests a permit to Permit No. TE–59889A–0 The applicant requests a permit to carry out the following actions in Applicant: Melissa C. Odell, San Diego, take (capture, handle, and release) the conjunction with surveys, population California. California tiger salamander (Ambystoma monitoring, and research activities californiense) in conjunction with throughout the range of each of the The applicant requests a permit to survey activities throughout the range of following species in California for the take (capture, handle, and release) the the species in California, for the purpose purpose of enhancing the species’ California tiger salamander (Ambystoma of enhancing the species’ survival. survival: californiense) and take (capture, collect, • Take (capture, collect, and kill) the and kill) the Conservancy fairy shrimp Permit No. TE–144960 Conservancy fairy shrimp (Branchinecta (Branchinecta conservatio), the conservatio), longhorn fairy shrimp longhorn fairy shrimp (Branchinecta Applicant: Strange Resource (Branchinecta longiantenna), Riverside Management, Wilseyville, California. longiantenna), and the vernal pool fairy shrimp (Streptocephalus woottoni), tadpole shrimp (Lepidurus packardi) in The applicant requests a permit to San Diego fairy shrimp (Branchinecta conjunction with survey activities take (capture, handle, and release) the sandiegonensis), and vernal pool throughout the range of each species in California tiger salamander (Ambystoma tadpole shrimp (Lepidurus packardi); California for the purpose of enhancing californiense) in conjunction with • Take (survey, live trap, capture, the species’ survival. survey activities throughout the range of handle, and release) the California tiger each species in California for the salamander (Ambystoma californiense), Permit No. TE–142435 purpose of enhancing the species’ blunt-nosed leopard lizard (Gambelia Applicant: Debra M. Shier, Topanga, survival. silus) Tipton kangaroo rat (Dipodomys California.

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The applicant requests a permit to Shoshone, Idaho intends to prepare an North Picabo Road. take (harass by survey, capture, handle, Environmental Assessment (EA) that The area described contains transport, conduct mate pairings, will analyze the amendment of the 1981 approximately 3.4 acres in Blaine captive breed, perform behavioral Sun Valley Management Framework County. experiments, conduct physiological Plan, and by this notice is announcing On October 26, 2010, BLM published validation of stress using an the beginning of the scoping process to a Notice of Realty Action proposing a Adrenocorticotrophic Hormone solicit public comments and identify direct sale of the above-described land, Challenge Test [ACTH challenge], issues. which segregated the land from conduct disease risk assessments, and DATES: This notice initiates the public appropriation under the public land release to the wild) the Pacific pocket scoping process for the land use plan laws, including the mining laws, except mouse (Perognathus longimembris amendment and associated EA. the sale provisions of the FLPMA. The pacificus) in conjunction with research, Comments on issues may be submitted segregative effect will terminate upon captive propagation and population in writing until December 12, 2011. The issuance of a patent, publication in the monitoring activities throughout the date(s) and location(s) of any scoping Federal Register of a termination of the range of each species in California for meetings will be announced at least segregation, or October 26, 2012, unless the purpose of enhancing the species’ 15 days in advance through local media, extended by the BLM State Director in survival. mailings to interested parties, and on accordance with 43 CFR 2711.1–2(d) Public Comments the BLM Idaho Web site at: http://www. prior to the termination date. As part of blm.gov/id/st/en/info/nepa.html. In its consideration of the proposed direct We invite public review and comment order to be included in the EA, all sale of this land, BLM will consider on each of these recovery permit comments must be received prior to the whether the Sun Valley Management applications. Comments and materials close of the 30 day scoping period or Framework Plan should be amended to we receive will be available for public 15 days after the last public meeting, address the sale. To the extent possible, inspection, by appointment, during whichever is later. The BLM will this land use planning process will be normal business hours at the address provide additional opportunities for integrated with the ongoing NEPA listed in the ADDRESSES section of this public participation upon publication of process for the proposed sale. This notice. the EA. Before including your address, phone notice initiates the public scoping number, email address, or other ADDRESSES: Comments on issues and process for the plan amendment and personal identifying information in your planning criteria related to the land use associated EA. comment, you should be aware that plan amendment should be addressed to The purpose of the public scoping your entire comment—including your Ruth A. Miller, BLM Shoshone Field process is to determine relevant issues personal identifying information—may Manager, 400 West F Street, Shoshone, that will influence the scope of the be made publicly available at any time. Idaho 83352. environmental analysis, including While you can ask us in your comment FOR FURTHER INFORMATION CONTACT: Tara alternatives, and guide the process for to withhold your personal identifying Hagen, Realty Specialist, BLM Shoshone developing the EA. The public is invited information from public review, we Field Office, telephone: (208) 732–7205; to provide scoping comments on the cannot guarantee that we will be able to address: 400 West F Street, Shoshone, issues that should be addressed in the do so. Idaho 83352. Please contact Tara Hagen preparation of the plan amendment, to have your name added to our mailing including: Lands, wildlife, migratory Michael Long, list. Persons who use a birds, recreation, wilderness, range, Acting Regional Director, Region 9, telecommunications device for the deaf minerals, cultural resources, watershed/ Sacramento, California. (TDD) may call the Federal Information soils, threatened/endangered species, [FR Doc. 2011–29167 Filed 11–9–11; 8:45 am] Relay Service (FIRS) at 1–(800) 877– and hazardous materials. The BLM will BILLING CODE 4310–55–P 8339 to contact the above individual use an interdisciplinary approach to during normal business hours. The FIRS develop the plan amendment in order to is available 24 hours a day, 7 days a consider the variety of resource issues DEPARTMENT OF THE INTERIOR week, to leave a message or question and concerns identified. Specialists with expertise in the following Bureau of Land Management with the above individual. You will receive a reply during normal business disciplines will be involved in the [LLIDT03000–L14300000.EU0000; IDI– hours. planning process: Rangeland 35249] SUPPLEMENTARY INFORMATION: The plan management, minerals and geology, forestry, outdoor recreation, Notice of Intent To Prepare an amendment and associated EA will address a proposed land sale in Blaine archaeology, paleontology, wildlife and Environmental Assessment for a fisheries, land and realty, hydrology, Possible Land Use Plan Amendment County, Idaho. The adjacent private landowner, Point of Rocks Ranch, has soils, sociology and economics. To Provide for a Proposed Direct Land Native American Tribal consultations Sale in Blaine County, ID submitted a proposal to the BLM to consider disposing of the following- will be conducted in accordance with AGENCY: Bureau of Land Management, described land by direct sale, in policy, and Tribal concerns will be Interior. accordance with Sections 203 and 209 given due consideration, including ACTION: Notice of intent. of the FLPMA, as amended, (43 U.S.C. impacts on Indian trust assets. Federal, 1713 and 1714) and implementing State, and local agencies, along with SUMMARY: In compliance with the regulations at 43 CFR part 2700, at no other stakeholders that may be National Environmental Policy Act of less that the appraised fair market value: interested or affected by the BLM’s 1969, as amended, and the Federal Land decision on this project are invited to Policy and Management Act of 1976 Boise Meridian participate in the scoping process and, (FLPMA), as amended, the Bureau of T. 1 S., R. 20 E., if eligible, may request or be requested Land Management (BLM), Twin Falls Sec. 15, that portion of public land in by the BLM to participate as a District, Shoshone Field Office, the NW1⁄4SW1⁄4 lying south of the cooperating agency.

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Before including your address, phone Field Office, and was necessary to Landing Road, Fairbanks, Alaska 99709– number, email address, or other determine federal interest lands. 4619. On November 29, the meeting starts at personal identifying information in your The lands we surveyed are: 9:30 a.m. in the Jade meeting room and the comment, you should be advised that council will accept public comment from Principal Meridian, Montana 3:30 p.m.–4:30 p.m. On November 30, the your entire comment—including your meeting begins in the same location at 9 a.m. personal identifying information—may T. 2 S., R. 3 W. be made publicly available at any time. The plat, in one sheet, representing Dated: November 4, 2011. While you can ask us in your comment the dependent resurvey of Mineral Bud C. Cribley, to withhold from public review your Survey No. 6594, Alice Lode, Township Acting State Director. personal identifying information, we 2 South, Range 3 West, Principal [FR Doc. 2011–29120 Filed 11–9–11; 8:45 am] cannot guarantee that we will be able to Meridian, Montana, was accepted BILLING CODE 4310–JA–P do so. October 28, 2011. We will place a copy Authority: 40 CFR 1501.7, 1508.22, and 43 of the plat, in one sheet, in the open CFR 1610.2. files. It will be available to the public as DEPARTMENT OF THE INTERIOR a matter of information. If the BLM Ruth A. Miller, receives a protest against this survey, as Bureau of Land Management Shoshone Field Manager. shown on this plat, in one sheet, prior [LLMTC 00900.L16100000.DP0000] [FR Doc. 2011–29171 Filed 11–9–11; 8:45 am] to the date of the official filing, we will BILLING CODE 4310–GG–P stay the filing pending our Notice of Public Meeting, Eastern consideration of the protest. We will not Montana Resource Advisory Council officially file this plat, in one sheet, Meeting DEPARTMENT OF THE INTERIOR until the day after we have accepted or AGENCY: Montana, Billings and Miles dismissed all protests and they have City Field Offices, Bureau of Land Bureau of Land Management become final, including decisions or Management, Interior. appeals. [LLMT926000–L14200000–BJ0000] ACTION: Notice of public meeting. Authority: 43 U.S.C. chapter 3. Notice of Filing of Plats of Survey; Steve L. Toth, SUMMARY: In accordance with the Federal Land Policy and Management Montana Acting Chief Cadastral Surveyor, Division of Resources. Act (FLPMA) and the Federal Advisory AGENCY: Bureau of Land Management, Committee Act of 1972 (FACA), the U.S. [FR Doc. 2011–29165 Filed 11–9–11; 8:45 am] Interior. Department of the Interior, Bureau of BILLING CODE 4310–DN–P ACTION: Notice of filing of plats of Land Management (BLM) Eastern survey. Montana Resource Advisory Council (RAC), will meet as indicated below. SUMMARY: The Bureau of Land DEPARTMENT OF THE INTERIOR DATES: The next regular meeting of the Management (BLM) will file the plat of Bureau of Land Management Eastern Montana Resource Advisory survey of the lands described below in Council will be held on Dec. 7, 2011, in the BLM Montana State Office, Billings, [LLAK910000–L13100000.PP0000– L.X.SS.052L0000] Miles City, Montana. The meeting will Montana, on December 12, 2011. start at 8 a.m. and adjourn at DATES: Protests of the survey must be Notice of Public Meeting, BLM–Alaska approximately 3:30 p.m. filed before December 12, 2011 to be Resource Advisory Council; ADDRESSES: When determined, the considered. Correction meeting location will be announced in ADDRESSES: Protests of the survey a news release. AGENCY: should be sent to the Branch of Bureau of Land Management, Alaska State Office, Interior. FOR FURTHER INFORMATION CONTACT: Cadastral Survey, Bureau of Land Mark Jacobsen, Public Affairs Specialist, ACTION: Notice of public meeting; Management, 5001 Southgate Drive, BLM Eastern Montana/Dakotas District, correction. Billings, Montana 59101–4669. 111 Garryowen Road, Miles City, FOR FURTHER INFORMATION CONTACT: SUMMARY: The Bureau of Land Montana, 59301. Telephone: (406) 233– _ Marvin Montoya, Cadastral Surveyor, Management (BLM) published a 2831, mark [email protected]. Persons Branch of Cadastral Survey, Bureau of document in the Federal Register of who use a telecommunications device Land Management, 5001 Southgate October 24, 2011, concerning for the deaf (TDD) may call the Federal Drive, Billings, Montana 59101–4669, announcement of the BLM Alaska Information Relay Service (FIRS) at 1– telephone (406) 896–5124 or (406) 896– Resource Advisory Council (RAC) (800) 677–8339 to contact the above _ 5009, Marvin [email protected]. meeting on November 29 and 30, 2011. individual during normal business Persons who use a telecommunications The document contained incorrect dates hours. The FIRS is available 24 hours a device for the deaf (TDD) may call the and times. day, 7 days a week to leave a message Federal Information Relay Service FOR FURTHER INFORMATION CONTACT: or question with the above individual. (FIRS) at 1–(800) 877–8339 to contact Thom Jennings, (907) 271–3335. You will receive a reply during normal the above individual during normal business hours. business hours. The FIRS is available 24 Correction SUPPLEMENTARY INFORMATION: The 15- hours a day, 7 days a week, to leave a In the Federal Register of October 24, member Council advises the Secretary message or question with the above 2011, in FR Doc. 2011–27394, on page of the Interior through the Bureau of individual. You will receive a reply 65747, in the third column, correct the Land Management on a variety of during normal business hours. DATES caption to read: planning and management issues SUPPLEMENTARY INFORMATION: This DATES: The meeting will be held associated with public land survey was executed at the request of November 29 and 30, 2011, at the Fairbanks management in Montana. At these the Bureau of Land Management, Dillon Princess Riverside Lodge, 4477 Pikes meetings, topics will include: Miles City

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and Billings Field Office manager this investigation may be viewed on the Persons filing written submissions updates, council member briefings, Commission’s electronic docket (EDIS) must file the original document and 12 work sessions and other issues that the at http://edis.usitc.gov. Hearing- true copies thereof on or before the council may raise. All meetings are impaired persons are advised that deadlines stated above with the Office open to the public and the public may information on this matter can be of the Secretary. Submissions should present written comments to the obtained by contacting the refer to the docket number (‘‘Docket No. Council. Each formal Council meeting Commission’s TDD terminal on (202) 2854’’) in a prominent place on the will also have time allocated for hearing 205–1810. cover page and/or the first page. The public comments. Depending on the SUPPLEMENTARY INFORMATION: The Commission’s rules authorize filing number of persons wishing to comment Commission has received a complaint submissions with the Secretary by and time available, the time for filed on behalf of VirnetX, Inc. on facsimile or electronic means only to the individual oral comments may be November 4, 2011. The complaint extent permitted by section 201.8 of the limited. Individuals who plan to attend alleges violations of section 337 of the rules (see Handbook for Electronic and need special assistance, such as Tariff Act of 1930 (19 U.S.C. 1337) in Filing Procedures, http://www.usitc.gov/ sign language interpretation, tour the importation into the United States, secretary/fed_reg_notices/rules/ transportation or other reasonable the sale for importation, and the sale documents/ accommodations should contact the within the United States after handbook_on_electronic_filing.pdf. BLM as provided above. importation of certain devices with Persons with questions regarding Melodie Lloyd, secure communication capabilities, electronic filing should contact the components thereof, and products Secretary (202) 205–2000). Acting State Director, containing the same. The complaint Any person desiring to submit a [FR Doc. 2011–29170 Filed 11–9–11; 8:45 am] names Apple Inc. of Cupertino, CA, as document to the Commission in BILLING CODE 4310–DN–P respondent. confidence must request confidential The complainant, proposed treatment. All such requests should be respondent, other interested parties, and directed to the Secretary to the INTERNATIONAL TRADE members of the public are invited to file Commission and must include a full COMMISSION comments, not to exceed five pages in statement of the reasons why the [DN 2854] length, on any public interest issues Commission should grant such raised by the complaint. Comments treatment. See 19 CFR 201.6. Documents Certain Devices With Secure should address whether issuance of an for which confidential treatment by the Communication Capabilities, exclusion order and/or a cease and Commission is properly sought will be Components Thereof, and Products desist order in this investigation would treated accordingly. All nonconfidential Containing the Same; Receipt of negatively affect the public health and written submissions will be available for Complaint; Solicitation of Comments welfare in the United States, public inspection at the Office of the Relating to the Public Interest competitive conditions in the United Secretary. States economy, the production of like This action is taken under the AGENCY: U.S. International Trade or directly competitive articles in the authority of section 337 of the Tariff Act Commission. United States, or United States of 1930, as amended (19 U.S.C. 1337), ACTION: Notice. consumers. and of sections 201.10 and 210.50(a)(4) In particular, the Commission is SUMMARY: of the Commission’s Rules of Practice Notice is hereby given that interested in comments that: the U.S. International Trade and Procedure (19 CFR 201.10, (i) Explain how the articles 210.50(a)(4)). Commission has received a complaint potentially subject to the orders are used entitled In Re Certain Devices with in the United States; By order of the Commission. Secure Communication Capabilities, (ii) Identify any public health, safety, Issued: November 7, 2011. Components Thereof, and Products or welfare concerns in the United States James R. Holbein, Containing the Same, DN 2854; the relating to the potential orders; Secretary to the Commission. Commission is soliciting comments on (iii) Indicate the extent to which like [FR Doc. 2011–29121 Filed 11–9–11; 8:45 am] any public interest issues raised by the or directly competitive articles are BILLING CODE 7020–02–P complaint. produced in the United States or are FOR FURTHER INFORMATION CONTACT: otherwise available in the United States, James R. Holbein, Secretary to the with respect to the articles potentially DEPARTMENT OF JUSTICE Commission, U.S. International Trade subject to the orders; and Commission, 500 E Street SW., (iv) Indicate whether Complainant, Notice of Lodging of Consent Decree Washington, DC 20436, telephone (202) Complainant’s licensees, and/or third under the Comprehensive 205–2000. The public version of the party suppliers have the capacity to Environmental Response, complaint can be accessed on the replace the volume of articles Compensation, and Liability Act Commission’s electronic docket (EDIS) potentially subject to an exclusion order at http://edis.usitc.gov, and will be and a cease and desist order within a Notice is hereby given that on October available for inspection during official commercially reasonable time. 28, 2011 a proposed Consent Decree business hours (8:45 a.m. to 5:15 p.m.) Written submissions must be filed no with the estate of Donald E. Horne, K.C. in the Office of the Secretary, U.S. later than by close of business, five 1986 Limited Partnership, and DEH International Trade Commission, 500 E business days after the date of Merrywood Company, in United States Street, SW., Washington, DC 20436, publication of this notice in the Federal of America v. Donald E. Horne, et al., telephone (202) 205–2000. Register. There will be further Civil Action No. 4:05–00497, was General information concerning the opportunities for comment on the lodged with the United States District Commission may also be obtained by public interest after the issuance of any Court for the Western District of accessing its Internet server (http:// final initial determination in this Missouri. The United States filed the www.usitc.gov). The public record for investigation. Complaint on May 27, 2005 on behalf of

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the Administrator of the Environmental DEPARTMENT OF JUSTICE their representatives to no more than Protection Agency pursuant to the two per organization. Exceptions to this Comprehensive Environmental Office of Justice Programs limit may occur, should space allow. Response, Compensation, and Liability [OJP (NIJ) Docket No. 1573] Participants planning to attend are Act of 1980, as amended, 42 U.S.C. responsible for their own travel 9601, et seq., seeking recovery of costs Ballistic-Resistant Body Armor arrangements. incurred in responding to the release or Standard Workshop Participants are strongly encouraged threat of release of hazardous substances to come prepared to ask questions and AGENCY: National Institute of Justice, at or in connection with the Armour to voice suggestions and concerns. DOJ. Road Superfund Site located at 2251 Registration information may be found ACTION: Notice. Armour Road North Kansas City, at http://www.justnet.org/Pages/BA- Workshops-Registration-2011.aspx. Missouri. The Complaint alleged claims SUMMARY: The National Institute of against Donald E. Horne (who died in Registration will close on November 21, Justice (NIJ) and the National Institute of 2011. 2007) and five other defendants. Standards and Technology (NIST) are DATES: The workshop will be held on jointly hosting a workshop focused on The Consent Decree addresses only Tuesday, November 29, 2011, beginning NIJ Standard-0101.06, Ballistic the claims against the estate of Donald at 9 a.m. The workshop will begin with Resistance of Body Armor, and the E. Horne, K.C. 1986 Limited a general session from 9 a.m. to 11 a.m. discussion is directed toward Partnership, and DEH Merrywood Following the general session, manufacturers, certification bodies, and Company. The Consent Decree will individual 30-minute breakout session test laboratories. This workshop is being resolve the United States’ claims against will be offered from 11:30 a.m. to 2:30 held specifically to discuss with these settling Defendants for the Site in p.m. interested parties the upcoming revision return for payments equaling 36.7% of ADDRESSES: National Institute of the assets of Donald E. Horne’s estate as of this standard and to receive input, comments, and recommendations. Standards and Technology (NIST), 100 described in the Consent Decree. The workshop will be held on Bureau Drive, Gaithersburg MD, For thirty (30) days after the date of Tuesday, November 29, 2011 at NIST, Building 101, Lecture Room A. this publication, the Department of 100 Bureau Drive, Gaithersburg MD, FOR FURTHER INFORMATION CONTACT: Justice will receive comments relating to Building 101, Lecture Room A. The Casandra Robinson, National Institute of the Consent Decree. Comments should workshop will begin with a general Justice, by telephone at 202–305–2596 be addressed to the Assistant Attorney session from 9 a.m. to 11 a.m. Following [Note: this is not a toll-free telephone General, Environment and Natural the general session, individual 30- number], or by email at Resources Division, and either emailed minute breakout session will be offered [email protected]. to [email protected] or from 11:30 a.m. to 2:30 a.m. for those Kristina Rose, mailed to P.O. Box 7611, U.S. interested in the following: Deputy Director, National Institute of Justice. Department of Justice, Washington, DC (1) One-on-one conversation with NIJ [FR Doc. 2011–29068 Filed 11–9–11; 8:45 am] 20044–7611. In either case, the leadership. comments should refer to United States (2) One-on-one discussion with BILLING CODE 4410–18–P of America v. Donald E. Horne, et al., Compliance Testing Program personnel. DOJ Ref No. 90–11–3–08035/1. (3) One-on-one discussion with personnel leading development of the DEPARTMENT OF LABOR During the comment period, the revised standard. Consent Decree may be examined on the Time slots for individual breakout Bureau of Labor Statistics following Department of Justice Web sessions may be requested from the Proposed Collection, Comment site: http://www.justice.gov/enrd/ registration page indicated below. _ Request Consent Decrees.html. A copy of the Additional time slots will be made Consent Decree may also be obtained by available if needed to accommodate ACTION: Notice. mail from the Consent Decree Library, attendee requests. P.O. Box 7611, U.S. Department of Workshop discussions will be SUMMARY: The Department of Labor, as Justice, Washington, DC 20044–7611, or documented and published on http:// part of its continuing effort to reduce by faxing or emailing a request to Tonia www.justnet.org. Information shared paperwork and respondent burden, Fleetwood ([email protected]), during the individual breakout sessions conducts a pre-clearance consultation fax no. (202) 514–0097, phone that NIJ views as beneficial to the program to provide the general public confirmation number (202) 514–1547. In broader body armor community will be and Federal agencies with an requesting a copy from the Consent summarized as part of the workshop opportunity to comment on proposed Decree Library, please enclose a check notes. Contributors of comments will and/or continuing collections of in the amount of $14.50 (25 cents per not be identified in the workshop notes. information, in accordance with the page reproduction cost) payable to the Each attendee is advised that it is the Paperwork Reduction Act of 1995 United States Treasury or, if by email or responsibility of the contributor to (PRA95) [44 U.S.C. 3506(c) (2)(A)]. This fax, please forward a check in that protect any information that they may program helps to ensure that requested amount to the Consent Decree Library at consider proprietary during both the data can be provided in the desired the stated address. workshop and any individual breakout format, reporting burden (time and session in which they may participate. financial resources) is minimized, Robert E. Maher, Jr., Space is limited at this workshop, and collection instruments are clearly Assistant Section Chief, Environmental as a result, only 50 participants will be understood, and the impact of collection Enforcement Section, Environment and allowed to register for the general requirements on respondents can be Natural Resources Division. session. Individual time slots will be properly assessed. The Bureau of Labor [FR Doc. 2011–29100 Filed 11–9–11; 8:45 am] available on the registration page. We Statistics (BLS) is soliciting comments BILLING CODE 4410–15–P request that each organization limit concerning the proposed extension of

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the ‘‘Job Openings and Labor Turnover to researchers. While these two methodology, or other aspects of the Survey.’’ A copy of the proposed measures are expected to move in survey. information collection request (ICR) can opposite directions over the course of III. Desired Focus of Comments be obtained by contacting the individual the business cycle, their relative levels listed below in the Addresses section of and movements depend on the The Bureau of Labor Statistics is this notice. efficiency of the labor market in particularly interested in comments DATES: Written comments must be matching workers and jobs. that: submitted to the office listed in the Along with the job openings rate, • Evaluate whether the proposed Addresses section below on or before trends in hires and separations may collection of information is necessary January 9, 2012. broadly identify which aggregate for the proper performance of the industries face the tightest labor ADDRESSES: Send comments to Amelia functions of the agency, including markets. Quits rates, the number of Vogel, BLS Clearance Officer, Division whether the information will have persons who quit during an entire of Management Systems, Bureau of practical utility. month as a percentage of total Labor Statistics, Room 4080, 2 • Evaluate the accuracy of the employment, may provide clues about Massachusetts Avenue, NE., agency’s estimate of the burden of the workers’ views of the labor market or Washington, DC 20212. Written proposed collection of information, their success in finding better jobs. In comments also may be transmitted by including the validity of the addition, businesses will be able to fax to (202) 691–5111 (this is not a toll methodology and assumptions used. compare their own turnover rates to the free number). • Enhance the quality, utility, and national, regional, and major industry FOR FURTHER INFORMATION CONTACT: clarity of the information to be division rates. collected. Amelia Vogel, BLS Clearance Officer, at The BLS uses the JOLTS form to • Minimize the burden of the (202) 691–6138 (this is not a toll free gather employment, job openings, hires, collection of information on those who number). (See ADDRESSES section.) and total separations from business are to respond, through the use of SUPPLEMENTARY INFORMATION: establishments. The information is appropriate automated, electronic, collected once a month at the BLS Data I. Background mechanical, or other technological Collection Center (DCC) in Atlanta, collection techniques or other forms of The Job Openings and Labor Turnover Georgia. The information is collected information technology, e.g., permitting Survey (JOLTS) collects data on job using Computer Assisted Telephone electronic submissions of responses. vacancies, labor hires, and labor Interviewing (CATI), Touch-tone Data separations. As the monthly JOLTS time Entry (TDE), FAX, email, and Web. An Type of Review: Extension of a series grow longer, their value in establishment is in the sample for 24 currently approved collection. assessing the business cycle, the consecutive months. Agency: Bureau of Labor Statistics. difficulty that employers have in hiring Title: Job Openings and Labor workers, and the extent of the mismatch II. Current Action Turnover Survey. between the unused supply of available Office of Management and Budget OMB Number: 1220–0170. workers and the unmet demand for clearance is being sought for the JOLTS. Affected Public: Federal Government; labor by employers will increase. The The BLS is requesting an extension to State, Local, or Tribal governments; study of the complex relationship the existing clearance for the JOLTS. Businesses or other for-profit; Not-for- between job openings and There are no major changes being made profit institutions; Small businesses and unemployment is of particular interest to the forms, procedures, data collection organizations.

Total Total Estimated total Affected public respondents Frequency responses Average time per response burden

Private ...... 9,017 Monthly ...... 108,204 10 min...... 18,034 State, Local, & Tribal Gov’t ... 1,415 Monthly ...... 16,980 10 min...... 2,830 Federal Gov’t ...... 393 Monthly ...... 4,716 10 min...... 786

TOTALS ...... 10,825 Monthly ...... 129,900 10 min...... 21,650

Total Burden Cost (capital/startup): DEPARTMENT OF LABOR extension of the information collection $0. requirements contained in the Electrical Total Burden Cost (operating/ Occupational Safety and Health Standards for Construction (29 CFR part maintenance): $0. Administration 1926, Subpart K) and for General Comments submitted in response to [Docket No. OSHA–2011–0187] Industry (29 CFR part 1910, Subpart S). this notice will be summarized and/or The Standards address safety included in the request for Office of Electrical Standards for Construction procedures for installation and Management and Budget approval of the and General Industry; Extension of the maintenance of electric utilization information collection request; they also Office of Management and Budget’s equipment that prevent death and will become a matter of public record. (OMB) Approval of the Information serious injuries among construction and Signed at Washington, DC, this 31st day of Collection (Paperwork) Requirements general industry workers in the October 2011. AGENCY: Occupational Safety and Health workplace caused by electrical hazards. Kimberley Hill, Administration (OSHA), Labor. DATES: Comments must be submitted Chief, Division of Management Systems, ACTION: Request for public comments. Bureau of Labor Statistics. (postmarked, sent, or received) by January 9, 2012. [FR Doc. 2011–29102 Filed 11–9–11; 8:45 am] SUMMARY: OSHA solicits public BILLING CODE 4510–24–P comments concerning its request for an ADDRESSES:

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Electronically: You may submit and respondent (i.e., employer) burden, Agency’s functions, including whether comments and attachments conducts a preclearance consultation the information is useful; electronically at http:// program to provide the public with an • The accuracy of OSHA’s estimate of www.regulations.gov, which is the opportunity to comment on proposed the burden (time and cost) of the Federal eRulemaking Portal. Follow the and continuing information collection information collection requirements, instructions online for submitting requirements in accordance with the including the validity of the comments. Paperwork Reduction Act of 1995 (44 methodology and assumptions used; Facsimile: If your comments, U.S.C. 3506(c)(2)(A)). • The quality, utility, and clarity of including attachments, are not longer the information collected; and This program ensures that • than 10 pages, you may fax them to the information is in the desired format, Ways to minimize the burden on OSHA Docket Office at (202) 693–1648. reporting burden (time and costs) is employers who must comply; for Mail, hand delivery, express mail, minimal, collection instruments are example, by using automated or other messenger, or courier service: When clearly understood, and OSHA’s technological information collection using this method, you must submit a estimate of the information collection and transmission techniques. copy of your comments and attachments burden is accurate. The Occupational III. Proposed Actions to the OSHA Docket Office, Docket No. Safety and Health Act of 1970 (the OSH OSHA–2011–0187, U.S. Department of OSHA is proposing to increase the Act) (29 U.S.C. 651 et seq.) authorizes existing burden hours estimated for the Labor, Occupational Safety and Health information collection by employers as Administration, Room N–2625, 200 Electrical Standards for Construction necessary or appropriate for and for General Industry. This increase Constitution Avenue NW., Washington, enforcement of the Act or for developing DC 20210. Deliveries (hand, express in burden hours from 151,172 hours to information regarding the causes and 170,098 hours, a total increase of 18,926 mail, messenger, and courier service) prevention of occupational injuries, are accepted during the Department of hours, is due to the increase in the time illnesses, and accidents (29 U.S.C. 657). it takes to acquire and post signs. The Labor’s and Docket Office’s normal The OSH Act also requires that OSHA business hours, 8:15 a.m. to 4:45 p.m., data used is primarily based on the final obtain such information with minimum e.t. economic analysis (FEA) prepared burden upon employers, especially Instructions: All submissions must during the revision of the final rule of include the Agency name and OSHA those operating small businesses, and to 29 CFR part 1910, Subpart S. There was docket number (OSHA–2011–0187) for reduce to the maximum extent feasible an increase in the cost of the labels from the Information Collection Request unnecessary duplication of efforts in $2.00 to $3.75 and OSHA has added the (ICR). All comments, including any obtaining information (29 U.S.C. 657). cost of caution and warning signs. The personal information you provide, are The information collection total cost over a five-year period to the placed in the public docket without requirements specified by the Electrical employer is $12,034,166 (or $2,406,833 change, and may be made available Standards for Construction and for per year). The Agency will summarize online at http://www.regulations.gov. General Industry alert workers to the any comments submitted in response to For further information on submitting presence and types of electrical hazards this notice, and will include this comments see the ‘‘Public in the workplace, thereby preventing summary in the request to OMB to Participation’’ heading in the section of serious injury and death by extend the approval of the information this notice titled SUPPLEMENTARY electrocution. The information collection requirements contained in INFORMATION. collection requirements in these these Standards. Docket: To read or download Standards involve the following: The Type of Review: Extension of a comments or other material in the employer using electrical equipment currently approved collection. docket, go to http://www.regulations.gov that is marked with the manufacturer’s Title: Electrical Standards for or the OSHA Docket Office at the name, trademark, or other descriptive Construction (29 CFR part 1926, Subpart address above. All documents in the markings that identify the producer of K) and for General Industry (29 CFR part docket (including this Federal Register the equipment, and marking the 1910, Subpart S). notice) are listed in the http:// equipment with the voltage, current, OMB Number: 1218–0130. www.regulations.gov index; however, wattage, or other ratings necessary; Affected Public: Business or other for- some information (e.g., copyrighted requiring each disconnecting means for profits; Not-for-profit institutions; material) is not publicly available to motors and appliances to be marked Federal Government; State, local, or read or download through the Web site. legibly to indicate its purpose, unless Tribal governments. All submissions, including copyrighted located and arranged so the purpose is Number of Respondents: 500,000. evident; requiring the entrances to Frequency of Response: Occasionally. material, are available for inspection Total Responses: 2,511,139. and copying at the OSHA Docket Office. rooms and other guarded locations Average Time per Response: Varies You may also contact Theda Kenney at containing exposed live parts to be from three minutes (.08 hour) to post the address below to obtain a copy of marked with conspicuous warning signs and construct each sign to four hours to the ICR. forbidding unqualified persons from document a hazardous classified FOR FURTHER INFORMATION CONTACT: entering; and, for construction location by a certified electrical Theda Kenney or Todd Owen, employers only, establishing and engineer. Directorate of Standards and Guidance, implementing the assured equipment Estimated Total Burden Hours: OSHA, U.S. Department of Labor, Room grounding conductor program instead of 170,098. N–3609, 200 Constitution Avenue NW., using ground-fault circuit interrupters. Estimated Cost Operation and Washington, DC 20210; telephone (202) II. Special Issues for Comment Maintenance): $2,406,833. 693–2222. IV. Public Participation—Submission of SUPPLEMENTARY INFORMATION: OSHA has a particular interest in comments on the following issues: Comments on this Notice and Internet I. Background • Whether the proposed information Access to Comments and Submissions The Department of Labor, as part of its collection requirements are necessary You may submit comments in continuing effort to reduce paperwork for the proper performance of the response to this document as follows:

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(1) Electronically at http:// Signed at Washington, DC, on November 4, Historical and Cultural Organizations www.regulations.gov, which is the 2011. Grants Program, submitted to the Federal eRulemaking Portal; (2) by David Michaels, Division of Public Programs at the facsimile (fax); or (3) by hard copy. All Assistant Secretary of Labor for Occupational August 17, 2011 deadline. comments, attachments, and other Safety and Health. Michael P. McDonald, material must identify the Agency name [FR Doc. 2011–29065 Filed 11–9–11; 8:45 am] and the OSHA docket number for the BILLING CODE 4510–26–P Advisory Committee, Management Officer. ICR (Docket No. OSHA–2011–0187). [FR Doc. 2011–28532 Filed 11–9–11; 8:45 am] You may supplement electronic BILLING CODE 7536–01–P submissions by uploading document NATIONAL FOUNDATION ON THE files electronically. If you wish to mail ARTS AND THE HUMANITIES additional materials in reference to an Meetings of Humanities Panel electronic or facsimile submission, you NATIONAL SCIENCE FOUNDATION must submit them to the OSHA Docket AGENCY: The National Endowment for National Science Board; Sunshine Act Office (see the section of this notice the Humanities. Meetings titled ADDRESSES). The additional ACTION: Notice of additional meeting. materials must clearly identify your SUMMARY: Pursuant to the provisions of The National Science Board’s electronic comments by your name, Subcommittee on Facilities (SCF), date, and the docket number so the the Federal Advisory Committee Act (Pub. L. 92–463, as amended), notice is pursuant to NSF regulations (45 CFR Agency can attach them to your hereby given that the following meeting part 614), the National Science comments. of the Humanities Panel will be held at Foundation Act, as amended (42 U.S.C. Because of security procedures, the the Old Post Office, 1100 Pennsylvania 1862n-5), and the Government in the use of regular mail may cause a Avenue NW., Washington, DC 20506. Sunshine Act (5 U.S.C. 552b), hereby significant delay in the receipt of FOR FURTHER INFORMATION CONTACT: gives notice in regard to the scheduling comments. For information about Michael P. McDonald, Advisory of a meeting for the transaction of security procedures concerning the Committee Management Officer, National Science Board business, as delivery of materials by hand, express National Endowment for the follows: delivery, messenger, or courier service, Humanities, Washington, DC 20506; DATE AND TIME: Monday, November 14, please contact the OSHA Docket Office telephone (202) 606–8322. Hearing- 2011 to 5 p.m., EST. at (202) 693–2350, (TTY (877) 889– impaired individuals are advised that 5627). information on this matter may be SUBJECT MATTER: Discussion of Mid- Comments and submissions are obtained by contacting the scale Instrumentation Report. posted without change at http:// Endowment’s TDD terminal on (202) 606–8282. STATUS: Open. www.regulations.gov. Therefore, OSHA SUPPLEMENTARY INFORMATION: The This meeting will be held by cautions commenters about submitting teleconference originating at the personal information such as social proposed meeting is for the purpose of panel review, discussion, evaluation National Science Board Office, National security numbers and dates of birth. and recommendation on applications Science Foundation, 4201Wilson Blvd., Although all submissions are listed in for financial assistance under the Arlington, VA 22230. A room will be the http://www.regulations.gov index, National Foundation on the Arts and the available for the public and NSF staff to some information (e.g., copyrighted Humanities Act of 1965, as amended, listen-in on this teleconference meeting. material) is not publicly available to including discussion of information All visitors must contact the Board read or download through this Web site. given in confidence to the agency by the Office at least one day prior to the All submissions, including copyrighted grant applicants. Because the proposed meeting to arrange for a visitor’s badge material, are available for inspection meeting will consider information that and obtain the room number. Call (703) and copying at the OSHA Docket Office. is likely to disclose trade secrets and 292–7000 to request your badge, which Information on using the http:// commercial or financial information will be ready for pick-up at the visitor’s www.regulations.gov Web site to submit obtained from a person and privileged desk on the day of the meeting. All comments and access the docket is or confidential and/or information of a visitors must report to the NSF visitor available at the Web site’s ‘‘User Tips’’ personal nature the disclosure of which desk at the 9th and N. Stuart Streets would constitute a clearly unwarranted link. Contact the OSHA Docket Office entrance to receive their visitor’s badge invasion of personal privacy, pursuant for information about materials not on the day of the teleconference. available through the Web site, and for to authority granted me by the assistance in using the Internet to locate Chairman’s Delegation of Authority to Please refer to the National Science docket submissions. Close Advisory Committee meetings, Board Web site (http://www.nsf.gov/nsb/ dated July 19, 1993, I have determined notices/) for information or schedule V. Authority and Signature that the meeting will be closed to the updates, or contact: Blane Dahl, public pursuant to subsections (c)(4), National Science Foundation, David Michaels, Ph.D., MPH, and (6) of section 552b of Title 5, United 4201Wilson Blvd., Arlington, VA 22230. Assistant Secretary of Labor for States Code. Telephone: (703) 292–7000. Occupational Safety and Health, Date: November 14, 2011. directed the preparation of this notice. Time: 10:30 a.m. to 11:30 a.m. Ann Bushmiller, The authority for this notice is the Room: 421. Senior Counsel to the National Science Board. Paperwork Reduction Act of 1995 (44 Program: This meeting, which will be [FR Doc. 2011–29344 Filed 11–8–11; 4:15 pm] U.S.C. 3506 et seq.) and Secretary of by teleconference, will review an BILLING CODE 7555–01–P Labor’s Order No. 5–2010 (75 FR application for the Civil War 55355). Sesquicentennial in America’s

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NATIONAL TRANSPORTATION NUCLEAR REGULATORY Renewal, U.S. Nuclear Regulatory SAFETY BOARD COMMISSION Commission, Washington, DC 20555– 0001; telephone: (301) 415–6337; email: SES Performance Review Board [Docket No. 50–391; NRC–2008–0369] [email protected]. SUPPLEMENTARY INFORMATION: AGENCY: National Transportation Safety Draft Supplement 2 to Final Board. Environmental Statement Related to I. Submitting Comments and Accessing the Operation of Watts Bar Nuclear ACTION: Notice. Information Plant, Unit 2; Tennessee Valley Authority Comments submitted in writing or in SUMMARY: Notice is hereby given of the electronic form will be posted on the appointment of members of the National AGENCY: Nuclear Regulatory NRC Web site and on the Federal Transportation Safety Board, Commission (NRC). rulemaking Web site, http://www. Performance Review Board (PRB). ACTION: Draft environmental statement; regulations.gov. Because your comments FOR FURTHER INFORMATION CONTACT: opportunity to comment and public will not be edited to remove any Emily T. Carroll, Chief, Human meeting. identifying or contact information, the Resources Division, Office of NRC cautions you against including any Administration, National Transportation SUMMARY: The U.S. Nuclear Regulatory information in your submission that you Safety Board, 490 L’Enfant Plaza, SW., Commission (NRC) is requesting do not want to be publicly disclosed. Washington, DC 20594–0001, (202) 314– comments on NUREG–0498, ‘‘Final The NRC requests that any party 6233. Environmental Statement, Supplement soliciting or aggregating comments SUPPLEMENTARY INFORMATION: Section 2, Related to the Operation of Watts Bar received from other persons for 4314(c)(1) through (5) of Title 5, United Nuclear Plant [WBN], Unit 2—Draft submission to the NRC inform those States Code requires each agency to Report for Comment’’ (draft SFES). The persons that the NRC will not edit their establish, in accordance with NRC will hold a public meeting on the comments to remove any identifying or regulations prescribed by the Office of draft SFES on December 8, 2011. contact information, and therefore, they Personnel Management, one or more DATES: Submit comments by December should not include any information in SES Performance Review Boards. The 27, 2011. Comments received after this their comments that they do not want board reviews and evaluates the initial date will be considered if it is practical publicly disclosed. appraisal of a senior executive’s to do so, but the NRC is able to ensure You can access publicly available performance by the supervisor and consideration only for comments documents related to this document considers recommendations to the received on or before this date. using the following methods: • NRC’s Public Document Room appointing authority regarding the ADDRESSES: Please include Docket ID (PDR): The public may examine and performance of the senior executive. NRC–2008–0369 in the subject line of have copied, for a fee, publicly available The following have been designated your comments. For additional documents at the NRC’s PDR, Room O1– as members of the Performance Review instructions on submitting comments F21, One White Flint North, 11555 Board of the National Transportation and instructions on accessing Rockville Pike, Rockville, Maryland Safety Board: documents related to this action, see 20852. ‘‘Submitting Comments and Accessing The Honorable Christopher A. Hart, • NRC’s Agencywide Documents Information’’ in the SUPPLEMENTARY Vice Chairman, National Access and Management System INFORMATION section of this document. Transportation Safety Board; PRB (ADAMS): Publicly available documents You may submit comments by any of Chair. created or received at the NRC are the following methods: The Honorable Earl Weener, Member, available online in the NRC Library at • Federal Rulemaking Web Site: Go to National Transportation Safety Board. http://www.nrc.gov/reading-rm/adams. http://www.regulations.gov and search David Tochen, General Counsel, html. From this page, the public can for documents filed under Docket ID National Transportation Safety Board. gain entry into ADAMS, which provides NRC–2008–0369. Address questions Dr. John Cavolowsky, Director, Airspace text and image files of the NRC’s public about NRC dockets to Carol Gallagher, Systems Program Office, Aeronautics documents. If you do not have access to telephone: (301) 492–3668; email: Research Mission Directorate, ADAMS or if there are problems in National Aeronautics and Space [email protected]. • Mail comments to: Cindy Bladey, accessing the documents located in Administration. Chief, Rules, Announcements, and ADAMS, contact the NRC’s PDR Jerold Gidner, Deputy Director, Office of Directives Branch (RADB), Office of reference staff at 1–(800) 397–4209, Strategic Employee and Administration, Mail Stop: TWB–05– (301) 415–4737, or by email to pdr. Organizational Development, B01M, U.S. Nuclear Regulatory [email protected]. The draft SFES is Department of the Interior. Commission, Washington, DC 20555– available electronically under ADAMS David L. Mayer, Managing Director, 0001. Accession Number ML112980199. • Federal Rulemaking Web Site: National Transportation Safety Board. • Fax comments to: RADB at (301) Public comments and supporting The Honorable Mark Rosekind, Member, 492–3446. National Transportation Safety Board. • Verbal comments at: Public meeting materials related to this notice can be (Alternate). on December 8, 2011. See Section IV, found at http://www.regulations.gov by Florence Carr, Deputy Managing Submitting Comments at Public searching on Docket ID NRC–2008– Director, Federal Maritime Meeting, of this document for more 0369. Commission. (Alternate). information regarding the public II. Background Dated: November 3, 2011. meeting. The Tennessee Valley Authority (TVA Candi Bing, FOR FURTHER INFORMATION CONTACT: or the applicant) submitted its Final Federal Register Coordinator. Carmen G. Fells, Project Manager, Supplemental Environmental Impact [FR Doc. 2011–29081 Filed 11–9–11; 8:45 am] Environmental Review and Guidance Statement for the Completion and BILLING CODE P Update Branch, Division of License Operation of WBN Unit 2 (June 2007)

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(FSEIS) by letter dated February 15, informal discussions 1 hour before the Act), the Commission must make a 2008 (ADAMS Accession No. start of each meeting session. No formal determination that such alternatives ML080510469), pursuant to Part 51 of comments on the draft SFES will be will achieve a level of stabilization and Title 10 of the Code of the Federal accepted during the informal containment of the sites concerned, and Regulations (10 CFR). discussions. To be considered, a level of protection for public health, On June 30, 1976, TVA submitted an comments must be provided either at safety, and the environment from application for an operating license for the transcribed public meeting sessions radiological and non-radiological WBN Unit 2, pursuant to 10 CFR Part or by any of the methods provided in hazards associated with such sites, after 50. An updated operating license the ADDRESSES section of this document. notice and opportunity for public application was submitted on March 4, Persons may register to attend or present hearing. Through this action, the 2009. The proposed action in response oral comments at the meeting by Commission intends to fulfill both the to the updated application is the contacting Ms. Carmen Fells, by notice and opportunity for public issuance of an operating license that telephone at 1–(800) 368–5642, hearing provisions of Section 274o. would authorize TVA to possess, use, extension 6337, or by email at Carmen. DATES: Submit comments by December and operate a second light-water nuclear [email protected] no later than December 1, 12, 2011. Comments received after this reactor (the facility), WBN Unit 2, 2011. Ms. Fells will need to be date will be considered if it is practical located on the applicant’s site in Rhea contacted no later than November 28, to do so, but the Commission cannot County, Tennessee. The WBN Unit 2 2011, if special equipment or assure consideration of comments would operate at a steady-state power accommodations are needed to attend or received after this date. level of 3411 megawatts thermal. present information at the public ADDRESSES: Please include Docket ID A notice of receipt and availability of meeting, so that the NRC staff can the updated application, which NRC–2011–0258 in the subject line of determine whether the request can be your comments. For additional included the FSEIS, was published in accommodated. the Federal Register on May 1, 2009 (74 instructions on submitting comments FR 20350). A notice of intent to prepare Dated at Rockville, Maryland, this 2nd day and instructions on accessing a supplement to the final environmental of November 2011. documents related to this action, see statement, which was prepared and For the Nuclear Regulatory Commission. ‘‘Submitting Comments and Accessing published in 1978 and to conduct the Stephen J. Campbell, Information’’ in the SUPPLEMENTARY scoping process was published in the Chief, Watts Bar Special Projects Branch, INFORMATION section of this document. Federal Register on September 11, 2009 Division of Operating Reactor Licensing, You may submit comments by any one (74 FR 46799). On October 6, 2009, the Office of Nuclear Reactor Regulation. of the following methods: NRC held two scoping meetings in [FR Doc. 2011–29130 Filed 11–9–11; 8:45 am] • Federal Rulemaking Web site: Go to Sweetwater, Tennessee, to obtain public BILLING CODE 7590–01–P http://www.regulations.gov and search input on the scope of the environmental for documents filed under Docket ID review. The NRC also solicited NRC–2011–0258. Address questions comments from Federal, State, Tribal, NUCLEAR REGULATORY about NRC dockets to Carol Gallagher, regional, and local agencies. COMMISSION telephone: (301) 492–3668; email: [NRC–2011–0258] [email protected]. III. Purpose • Mail comments to: Cindy Bladey, The purpose of this document is to Proposed Alternative Soils Standards Chief, Rules, Announcements, and inform the public that a draft SFES for the Uravan, Colorado Uranium Mill Directives Branch (RADB), Office of related to the review of the operating Administration, Mail Stop: TWB–05– license application has been prepared in AGENCY: Nuclear Regulatory B01M, U.S. Nuclear Regulatory accordance with 10 CFR 51.92 and to Commission. Commission, Washington, DC 20555– provide the public an opportunity to ACTION: Uranium milling alternative 0001. comment. standards. • Fax comments to: RADB at (301) 492–3446. IV. Submitting Comments at Public SUMMARY: By letter dated October 10, FOR FURTHER INFORMATION CONTACT: Meeting 2007, the Colorado Department of Dennis M. Sollenberger, Office of The NRC staff will hold a public Public Health and the Environment Federal and State Materials and meeting to present an overview of the (CDPHE)’s, Hazardous Materials and Environmental Management Programs, draft SFES and to accept public Waste Management Division (the U.S. Nuclear Regulatory Commission, comments on the document. The public Division) submitted a proposal for Washington, DC 20555–0001, telephone: meeting will be held at the Magnuson alternative standards for soil clean up in (301) 415–2819; email: Hotel at 1421 Murrays Chapel Road in four areas of the Uravan Site in [email protected]. Sweetwater, Tennessee, on Thursday, Montrose County, Colorado. The December 8, 2011. The meeting will Division approved the proposed SUPPLEMENTARY INFORMATION: consist of two sessions, which will alternative standards and requested the cover the same subjects. The sessions U.S. Nuclear Regulatory Commission’s Submitting Comments and Accessing will convene at 2 p.m. and 6:30 p.m. (NRC or the Commission) concurrence. Information and will continue until 4 p.m. and Colorado’s proposed alternative soil Comments submitted in writing or in 8:30 p.m., as necessary. The meeting standards are to leave the remaining electronic form will be posted on the will be transcribed and will include: (1) radioactive contamination in place in NRC Web site and on the Federal A presentation of the contents of the these four areas without any further rulemaking Web site, http:// draft SFES and (2) the opportunity for remediation. The NRC staff has www.regulations.gov. Because your interested government agencies, determined that Colorado’s proposal comments will not be edited to remove organizations, and individuals to constitutes use of alternative standards. any identifying or contact information, provide comments on the draft SFES. Under Section 274o of the Atomic the NRC cautions you against including Additionally, the NRC staff will host Energy Act of 1954, as amended (the any information in your submission that

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you do not want to be publicly processed primarily for their source administered by the CDPHE through its disclosed. material content or which are used for Section 274b Agreement with the NRC. The NRC requests that any party the disposal of Section 11e.(2) The Uravan mill ceased operations in soliciting or aggregating comments byproduct material. Before the State can 1984 and began decommissioning received from other persons for adopt alternative standards, the planning and implementation. Under submission to the NRC inform those Commission must make the the Comprehensive Environmental persons that the NRC will not edit their determination that the alternative Response, Compensation, and Liability comments to remove any identifying or standards will achieve a level of Act (CERCLA), this site was listed on contact information, and therefore, they stabilization and containment of the site the National Priorities List (NPL) in should not include any information in concerned, and the alternative standards 1986. The CDPHE is designated as the their comments that they do not want will provide an adequate level of Lead Agency at this site under a publicly disclosed. protection for public health, safety, and Memorandum of Agreement signed with You can access publicly available the environment from radiological and Region VIII of the U.S. Environmental documents including comments related non-radiological hazards associated Protection Agency (EPA) in 1986. to this proposed action using the with the site. In addition, before making The site covers over 500 acres, most following methods: that determination, the NRC must of which is in very steep, rugged terrain. • NRC’s Public Document Room provide notice and an opportunity for The remainder of the site is dominated (PDR): The public may examine and public hearing prior to approving the by the San Miguel River Valley. have copied, for a fee, publicly available site-specific alternative standards. The Remedial activities have concluded and documents at the NRC’s PDR, O1–F21, Commission is using the notice and the final cap is in place over the One White Flint North, 11555 Rockville opportunity for comment process disposal areas. Pike, Rockville, Maryland 20852. through this Federal Register notice to • Portions of the site will be titled to the NRC’s Agencywide Documents fulfill both the notice and opportunity U.S. Department of Energy (DOE) for Access and Management System for public hearing provisions of the Act. Legacy Management. Other portions of (ADAMS): Publicly available documents This approach of allowing interested the site will be transferred to other created or received at the NRC are persons to provide comments before the Federal agencies (e.g., Bureau of Land available online in the NRC Library at Commission reaches a determination on Management (BLM)) or to a land trust http://www.nrc.gov/reading-rm/ the proposed alternative standards was for institutional management. Montrose adams.html. From this page, the public approved by the Commission in the County Road Y–11 bisects the site. can gain entry into ADAMS, which Staff Requirements Memorandum (SRM) The CDPHE believes the licensee has provides text and image files of the for SECY–03–0025, ‘‘Utah Alternative remediated the site to the extent NRC’s public documents. If you do not Groundwater Protection Standards; practical and has identified four discrete have access to ADAMS or if there are Process for Implementation of the areas that are not in full compliance problems in accessing the documents Alternative Standards Provision in with the soil remediation standards. The located in ADAMS, contact the NRC’s Section 274o of the Atomic Energy Act licensee has proposed and CDPHE PDR reference staff at 1–(800) 397–4209, of 1954, As Amended,’’ dated April 21, agrees that no further remediation is (301) 415–4737, or by email to 2003 (ADAMS Accession Nos. warranted for these areas. [email protected]. ML032901053 for the SRM, This is the first site specific • Federal Rulemaking Web Site: ML032901045 for the SECY paper). The alternative standards to be proposed by Public comments and supporting NRC staff is following the same process an Agreement State (generic alternative materials related to this proposed action and has evaluated the Colorado standards were proposed and approved can be found at http:// proposal and has made a preliminary for Utah). There is a provision for www.regulations.gov by searching on determination that the proposed alternative standards in the introduction Docket ID NRC–2011–0258. alternative standards for the Uravan site to Appendix A of 6 CCR (Code of Background in Colorado are acceptable. Colorado Regulations) 1007–1, part 18 (equivalent to Title 10 of the Code of Since Section 274 of the Act was Discussion Federal Regulations (CFR), part 40, added in 1959, the Commission has The Uravan site began operations in Appendix A) which allows for entered into Agreements with 37 States 1912 as a radium mill and later ‘‘alternates to the requirements with that relinquished Federal authority. expanded operations to include Commission approval.’’ This is based on Under these agreements, regulatory extraction of other metals including language found in Section 274o of the authority was assumed by each State uranium. The Uravan site was a Act. Section 274o states in part that, under State law to regulate certain licensed and operating mill at the time radioactive materials within the State. of passage of the Uranium Mill Tailings ‘‘* * * the State may adopt alternatives The NRC periodically reviews the Radiation Control Act of 1978 (including, where appropriate, site-specific performance of the Agreement States to (UMTRCA) (November 1978) making it alternatives) to the requirements adopted and enforced by the Commission for the same assure compliance with the provisions subject to regulation under Title II of purpose if after notice and opportunity for of Section 274. In 1978, the Act was UMTRCA, even though some of the public hearing, the Commission determines further amended by adding a new contamination was a result of practices that such alternatives will achieve a level of subsection, Section 274o, which going back to earlier operations. Specific stabilization and containment of the sites required Agreement States to mention of this situation and calls for concerned, and a level of protection for specifically amend their Agreements to active programs to address residual public health, safety, and the environment regulate uranium mill tailings (11e.(2) contamination during the operational from radiological and non-radiological byproduct material). Six Agreement phase are mentioned in NUREG–0706, hazards associated with such sites, which is equivalent to, to the extent practicable, or States have this authority as part of their Final Generic Environmental Impact more stringent than the level which would be Agreements. Under Section 274o of the Statement on Uranium Milling (ADAMS achieved by standards and requirements Act, an Agreement State may adopt site- Accession Nos. ML032751663, adopted and enforced by the Commission for specific alternative standards with ML032751667, ML032751669). This site the same purpose and any final standards respect to sites at which ores are is part of the UMTRCA Title II program promulgated by the Administrator of the EPA

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in accordance with Section 275. Such license and long-term care of the site by four areas are candidates for alternative alternative State requirements may take into DOE. The CDPHE recommended the standards. account local or regional conditions, application of the contemporary dose The NRC staff evaluated Colorado’s including geology, typography, hydrology, limit for restricted release found in the proposed alternate soil standards for the and meteorology.’’ License Termination Rule (LTR), which four discrete areas and the justification Similar language codifying this in Colorado regulation is found at CCR for the alternate soil standards for the requirement can be found in 10 CFR (Code of Colorado Regulations) 1007– Uravan Site in Montrose County, 150.31(d). 04, Section 61.3. Since the federal LTR Colorado (CO RML 660–02). The The NRC’s Office of Nuclear Materials explicitly excludes uranium milling individual areas are discussed in more Safety and Safeguards informed NRC’s facilities already subject to Appendix A detail in the NRC staff’s assessment Region IV in 1988, in a memorandum to 10 CFR part 40 and since the (ADAMS Accession No. ML11220A308). titled, ‘‘Use of Title I Supplemental licensee’s proposed alternative Therefore, the NRC staff has made a Standards for Title II’’ (ADAMS standards were developed using the preliminary determination that the Accession No. ML111670171), that, if a Title I supplemental standards that are State’s proposal to leave the materials in request for alternative standards was to specific to uranium milling facilities, place provides levels of protection to be considered, the application of 40 CFR the NRC staff does not recommend public health and safety and protection 192.21, Supplemental Standards, as pursuing the use of the LTR standard for of the environment from radiological guidance would be appropriate. The this uranium recovery facility. and non-radiological hazards associated Uravan Consent Decree and Remedial Challenges to worker safety prevented with each of the four areas, that are Action Plan approved by the federal additional remediation along the cliff equivalent to, to the extent practicable, district court in 1987, included the face that makes up a majority of the Mill or more stringent than levels which possible use of Applicable or Relevant Hillside Area under consideration for would be achieved by the standards and and Appropriate Requirements alternate standards. Remediation was requirements adopted and enforced by (ARARs). If alternative standards are performed as much as possible and was the Commission for the same purpose agreed to by the NRC, the alternative terminated when safety to workers (specifically the soil cleanup standards standards could be used as part of the became too much of a risk, costs for radium) contained in 10 CFR Part 40, basis for the State of Colorado and the continued show diminishing returns, Appendix A and the Colorado EPA to proceed with delisting the and concern arose that additional requirements in 6 CCR 1007–1, Part 18, Uravan site from the NPL. removal could cause mass wasting of Appendix A. Four discrete areas of the site (about the cliff face which would cause Section 274o Hearing for Alternative 40 acres total) could not meet the environmental harm to the riparian area Standards standard for background level of and the San Miguel River. Two other areas, the River Ponds Area and the A– The Commission has approved the radium-226 in soil, found in the use of a hearing process similar to the Colorado Rules and Regulations Plant North Area, were cleaned as much as possible prior to annual spring provisions in Subpart H of 10 CFR part Pertaining to Radiation Control, 6 CCR 2 for the ‘‘hearing’’ component required 1007–1, Part 18, Appendix A, Criterion flooding that has since buried the areas under up to 3 feet of sediment (the San by the last paragraph of Section 274o of 6. This standard is that the background the Act. The proposed alternate level is not exceeded by more than 5 Miguel River is a free-flowing river and does not have any dams to control flow). standards have been reviewed and pCi/g (picocuries per gram) of radium- agreed to by the State of Colorado. A 226 averaged over the first 15 This riparian area now hosts fauna and wildlife that would not be best served hearing process similar to the provisions centimeters (cm) below the surface and in Subpart H is not intended to 15 pCi/g of radium-226 averaged over 15 if remediation were to continue. The final area, County Road Y–11, has duplicate the State’s process; rather, it cm thick layers more than 15 cm below will be used to provide sufficient the surface. The four discrete areas are contaminated materials present at depths greater than 3 feet, assuring that information for the Commission to make referred to as: the Mill Hillside Area; A– the determination required in Section Plant North Area; River Ponds Area; and routine maintenance activities of the road can be conducted without creating 274o of the Act. County Road Y–11. The areas were Pursuant to the hearing process set worker exposure. County Road Y–11 remediated as best as practical, and the forth in Subpart H of 10 CFR part 2, the will remain under institutional controls specifics are described in the licensee’s Commission is requesting information agreed to by the County, BLM, and DOE. report submitted to the CDPHE (ADAMS from interested members of the public Accession No. ML081150505). The The alternative standards will be on the alternative standards proposed licensee proposed to the CDPHE that protective even if institutional controls by the State of Colorado of leaving the alternative standards be applied to these fail in the distant future. This is based remaining residual soil contamination four areas of the Uravan site. The on two limited assumptions: (1) The in place in the four designated areas, in licensee’s proposal to the CDPHE was to cliff face will not be developed for lieu of clean up to the 5/15 pCi/g leave the remaining materials in place residential construction, and (2) the San standard in 10 CFR part 40, Appendix and conduct no further remediation. Miguel River will not be relocated. Both A, Criterion 6.6. The NRC staff will The CDPHE has accepted the of these assumptions are realistic. evaluate the information received and licensee’s report and believes the areas All four areas have been cleaned to provide the information to the were remediated to levels that are levels that are considered ALARA, will Commission for a final determination. ALARA, and are protective of public be under permanent institutional The issue under consideration is: health. This conclusion is further control, and meet the EPA supplemental supported by applying the criteria for standards requirements in 40 CFR Do the Colorado proposed alterative soil supplemental standards in UMTRCA 192.21. Additional cleanup work in the standards for the four discrete areas of the Uravan site achieve a level of stabilization Title I standards in 40 CFR 192.21, and areas would present safety or and containment of the sites concerned, and through dose calculations for reasonable environmental challenges with little a level of protection for public health, safety future use given the status of the areas corresponding reduction in dose. and the environment from radiological and after the termination of the specific Therefore, the NRC staff believes the non-radiological hazards associated with

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such sites, which is equivalent to, to the Eastern Time: Deadline for notices to supporting material on its Web site at extent practicable, or more stringent than the intervene. See the Procedural Schedule http://www.prc.gov. Additional filings level which would be achieved by standards in the SUPPLEMENTARY INFORMATION in this case and participant’s and requirements adopted and enforced by section for other dates of interest. submissions also will be posted on the the Commission for the same purpose and Web site, if provided in electronic any final standards promulgated by the ADDRESSES: Submit comments Administrator of the EPA in accordance with electronically by accessing the ‘‘Filing format or amenable to conversion, and Section 275 of the Act? Online’’ link in the banner at the top of not subject to a valid protective order. the Commission’s Web site (http:// Information on how to use the Environmental Analysis www.prc.gov) or by directly accessing Commission’s Web site is available The environmental impact of a the Commission’s Filing Online system online or by contacting the Commission determination that an at https://www.prc.gov/prc-pages/filing- Commission’s webmaster via telephone Agreement State’s alternative standards online/login.aspx. Commenters who at (202) 789–6873 or via electronic mail have been found to provide a level of cannot submit their views electronically at [email protected]. protection that is equivalent to, to the should contact the person identified in The appeal and all related documents extent practicable, or more stringent the FOR FURTHER INFORMATION CONTACT are also available for public inspection than standards promulgated by the NRC section as the source for case-related in the Commission’s docket section. or the Administrator of the EPA under information for advice on alternatives to Docket section hours are 8 a.m. to Section 275 of the Act is within the electronic filing. 4:30 p.m., Eastern Time, Monday through Friday, except on Federal generic impact analysis conducted by FOR FURTHER INFORMATION CONTACT: government holidays. Docket section the NRC and the EPA in promulgating Stephen L. Sharfman, General Counsel, personnel may be contacted via their standards and the requirements at (202) 789–6820 (case-related electronic mail at [email protected] (NUREG–0706, ‘‘Final Generic information) or [email protected] Environmental Impact Statement on or via telephone at (202) 789–6846. (electronic filing assistance). Filing of documents. All filings of Uranium Milling,’’ (ADAMS Accession SUPPLEMENTARY INFORMATION: Notice is Nos. ML032751663, ML032751667, and documents in this case shall be made hereby given that, pursuant to 39 U.S.C. using the Internet (Filing Online) ML032751669) and EPA 520/1–83–008, 404(d), on October 27, 2011, the ‘‘Final Environmental Impact Statement pursuant to Commission rules 9(a) and Commission received a petition for 10(a) at the Commission’s Web site, for Standards for the Control of review of the Postal Service’s Byproduct Materials from Uranium http://www.prc.gov, unless a waiver is determination to close the West obtained. See 39 CFR 3001.9(a) and Processing’’ (ADAMS Accession Nos. Edmeston post office in West Edmeston, 3001.10(a). Instructions for obtaining an ML032751396 and ML032751400)). Any New York. The petition for review was account to file documents online may be site-specific application of alternative filed by Jason Elias and the Concerned found on the Commission’s Web site, standards in Agreement States will be Citizens of West Edmeston (Petitioners) http://www.prc.gov, or by contacting the evaluated under the State’s and is postmarked October 19, 2011. Commission’s docket section at prc- environmental assessment required of The Commission hereby institutes a [email protected] or via telephone at the State under Section 274o of the Act. proceeding under 39 U.S.C. 404(d)(5) (202) 789–6846. Dated at Rockville, Maryland, this 3rd day and establishes Docket No. A2012–41 to Commission reserves the right to of November, 2011. consider Petitioners’ appeal. If redact personal information which may For the Nuclear Regulatory Commission. Petitioners would like to further explain infringe on an individual’s privacy Brian J. McDermott, their position with supplemental rights from documents filed in this Director, Division of Materials Safety and information or facts, Petitioners may proceeding. State Agreements, Office of Federal and State either file a Participant Statement on Intervention. Persons, other than the Materials and Environmental Management PRC Form 61 or file a brief with the Petitioners and respondents, wishing to Programs. Commission no later than December 1, be heard in this matter are directed to [FR Doc. 2011–29129 Filed 11–9–11; 8:45 am] 2011. file a notice of intervention. See 39 CFR BILLING CODE 7590–01–P Categories of issues apparently raised. 3001.111(b). Notices of intervention in Petitioners contend (1) Failure of the this case are to be filed on or before Postal Service to follow procedures November 29, 2011. A notice of POSTAL REGULATORY COMMISSION required by law regarding the closures intervention shall be filed using the (see 39 U.S.C. 404(d)(5)(B)); and (2) that Internet (Filing Online) at the [Docket No. A2012–41; Order No. 948] there are factual errors contained in the Commission’s Web site, http:// Post Office Closing Final Determination. www.prc.gov, unless a waiver is After the Postal Service files the obtained for hardcopy filing. See 39 CFR AGENCY: Postal Regulatory Commission. administrative record and the 3001.9(a) and 3001.10(a). ACTION: Notice. Commission reviews it, the Commission Further procedures. By statute, the may find that there are more legal issues Commission is required to issue its SUMMARY: This document informs the than those set forth above, or that the decision within 120 days from the date public that an appeal of the closing of Postal Service’s determination disposes it receives the appeal. See 39 U.S.C. the West Edmeston, New York post of one or more of those issues. The 404(d)(5). A procedural schedule has office has been filed. It identifies deadline for the Postal Service to file the been developed to accommodate this preliminary steps and provides a applicable administrative record with statutory deadline. In the interest of procedural schedule. Publication of this the Commission is November 14, 2011. expedition, in light of the 120-day document will allow the Postal Service, See 39 CFR 3001.113. In addition, the decision schedule, the Commission may petitioners, and others to take due date for any responsive pleading by request the Postal Service or other appropriate action. the Postal Service to this notice is participants to submit information or DATES: November 14, 2011: November 14, 2011. memoranda of law on any appropriate Administrative record due (from Postal Availability; Web site posting. The issue. As required by Commission rules, Service); November 29, 2011, 4:30 p.m., Commission has posted the appeal and if any motions are filed, responses are

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due 7 days after any such motion is 2. Any responsive pleading by the represent the interests of the general filed. See 39 CFR 3001.21. Postal Service to this notice is due no public. It is ordered: later than November 14, 2011. 5. The Secretary shall arrange for publication of this notice and order and 1. The Postal Service shall file the 3. The procedural schedule listed below is hereby adopted. Procedural Schedule in the Federal applicable administrative record Register. regarding this appeal no later than 4. Pursuant to 39 U.S.C. 505, Malin By the Commission. November 14, 2011. Moench is designated officer of the Commission (Public Representative) to Shoshana M. Grove, Secretary.

PROCEDURAL SCHEDULE

October 27, 2011 ...... Filing of Appeal. November 14, 2011 ...... Deadline for the Postal Service to file the applicable administrative record in this appeal. November 14, 2011 ...... Deadline for the Postal Service to file any responsive pleading. November 29, 2011 ...... Deadline for notices to intervene (see 39 CFR 3001.111(b)). December 1, 2011 ...... Deadline for Petitioners’ Form 61 or initial brief in support of petition (see 39 CFR 3001.115(a) and (b)). December 21, 2011 ...... Deadline for answering brief in support of the Postal Service (see 39 CFR 3001.115(c)). January 5, 2011 ...... Deadline for reply briefs in response to answering briefs (see 39 CFR 3001.115(d)). January 12, 2011 ...... Deadline for motions by any party requesting oral argument; the Commission will schedule oral argument only when it is a necessary addition to the written filings (see 39 CFR 3001.116). February 16, 2012 ...... Expiration of the Commission’s 120-day decisional schedule (see 39 U.S.C. 404(d)(5)).

[FR Doc. 2011–29126 Filed 11–9–11; 8:45 am] FOR FURTHER INFORMATION CONTACT: the Postal Service to this notice is BILLING CODE 7710–FW–P Stephen L. Sharfman, General Counsel, November 14, 2011. at (202) 789–6820 (case-related Availability; Web site posting. The information) or [email protected] Commission has posted the appeal and POSTAL REGULATORY COMMISSION (electronic filing assistance). supporting material on its Web site at SUPPLEMENTARY INFORMATION: Notice is http://www.prc.gov. Additional filings [Docket No. A2012–42; Order No. 949] hereby given that, pursuant to 39 U.S.C. in this case and participant’s 404(d), on October 27, 2011, the submissions also will be posted on the Post Office Closing Commission received a petition for Web site, if provided in electronic AGENCY: Postal Regulatory Commission. review of the Postal Service’s format or amenable to conversion, and determination to close the Amoret post ACTION: Notice. not subject to a valid protective order. office in Amoret, Missouri. The petition Information on how to use the SUMMARY: This document informs the for review was filed by Mildred Bell and Commission’s Web site is available public that an appeal of the closing of the Concerned Citizens of Amoret online or by contacting the the Amoret, Missouri post office has (Petitioners) and is postmarked October Commission’s webmaster via telephone been filed. It identifies preliminary 14, 2011. The Commission hereby at (202) 789–6873 or via electronic mail steps and provides a procedural institutes a proceeding under 39 U.S.C. at [email protected]. 404(d)(5) and establishes Docket No. schedule. Publication of this document The appeal and all related documents A2012–42 to consider Petitioners’ will allow the Postal Service, are also available for public inspection appeal. If Petitioners would like to petitioners, and others to take in the Commission’s docket section. appropriate action. further explain their position with supplemental information or facts, Docket section hours are 8 a.m. to DATES: November 14, 2011: Petitioners may either file a Participant 4:30 p.m., Eastern Time, Monday Administrative record due (from Postal Statement on PRC Form 61 or file a brief through Friday, except on Federal Service); November 29, 2011, 4:30 p.m., with the Commission no later than government holidays. Docket section Eastern Time: Deadline for notices to December 1, 2011. personnel may be contacted via intervene. See the Procedural Schedule Categories of issues apparently raised. electronic mail at in the SUPPLEMENTARY INFORMATION Petitioners contend failure of the Postal [email protected] or via telephone at section for other dates of interest. Service to follow procedures required (202) 789–6846. ADDRESSES: Submit comments by law regarding the closures (see 39 Filing of documents. All filings of electronically by accessing the ‘‘Filing U.S.C. 404(d)(5)(B)). documents in this case shall be made Online’’ link in the banner at the top of After the Postal Service files the using the Internet (Filing Online) the Commission’s Web site (http:// administrative record and the pursuant to Commission rules 9(a) and www.prc.gov) or by directly accessing Commission reviews it, the Commission 10(a) at the Commission’s Web site, the Commission’s Filing Online system may find that there are more legal issues http://www.prc.gov, unless a waiver is at https://www.prc.gov/prc-pages/filing- than those set forth above, or that the obtained. See 39 CFR 3001.9(a) and online/login.aspx. Commenters who Postal Service’s determination disposes 3001.10(a). Instructions for obtaining an cannot submit their views electronically of one or more of those issues. The account to file documents online may be should contact the person identified in deadline for the Postal Service to file the found on the Commission’s Web site, the FOR FURTHER INFORMATION CONTACT applicable administrative record with http://www.prc.gov, or by contacting the section as the source for case-related the Commission is November 14, 2011. Commission’s docket section at prc- information for advice on alternatives to See 39 CFR 3001.113. In addition, the [email protected] or via telephone at electronic filing. due date for any responsive pleading by (202) 789–6846.

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Commission reserves the right to Further procedures. By statute, the regarding this appeal no later than redact personal information which may Commission is required to issue its November 14, 2011. infringe on an individual’s privacy decision within 120 days from the date 2. Any responsive pleading by the rights from documents filed in this it receives the appeal. See 39 U.S.C. Postal Service to this notice is due no proceeding. 404(d)(5). A procedural schedule has later than November 14, 2011. been developed to accommodate this 3. The procedural schedule listed Intervention. Persons, other than the statutory deadline. In the interest of below is hereby adopted. Petitioners and respondents, wishing to expedition, in light of the 120-day 4. Pursuant to 39 U.S.C. 505, James be heard in this matter are directed to decision schedule, the Commission may Waclawski is designated officer of the file a notice of intervention. See 39 CFR request the Postal Service or other Commission (Public Representative) to 3001.111(b). Notices of intervention in participants to submit information or represent the interests of the general this case are to be filed on or before memoranda of law on any appropriate public. November 29, 2011. A notice of issue. As required by Commission rules, 5. The Secretary shall arrange for intervention shall be filed using the if any motions are filed, responses are publication of this notice and order and Internet (Filing Online) at the due 7 days after any such motion is Procedural Schedule in the Federal Commission’s Web site, http:// filed. See 39 CFR 3001.21. Register. www.prc.gov, unless a waiver is It is ordered: By the Commission. obtained for hardcopy filing. See 39 CFR 1. The Postal Service shall file the Shoshana M. Grove, 3001.9(a) and 3001.10(a). applicable administrative record Secretary.

PROCEDURAL SCHEDULE

October 27, 2011 ...... Filing of Appeal. November 14, 2011 ...... Deadline for the Postal Service to file the applicable administrative record in this appeal. November 14, 2011 ...... Deadline for the Postal Service to file any responsive pleading. November 29, 2011 ...... Deadline for notices to intervene (see 39 CFR 3001.111(b)). December 1, 2011 ...... Deadline for Petitioners’ Form 61 or initial brief in support of petition (see 39 CFR 3001.115(a) and (b)). December 21, 2011 ...... Deadline for answering brief in support of the Postal Service (see 39 CFR 3001.115(c)). January 5, 2011 ...... Deadline for reply briefs in response to answering briefs (see 39 CFR 3001.115(d)). January 12, 2011 ...... Deadline for motions by any party requesting oral argument; the Commission will schedule oral argument only when it is a necessary addition to the written filings (see 39 CFR 3001.116). February 13, 2012 ...... Expiration of the Commission’s 120-day decisional schedule (see 39 U.S.C. 404(d)(5)).

[FR Doc. 2011–29127 Filed 11–9–11; 8:45 am] the Commission’s Filing Online system Petitioners may either file a Participant BILLING CODE 7710–FW–P at https://www.prc.gov/prc-pages/filing- Statement on PRC Form 61 or file a brief online/login.aspx. Commenters who with the Commission no later than cannot submit their views electronically December 1, 2011. POSTAL REGULATORY COMMISSION should contact the person identified in Categories of issues apparently raised. Petitioners contend that (1) The Postal [Docket No. A2012–38; Order No. 944] the FOR FURTHER INFORMATION CONTACT section as the source for case-related Service failed to consider the effect of Post Office Closing information for advice on alternatives to the closing on the community (see 39 electronic filing. U.S.C. 404(d)(2)(A)(i)); and (2) the Postal AGENCY: Postal Regulatory Commission. Service failed to consider whether or FOR FURTHER INFORMATION CONTACT: ACTION: Notice. not it will continue to provide a Stephen L. Sharfman, General Counsel, maximum degree of effective and SUMMARY: at (202) 789–6820 (case-related This document informs the regular postal services to the community information) or [email protected] public that an appeal of the closing of (see 39 U.S.C. 404(d)(2)(A)(iii)). the New Boston, Illinois post office has (electronic filing assistance). After the Postal Service files the been filed. It identifies preliminary SUPPLEMENTARY INFORMATION: Notice is administrative record and the steps and provides a procedural hereby given that, pursuant to 39 U.S.C. Commission reviews it, the Commission schedule. Publication of this document 404(d), on October 27, 2011, the may find that there are more legal issues will allow the Postal Service, Commission received two petitions for than those set forth above, or that the petitioners, and others to take review of the Postal Service’s Postal Service’s determination disposes appropriate action. determination to close the New Boston of one or more of those issues. The DATES: November 11, 2011: post office in New Boston, Illinois. The deadline for the Postal Service to file the Administrative record due (from Postal first petition for review was filed by applicable administrative record with Service); November 28, 2011, 4:30 p.m., Barbara O’Hearn. The second petition the Commission is November 11, 2011. Eastern Time: Deadline for notices to for review was filed by Lu Ann Krengle. See 39 CFR 3001.113. In addition, the intervene. See the Procedural Schedule The earliest postmark date is October due date for any responsive pleading by in the SUPPLEMENTARY INFORMATION 17, 2011. The Commission hereby the Postal Service to this notice is section for other dates of interest. institutes a proceeding under 39 U.S.C. November 11, 2011. ADDRESSES: Submit comments 404(d)(5) and establishes Docket No. Availability; Web site posting. The electronically by accessing the ‘‘Filing A2012–38 to consider Petitioners’ Commission has posted the appeal and Online’’ link in the banner at the top of appeal. If Petitioners would like to supporting material on its Web site at the Commission’s Web site (http:// further explain their position with http://www.prc.gov. Additional filings www.prc.gov) or by directly accessing supplemental information or facts, in this case and participant’s

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submissions also will be posted on the http://www.prc.gov, or by contacting the request the Postal Service or other Web site, if provided in electronic Commission’s docket section at prc- participants to submit information or format or amenable to conversion, and [email protected] or via telephone at memoranda of law on any appropriate not subject to a valid protective order. (202) 789–6846. issue. As required by Commission rules, Information on how to use the Commission reserves the right to if any motions are filed, responses are Commission’s Web site is available redact personal information which may due 7 days after any such motion is online or by contacting the infringe on an individual’s privacy filed. See 39 CFR 3001.21. Commission’s webmaster via telephone rights from documents filed in this It is ordered: proceeding. at (202) 789–6873 or via electronic mail 1. The Postal Service shall file the at [email protected]. Intervention. Persons, other than the Petitioners and respondents, wishing to applicable administrative record The appeal and all related documents be heard in this matter are directed to regarding this appeal no later than are also available for public inspection file a notice of intervention. See 39 CFR November 11, 2011. in the Commission’s docket section. 3001.111(b). Notices of intervention in 2. Any responsive pleading by the Docket section hours are 8 a.m. to this case are to be filed on or before Postal Service to this notice is due no 4:30 p.m., Eastern Time, Monday November 28, 2011. A notice of later than November 11, 2011. through Friday, except on Federal intervention shall be filed using the 3. The procedural schedule listed government holidays. Docket section Internet (Filing Online) at the below is hereby adopted. personnel may be contacted via Commission’s Web site, http:// 4. Pursuant to 39 U.S.C. 505, Tracy electronic mail at [email protected] www.prc.gov, unless a waiver is or via telephone at (202) 789–6846. Ferguson is designated officer of the obtained for hardcopy filing. See 39 CFR Commission (Public Representative) to Filing of documents. All filings of 3001.9(a) and 3001.10(a). represent the interests of the general documents in this case shall be made Further procedures. By statute, the public. using the Internet (Filing Online) Commission is required to issue its 5. The Secretary shall arrange for pursuant to Commission rules 9(a) and decision within 120 days from the date publication of this notice and order and 10(a) at the Commission’s Web site, it receives the appeal. See 39 U.S.C. Procedural Schedule in the Federal http://www.prc.gov, unless a waiver is 404(d)(5). A procedural schedule has Register. obtained. See 39 CFR 3001.9(a) and been developed to accommodate this 3001.10(a). Instructions for obtaining an statutory deadline. In the interest of By the Commission. account to file documents online may be expedition, in light of the 120-day Shoshana M. Grove, found on the Commission’s Web site, decision schedule, the Commission may Secretary.

PROCEDURAL SCHEDULE

October 27, 2011 ...... Filing of Appeal. November 11, 2011 ...... Deadline for the Postal Service to file the applicable administrative record in this appeal. November 11, 2011 ...... Deadline for the Postal Service to file any responsive pleading. November 28, 2011 ...... Deadline for notices to intervene (see 39 CFR 3001.111(b)). December 1, 2011 ...... Deadline for Petitioners’ Form 61 or initial brief in support of petition (see 39 CFR 3001.115(a) and (b)). December 21, 2011 ...... Deadline for answering brief in support of the Postal Service (see 39 CFR 3001.115(c)). January 5, 2011 ...... Deadline for reply briefs in response to answering briefs (see 39 CFR 3001.115(d)). January 12, 2011 ...... Deadline for motions by any party requesting oral argument; the Commission will schedule oral argument only when it is a necessary addition to the written filings (see 39 CFR 3001.116). February 14, 2012 ...... Expiration of the Commission’s 120-day decisional schedule (see 39 U.S.C. 404(d)(5)).

[FR Doc. 2011–29135 Filed 11–9–11; 8:45 am] In accordance with Section 103(b)(6) the National Science and Technology BILLING CODE 7710–FW–P of the America COMPETES Council (NSTC). Reauthorization Act of 2010 (ACRA; SUPPLEMENTARY INFORMATION: Pub. L. 111–358), this Request for Information (RFI) offers the opportunity Purpose OFFICE OF SCIENCE AND for interested individuals and TECHNOLOGY POLICY organizations to provide In accordance with Section 103(b)(6) recommendations on approaches for of the America COMPETES Request For Information: Public ensuring long-term stewardship and Reauthorization Act of 2010 (ACRA; Access to Digital Data Resulting from encouraging broad public access to Pub. L. 111–358), this Request for Federally Funded Scientific Research; unclassified digital data that result from Information (RFI) offers the opportunity Correction federally funded scientific research. The for interested individuals and public input provided through this organizations to provide ACTION: Notice of Request for Notice will inform deliberations of the recommendations on approaches for Information (RFI). National Science and Technology ensuring long-term stewardship and Council’s Interagency Working Group encouraging broad public access to SUMMARY: The RFI is being corrected to on Digital Data. unclassified digital data that result from change the response date to January 2, Release Date: November 3, 2011. 2012 to reflect a 60 day response time. Response Date: January 2, 2012. federally funded scientific research. The public input provided through this The RFI was published in the Federal ADDRESSES: [email protected]. Register, Volume 76, Number 214, on Issued By: Office of Science and Notice will inform deliberations of the November 4, 2011, pages 68517–68518. Technology Policy (OSTP) on behalf of National Science and Technology

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Council’s Interagency Working Group management and data sharing from federally funded scientific on Digital Data. requirements for specific types of research? projects, such as genome-wide Background (3) How could Federal agencies take association studies. into account inherent differences The multi-agency Interagency In January 2011, the National Science between scientific disciplines and Working Group on Digital Data Foundation (NSF) reaffirmed its data different types of digital data when (Working Group), established under the management policy requirement, developing policies on the management National Science and Technology indicating that proposals must include a of data? Council (NSTC) Committee on Science Data Management Plan that describes (4) How could agency policies (CoS), has been tasked with developing how funded researchers will conform to consider differences in the relative costs options for implementing the digital NSF policy on the dissemination and and benefits of long-term stewardship data policy and standards requirements sharing of research results. The NSF and dissemination of different types of of Section 103 of ACRA. OSTP will policy is clear that ‘‘Investigators are data resulting from federally funded issue a report to Congress, in accordance expected to share with other research? with Section 103(e) of ACRA, describing researchers, at no more than (5) How can stakeholders (e.g., priorities for the development of agency incremental cost and within a research communities, universities, policies for ensuring broad public reasonable time, the primary data, research institutions, libraries, scientific access to the results of federally funded samples, physical collections and other publishers) best contribute to the unclassified research, the status of supporting materials created or gathered implementation of data management agency policies for public access to in the course of work under NSF plans? digital data resulting from federally grants.’’ Such models may not (6) How could funding mechanisms funded research, and a summary of necessarily be appropriate for all types be improved to better address the real public input collected from this RFI and of federally sponsored research. costs of preserving and making digital other mechanisms. The Working Group data accessible? is considering steps that can be taken by As agencies consider how to further Federal agencies to encourage and develop digital data policies, it is (7) What approaches could agencies coordinate the development of agency important to note that all policies for take to measure, verify, and improve policies and standards to promote long- increasing accountability and access to compliance with Federal data term preservation of and access to digital data must follow statutory stewardship and access policies for digital data resulting from federally requirements and follow best practices scientific research? How can the burden funded scientific research. Ideally, such for protecting confidentiality, personal of compliance and verification be policies would harmonize, to the extent privacy, proprietary interests, minimized? practicable and feasible, data intellectual property rights, author (8) What additional steps could management plans for digital data that attribution, and for ensuring that agencies take to stimulate innovative are collected or otherwise produced homeland and national security use of publicly accessible research data either by the agency itself or interests are not compromised. The in new and existing markets and extramurally with Federal funds. The Working Group is now seeking industries to create jobs and grow the 2009 report of the Interagency Working additional insight from ‘‘non-Federal economy? Group on Digital Data of the National stakeholders, including the public, (9) What mechanisms could be Science and Technology Council, universities, nonprofit and for-profit developed to assure that those who ‘‘Harnessing the Power of Digital Data,’’ publishers, libraries, federally funded produced the data are given appropriate recommended that agencies lay the and non-federally funded research attribution and credit when secondary foundations for digital scientific data scientists, and other organizations and results are reported? institutions with an interest in long- policy and make their policies publicly Standards for Interoperability, Reuse term stewardship and improved public available. It also recommended that and Repurposing agencies consider requiring data access to the results of federally funded management plans for projects that will research,’’ as described in Section (10) What digital data standards generate ‘‘preservation data’’—those 103(b)(6) of ACRA. Specifically the would enable interoperability, reuse, data for which the benefits of Working Group seeks further public and repurposing of digital scientific preservation exceed the costs. Federal comment on the questions listed below: data? For example, MIAME (minimum information about a microarray science agencies already have some Preservation, Discoverability, and experiment; see Brazma et al., 2001, experience with policies to promote Access long-term preservation and access to Nature Genetics 29, 371) is an example scientific data. Indeed current Federal (1) What specific Federal policies of a community-driven data standards policies promote and in many cases would encourage public access to and effort. require Federal agencies to make the the preservation of broadly valuable (11) What are other examples of digital data generated by Federal digital data resulting from federally standards development processes that agencies more publically accessible. funded scientific research, to grow the were successful in producing effective However, such policies do not routinely U.S. economy and improve the standards and what characteristics of cover data generated through Federal productivity of the American scientific the process made these efforts grants, cooperative agreements, and enterprise? successful? some other types of funding mechanism. (2) What specific steps can be taken (12) How could Federal agencies Exceptions include, the National to protect the intellectual property promote effective coordination on Institutes of Health’s (NIH) Data Sharing interests of publishers, scientists, digital data standards with other nations Policy, which requires all investigator- Federal agencies, and other and international communities? initiated applications with direct costs stakeholders, with respect to any (13) What policies, practices, and greater than $500,000 in any single year existing or proposed policies for standards are needed to support linking provide a data management plan. In encouraging public access to and between publications and associated addition, NIH has more specific data preservation of digital data resulting data?

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Response to this RFI is voluntary. SECURITIES AND EXCHANGE the Exchange, and at the Commission’s Responders are free to address any or all COMMISSION Public Reference Room. the above items, as well as provide [Release No. 3306; File No.: 801–35969] II. Self-Regulatory Organization’s additional information that they think is Statement of the Purpose of, and relevant to developing policies Investment Advisers Act of 1940; In the Statutory Basis for, the Proposed Rule consistent with increased preservation Matter of Creative Investment Change and dissemination of broadly useful Research, Inc., 1050 17th Street NW., digital data resulting from federally Suite 1000, Washington, DC 20036; In its filing with the Commission, the funded research. Please note that the Notice of Intention to Cancel Exchange included statements Government will not pay for response Registration Pursuant to Section concerning the purpose of, and basis for, preparation or for the use of any 203(h) of the Investment Advisers Act the proposed rule change and discussed information contained in the response. of 1940 any comments it received on the proposed rule change. The text of these How To Submit a Response October 24, 2011. statements may be examined at the All comments must be submitted Correction places specified in Item IV below. The self-regulatory organization has electronically to: [email protected]. In notice document 2011–27900, appearing on pages 67005–67006 in the prepared summaries, set forth in Responses to this RFI will be accepted Sections A, B and C below, of the most through January 2, 2012. You will issue of October 28, 2011, make the following correction: significant aspects of such statements. receive an electronic confirmation On page 67005, in the second column, acknowledging receipt of your response, A. Self-Regulatory Organization’s the subject heading should read as set Statement of the Purpose of, and but will not receive individualized forth above. feedback on any suggestions. No basis Statutory Basis for, the Proposed Rule [FR Doc. C1–2011–27900 Filed 11–9–11; 8:45 am] Change for claims against the U.S. Government BILLING CODE 1505–01–D shall arise as a result of a response to 1. Purpose this request for information or from the ISE proposes to amend its Schedule of Government’s use of such information. SECURITIES AND EXCHANGE Fees to adopt subscription fees for the COMMISSION Inquiries sale of the ISE Implied Volatility and [Release No. 34–65678; File No. SR–ISE– Greeks Feed. The Exchange previously Specific questions about this RFI 2011–67] submitted a proposed rule change to should be directed to the following establish this data feed.3 email address: [email protected]. Self-Regulatory Organizations; ISE Implied Volatility and Greeks Feed Form should include: International Securities Exchange, LLC; Notice of Filing and Immediate [Assigned ID #] Effectiveness of Proposed Rule The ISE Implied Volatility and Greeks [Assigned Entry date] Change Relating to Market Data Fees Feed delivers real-time implied Name/Email volatilities and risk parameters for Affiliation/Organization November 3, 2011. equity, index and ETF options. This City, State Pursuant to Section 19(b)(1) of the information is used to track an option’s Comment 1 Securities Exchange Act of 1934 price relative to changes in volatility Comment 2 (‘‘Exchange Act’’) 1 and Rule 19b–4 and the underlying security’s price, Comment 3 thereunder,2 notice is hereby given that, which affects the theoretical price of an Comment 4 on October 24, 2011, the International option. The risk parameters are useful Comment 5 Securities Exchange, LLC (the for delta neutral option execution and Comment 6 ‘‘Exchange’’ or the ‘‘ISE’’) filed with the monitoring an option’s time premium Comment 7 Securities and Exchange Commission decay. The ISE Implied Volatility and Comment 8 (the ‘‘Commission’’) the proposed rule Greeks Feed is also useful for investing Comment 9 change as described in Items I, II, and and hedging strategies such as placing Comment 10 III below, which Items have been orders based on changes in levels of Comment 11 prepared by the Exchange. The volatility. The ISE Implied Volatility In addition, please identify any other Commission is publishing this notice to and Greeks Feed includes real-time items the Working Group might solicit comments on the proposed rule implied volatilities for the bid, ask and consider for Federal policies related to change from interested persons. mid-point price as well as delta, gamma, vega, theta and rho for each option public access to peer-reviewed scholarly I. Self-Regulatory Organization’s series. The ISE Implied Volatility and publications resulting from federally Statement of the Terms of Substance of Greeks Feed is a low latency feed that supported research. the Proposed Rule Change produces data for the entire universe of Please attach any documents that The Exchange proposes to amend its U.S. options disseminated by the support your comments to the Schedule of Fees to adopt subscription Options Price Reporting Authority questions. fees for the sale of a market data offering (OPRA). The Exchange believes the ISE called the ISE Implied Volatility and Implied Volatility and Greeks Feed Ted Wackler, Greeks Feed. The text of the proposed provides valuable information that can Deputy Chief of Staff. rule change is available on the help users make informed investment [FR Doc. 2011–29166 Filed 11–9–11; 8:45 am] Exchange’s Web site http:// decisions. BILLING CODE P www.ise.com, at the principal office of 3 See Exchange Act Release No. 65295 (September 1 15 U.S.C. 78s(b)(1). 8, 2011), 76 FR 56832 (September 14, 2011) (SR– 2 17 CFR 240.19b–4. ISE–2011–55).

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Proposed Fees for ISE Implied Volatility changes in the technology used to • $4,000 per month for up to and Greeks Feed distribute market data. 100,000 unique option symbols. Managed Data Access Service • $5,000 per month for an The Exchange proposes to make the provides an alternative delivery option unlimited number of unique option ISE Implied Volatility and Greeks Feed for the ISE Implied Volatility and symbols. available to both members and non- Greeks Feed. The Managed Data Access • $250 per month API log-in fee for members on a subscription basis, as Distributor must agree to reformat, Managed Data Access Recipients. This follows: redisplay and/or alter the ISE Implied fee is only applicable to recipients who • $5,000 per month per Business Volatility and Greeks Feed prior to utilize an API to receive the ISE Implied Unit 4 for Subscribers 5 who are retransmission, but not to affect the Volatility & Greeks Feed from a Professionals, and $50 per controlled integrity of the ISE Implied Volatility Managed Data Access Distributor. 6 and Greeks Feed and not to render it device per month after the first 50 2. Statutory Basis controlled devices. This subscription inaccurate, unfair, uninformative, level is for internal use only and fictitious, misleading, or discriminatory. The basis under the Securities includes the first 50 controlled devices. The Exchange will maintain contracts Exchange Act of 1934 (the ‘‘Act’’) for with Managed Data Access Recipients, this proposed rule change is the In addition, the Exchange is requirement under Section 6(b)(4) that proposing to create a new data who may use the information in the ISE Implied Volatility and Greeks Feed for an exchange have an equitable distribution model, called the Managed allocation of reasonable dues, fees and Data Access Service 7 to further the internal purposes only and may be liable for any unauthorized use under other charges among its members and distribution of the ISE Implied Volatility other persons using its facilities. The and Greeks Feed.8 Under this the Managed Data Access Service. In the past, the Exchange has Exchange believes that the proposed distribution model, Managed Data rule change is consistent with the Access Distributors 9 are required to considered this type of distribution to be an uncontrolled data product if the provisions of Section 6 of the Act,11 in monitor the delivery of the data in the general, and with Sections 6(b)(4) of the Managed Data Access Service to their Managed Data Access Distributor does not control both the entitlements and Act,12 in particular, in that it provides clients, the Managed Data Access for the equitable allocation of reasonable Recipients.10 This new pricing and the display of the information. Over the last several years, Managed Data Access dues, fees and other charges among administrative option is in response to members and issuers and other persons industry demand, as well as due to Distributors have improved the technical delivery and monitoring using any facility or system which ISE capabilities of data therefore Managed operates or controls. 4 A ‘‘Business Unit’’ is a separate and distinct The Exchange believes that the business group at a Subscriber firm that has access Data Access Service is a response to an to the ISE Implied Volatility and Greeks Feed. A industry need to administer new types proposed rule change is also consistent market making desk, a risk management group, etc. of technical deliveries. with Section 6(b)(8) of the Act 13 in that would each be considered a Business Unit. it does not impose any burden on 5 A ‘‘Subscriber’’ is any firm that receives the ISE Proposed Fees for ISE Implied Volatility competition not necessary or Implied Volatility and Greeks Feed directly from and Greeks Feed as a Managed Data appropriate in furtherance of the the ISE or indirectly through a redistributor and Access Service then distributes it either internally or externally. A purposes of the Act. The fees charged redistributor includes market data vendors and The Exchange proposes to charge for would be the same for all market connectivity providers such as extranet and private Managed Data Access Service for the participants, and therefore do not network providers. unreasonably discriminate among 6 A ‘‘controlled device’’ is any device that a ISE Implied Volatility and Greeks Feed, Subscriber or Managed Data Access Distributor of as follows: market participants. the ISE Implied Volatility and Greeks Feed permits • $1,500 per month for Managed Data In adopting Regulation NMS, the to access the information in the ISE Implied Access Distributors who distribute the Commission granted self-regulatory Volatility and Greeks Feed. data feed externally through a organizations and broker-dealers 7 ‘‘Managed Data Access Service’’ is any retransmission data product containing the ISE controlled device to Non-Professional increased authority and flexibility of Implied Volatility and Greeks Feed offered by a recipients, and $1 per controlled device offer new and unique market data to the Managed Data Access Distributor, as defined below, per month. public. It was believed that this where the Managed Data Access Distributor • $1,500 per month for Managed Data authority would expand the amount of manages and monitors, but does not necessarily control, the information. Access Distributors who distribute the data available to consumers, and also 8 The Exchange notes that a managed data data feed externally through a spur innovation and competition for the solution is not a novel distribution model. At least controlled device to Professional provision of market data. one other exchange currently offers a managed data recipients, and $50 per controlled The Commission concluded that solution to distribute its proprietary market data. Regulation NMS—by deregulating the See Exchange Act Release No. 34–63276 (November device per month. 8, 2010), 75 FR 69717 (November 15, 2010) (SR– • $1,500 per month for Managed Data market in proprietary data—would itself NASDAQ–2010–138). Access Distributors who distribute the further the Act’s goals of facilitating 9 A ‘‘Managed Data Access Distributor’’ is a data feed internally from an Application efficiency and competition: subscriber of the ISE Implied Volatility and Greeks Feed that permits access to the information in the Programming Interface (API) to [E]fficiency is promoted when broker- ISE Implied Volatility and Greeks Feed through a Professional recipients, and a monthly dealers who do not need the data beyond the ‘‘controlled device.’’ A Managed Data Access fee based on the number of unique prices, sizes, market center identifications of Distributor can also offer a data feed solution, option symbols received by the the NBBO and consolidated last sale including an Application Programming Interface information are not required to receive (and (API) or similar automated delivery solutions, with recipient, as follows: • $1,000 per month for up to 10,000 pay for) such data. The Commission also only limited entitlement controls (e.g., usernames believes that efficiency is promoted when and/or passwords) to a recipient of the information. unique option symbols. broker-dealers may choose to receive (and 10 A ‘‘Managed Data Access Recipient’’ is a • $2,000 per month for up to 25,000 subscriber to the Managed Data Access Service for unique option symbols. 11 15 U.S.C. 78f. the purpose of accessing the ISE Implied Volatility • and Greeks Feed offered by a Managed Data Access $3,000 per month for up to 50,000 12 15 U.S.C. 78f(b)(4). Distributor. unique option symbols. 13 15 U.S.C. 78f(b)(8).

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pay for) additional market data based on their for data and other products available to ‘consolidated transactional reporting own internal analysis of the need for such persons that are not members of the self- system.’’’ 15 14 data. regulatory organization must be The court’s conclusions about By removing ‘‘unnecessary regulatory approved by the Commission after first Congressional intent are therefore restrictions’’ on the ability of exchanges being published for comment. At the reinforced by the Dodd-Frank Act to sell their own data, Regulation NMS time, the Commission supported the amendments, which create a advanced the goals of the Act and the adoption of the policy and the rule by presumption that exchange fees, principles reflected in its legislative pointing out that unlike members, including market data fees, may take history. If the free market should whose representation in self-regulatory effect immediately, without prior determine whether proprietary data is organization governance was mandated Commission approval, and that the sold to broker-dealers at all, it follows by the Act, non-members should be Commission should take action to that the price at which such data is sold given the opportunity to comment on suspend a fee change and institute a should be set by the market as well. proceeding to determine whether the fee fees before being required to pay them, On July 21, 2010, President Barak [sic] change should be approved or and that the Commission should Obama signed into law H.R. 4173, the disapproved only where the Dodd-Frank Wall Street Reform and specifically approve all such fees. ISE Commission has concerns that the Consumer Protection Act of 2010 believes that the amendment to Section change may not be consistent with the (‘‘Dodd-Frank Act’’), which amended 19 reflects Congress’s conclusion that Act. Section 19 of the Act. Among other the evolution of self-regulatory The Exchange believes that the things, Section 916 of the Dodd-Frank organization governance and proposed market data fees are consistent Act amended paragraph (A) of Section competitive market structure have with the requirements of the Act 19(b)(3) of the Act by inserting the rendered the Commission’s prior policy because competition provides an phrase ‘‘on any person, whether or not on non-member fees obsolete. effective constraint on the market data the person is a member of the self- Specifically, many exchanges have fees that the Exchange has the ability regulatory organization’’ after ‘‘due, fee evolved from member-owned not-for- and the incentive to charge. ISE has a or other charge imposed by the self- profit corporations into for-profit compelling need to attract order flow regulatory organization.’’ As a result, all investor-owned corporations (or from market participants in order to SRO rule proposals establishing or subsidiaries of investor-owned maintain its share of trading volume. changing dues, fees, or other charges are corporations). Accordingly, exchanges This compelling need to attract order immediately effective upon filing no longer have narrow incentives to flow imposes significant pressure on ISE regardless of whether such dues, fees, or manage their affairs for the exclusive to act reasonably in setting the fees for other charges are imposed on members benefit of their members, but rather its market data offerings, particularly of the SRO, non-members, or both. have incentives to maximize the appeal given that the market participants that Section 916 further amended paragraph of their products to all customers, will pay such fees often will be the same (C) of Section 19(b)(3) of the Act to read, whether members or nonmembers, so as market participants from whom ISE in pertinent part, ‘‘At any time within must attract order flow. These market the 60-day period beginning on the date to broaden distribution and grow revenues. Moreover, we believe that the participants include broker-dealers that of filing of such a proposed rule change control the handling of a large volume change also reflects an endorsement of in accordance with the provisions of of customer and proprietary order flow. the Commission’s determinations that paragraph (1) [of Section 19(b)], the Given the portability of order flow from reliance on competitive markets is an Commission summarily may one exchange to another, any exchange temporarily suspend the change in the appropriate means to ensure equitable that sought to charge unreasonably high rules of the self-regulatory organization and reasonable prices. Simply put, the market data fees would risk alienating made thereby, if it appears to the change reflects a presumption that all many of the same customers on whose Commission that such action is fee changes should be permitted to take orders it depends for competitive necessary or appropriate in the public effect immediately, since the level of all survival. ISE currently competes with interest, for the protection of investors, fees are constrained by competitive eight options exchanges for order or otherwise in furtherance of the forces. flow.16 purposes of this title. If the Commission The recent decision of the United ISE is constrained in pricing the ISE takes such action, the Commission shall States Court of Appeals for the District Implied Volatility and Greeks Feed by institute proceedings under paragraph of Columbia Circuit in NetCoaliton [sic] the availability to market participants of (2)(B) [of Section 19(b)] to determine alternatives to purchasing ISE products. whether the proposed rule should be v. SEC, No. 09–1042 (D.C. Cir. 2010), although reviewing a Commission ISE must consider the extent to which approved or disapproved.’’ market participants would choose one ISE believes that these amendments to decision made prior to the effective date or more alternatives instead of Section 19 of the Act reflect Congress’s of the Dodd-Frank Act, upheld the purchasing the Exchange’s data. intent to allow the Commission to rely Commission’s reliance upon For the reasons cited above, the upon the forces of competition to ensure competitive markets to set reasonable Exchange believes that the proposed that fees for market data are reasonable and equitably allocated fees for market fees for the ISE Implied Volatility and and equitably allocated. Although data. ‘‘In fact, the legislative history Section 19(b) had formerly authorized indicates that the Congress intended 15 NetCoaltion [sic], at 15 (quoting H.R. Rep. No. immediate effectiveness for a ‘‘due, fee that the market system ‘evolve through 94–229, at 92 (1975), as reprinted in 1975 or other charge imposed by the self- the interplay of competitive forces as U.S.C.C.A.N. 321, 323). regulatory organization,’’ the unnecessary regulatory restrictions are 16 The Commission has previously made a finding Commission adopted a policy and that the options industry is subject to significant removed’ and that the SEC wield its competitive forces. See Securities Exchange Act subsequently a rule stipulating that fees regulatory power ‘in those situations Release No. 59949 (May 20, 2009), 74 FR 25593 where competition may not be (May 28, 2009) (SR–ISE–2009–97) (order approving 14 See Securities Exchange Act Release No. 51808 ISE’s proposal to establish fees for a real-time depth (June 9, 2005), 70 FR 37496 (June 29, 2005). sufficient,’ such as in the creation of a of market offering).

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Greeks Feed are equitable, fair, which platform to post an order will competition for order flow implies a reasonable and not unreasonably depend on the attributes of the platform high degree of price sensitivity on the discriminatory. The Exchange further where the order can be posted, part of broker-dealers with order flow, believes that the continued availability including the execution fees, data since they may readily reduce costs by of the ISE Implied Volatility and Greeks quality and price and distribution of its directing orders toward the lowest-cost Feed enhances transparency, fosters data products. Without the prospect of trading venues. A broker-dealer that competition among orders and markets, a taking order seeing and reacting to a shifted its order flow from one platform and enables buyers and sellers to obtain posted order on a particular platform, to another in response to order better prices. In addition, the Exchange the posting of the order would execution price differentials would both believes that no substantial accomplish little. Without trade reduce the value of that platform’s countervailing basis exists to support a executions, exchange data products market data and reduce its own need to finding that the proposed terms and fees cannot exist. Data products are valuable consume data from the disfavored for this product fails to meet the to many end users only insofar as they platform. Similarly, if a platform requirements of the Act. provide information that end users increases its market data fees, the expect will assist them or their change will affect the overall cost of B. Self-Regulatory Organization’s customers in making trading decisions. doing business with the platform, and Statement on Burden on Competition The costs of producing market data affected broker-dealers will assess ISE does not believe that the proposed include not only the costs of the data whether they can lower their trading rule change will result in any burden on distribution infrastructure, but also the costs by directing orders elsewhere and competition that is not necessary or costs of designing, maintaining, and thereby lessening the need for the more appropriate in furtherance of the operating the exchange’s transaction expensive data. purposes of the Act, as amended. execution platform and the cost of Analyzing the cost of market data Notwithstanding its determination that regulating the exchange to ensure its fair distribution in isolation from the cost of the Commission may rely upon operation and maintain investor all of the inputs supporting the creation competition to establish fair and confidence. The total return that a of market data will inevitably equitably allocated fees for market data, trading platform earns reflects the underestimate the cost of the data. Thus, the NetCoaltion [sic] court found that revenues it receives from both products because it is impossible to create data the Commission had not, in that case, and the joint costs it incurs. Moreover, without a fast, technologically robust, compiled a record that adequately an exchange’s customers view the costs and well-regulated execution system, supported its conclusion that the market of transaction executions and of data as system costs and regulatory costs affect for the data at issue in the case was a unified cost of doing business with the the price of market data. It would be competitive. exchange. A broker-dealer will direct equally misleading, however, to For the reasons discussed above, ISE orders to a particular exchange only if attribute all of the exchange’s costs to believes that the Dodd-Frank Act the expected revenues from executing the market data portion of an exchange’s amendments to Section 19 materially trades on the exchange exceed net joint product. Rather, all of the alter the scope of the Commission’s transaction execution costs and the cost exchange’s costs are incurred for the review of future market data filings, by of data that the broker-dealer chooses to unified purposes of attracting order creating a presumption that all fees may buy to support its trading decisions (or flow, executing and/or routing orders, take effect immediately, without prior those of its customers). The choice of and generating and selling data about analysis by the Commission of the data products is, in turn, a product of market activity. The total return that an competitive environment. Even in the the value of the products in making exchange earns reflects the revenues it absence of this important statutory profitable trading decisions. If the cost receives from the joint products and the change, however, ISE believes that a of the product exceeds its expected total costs of the joint products. record may readily be established to value, the broker-dealer will choose not Competition among trading platforms demonstrate the competitive nature of to buy it. can be expected to constrain the the market in question. Moreover, as a broker-dealer chooses aggregate return each platform earns As recently noted by a number of to direct fewer orders to a particular from the sale of its joint products, but exchanges,17 there is intense exchange, the value of the product to different platforms may choose from a competition between trading platforms that broker-dealer decrease, for two range of possible, and equally that provide transaction execution and reasons. First, the product will contain reasonable, pricing strategies as the routing services and proprietary data less information, because executions of means of recovering total costs. For products. Transaction execution and the broker-dealer’s orders will not be example, some platforms may choose to proprietary data products are reflected in it. Second, and perhaps pay rebates to attract orders, charge complementary in that market data is more important, the product will be less relatively low prices for market both an input and a byproduct of the valuable to that broker-dealer because it information (or provide information free execution service. In fact, market data does not provide information about the of charge) and charge relatively high and trade execution are a paradigmatic venue to which it is directing its orders. prices for accessing posted liquidity. example of joint products with joint Data from the competing venue to Other platforms may choose a strategy costs. The decision whether and on which the broker-dealer is directing of paying lower rebates (or no rebates) orders will become correspondingly to attract orders, setting relatively high 17 See Securities Exchange Act Release Nos. more valuable. Thus, a super- prices for market information, and 63084 (October 13, 2010), 75 FR 64379 (October 19, competitive increase in the fees charged setting relatively low prices for 2010) (Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Revise an Optional for either transactions or data has the accessing posted liquidity. In this Depth Data Enterprise License Fee for Broker-Dealer potential to impair revenues from both environment, there is no economic basis Distribution of Depth-of-Book Data) (SR–NASDAQ– products. ‘‘No one disputes that for regulating maximum prices for one 2010–125); and 62887 (September 10, 2010), 75 FR competition for order flow is ‘fierce’.’’ 18 of the joint products in an industry in 57092 (September 17, 2010) (Notice of Filing and Immediate Effectiveness of Proposed Rule Change However, the existence of fierce which suppliers face competitive Relating to Market Data Feeds) (SR–PHLX–2010– constraints with regard to the joint 121). 18 NetCoalition, at 24. offering.

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The market for market data products reports that exist in the marketplace. III. Date of Effectiveness of the is competitive and inherently Market data vendors provide another Proposed Rule Change and Timing for contestable because there is fierce form of price discipline for proprietary Commission Action competition for the inputs necessary to data products because they control the The foregoing rule change has become the creation of proprietary data and primary means of access to end users. effective pursuant to Section strict pricing discipline for the Vendors impose price restraints based 19(b)(3)(A)(ii) of the Act 19 and Rule proprietary products themselves. upon their business models. For 19b–4(f)(2) 20 thereunder. At any time Numerous exchanges compete with example, vendors such as Bloomberg within 60 days of the filing of the each other for listings, trades, and and Reuters that assess a surcharge on proposed rule change, the Commission market data itself, providing virtually data they sell may refuse to offer summarily may temporarily suspend limitless opportunities for entrepreneurs proprietary products that end users will such rule change if it appears to the who wish to produce and distribute not purchase in sufficient numbers. Commission that such action is their own market data. This proprietary Internet portals, such as Google, impose necessary or appropriate in the public data is produced by each individual a discipline by providing only data that interest, for the protection of investors, exchange, as well as other entities, in a will enable them to attract ‘‘eyeballs’’ or otherwise in furtherance of the vigorously competitive market. that contribute to their advertising purposes of the Act. If the Commission Broker-dealers currently have revenue. Retail broker-dealers, such as takes such action, the Commission shall numerous alternative venues for their Schwab and Fidelity, offer their institute proceedings to determine order flow, including numerous self- customers proprietary data only if it whether the proposed rule change regulatory organization (‘‘SRO’’) promotes trading and generates should be approved or disapproved. markets, as well as internalizing broker- sufficient commission revenue. dealers (‘‘BDs’’) and various forms of Although the business models may IV. Solicitation of Comments alternative trading systems (‘‘ATSs’’), differ, these vendors’ pricing discipline Interested persons are invited to including dark pools and electronic is the same: they can simply refuse to submit written data, views, and communication networks (‘‘ECNs’’). purchase any proprietary data product arguments concerning the foregoing, Each SRO market competes to produce that fails to provide sufficient value. including whether the proposed rule transaction reports via trade executions, NASDAQ and other producers of change is consistent with the Exchange and two FINRA-regulated Trade proprietary data products must Act. Comments may be submitted by Reporting Facilities (‘‘TRFs’’) compete understand and respond to these any of the following methods: to attract internalized transaction varying business models and pricing reports. Competitive markets for order disciplines in order to market Electronic Comments flow, executions, and transaction proprietary data products successfully. • Use the Commission’s Internet reports provide pricing discipline for Competition among platforms has comment form (http://www.sec.gov/ the inputs of proprietary data products. driven ISE continually to improve its rules/sro.shtml); or The large number of SROs, TRFs, BDs, platform data offerings and to cater to • Send an email to rule- and ATSs that currently produce customers’ data needs. For example, ISE [email protected]. Please include File proprietary data or are currently capable has developed and maintained multiple Number SR–ISE–2011–67 on the subject of producing it provides further pricing delivery mechanisms that enable line. discipline for proprietary data products. customers to receive data in the form Paper Comments Each SRO, TRF, ATS, and BD is and manner they prefer and at the currently permitted to produce lowest cost to them. ISE offers front end • Send paper comments in triplicate proprietary data products, and many applications such as its PrecISE Trade to Elizabeth M. Murphy, Secretary, currently do or have announced plans to application which helps customers Securities and Exchange Commission, do so, including NASDAQ, NYSE, utilize data. ISE offers data via multiple 100 F Street NE., Washington, DC NYSE Amex, NYSEArca, and BATS. extranet providers, thereby helping to 20549–1090. Any ATS or BD can combine with any reduce network and total cost for its All submissions should refer to File other ATS, BD, or multiple ATSs or BDs data products. Despite these Number SR–ISE–2011–67. This file to produce joint proprietary data enhancements and a dramatic increase number should be included on the products. Additionally, order routers in message traffic, ISE’s fees for market subject line if email is used. To help the and market data vendors can facilitate data have, for the most part, remained Commission process and review your single or multiple broker-dealers’ flat. comments more efficiently, please use production of proprietary data products. The vigor of competition for market only one method. The Commission will The potential sources of proprietary data is significant and the Exchange post all comments on the Commission’s products are virtually limitless. The fact believes that this proposal clearly Internet Web site (http://www.sec.gov/ that proprietary data from ATSs, BDs, evidences such competition. ISE is rules/sro.shtml). Copies of the and vendors can by-pass SROs is offering a new pricing model in order to submission, all subsequent significant in two respects. First, non- keep pace with changes in the industry amendments, all written statements SROs can compete directly with SROs and evolving customer needs. with respect to the proposed rule for the production and sale of change that are filed with the C. Self-Regulatory Organization’s proprietary data products, as BATS and Commission, and all written Statement on Comments on the Arca did before registering as exchanges communications relating to the Proposed Rule Change Received From by publishing proprietary book data on proposed rule change between the Members, Participants, or Others the Internet. Second, because a single Commission and any person, other than order or transaction report can appear in The Exchange has not solicited, and those that may be withheld from the an SRO proprietary product, a non-SRO does not intend to solicit, comments on public in accordance with the proprietary product, or both, the data this proposed rule change. The provisions of 5 U.S.C. 552, will be available in proprietary products is Exchange has not received any exponentially greater than the actual unsolicited written comments from 19 15 U.S.C. 78s(b)(3)(A)(ii). number of orders and transaction members or other interested parties. 20 17 CFR 240.19b–4(f)(2).

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available for Web site viewing and of the Exchange pursuant to EDGA Rule Opening Session and the Post-Closing printing in the Commission’s Public 15.1(a) and (c). All of the changes Session, the ROUC strategy is the only Reference Room, 100 F Street NE., described herein are applicable to EDGA means for Members to post liquidity to Washington, DC 20549, on official Members. The text of the proposed rule an away exchange. The ROUC routing business days between the hours of change is available on the Exchange’s strategy checks the System for available 10 a.m. and 3 p.m. Copies of the filing Internet Web site at http:// shares and then is sent sequentially to also will be available for inspection and www.directedge.com. destinations on the System routing copying at the principal office of the II. Self-Regulatory Organization’s table, Nasdaq OMX BX, and NYSE. If Exchange. All comments received will Statement of the Purpose of, and shares remain unexecuted after routing, be posted without change; the Statutory Basis for, the Proposed Rule they are posted to EDGX. The rebate is Commission does not edit personal Change designed to incentivize Members to also identifying information from route through EDGA during the Pre- submissions. You should submit only In its filing with the Commission, the Opening Session and the Post-Closing information that you wish to make self-regulatory organization included Session to reach multiple sources of available publicly. All submissions statements concerning the purpose of, liquidity before routing to other low cost should refer to File Number SR–ISE– and basis for, the proposed rule change destinations, and thereby potentially 2011–67 and should be submitted on or and discussed any comments it received increases volume on EDGA to the extent before December 1, 2011. on the proposed rule change. The text an order using the ROUC routing of these statements may be examined at strategy executes on EDGA. The rebate For the Commission, by the Division of the places specified in Item IV below. Trading and Markets, pursuant to delegated allows Members to reach multiple authority.21 The self-regulatory organization has sources of liquidity by routing order prepared summaries, set forth in Kevin M. O’Neill, flow through EDGA rather than going sections A, B and C below, of the most directly to various venues. The rebate Deputy Secretary. significant aspects of such statements. [FR Doc. 2011–29103 Filed 11–9–11; 8:45 am] also provides Members with a flat rate BILLING CODE 8011–01–P A. Self-Regulatory Organization’s of $0.0027 per share rebate if the ROUC Statement of the Purpose of, and routing strategy posts to EDGX. When Statutory Basis for, the Proposed Rule the Exchange’s routing broker/dealer, SECURITIES AND EXCHANGE Change Direct Edge ECN LLC d/b/a DE Route (‘‘DE Route’’) achieves certain tiers on COMMISSION Purpose EDGX, it is able to pass through a better [Release No. 34–65684; File No. SR–EDGA– Currently, a rebate of $0.0027 per rebate than if it had not achieved a tier.9 2011–35] share is provided to Members who add For example, if the Member had routed liquidity on the EDGX Exchange, Inc. Self-Regulatory Organizations; EDGA to EDGX directly and the order had (‘‘EDGX’’) via an EDGA-originated Exchange, Inc.; Notice of Filing and added liquidity to EDGX, the Member ROUC routing strategy, as defined in Immediate Effectiveness of Proposed could receive rebates ranging from Exchange Rule 11.9(b)(3)(a), during Rule Change Relating to Amendments $0.0023–$0.0034, depending on if a Regular Trading Hours.4 This situation 10 to the EDGA Exchange, Inc. Fee volume threshold were satisfied. The yields Flag P. The Exchange proposes to Schedule $0.0027 per share rebate thus represents apply Flag P’s rebate to the Pre-Opening a rate in between these various tiered November 4, 2011. Session 5 and Post-Closing Session 6 so and non-tiered rebates provided for Pursuant to Section 19(b)(1) of the that Members may earn the same rebate adding liquidity to EDGX. This allows Securities Exchange Act of 1934 (the for adding liquidity on EDGX as they EDGA Members to share in potential ‘‘Act’’),1 and Rule 19b–4 thereunder,2 earn during Regular Trading Hours, volume tier savings realized by DE notice is hereby given that on October which is defined as ‘‘pre & post market’’ Route when it achieves certain tiers. 24, 2011, the EDGA Exchange, Inc. (the in EDGA’s fee schedule. The Exchange proposes to implement This type of rate is also similar to ‘‘Exchange’’ or the ‘‘EDGA’’) filed with EDGA’s rate for removing liquidity from the Securities and Exchange this amendment to its fee schedule on October 24, 2011. LavaFlow (Flag U). The standard Commission (‘‘Commission’’) the removal rate of $0.0029 per share is proposed rule change as described in Basis reduced to $0.0023 per share for orders Items I, II, and III below, which items The Exchange believes that the routed to LavaFlow that achieve certain have been prepared by the self- proposed rule change is consistent with volume thresholds, as EDGA Members regulatory organization. The the objectives of Section 6 of the Act,7 are able to share in potential volume tier Commission is publishing this notice to in general, and furthers the objectives of savings realized by EDGA when routing solicit comments on the proposed rule 11 Section 6(b)(4),8 in particular, as it is to LavaFlow. This rebate is also change from interested persons. designed to provide for the equitable comparable to other rebates offered by I. Self-Regulatory Organization’s allocation of reasonable dues, fees and the Exchange that add liquidity, such as Statement of the Terms of Substance of other charges among its members and the ROOC 12 routing strategy, which the Proposed Rule Change other persons using its facilities. yields Flags 8 and 9.13 For Flags 8 and The Exchange believes that the rebate The Exchange proposes to amend its for Flag P of $0.0027 per share is an 9 See EDGX fee schedule, footnote 1. fees and rebates applicable to Members 3 equitable allocation of reasonable dues, 10 Id. fees, and other charges. During the Pre- 11 See footnote 6 of the EDGA fee schedule. 21 17 CFR 200.30–3(a)(12). 12 See EDGA Exchange Rule 11.9(b)(3)(n). 1 15 U.S.C. 78s(b)(1). 13 See the EDGA Fee Schedule where Flag 8 offers 4 See EDGA Exchange Rule 1.5(w). 2 17 CFR 240.19b–4. a rebate of $.0015 where a member routes an order 5 3 A Member is any registered broker or dealer, or See EDGA Exchange Rule 1.5(q). to NYSE Amex using the ROOC routing strategy and any person associated with a registered broker or 6 See EDGA Exchange Rule 1.5(p). adds liquidity, and Flag 9 offers a rebate of $.0021 dealer, that has been admitted to membership in the 7 15 U.S.C. 78f. where a member routes an order to NYSE Arca Exchange. 8 15 U.S.C. 78f(b)(4). using the ROOC routing strategy and adds liquidity.

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9, the Exchange passes through the B. Self-Regulatory Organization’s Internet Web site (http://www.sec.gov/ default rebate (i.e., non-tier) from the Statement on Burden on Competition rules/sro.shtml). Copies of the primary listing market (i.e., NYSE Arca, The proposed rule change does not submission, all subsequent NYSE Amex) to Members because DE impose any burden on competition that amendments, all written statements Route does not generally achieve a is not necessary or appropriate in with respect to the proposed rule favorable tier rate. This rate is also furtherance of the purposes of the Act. change that are filed with the consistent with the processing of similar Commission, and all written routing strategies by EDGA’s C. Self-Regulatory Organization’s communications relating to the competitors where EDGA takes into Statement on Comments on the proposed rule change between the account the rates that it is charged or Proposed Rule Change Received From Commission and any person, other than rebated when routing to other low cost Members, Participants or Others those that may be withheld from the destinations.14 Finally, as another The Exchange has not solicited, and public in accordance with the example, when EDGA routes to a does not intend to solicit, comments on provisions of 5 U.S.C. 552, will be primary exchange’s opening cross, (Flag this proposed rule change. The available for Web site viewing and O), the Exchange passes through the tier Exchange has not received any printing in the Commission’s Public savings that DE Route achieves on an unsolicited written comments from Reference Room, 100 F Street NE., away exchange to its Members.15 This members or other interested parties. Washington, DC 20549, on official tier savings takes the form of a cap of business days between the hours of Members’ fees at $10,000 per month for III. Date of Effectiveness of the 10 a.m. and 3 p.m. Copies of the filing using Flag O. Proposed Rule Change and Timing for also will be available for inspection and The Exchange believes that the rebate Commission Action copying at the principal office of the of $0.0027 is reasonable as it is The foregoing rule change has become Exchange. All comments received will consistent with how other exchanges effective pursuant to Section 19(b)(3) of be posted without change; the pass through charges or rebates for the Act 16 and Rule 19b–4(f)(2) 17 Commission does not edit personal orders routed to a different exchange thereunder. At any time within 60 days identifying information from that add liquidity. For example, when of the filing of such proposed rule submissions. You should submit only Nasdaq routes to Nasdaq PSX, Nasdaq change, the Commission summarily may information that you wish to make passes back Nasdaq PSX’s standard temporarily suspend such rule change if available publicly. All submissions charge of $0.0027 per share. When it appears to the Commission that such should refer to File Number SR–EDGA– NYSE Arca routes to NYSE, NYSE Arca action is necessary or appropriate in the 2011–35 and should be submitted on or passes back the standard NYSE rebate of public interest, for the protection of before December 1, 2011. $0.0015 per share. These rebates investors, or otherwise in furtherance of For the Commission, by the Division of generally approximate what the the purposes of the Act. originating exchange receives from the Trading and Markets, pursuant to delegated authority.18 exchange that is routed to plus or minus IV. Solicitation of Comments Kevin M. O’Neill, a certain differential. EDGA’s pricing is Interested persons are invited to consistent with this premise. submit written data, views, and Deputy Secretary. The Exchange believes that the arguments concerning the foregoing, [FR Doc. 2011–29106 Filed 11–9–11; 8:45 am] proposed rebate is non-discriminatory including whether the proposed rule BILLING CODE 8011–01–P in that it applies uniformly to all change is consistent with the Act. Members. Comments may be submitted by any of The Exchange also notes that it the following methods: SECURITIES AND EXCHANGE operates in a highly competitive market COMMISSION in which market participants can Electronic Comments readily direct order flow to competing • [Release No. 34–65687; File No. SR–BX– Use the Commission’s Internet 2011–073] venues if they deem fee levels at a comment form (http://www.sec.gov/ particular venue to be excessive. The rules/sro.shtml); or Self-Regulatory Organizations; proposed rule change reflects a • Send an email to rule- NASDAQ OMX BX, Inc.; Notice of Filing competitive pricing structure designed [email protected]. Please include File of Proposed Rule Change To Modify to incent market participants to direct Number SR–EDGA–2011–35 on the Rule 7034 Regarding Low Latency their order flow to the Exchange. The subject line. Network Connections Exchange believes that the proposed rates are equitable and non- Paper Comments November 4, 2011. discriminatory in that they apply • Send paper comments in triplicate Pursuant to Section 19(b)(1) of the uniformly to all Members. The to Elizabeth M. Murphy, Secretary, Securities Exchange Act of 1934 Exchange believes the fees and credits Securities and Exchange Commission, (‘‘Act’’),1 and Rule 19b–4 thereunder,2 remain competitive with those charged 100 F Street NE., Washington, DC notice is hereby given that on October by other venues and therefore continue 20549–1090. 31, 2011, NASDAQ OMX BX, Inc. (‘‘BX’’ to be reasonable and equitably allocated All submissions should refer to File or ‘‘Exchange’’) filed with the Securities to Members. Number SR–EDGA–2011–35. This file and Exchange Commission number should be included on the (‘‘Commission’’) the proposed rule 14 See also BATS BZX fee schedule, describing subject line if email is used. To help the change as described in Items I, II, and Discounted Destination Specific Routing (‘‘One Under’’) to NYSE, NYSE ARCA and NASDAQ. See Commission process and review your III below, which Items have been Securities Exchange Act Release No. 62858, 75 FR comments more efficiently, please use prepared by the Exchange. The 55838 (September 14, 2010) (SR–BATS–2010–023) only one method. The Commission will Commission is publishing this notice to (modifying the BATS fee schedule in order to post all comments on the Commission’s amend the fees for its BATS + NYSE Arca destination specific routing option to continue to 18 17 CFR 200.30–3(a)(12). offer a ‘‘one under’’ pricing model). 16 15 U.S.C. 78s(b)(3)(A). 1 15 U.S.C. 78s(b)(1). 15 See footnote 5 of the EDGA fee schedule. 17 17 CFR 19b–4(f)(2). 2 17 CFR 240.19b–4.

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solicit comments on the proposed rule Background equipment in the Exchange’s data change from interested persons. Currently the Exchange provides a center, one carrier has, to date, agreed to offer connections under the program I. Self-Regulatory Organization’s cross connect from a client’s cabinet to and others are in negotiations with the Statement of the Terms of Substance of its requested telecommunication Exchange; additional carriers are the Proposed Rule Change carrier’s cabinet (known as a ‘‘telco cross connect’’). Through the enhanced eligible to join the program upon The Exchange, pursuant to Section point-to-point connectivity service, meeting the same terms and conditions. 19(b)(1) of the Act 3 and Rule 19b–4 clients will now have the option to Under the program, co-located thereunder,4 proposes to modify receive low latency network customers will have the opportunity to Exchange Rule 7034 entitled ‘‘Co- connectivity from the Exchange’s data request these new low latency network Location Services’’ to establish a center to the client’s chosen venue(s), in telecommunication connections through program for offering low latency addition to the telco cross connect. the same process used to request a new network connections and to establish These connections can be utilized to co-located cabinet and other co-location the initial fees for such connections. send market data to and receive orders services, with no need for direct fee The Exchange also proposes from the chosen venues. negotiations or new service agreements administrative modifications to The enhanced point-to-point with telecommunication carriers. The Exchange Rule 7034. connectivity provides the Exchange’s co-located customer will choose the The text of the proposed rule change co-location customers the opportunity connection destination,7 but the is available at http:// to obtain low latency network elimination of direct negotiations and www.nasdaqomxbx.cchwallstreet.com/, connectivity with greater ease than is separate service agreements with the at the Exchange’s principal office, on currently the case, and at a competitive telecommunications provider for these the Commission’s Web site at http:// price. Currently, co-location customers services will allow them to obtain a www.sec.gov, and at the Commission’s obtain similar services by negotiating similar service at a competitive price Public Reference Room. fees, obtaining service level agreements, and with greater ease of and executing service agreements implementation. In addition, the II. Self-Regulatory Organization’s directly with approved proposed low latency network Statement of the Purpose of, and telecommunication carriers. A co- connectivity fees include cross Statutory Basis for, the Proposed Rule located customer is currently charged a connections and eliminate a separate fee Change monthly negotiated fee by the for that service. In its filing with the Commission, the telecommunications carrier in addition The Exchange is making the low Exchange included statements to a cross connection fee by the latency network telecommunication concerning the purpose of and basis for Exchange. There are currently 16 connections available as a convenience the proposed rule change and discussed approved telecommunication carriers to customers and notes that receipt of any comments it received on the with equipment in the Exchange’s data these connections is completely proposed rule change. The text of these center, with additional carriers added at voluntary. Customers retain the option statements may be examined at the the request of a client. In order to of contracting directly with places specified in Item IV below. The provide the new connectivity option telecommunication providers, including Exchange has prepared summaries, set described in this proposed rule change, either the provider(s) that participate in forth in sections A, B, and C below, of the Exchange established a low-latency the program, the current providers in 5 the most significant aspects of such minimum standard, approached those the data center who have not yet agreed statements. telecommunications carriers with low to participate, or any new carrier that is latency connections to select major approved to install equipment in the A. Self-Regulatory Organization’s financial trading and co-location venues Exchange’s data center. Statement of the Purpose of, and in the New York and New Jersey Low Latency Pricing Structure Statutory Basis for, the Proposed Rule metropolitan areas, Toronto, and Change Chicago that met the low-latency The Exchange proposes: (1) A one- 6 time fee of $1,165 for the installation of 1. Purpose minimum standard, and invited them to agree to discounted rates. In effect, 100 MB of telecommunication Low Latency Network Connection the Exchange is obtaining wholesale connectivity to select New York and Option rates from the carriers and then charging New Jersey metropolitan area financial a markup to compensate it for its efforts trading and co-location venues, which The purpose of the proposed rule includes fiber telecommunication cross change is to modify Exchange Rule to negotiate and establish the arrangement and integrate the connects within the NASDAQ OMX 7034, which governs the Exchange’s data center, along with a per-month program for co-location services, to offer connectivity into the Exchange co- location connectivity offering, as well as connectivity fee of $1,650; (2) a one- new options for low latency network time fee of $2,150 for the installation of telecommunication connections and to administrative costs associated with establishing and maintaining each new 1G of telecommunication connectivity establish the initial fees for such to select New York and New Jersey connections. As its initial offering, the connection. Of the 16 approved telecommunication carriers with metropolitan area financial trading and Exchange proposes to offer point-to- co-location venues, which includes fiber point telecommunication connectivity 5 telecommunication cross connects from the co-location facility to select The low-latency minimum standard is less than or equal to 0.41 milliseconds for New York/New within the NASDAQ OMX data center, major financial trading and co-location Jersey routes, less than or equal to 10.1 milliseconds along with a per-month connectivity fee venues in the New York and New Jersey for Toronto routes, and less than or equal to 17 of $2,150; (3) a one-time fee of $5,000 milliseconds for Chicago routes. This standard will metropolitan areas, Toronto, and for the installation of 10G of Chicago. change as the technology improves and the latency is further reduced. 6 The Exchange selected these locations because 7 As additional providers join the program, 3 15 U.S.C. 78s(b)(1). of the high numbers of member firms and/or customers will also have the opportunity to choose 4 17 CFR 240.19b–4. liquidity venues located there. from among these providers.

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telecommunication connectivity to Elimination of Obsolete Rule Language include a markup to allow the Exchange select New York and New Jersey Concerning Waiver of Fees to cover its administrative costs and to metropolitan area financial trading and The Exchange also proposes to earn a profit on its provision of the co-location venues, which includes fiber eliminate references to certain fee service. The Exchange believes that it is telecommunication cross connects waivers that expired July 31, 2011.9 reasonable to use fees assessed on this within the NASDAQ OMX data center, Since the fee waivers expired, such basis as a means to recoup the along with a per-month connectivity fee language is no longer necessary. Exchange’s share of the costs associated of $5,000; (4) a one-time fee of $5,150 with the proposed low latency network for the installation of 100 MB of 2. Statutory Basis telecommunication connections, telecommunication connectivity to The Exchange believes that its provide a convenience for the select Toronto area financial trading and proposal is consistent with Section 6(b) customers, and to the extent the costs co-location venues, which includes fiber of the Act 10 in general, and Sections are covered, provide the Exchange a telecommunication cross connects 6(b)(4) and (b)(5) of the Act 11 in profit. The Exchange further believes within the NASDAQ OMX data center, particular, in that it provides for the that the proposed fees are reasonable in along with a per-month connectivity fee equitable allocation of reasonable dues, light of the costs associated with the of $4,350; (5) a one-time fee of $8,200 fees and other charges among members service and the fees charged by other for the installation of 1G of and issuers and other persons using any trading venues for comparable 12 telecommunication connectivity to facility or system which the Exchange services. select Toronto area financial trading and operates or controls, and is designed to The proposed co-location services are entirely voluntary and available to all co-location venues, which includes fiber promote just and equitable principles of members, with uniform fees charged to telecommunication cross connects trade, to remove impediments to and all market participants that opt to obtain within the NASDAQ OMX data center, perfect the mechanism of a free and connectivity through the Exchange. along with a per-month connectivity fee open market and a national market Moreover, market participants may of $10,450; (6) a one-time fee of $15,150 system, and, in general to protect choose to obtain services through the for the installation of 10G of investors and the public interest. The Exchange, or may choose to negotiate telecommunication connectivity to proposal is designed to provide a their own connectivity with 16 different select Toronto area financial trading and method of connectivity between the providers. Accordingly, the Exchange’s co-location venues, which includes fiber Exchange’s co-location facility and telecommunication cross connects proposed fees are non-discriminatory, various remote locations. Currently, and equitably allocated to market within the NASDAQ OMX data center, market participants obtain such along with a per-month connectivity fee participants that choose to avail connections by negotiating directly with themselves of the Exchange’s services, of $32,400; (7) a one-time fee of $4,850 telecommunication providers. Through for the installation of 100 MB of rather than obtaining comparable its efforts to negotiate standard services directly. telecommunication connectivity to wholesale rates with providers, the select Chicago area financial trading and Exchange seeks to offer market B. Self-Regulatory Organization’s co-location venues, which includes fiber participants an opportunity to obtain Statement on Burden on Competition telecommunication cross connects the same connectivity service at a The Exchange does not believe that within the NASDAQ OMX data center, potentially lower cost and with greater the proposed rule change will impose along with a per-month connectivity fee ease of implementation. The Exchange any burden on competition not of $8,350; (8) a one-time fee of $5,900 believes that this change will be necessary or appropriate in furtherance for the installation of 1G of unambiguously beneficial to market of the purposes of the Act. First, telecommunication connectivity to participants, who will retain all current competition between the Exchange and select Chicago area financial trading and options for obtaining connectivity competing trading venues will be co-location venues, which includes fiber through direct negotiations with enhanced by allowing the Exchange to telecommunication cross connects telecommunications providers, while offer its market participants within the NASDAQ OMX data center, also receiving a new option for connectivity to its data center at a along with a per-month connectivity fee obtaining the service through the potentially lower price, and with greater of $16,400; and (9) a one-time fee of Exchange’s program. ease. As noted above, NYSE already $12,050 for the installation of 10G of The proposed fees for the service offers comparable services, at telecommunication connectivity to cover the costs charged to the Exchange comparable fees, to its market select Chicago area financial trading and by telecommunication provider(s). The participants. Accordingly, the proposal co-location venues, which includes fiber fees charged to the Exchange are based will allow the Exchange to enhance its telecommunication cross connects on anticipated bandwidth necessary for competitive standing vis-a`-vis other within the NASDAQ OMX data center, the connections and distances to the trading venues. Conversely, any delay in along with a per-month connectivity fee available locations covered by the the effectiveness of the proposed rule of $39,750. service (New York/New Jersey, Chicago, change would burden competition by The fees are based on anticipated and Toronto). The proposed fees also preventing the Exchange from mounting bandwidth necessary for the a response to a primary competitor. connections and distances to these nysetechnologies.nyx.com/sites/ Second, competition among market select venues. Furthermore, the technologies.nyx.com/files/ SFTI_Americas_Market_Connectivity.pdf; http:// participants will be supported by Exchange believes the fees are allowing small and large participants to reasonable as they are similar and nysetechnologies.nyx.com/global-connectivity/sfti- americas. pay a lower price for data center competitive with fees charged for 9 See Securities Exchange Act Release No. 64631 8 connectivity. similar services by other entities. (June 8, 2011), 76 FR 34785 (June 14, 2011) (SR– The Exchange believes that the BX–2011–032); and Securities Exchange Act proposed rule change will likewise 8 See http://www.cmegroup.com/globex/files/ Release No. 64840 (July 8, 2011), 76 FR 41534 (July CMEGlobexConnectionAgrmt.pdf; http:// 14, 2011)(SR–BX–2011–043). enhance competition among nysetechnologies.nyx.com/global-connectivity/sfti- 10 15 U.S.C. 78f(b). americas/sfti-ip-americas; http:// 11 15 U.S.C. 78f(b)(4) and (5). 12 See supra n. 8.

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telecommunications providers that seek to determine whether the proposed rule For the Commission, by the Division of to offer connections between market change should be disapproved. Trading and Markets, pursuant to delegated participants and the Exchange’s data authority.13 center. As discussed above, the IV. Solicitation of Comments Kevin M. O’Neill, Exchange does not discriminate among Interested persons are invited to Deputy Secretary. telecommunication providers, but rather submit written data, views, and [FR Doc. 2011–29108 Filed 11–9–11; 8:45 am] allows providers to access the data arguments concerning the foregoing, BILLING CODE 8011–01–P center upon request of a market including whether the proposed rule participant. As a result, 16 providers are change is consistent with the Act. SECURITIES AND EXCHANGE currently connected. Likewise, the Comments may be submitted by any of Exchange does not discriminate among COMMISSION the following methods: providers with respect to eligibility to [Release No. 34–65689; File No. SR–Phlx– offer connectivity through the Exchange Electronic Comments 2011–142] under the service proposed in this • filing, provided the latency, Use the Commission’s Internet Self-Regulatory Organizations; destinations, and fees offered by the comment form (http://www.sec.gov/ NASDAQ OMX PHLX LLC; Notice of provider are consistent with the rules/sro.shtml); or Filing and Immediate Effectiveness of minimum standards established by the • Send an email to rule- Proposed Rule Change To Modify its Exchange. Thus, telecommunications [email protected]. Please include File Co-Location Fee Schedule Regarding providers can choose to participate in Number SR–BX–2011–073 on the Low Latency Network Connections the program, or can choose to service subject line. market participants exclusively through November 4, 2011. direct negotiations with customers. The Paper Comments Pursuant to Section 19(b)(1) of the Exchange’s approach is consistent with • Securities Exchange Act of 1934 its own economic incentives to facilitate Send paper comments in triplicate (‘‘Act’’),1 and Rule 19b–4 thereunder,2 as many market participants as possible to Elizabeth M. Murphy, Secretary, notice is hereby given that on October in connecting to its market. Burdening Securities and Exchange Commission, 31, 2011, NASDAQ OMX PHLX LLC competition among telecommunications 100 F Street NE., Washington, DC (‘‘Phlx’’ or ‘‘Exchange’’) filed with the providers would be antithetical to the 20549–1090. Securities and Exchange Commission Exchange’s own competitive interests, All submissions should refer to File (‘‘Commission’’) the proposed rule since impaired competition would make Number SR–BX–2011–073. This file change as described in Items I, II, and it more expensive and more difficult for number should be included on the III below, which Items have been market participants to send order flow subject line if email is used. To help the prepared by the Exchange. The to the Exchange. Commission process and review your Commission is publishing this notice to The Exchange expects that the result comments more efficiently, please use solicit comments on the proposed rule of the proposal will be a reduction in only one method. The Commission will change from interested persons. fees charged to market participants, the post all comments on the Commission’s I. Self-Regulatory Organization’s very essence of competition. To the Internet Web site (http://www.sec.gov/ extent that fees under the program are Statement of the Terms of Substance of rules/sro.shtml). Copies of the the Proposed Rule Change less expensive than the rates currently submission, all subsequent paid by many market participants, the amendments, all written statements The Exchange proposes to modify the welfare of these market participants will with respect to the proposed rule Exchange Fee Schedule, Section X(b) increase, and other telecommunications change that are filed with the entitled ‘‘Co-Location Services’’ to providers will be incentivized to lower Commission, and all written establish a program for offering low their own rates. This will, in turn, communications relating to the latency network connections and to facilitate the introduction of greater proposed rule change between the establish the initial fees for such volumes of order flow to the Exchange. Commission and any person, other than connections. The Exchange also proposes administrative modifications C. Self-Regulatory Organization’s those that may be withheld from the to the Exchange Fee Schedule, Section Statement on Comments on the public in accordance with the X(b). Proposed Rule Change Received From provisions of 5 U.S.C. 552, will be The text of the proposed rule change Members, Participants, or Others available for Web site viewing and printing in the Commission’s Public is available at http:// No written comments were either www.nasdaqtrader.com/ solicited or received. Reference Room, 100 F Street NE., Washington, DC 20549, on official micro.aspx?id=PHLXRulefilings, at the III. Date of Effectiveness of the business days between the hours of 10 Exchange’s principal office, on the Proposed Rule Change and Timing for a.m. and 3 p.m. Copies of such filing Commission’s Web site at http:// Commission Action also will be available for inspection and www.sec.gov, and at the Commission’s Public Reference Room. Within 45 days of the date of copying at the principal office of the publication of this notice in the Federal Exchange. All comments received will II. Self-Regulatory Organization’s Register or within such longer period (i) be posted without change; the Statement of the Purpose of, and as the Commission may designate up to Commission does not edit personal Statutory Basis for, the Proposed Rule 90 days of such date if it finds such identifying information from Change submissions. You should submit only longer period to be appropriate and In its filing with the Commission, the information that you wish to make publishes its reasons for so finding or Exchange included statements (ii) as to which the Exchange consents, available publicly. All submissions should refer to File Number SR–BX– the Commission shall: (a) by order 13 17 CFR 200.30–3(a)(12). approve or disapprove such proposed 2011–073 and should be submitted on 1 15 U.S.C. 78s(b)(1). rule change, or (b) institute proceedings or before December 1, 2011. 2 17 CFR 240.19b–4.

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concerning the purpose of and basis for center, with additional carriers added at to customers and notes that receipt of the proposed rule change and discussed the request of a client. In order to these connections is completely any comments it received on the provide the new connectivity option voluntary. Customers retain the option proposed rule change. The text of these described in this proposed rule change, of contracting directly with statements may be examined at the the Exchange established a low-latency telecommunication providers, including places specified in Item IV below. The minimum standard,3 approached those either the provider(s) that participate in Exchange has prepared summaries, set telecommunications carriers with low the program, the current providers in forth in sections A, B, and C below, of latency connections to select major the data center who have not yet agreed the most significant aspects of such financial trading and co-location venues to participate, or any new carrier that is statements. in the New York and New Jersey approved to install equipment in the metropolitan areas, Toronto, and Exchange’s data center. A. Self-Regulatory Organization’s Chicago that met the low-latency Statement of the Purpose of, and Low Latency Pricing Structure minimum standard,4 and invited them Statutory Basis for, the Proposed Rule to agree to discounted rates. In effect, The Exchange proposes: (1) A one- Change the Exchange is obtaining wholesale time fee of $1,165 for the installation of 1. Purpose rates from the carriers and then charging 100 MB of telecommunication a markup to compensate it for its efforts connectivity to select New York and Low Latency Network Connection New Jersey metropolitan area financial Option to negotiate and establish the arrangement and integrate the trading and co-location venues, which The purpose of the proposed rule connectivity into the Exchange co- includes fiber telecommunication cross change is to modify the Exchange Fee location connectivity offering, as well as connects within the NASDAQ OMX Schedule, Section X(b) entitled ‘‘Co- administrative costs associated with data center, along with a per-month Location Services’’ to offer new options establishing and maintaining each new connectivity fee of $1,650; (2) a one- for low latency network connection. Of the 16 approved time fee of $2,150 for the installation of telecommunication connections and to telecommunication carriers with 1G of telecommunication connectivity establish the initial fees for such equipment in the Exchange’s data to select New York and New Jersey connections. As its initial offering, the center, one carrier has, to date, agreed metropolitan area financial trading and Exchange proposes to offer point-to- to offer connections under the program co-location venues, which includes fiber point telecommunication connectivity and others are in negotiations with the telecommunication cross connects from the co-location facility to select Exchange; additional carriers are within the NASDAQ OMX data center, major financial trading and co-location eligible to join the program upon along with a per-month connectivity fee venues in the New York and New Jersey meeting the same terms and conditions. of $2,150; (3) a one-time fee of $5,000 metropolitan areas, Toronto, and Under the program, co-located for the installation of 10G of Chicago. customers will have the opportunity to telecommunication connectivity to select New York and New Jersey Background request these new low latency network telecommunication connections through metropolitan area financial trading and Currently the Exchange provides a the same process used to request a new co-location venues, which includes fiber cross connect from a client’s cabinet to co-located cabinet and other co-location telecommunication cross connects its requested telecommunication services, with no need for direct fee within the NASDAQ OMX data center, carrier’s cabinet (known as a ‘‘telco negotiations or new service agreements along with a per-month connectivity fee cross connect’’). Through the enhanced with telecommunication carriers. The of $5,000; (4) a one-time fee of $5,150 point-to-point connectivity service, co-located customer will choose the for the installation of 100 MB of clients will now have the option to connection destination,5 but the telecommunication connectivity to receive low latency network elimination of direct negotiations and select Toronto area financial trading and connectivity from the Exchange’s data separate service agreements with the co-location venues, which includes fiber center to the client’s chosen venue(s), in telecommunications provider for these telecommunication cross connects addition to the telco cross connect. services will allow them to obtain a within the NASDAQ OMX data center, These connections can be utilized to similar service at a competitive price along with a per-month connectivity fee send market data to and receive orders and with greater ease of of $4,350; (5) a one-time fee of $8,200 from the chosen venues. implementation. In addition, the for the installation of 1G of The enhanced point-to-point proposed low latency network telecommunication connectivity to connectivity provides the Exchange’s connectivity fees include cross select Toronto area financial trading and co-location customers the opportunity connections and eliminate a separate fee co-location venues, which includes fiber to obtain low latency network for that service. telecommunication cross connects connectivity with greater ease than is The Exchange is making the low within the NASDAQ OMX data center, currently the case, and at a competitive latency network telecommunication along with a per-month connectivity fee price. Currently, co-location customers connections available as a convenience of $10,450; (6) a one-time fee of $15,150 obtain similar services by negotiating for the installation of 10G of fees, obtaining service level agreements, 3 The low-latency minimum standard is less than telecommunication connectivity to and executing service agreements or equal to 0.41 milliseconds for New York/New select Toronto area financial trading and directly with approved Jersey routes, less than or equal to 10.1 milliseconds co-location venues, which includes fiber for Toronto routes, and less than or equal to 17 telecommunication carriers. A co- milliseconds for Chicago routes. This standard will telecommunication cross connects located customer is currently charged a change as the technology improves and the latency within the NASDAQ OMX data center, monthly negotiated fee by the is further reduced. along with a per-month connectivity fee telecommunications carrier in addition 4 The Exchange selected these locations because of $32,400; (7) a one-time fee of $4,850 to a cross connection fee by the of the high numbers of member firms and/or for the installation of 100 MB of liquidity venues located there. Exchange. There are currently 16 5 As additional providers join the program, telecommunication connectivity to approved telecommunication carriers customers will also have the opportunity to choose select Chicago area financial trading and with equipment in the Exchange’s data from among these providers. co-location venues, which includes fiber

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telecommunication cross connects method of connectivity between the B. Self-Regulatory Organization’s within the NASDAQ OMX data center, Exchange’s co-location facility and Statement on Burden on Competition along with a per-month connectivity fee various remote locations. Currently, The Exchange does not believe that of $8,350; (8) a one-time fee of $5,900 market participants obtain such the proposed rule change will impose for the installation of 1G of connections by negotiating directly with any burden on competition not telecommunication connectivity to telecommunication providers. Through necessary or appropriate in furtherance select Chicago area financial trading and its efforts to negotiate standard of the purposes of the Act. First, co-location venues, which includes fiber wholesale rates with providers, the competition between the Exchange and telecommunication cross connects Exchange seeks to offer market competing trading venues will be within the NASDAQ OMX data center, participants an opportunity to obtain enhanced by allowing the Exchange to along with a per-month connectivity fee the same connectivity service at a offer its market participants of $16,400; and (9) a one-time fee of potentially lower cost and with greater connectivity to its data center at a $12,050 for the installation of 10G of ease of implementation. The Exchange potentially lower price, and with greater telecommunication connectivity to believes that this change will be ease. As noted above, NYSE already select Chicago area financial trading and unambiguously beneficial to market offers comparable services, at co-location venues, which includes fiber participants, who will retain all current comparable fees, to its market telecommunication cross connects options for obtaining connectivity participants. Accordingly, the proposal within the NASDAQ OMX data center, through direct negotiations with will allow the Exchange to enhance its along with a per-month connectivity fee telecommunications providers, while competitive standing vis-a`-vis other of $39,750. also receiving a new option for The fees are based on anticipated trading venues. Conversely, any delay in obtaining the service through the bandwidth necessary for the the effectiveness of the proposed rule Exchange’s program. connections and distances to these change would burden competition by select venues. Furthermore, the The proposed fees for the service preventing the Exchange from mounting Exchange believes the fees are cover the costs charged to the Exchange a response to a primary competitor. reasonable as they are similar and by telecommunication provider(s). The Second, competition among market competitive with fees charged for fees charged to the Exchange are based participants will be supported by similar services by other entities.6 on anticipated bandwidth necessary for allowing small and large participants to the connections and distances to the pay a lower price for data center Elimination of Obsolete Rule Language available locations covered by the connectivity. Concerning Waiver of Fees service (New York/New Jersey, Chicago, The Exchange believes that the The Exchange also proposes to and Toronto). The proposed fees also proposed rule change will likewise eliminate references to certain fee include a markup to allow the Exchange enhance competition among waivers that expired July 31, 2011.7 to cover its administrative costs and to telecommunications providers that seek Since the fee waivers expired, such earn a profit on its provision of the to offer connections between market language is no longer necessary. service. The Exchange believes that it is participants and the Exchange’s data center. As discussed above, the 2. Statutory Basis reasonable to use fees assessed on this basis as a means to recoup the Exchange does not discriminate among The Exchange believes that its Exchange’s share of the costs associated telecommunication providers, but rather proposal is consistent with Section 6(b) with the proposed low latency network allows providers to access the data of the Act 8 in general, and Sections telecommunication connections, center upon request of a market 6(b)(4) and (b)(5) of the Act 9 in provide a convenience for the participant. As a result, 16 providers are particular, in that it provides for the currently connected. Likewise, the customers, and to the extent the costs equitable allocation of reasonable dues, Exchange does not discriminate among are covered, provide the Exchange a fees and other charges among members providers with respect to eligibility to profit. The Exchange further believes and issuers and other persons using any offer connectivity through the Exchange that the proposed fees are reasonable in facility or system which the Exchange under the service proposed in this light of the costs associated with the operates or controls, and is designed to filing, provided the latency, service and the fees charged by other promote just and equitable principles of destinations, and fees offered by the trading venues for comparable trade, to remove impediments to and provider are consistent with the services.10 perfect the mechanism of a free and minimum standards established by the open market and a national market The proposed co-location services are Exchange. Thus, telecommunications system, and, in general to protect entirely voluntary and available to all providers can choose to participate in investors and the public interest. The members, with uniform fees charged to the program, or can choose to service proposal is designed to provide a all market participants that opt to obtain market participants exclusively through connectivity through the Exchange. direct negotiations with customers. The 6 See http://www.cmegroup.com/globex/files/ Moreover, market participants may Exchange’s approach is consistent with CMEGlobexConnectionAgrmt.pdf; http:// choose to obtain services through the nysetechnologies.nyx.com/global-connectivity/sfti- its own economic incentives to facilitate americas/sfti-ip-americas; http:// Exchange, or may choose to negotiate as many market participants as possible nysetechnologies.nyx.com/sites/ their own connectivity with 16 different in connecting to its market. Burdening technologies.nyx.com/files/ providers. Accordingly, the Exchange’s _ _ _ competition among telecommunications SFTI Americas Market Connectivity.pdf; http:// proposed fees are non-discriminatory, nysetechnologies.nyx.com/global-connectivity/sfti- providers would be antithetical to the americas. and equitably allocated to market Exchange’s own competitive interests, 7 See Securities Exchange Act Release No. 64629 participants that choose to avail since impaired competition would make (June 8, 2011), 76 FR 34798 (June 14, 2011) (SR– themselves of the Exchange’s services, it more expensive and more difficult for Phlx–2011–77); and Securities Exchange Act rather than obtaining comparable Release No. 64842 (July 8, 2011), 76 FR 41536 (July market participants to send order flow 14, 2011) (SR–Phlx–2011–97). services directly. to the Exchange. 8 15 U.S.C. 78f(b). The Exchange expects that the result 9 15 U.S.C. 78f(b)(4) and (5). 10 See supra n. 6. of the proposal will be a reduction in

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fees charged to market participants, the rules/sro.shtml). Copies of the to grant exemptions from certain equity very essence of competition. To the submission, all subsequent trade reporting obligations for extent that fees under the program are amendments, all written statements alternative trading systems (‘‘ATSs’’) less expensive than the rates currently with respect to the proposed rule meeting specified criteria. The proposed paid by many market participants, the change that are filed with the rule change was published for comment welfare of these market participants will Commission, and all written in the Federal Register on September increase, and other telecommunications communications relating to the 29, 2011.3 The Commission received providers will be incentivized to lower proposed rule change between the three comment letters on the proposed their own rates. This will, in turn, Commission and any person, other than rule change.4 FINRA responded to the facilitate the introduction of greater those that may be withheld from the comments in a letter dated November 4, volumes of order flow to the Exchange. public in accordance with the 2011.5 This order approves the provisions of 5 U.S.C. 552, will be proposed rule change. C. Self-Regulatory Organization’s available for Web site viewing and II. Description of the Proposal Statement on Comments on the printing in the Commission’s Public Proposed Rule Change Received From Reference Room, 100 F Street NE., Proposed FINRA Rules 6183 and 6625 Members, Participants, or Others Washington, DC 20549, on official will provide FINRA with new authority No written comments were either business days between the hours of 10 to exempt a member ATS that meets the solicited or received. a.m. and 3 p.m. Copies of such filing specified criteria from the trade also will be available for inspection and reporting obligation under the equity III. Date of Effectiveness of the copying at the principal office of the trade reporting rules. In addition, Proposed Rule Change and Timing for Exchange. All comments received will FINRA will adopt a conforming change Commission Action be posted without change; the to Rule 9610 to specify that FINRA has Within 45 days of the date of Commission does not edit personal exemptive authority under the new publication of this notice in the Federal identifying information from rules. Register or within such longer period (i) submissions. You should submit only As described in the Notice, existing as the Commission may designate up to information that you wish to make FINRA rules require the reporting of 90 days of such date if it finds such available publicly. All submissions over-the-counter (‘‘OTC’’) transactions longer period to be appropriate and should refer to File Number SR–Phlx– in equity securities 6 by the ‘‘executing publishes its reasons for so finding or 2011–142 and should be submitted on party.’’ The term ‘‘executing party’’ is (ii) as to which the Exchange consents, or before December 1, 2011. defined as the FINRA member that the Commission shall: (a) By order receives an order for handling or For the Commission, by the Division of execution or is presented an order approve or disapprove such proposed Trading and Markets, pursuant to delegated rule change, or (b) institute proceedings authority.11 against its quote, does not subsequently re-route the order, and executes the to determine whether the proposed rule Kevin M. O’Neill, change should be disapproved. transaction. For a trade executed on an Deputy Secretary. ATS, the ATS is the ‘‘executing party’’ IV. Solicitation of Comments [FR Doc. 2011–29110 Filed 11–9–11; 8:45 am] and thus has the trade reporting Interested persons are invited to BILLING CODE 8011–01–P obligation.7 submit written data, views, and arguments concerning the foregoing, 3 See Securities Exchange Act Release No. 65388 SECURITIES AND EXCHANGE including whether the proposed rule (September 23, 2011), 76 FR 60567 (July 26, 2011) COMMISSION (‘‘Notice’’). change is consistent with the Act. 4 See letter from Suzanne H. Shatto, dated Comments may be submitted by any of [Release No. 34–65695; File No. SR–FINRA– October 20, 2011 (‘‘Shatto Letter’’); letter from the following methods: 2011–051] Naphtali M. Hamlet, Investor, dated October 21, 2011 (‘‘Hamlet Letter’’); letter from Daniel Zinn, Electronic Comments Self-Regulatory Organizations; General Counsel, OTC Markets Group Inc., dated • Financial Industry Regulatory October 20, 2011 (‘‘OTC Markets Letter’’). Use the Commission’s Internet 5 Authority, Inc.; Order Approving See letter from Lisa C. Horrigan, Associate comment form (http://www.sec.gov/ General Counsel, FINRA, to Elizabeth M. Murphy, rules/sro.shtml); or Proposed Rule Change To Allow Secretary, Commission, dated November 4, 2011 • Send an email to rule- FINRA To Grant Exemptions From (‘‘FINRA Response’’). [email protected]. Please include File Certain Equity Trade Reporting 6 Specifically, these transactions are: (1) Obligations for Certain Alternative Transactions in NMS stocks, as defined in SEC Rule Number SR–Phlx–2011–142 on the 600(b) of Regulation NMS, effected otherwise than subject line. Trading Systems on an exchange, which are reported through the Alternative Display Facility or a Trade Reporting Paper Comments November 4, 2011. Facility; and (2) transactions in OTC Equity • Securities and Restricted Equity Securities, as those Send paper comments in triplicate I. Introduction terms are defined in Rule 6420, which are reported to Elizabeth M. Murphy, Secretary, On September 16, 2011, the Financial through the OTC Reporting Facility. As noted in the Securities and Exchange Commission, Industry Regulatory Authority, Inc. proposal, the new rules will apply to OTC 100 F Street NE., Washington, DC transactions in equity securities only. The rules will (‘‘FINRA’’) filed with the Securities and not apply to TRACE-eligible securities. TRACE- 20549–1090. Exchange Commission (‘‘SEC’’ or eligible securities are subject to a separate reporting All submissions should refer to File ‘‘Commission’’), pursuant to Section structure under FINRA’s Rule 6700 Series. 7 Number SR–Phlx–2011–142. This file 19(b)(1) of the Securities Exchange Act See Securities Exchange Act Release No. 58903 (November 5, 2008), 73 FR 67905 (November 17, number should be included on the 1 of 1934 (‘‘Act’’) and Rule 19b–4 2008) (Order Approving File No. SR–FINRA–2008– subject line if email is used. To help the thereunder,2 a proposed rule change to 011); and Regulatory Notice 09–08 (January 2009). Commission process and review your adopt new rules that will allow FINRA See also, e.g., Trade Reporting Frequently Asked comments more efficiently, please use Questions, Sections 307 and 308, available at http://www.finra.org/Industry/Regulation/ only one method. The Commission will 11 17 CFR 200.30–3(a)(12). Guidance/P038942. As described in the proposal, post all comments on the Commission’s 1 15 U.S.C. 78s(b)(1). the term ATS includes electronic communications Internet Web site (http://www.sec.gov/ 2 17 CFR 240.19b–4. networks.

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Under FINRA’s new rules, for an ATS Where FINRA grants an exemption expressed concern about dark pools and to qualify for an exemption, the pursuant to Rules 6183 or 6625, the ATS their potential impact on the fairness following conditions must be satisfied: will not be deemed a party to the trade and transparency of the national market First, trades must be between ATS for purposes of FINRA trade reporting system.12 One of these commenters subscribers that are both FINRA rules and will not be identified in trade suggested that dark pools be prohibited members. For any trades between non- reports submitted to FINRA. The ATS entirely.13 FINRA responded that these members or a FINRA member and a will bear no responsibility for reporting arguments are not germane to the non-member, the exemption will not such transactions. The transaction, proposal, which does not change the apply, and the ATS will have the trade however, must be reported to FINRA by level of transparency that currently reporting obligation under FINRA rules. the member subscriber that, as between exists.14 FINRA stated that all trades In addition, the ATS must the two member subscribers who are the executed on an ATS, including a dark demonstrate that the following criteria counterparties, satisfies the definition of pool, must be reported to FINRA and are are met: (1) The member subscribers ‘‘executing party’’ under paragraph (b) publicly disseminated. With respect to must be fully disclosed to one another of Rules 6282, 6380A, 6380B, or 6622. any ATS that is granted an exemption at all times on the ATS; (2) although the In addition, where an ATS has been system brings together the orders of under the proposed rule change, all of granted an exemption under the new the trades executed on the ATS would buyers and sellers and uses established, rules, the member subscribers, as the non-discretionary methods under which continue to be reported for public parties identified in the trade report, dissemination. such orders interact with each other, the will be assessed regulatory transaction system does not permit automatic fees under Section 3 of Schedule A to Another commenter challenged the 15 execution. A member subscriber must the FINRA By-Laws and the Trading need for any new rules at all. This take affirmative steps beyond the Activity Fee under FINRA By-Laws, commenter asserted that any ATS that submission of an order to agree to a Schedule A, § 1(b)(2). The ATS would meets the criteria set out in the trade with another member subscriber; not be assessed such fees. proposed rule change would not be an (3) the trade does not pass through any Notwithstanding an exemption, any executing party, and consequently, ATS account, and the ATS does not in transactions that occur through the ATS would not be subject to any reporting any way hold itself out to be a party to would be considered volume of the ATS obligation under current FINRA rules. the trade; and (4) the ATS does not for purposes of, among other things, On this basis, the commenter concluded exchange shares or funds on behalf of various provisions of Regulation ATS. that the proposal is unnecessary and the member subscribers, take either side Such provisions include the should not be approved by the of the trade for clearing or settlement recordkeeping requirements of Rule Commission, because no FINRA purposes, including, but not limited to, 302,8 the display requirements under exemption is necessary for entities that at DTC or otherwise, or in any other way Rule 301(b)(3),9 the access requirements bear no regulatory obligation. insert itself into the trade. under Rule 301(b)(5),10 and the The ATS and its FINRA member FINRA responded that this capacity, integrity, and security subscribers must also acknowledge and commenter’s assertion is based on an requirements of Rule 301(b)(6).11 agree in writing that the ATS shall not erroneous interpretation of FINRA rules The effect of an exemption provided and directly at odds with statements be deemed a party to the trade for pursuant to FINRA Rules 6183 and 6625 purposes of trade reporting and that made by FINRA in the original filing.16 is illustrated in the following example FINRA noted previous interpretations trades shall be reported by the that was included in the Notice: FINRA subscriber that, as between the two and guidance that an ATS is the member BD1 displays a quote through ‘‘executing party’’ and has the trade counterparties to the trade, would ATS X and member BD2 routes an order satisfy the definition of ‘‘executing reporting obligation where the to BD1 for the price and size of BD1’s party’’ under FINRA trade reporting transaction is executed on the ATS.17 quote using a messaging system rules. An ATS that is granted an FINRA reiterated its belief that an ATS provided by ATS X. BD1 does not exemption would have to obtain such that satisfies the criteria set forth in the subsequently re-route the order and written agreements from all of its FINRA proposal has a more limited executes the trade. Assuming that ATS member subscribers prior to relying on involvement in the trade execution than X meets all of the criteria set forth in the the exemption. Any ATS granted an the member subscribers, and therefore, proposed rule and has been granted an exemption under the new rules would the proposed exemption is appropriate exemption by FINRA, it will not be be required to retain the written in this narrow instance. deemed a party to the trade for trade agreements and be able to produce them reporting purposes and should not be The commenter further stated that, to FINRA upon request. notwithstanding its opposition, were the Finally, the ATS must agree to identified as such in the trade report submitted to FINRA. In this example, Commission inclined to approve provide to FINRA on a monthly basis, FINRA’s proposal, the proposed rules or such other basis as prescribed by BD1 is the ‘‘executing party’’ and has should be modified.18 First, the FINRA, data relating to the volume of the obligation to report the trade commenter asserted that the exemption trades, by security, executed by the between BD1 and BD2. FINRA stated that the proposed rule authority should be expanded to cover ATS’s member subscribers using the change will be effective on the date of TRACE-eligible securities, because there ATS’s system (e.g., number of trades, Commission approval. is no meaningful basis to distinguish the number of shares traded and total reporting rules and obligations settlement value for each security III. Summary of Comment Letters traded). The ATS also must Among the three comment letters 12 acknowledge that failure to report such See Shatto Letter; Hamlet Letter. received, two of the commenters 13 See Shatto Letter. data to FINRA, in addition to 14 See FINRA Response at 3. constituting a violation of FINRA rules, 8 17 CFR 242.302. 15 See OTC Markets Letter at 1–2. would result in revocation of any 9 17 CFR 242.301(b)(3). 16 See FINRA Response at 1–2. exemption granted pursuant to the new 10 17 CFR 242.301(b)(5). 17 See note 7 supra. rules. 11 17 CFR 242.301(b)(6). 18 See OTC Markets Letter at 2.

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associated with this class of securities rule change is consistent with the SECURITIES AND EXCHANGE from those for other securities. provisions of Section 15A(b)(6) of the COMMISSION FINRA responded that the comment Act,25 which requires, among other goes beyond the scope of the instant things, that FINRA rules be designed to [Release No. 34–65694; File No. SR–BATS– 2011–046] proposal, but that it would consider the prevent fraudulent and manipulative comment separately.19 FINRA stated acts and practices, to promote just and Self-Regulatory Organizations; BATS that if it determines that a similar equitable principles of trade, and, in Exchange, Inc.; Notice of Filing and exemption is appropriate for TRACE general, to protect investors and the Immediate Effectiveness of Proposed reporting, FINRA would submit a public interest. Rule Change Related to Fees for Use separate rule filing to effect that change. In addition, the commenter argued As described above, the proposal is of BATS Exchange, Inc. that the criteria for the exemption designed to provide FINRA the November 4, 2011. 20 authority to exempt an ATS from should be clarified in certain respects. Pursuant to Section 19(b)(1) of the reporting obligations under FINRA’s FINRA disagreed with the comment and Securities Exchange Act of 1934 (the reasserted its belief that the criteria for equity trade reporting rules where the ‘‘Act’’) 1 and Rule 19b–4 thereunder,2 21 the exemption were sufficiently clear. ATS does not perform all the functions notice is hereby given that on October Finally, the commenter argued that normally associated with those of an 31, 2011, BATS Exchange, Inc. (the the proposed exemption should be executing party. Where an exemption is ‘‘Exchange’’ or ‘‘BATS’’) filed with the automatic, and not subject to FINRA granted, the duty to report will fall on Securities and Exchange Commission staff discretion.22 The commenter one of the subscribers that is a (‘‘Commission’’) the proposed rule maintained that FINRA has not counterparty to the trade and that itself change as described in Items I, II, and explained the ‘‘relevant factors’’ that satisfies the definition of ‘‘executing III below, which Items have been FINRA staff would consider, which party.’’ The Commission believes that prepared by the Exchange. The could lead to inconsistent application of the exemption mechanism is reasonably Exchange has designated the proposed the new rules. FINRA responded that it designed to promote efficient reporting rule change as one establishing or is important for its staff to have the of OTC transactions in equity securities, changing a member due, fee, or other opportunity to review an ATS’s and that FINRA can—consistent with charge imposed by the Exchange under application for exemptive relief and to the Exchange Act—be afforded some Section 19(b)(3)(A)(ii) of the Act 3 make a determination whether the ATS and discretion regarding which of its 4 meets the criteria in the proposed rule Rule 19b–4(f)(2) thereunder, which before the ATS is able to rely on the members should have the duty to report renders the proposed rule change effective upon filing with the exemption.23 FINRA believes that it is a trade when there are multiple Commission. The Commission is important to know in advance which members who could potentially assume publishing this notice to solicit party—the ATS or one of its that duty. comments on the proposed rule change subscribers—will have the trade The Commission does not believe that from interested persons. reporting obligation. FINRA stated that, any commenters raised issues that while it expects to grant an exemption would preclude approval of this I. Self-Regulatory Organization’s to any ATS that can demonstrate that it proposal. The Commission believes that Statement of the Terms of Substance of meets all of the criteria set forth in the the proposal is sufficiently clear, and the Proposed Rule Change new rules, FINRA staff should have modifications are not necessary to allow The Exchange proposes [sic] amend notice and discretion in the event of a the Commission to find it consistent the fee schedule applicable to disagreement with an ATS about with the Act. Furthermore, the Members 5 and non-members of the whether it qualifies for an exemption comments that raised issues with dark Exchange pursuant to BATS Rules under the proposed rule. FINRA plans pools go beyond the scope of the present 15.1(a) and (c). While changes to the fee to post on its Web site which ATSs are proposal. All transactions currently schedule pursuant to this proposal will operating under any exemption granted subject to reporting will continue to be be effective upon filing, the changes will pursuant to the new rules. reported; the new rules merely allow become operative on November 1, 2011. IV. Discussion and Commission’s FINRA to reassign the duty to report in The text of the proposed rule change Findings certain circumstances. is available at the Exchange’s Web site at http://www.batstrading.com, at the The Commission has carefully V. Conclusion reviewed the proposed rule change, the principal office of the Exchange, and at comments received, and FINRA’s It is therefore ordered, pursuant to the Commission’s Public Reference response to the comments, and finds Section 19(b)(2) of the Act,26 that the Room. that the proposed rule change is proposed rule change (SR–FINRA– II. Self-Regulatory Organization’s consistent with the requirements of the 2011–051) be, and it hereby is, Statement of the Purpose of, and Act and the rules and regulations approved. Statutory Basis for, the Proposed Rule thereunder applicable to a national For the Commission, by the Division of Change securities association.24 In particular, Trading and Markets, pursuant to delegated In its filing with the Commission, the the Commission finds that the proposed authority.27 Exchange included statements Kevin M. O’Neill, 19 See FINRA Response at 2. concerning the purpose of and basis for 20 See OTC Markets Letter at 3–6. Deputy Secretary. the proposed rule change and discussed 21 See FINRA Response at 2. [FR Doc. 2011–29114 Filed 11–9–11; 8:45 am] 22 1 15 U.S.C. 78s(b)(1). See OTC Markets Letter at 7. BILLING CODE 8011–01–P 23 See FINRA Response at 2–3. 2 17 CFR 240.19b–4. 24 In approving this proposed rule change, the 3 15 U.S.C. 78s(b)(3)(A)(ii). Commission has considered the rule’s impact on 25 15 U.S.C. 78o–3(b)(6). 4 17 CFR 240.19b–4(f)(2). efficiency, competition, and capital formation. See 26 15 U.S.C. 78s(b)(2). 5 A Member is any registered broker or dealer that 15 U.S.C. 78c(f). 27 17 CFR 200.30–3(a)(12). has been admitted to membership in the Exchange.

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any comments it received on the align Professionals with other requirements in order to qualify for the proposed rule change. The text of these sophisticated market participants, the QIP at this time. statements may be examined at the Exchange proposes to modify its fee 2. Statutory Basis places specified in Item IV below. The schedule by listing a Professional with Exchange has prepared summaries, set a Firm and Market Maker in every The Exchange believes that the forth in Sections A, B, and C below, of instance where a distinction is made for proposed rule change is consistent with the most significant parts of such options fees and rebates based on the the requirements of the Act and the statements. capacity of the User or the counter- rules and regulations thereunder that party. For instance, the Exchange are applicable to a national securities A. Self-Regulatory Organization’s exchange, and, in particular, with the Statement of the Purpose of, and currently charges a fee of $0.42 per contract for all Firm and Market Maker requirements of Section 6 of the Act.7 Statutory Basis for, the Proposed Rule Specifically, the Exchange believes that Change orders that remove liquidity from BATS Options. The Exchange proposes to the proposed rule change is consistent 8 1. Purpose charge this same fee for all Professional with Section 6(b)(4) of the Act, in that it provides for the equitable allocation The Exchange proposes to modify the orders that remove liquidity from BATS of reasonable dues, fees and other ‘‘Options Pricing’’ section of its fee Options. charges among members and other schedule to: (i) Recognize a new Modification to Quoting Incentive persons using any facility or system category of participant, a ‘‘Professional’’, Program (QIP) which the Exchange operates or in light of recent changes the Exchange controls. The Exchange notes that it made to its rules that become operative BATS Options offers a Quoting operates in a highly competitive market November 1, 2011; and (ii) modify the Incentive Program (QIP), through which in which market participants can Quoting Incentive Program, which is a Members receive a rebate of $0.05 per readily direct order flow to competing program intended to incentivize contract, in addition to any other venues if they deem fee levels at a sustained, aggressive quoting on the applicable liquidity rebate, for particular venue to be excessive. executions subject to the QIP. Currently BATS options platform (‘‘BATS The Exchange believes it is equitable, to qualify for the QIP a BATS Options Options’’). In addition to these changes, reasonable and non-discriminatory to the Exchange proposes to correct a Market Maker must be at the NBB or assess fees and provide liquidity rebates typographical error on the fee schedule. NBO 70% of the time for series trading for Professional orders that are the same Specifically, the Exchange no longer between $0.03 and $5.00 for the front as those fees and rebates for Firms and offers a discounted fee to remove three (3) expiration months in that Market Makers. The Exchange believes liquidity for Firm or Market Makers that underlying during the current trading that application of a simple pricing meet certain average daily volume month. A Member not registered as a structure that groups all sophisticated requirements but the fee schedule still BATS Options Market Maker can also participants together is advantageous to contains language indicating that such a qualify for the QIP by quoting at the all Members of BATS Options. As stated reduced fee is available. The Exchange NBB or NBO 80% of the time in the above, the Exchange operates within a proposes to delete this language. same series. The Exchange proposes to highly competitive market. The Professional Pricing modify the qualification levels to make Exchange, however, does not assess qualifying for the QIP attainable by ongoing fess [sic] for BATS Options The Exchange recently modified the more Members and BATS Options rules applicable to BATS Options to market data or fees related to order Market Makers. Specifically, the cancellation. Professional accounts, amend Rule 16.1 (Definitions) to adopt Exchange proposes to reduce the level at a definition of ‘‘Professional’’ on the while otherwise considered to be which a BATS Options Market Maker Customers by virtue of not being broker- Exchange and require that all must be at the NBB or NBO from 70% Professional orders be appropriately dealers, generally engage in trading to 60% and for Members not registered activity more similar to broker-dealer marked by members of BATS Options as a BATS Options Market Maker from 6 proprietary trading accounts (more than (‘‘Options Members’’). As defined in 80% to 70%. Rule 16.1, which, as modified becomes 390 orders per day on average). This All other aspects of the QIP currently operative November 1, 2011, the term level of trading activity draws on a in place will remain the same. As is true ‘‘Professional’’ means any person or greater amount of Exchange system under the current operation of the QIP, entity that (i) is not a broker or dealer resources than that of non-Professional the Exchange will determine whether a in securities, and (ii) places more than Customers. Simply, the more orders Member qualifies for QIP rebates at the 390 orders in listed options per day on submitted to the Exchange, the more end of each month by looking back at average during a calendar month for its messages sent to and received from the each Member’s (including BATS own beneficial account(s). Exchange, and the more Exchange Options Market Makers) quoting The Exchange currently charges and system resources utilized. This level of statistics during that month. If at the provides rebates based on the capacity trading activity by Professional accounts end of the month a Market Maker meets in which a User is acting, either as a results in greater ongoing operational the 60% criteria or a Member that is not Firm, as a Market Maker, or on behalf costs to the Exchange. As such, the registered as a Market Maker meets the of a Customer. With respect to rebates, Exchange aims to recover its costs by 70% criteria, the Exchange will provide the Exchange also currently assessing Professional accounts the the additional rebate for all executions differentiates the rebate paid to Firms same fees that it assesses to other subject to the QIP executed by that and Market Makers depending on the sophisticated Exchange market Member during that month. The capacity of the counter-party to the participants. Generally, competing Exchange will provide Members with a trade, either a Customer or another Firm options exchanges assess Professionals report on a daily basis with quoting or Market Maker. In order to properly fees at rates more comparable to fees statistics so such Members can charged to broker-dealers. Sending 6 Securities Exchange Act Release No. 65500 determine whether or not they are (October 6, 2011), 76 FR 63686 (October 13, 2011) meeting the QIP criteria. The Exchange 7 15 U.S.C. 78f. (SR–BATS–2011–041). is not proposing to impose any ADV 8 15 U.S.C. 78f(b)(4).

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orders to and trading on the Exchange Exchange participants are not required B. Self-Regulatory Organization’s are entirely voluntary. Under these to use the routing services. Rather, Statement on Burden on Competition circumstances, Exchange transaction Exchange routing services are The Exchange does not believe that fees must be competitive to attract order completely optional. Exchange the proposed rule change imposes any flow, execute orders, and grow its participants can manage their own burden on competition. market. As such, the Exchange believes routing to different options exchanges or its trading fees proposed for can utilize a myriad of other routing C. Self-Regulatory Organization’s Statement on Comments on the Professional accounts are fair and solutions that are available to market Proposed Rule Change Received From reasonable. While Professional orders participants. Further, as noted above, will be assessed comparably higher Members, Participants or Others the characteristics of Professional transaction fees than those assessed to accounts tend to be more similar to No written comments were solicited other Customer orders, as proposed, or received. because Professional orders will be broker-dealers than to non-Professional treated in the same manner as Firm and Customers. As such, the Exchange III. Date of Effectiveness of the Market Maker orders, Professional believes Professionals are more likely to Proposed Rule Change and Timing for orders will have the ability to achieve a be able to directly route their orders to Commission Action higher rebate of $0.32 per contract when the exchange venues where they wish to Pursuant to Section 19(b)(3)(A)(ii) of executing against other Firm, Market trade. By assessing a fee on Professional the Act 11 and Rule 19b–4(f)(2) Maker or Professional orders (as accounts for routing orders, the thereunder,12 the Exchange has compared to a $0.30 per contract rebate Exchange aims to recover its costs in designated this proposal as establishing that a Customer order would receive).9 providing this optional service to its or changing a due, fee, or other charge The Exchange also notes that Participants and their Professional applicable to the Exchange’s Members Professional orders will still qualify for customer accounts. The Exchange and non-members, which renders the additional rebates under existing believes that providing Customers a proposed rule change effective upon programs such as the Exchange’s preferred rate for routing is consistent filing. Quoting Incentive and NBBO Setter with the long history in the options At any time within 60 days of the Programs. markets of such customers being given filing of the proposed rule change, the Moreover, the Exchange believes it is preferred fees. Commission summarily may equitable and not unfairly temporarily suspend such rule change if Additionally, the Exchange believes discriminatory to charge Customers it appears to the Commission that such lower fees than fees charged to that the proposed modification to the action is necessary or appropriate in the Professional accounts, which are more Quoting Incentive Program, which is public interest, for the protection of akin to broker-dealer accounts. The similar to a fee structure in place on at investors, or otherwise in furtherance of securities markets generally, and the least one of the Exchange’s the purposes of the Act. Exchange in particular, have historically competitors,10 will further incentivize aimed to improve markets for investors the provision of competitively priced, IV. Solicitation of Comments and develop various features within the sustained liquidity that will create Interested persons are invited to market structure for customer benefit. tighter spreads, benefitting both submit written data, views and As such, the Exchange believes the Members and public investors. The arguments concerning the foregoing, proposed fees for Professional accounts, Exchange also believes that continuing including whether the proposed rule as compared to Customer transaction to maintain a slightly lower threshold change is consistent with the Act. fees, is appropriate and not unfairly for meeting the QIP for registered BATS Comments may be submitted by any of discriminatory. Options Market Makers appropriately the following methods: Finally, the Exchange believes that incentivizes Members of BATS Options the proposed change to charge the same Electronic Comments to register with the Exchange as Options • fee for routing Professional customer Market Makers. While the Exchange Use the Commission’s Internet orders to various markets as is charged does wish to allow participation in the comment form (http://www.sec.gov/ for Firm and Market Maker orders is QIP by all Members, the Exchange rules/sro.shtml); or reasonable, equitable, and not unfairly • Send an email to rule- believes that registration by additional discriminatory in that the fee will allow [email protected]. Please include File the Exchange to recoup its costs Members as Market Makers will help to Number SR–BATS–2011–046 on the attendant with offering optional routing continue to increase the breadth and subject line. services. The Exchange incurs various depth of quotations available on the costs related to providing routing Exchange. The Exchange notes that in Paper Comments services. In order to better recover those addition to the fact that the QIP will be • Send paper comments in triplicate related costs and to potentially generate available to all Members, the proposal is to Elizabeth M. Murphy, Secretary, additional revenue, the Exchange not unfairly discriminatory despite a Securities and Exchange Commission, proposes a routing fee to provide this slightly higher quotation requirement 100 F Street NE., Washington, DC optional service to Professional for non-Market Makers due to the fact 20549–1090. accounts. The Exchange also notes that that registration as a BATS Options All submissions should refer to File although routing is available to Market Maker is equally available to all Number SR–BATS–2011–046. This file Exchange participants for customer Members. number should be included on the orders, including Professionals, subject line if email is used. To help the 10 See Securities Exchange Act Release No. 61869 Commission process and review your 9 The Exchange notes that when executing against (April 7, 2010), 75 FR 19449 (April 14, 2010) (SR– comments more efficiently, please use a Customer order, a Professional order will receive ISE–2010–25) (notice of filing and immediate only one method. The Commission will a liquidity rebate of $0.22 per contract. This is the effectiveness of changes to fees and rebates same liquidity rebate provided to Firm and Market including adoption of specific rebates for market Maker orders that execute against Customer orders makers qualifying for the Market Maker Plus 11 15 U.S.C. 78s(b)(3)(A)(ii). today. program). 12 17 CFR 240.19b–4(f)(2).

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post all comments on the Commission’s publishing this notice to solicit applies only to limit orders involving Internet Web site (http://www.sec.gov/ comments on the proposed rule change NMS stocks; the proposed rule change rules/sro/shtml). Copies of the from interested persons. extends the requirement to all OATS- submission, all subsequent eligible securities. I. Self-Regulatory Organization’s amendments, all written statements FINRA is also proposing amendments Statement of the Terms of Substance of with respect to the proposed rule to Rule 7450 to codify the specific time the Proposed Rule Change change that are filed with the by which OATS reports must be Commission, and all written FINRA is proposing to amend (i) transmitted to FINRA. communications relating to the Rules 5320 and 7440 to require that proposed rule change between the members report to the Order Audit Trail (1) Customer Order Protection Commission and any person, other than System (‘‘OATS’’) information barriers First, FINRA is proposing to require those that may be withheld from the put into place by the member in reliance members to identify on OATS reports public in accordance with the on Supplementary Material .02 to Rule information barriers that the member provisions of 5 U.S.C. 552, will be 5320; (ii) Rule 7440 to require that has in place in reliance on the No- available for Web site viewing and members report customer instructions Knowledge Exception in Supplementary printing in the Commission’s Public regarding the display of a customer’s Material .02 to Rule 5320. Reference Room, 100 F Street NE., limit order in any OATS-eligible On February 11, 2011, the SEC Washington, DC 20549, on official security; and (iii) Rule 7450 to codify approved FINRA’s proposed rule change business days between the hours of 10 the specific time OATS reports must be to consolidate NASD Rule 2111 and IM– a.m. and 3 p.m. Copies of such filing transmitted to FINRA. 2110–2 into new FINRA Rule 5320.3 will also be available for inspection and The text of the proposed rule change Under Rule 5320, a member that accepts copying at the principal office of the is available on FINRA’s Web site at and holds an order in an equity security Exchange. All comments received will http://www.finra.org, at the principal from its own customer, or a customer of be posted without change; the office of FINRA and at the another broker-dealer, without Commission does not edit personal Commission’s Public Reference Room. immediately executing the order is identifying information from prohibited from trading that security on II. Self-Regulatory Organization’s submissions. You should submit only the same side of the market for its own Statement of the Purpose of, and information that you wish to make proprietary account at a price that Statutory Basis for, the Proposed Rule available publicly. All submissions would satisfy the customer order unless Change should refer to File No. SR–BATS– the member immediately thereafter 2011–046 and should be submitted on In its filing with the Commission, executes the customer order up to the or before December 1, 2011. FINRA included statements concerning size and at the same, or better, price at For the Commission, by the Division of the purpose of and basis for the which the member traded for its Trading and Markets, pursuant to delegated proposed rule change and discussed any proprietary account. The No-Knowledge authority.13 comments it received on the proposed Exception in Supplementary Material Kevin M. O’Neill, rule change. The text of these statements .02 to Rule 5320 provides that if a firm Deputy Secretary. may be examined at the places specified implements and uses an effective [FR Doc. 2011–29113 Filed 11–9–11; 8:45 am] in Item IV below. FINRA has prepared system of internal controls—such as BILLING CODE 8011–01–P summaries, set forth in sections A, B, appropriate information barriers—that and C below, of the most significant operate to prevent one trading unit from aspects of such statements. obtaining knowledge of customer orders SECURITIES AND EXCHANGE A. Self-Regulatory Organization’s held by a separate trading unit, those COMMISSION Statement of the Purpose of, and other trading units may trade in a [Release No. 34–65692; File No. SR–FINRA– Statutory Basis for, Proposed Rule proprietary capacity at prices that 2011–063] Change would satisfy the customer orders held by the separate, walled-off trading unit.4 Self-Regulatory Organizations; 1. Purpose When FINRA originally proposed Financial Industry Regulatory FINRA is proposing two changes to Rule 5320, members claiming the No- Authority, Inc.; Notice of Filing of the order recording requirements in Knowledge Exception would have been Proposed Rule Change Relating to Rule 7440 of the OATS rules to reflect required to assign and use a unique Amendments to the Order Audit Trail two recent amendments to other FINRA market participant identifier (‘‘MPID’’) 5 System Rules rules. First, the proposed rule change for any walled-off market-making desk. requires members relying on the ‘‘No- In response to commenters’ concerns November 4, 2011. with the proposed MPID requirement, Pursuant to Section 19(b)(1) of the Knowledge Exception’’ in Supplementary Material .02 to Rule FINRA amended the proposal to delete Securities Exchange Act of 1934 the unique MPID requirement, but 1 2 5320 (Prohibition Against Trading (‘‘Act’’) and Rule 19b–4 thereunder, stated that it intended to examine notice is hereby given that on October Ahead of Customer Orders) to report information to OATS regarding the alternative means of achieving the same 28, 2011, Financial Industry Regulatory regulatory objective of being able to Authority, Inc. (‘‘FINRA’’) filed with the information barriers adopted by the member in reliance on the exception. Securities and Exchange Commission 3 See Securities Exchange Act Release No. 63895 (‘‘SEC’’ or ‘‘Commission’’) the proposed The proposed rule change also adds this (February 11, 2011), 76 FR 9386 (February 17, rule change as described in Items I, II, requirement into Supplementary 2011). and III below, which Items have been Material .02 of Rule 5320. Second, the 4 The Commission notes that the No-Knowledge prepared by FINRA. The Commission is proposed rule change extends the Exception in Supplementary Material .02 to FINRA existing requirement to reflect on OATS Rule 5320 contains different procedures for OTC equity securities. 13 17 CFR 200.30–3(a)(12). reports a customer’s instruction 5 See Securities Exchange Act Release No. 61168 1 15 U.S.C. 78s(b)(1). regarding display of the customer’s limit (December 15, 2009), 74 FR 68084 (December 22, 2 17 CFR 240.19b–4. orders. The requirement currently 2009).

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determine on an automated basis those members are only required to populate Reporting Technical Specifications, as customer orders that are received from the Customer Instruction Flag when the described in more detail below. walled-off desks.6 The proposed rule order involves a security subject to SEC Rule 7450(b) provides that, generally, change accomplishes the objective by Regulation NMS. reports should be transmitted on the day adding provisions to the No-Knowledge On June 22, 2010, the Commission of the order event unless information is Exception and to Rule 7440 that require approved Rule 6460,9 which became not available.12 In addition, if the firms relying on the exception to effective on May 9, 2011.10 Rule 6460 member aggregates information, the identify the information barriers to generally requires OTC market makers information must be transmitted FINRA in their OATS reports.7 to display a customer limit order in an ‘‘during such business hours as may be Through the use of OATS, FINRA will OTC equity security held by the OTC prescribed by FINRA.’’ be able to ascertain, on an automated market maker that is at a price that The proposed rule change would basis, those firms claiming the No- would improve the bid or offer of such update the language in the rule, which Knowledge Exception. This will reduce OTC market maker in such security or has not been changed substantially the potential for ‘‘false positive’’ alerts that would represent more than a de since it was adopted in 1998, and codify by allowing FINRA to account for the minimis change in relation to the size a specific deadline that members must existence of information barriers when associated with the OTC market maker’s meet. When the rule language was running automated surveillance patterns bid or offer. Rule 6460(b) includes adopted, and before OATS reporting designed to identify inappropriate exceptions to the display requirement was implemented in 1999, the rule trading ahead of customer orders. for OTC equity securities that mirror the language acknowledged that firms could FINRA believes that the new exceptions in Rule 604(b) of SEC choose to report OATS data to FINRA requirements will substantially reduce Regulation NMS.11 on a rolling basis throughout the day, or the number of ‘‘false positives’’ that are FINRA is proposing to require that reports could be aggregated into one or identified through automated OATS Reporting Members indicate on more transmissions and submitted surveillance patterns by being able to all OATS reports for customer limit ‘‘during such business hours as may be account for information barriers when orders, including OTC equity securities, prescribed by [FINRA].’’ This rule trading ahead may otherwise be whether the customer has instructed the language further reflected the fact that, indicated. member not to display the limit order or at the time the rules were proposed, (2) Limit Order Display to display a limit order of block size. As issues involving the capacity of OATS a result, OATS Reporting Members and technological changes could affect Rule 7440(b)(14) requires OATS would be required to populate the the manner and timing of transmitting Reporting Members to identify ‘‘any Customer Instruction Flag for all limit order information to OATS. In its initial request by a customer that an order not orders, not just those involving NMS filing with the Commission, FINRA be displayed, or that a block size order stocks. Use of the Customer Instruction noted: be displayed, pursuant to Rule 604(b) of 8 Flag for all limit orders reported to Based on further development of the Order SEC Regulation NMS.’’ These customer OATS will notify FINRA that a requests are identified in the OATS Audit System and determinations relating to customer has requested display of a system capacity and other factors, NASDR system through a ‘‘Customer Instruction limit order that would not otherwise be will prescribe the hours during which Flag’’ that indicates whether the required to be displayed under information may be transmitted. The customer has requested that the firm applicable rules as well as avoid prescribed hours likely will extend past the handle its limit order in a specified way. end of the trading day. The proposal potential ‘‘false positives’’ generated by Because of the reference in Rule contemplates that all Order information, customer limit orders that are not being 7440(b)(14) to SEC Regulation NMS, along with corresponding ACT data that has displayed due to the customer’s request. been integrated with such information, will be available to NASDR staff at the beginning 6 See Securities Exchange Act Release No. 63895 (3) Order Data Transmission of the trading day following the day on (February 11, 2011), 76 FR 9386 (February 17, Requirements 2011). which the information has been 13 7 Members are permitted to report this Rule 7450 requires members to report transmitted. information to OATS on a voluntary basis. See order information recorded pursuant to FINRA (then NASDR) began testing OATS Reporting Technical Specifications, at iii (ed. Rule 7440. Paragraph (a) of the rule May 3, 2011); see also OATS for all NMS Stocks the capabilities of its systems in August Frequently Asked Questions, Question 12, available imposes the general requirement that 1998 in anticipation of the at www.finra.org/oats. FINRA has encouraged members report applicable order implementation of Phase One of OATS members to do so to avoid ‘‘false positive’’ results information to FINRA that the member in early 1999.14 In the November 30, that can be caused by automated surveillance is required to record by Rule 7440. patterns aggregating trading data without regard to information barriers that firms have put in place Paragraph (b) of the rule addresses the 12 FINRA announced that OATS reports would be pursuant to the No-Knowledge Exception. See form the order data must take and the marked late if submitted after 8 a.m. Eastern Time Regulatory Notice 11–24, n.12 (May 2011). The timing of order reports. Paragraph (c) on the calendar day following the OATS Business proposed rule change would make reporting of the concerns the use of reporting agent Day on which the order event occurred in the May information mandatory for those members relying 3, 2011 edition of the OATS Reporting Technical on the No-Knowledge Exception. agreements that a member may use to Specifications. See OATS Reporting Technical 8 Rule 604 of SEC Regulation NMS generally allow a third party to report information Specifications, at 8–1 (ed. May 3, 2011). Previously, requires OTC market makers in NMS stocks to to OATS on behalf of the member. The OATS reports were marked late if received after 5 display customer limit orders that would improve proposed rule change amends paragraph a.m. Eastern Time. See OATS Reporting Technical the market maker’s published bid or offer (either by Specifications, at 8–1 (ed. November 8, 2010); Letter price or size). See 17 CFR 242.604(a)(2). Rule (b) of Rule 7450 to codify the specific from Brant Brown, Associate General Counsel, 604(b)(2) of SEC Regulation NMS excepts from the time OATS reports must be transmitted FINRA, to Elizabeth Murphy, Secretary, SEC display requirement any customer limit order that to FINRA, which is the same time that (October 28, 2010) relating to SR–FINRA–2010–044. is placed by a customer who expressly requests that currently is required under the OATS 13 See Securities Exchange Act Release No. 38990 the order not be displayed. See 17 CFR (August 28, 1997), 62 FR 47096, 47103 (September 242.604(b)(2). Rule 604(b)(4) of SEC Regulation 5, 1997) (Notice of Filing of Proposed Rule Change NMS excepts from the display requirement any 9 See Securities Exchange Act Release No. 62359 SR–NASD–97–56). customer limit order of block size unless the (June 22, 2010), 75 FR 37488 (June 29, 2010). 14 See SR–NASD–97–56, Amendment No. 4; customer requests that the order be displayed. See 10 See Regulatory Notice 10–42 (September 2010). NASD Special Notice to Members 98–33 (March 17 CFR 242.604(b)(4). 11 See FINRA Rule 6460(b)(2), (b)(4). 1998).

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1998 version of the OATS Reporting The effective date of the proposed (B) Institute proceedings to determine Technical Specifications, FINRA rule change will be no later than 120 whether the proposed rule change prescribed that, for purposes of OATS days after Commission approval. should be disapproved. reporting, an OATS business day would 2. Statutory Basis IV. Solicitation of Comments begin after the close of the Nasdaq Stock Market on one market day (4:00:01 p.m. FINRA believes that the proposed rule Interested persons are invited to Eastern Time) and end with the close of change is consistent with the provisions submit written data, views, and the Nasdaq Stock Market on the next of Section 15A(b)(6) of the Act,18 which arguments concerning the foregoing, market day (4:00:00 p.m. Eastern Time). requires, among other things, that including whether the proposed rule Orders received during an OATS FINRA rules must be designed to change is consistent with the Act. business day would be required to be prevent fraudulent and manipulative Comments may be submitted by any of submitted to OATS by 4:00:00 a.m. acts and practices, to promote just and the following methods: Eastern Time the following calendar equitable principles of trade, and, in day.15 This was intended to provide general, to protect investors and the Electronic Comments firms with adequate time to aggregate public interest. FINRA believes that the • Use the Commission’s Internet data files and transmit them to FINRA proposed rule change will enhance comment form (http://www.sec.gov/ before the beginning of the next trading FINRA’s automated surveillance rules/sro.shtml); or day. systems by providing customer • Send an email to rule- FINRA is proposing to replace the instruction information relating to limit [email protected]. Please include File current rule language regarding the orders and significantly reducing the Number SR–FINRA–2011–063 on the timing of OATS transmissions to FINRA incidence of ‘‘false positive’’ results subject line. with a specific requirement. Under the caused by identifying permitted trading proposed rule, all order events that activity in automated surveillance Paper Comments patterns. By reducing ‘‘false positive’’ occur on a particular OATS Business • Day must be transmitted to FINRA by results, FINRA can focus its resources Send paper comments in triplicate 8:00 a.m. Eastern Time on the calendar on trading activity that has properly to Elizabeth M. Murphy, Secretary, day following the end of the OATS been identified as warranting further Securities and Exchange Commission, Business Day. For purposes of the rule, regulatory scrutiny, thus promoting just 100 F Street NE., Washington, DC an ‘‘OATS Business Day’’ begins at and equitable principles of trade and 20549–1090. 4:00:01 p.m. Eastern Time on one protecting investors and the public All submissions should refer to File market day and ends at 4:00:00 p.m. interest. FINRA also believes that Number SR–FINRA–2011–063. This file Eastern Time on the next market day.16 codifying the time by which OATS number should be included on the FINRA is retaining the exception for reports must be submitted will promote subject line if email is used. To help the information that is not available by the just and equitable principles of trade by Commission process and review your time the report must be transmitted; in ensuring that all members are aware of comments more efficiently, please use such cases, the report must be their reporting obligations. only one method. The Commission will transmitted on the day that the B. Self-Regulatory Organization’s post all comments on the Commission’s 17 information becomes available. Statement on Burden on Competition Internet Web site (http://www.sec.gov/ rules/sro.shtml). Copies of the 15 See NASD Notice to Members 99–04 (January FINRA does not believe that the submission, all subsequent 1999). FINRA extended the time from 4:00 a.m. proposed rule change will result in any amendments, all written statements Eastern Time to 5:00 a.m. Eastern Time in 2007 burden on competition that is not with respect to the proposed rule connection with the expansion of OATS to OTC necessary or appropriate in furtherance equity securities. See August 21, 2007 Addendum change that are filed with the to OATS Reporting Technical Specifications (ed. of the purposes of the Act. Commission, and all written August 6, 2007). C. Self-Regulatory Organization’s communications relating to the 16 Thus, for example, assuming no holidays, if an proposed rule change between the order is received at 5:00:00 p.m. Eastern Time on Statement on Comments on the Wednesday, the order event occurs on the OATS Proposed Rule Change Received From Commission and any person, other than Business Day ending Thursday at 4:00:00 p.m. Members, Participants or Others those that may be withheld from the Eastern Time. Receipt of the order (and any public in accordance with the Written comments were neither subsequent event(s) regarding the order until provisions of 5 U.S.C. 552, will be Thursday at 4:00:00 p.m. Eastern Time) must be solicited nor received. reported by 8:00:00 a.m. on Friday. Order events available for Web site viewing and occurring on market days during regular market III. Date of Effectiveness of the printing in the Commission’s Public hours (i.e., before 4:00:01 p.m. Eastern Time) are Proposed Rule Change and Timing for Reference Room, 100 F Street NE., reported by 8:00:00 a.m. Eastern Time on the Commission Action Washington, DC 20549, on official following calendar day. 17 This provision was initially intended to Within 45 days of the date of business days between the hours of address circumstances where complete information publication of this notice in the Federal 10 a.m. and 3 p.m. Copies of such filing is not available at the time an order report must be Register or within such longer period (i) also will be available for inspection and submitted (for example, where an order is executed copying at the principal office of over the course of multiple days, and the total as the Commission may designate up to execution information is not available on the same 90 days of such date if it finds such FINRA. All comments received will be day the order is received). See Securities Exchange longer period to be appropriate and posted without change; the Commission Act Release No. 38990 (August 28, 1997), 62 FR publishes its reasons for so finding or does not edit personal identifying 47096 (September 5, 1997). The provision was information from submissions. You amended in 2006 to also address circumstances (ii) as to which the self-regulatory where a firm has traded a security that has not been organization consents, the Commission should submit only information that assigned a symbol and can report the information will: you wish to make available publicly. All only after a symbol has been requested, which must (A) By order approve or disapprove submissions should refer to File be done promptly, and assigned. See Securities Number SR–FINRA–2011–063 and Exchange Act Release No. 54585 (October 10, 2006), such proposed rule change, or 71 FR 61112 (October 17, 2006); Notice to Members should be submitted on or before 06–70 (December 2006). 18 15 U.S.C. 78o–3(b)(6). December 1, 2011.

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For the Commission, by the Division of of the most significant parts of such system itself, that transmits that order to Trading and Markets, pursuant to delegated statements. the Exchange. authority.19 The Exchange therefore proposes to A. Self-Regulatory Organization’s Kevin M. O’Neill, eliminate this contradiction in the Statement of the Purpose of, and Deputy Secretary. language by clarifying that, to qualify for Statutory Basis for, the Proposed Rule the Discount, an entire customer order [FR Doc. 2011–29112 Filed 11–9–11; 8:45 am] Change BILLING CODE 8011–01–P quantity must be tied to a single order 1. Purpose ID within the front end system that is The Exchange recently amended its used to enter and/or transmit the order. SECURITIES AND EXCHANGE Fees Schedule to clarify the process for This clarifies that, if a broker receives a COMMISSION the qualification of a customer order for Large Customer Order from a customer, the Customer Large Trade Discount (the enters it into their own front end [Release No. 34–65690; File No. SR–CBOE– ‘‘Discount’’), which is intended to cap system, and then telephones the order 2011–103] fees on large customer trades (the into the Exchange, the Large Customer quantity of contracts necessary for a Order will still qualify for the Discount. Self-Regulatory Organizations; large customer trade to qualify for the Any party that requests that an order Chicago Board Options Exchange, Discount varies by product).3 The entered in this process be granted the Incorporated; Notice of Filing and Exchange now proposes to amend the Discount will still have to grant the Immediate Effectiveness of a Proposed Fees Schedule once again to further Exchange access to effectively audit the Rule Change To Clarify the Process for clarify the process for qualification of a front end system, and will have to the Qualification of the Customer customer order for the Discount. submit a customer large trade discount Large Trade Discount Currently, to qualify for the Discount, request which identifies all necessary trade-related information to the November 4, 2011. an entire customer order quantity must be tied to a single order ID either within Exchange within 3 business days of the Pursuant to Section 19(b)(1) of the the CBOEdirect system or in FBW or transactions.5 Securities Exchange Act of 1934 (the PULSe or in the front end system used The proposed rule change would clear ‘‘Act’’) 1 and Rule 19b–4 thereunder,2 to transmit the order (provided the up any confusion regarding the entry notice is hereby given that on October Exchange is granted access to effectively and qualification of Large Customer 28, 2011, the Chicago Board Options audit such front end system). The order Orders and thereby make it easier for Exchange, Incorporated (the ‘‘Exchange’’ must be entered in its entirety on one brokers to ensure that their Large or ‘‘CBOE’’) filed with the Securities system so that the Exchange can clearly Customer Orders qualify for the and Exchange Commission (the identify the total size of the order.4 Discount. ‘‘Commission’’) the proposed rule There is a minor contradiction in the The proposed change is to take effect change as described in Items I, II, and wording in regards to the entry of a on November 1, 2011. III below, which Items have been customer order large enough to qualify 2. Statutory Basis prepared by the Exchange. The for the Discount (a ‘‘Large Customer Commission is publishing this notice to Order’’) entered into a front end system, The proposed rule change is solicit comments on the proposed rule which may be a non-CBOE system (a consistent with Section 6(b) of the Act,6 change from interested persons. system used by a broker) that is used to in general, and furthers the objectives of 7 I. Self-Regulatory Organization’s enter orders. Under the current Section 6(b)(5) of the Act in particular, Statement of the Terms of Substance of language, the entire order quantity must in that it is designed to remove the Proposed Rule Change be tied to a single order ID within the impediments to and perfect the front end system used to transmit the mechanism of a free and open market The Exchange proposes to amend its order. However, in the parenthetical and a national market system, and, in Customer Large Trade Discount. The that follows, the language states that the general, to protect investors and the text of the proposed rule change is order must be entered in its entirety on public interest. By clarifying the process available on the Exchange’s Web site one system; it does not state that the for the qualification of Large Customer (http://www.cboe.org/legal), at the order has to be transmitted from that Orders for the Discount and eliminating Exchange’s Office of the Secretary, and system. It has come to the Exchange’s a contradiction in the Fees Schedule at the Commission. attention that some brokers receive language regarding such process, the II. Self-Regulatory Organization’s Large Customer Orders from customers proposed rule change eliminates Statement of the Purpose of, and and enter those Large Customer Orders confusion, thereby removing an Statutory Basis for, the Proposed Rule into their front end systems, but then impediment to and perfecting the Change telephone or otherwise transmit those mechanism of a free and open market orders to the CBOE trading floor. This system. The clarification of this process In its filing with the Commission, the process would qualify the Large will also make it easier for CBOE to self-regulatory organization included Customer Order for the Discount under administer the Discount and ensure that statements concerning the purpose of the parenthetical (since the Large it is appropriately assessed when it is and basis for the proposed rule change Customer Order is entered in its entirety applicable. and discussed any comments it received into the front end system), but on the proposed rule change. The text B. Self-Regulatory Organization’s technically would not qualify the Large of those statements may be examined at Statement on Burden on Competition Customer Order for the Discount under the places specified in Item IV below. the previous sentence, since it is the CBOE does not believe that the The Exchange has prepared summaries, telephone call, and not the front end proposed rule change will impose any set forth in sections A, B, and C below, burden on competition not necessary or 3 See Securities Exchange Act Release No. 65491 19 17 CFR 200.30–3(a)(12). (October 6, 2011), 76 FR 63680 (October 13, 2011) 5 See Note 4. 1 15 U.S.C. 78s(b)(1). (SR–CBOE–2011–093). 6 15 U.S.C. 78f(b). 2 17 CFR 240.19b–4. 4 See Exchange Fees Schedule, Section 18. 7 15 U.S.C. 78f(b)(5).

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appropriate in furtherance of the amendments, all written statements I. Self-Regulatory Organization’s purposes of the Act. with respect to the proposed rule Statement of the Terms of Substance of change that are filed with the the Proposed Rule Change C. Self-Regulatory Organization’s Commission, and all written Statement on Comments on the communications relating to the The Exchange, pursuant to Section Proposed Rule Change Received From 3 proposed rule change between the 19(b)(1) of the Act and Rule 19b–4 Members, Participants or Others 4 Commission and any person, other than thereunder, proposes to modify No written comments were solicited those that may be withheld from the Exchange Rule 7034 entitled ‘‘Co- or received with respect to the proposed public in accordance with the Location Services’’ to establish a rule change. provisions of 5 U.S.C. 552, will be program for offering low latency network connections and to establish III. Date of Effectiveness of the available for Web site viewing and the initial fees for such connections. Proposed Rule Change and Timing for printing in the Commission’s Public The Exchange also proposes Commission Action Reference Room, 100 F Street NE., Washington, DC 20549, on official administrative modifications to The proposed rule change is business days between the hours of Exchange Rule 7034. designated by the Exchange as 10:00 a.m. and 3:00 p.m. Copies of such The text of the proposed rule change establishing or changing a due, fee, or filing will also be available for is available on the Exchange’s Web site other charge, thereby qualifying for inspection and copying at the principal at http:// effectiveness on filing pursuant to office of the Exchange. All comments www.nasdaq.cchwallstreet.com, at the Section 19(b)(3)(A) of the Act 8 and received will be posted without change; principal office of the Exchange, on the subparagraph (f)(2) of Rule 19b–4 9 the Commission does not edit personal Commission’s Web site at http:// thereunder. At any time within 60 days identifying information from www.sec.gov, and at the Commission’s of the filing of the proposed rule change, submissions. You should submit only Public Reference Room. the Commission summarily may information that you wish to make temporarily suspend such rule change if available publicly. All submissions II. Self-Regulatory Organization’s it appears to the Commission that such should refer to File No. SR–CBOE– Statement of the Purpose of, and action is necessary or appropriate in the 2011–103 and should be submitted on Statutory Basis for, the Proposed Rule public interest, for the protection of or before December 1, 2011. Change investors, or otherwise in furtherance of the purposes of the Act. For the Commission, by the Division of In its filing with the Commission, the Trading and Markets, pursuant to delegated Exchange included statements authority.10 IV. Solicitation of Comments concerning the purpose of and basis for Interested persons are invited to Kevin M. O’Neill, the proposed rule change and discussed submit written data, views and Deputy Secretary. any comments it received on the arguments concerning the foregoing, [FR Doc. 2011–29111 Filed 11–9–11; 8:45 am] proposed rule change. The text of these including whether the proposed rule BILLING CODE 8011–01–P statements may be examined at the change is consistent with the Act. places specified in Item IV below. The Comments may be submitted by any of Exchange has prepared summaries, set the following methods: SECURITIES AND EXCHANGE forth in sections A, B, and C below, of COMMISSION Electronic Comments the most significant aspects of such statements. • [Release No. 34–65688; File No. SR– Use the Commission’s Internet NASDAQ–2011–146] comment form (http://www.sec.gov/ A. Self-Regulatory Organization’s rules/sro.shtml); or Self-Regulatory Organizations; The Statement of the Purpose of, and • Send an email to rule- NASDAQ Stock Market LLC; Notice of Statutory Basis for, the Proposed Rule [email protected]. Please include File Filing of Proposed Rule Change To Change Number SR–CBOE–2011–103 on the Modify Rule 7034 Regarding Low 1. Purpose subject line. Latency Network Connections Low Latency Network Connection Paper Comments November 4, 2011. Option • Send paper comments in triplicate Pursuant to Section 19(b)(1) of the to Elizabeth M. Murphy, Secretary, Securities Exchange Act of 1934 The purpose of the proposed rule Securities and Exchange Commission, (‘‘Act’’),1 and Rule 19b–4 2 thereunder, change is to modify Exchange Rule 100 F Street NE., Washington, DC notice is hereby given that on October 7034, which governs the Exchange’s 20549–1090. 31, 2011, The NASDAQ Stock Market program for co-location services, to offer All submissions should refer to File LLC (‘‘NASDAQ’’ or ‘‘Exchange’’) filed new options for low latency network Number SR–CBOE–2011–103. This file with the Securities and Exchange telecommunication connections and to number should be included on the Commission (‘‘SEC’’ or ‘‘Commission’’) establish the initial fees for such subject line if email is used. To help the the proposed rule change as described connections. As its initial offering, the Commission process and review your in Items I, II, and III, below, which Items Exchange proposes to offer point-to- comments more efficiently, please use have been prepared by the Exchange. point telecommunication connectivity only one method. The Commission will The Commission is publishing this from the co-location facility to select post all comments on the Commission’s notice to solicit comments on the major financial trading and co-location Internet Web site (http://www.sec.gov/ proposed rule change from interested venues in the New York and New Jersey rules/sro/shtml). Copies of the persons. metropolitan areas, Toronto, and submission, all subsequent Chicago. 10 17 CFR 200.30–3(a)(12). 8 15 U.S.C. 78s(b)(3)(A). 1 15 U.S.C. 78s(b)(1). 3 15 U.S.C. 78s(b)(1). 9 17 CFR 240.19b–4(f)(2). 2 17 CFR 240.19b–4. 4 17 CFR 240.19b–4.

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Background equipment in the Exchange’s data telecommunication connectivity to Currently the Exchange provides a center, one carrier has, to date, agreed select New York and New Jersey cross connect from a client’s cabinet to to offer connections under the program metropolitan area financial trading and its requested telecommunication and others are in negotiations with the co-location venues, which includes fiber carrier’s cabinet (known as a ‘‘telco Exchange; additional carriers are telecommunication cross connects cross connect’’). Through the enhanced eligible to join the program upon within the NASDAQ OMX data center, point-to-point connectivity service, meeting the same terms and conditions. along with a per-month connectivity fee clients will now have the option to Under the program, co-located of $5,000; (4) a one-time fee of $5,150 receive low latency network customers will have the opportunity to for the installation of 100 MB of connectivity from the Exchange’s data request these new low latency network telecommunication connectivity to center to the client’s chosen venue(s), in telecommunication connections through select Toronto area financial trading and addition to the telco cross connect. the same process used to request a new co-location venues, which includes fiber These connections can be utilized to co-located cabinet and other co-location telecommunication cross connects send market data to and receive orders services, with no need for direct fee within the NASDAQ OMX data center, from the chosen venues. negotiations or new service agreements along with a per-month connectivity fee The enhanced point-to-point with telecommunication carriers. The of $4,350; (5) a one-time fee of $8,200 connectivity provides the Exchange’s co-located customer will choose the for the installation of 1G of co-location customers the opportunity connection destination,7 but the telecommunication connectivity to to obtain low latency network elimination of direct negotiations and select Toronto area financial trading and connectivity with greater ease than is separate service agreements with the co-location venues, which includes fiber currently the case, and at a competitive telecommunications provider for these telecommunication cross connects price. Currently, co-location customers services will allow them to obtain a within the NASDAQ OMX data center, obtain similar services by negotiating similar service at a competitive price along with a per-month connectivity fee fees, obtaining service level agreements, and with greater ease of of $10,450; (6) a one-time fee of $15,150 and executing service agreements implementation. In addition, the for the installation of 10G of directly with approved proposed low latency network telecommunication connectivity to telecommunication carriers. A co- connectivity fees include cross select Toronto area financial trading and located customer is currently charged a connections and eliminate a separate fee co-location venues, which includes fiber monthly negotiated fee by the for that service. telecommunication cross connects telecommunications carrier in addition The Exchange is making the low within the NASDAQ OMX data center, to a cross connection fee by the latency network telecommunication along with a per-month connectivity fee Exchange. There are currently 16 connections available as a convenience of $32,400; (7) a one-time fee of $4,850 approved telecommunication carriers to customers and notes that receipt of for the installation of 100 MB of with equipment in the Exchange’s data these connections is completely telecommunication connectivity to center, with additional carriers added at voluntary. Customers retain the option select Chicago area financial trading and the request of a client. In order to of contracting directly with co-location venues, which includes fiber provide the new connectivity option telecommunication providers, including telecommunication cross connects described in this proposed rule change, either the provider(s) that participate in within the NASDAQ OMX data center, the Exchange established a low-latency the program, the current providers in along with a per-month connectivity fee minimum standard,5 approached those the data center who have not yet agreed of $8,350; (8) a one-time fee of $5,900 telecommunications carriers with low to participate, or any new carrier that is for the installation of 1G of latency connections to select major approved to install equipment in the telecommunication connectivity to financial trading and co-location venues Exchange’s data center. select Chicago area financial trading and in the New York and New Jersey Low Latency Pricing Structure co-location venues, which includes fiber metropolitan areas, Toronto, and telecommunication cross connects Chicago that met the low-latency The Exchange proposes: (1) A one- within the NASDAQ OMX data center, minimum standard,6 and invited them time fee of $1,165 for the installation of along with a per-month connectivity fee to agree to discounted rates. In effect, 100 MB of telecommunication of $16,400; and (9) a one-time fee of the Exchange is obtaining wholesale connectivity to select New York and $12,050 for the installation of 10G of rates from the carriers and then charging New Jersey metropolitan area financial telecommunication connectivity to a markup to compensate it for its efforts trading and co-location venues, which select Chicago area financial trading and to negotiate and establish the includes fiber telecommunication cross co-location venues, which includes fiber arrangement and integrate the connects within the NASDAQ OMX telecommunication cross connects connectivity into the Exchange co- data center, along with a per-month within the NASDAQ OMX data center, location connectivity offering, as well as connectivity fee of $1,650; (2) a one- along with a per-month connectivity fee administrative costs associated with time fee of $2,150 for the installation of of $39,750. establishing and maintaining each new 1G of telecommunication connectivity The fees are based on anticipated connection. Of the 16 approved to select New York and New Jersey bandwidth necessary for the telecommunication carriers with metropolitan area financial trading and connections and distances to these co-location venues, which includes fiber select venues. Furthermore, the 5 The low-latency minimum standard is less than telecommunication cross connects Exchange believes the fees are or equal to 0.41 milliseconds for New York/New within the NASDAQ OMX data center, reasonable as they are similar and Jersey routes, less than or equal to 10.1 milliseconds along with a per-month connectivity fee for Toronto routes, and less than or equal to 17 competitive with fees charged for of $2,150; (3) a one-time fee of $5,000 8 milliseconds for Chicago routes. This standard will similar services by other entities. change as the technology improves and the latency for the installation of 10G of is further reduced. 8 See http://www.cmegroup.com/globex/files/ 6 The Exchange selected these locations because 7 As additional providers join the program, CMEGlobexConnectionAgrmt.pdf; http:// of the high numbers of member firms and/or customers will also have the opportunity to choose nysetechnologies.nyx.com/global-connectivity/sfti- liquidity venues located there. from among these providers. americas/sfti-ip-americas; http://

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Elimination of Obsolete Rule Language include a markup to allow the Exchange telecommunications providers that seek Concerning Waiver of Fees to cover its administrative costs and to to offer connections between market The Exchange also proposes to earn a profit on its provision of the participants and the Exchange’s data eliminate references to certain fee service. The Exchange believes that it is center. As discussed above, the waivers that expired July 31, 2011.9 reasonable to use fees assessed on this Exchange does not discriminate among Since the fee waivers expired, such basis as a means to recoup NASDAQ’s telecommunication providers, but rather language is no longer necessary. share of the costs associated with the allows providers to access the data proposed low latency network center upon request of a market 2. Statutory Basis telecommunication connections, participant. As a result, 16 providers are The Exchange believes that its provide a convenience for the currently connected. Likewise, the proposal is consistent with Section 6(b) customers, and to the extent the costs Exchange does not discriminate among of the Act 10 in general, and Sections are covered, provide the Exchange a providers with respect to eligibility to 6(b)(4) and (b)(5) of the Act 11 in profit. The Exchange further believes offer connectivity through the Exchange particular, in that it provides for the that the proposed fees are reasonable in under the service proposed in this equitable allocation of reasonable dues, light of the costs associated with the filing, provided the latency, fees and other charges among members service and the fees charged by other destinations, and fees offered by the and issuers and other persons using any trading venues for comparable provider are consistent with the 12 facility or system which the Exchange services. minimum standards established by the operates or controls, and is designed to The proposed co-location services are Exchange. Thus, telecommunications entirely voluntary and available to all promote just and equitable principles of providers can choose to participate in members, with uniform fees charged to trade, to remove impediments to and the program, or can choose to service all market participants that opt to obtain perfect the mechanism of a free and market participants exclusively through connectivity through the Exchange. open market and a national market direct negotiations with customers. The Moreover, market participants may system, and, in general to protect Exchange’s approach is consistent with choose to obtain services through the investors and the public interest. The its own economic incentives to facilitate Exchange, or may choose to negotiate as many market participants as possible proposal is designed to provide a their own connectivity with 16 different in connecting to its market. Burdening method of connectivity between the providers. Accordingly, the Exchange’s competition among telecommunications Exchange’s co-location facility and proposed fees are non-discriminatory, providers would be antithetical to the various remote locations. Currently, and equitably allocated to market Exchange’s own competitive interests, market participants obtain such participants that choose to avail since impaired competition would make connections by negotiating directly with themselves of the Exchange’s services, it more expensive and more difficult for telecommunication providers. Through rather than obtaining comparable market participants to send order flow its efforts to negotiate standard services directly. to the Exchange. wholesale rates with providers, the The Exchange expects that the result B. Self-Regulatory Organization’s Exchange seeks to offer market of the proposal will be a reduction in Statement on Burden on Competition participants an opportunity to obtain fees charged to market participants, the the same connectivity service at a The Exchange does not believe that very essence of competition. To the potentially lower cost and with greater the proposed rule change will impose extent that fees under the program are ease of implementation. The Exchange any burden on competition not less expensive than the rates currently believes that this change will be necessary or appropriate in furtherance paid by many market participants, the unambiguously beneficial to market of the purposes of the Act. First, welfare of these market participants will participants, who will retain all current competition between the Exchange and increase, and other telecommunications options for obtaining connectivity competing trading venues will be providers will be incentivized to lower through direct negotiations with enhanced by allowing the Exchange to their own rates. This will, in turn, telecommunications providers, while offer its market participants facilitate the introduction of greater also receiving a new option for connectivity to its data center at a volumes of order flow to the Exchange. obtaining the service through the potentially lower price, and with greater Exchange’s program. ease. As noted above, NYSE already C. Self-Regulatory Organization’s The proposed fees for the service offers comparable services, at Statement on Comments on the cover the costs charged to the Exchange comparable fees, to its market Proposed Rule Change Received From by telecommunication provider(s). The participants. Accordingly, the proposal Members, Participants, or Others fees charged to the Exchange are based will allow the Exchange to enhance its No written comments were either on anticipated bandwidth necessary for competitive standing vis-a`-vis other solicited or received. the connections and distances to the trading venues. Conversely, any delay in III. Date of Effectiveness of the available locations covered by the the effectiveness of the proposed rule Proposed Rule Change and Timing for service (New York/New Jersey, Chicago, change would burden competition by Commission Action and Toronto). The proposed fees also preventing the Exchange from mounting a response to a primary competitor. Within 45 days of the date of nysetechnologies.nyx.com/sites/ Second, competition among market publication of this notice in the Federal technologies.nyx.com/files/ Register or within such longer period (i) SFTI_Americas_Market_Connectivity.pdf; http:// participants will be supported by nysetechnologies.nyx.com/global-connectivity/sfti- allowing small and large participants to as the Commission may designate up to americas. pay a lower price for data center 90 days of such date if it finds such 9 See Securities Exchange Act Release No. 64630 connectivity. longer period to be appropriate and (June 8, 2011), 76 FR 34783 (June 14, 2011) (SR– The Exchange believes that the publishes its reasons for so finding or NASDAQ–2011–074); and Securities Exchange Act Release No. 64858 (July 12, 2011), 76 FR 42152 proposed rule change will likewise (ii) as to which the Exchange consents, (July 18, 2011) (SR–NASDAQ–2011–094). enhance competition among the Commission shall: (a) By order 10 15 U.S.C. 78f(b). approve or disapprove such proposed 11 15 U.S.C. 78f(b)(4) and (5). 12 See supra n. 8. rule change, or (b) institute proceedings

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to determine whether the proposed rule For the Commission, by the Division of the places specified in Item IV below. change should be disapproved. Trading and Markets, pursuant to delegated The self-regulatory organization has authority.13 prepared summaries, set forth in IV. Solicitation of Comments Kevin M. O’Neill, sections A, B and C below, of the most Interested persons are invited to Deputy Secretary. significant aspects of such statements. [FR Doc. 2011–29109 Filed 11–9–11; 8:45 am] submit written data, views, and A. Self-Regulatory Organization’s arguments concerning the foregoing, BILLING CODE 8011–01–P Statement of the Purpose of, and including whether the proposed rule Statutory Basis for, the Proposed Rule change is consistent with the Act. Change Comments may be submitted by any of SECURITIES AND EXCHANGE the following methods: COMMISSION Purpose Electronic Comments [Release No. 34–65685; File No. SR–EDGA– The Exchange proposes to increase its 2011–36] charge for customer internalization on • Use the Commission’s Internet Flag 5 from $0.0001 per share, per side, comment form (http://www.sec.gov/ Self-Regulatory Organizations; EDGA to $0.00015 per share per side, to move rules/sro.shtml); or Exchange, Inc.; Notice of Filing and in lockstep with the proposed maker/ • Immediate Effectiveness of Proposed taker fee spread of $0.0003, which was Send an email to rule- Rule Change Relating to Amendments [email protected]. Please include File implemented in the October 1, 2011 fee to the EDGA Exchange, Inc. Fee schedule, where the Exchange Number SR–NASDAQ–2011–146 on the Schedule subject line. decreased its rebate from $0.0005 per share to $0.0004 per share for adding Paper Comments November 4, 2011. Pursuant to Section 19(b)(1) of the liquidity and increased its charge from $0.0006 per share to $0.0007 per share • Send paper comments in triplicate Securities Exchange Act of 1934 (the for removing liquidity. The increase in to Elizabeth M. Murphy, Secretary, ‘‘Act’’),1 and Rule 19b–4 thereunder,2 the charge for Flag 5 corresponds to the Securities and Exchange Commission, notice is hereby given that on October Exchange’s increase in its charge for 100 F Street NE., Washington, DC 31, 2011, the EDGA Exchange, Inc. (the customer internalization in Flag E from 20549–1090. ‘‘Exchange’’ or the ‘‘EDGA’’) filed with $0.0001 per share, per side (prior to the Securities and Exchange All submissions should refer to File October 1, 2011) to $0.00015 per share Commission (‘‘Commission’’) the Number SR–NASDAQ–2011–146. This per side on October 1, 2011. proposed rule change as described in file number should be included on the The Exchange proposes to add a new Items I, II, and III below, which items subject line if email is used. To help the tier that provides if a Member, on a have been prepared by the self- Commission process and review your daily basis, measured monthly, posts regulatory organization. The comments more efficiently, please use more than 0.25% of the Total Commission is publishing this notice to only one method. The Commission will Consolidated Volume 4 (‘‘TCV’’) in solicit comments on the proposed rule post all comments on the Commission’s average daily volume and removes more change from interested persons. Internet Web site (http://www.sec.gov/ than 0.25% of TCV in average daily rules/sro.shtml). Copies of the I. Self-Regulatory Organization’s volume, then the Member will receive a submission, all subsequent Statement of the Terms of Substance of rebate of $0.0005 per share. This amendments, all written statements the Proposed Rule Change amendment is reflected in the language in footnote 4 of the Exchange’s fee with respect to the proposed rule The Exchange proposes to amend its schedule. The new tier will also apply change that are filed with the fees and rebates applicable to Members 3 to Flags B, V, Y, 3 and 4, as these flags Commission, and all written of the Exchange pursuant to EDGA Rule communications relating to the have a footnote 4 appended to them. 15.1(a) and (c). All of the changes The Exchange also proposes to proposed rule change between the described herein are applicable to EDGA Commission and any person, other than decrease the charge assessed for a Members. The text of the proposed rule Directed Intermarket Sweep Order 5 those that may be withheld from the change is available on the Exchange’s public in accordance with the (‘‘Directed ISO’’) from $0.0033 per share Internet Web site at http:// to $0.0032 per share, which is reflected provisions of 5 U.S.C. 552, will be www.directedge.com. available for Web site viewing and in Flag S of the Exchange’s fee schedule. printing in the Commission’s Public II. Self-Regulatory Organization’s The Exchange proposes to implement Reference Room, 100 F Street NE., Statement of the Purpose of, and these amendments to its fee schedule on Washington, DC 20549, on official Statutory Basis for, the Proposed Rule November 1, 2011. business days between the hours of Change Basis 10 a.m. and 3 p.m. Copies of such filing In its filing with the Commission, the The Exchange believes that the also will be available for inspection and self-regulatory organization included proposed rule change is consistent with copying at the principal office of the statements concerning the purpose of, the objectives of Section 6 of the Exchange. All comments received will and basis for, the proposed rule change Exchange Act,6 in general, and furthers be posted without change; the and discussed any comments it received the objectives of Section 6(b)(4),7 in Commission does not edit personal on the proposed rule change. The text particular, as it is designed to provide identifying information from of these statements may be examined at submissions. You should submit only 4 TCV is defined as volume reported by all information that you wish to make 13 17 CFR 200.30–3(a)(12). exchanges and trade reporting facilities to the available publicly. All submissions 1 15 U.S.C. 78s(b)(1). consolidated transaction reporting plans for Tapes should refer to File Number SR– 2 17 CFR 240.19b–4. A, B and C securities for the month prior to the month in which the fees are calculated. NASDAQ–2011–146 and should be 3 A Member is any registered broker or dealer, or any person associated with a registered broker or 5 See Exchange Rule 11.5(d)(2). submitted on or before December 1, dealer, that has been admitted to membership in the 6 15 U.S.C. 78f. 2011. Exchange. 7 15 U.S.C. 78f(b)(4).

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for the equitable allocation of reasonable revenue to the Exchange, and would The Exchange believes that the dues, fees and other charges among its allow the Exchange to spread its proposed decrease in the rate for members and other persons using its administrative and infrastructure costs Directed ISOs from $0.0033 per share to facilities. over a greater number of shares, leading $0.0032 per share represents an The Exchange proposes to increase its to lower per share costs. These lower equitable allocation of reasonable dues, charge for customer internalization in per share costs would allow the fees, and other charges. The Exchange Flag 5 from $0.0001 per share, per side, Exchange to pass on the savings to believes that this decreased fee to to $0.00015 per share per side. This Members in the form of a rebate of Members would provide an incentive increase will enable the charge on Flag $0.0005 per share. The Exchange for Members to provide liquidity that believes that the proposed rebate is 5 to move in lockstep with the supports the quality of price discovery Exchange’s October 1, 2011 decrease in nondiscriminatory in that it applies and promotes market transparency. its rebate from $0.0005 per share to uniformly to all Members. Such increased volume also increases $0.0004 per share for adding liquidity Currently, there is a tier on EDGA’s potential revenue to the Exchange, and and increase in its charge from $0.0006 fee schedule that provides a rebate of to $0.0007 per share for removing $0.0005 per share where a Member, on would allow the Exchange to spread its liquidity. The latter amendments to the a daily basis, measured monthly, posts administrative and infrastructure costs Exchange’s fee schedule were designed more than 1% of the TCV in average over a greater number of shares, leading to allow the Exchange to compete with daily volume. Based on average TCV for to lower per share costs. These lower other market centers.8 In addition, the September 2011 (8.5 billion), in order to per share costs would allow the increase in the charge for Flag 5 a Member to qualify for a rebate of Exchange to pass on the savings to corresponds to the Exchange’s increase $0.0005 per share under this criteria, the Members in the form of a lower fee. The in its charge for customer Member would have to post 85 million fee is reasonable when compared to internalization in Flag E from $0.0001 shares. other market centers’ fees for Directed per share, per side, to $0.00015 per Another way to qualify for a rebate of ISOs, including, BATS that charges a fee share per side on its October 1, 2011, fee $0.0005 per share, as proposed in this of $0.0033 per share and NASDAQ that schedule. The increased revenue to the filing, would be for the Member, based charges a fee of $0.0035 per share for Exchange from the rate increase would on average TCV for September 2011 (8.5 routing Directed ISOs.10 The Exchange allow the Exchange to have additional billion), to add more than 22,000,000 believes that the proposed rate is non- revenue to offset administrative and shares and remove more than discriminatory in that it applies infrastructure costs. The Exchange 22,000,000 shares. The Exchange uniformly to all Members. believes that the proposed rate is non- believes that adding an additional way The Exchange also notes that it discriminatory in that it applies to qualify for the $0.0005 rebate per operates in a highly competitive market uniformly to all Members. share represents an equitable allocation The Exchange’s proposal to amend its of reasonable dues, fees, and other in which market participants can fee schedule to create a tier to provide charges since other exchanges offer readily direct order flow to competing an increased rebate of $0.0005 per share similar rebates for adding and removing venues if they deem fee levels at a if Members post more than 0.25% of the different amounts of liquidity based on particular venue to be excessive. The TCV in average daily volume and the inherent value of said activity to proposed rule change reflects a remove more than 0.25% of TCV in their exchange. Likewise, the Exchange competitive pricing structure designed average daily volume is designed to values Members that post more than to incent market participants to direct incentivize Members to both add and 0.25% of TCV in average daily volume their order flow to the Exchange. The remove liquidity from EDGA. and remove more than 0.25% of TCV in Exchange believes that the proposed The potential increase in volume from average daily volume similar to rates are equitable and non- the new tier benefits all investors by Members that post more than 1% of discriminatory in that they apply deepening EDGA’s liquidity pool, TCV in average daily volume. The uniformly to all Members. The supporting the quality of price Exchange believes that adding another Exchange believes the fees and credits discovery, promoting market means to qualify for the tiered rebate remain competitive with those charged transparency and improving investor incentivizes adders and removers of by other venues and therefore continue protection. Volume-based discounts liquidity as well as just adders of to be reasonable and equitably allocated liquidity and the practice of offering such as the rebate proposed herein have to Members. been widely adopted in the cash tiers to attract removers of liquidity to equities markets and provide discounts an exchange has become commonplace B. Self-Regulatory Organization’s that are reasonably related to the value throughout the equities markets.9 Statement on Burden on Competition to an exchange’s market quality associated with higher levels of market 9 See NASDAQ’s price list where NASDAQ offers The proposed rule change does not a rebate of $0.00295 per share for members adding impose any burden on competition that activity, such as higher levels of greater than 1.0% and adding and removing greater liquidity provision and introduction of than 200,000 total contracts on the NASDAQ is not necessary or appropriate in higher volumes of orders into the price Options Market, and NASDAQ offers a rebate of furtherance of the purposes of the Act. and volume discovery processes. Such $0.0029 per share for members adding greater than 0.15% and adding and removing greater than increased volume increases potential 115,000 total contracts on the NASDAQ Options Market. In addition, NASDAQ also offers a rebate 8 In its October 2011 fee filing, the Exchange of $0.0029 per share for members adding a liquidity for members who have an ADV equal to stated that the proposed maker/taker fee spread of minimum of 2 million shares per day and removing or greater than 1.0% of average TCV, where ADV $0.0002 or $0.0003, depending on if a tier is met greater than 0.65%. NASDAQ also offers a rebate of means average daily volume calculated as the (see footnote 4), was reasonable as the proposed $0.0025 per share for members that add a minimum number of shares added or removed, combined, per maker/taker spread was competitive with other of 2 million shares per day and remove greater than market centers maker/taker spreads (BATS BZX 0.45%. See also http://www.nasdaqtrader.com/ day on a monthly basis. See also http:// Exchange, 0–$0.0004 per share), Nasdaq OMX PSX Trader.aspx?id=PriceListTrading2. See also the www.batstrading.com/resources/regulation/ _ _ _ ($.0001–$.0003 per share), and Nasdaq BX BATS Exchange Fee schedule where BATS offers a rule book/BZX Fee Schedule.pdf. ($0.0001–$0.0013) per share). rebate of $0.0029 per share for adding displayed 10 Id.

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C. Self-Regulatory Organization’s communications relating to the I. Self-Regulatory Organization’s Statement on Comments on the proposed rule change between the Statement of the Terms of Substance of Proposed Rule Change Received From Commission and any person, other than the Proposed Rule Change Members, Participants or Others those that may be withheld from the The Exchange proposes to amend its The Exchange has not solicited, and public in accordance with the fees and rebates applicable to Members 3 does not intend to solicit, comments on provisions of 5 U.S.C. 552, will be of the Exchange pursuant to EDGX Rule this proposed rule change. The available for Web site viewing and 15.1(a) and (c). All of the changes Exchange has not received any printing in the Commission’s Public described herein are applicable to EDGX unsolicited written comments from Reference Room, 100 F Street NE., Members. The text of the proposed rule members or other interested parties. Washington, DC 20549, on official change is available on the Exchange’s Internet Web site at http:// III. Date of Effectiveness of the business days between the hours of 10 www.directedge.com. Proposed Rule Change and Timing for a.m. and 3 p.m. Copies of the filing also Commission Action will be available for inspection and II. Self-Regulatory Organization’s copying at the principal office of the The foregoing rule change has become Statement of the Purpose of, and Exchange. All comments received will Statutory Basis for, the Proposed Rule effective pursuant to Section 19(b)(3) of be posted without change; the the Act 11 and Rule 19b–4(f)(2) 12 Change Commission does not edit personal thereunder. At any time within 60 days In its filing with the Commission, the identifying information from of the filing of such proposed rule self-regulatory organization included change, the Commission summarily may submissions. You should submit only statements concerning the purpose of, temporarily suspend such rule change if information that you wish to make and basis for, the proposed rule change it appears to the Commission that such available publicly. All submissions and discussed any comments it received action is necessary or appropriate in the should refer to File Number SR–EDGA– on the proposed rule change. The text public interest, for the protection of 2011–36 and should be submitted on or of these statements may be examined at investors, or otherwise in furtherance of before December 1, 2011. the places specified in Item IV below. the purposes of the Act. For the Commission, by the Division of The self-regulatory organization has prepared summaries, set forth in IV. Solicitation of Comments Trading and Markets, pursuant to delegated authority.13 sections A, B and C below, of the most Interested persons are invited to Kevin M. O’Neill, significant aspects of such statements. submit written data, views, and arguments concerning the foregoing, Deputy Secretary. A. Self-Regulatory Organization’s including whether the proposed rule [FR Doc. 2011–29107 Filed 11–9–11; 8:45 am] Statement of the Purpose of, and change is consistent with the Act. BILLING CODE 8011–01–P Statutory Basis for, the Proposed Rule Comments may be submitted by any of Change the following methods: Purpose SECURITIES AND EXCHANGE Electronic Comments COMMISSION The Exchange proposes to decrease • the charge assessed for a Directed Use the Commission’s Internet 4 comment form (http://www.sec.gov/ Intermarket Sweep Order (‘‘Directed [Release No. 34–65683; File No. SR–EDGX– ISO’’) from $0.0033 per share to $0.0032 rules/sro.shtml); or 2011–34] • Send an email to rule- per share, which is reflected in Flag S [email protected]. Please include File of the Exchange’s fee schedule. Self-Regulatory Organizations; EDGX The Exchange proposes to correct an Number SR–EDGA–2011–36 on the Exchange, Inc.; Notice of Filing and subject line. administrative error by appending Immediate Effectiveness of Proposed footnote 1 to the H Flag on the Paper Comments Rule Change Relating to Amendments Exchange’s fee schedule. The H flag was • Send paper comments in triplicate to the EDGX Exchange, Inc. Fee added on October 1, 2011,5 and is to Elizabeth M. Murphy, Secretary, Schedule another flag that adds liquidity on EDGX. Currently, the flags that add Securities and Exchange Commission, November 4, 2011. 100 F Street NE., Washington, DC liquidity on EDGX and count towards 20549–1090. Pursuant to Section 19(b)(1) of the the tiers identified in footnote 1 are B, All submissions should refer to File Securities Exchange Act of 1934 (the V, Y, 3, 4, and MM. 1 2 The Exchange proposes to implement Number SR–EDGA–2011–36. This file ‘‘Act’’), and Rule 19b–4 thereunder, these amendments to its fee schedule on number should be included on the notice is hereby given that on October November 1, 2011. subject line if email is used. To help the 31, 2011, the EDGX Exchange, Inc. (the Commission process and review your ‘‘Exchange’’ or the ‘‘EDGX’’) filed with Basis the Securities and Exchange comments more efficiently, please use The Exchange believes that the only one method. The Commission will Commission (‘‘Commission’’) the proposed rule changes are consistent post all comments on the Commission’s proposed rule change as described in with the objectives of Section 6 of the Internet Web site (http://www.sec.gov/ Items I, II, and III below, which items Exchange Act,6 in general, and furthers rules/sro.shtml). Copies of the have been prepared by the self- submission, all subsequent regulatory organization. The 3 A Member is any registered broker or dealer, or amendments, all written statements Commission is publishing this notice to any person associated with a registered broker or with respect to the proposed rule solicit comments on the proposed rule dealer, that has been admitted to membership in the change that are filed with the change from interested persons. Exchange. 4 See Exchange Rule 11.5(d)(2). Commission, and all written 5 See Securities Exchange Act Release No. 65541 13 17 CFR 200.30–3(a)(12). (October 12, 2011), 76 FR 64409 (October 18, 2011) 11 15 U.S.C. 78s(b)(3)(A). 1 15 U.S.C. 78s(b)(1). (SR–EDGX–2011–31). 12 17 CFR 19b–4(f)(2). 2 17 CFR 240.19b–4. 6 15 U.S.C. 78f.

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the objectives of Section 6(b)(4),7 in as the ones proposed herein have been public interest, for the protection of particular, as it is designed to provide widely adopted in the cash equities investors, or otherwise in furtherance of for the equitable allocation of reasonable markets, and are equitable because they the purposes of the Act. dues, fees and other charges among its are open to all members on an equal IV. Solicitation of Comments members and other persons using its basis and provide discounts that are facilities. reasonably related to the value to an Interested persons are invited to The Exchange believes that the exchange’s market quality associated submit written data, views, and proposed decrease in the rate for with higher levels of market activity, arguments concerning the foregoing, Directed ISOs from $0.0033 per share to such as higher levels of liquidity including whether the proposed rule $0.0032 per share represents an provision and introduction of higher change is consistent with the Act. equitable allocation of reasonable dues, volumes of orders into the price and Comments may be submitted by any of fees, and other charges. The Exchange volume discovery processes. In the following methods: believes that this decreased fee to addition, by correcting this Members would provide an incentive administrative error, the Exchange adds Electronic Comments for Members to provide liquidity that additional transparency to its fee • Use the Commission’s Internet supports the quality of price discovery schedule for Members. comment form (http://www.sec.gov/ and promotes market transparency. The Exchange also notes that it rules/sro.shtml); or Such increased volume also increases operates in a highly competitive market • Send an email to rule- potential revenue to the Exchange, and in which market participants can [email protected]. Please include File would allow the Exchange to spread its readily direct order flow to competing Number SR–EDGX–2011–34 on the administrative and infrastructure costs venues if they deem fee levels at a subject line. over a greater number of shares, leading particular venue to be excessive. The to lower per share costs. These lower proposed rule change reflects a Paper Comments per share costs would allow the competitive pricing structure designed • Exchange to pass on the savings to to incent market participants to direct Send paper comments in triplicate Members in the form of a lower fee. The their order flow to the Exchange. The to Elizabeth M. Murphy, Secretary, fee is reasonable when compared to Exchange believes that the proposed Securities and Exchange Commission, other market centers’ fees for Directed rates are equitable and non- 100 F Street NE., Washington, DC ISOs, including, BATS that charges a fee discriminatory in that they apply 20549–1090. of $0.0033 per share and NASDAQ that uniformly to all Members. The All submissions should refer to File charges a fee of $0.0035 per share for Exchange believes the fees and credits Number SR–EDGX–2011–34. This file routing Directed ISOs.8 The Exchange remain competitive with those charged number should be included on the believes that the proposed rate is non- by other venues and therefore continue subject line if email is used. To help the discriminatory in that it applies to be reasonable and equitably allocated Commission process and review your uniformly to all Members. to Members. comments more efficiently, please use The Exchange proposes to correct an B. Self-Regulatory Organization’s only one method. The Commission will administrative error by appending Statement on Burden on Competition post all comments on the Commission’s footnote 1 to the H Flag on the Internet Web site (http://www.sec.gov/ Exchange’s fee schedule. The H flag was The proposed rule change does not rules/sro.shtml). Copies of the added on October 1, 2011, and is impose any burden on competition that submission, all subsequent another flag that adds liquidity on is not necessary or appropriate in amendments, all written statements EDGX and counts towards the tiers furtherance of the purposes of the Act. with respect to the proposed rule identified in footnote 1. The Exchange C. Self-Regulatory Organization’s change that are filed with the believes that providing discounts for Statement on Comments on the Commission, and all written adding liquidity to the Exchange would Proposed Rule Change Received From communications relating to the incent liquidity. In addition, such Members, Participants or Others proposed rule change between the increased volume increases potential Commission and any person, other than The Exchange has not solicited, and revenue to the Exchange, and would those that may be withheld from the does not intend to solicit, comments on allow the Exchange to spread its public in accordance with the this proposed rule change. The administrative and infrastructure costs provisions of 5 U.S.C. 552, will be Exchange has not received any over a greater number of shares, leading available for Web site viewing and unsolicited written comments from to lower per share costs. These lower printing in the Commission’s Public members or other interested parties. per share costs would allow the Reference Room, 100 F Street NE., Exchange to pass on the savings to III. Date of Effectiveness of the Washington, DC 20549, on official Members in the form of a higher rebate. Proposed Rule Change and Timing for business days between the hours of The increased liquidity also benefits all Commission Action 10 a.m. and 3 p.m. Copies of the filing investors by deepening EDGX’s liquidity The foregoing rule change has become also will be available for inspection and pool, offering additional flexibility for effective pursuant to Section 19(b)(3) of copying at the principal office of the all investors to enjoy cost savings, the Act 9 and Rule 19b–4(f)(2) 10 Exchange. All comments received will supporting the quality of price thereunder. At any time within 60 days be posted without change; the discovery, promoting market of the filing of such proposed rule Commission does not edit personal transparency and improving investor change, the Commission summarily may identifying information from protection. Volume-based rebates such temporarily suspend such rule change if submissions. You should submit only it appears to the Commission that such information that you wish to make 7 15 U.S.C. 78f(b)(4). action is necessary or appropriate in the available publicly. All submissions 8 See http://www.batstrading.com/resources/ should refer to File Number SR–EDGX– regulation/rule_book/BZX_FeeSchedule.pdf. See also http://www.nasdaqtrader.com/ 9 15 U.S.C. 78s(b)(3)(A). 2011–34 and should be submitted on or Trader.aspx?id=PriceListTrading2. 10 17 CFR 19b–4(f)(2). before December 1, 2011.

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For the Commission, by the Division of and (C) below, of the most significant qualify for portfolio margining Trading and Markets, pursuant to delegated aspects of these statements.3 treatment. ICC does not believe that the authority.11 fact that the portfolio margining element (A) Self-Regulatory Organization’s Kevin M. O’Neill, of the proposed Decomp Model will Statement of the Purpose of, and Deputy Secretary. apply only to a Clearing Participant’s Statutory Basis for, the Proposed Rule proprietary account raises an issue of [FR Doc. 2011–29105 Filed 11–9–11; 8:45 am] Change BILLING CODE 8011–01–P unfair discrimination. Importantly, the The enhancements effected by this portfolio margining aspect of the proposed rule change have been Decomp Model does not unfairly SECURITIES AND EXCHANGE reviewed and/or recommended by the discriminate with respect to similarly COMMISSION ICC Risk Working Group, ICC Risk situated participants because it is Committee, ICC Board of Managers, an available to any participant for whom [Release No. 34–65699; File No. SR–ICC– independent third-party risk expert 2011–03] ICC is currently able to provide portfolio (Finance Concepts), the Federal Reserve margin treatment. Again, ICC does not Self-Regulatory Organizations; ICE Bank of New York and the New York currently offer clearing in CDS Single Clear Credit LLC; Notice of Filing of State Banking Department. Names for customer-related Proposed Rule Change to Adopt ICC’s Implementation of these enhancements transactions. In the event that ICC Enhanced Margin Methodology (the to the ICC risk methodology will result makes CDS Single Name clearing ‘‘Decomp Model’’) in a better measurement of the risk available for customer-related associated with clearing CDS Indices. transactions and provided that the SEC November 7, 2011. A fundamental aspect of the Decomp and CFTC grant the requisite approval Pursuant to Section 19(b)(1) of the Model is the recognition that the CDS as discussed below, ICC will offer Securities Exchange Act of 1934 Indices cleared by ICC are essentially a portfolio margining with respect to (‘‘Act’’) 1 and Rule 19b–4 thereunder 2 composition of specific Single Name customer-related transactions. The notice is hereby given that on November CDS instruments. As a result of the proposed rule amendments are not 4, 2011, ICE Clear Credit LLC (‘‘ICC’’) decomposition of the CDS Indices, ICC designed to permit unfair filed with the Securities and Exchange will be able to (1) incorporate jump-to- discrimination among participants in Commission (‘‘Commission’’) the default risk as a component of the risk the use of ICC’s clearing services. ICC is proposed rule change as described in margin associated with CDS Indices and not discriminating among proprietary Items I, II, and III below, which Items (2) provide appropriate portfolio margin participants or among customers. have been prepared primarily by ICC. treatment between CDS Indices and Proprietary accounts are not subject to The Commission is publishing this offsetting CDS Single Name positions. the SEC’s customer protection rules and notice to solicit comments on the Incorporating jump-to-default risk as a thus are not subject to the same proposed rule change from interested component of the Decomp Model will restrictions that the SEC has imposed on persons. result in a better measurement of the customer accounts. Specifically, ICC risk associated with clearing CDS clears proprietary CDS Index and CDS I. Self-Regulatory Organization’s Indices. Single Name positions in the same Statement of the Terms of Substance of Recognizing the highly correlated commingled house account origin. the Proposed Rule Change relationship between long-short Whereas, as customer-related positions The ICC Decomp Model includes the positions in CDS Indices and the in CDS Indices and CDS Single Names following enhancements to the ICC underlying CDS Single Name must be maintained, as a matter of law, margin methodology for Credit Default constituents of the CDS Indices will in separate accounts. Thus, ICC is Swap (‘‘CDS’’) Indices: replacing provide for fundamental and unable to commingle and portfolio standard deviation with Mean Absolute appropriate portfolio margin treatment. margin customer-related CDS Index and deviation (‘‘MAD’’) as a measure of To date, ICC has not offered such CDS Single Name positions without the spread volatility, use of an auto fundamental and appropriate portfolio SEC’s and CFTC’s approval of ICC’s regressive process to obtain multi- treatment strictly for operational pending petitions. horizon risk measures, expansion of reasons. However, on or about On or about November 7, 2011, ICC spread response scenarios, introduction December 12, 2011, ICC will be formally filed with the SEC a petition to of liquidity requirements, and base operationally ready to offer such provide portfolio margining treatment concentration charges. portfolio margining treatment with for customer-related positions (the respect to its clearing participants’ ‘‘Customer-related Portfolio Margining II. Self-Regulatory Organization’s proprietary positions. Request’’) in anticipation of ICC offering Statement of the Purpose of, and As noted above, the proposed change clearing of CDS Single Names for Statutory Basis for, the Proposed Rule in the ICC margin methodology will customer-related transactions in the Change provide appropriate portfolio margining future. The Customer-related Portfolio In its filing with the Commission, ICC treatment only with respect to ICC Margining Request is posted on the ICC included statements concerning the clearing participants’ proprietary Web site and will be posted on the purpose of and basis for the proposed positions. The portfolio margining SEC’s Web site.4 In short, the Customer- rule change and discussed any treatment will only be available to ICC related Portfolio Margining Request, if comments it received on the proposed clearing participants’ proprietary granted by the SEC, would provide all rule change. The text of these statements positions because ICC does not customers with the same portfolio may be examined at the places specified currently clear CDS Single Names for margining treatment that is being in Item IV below. ICC has prepared customer-related transactions. summaries, set forth in sections (A), (B), Accordingly, currently, there are no 4 Available at: https://www.theice.com/ publicdocs/globalmarketfacts/docs/ customer-related positions that would legislativecomments/ICC_Commingling_ 11 17 CFR 200.30–3(a)(12). PortfolioMargining_Petitions.pdf. The petition also 1 15 U.S.C. 78s(b)(1). 3 The Commission has modified the text of the will be available on the Commission’s public Web 2 17 CFR 240.19b–4. summaries prepared by ICC. site at: http://www.sec.gov/rules/petitions.shtml.

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proposed in this submission for the rules/sro.shtml) or Send an email to SECURITIES AND EXCHANGE proprietary accounts. However, in order [email protected]. Please include COMMISSION to obtain portfolio margining treatment File Number SR–ICC–2011–03 on the for customers, ICC was required to file subject line. [Release No. 34–65679, File No. SR–MSRB– the separate Customer-related Portfolio 2011–17] Paper Comments Margining Request. Although the SEC Self-Regulatory Organizations; has not published ICC’s Customer- Send paper comments in triplicate to Municipal Securities Rulemaking related Portfolio Margining Request for Elizabeth M. Murphy, Secretary, Board; Order Granting Approval of public comment, the SEC is interested Securities and Exchange Commission, Proposed Rule Change Regarding in receiving comments from the public. Professional Qualifications and ICC believes that the proposed rule 100 F Street NE., Washington, DC 20549–1090. Information Concerning Associated change will facilitate the prompt and Persons accurate settlement of security-based All submissions should refer to File swaps and contribute to the Number SR–ICC–2011–03. This file November 3, 2011. safeguarding of securities and funds number should be included on the I. Introduction associated with security-based swap subject line if email is used. To help the transactions. As discussed above, ICC Commission process and review your On September 13, 2011, the does not believe that the portfolio comments more efficiently, please use Municipal Securities Rulemaking Board margining-related proposed changes only one method. The Commission will (‘‘MSRB’’ or ‘‘Board’’), filed with the Securities and Exchange Commission raise an issue of unfair discrimination in post all comments on the Commission’s the use of ICC’s clearing services by (‘‘Commission’’), pursuant to Section Internet Web site (http://www.sec.gov/ similarly situated participants. 19(b)(1) of the Securities Exchange Act rules/sro.shtml). Copies of the of 1934 (‘‘Exchange Act’’),1 and Rule (B) Self-Regulatory Organization’s submission, all subsequent 19b–4 thereunder,2 a proposed rule Statement on Burden on Competition amendments, all written statements change consisting of amendments to ICC does not believe the proposed with respect to the proposed rule Rule G–3, on professional qualifications, rule change would have any impact, or change that are filed with the and Rule G–7, on information impose any burden, on competition. Commission, and all written concerning associated persons. The communications relating to the proposed rule change was published for (C) Self-Regulatory Organization’s proposed rule change between the Statement on Comments on the comment in the Federal Register on Commission and any person, other than 3 Proposed Rule Change Received from September 30, 2011. The Commission those that may be withheld from the Members, Participants or Others received one comment letter regarding public in accordance with the the proposed rule change and the Written comments relating to the provisions of 5 U.S.C. 552, will be MSRB’s response to that comment proposed rule change have not been available for Web site viewing and letter.4 solicited or received. ICC will notify the printing in the Commission’s Public This order approves the proposed rule Commission of any written comments Reference Section, 100 F Street NE., change. received by ICC. Washington, DC 20549, on official II. Background and Description of III. Date of Effectiveness of the business days between the hours of Proposal Proposed Rule Change and Timing for 10 a.m. and 3 p.m. Copies of such filings Commission Action will also be available for inspection and MSRB Rule G–3(a)(i) defines a copying at the principal office of ICC municipal securities representative as a Within 45 days of the date of natural person associated with a broker, and on ICC’s Web site at https://www. publication of this notice in the Federal dealer or municipal securities dealer theice.com/publicdocs/regulatory_ Register or within such longer period (‘‘dealer’’), other than a person whose filings/ICEClearCredit_110411.pdf. up to 90 days (i) as the Commission may functions are solely clerical or designate if it finds such longer period All comments received will be posted ministerial, whose activities include one to be appropriate and publishes its without change; the Commission does or more of the following: reasons for so finding or (ii) as to which not edit personal identifying 1. Underwriting, trading or sales of the self-regulatory organization information from submissions. You municipal securities; consents, the Commission will: should submit only information that 2. Financial advisory or consultant (A) By order approve or disapprove you wish to make available publicly. All services for issuers in connection with the proposed rule change or submissions should refer to File the issuance of municipal securities; (B) Institute proceedings to determine Number SR–ICC–2011–03 and should 3. Research or investment advice with whether the proposed rule change be submitted on or before December 1, respect to municipal securities; or should be disapproved. 2011. 4. Any other activities that involve IV. Solicitation of Comments communication, directly or indirectly, For the Commission, by the Division of with public investors in municipal Interested persons are invited to Trading and Markets, pursuant to delegated securities provided, however, that the submit written data, views, and authority.5 arguments concerning the foregoing, Kevin M. O’Neill, 1 15 U.S.C. 78s(b)(1). including whether the proposed rule Deputy Secretary. 2 17 CFR 240.19b–4. change is consistent with the Act. 3 [FR Doc. 2011–29163 Filed 11–9–11; 8:45 am] See Securities Exchange Act Release No. 65393 Comments may be submitted by any of (September 26, 2011), 76 FR 60953 (the the following methods: BILLING CODE P ‘‘Commission’s Notice’’). 4 See letter from Marian H. Desilets, President, Electronic Comments Association of Registration Management, Inc., dated • October 7, 2011, and letter from Margaret C. Henry, Use the Commission’s Internet General Counsel, Market Regulation, MSRB, dated comment form (http://www.sec.gov/ 5 17 CFR 200.30–3(a)(12). October 28, 2011.

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activities enumerated in 3 and 4 above limited exclusively to sales activities. comply with ongoing registration are limited to such activities as they The proposed rule change would requirements. The commenter further relate to the activities enumerated in 1 provide that an individual could qualify stated that this protocol of individual and 2 above. as a municipal securities sales limited exams is making it difficult for An individual seeking to become representative by passage of the Series registered persons to fully and easily qualified as a municipal securities 7 examination. Other individuals would understand what is required at all times representative must pass either of two be required to pass the Series 52 to ensure and remain compliant. qualification examinations—the examination in order to qualify as full The MSRB responded that the Municipal Securities Representative municipal securities representatives, commenter’s letter mistakenly states Qualification Examination (Series 52) or unless they had passed the Series 7 that the MSRB’s Series 52 and 53 the General Securities Registered examination prior to the effective date examinations were among those new Representative Examination (Series 7). of the proposed rule change and had examinations and that comments of that On September 7, 2011, FINRA filed maintained this registration. nature are more appropriately addressed with the Commission a proposed rule The proposed rule change would also to the Commission or FINRA. The change to restructure the Series 7 require a municipal securities limited MSRB stated that it only took action examination to focus on a broader range representative who wished to become a with respect to the Series 7 qualification of securities products available for sale municipal securities principal to pass because of FINRA’s decision to change by registered representatives. The effect the Series 52 examination prior to the focus of the exam. of these changes would be a de- taking the Series 53 municipal securities The commenter further stated that the emphasis on non-sales aspects of the principal examination. Otherwise, the revised rule could potentially require activities of securities professionals. In proposed amendments to Rule G–3 larger firms to have many of its focusing on general principles would not distinguish between registered representatives obtain an applicable to the buying and selling of ‘‘municipal securities sales limited additional license to ensure continuity a broad range of securities, rather than representatives’’ and other ‘‘municipal and coverage across all business lines, specific products, the restructured securities representatives.’’ and that it is not clear if firms will be Series 7 examination would reduce the The MSRB also filed proposed required to apply for ‘‘MR position number of questions that test for amendments to MSRB Rule G–7, on codes’’ in order for their associated specific knowledge of municipal information concerning associated persons to be grandfathered. The MSRB securities and the rules of the MSRB. persons. Rule G–7 requires brokers, responded that a dealer need take no Given the shift in emphasis of the Series dealers and municipal securities dealers action in order for its associated persons 7 examination and the reduced number (‘‘dealers’’) to keep records concerning to be grandfathered. of municipal questions, in the view of their associated persons, including the The commenter also inquired whether the MSRB, passage of the Series 7 category of function they perform the MSRB will permit FINRA to examination would no longer represent ‘‘whether municipal securities grandfather additional associated a useful gauge of whether a securities principal, municipal securities sales persons who might have let their Series professional was qualified to perform principal, municipal securities 7 registrations lapse before November 7, municipal securities activities other representative or financial and 2011. The MSRB responded that the than sales to, and purchases from, operations principal.’’ The proposed proposal would not permit such customers 5 of municipal securities rule change would add ‘‘municipal additional grandfathering. (‘‘sales activities’’). securities sales limited representative’’ The commenter requested that the As a result of this restructured Series to that list.6 Additionally, the proposed effective date of the MSRB proposal be 7 examination, the MSRB filed the rule change would streamline Rule G– delayed until late first quarter of 2012 proposed rule change consisting of 7(b) by simply requiring that dealers at the earliest to allow firms to be able amendments to MSRB Rule G–3, on obtain either Form U4 (in the case of to adequately identify and prepare professional qualifications. The non-bank dealers) or Form MSD–4 (in (budget, staffing, etc.) for compliance as proposed rule change would provide the case of bank dealers), rather than well as allow member firms to meet that the Series 7 examination would no repeating the categories of information other already announced regulatory longer qualify individuals as required by those forms. obligations along with year-end renewal ‘‘municipal securities representatives,’’ process workloads and annual training unless they were engaged solely in sales III. Discussion of Comments and requirements. The commenter further activities or they passed the Series 7 MSRB’s Response requested consideration of the fact that examination prior to the effective date The Commission received one the industry had not been apprised of of the proposed rule change. Instead, comment letter from the Association of the change until nearly 45 days prior to passage of the Series 52 examination Registration Management, Inc. and a the proposed implementation, stating would be required for any municipal response from the MSRB to the that such timing will cause an securities activities other than sales comment letter.7 unnecessary hardship. activities. The commenter expressed concern The MSRB responded that it made the The proposed rule change would about the number of individual product decision to have the changes to Rule G– create a sub-category of municipal and regulation specific examinations 3 take effect at the same time as FINRA’s securities representative referred to as a proposed, introduced or reintroduced changes to the Series 7 examination and ‘‘municipal securities sales limited within the past 18 months, and stated that FINRA’s revised Series 7 will begin representative’’ and would apply to that these have caused considerable to be implemented on November 7, individuals whose activities with burden on the industry to effectively 2011. The MSRB further stated that at respect to municipal securities are implement standards within firms to that time, the number of municipal questions will be reduced, and those 5 ‘‘Customer’’ is defined in MSRB Rule D–9 as 6 The proposed rule change would also add questions will address only sales ‘‘any person other than a broker, dealer or ‘‘municipal fund securities limited principal’’ to activities. Accordingly, the MSRB stated municipal securities dealer acting in its capacity as this list to reflect the previous creation of this such or an issuer in transactions involving the sale separate category. that such examination would no longer by the issuer of a new issue of its securities.’’ 7 See supra note 4. assess an associated person’s ability to

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perform other municipal securities financial instruments, economic (5) Section 1308(a) of the Foreign activities in a competent manner, so no activity, government policy, factors Relations Authorization Act for FY delay in the effective date of the Rule G– affecting interest rates, and applicable 2003, Public Law 107–228; 3 changes is appropriate. Federal securities laws and regulations. (6) Determination and Congressional The Commission has carefully The proposed rule change will also Reporting Requirement Concerning considered the commenter’s concerns more closely align the information Israeli Participation in the IAEA about the MSRB’s proposed changes to dealers are required to obtain pursuant required by the Foreign Operations, the licensing requirements for to Rule G–7 with the information Export Financing, and Related Programs associated persons of brokers, dealers or already required by FINRA and the bank Appropriations Act, 2006, Title II of municipal securities dealers for regulators, thereby reducing the Public Law 109–102; and municipal securities activities other administrative burden on such dealers. (7) Certification consistent with than sales to customers, the scope of the section 2(7)(C)(i) of the resolution of V. Conclusion ‘‘grandfather’’ provisions, and the advice and consent to ratification of the effective date of the proposed rule It is therefore ordered, pursuant to Chemical Weapons Convention adopted change, and does not believe the Section 19(b)(2) of the Exchange Act,9 by the Senate on April 24, 1997, with proposed changes are inconsistent with that the proposed rule change (SR– respect to the effectiveness and viability the Exchange Act. MSRB–2011–17) be, and it hereby is, of the Australia Group. approved. Any act, executive order, regulation or IV. Discussion and Commission procedure subject to, or affected by this Findings For the Commission, by the Division of Trading and Markets, pursuant to delegated delegation shall be deemed to be such The Commission has carefully authority.10 act, executive order, regulation or considered the proposed rule change, Kevin M. O’Neill, procedure, as amended from time to the comment letter received, and the Deputy Secretary. time. MSRB’s response to the comment letter [FR Doc. 2011–29104 Filed 11–9–11; 8:45 am] Notwithstanding this delegation of and finds that the proposed rule change authority, the Secretary, the Deputy BILLING CODE 8011–01–P is consistent with the requirements of Secretary, or the Deputy Secretary for the Exchange Act and the rules and Management and Resources may at any regulations thereunder applicable to the time exercise any authority or function MSRB.8 The Commission believes that DEPARTMENT OF STATE delegated by this delegation or the proposed rule change is consistent authority. with the provisions of Section [Delegation of Authority: 304–1] This Delegation of authority 15B(b)(2)(A) of the Exchange Act, which supersedes Delegation of Authority 304, authorizes the MSRB to prescribe Delegation by the Secretary of State to dated February 16, 2006, and shall be ‘‘standards of training, experience, the Under Secretary of State for Arms published in the Federal Register. competence, and such other Control and International Security of Authority To Submit Certain Non- Dated: October 28, 2011. qualifications as the Board finds Hillary Rodham Clinton, necessary or appropriate in the public Proliferation Reports to Congress Secretary of State. interest or for the protection of investors By virtue of the authority vested in and municipal entities or obligated [FR Doc. 2011–29154 Filed 11–9–11; 8:45 am] me as the Secretary of State, including BILLING CODE 4710–27–P persons.’’ Section 15B(b)(2)(A) of the Section 1 of the State Department Basic Exchange Act also provides that the Authorities Act, as amended (22 U.S.C. Board may appropriately classify 2651a), the authorities enumerated DEPARTMENT OF TRANSPORTATION municipal securities brokers, municipal below, and Executive Order 13346, I securities dealers, and municipal hereby delegate to the Under Secretary Office of the Secretary advisors and persons associated with for Arms Control and International municipal securities brokers, municipal Security, to the extent authorized by [Docket No. DOT–OST–2011–0129] securities dealers, and municipal law, the authority to approve Proposed Information Collection advisors and require persons in any submission of reports to Congress Request; Notice of New Requirements such class to pass tests prescribed by the pursuant to: and Procedures for Grant Payment Board. (1) Section 1344 of the Foreign Request Submission The proposed rule change is also Relations Authorization Act, Fiscal Year consistent with the provisions of 2003, Public Law 207–228; AGENCY: Department of Transportation Section 15B(b)(2)(A) of the Exchange (2) Section 2809(c)(2) of the Foreign (DOT). Act in that the proposed rule change Affairs Reform and Restructuring Act of will ensure that individuals seeking to ACTION: Notice with request for 1998, Public Law 105–277; comments. engage in more than sales activities will (3) Section 1343(a) of the Iran Nuclear be tested on their qualification and Proliferation Prevent Act of 2002 SUMMARY: The DOT invites the public competency to engage in such other (incorporated in the Foreign Relations and other Federal agencies to comment municipal securities activities. These Authorization Act, Fiscal Year 2003), on a proposed information collection individuals will be required to pass an Public Law 107–228; concerning new requirements and examination that includes questions (4) Section 204(c) of the International procedures for grant payment request both on municipal securities and the Emergency Economic Powers Act submission. DOT will submit the municipal markets and on U.S. (50 U.S.C. 1701 et seq.) and Section proposed information collection request government, Federal agency and other 401(c) of the National Emergencies Act to the Office of Management and Budget (50 U.S.C. 1601 et seq.); (OMB) for review, as required by the 8 In approving the proposed rule change, the Commission notes that it has considered the Paperwork Reduction Act of 1995 (PRA) proposed rule’s impact on efficiency, competition 9 15 U.S.C. 78s(b)(2). (44 U.S.C. 3506(c)(2)(A)). This notice and capital formation. 15 U.S.C. 78c (f). 10 17 CFR 200.30–3(a)(12). sets forth new requirements and

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procedures for grantees that submit and DOT OAs must process payment DEPARTMENT OF TRANSPORTATION receive payments from DOT Operating requests electronically. Administrations (OAs).1 DOT is • The identities of system users must Office of the Secretary updating systems that support grant be verified prior to receiving access to Notice of Applications for Certificates payments and there will be changes to the Delphi eInvoicing system. Users of Public Convenience and Necessity the way grantees complete and submit must complete a user request form and and Foreign Air Carrier Permits Filed payment requests. Simplifying the DOT provide the following information: Full Under Subpart B (Formerly Subpart Q) grant payment process will save both name, work address, work phone During the Week Ending October 22, the grantee and the Federal Government number, work email address, home 2011 time and expense that come with paper- address and home phone number. Once based grant application and payment completed, this form must be presented The following Applications for administration. Note: At this time, this to a Notary Public for verification. Once Certificates of Public Convenience and requirement is not applicable to DOT notarized, the prospective grantee user Necessity and Foreign Air Carrier grant recipients requesting payment will return the form to receive their Permits were filed under Subpart B electronically through the National login credentials. (formerly Subpart Q) of the Department Highway Traffic Safety Administration’s • DOT Office of Financial of Transportation’s Procedural Grant Tracking System (GTS), the Management officials may allow Regulations (See 14 CFR 301.201 et Federal Highway Administration’s exceptions to the requirement that seq.). The due date for Answers, Rapid Approval State Payment System grantees register and submit payment Conforming Applications, or Motions to (RASPS), or Federal Transit requests through the Delphi eInvoicing Modify Scope are set forth below for Administration (FTA) grant recipients system under limited circumstances. each application. Following the Answer requesting payment through the Recipients may apply for an exemption period DOT may process the application Electronic Clearing House Operation by submitting an electronic Waiver by expedited procedures. Such System (ECHO–Web). Request Form to the DOT Office of procedures may consist of the adoption DATES: Comments must be submitted on Financial Management. The exceptions of a show-cause order, a tentative order, or before January 9, 2012. will be considered on a case by case or in appropriate cases a final order FOR FURTHER INFORMATION CONTACT: basis via Waiver Request Form. without further proceedings. Requests for additional information Affected Public: DOT Grant Docket Number: DOT–OST–2011– should be directed to US Department of Recipients. 0193. Transportation, Office of Financial Estimated Number of Respondents: Date Filed: October 21, 2011. Management, B–30, room W93–431, 11,000. Due Date for Answers, Conforming 1200 New Jersey Avenue SE., Applications, or Motion to Modify Estimated Number of Responses: Washington DC 20590–0001, (202) 366– Scope: November 14, 2011. 11,000. 1306, [email protected]. Description: Application of GoJet SUPPLEMENTARY INFORMATION: Annual Estimated Total Annual Airlines, LLC (‘‘GOJET’’) requesting an Title: Notice of Requirements and Burden Hours: 22,000 (initial amendment to its certificate authority, Procedures for Grant Payment Request registration only). to wit a removal of the restriction on the Submission. Frequency of Collection: One time. total number of aircraft GOJET can OMB Control Number: XXXX–XXXX. ADDRESSES: Send comments regarding operate and/or an increase in the Type of Request: New information the burden estimate, including number by fifteen (15) aircraft. collection. suggestions for reducing the burden, to Background: This notice sets forth Renee V. Wright, U.S. Department of Transportation, requirements and procedures for Program Manager, Docket Operations, Office of Financial Management, B–30, grantees that receive payments from Federal Register Liaison. Room W93–431, 1200 New Jersey DOT OAs, with the exception of DOT [FR Doc. 2011–29123 Filed 11–9–11; 8:45 am] Avenue SE., Washington DC 20590– grant recipients requesting payment BILLING CODE 4910–9X–P 0001, (202) 366–1306, electronically through the NHTSA’s [email protected]. GTS, the FHWA’s RASPS, or FTA grant recipients requesting payment through Comments: Comments are invited on: DEPARTMENT OF TRANSPORTATION the ECHO–Web. The proposed Whether the proposed collection of procedures provide that— information is necessary for the proper Federal Motor Carrier Safety • Grantees will now be required to performance of the functions of the Administration Department, including whether the have electronic internet access to [Docket No. FMCSA–2001–9561; FMCSA– register in the Delphi eInvoicing system. information will have practical utility; 2002–13411; FMCSA–2005–22194; FMCSA– • Grantees will be required to submit the accuracy of the Department’s 2007–27897; FMCSA–2007–28695; FMCSA– payment requests electronically and estimate of the burden of the proposed 2009–0206] information collection; ways to enhance 1 The DOT OAs are: Office of the Secretary of the quality, utility and clarity of the Qualification of Drivers; Exemption Transportation (OST), Federal Aviation information to be collected; and ways to Applications; Vision Administration (FAA), Federal Highway minimize the burden of the collection of Administration (FHWA), Federal Motor Carrier AGENCY: information on respondents. Federal Motor Carrier Safety Safety Administration (FMCSA), Federal Railroad Administration (FMCSA), DOT. Administration (FRA), Federal Transit Issued in Washington, DC, on November 1, ACTION: Notice of renewal of Administration (FTA), Maritime Administration 2011. (MARAD), National Highway Traffic Safety exemptions; request for comments. Administration (NHTSA), Office of Inspector David Rivait. General (OIG), Pipeline and Hazardous Materials Deputy Chief Financial Officer, Department SUMMARY: FMCSA announces its Safety Administration (PHMSA), Research and of Transportation. Innovative Technology Administration (RITA), decision to renew the exemptions from Saint Lawrence Seaway Development Corporation [FR Doc. 2011–28747 Filed 11–9–11; 8:45 am] the vision requirement in the Federal (SLSDC) and Surface Transportation Board (STB). BILLING CODE 4910–9X–P Motor Carrier Safety Regulations for 18

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individuals. FMCSA has statutory Privacy Act: Anyone may search the each individual has a physical authority to exempt individuals from electronic form of all comments examination every year (a) by an the vision requirement if the received into any of our dockets by the ophthalmologist or optometrist who exemptions granted will not name of the individual submitting the attests that the vision in the better eye compromise safety. The Agency has comment (or of the person signing the continues to meet the requirements in concluded that granting these comment, if submitted on behalf of an 49 CFR 391.41(b)(10), and (b) by a exemption renewals will provide a level association, business, labor union, etc.). medical examiner who attests that the of safety that is equivalent to or greater You may review DOT’s Privacy Act individual is otherwise physically than the level of safety maintained Statement for the FDMS published in qualified under 49 CFR 391.41; (2) that without the exemptions for these the Federal Register on January 17, each individual provides a copy of the commercial motor vehicle (CMV) 2008 (73 FR 3316), or you may visit ophthalmologist’s or optometrist’s drivers. http://edocket.access.gpo.gov/2008/pdf/ report to the medical examiner at the E8-785.pdf. time of the annual medical examination; DATES: This decision is effective and (3) that each individual provide a December 6, 2011. Comments must be FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical copy of the annual medical certification received on or before December 12, to the employer for retention in the 2011. Programs Division, (202) 366–4001, [email protected], FMCSA, driver’s qualification file and retains a ADDRESSES: You may submit comments Department of Transportation, 1200 copy of the certification on his/her bearing the Federal Docket Management New Jersey Avenue SE., Room W64– person while driving for presentation to System (FDMS) numbers: FMCSA– 224, Washington, DC 20590–0001. a duly authorized Federal, State, or local 2001–9561; FMCSA–2002–13411; Office hours are from 8:30 a.m. to 5 p.m. enforcement official. Each exemption FMCSA–2005–22194; FMCSA–2007– Monday through Friday, except Federal will be valid for two years unless 27897; FMCSA–2007–28695; FMCSA– holidays. rescinded earlier by FMCSA. The exemption will be rescinded if: (1) The 2009–0206, using any of the following SUPPLEMENTARY INFORMATION: methods: person fails to comply with the terms • Federal eRulemaking Portal: Go to Background and conditions of the exemption; (2) the http://www.regulations.gov. Follow the Under 49 U.S.C. 31136(e) and 31315, exemption has resulted in a lower level on-line instructions for submitting FMCSA may renew an exemption from of safety than was maintained before it comments. the vision requirements in 49 CFR was granted; or (3) continuation of the • Mail: Docket Management Facility; 391.41(b)(10), which applies to drivers exemption would not be consistent with U.S. Department of Transportation, 1200 of CMVs in interstate commerce, for a the goals and objectives of 49 U.S.C. New Jersey Avenue SE., West Building two-year period if it finds ‘‘such 31136(e) and 31315. Ground Floor, Room W12–140, exemption would likely achieve a level Basis for Renewing Exemptions Washington, DC 20590–0001. of safety that is equivalent to or greater • Under 49 U.S.C. 31315(b)(1), an Hand Delivery or Courier: West than the level that would be achieved exemption may be granted for no longer Building Ground Floor, Room W12–140, absent such exemption.’’ The than two years from its approval date 1200 New Jersey Avenue SE., procedures for requesting an exemption and may be renewed upon application Washington, DC, between 9 a.m. and (including renewals) are set out in 49 for additional two year periods. In 5 p.m., Monday through Friday, except CFR part 381. accordance with 49 U.S.C. 31136(e) and Federal Holidays. 31315, each of the 18 applicants has • Exemption Decision Fax: 1–(202) 493–2251. satisfied the entry conditions for This notice addresses 18 individuals Instructions: Each submission must obtaining an exemption from the vision who have requested renewal of their include the Agency name and the requirements (66 FR 30502; 66 FR docket number for this notice. Note that exemptions in accordance with FMCSA 41654; 67 FR 76439; 68 FR 10298; 70 FR DOT posts all comments received procedures. FMCSA has evaluated these 41811; 70 FR 57353; 70 FR 72689; 72 FR without change to http:// 18 applications for renewal on their 39879; 72 FR 40362; 72 FR 46261; 72 FR www.regulations.gov, including any merits and decided to extend each 52419; 72 FR 54972; 72 FR 62897; 74 FR personal information included in a exemption for a renewable two-year 43217; 74 FR 49069; 74 FR 57551; 74 FR comment. Please see the Privacy Act period. They are: 60021). Each of these 18 applicants has heading below. Donald R. Beauchesne requested renewal of the exemption and Docket: For access to the docket to John E. Bell has submitted evidence showing that read background documents or Henry L Chastain the vision in the better eye continues to comments, go to http:// Thomas R. Crocker meet the requirement specified at 49 www.regulations.gov at any time or Steven C. Durst CFR 391.41(b)(10) and that the vision Room W12–140 on the ground level of Clinton D. Edwards Gerald W. Fox impairment is stable. In addition, a the West Building, 1200 New Jersey Richard L. Gandee review of each record of safety while Avenue SE., Washington, DC, between John L. Hynes driving with the respective vision a.m. and 5 p.m., Monday through Richard H. Kind deficiencies over the past two years Friday, except Federal holidays. The Jason E. Mallette indicates each applicant continues to Federal Docket Management System Thomas C. Meadows meet the vision exemption (FDMS) is available 24 hours each day, David A. Morris requirements. These factors provide an 365 days each year. If you want Leigh E. Moseman adequate basis for predicting each acknowledgment that we received your Ronald F. Prezzia driver’s ability to continue to drive comments, please include a self- Richard P. Stanley safely in interstate commerce. addressed, stamped envelope or Paul D. Stoddard Therefore, FMCSA concludes that postcard or print the acknowledgement Scott A. Tetter extending the exemption for each page that appears after submitting The exemptions are extended subject renewal applicant for a period of two comments on-line. to the following conditions: (1) That years is likely to achieve a level of safety

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equal to that existing without the DEPARTMENT OF TRANSPORTATION comment. Please see the Privacy Act exemption. heading below. Federal Motor Carrier Safety Docket: For access to the docket to Request for Comments Administration read background documents or comments, go to http:// FMCSA will review comments [Docket No. FMCSA–1999–5578; FMCSA– www.regulations.gov at any time or received at any time concerning a 2004–19477; FMCSA–2005–21711; FMCSA– Room W12–140 on the ground level of particular driver’s safety record and 2007–27897; FMCSA–2007–29019; FMCSA– 2009–0154] the West Building, 1200 New Jersey determine if the continuation of the Avenue SE., Washington, DC, between exemption is consistent with the Qualification of Drivers; Exemption 9 a.m. and 5 p.m., Monday through requirements at 49 U.S.C. 31136(e) and Applications; Vision Friday, except Federal holidays. The 31315. However, FMCSA requests that Federal Docket Management System interested parties with specific data AGENCY: Federal Motor Carrier Safety (FDMS) is available 24 hours each day, concerning the safety records of these Administration (FMCSA), DOT. 365 days each year. If you want drivers submit comments by December ACTION: Notice of renewal of acknowledgment that we received your 12, 2011. exemptions; request for comments. comments, please include a self- addressed, stamped envelope or FMCSA believes that the SUMMARY: FMCSA announces its requirements for a renewal of an postcard or print the acknowledgement decision to renew the exemptions from page that appears after submitting exemption under 49 U.S.C. 31136(e) and the vision requirement in the Federal 31315 can be satisfied by initially comments on-line. Motor Carrier Safety Regulations for 24 Privacy Act: Anyone may search the granting the renewal and then individuals. FMCSA has statutory electronic form of all comments requesting and evaluating, if needed, authority to exempt individuals from received into any of our dockets by the subsequent comments submitted by the vision requirement if the name of the individual submitting the interested parties. As indicated above, exemptions granted will not comment (or of the person signing the the Agency previously published compromise safety. The Agency has comment, if submitted on behalf of an notices of final disposition announcing concluded that granting these association, business, labor union, etc.). its decision to exempt these 18 exemption renewals will provide a level You may review DOT’s Privacy Act individuals from the vision requirement of safety that is equivalent to or greater Statement for the FDMS published in in 49 CFR 391.41(b)(10). The final than the level of safety maintained the Federal Register on January 17, decision to grant an exemption to each without the exemptions for these 2008 (73 FR 3316), or you may visit of these individuals was made on the commercial motor vehicle (CMV) http://edocket.access.gpo.gov/2008/pdf/ merits of each case and made only after drivers. E8-785.pdf. careful consideration of the comments DATES: This decision is effective FOR FURTHER INFORMATION CONTACT: received to its notices of applications. November 28, 2011. Comments must be Elaine M. Papp, Chief, Medical The notices of applications stated in received on or before December 12, Programs Division, (202) 366–4001, detail the qualifications, experience, 2011. [email protected], FMCSA, Department of Transportation, 1200 and medical condition of each applicant ADDRESSES: You may submit comments for an exemption from the vision New Jersey Avenue SE., Room W64– bearing the Federal Docket Management 224, Washington, DC 20590–0001. requirements. That information is System (FDMS) numbers: FMCSA– available by consulting the above cited Office hours are from 8:30 a.m. to 5 p.m. 1999–5578; FMCSA–2004–19477; Monday through Friday, except Federal Federal Register publications. FMCSA–2005–21711; FMCSA–2007– holidays. 27897; FMCSA–2007–29019; FMCSA– Interested parties or organizations SUPPLEMENTARY INFORMATION: possessing information that would 2009–0154, using any of the following otherwise show that any, or all, of these methods: Background • drivers are not currently achieving the Federal eRulemaking Portal: Go to Under 49 U.S.C. 31136(e) and 31315, statutory level of safety should http://www.regulations.gov. Follow the FMCSA may renew an exemption from immediately notify FMCSA. The on-line instructions for submitting the vision requirements in 49 CFR comments. 391.41(b)(10), which applies to drivers Agency will evaluate any adverse • evidence submitted and, if safety is Mail: Docket Management Facility; of CMVs in interstate commerce, for a U.S. Department of Transportation, 1200 being compromised or if continuation of two-year period if it finds ‘‘such New Jersey Avenue SE., West Building the exemption would not be consistent exemption would likely achieve a level Ground Floor, Room W12–140, with the goals and objectives of 49 of safety that is equivalent to or greater Washington, DC 20590–0001. than the level that would be achieved U.S.C. 31136(e) and 31315, FMCSA will • Hand Delivery or Courier: West take immediate steps to revoke the absent such exemption.’’ The Building Ground Floor, Room W12–140, procedures for requesting an exemption exemption of a driver. 1200 New Jersey Avenue SE., (including renewals) are set out in 49 Issued on: October 28, 2011. Washington, DC, between 9 a.m. and CFR part 381. 5 p.m., Monday through Friday, except Larry W. Minor, Exemption Decision Associate Administrator for Policy. Federal Holidays. • Fax: 1–(202) 493–2251. This notice addresses 24 individuals [FR Doc. 2011–29161 Filed 11–9–11; 8:45 am] Instructions: Each submission must who have requested renewal of their BILLING CODE 4910–EX–P include the Agency name and the exemptions in accordance with FMCSA docket number for this notice. Note that procedures. FMCSA has evaluated these DOT posts all comments received 24 applications for renewal on their without change to http:// merits and decided to extend each www.regulations.gov, including any exemption for a renewable two-year personal information included in a period. They are:

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Robert E. Bequeaith requirements (64 FR 27027; 64 FR otherwise show that any, or all, of these Lloyd K. Brown 51568; 66 FR 48504; 68 FR 54775; 69 FR drivers are not currently achieving the Larry Chinn 64806; 70 FR 2705; 70 FR 48797; 70 FR statutory level of safety should Kecia D. Clark-Welch 53412; 70 FR 61493; 72 FR 1054; 72 FR immediately notify FMCSA. The Tommy R. Crouse 52422; 72 FR 58362; 72 FR 67344; 72 FR Agency will evaluate any adverse Ben W. Davis 84971; 74 FR 26464; 74 FR 37295; 74 FR evidence submitted and, if safety is Charles A. DeKnikker, Sr. 48343; 74 FR 57553; 74 FR 76439). Each being compromised or if continuation of Earl M. Frederick of these 24 applicants has requested the exemption would not be consistent Loren H. Geiken renewal of the exemption and has with the goals and objectives of 49 John N. Guilford submitted evidence showing that the U.S.C. 31136(e) and 31315, FMCSA will John E. Halcomb vision in the better eye continues to take immediate steps to revoke the Rayford R. Harper meet the standard specified at 49 CFR exemption of a driver. Michael A. Hershberger 391.41(b)(10) and that the vision Issued on: October 28, 2011. Patrick J. Hogan, Jr. impairment is stable. In addition, a Todd A. McBrian review of each record of safety while Larry W. Minor, Amilton T. Monteiro driving with the respective vision Associate Administrator for Policy. Harold W. Mumford deficiencies over the past two years [FR Doc. 2011–29162 Filed 11–9–11; 8:45 am] John W. Myre indicates each applicant continues to BILLING CODE 4910–EX–P David G. Oakley meet the vision exemption Charles D. Oestreich requirements. These factors provide an John S. Olsen DEPARTMENT OF TRANSPORTATION Thomas J. Prusik adequate basis for predicting each driver’s ability to continue to drive Brent L. Seaux Federal Motor Carrier Safety safely in interstate commerce. Glen W. Sterling Administration Therefore, FMCSA concludes that The exemptions are extended subject extending the exemption for each [Docket No. FMCSA–2011–0298] to the following conditions: (1) That renewal applicant for a period of two each individual has a physical years is likely to achieve a level of safety Qualification of Drivers; Exemption examination every year (a) by an equal to that existing without the Applications; Vision ophthalmologist or optometrist who exemption. attests that the vision in the better eye AGENCY: Federal Motor Carrier Safety continues to meet the standard in 49 Request for Comments Administration (FMCSA), DOT. CFR 391.41(b)(10), and (b) by a medical FMCSA will review comments ACTION: Notice of applications for examiner who attests that the individual received at any time concerning a exemptions; request for comments. is otherwise physically qualified under particular driver’s safety record and SUMMARY: FMCSA announces receipt of 49 CFR 391.41; (2) that each individual determine if the continuation of the applications from 7 individuals for provides a copy of the ophthalmologist’s exemption is consistent with the exemption from the vision requirement or optometrist’s report to the medical requirements at 49 U.S.C. 31136(e) and in the Federal Motor Carrier Safety examiner at the time of the annual 31315. However, FMCSA requests that Regulations. If granted, the exemptions medical examination; and (3) that each interested parties with specific data would enable these individuals to individual provide a copy of the annual concerning the safety records of these qualify as drivers of commercial motor medical certification to the employer for drivers submit comments by December vehicles (CMVs) in interstate commerce retention in the driver’s qualification 12, 2011. file and retains a copy of the FMCSA believes that the without meeting the Federal vision certification on his/her person while requirements for a renewal of an requirement. driving for presentation to a duly exemption under 49 U.S.C. 31136(e) and DATES: Comments must be received on authorized Federal, State, or local 31315 can be satisfied by initially or before December 12, 2011. enforcement official. Each exemption granting the renewal and then ADDRESSES: You may submit comments will be valid for two years unless requesting and evaluating, if needed, bearing the Federal Docket Management rescinded earlier by FMCSA. The subsequent comments submitted by System (FDMS) Docket No. FMCSA– exemption will be rescinded if: (1) The interested parties. As indicated above, 2011–0298 using any of the following person fails to comply with the terms the Agency previously published methods: and conditions of the exemption; (2) the notices of final disposition announcing • Federal eRulemaking Portal: Go to exemption has resulted in a lower level its decision to exempt these 24 http://www.regulations.gov. Follow the of safety than was maintained before it individuals from the vision requirement online instructions for submitting was granted; or (3) continuation of the in 49 CFR 391.41(b)(10). The final comments. exemption would not be consistent with decision to grant an exemption to each • Mail: Docket Management Facility; the goals and objectives of 49 U.S.C. of these individuals was made on the U.S. Department of Transportation, 1200 31136(e) and 31315. merits of each case and made only after New Jersey Avenue SE., West Building careful consideration of the comments Ground Floor, Room W12–140, Basis for Renewing Exemptions received to its notices of applications. Washington, DC 20590–0001. Under 49 U.S.C. 31315(b)(1), an The notices of applications stated in • Hand Delivery: West Building exemption may be granted for no longer detail the qualifications, experience, Ground Floor, Room W12–140, 1200 than two years from its approval date and medical condition of each applicant New Jersey Avenue SE., Washington, and may be renewed upon application for an exemption from the vision DC, between 9 a.m. and 5 p.m., Monday for additional two year periods. In requirements. That information is through Friday, except Federal accordance with 49 U.S.C. 31136(e) and available by consulting the above cited Holidays. 31315, each of the 24 applicants has Federal Register publications. • Fax: 1 (202) 493–2251. satisfied the entry conditions for Interested parties or organizations Instructions: Each submission must obtaining an exemption from the vision possessing information that would include the Agency name and the

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docket numbers for this notice. Note exemption will achieve the required required to operate a commercial that all comments received will be level of safety mandated by statute. vehicle.’’ Mr. Hammock reported that he posted without change to http:// has driven straight trucks for 17 years, Qualifications of Applicants www.regulations.gov, including any accumulating 601,120 miles. He holds a personal information provided. Please Adam O. Carson Class D operator’s license from see the Privacy Act heading below for Mr. Carson, age 29, has had Alabama. His driving record for the last further information. retinopathy in his left eye since birth. 3 years shows no crashes and no Docket: For access to the docket to The best corrected visual acuity in his convictions for moving violations in a read background documents or right eye 20/30 and in his left eye, light CMV. comments, go to http:// perception. Following an examination John T. Thor www.regulations.gov at any time or in 2011, his ophthalmologist noted, ‘‘I Room W12–140 on the ground level of believe that his vision is sufficient to Mr. Thor, 70, has had malignant the West Building, 1200 New Jersey perform his driving tasks required to melanoma in his right eye since the mid Avenue SE., Washington, DC, between operate a commercial vehicle.’’ Mr. 1990’s. The best corrected visual acuity 9 a.m. and 5 p.m., Monday through Carson reported that he has driven in his right eye 20/500 and in his left Friday, except Federal holidays. The straight trucks for 9.4 years, eye, 20/20. Following an examination in FDMS is available 24 hours each day, accumulating 18,800 miles. He holds a 2011, his optometrist noted, ‘‘In my 365 days each year. If you want Class D operator’s license from opinion, Mr. John Thor has adequate acknowledgment that we received your Mississippi. His driving record for the vision to perform the tasks required to comments, please include a self- last 3 years shows no crashes and no operate a commercial vehicle.’’ Mr. Thor addressed, stamped envelope or convictions for moving violations in a reported that he has driven straight postcard or print the acknowledgement CMV. trucks for 50 years, accumulating page that appears after submitting 500,000 miles and tractor-trailer comments online. Michael P. Eisenreich combinations for 6 years, accumulating Privacy Act: Anyone may search the Mr. Eisenreich, 47, has a prosthetic 360,000 miles. He holds a Class A CDL electronic form of all comments left eye due to a traumatic injury received into any of our dockets by the sustained in 1984. The best corrected from Minnesota. His driving record for name of the individual submitting the visual acuity in his right eye 20/20. the last 3 years shows 1 crash, due to comment (or of the person signing the Following an examination in 2011, his weather, and no convictions for moving comment, if submitted on behalf of an optometrist noted, ‘‘I certify that in my violations in a CMV. association, business, labor union, etc.). opinion that he can safely perform the George Ulferts You may review DOT’s Privacy Act driving tasks required to operate a Statement for the FDMS published in commercial vehicle.’’ Mr. Eisenreich Mr. Ulferts, 46, has had a completely the Federal Register on January 17, reported that he has driven tractor- detached retina in his left eye since 2008 (73 FR 3316), or you may visit trailer combinations for 5 years, February of 2008. The best corrected http://edocket.access.gpo.gov/2008/pdf/ accumulating 195,000 miles. He holds a visual acuity in his right eye 20/20 and E8–785.pdf. Class A Commercial Driver’s License in his left eye, light perception. FOR FURTHER INFORMATION CONTACT: (CDL) from Minnesota. His driving Following an examination in 2011, his Elaine M. Papp, Chief, Medical record for the last 3 years shows no optometrist noted, ‘‘It is of medical Programs Division, (202) 366–4001, crashes and no convictions for moving opinion that Mr. Ulfrets has the [email protected], FMCSA, violations in a CMV. appropriate level of acuity in his right Department of Transportation, 1200 Carlton G. Frank eye to sufficiently perform the driving New Jersey Avenue SE., Room W64– tasks required to operate a commercial Mr. Frank, 49, has had central vehicle.’’ Mr. Ulfrets reported that he 224, Washington, DC 20590–0001. scarring in his left eye since 2006. The Office hours are from 8:30 a.m. to has driven straight trucks for 25 years, best corrected visual acuity in his right accumulating 625,000 miles. He holds a 5 p.m., Monday through Friday, except eye 20/15 and in his left eye, 20/60. Federal holidays. Class D operator’s license from Iowa. Following an examination in 2011, his His driving record for the last 3 years SUPPLEMENTARY INFORMATION: optometrist noted, ‘‘In summary, Mr. shows no crashes and no convictions for Background Frank’s condition remains stable, and he moving violations in a CMV. has sufficient vision to perform driving Under 49 U.S.C. 31136(e) and 31315, tasks required to operate a commercial Donald F. Wilton FMCSA may grant an exemption from vehicle.’’ Mr. Frank reported that he has the Federal Motor Carrier Safety driven buses for 3 years, accumulating Mr. Wilton, 42, has had amblyopia in Regulations for a 2-year period if it finds 66,000 miles. He holds a Class B CDL his left eye since childhood. The best ‘‘such exemption would likely achieve a from Florida. His driving record for the corrected visual acuity in his right eye level of safety that is equivalent to or last 3 years shows no crashes and no 20/20 and in his left eye, 20/70. greater than the level that would be convictions for moving violations in a Following an examination in 2011, his achieved absent such exemption.’’ CMV. optometrist noted, ‘‘I certify that Mr. FMCSA can renew exemptions at the Wilton shows sufficient vision to end of each 2-year period. The 7 Roger W. Hammock operate a commercial vehicle.’’ Mr. individuals listed in this notice have Mr. Hammock, 43, has had amblyopia Wilton reported that he has driven each requested such an exemption from in his right eye since childhood. The tractor-trailer combinations for 23 years, the vision requirement in 49 CFR best corrected visual acuity in his right accumulating 2.3 million miles. He 391.41(b)(10), which applies to drivers eye 20/70 and in his left eye, 20/20. holds a Class A CDL from California. of CMVs in interstate commerce. Following an examination in 2011, his His driving record for the last 3 years Accordingly, the Agency will evaluate optometrist noted, ‘‘In my medical shows no crashes, but one conviction the qualifications of each applicant to opinion, Roger Hammock has sufficient for a moving violation in a CMV; failure determine whether granting an vision to perform the driving tasks to stop at a traffic signal.

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Request for Comments System (FDMS) numbers: FMCSA– Monday through Friday, except Federal In accordance with 49 U.S.C. 31136(e) 1999–5748; FMCSA–1999–5578; holidays. and 31315, FMCSA requests public FMCSA–2002–12844; FMCSA–2003– SUPPLEMENTARY INFORMATION: comment from all interested persons on 15892; FMCSA–2005–21711, using any of the following methods: Background the exemption petitions described in • this notice. The Agency will consider all Federal eRulemaking Portal: Go to Under 49 U.S.C. 31136(e) and 31315, comments received before the close of http://www.regulations.gov. Follow the FMCSA may renew an exemption from business December 12, 2011. Comments on-line instructions for submitting the vision requirements in 49 CFR will be available for examination in the comments. 391.41(b)(10), which applies to drivers • Mail: Docket Management Facility; docket at the location listed under the of CMVs in interstate commerce, for a U.S. Department of Transportation, 1200 ADDRESSES section of this notice. The two-year period if it finds ‘‘such New Jersey Avenue SE., West Building Agency will file comments received exemption would likely achieve a level Ground Floor, Room W12–140, after the comment closing date in the of safety that is equivalent to or greater Washington, DC 20590–0001. public docket, and will consider them to than the level that would be achieved • Hand Delivery or Courier: West the extent practicable. absent such exemption.’’ The Building Ground Floor, Room W12–140, In addition to late comments, FMCSA procedures for requesting an exemption 1200 New Jersey Avenue SE., will also continue to file, in the public (including renewals) are set out in 49 Washington, DC, between 9 a.m. and docket, relevant information that CFR part 381. 5 p.m., Monday through Friday, except becomes available after the comment Federal Holidays. Exemption Decision closing date. Interested persons should • Fax: 1–(202) 493–2251. monitor the public docket for new This notice addresses 20 individuals material. Instructions: Each submission must who have requested renewal of their include the Agency name and the exemptions in accordance with FMCSA Issued on: November 3, 2011. docket number for this notice. Note that procedures. FMCSA has evaluated these Larry W. Minor, DOT posts all comments received 20 applications for renewal on their Associate Administrator for Policy. without change to http://www. merits and decided to extend each [FR Doc. 2011–29160 Filed 11–9–11; 8:45 am] regulations.gov, including any personal exemption for a renewable two-year BILLING CODE 4910–EX–P information included in a comment. period. They are: Please see the Privacy Act heading Thomas E. Adams below. Terry J. Aldridge DEPARTMENT OF TRANSPORTATION Docket: For access to the docket to Lennie D. Baker, Jr. read background documents or Jerry D. Bridges Federal Motor Carrier Safety comments, go to http://www. William J. Corder Administration regulations.gov at any time or Room Gary R. Gutschow [Docket No. FMCSA–1999–5748; FMCSA– W12–140 on the ground level of the James J. Hewitt 1999–5578; FMCSA–2002–12844; FMCSA– West Building, 1200 New Jersey Avenue Albert E. Malley 2003–15892; FMCSA–2005–21711] SE., Washington, DC, between 9 a.m. Eugene P. Martin and 5 p.m., Monday through Friday, David L. Menken Qualification of Drivers; Exemption except Federal holidays. The Federal Rodney M. Mimbs Applications; Vision Docket Management System (FDMS) is Walter F. Moniowczak available 24 hours each day, 365 days William G. Mote AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. each year. If you want acknowledgment James R. Murphy that we received your comments, please Chris A. Ritenour ACTION: Notice of renewal of include a self-addressed, stamped Ronald L. Roy exemptions; request for comments. envelope or postcard or print the Thaoms D. Walden SUMMARY: FMCSA announces its acknowledgement page that appears Thomas E. Walsh decision to renew the exemptions from after submitting comments on-line. Kevin P. Weinhold the vision requirement in the Federal Privacy Act: Anyone may search the Thomas A. Wise Motor Carrier Safety Regulations for 20 electronic form of all comments The exemptions are extended subject individuals. FMCSA has statutory received into any of our dockets by the to the following conditions: (1) That authority to exempt individuals from name of the individual submitting the each individual has a physical the vision requirement if the comment (or of the person signing the examination every year (a) by an exemptions granted will not comment, if submitted on behalf of an ophthalmologist or optometrist who compromise safety. The Agency has association, business, labor union, etc.). attests that the vision in the better eye concluded that granting these You may review DOT’s Privacy Act continues to meet the requirements in exemption renewals will provide a level Statement for the FDMS published in 49 CFR 391.41(b)(10), and (b) by a of safety that is equivalent to or greater the Federal Register on January 17, medical examiner who attests that the than the level of safety maintained 2008 (73 FR 3316), or you may visit individual is otherwise physically without the exemptions for these http://www.edocket.access.gpo.gov/ qualified under 49 CFR 391.41; (2) that commercial motor vehicle (CMV) 2008/pdf/E8-785.pdf. each individual provides a copy of the drivers. FOR FURTHER INFORMATION CONTACT: ophthalmologist’s or optometrist’s Elaine M. Papp, Chief, Medical report to the medical examiner at the DATES: This decision is effective Programs, (202) 366–4001, time of the annual medical examination; November 30, 2011. Comments must be [email protected], FMCSA, and (3) that each individual provide a received on or before December 12, Department of Transportation, 1200 copy of the annual medical certification 2011. New Jersey Avenue SE., Room W64– to the employer for retention in the ADDRESSES: You may submit comments 224, Washington, DC 20590–0001. driver’s qualification file and retains a bearing the Federal Docket Management Office hours are from 8:30 a.m. to 5 p.m. copy of the certification on his/her

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person while driving for presentation to granting the renewal and then DATES: Submit comments on or before a duly authorized Federal, State, or local requesting and evaluating, if needed, December 12, 2011. enforcement official. Each exemption subsequent comments submitted by ADDRESSES: Comments should refer to will be valid for two years unless interested parties. As indicated above, docket number MARAD–2011–0146. rescinded earlier by FMCSA. The the Agency previously published Written comments may be submitted by exemption will be rescinded if: (1) The notices of final disposition announcing hand or by mail to the Docket Clerk, person fails to comply with the terms its decision to exempt these 20 U.S. Department of Transportation, and conditions of the exemption; (2) the individuals from the vision requirement Docket Operations, M–30, West exemption has resulted in a lower level in 49 CFR 391.41(b)(10). The final Building Ground Floor, Room W12–140, of safety than was maintained before it decision to grant an exemption to each 1200 New Jersey Avenue SE., was granted; or (3) continuation of the of these individuals was made on the Washington, DC 20590. You may also exemption would not be consistent with merits of each case and made only after send comments electronically via the the goals and objectives of 49 U.S.C. careful consideration of the comments Internet at http://www.regulations.gov. 31136(e) and 31315. received to its notices of applications. All comments will become part of this Basis for Renewing Exemptions The notices of applications stated in docket and will be available for detail the qualifications, experience, inspection and copying at the above Under 49 U.S.C. 31315(b)(1), an and medical condition of each applicant address between 10 a.m. and 5 p.m., exemption may be granted for no longer for an exemption from the vision E.T., Monday through Friday, except than two years from its approval date requirements. That information is federal holidays. An electronic version and may be renewed upon application available by consulting the above cited of this document and all documents for additional two year periods. In Federal Register publications. entered into this docket is available on accordance with 49 U.S.C. 31136(e) and Interested parties or organizations the World Wide Web at http:// 31315, each of the 20 applicants has possessing information that would www.regulations.gov. satisfied the entry conditions for otherwise show that any, or all, of these obtaining an exemption from the vision FOR FURTHER INFORMATION CONTACT: drivers are not currently achieving the requirements (64 FR 27027; 64 FR Joann Spittle, U.S. Department of statutory level of safety should 40404; 64 FR 51568; 64 FR 66962; 66 FR Transportation, Maritime immediately notify FMCSA. The 63289; 67 FR 68719; 68 FR 2629; 68 FR Administration, 1200 New Jersey Agency will evaluate any adverse 52811; 68 FR 61860; 68 FR 64944;70 FR Avenue SE., Room W21–203, evidence submitted and, if safety is 48797; 70 FR 61165; 70 FR 61493;70 FR Washington, DC 20590. Telephone (202) being compromised or if continuation of 67776; 74 FR 62632). Each of these 20 366–5979, Email [email protected]. the exemption would not be consistent applicants has requested renewal of the SUPPLEMENTARY INFORMATION: As with the goals and objectives of 49 exemption and has submitted evidence described by the applicant the intended U.S.C. 31136(e) and 31315, FMCSA will showing that the vision in the better eye service of the vessel REEL ATTITUDE take immediate steps to revoke the continues to meet the requirement is: specified at 49 CFR 391.41(b)(10) and exemption of a driver. Intended Commercial Use of Vessel: that the vision impairment is stable. In Issued on: October 28, 2011. ‘‘Fishing Charter passenger less than 6.’’ addition, a review of each record of Larry W. Minor, Geographic Region: ‘‘Maryland.’’ safety while driving with the respective Associate Administrator for Policy. The complete application is given in vision deficiencies over the past two [FR Doc. 2011–29153 Filed 11–9–11; 8:45 am] DOT docket MARAD–2011–0146 at http://www.regulations.gov. Interested years indicates each applicant continues BILLING CODE 4910–EX–P to meet the vision exemption parties may comment on the effect this requirements. These factors provide an action may have on U.S. vessel builders adequate basis for predicting each DEPARTMENT OF TRANSPORTATION or businesses in the U.S. that use U.S.- driver’s ability to continue to drive flag vessels. If MARAD determines, in safely in interstate commerce. Maritime Administration accordance with 46 U.S.C. 12121 and Therefore, FMCSA concludes that MARAD’s regulations at 46 CFR part extending the exemption for each [Docket No. MARAD–2011 0146] 388, that the issuance of the waiver will renewal applicant for a period of two have an unduly adverse effect on a U.S.- years is likely to achieve a level of safety Requested Administrative Waiver of vessel builder or a business that uses equal to that existing without the the Coastwise Trade Laws; Vessel U.S.-flag vessels in that business, a exemption. REEL ATTITUDE; Invitation for Public waiver will not be granted. Comments Comments should refer to the docket number of Request for Comments this notice and the vessel name in order FMCSA will review comments AGENCY: Maritime Administration, for MARAD to properly consider the received at any time concerning a Department of Transportation. comments. Comments should also state particular driver’s safety record and ACTION: Notice. the commenter’s interest in the waiver determine if the continuation of the application, and address the waiver exemption is consistent with the SUMMARY: As authorized by 46 U.S.C. criteria given in 388.4 of MARAD’s requirements at 49 U.S.C. 31136(e) and 12121, the Secretary of Transportation, regulations at 46 CFR part 388. 31315. However, FMCSA requests that as represented by the Maritime interested parties with specific data Administration (MARAD), is authorized Privacy Act concerning the safety records of these to grant waivers of the U.S.-build Anyone is able to search the drivers submit comments by December requirement of the coastwise laws under electronic form of all comments 12, 2011. certain circumstances. A request for received into any of our dockets by the FMCSA believes that the such a waiver has been received by name of the individual submitting the requirements for a renewal of an MARAD. The vessel, and a brief comment (or signing the comment, if exemption under 49 U.S.C. 31136(e) and description of the proposed service, is submitted on behalf of an association, 31315 can be satisfied by initially listed below. business, labor union, etc.). You may

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review DOT’s complete Privacy Act Management and Budget, 726 Jackson That final rule added two new sections, Statement in the Federal Register Place NW., Washington, DC 20503, 49 CFR 191.22 and 195.64, to the published on April 11, 2000 (Volume ATTN: Desk Officer for the U.S. pipeline safety regulations for the 65, Number 70; Pages 19477–78). Department of Transportation. establishment of a national pipeline • Dated: November 3, 2011. Email: Office of Information and operator registry, which will be used by Regulatory Affairs, Office of By Order of the Maritime Administrator. operators to obtain an Operator Management and Budget, at the Identification (OPID) number. PHMSA Julie P. Agarwal, following address: is proposing to use two forms as part of Secretary, Maritime Administration. [email protected]. this information collection. When an [FR Doc. 2011–29156 Filed 11–9–11; 8:45 am] Requests for a copy of the Information operator requests an initial OPID BILLING CODE 4910–81–P Collection should be directed to Angela number, an online form titled ‘‘OPID Dow by telephone at (202) 366–1246, by Assignment Request (PHMSA F fax at (202) 366–4566, by email at 1000.1)’’ will be used. For an operator DEPARTMENT OF TRANSPORTATION [email protected], or by mail at U.S. notifying PHMSA of certain required Department of Transportation, PHMSA, changes associated with an OPID (see 49 Pipeline and Hazardous Materials 1200 New Jersey Avenue SE., PHP–30, Administration CFR 191.22 and 195.64) or for operators Washington, DC 20590–0001. updating their OPID information, a form [Docket No. PHMSA–2008–0291] SUPPLEMENTARY INFORMATION: Section titled ‘‘Operator Registry Notification 1320.8(d), Title 5, Code of Federal (PHMSA F 1000.2)’’ will be used. Pipeline Safety: Information Collection Regulations requires PHMSA to provide Copies of these forms have been placed Activities interested members of the public and in the docket and are available for affected agencies an opportunity to comment. ACTION: Request for public comments comment on information collection and and OMB approval of new Information recordkeeping requests. This notice II. Summary of Comments/Topics Collection. identifies a new information collection During the two month response AGENCY: Pipeline and Hazardous request that PHMSA will be submitting period, PHMSA received a combined Materials Safety Administration to OMB for approval. The information comment from American Petroleum SUMMARY: On December 13, 2010, in collection will be titled: ‘‘National Institute (API) and American Oil accordance with the Paperwork Registry of Pipeline and Liquefied Pipelines Association (AOPL) on the Reduction Act of 1995, the Pipeline and Natural Gas Operators.’’ PHMSA proposal outlined in the December 2010 Hazardous Materials Safety published a final rule in the Federal Federal Register notice. Administration (PHMSA) published a Register on November 26, 2010 (75 FR A. OPID Assignment Request (Form notice in the Federal Register of its 72878), titled ‘‘Pipeline Safety: Updates PHMSA F 1000.1) intent to create a national registry of to Pipeline and Liquefied Natural Gas pipeline and liquefied natural gas (LNG) Reporting Requirements.’’ That final A1. API–AOPL noted that Step 1, operators. PHMSA received one rule added two new sections, 49 CFR ‘‘Enter Basic Information,’’ incorrectly comment in response to that notice. 191.22 and 195.64, to the pipeline safety implies that some rural low-stress PHMSA is publishing this notice to regulations for the establishment of a hazardous liquid pipelines are not respond to the comment, to provide the ‘‘National Registry of Pipeline and subject to part 195 although they are public with an additional 30 days to Liquefied Natural Gas Operators,’’ required to submit reports under comment on the proposed revisions to which will be used by operators to Subpart B. They noted that being subject the operator registry forms, including obtain an Operator Identification (OPID) to Subpart B is being subject to Part 195. the form instructions, and to announce number. The following information is They also note that this step incorrectly that the revised Information Collections provided for each information implies that unregulated rural gathering will be submitted to the Office of collection: (1) Title of the information lines are subject to reporting Management and Budget for approval. collection; (2) Office of Management requirements. and Budget (OMB) control number; (3) DATES: Response: PHMSA agrees and has Comments on this notice must be Type of request; (4) Abstract of the revised and reordered the elements of received by December 12, 2011 to be information collection activity; (5) Question 1 in this step to better align assured of consideration. Description of affected public; (6) these elements with the degree to which FOR FURTHER INFORMATION CONTACT: Estimate of total annual reporting and pipelines are subject to part 195. Angela Dow by telephone at (202) 366– recordkeeping burden; and (7) 1246, by fax at (202) 366–4566, by email Frequency of collection. PHMSA will A2. In Step 2, API–AOPL requested at [email protected], or by mail at request a three-year term of approval for clarification of the term ‘‘vessels’’ in the U.S. Department of Transportation, item ‘‘Hazardous Liquid Breakout Tanks each information collection activity. → Pipeline and Hazardous Materials Safety The comments are summarized and Total Number of Tanks/Caverns/ Administration, 1200 New Jersey addressed below as specified in the Vessels.’’ Avenue SE., PHP–30, Washington, DC following outline: Response: This item meant to indicate 20590–0001. that the operator should report the total I. Background number of tanks, caverns, or other ADDRESSES: You may submit comments II. Summary of Comments/Topics identified by the docket number III. Proposed Information Collection containers (i.e., vessels) that serve as PHMSA–2008–0291 by any of the Revisions and Request for Comments breakout tanks. PHMSA agrees that the following methods: term ‘‘vessels,’’ is not used elsewhere • Federal eRulemaking Portal: http:// I. Background and could cause confusion. PHMSA also www.regulations.gov. Follow the online PHMSA published a final rule in the concludes that the intended clarification instructions for submitting comments. Federal Register on November 26, 2010, is unnecessary and has revised this item • Fax: 1 (202) 395–6566. (75 FR 72878), titled ‘‘Pipeline Safety: to indicate only that operators should • Mail: Office of Information and Updates to Pipeline and Liquefied report the total number of breakout Regulatory Affairs, Office of Natural Gas Reporting Requirements.’’ tanks.

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A3. API–AOPL commented that for OPID 67890 are part of an Integrity A12. API–AOPL questioned whether identifying all counties through which a Management Program that is this same form would be used to pipeline passes will be an additional administered by the operator under its validate/collect information for existing reporting burden. They suggested that a existing OPID 12345, then the primary OPIDs and requested that any such drop-down list including all counties in OPID would be 12345). The designation information collection be delayed until each state be provided as part of the of which multiple OPIDs is ‘‘primary’’ is the on-line reporting system is available. online reporting system. at the operator’s discretion, but it is Response: 49 CFR 191.22(b) and Response: PHMSA agrees and will important that once a particular OPID is 195.64(b) require validation of include drop-down lists in the online selected as ‘‘primary,’’ the operator information for existing OPIDs by gas reporting system to facilitate providing continue to list this same OPID as pipeline/LNG operators and hazardous this information. ‘‘primary’’ in future notifications liquid pipeline operators, respectively. A4. API–AOPL pointed out a concerning the safety program in This same form will be used for that formatting error in that the statement at question. PHMSA has clarified this in purpose. PHMSA is planning for the on- the bottom of each page indicating that the instructions. line reporting system to be available to a step continues did not always refer to A8. Step 4, Question 1, asks for operators for validation purposes before the correct question number. information about the ‘‘operator contact validation is required. Response: PHMSA has revised the responsible for assuring compliance’’ form to fix this error. B. Operator Registry Notification (Form with PHMSA regulations. API–AOPL PHMSA F 1000.2) A5. API–AOPL asked that PHMSA noted that several personnel could fit clarify the reason for requesting right-of- this description and requested B1. API–AOPL noted that Step 1, way miles as well as pipeline miles additional clarification. Question 7, indicates the operator is to (Step 2, Question 3). They noted that Response: PHMSA agrees that this select only one type of facility and not all companies calculate right-of-way description was vague. Ultimately, any asked whether the form was to be miles for business purposes and that operator personnel who perform or completed multiple times for an reporting this information could result manage work required by the operator with more than one type of in additional burden. regulations have some responsibility for facility covered by the same OPID. They Response: PHMSA has agreed to assuring compliance. This question was also noted that Step 3, Question 1, remove the question concerning right- intended to collect information allows operators to select all pipeline of-way miles. regarding the person who oversees facility types that apply, in apparent A6. Step 2, Question 4, asks for a brief contradiction to this limitation to one description of the pipelines/facilities compliance and typically is the principal contact with PHMSA to facility type. covered by an OPID assignment request. Response: PHMSA has modified the discuss regulatory issues. This would API–AOPL noted that the amount of form to allow operators to select all include such titles as ‘‘Manager of detail to be provided in this description facility types that apply. Compliance,’’ ‘‘Regulatory Compliance is not clear and suggested that PHMSA B2. API–AOPL requested that PHMSA Officer,’’ ‘‘DOT Compliance include examples in the instructions. clarify whether a separate form is Supervisor,’’ ‘‘Pipeline Safety Manager,’’ They noted that this form is applicable required for each type of change listed etc. PHMSA has revised the form to to hazardous liquid pipelines and gas in Step 2. pipelines as well as LNG facilities and state ‘‘operator contact responsible for Response: No. Operators may report requested that the examples address all overseeing compliance’’ and has multiple types of changes in a single of these types of facilities. included these position titles as notification. Response: PHMSA agrees that examples in the instructions. B3. API–AOPL requested clarification examples for each facility type would be A9. API–AOPL requested that the as to whether one or both operators useful and has included them in the contact information collected in Step 4 must file a notification in the case of a revised instructions. be kept confidential. transfer of assets. They also questioned A7. Step 3 collects information Response: PHMSA does not intend to whether the date to be reported should concerning PHMSA-required safety make this information publicly be the date on which ownership or programs. Pipeline operators with available. It could be subject to release operating responsibility is transferred in systems covered by multiple OPIDs under a Freedom of Information Act cases where they do not occur often manage these as common request, but all such releases are subject simultaneously. programs covering all (or multiple) to privacy exemptions in that Act and Response: Both operators are required OPIDs. This step asks that the operator the Privacy Act. to file a notification in the event of a designate the ‘‘primary’’ OPID for each A10. API–AOPL noted that the transfer of assets, each reporting the program. API–AOPL requested various ‘‘contacts’’ included in Step 4 change affecting their OPID(s). The date clarification as to how the designation are often located at a common address should be the date operating of an OPID as ‘‘primary’’ is to be made. and asked that the form allow for responsibility is transferred. The Response: This ‘‘primary’’ OPID entering this information only once. instructions have been revised to clarify designation is intended to represent the Response: PHMSA has revised the this. OPID that should be the focus of online reporting system to allow B4. For changes involving the name of PHMSA inspection activities covering designation of a common address for an operator (TYPE A) or the entity the specific safety program in question. multiple contacts. responsible for operation (TYPE B), the As such, it should be the OPID under A11. API–AOPL requested that the form asks an operator to enter the reason which that particular safety program is online reporting system provide a for the change. API–AOPL asked for managed or administered, and typically simple mechanism for updating contact justification for requiring this will be associated with the physical information for an OPID. information and why reports are needed location where the main documentation Response: PHMSA agrees that such a for this type of change when there is no and description of the safety program mechanism will be useful and has plans simple mechanism for reporting smaller exist. (For example, if the pipelines to incorporate such a mechanism in the changes such as address or name of covered by an OPID assignment request near future. Senior Executive Officer.

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Response: The operator of a pipeline transportation’’ of the commodity. (Both pipe, (including replacement of 10 or facility is responsible for compliance definitions are included in the more miles of an existing pipeline) with pipeline safety regulations. instructions under TYPE E.) API–AOPL should be reported as TYPE G. Accordingly, PHMSA’s regulatory is correct that the acquisition/ Construction of line pipe costing more activities are focused on the operating divestiture of an entire pipeline than $10 million but involving less than entity. PHMSA thus needs to know consisting of only a few miles would 10 miles need not be reported. whether changes of this type reflect a need to be reported as TYPE E while B8. Changes of TYPES F and G must new operating entity. A change in name acquisition/divestiture of the same be submitted 60 days before planned of operator can, for example, reflect a amount of pipe that did not involve sale start of construction. API–AOPL noted corporate re-branding or it can mean a of a complete facility would not need to that construction dates often slip. They more significant change in the operating be reported. The difference reflects questioned whether reported dates for company. A change in responsible PHMSA’s need for the information. anticipated start of work would need to entity could be due to a sale of assets PHMSA regulates the operator of a be updated. or to a shift in responsibility from one facility. If a complete facility changes Response: No. As described above, the subsidiary of a common parent hands, then PHMSA needs to update its purpose of these notifications is for company to another. The potential effect records, inspection plans, etc., to assure PHMSA to plan for inspections to be of these changes on continuity in that appropriate attention is paid to the conducted during construction. responsibility for compliance would new operator. If, on the other hand, a Notifications of this type will prompt vary, and determine PHMSA’s follow- larger operator acquires or divests itself PHMSA to contact the operator to up to the notification. This form only of a few miles of pipe, significant arrange for such inspections. PHMSA requires reporting of those changes changes in PHMSA oversight plans are expects that the operator will keep where the regulations require that an not needed. PHMSA will obtain PHMSA informed of changes in the operator notify PHMSA. Changes in information about these changes anticipated date of field operations as address or contact information for key through routine inspections and update part of these pre-inspection interactions. personnel are not required to be its records/plans as appropriate. To B9. API–AOPL commented that it was reported. PHMSA plans, however, to reduce the aggregate reporting burden inappropriate to include an operations provide on-line means to report such associated with this form, we will not question referring to maximum changes in basic information in the near require that operators report allowable operating pressure (MAOP) in future. acquisition/divestiture of small amounts an OPID data form (TYPE G). B5. For several change types which of pipe (< 50 miles). PHMSA has made Response: PHMSA disagrees. This involve changes in operating changes to clarify these distinctions. question applies only to gas responsibility, the draft form included a B7. Change TYPE F involves transmission pipelines and asks question on whether the operator ‘‘rehabilitation, replacement, whether the new pipeline will use wanted PHMSA to deactivate the modification, upgrade, uprate, or update alternate MAOP under 49 CFR 192.620. existing OPID. API–AOPL noted that of facilities, other than a section of line Pipe to be operated at alternate MAOP only the holder of a specific OPID pipe that costs $10 million or more.’’ is subject to many requirements not should be able to request deactivation. API–AOPL requested clarification, applicable to other pipelines and for Response: PHMSA agrees that only including the basis for the stated which special inspections by PHMSA the holder of an OPID should be able to exclusion. They asked if rehabilitation may be required. As noted above, the request deactivation and that this of line pipe costing more than $11 purpose for notifications of this type is question should not be included on a million would need to be reported. for PHMSA to manage its inspection form that will be completed by both Response: Construction-type changes resources. parties involved in a transfer of are reported as either TYPE F or G. B10. API–AOPL commented that it responsibilities. PHMSA has deleted Pipeline operators continually was not clear which portions of Step 3 this question from the form. The construct/rehabilitate facilities, and need to be completed for each change question was not intended to result in routine activities of this type are ‘‘Type’’ in Step 2. automatic deactivation, but rather to addressed as part of PHMSA’s routine Response: The on-line reporting prompt PHMSA to follow-up with the inspection program. These notifications system will be configured so that only reporting operator. PHMSA will instead are to collect information on larger those questions applicable to the change address the question of OPID changes for which special inspections types selected in Question 2 will be deactivation as part of its normal may be required. Thus, a reporting presented for answers. This should contact with operators. threshold was needed. For line pipe, a resolve the confusion. B6. API–AOPL asked for clarification threshold based on miles of pipe to be B11. Step 3, Question 4, asks for a concerning changes of TYPE D constructed is appropriate. Cost is not brief description of the pipelines/ (acquisition/divestiture of 50 or more an appropriate threshold for changes in facilities covered by this notification. miles of pipe) and TYPE E (acquisition/ line pipe because per-mile construction API–AOPL asked that examples be divestiture of a pipeline facility). They costs vary significantly depending on included indicating the level of detail noted, for example, that a ‘‘pipeline the environment in which construction that PHMSA expects in these facility’’ may consist of only a few miles is to occur (e.g., rural vs. urban). A notifications. of pipe and questioned whether mileage threshold alone, however, Response: PHMSA has included acquisition/divestiture of such a facility would not identify other significant examples in the instructions. should be reported as TYPE E when a changes (e.g., construction of a new transaction involving the same mileage pump/compressor station) for which C. Comments Applicable to Both Forms would not be reported as TYPE D. construction inspections would be C1. API–AOPL noted that the paper Response: ‘‘Pipeline facility’’ is appropriate. Changes not involving forms are confusing, in large part defined in both Parts 192 and 195 and construction of line pipe and which are because it is difficult to track which includes ‘‘new and existing pipelines, expected to cost $10 million or more questions in later steps apply to specific right-of-ways, and any equipment, should be reported as TYPE F. change types selected in earlier steps. facility, or building used in the Construction of 10 miles or more of line They suggested that PHMSA make

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maximum use of on-line reporting, with D. Master Meter and Small Petroleum Issued in Washington, DC on November 3, the on-line system limiting the Gas Systems 2011. questions presented for completion, The form will specify that operators of Jeffrey D. Wiese, making maximum use of drop-down master meter systems or operators that Associate Administrator for Pipeline Safety. menus, etc. solely operate petroleum gas systems [FR Doc. 2011–29084 Filed 11–8–11; 8:45 am] Response: PHMSA agrees. The new which serve fewer than 100 customers BILLING CODE 4910–60–P regulation requires on-line reporting. from a single source (small petroleum The purpose of the paper form is to gas operators) do not need to follow the collect public comments. The on-line Operator Registry requirements in 49 DEPARTMENT OF TRANSPORTATION system will use ‘‘smart navigation’’ that CFR 191.22 and 195.64. However, this will screen later questions based on Pipeline and Hazardous Materials exception does not extend to operators information entered earlier. Drop down Safety Administration of these systems who also operate other menus will be used whenever possible. system types. Small petroleum gas [Docket No. PHMSA–2011–0294 (PDA– C2. API–AOPL expects the time it 35(R)] takes to complete the form to exceed the operators that do not have an OPID and 15 minutes PHMSA proposed by up to are required to file an incident report New Jersey Regulations on three times as much. will be able to request an OPID during Transportation of Regulated Medical Response: Completion of the OPID the incident filing process. Waste Assignment Request form is intended to III. Proposed Information Collection AGENCY: Pipeline and Hazardous be a one-time effort to collect as much Revisions and Request for Comments as possible of the operator’s information Materials Safety Administration that PHMSA needs. Once this The forms to be created as a result of (PHMSA), DOT. information is completed, PHMSA does this information collection are the OPID ACTION: Public notice and invitation to not require the operator to undertake Assignment Request form and the comment. this effort again. The Operator Registry Operator Registry Notification form. The SUMMARY: Interested parties are invited Notification form will be used to update burden hours associated with these to comment on an application by the any pertinent information that may have information collections are specified as Healthcare Waste Institute (Institute) for changed based on PHMSA’s notification follows: an administrative determination as to requirements since the OPID was Title of Information Collection: whether Federal hazardous material originally issued. Operators will not National Registry of Pipeline and transportation law preempts regulations have to complete the entire form. They Liquefied Natural Gas Operators. OMB Control Number: Pending. of the New Jersey Department of will only update the section that is Type of Request: New information Environmental Protection (NJDEP) applicable to the change for which collection. which apply to the transportation of PHMSA is being notified. Given that Abstract: PHMSA is requiring each regulated medical waste in commerce, most companies know this information operator to have an OPID number. The including the packaging of regulated prior to informing PHMSA, we estimate OPID number will contain detailed medical waste for transportation; that the average time for completing information on the operator. In addition, marking and labeling of containers of these forms will be 15 minutes. PHMSA is requiring that an operator C3. API–AOPL commented that the regulated medical waste offered for provide PHMSA with update transportation or transported; the forms request information not specified notifications for certain changes to in the rule or discussed in the description of regulated medical waste information initially provided by the on documents accompanying shipments rulemaking (e.g., the counties through operator. which involved pipeline is routed). of regulated medical waste and the use Affected Public: Pipeline Operators. and retention of such documents; and They noted that this could be construed Recordkeeping: as rulemaking without notice and the marking of vehicles which transport Estimated Number of Respondents: regulated medical waste. comment. 2,753. DATES: Response: The rule did not specify the Estimated Total Annual Burden Comments received on or before particular information that must be Hours: 5,506. December 27, 2011 and rebuttal submitted for each type of notification. Frequency of collection: On occasion. comments received on or before That is the purpose of these forms, and Comments are invited on: February 8, 2012 will be considered the forms have been subjected to notice (a) The need for the proposed before an administrative determination and comment. collection of information for the proper is issued by PHMSA’s Chief Counsel. C4. API–AOPL suggested that PHMSA performance of the functions of the Rebuttal comments may discuss only expand the instructions, where possible, agency, including whether the those issues raised by comments to include more detail and specific information will have practical utility; received during the initial comment examples. They noted that operators (b) The accuracy of the agency’s period and may not discuss new issues. want to submit all of the information the estimate of the burden of the proposed ADDRESSES: The Institute’s application agency needs and that more detailed collection of information, including the and all comments received may be instructions would help facilitate this. validity of the methodology and reviewed in the Docket Operations Response: PHMSA appreciates API– assumptions used; Facility (M–30), U.S. Department of AOPL’s comments on these forms and (c) Ways to enhance the quality, Transportation, West Building Ground pipeline operators’ efforts to submit utility, and clarity of the information to Floor, Room W12–140, 1200 New Jersey information as needed. PHMSA has be collected; and Avenue SE., Washington, DC 20590. revised the instructions to include more (d) Ways to minimize the burden of The application and all comments are specificity and details. PHMSA invites the collection of information on those available on the U.S. Government stakeholders to submit suggestions for who are to respond, including the use Regulations.gov Web site: http:// additional changes at any time, which of appropriate automated, electronic, www.regulations.gov. will be considered for future revisions mechanical, or other technological Comments must refer to Docket No. of these instructions. collection techniques. PHMSA–2011–0294 and may be

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submitted by any of the following Department of Transportation, 1200 and the HMR, as the NJDEP methods: New Jersey Avenue SE., Washington, requirements are enforced and applied. • Federal eRulemaking Portal: Go to DC 20590; telephone No. (202) 366– The Institute notes that certain non- http://www.regulations.gov. Follow the 4400; facsimile No. (202) 366–7041. Federal requirements on the online instructions for submitting SUPPLEMENTARY INFORMATION: transportation of medical waste have comments. been found to be preempted in • Fax: 1–(202) 493–2251. I. Application for a Preemption Preemption Determination (PD) No. • Mail: Docket Operations Facility Determination 23(RF), ‘‘Morrisville, PA Requirements (M–30), U.S. Department of The Institute has applied to PHMSA for Transportation of ‘Dangerous Transportation, West Building Ground for a determination whether Federal Waste,’’’ 66 FR 37260 (July 17, 2001), Floor, Room W12–140, 1200 New Jersey hazardous material transportation law, decision on petition for reconsideration, Avenue SE., Washington, DC 20590. 49 U.S.C. 5101 et seq., preempts 67 FR 2948 (Jan. 22, 2002), and PD– • Hand Delivery: Docket Operations requirements in Subchapter 3A of Title 29(R), ‘‘Massachusetts Requirements on Facility (M–30), U.S. Department of 7, Chapter 26 of the New Jersey the Storage and Disposal of Infectious or Transportation, West Building Ground Administrative Code, on the Physically Dangerous Medical or Floor, Room W12–140, 1200 New Jersey transportation of regulated medical Biological Waste,’’ 69 FR 34715 (June Avenue SE., Washington, DC 20590, waste in commerce regarding: 22, 2004). As explained in those between 9 a.m. and 5 p.m., Monday • Packaging regulated medical waste decisions, DOT regulates the through Friday, except Federal holidays. for transport off-site, in Sections 7:26– transportation of regulated medical A copy of each comment must also be 3A.10 (segregation of sharps, fluids waste as a Division 6.2 hazardous sent to (1) Alice P. Jacobson, Esq., (greater than 20 cc), and ‘‘other’’ material. PD–23(RF), 66 FR at 37260–61; 2 Director, Healthcare Waste Institute, regulated medical waste); 7:26–3A–11 PD–29(R), 69 FR at 34717. See also 49 4301 Connecticut Avenue NW., Suite (‘‘oversized’’ regulated medical waste CFR 173.134(a)(5). 300, Washington, DC 20008, and (2) that is ‘‘too large to be placed in a II. Federal Preemption Mary Jo M. Aiello, Administrator, New plastic bag or standard container’’); and Section 5125 of 49 U.S.C. contains Jersey Department of Environmental 7:26–3A.27(g) (conditions when a express preemption provisions relevant Protection, Solid and Hazardous Waste transporter must comply with ‘‘pre- to this proceeding. As amended by Management Program, Mail Code 401– transport’’ requirements). 02C, P.O. Box 420, Trenton, NJ 08625– • Section 1711(b) of the Homeland Labeling and marking containers of Security Act of 2002 (Pub. L. 107–296, 0420. A certification that a copy has regulated medical waste with additional been sent to these persons must also be 116 Stat. 2320), 49 U.S.C. 5125(a) information, in Sections 7:26–3A.14 and provides that a requirement of a State, included with the comment. (The 7:26–3A.15, respectively, and 7:26– following format is suggested: ‘‘I certify political subdivision of a State, or 3A.28(c) (additional labeling by a Indian Tribe is preempted—unless the that copies of this comment have been ‘‘subsequent transporter’’ when sent to Mses. Jacobson and Aiello at the non-Federal requirement is authorized ‘‘regulated medical waste is handled by by another Federal law or DOT grants a addresses specified in the Federal more than one transporter’’). Register.’’) • waiver of preemption under § 5125(e) Preparation, use, and retention of a —if Anyone is able to search the ‘‘tracking form’’ describing a shipment electronic form of all comments of regulated medical waste, in Sections (1) Complying with a requirement of the State, political subdivision, or Tribe and a received into any of our dockets by the 7:26–3A.19, 7:26–3A.21, 7:26–3A.28, name of the individual submitting the requirement of this chapter, a regulation 7:26–3A.31 through 7:26–3A.34, 7:26– prescribed under this chapter, or a hazardous comment (or signing a comment 3A.41, and (with respect to rail materials transportation security regulation submitted on behalf of an association, transporters) 7:26–3A–45 & 7:26– or directive issued by the Secretary of business, labor union, etc.). You may 3A.46.1 Homeland Security is not possible; or review DOT’s complete Privacy Act • Preparation and retention of (2) The requirement of the State, political Statement in the Federal Register ‘‘exception reports,’’ in Sections 7:26– subdivision, or Tribe, as applied or enforced, published on April 11, 2000 (65 FR 3A.21, 7:26–3A.22, and 7:26–3A.36. is an obstacle to accomplishing and carrying out this chapter, a regulation prescribed 19477–78), or you may visit http:// • Marking a motor vehicle used to www.regulations.gov. under this chapter, or a hazardous materials transport regulated medical waste with transportation security regulation or directive A subject matter index of hazardous additional information, in Section 7:26– issued by the Secretary of Homeland materials preemption cases, including a 3A.30. Security. listing of all inconsistency rulings and In summary, the Institute contends These two paragraphs set forth the preemption determinations, is available that these requirements are preempted through PHMSA’s home page at http:// ‘‘dual compliance’’ and ‘‘obstacle’’ because they are (1) not ‘‘substantively criteria that PHMSA’s predecessor www.phmsa.dot.gov. From the home the same as’’ requirements in the agency, the Research and Special page, click on ‘‘Hazmat Safety Federal hazardous material Programs Administration, had applied Community,’’ then on ‘‘Regulations,’’ transportation law or the Hazardous in issuing inconsistency rulings prior to then on ‘‘Preemption Documents’’ under Materials Regulations (HMR), 49 CFR 1990, under the original preemption ‘‘Chief Counsel’s Decisions.’’ A paper parts 171–180, on the transportation of provision in the Hazardous Materials copy of the index will be provided at no regulated medical waste, or (2) Transportation Act (HMTA). Public Law cost upon request to Mr. Hilder, at the otherwise an ‘‘obstacle’’ to 93–633 112(a), 88 Stat. 2161 (1975). The address and telephone number set forth accomplishing and carrying out Federal dual compliance and obstacle criteria in FOR FURTHER INFORMATION CONTACT hazardous material transportation law below. 2 In 1991, after a two-year demonstration FOR FURTHER INFORMATION CONTACT: 1 In its application, the Institute refers to Section program, the U.S. Environmental Protection Agency 7:26–3A.47 (‘‘Alternative or innovative technology (EPA) decided not to regulate medical waste, so that Frazer C. Hilder, Office of Chief Counsel authorization’’), but it seems clear that it meant to medical waste is not a ‘‘hazardous waste’’ under the (PHC–2), Pipeline and Hazardous refer to Section 7:26–3A.46 (‘‘Rail shipment Resource Conservation and Recovery Act, 42 U.S.C. Materials Safety Administration, U.S. tracking form requirements’’). 6901 et seq. Id.

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are based on U.S. Supreme Court hazardous materials. More than thirty and consideration of written comments, decisions on preemption. Hines v. years ago, when it was considering the PHMSA publishes its determination in Davidowitz, 312 U.S. 52 (1941); Florida HMTA, the Senate Commerce the Federal Register. See 49 CFR Lime & Avocado Growers, Inc. v. Paul, Committee ‘‘endorse[d] the principle of 107.209(c). A short period of time is 373 U.S. 132 (1963); Ray v. Atlantic preemption in order to preclude a allowed for filing of petitions for Richfield, Inc., 435 U.S. 151 (1978). multiplicity of State and local reconsideration. 49 CFR 107.211. A Subsection (b)(1) of 49 U.S.C. 5125 regulations and the potential for varying petition for judicial review of a final provides that a non-Federal requirement as well as conflicting regulations in the preemption determination must be filed concerning any of the following subjects area of hazardous materials in the United States Court of Appeals is preempted—unless authorized by transportation.’’ S. Rep. No. 1102, 93rd for the District of Columbia or in the another Federal law or DOT grants a Cong. 2nd Sess. 37 (1974). When Court of Appeals for the United States waiver of preemption—when the non- Congress expanded the preemption for the circuit in which the petitioner Federal requirement is not provisions in 1990, it specifically found: resides or has its principal place of ‘‘substantively the same as’’ a provision business, within 60 days after the (3) Many States and localities have enacted of Federal hazardous material laws and regulations which vary from determination becomes final. 49 U.S.C. transportation law, a regulation Federal laws and regulations pertaining to 5127(a). prescribed under that law, or a the transportation of hazardous materials, Preemption determinations do not hazardous materials security regulation thereby creating the potential for address issues of preemption arising or directive issued by the Department of unreasonable hazards in other jurisdictions under the Commerce Clause, the Fifth Homeland Security: and confounding shippers and carriers which Amendment or other provisions of the attempt to comply with multiple and (A) The designation, description, and Constitution, or statutes other than the conflicting registration, permitting, routing, classification of hazardous material. Federal hazardous material (B) The packing, repacking, handling, notification, and other regulatory transportation law unless it is necessary labeling, marking, and placarding of requirements, to do so in order to determine whether (4) Because of the potential risks to life, hazardous material. a requirement is authorized by another (C) The preparation, execution, and use of property, and the environment posed by unintentional releases of hazardous Federal law, or whether a fee is ‘‘fair’’ shipping documents related to hazardous within the meaning of 49 U.S.C. material and requirements related to the materials, consistency in laws and number, contents, and placement of those regulations governing the transportation of 5125(f)(1). A State, local or Indian Tribe documents. hazardous materials is necessary and requirement is not authorized by (D) The written notification, recording, and desirable, another Federal law merely because it is reporting of the unintentional release in (5) In order to achieve greater uniformity not preempted by another Federal transportation of hazardous material. and to promote the public health, welfare, statute. Colorado Pub. Util. Comm’n v. (E) The designing, manufacturing, and safety at all levels, Federal standards for Harmon, above, 951 F.2d at 1581 n.10. fabricating, inspecting, marking, maintaining, regulating the transportation of hazardous In making preemption determinations reconditioning, repairing, or testing a materials in intrastate, interstate, and foreign under 49 U.S.C. 5125(d), PHMSA is commerce are necessary and desirable. package, container, or packaging component guided by the principles and policies set that is represented, marked, certified, or sold Public Law 101–615 2, 104 Stat. 3244. as qualified for use in transporting hazardous forth in Executive Order No. 13132, material.3 (In 1994, Congress revised, codified and entitled ‘‘Federalism’’ (64 FR 43255 enacted the HMTA ‘‘without substantive (Aug. 10, 1999)), and the President’s To be ‘‘substantively the same,’’ the change,’’ at 49 U.S.C. chapter 51. Public May 20, 2009 memorandum on non-Federal requirement must conform Law 103–272, 108 Stat. 745 (July 5, ‘‘Preemption’’ (74 FR 24693 (May 22, ‘‘in every significant respect to the 1994).) A United States Court of 2009)). Section 4(a) of that Executive Federal requirement. Editorial and other Appeals has found uniformity was the Order authorizes preemption of State similar de minimis changes are ‘‘linchpin’’ in the design of the Federal 4 laws only when a statute contains an permitted.’’ 49 CFR 107.202(d). laws governing the transportation of express preemption provision, there is The 2002 amendments and 2005 hazardous materials. Colorado Pub. Util. other clear evidence Congress intended reenactment of the preemption Comm’n v. Harmon, 951 F.2d 1571, to preempt State law, or the exercise of provisions in 49 U.S.C. 5125 reaffirmed 1575 (10th Cir. 1991). State authority directly conflicts with Congress’s long-standing view that a the exercise of Federal authority. The III. Preemption Determinations single body of uniform Federal President’s May 20, 2009 memorandum regulations promotes safety (including Under 49 U.S.C. 5125(d)(1), any sets forth the policy ‘‘that preemption of security) in the transportation of person (including a State, political State law by executive departments and subdivision of a State, or Indian Tribe) agencies should be undertaken only 3 Subparagraph (E) was editorially revised in Sec. directly affected by a requirement of a 7122(a) of the Hazardous Materials Transportation with full consideration of the legitimate Safety and Security Reauthorization Act of 2005, State, political subdivision or Tribe may prerogatives of the States and with a which is Title VII of the Safe, Accountable, apply to the Secretary of Transportation sufficient legal basis for preemption.’’ Flexible, Efficient Transportation Equity Act: A for a determination whether the Section 5125 contains express Legacy for Users (SAFETEA–LU), Public Law 109– requirement is preempted. The 59, 119. Stat. 1891 (Aug. 10, 2005). Technical preemption provisions, which PHMSA corrections to cross-references in subsections (d), Secretary of Transportation has has implemented through its (e), and (g) were made in Public Law 110–244, Sec. delegated authority to PHMSA to make regulations. 302(b), 122 Stat. 1618 (June 6, 2008). determinations of preemption, except 4 Additional standards apply to preemption of for those concerning highway routing IV. Public Comments non-Federal requirements on highway routes over which hazardous materials may or may not be (which have been delegated to the All comments should be directed to transported and fees related to transporting Federal Motor Carrier Safety whether 49 U.S.C. 5125 preempts the hazardous material. See 49 U.S.C. 5125(c) and (f). Administration). 49 CFR 1.53(b). New Jersey regulations on the See also 49 CFR 171.1(f) which explains that a Section 5125(d)(1) requires notice of transportation of regulated medical ‘‘facility at which functions regulated under the HMR are performed may be subject to applicable an application for a preemption waste in commerce. Comments should laws and regulations of state and local governments determination to be published in the specifically address the preemption and Indian tribes.’’ Federal Register. Following the receipt criteria discussed in Part II above.

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Issued in Washington, DC, on November 7, issues,1 formal expressions of intent to By the Board. 2011. file an OFA under 49 CFR Rachel D. Campbell, Vanessa L. Allen Sutherland, 1152.27(c)(2),2 and trail use/rail banking Director, Office of Proceedings. Chief Counsel. requests under 49 CFR 1152.29 must be Jeffrey Herzig, [FR Doc. 2011–29155 Filed 11–9–11; 8:45 am] filed by November 21, 2011. Petitions to Clearance Clerk. BILLING CODE 4910–60–P reopen or requests for public use [FR Doc. 2011–29095 Filed 11–9–11; 8:45 am] conditions under 49 CFR 1152.28 must BILLING CODE 4915–01–P be filed by November 30, 2011, with the DEPARTMENT OF TRANSPORTATION Surface Transportation Board, 395 E Street SW., Washington, DC 20423– DEPARTMENT OF TRANSPORTATION Surface Transportation Board 0001. A copy of any petition filed with the Surface Transportation Board [Docket No. AB 55 (Sub-No. 713X)] Board should be sent to CSXT’s representative: Louis E. Gitomer, 600 [Docket No. FD 35559] CSX Transportation, Inc.— Baltimore Ave., Suite 301, Towson, MD Saratoga and North Creek Railway, Abandonment Exemption—in Monroe 21204. LLC—Operation Exemption—Tahawus County, AL If the verified notice contains false or Line misleading information, the exemption CSX Transportation, Inc. (CSXT), filed is void ab initio. Saratoga and North Creek Railway, a verified notice of exemption under 49 CSXT has filed a combined LLC (Saratoga),1 a Class III rail carrier, CFR part 1152 subpart F—Exempt environmental and historic report has filed a verified notice of exemption Abandonments to abandon an which addresses the effects, if any, of under 49 CFR 1150.41 to operate an approximately 1.5-mile rail line on its the abandonment on the environment approximately 29.71-mile line of Southern Region, Atlanta Division, and historic resources. OEA will issue railroad, known as the Tahawus Line. Southern Alabama Subdivision, an environmental assessment (EA) by Saratoga states that the Tahawus Line between mileposts 0RA 676.27 and 0RA November 15, 2011. Interested persons currently is private track owned by NL 677.79 at the end of the track, in Hybart, may obtain a copy of the EA by writing Industries, Inc. (NL), an industrial Monroe County, AL. The line traverses to OEA (Room 1100, Surface concern which is selling the line to United States Postal Service Zip Code Transportation Board, Washington, DC Saratoga in the very near future.2 The 36481. 20423–0001) or by calling OEA at (202) rail line extends between the existing CSXT has certified that: (1) No local 245–0305. Assistance for the hearing connection with Saratoga at milepost traffic has moved over the line for at impaired is available through the NC 0.0 at North Creek, N.Y., and its least 2 years; (2) there is no overhead Federal Information Relay Service at 1– terminus at milepost NC 29.71 at traffic on the line; (3) no formal (800) 877–8339. Comments on Newcomb. Saratoga intends to provide complaint filed by a user of rail service environmental and historic preservation common carrier rail service over the on the line (or by a state or local matters must be filed within 15 days subject line connecting to its existing government entity acting on behalf of after the EA becomes available to the trackage at North Creek and extending such user) regarding cessation of service public. to its connection with CP at Saratoga over the line either is pending with the Environmental, historic preservation, Springs. Surface Transportation Board (Board) or public use, or trail use/rail banking Saratoga certifies that as a result of with any U.S. District Court or has been conditions will be imposed, where this transaction its projected annual decided in favor of complainant within appropriate, in a subsequent decision. the 2-year period; and (4) the Pursuant to the provisions of 49 CFR 1 Saratoga is a limited liability company, wholly requirements at 49 CFR 1105.7(c) 1152.29(e)(2), CSXT shall file a notice of owned by San Luis & Rio Grande Railroad (SLRG). consummation with the Board to signify SLRG is a Class III rail carrier and a subsidiary of (environmental report), 49 CFR 1105.11 Permian Basin Railways, Inc. (Permian), which in (transmittal letter), 49 CFR 1105.12 that it has exercised the authority turn is owned by Iowa Pacific Holdings, LLC (IPH). (newspaper publication), and 49 CFR granted and fully abandoned the line. If IPH and Permian formed Saratoga for the purpose consummation has not been effected by of operating the entire Tahawus Line between 1152.50(d)(1) (notice to governmental Newcomb, N.Y., on the north and Saratoga Springs, agencies) have been met. CSXT’s filing of a notice of consummation by November 10, 2012, N.Y., on the south, interchanging traffic with the As a condition to this exemption, any Delaware & Hudson Railway Company, Inc. d/b/a and there are no legal or regulatory employee adversely affected by the Canadian Pacific (CP) at Saratoga Springs. In 2 barriers to consummation, the authority previous proceedings, the Board authorized abandonment shall be protected under to abandon will automatically expire. Saratoga to operate between Saratoga Springs and Oregon Short Line Railroad— Board decisions and notices are North Creek. See Saratoga & N. Creek Ry.—Acquis. & Operation Exemption—Del. & Hudson Ry., Abandonment Portion Goshen Branch available on our Web site at http:// Between Firth & Ammon, in Bingham & Docket No. FD 35500 (STB served June 1, 2011) and www.stb.dot.gov. Saratoga & N. Creek Ry., LLC—Operation Bonneville Counties, Idaho, 360 I.C.C. Exemption—Warren Cnty., N.Y., Docket No. FD 91 (1979). To address whether this Decided: November 4, 2011. 35500 (Sub-No. 1) (STB served June 1, 2011). condition adequately protects affected 2 Saratoga states that the subject trackage is employees, a petition for partial 1 The Board will grant a stay if an informed exempt from Board regulation and has never been decision on environmental issues (whether raised operated in common carrier service and therefore it revocation under 49 U.S.C. 10502(d) by a party or by the Board’s Office of Environmental does not need any Board authority to acquire this must be filed. Analysis (OEA) in its independent investigation) trackage as such property is outside the Board’s Provided no formal expression of cannot be made before the exemption’s effective jurisdiction. Saratoga cites B. Willis, C.P.A., Inc.— date. See Exemption of Out-of-Serv. Rail Lines, 5 Petition for Declaratory Order, FD No. 34013 (STB intent to file an offer of financial I.C.C.2d 377 (1989). Any request for a stay should served Oct. 3, 2001) (B. Willis)., aff’d sub nom. B. assistance (OFA) has been received, this be filed as soon as possible so that the Board may Willis, C.P.A., Inc. v. STB, 51 Fed Appx. 321 (D.C. exemption will be effective on take appropriate action before the exemption’s Cir. 2002) in support of this proposition. Saratoga December 10, 2011, unless stayed effective date. states that it has executed an agreement to acquire 2 Each OFA must be accompanied by the filing the line from NL and that it anticipates pending reconsideration. Petitions to fee, which is currently set at $1,500. See 49 CFR consummating the acquisition before the exemption stay that do not involve environmental 1002.2(f)(25). in this proceeding becomes effective.

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revenues will not exceed $5 million and DATES: Written comments should be are correctly reporting the amount of will not result in Saratoga becoming a received on or before December 12, 2011 wagers and paying the required tax. Class I or Class II rail carrier. to be assured consideration. Respondents: Private Sector: Saratoga states that it intends to Businesses or other for-profits. Internal Revenue Service (IRS) consummate the transaction at least 30 Estimated Total Burden Hours: days from the effective date of the OMB Number: 1545–0108. 418,362. exemption (around late November Type of Review: Extension without OMB Number: 1545–0619. 2011). The earliest this transaction can change of a currently approved Type of Review: Revision of a be consummated is November 24, 2011, collection. currently approved collection. the effective date of the exemption (30 Title: Annual Summary and Title: Credit for Increasing Research days after the exemption was filed). Transmittal of U.S. Information Returns. Activities. If the notice contains false or Forms: 1096. Form: 6765. misleading information, the exemption Abstract: Form 1096 is used to Abstract: IRC section 38 allows a is void ab initio. Petitions to revoke the transmit information returns (Forms credit against income tax (determined exemption under 49 U.S.C. 10502(d) 1099, 1098, 5498, and W–2G) to the IRS under IRC section 41) for an increase in may be filed at any time. The filing of Service Centers. Under IRC section 6041 research activities in a trade or business. a petition to revoke will not and related sections, a separate Form Form 6765 is used by businesses automatically stay the transaction. Stay 1096 is used for each type of return sent individuals engaged in a trade or petitions must be filed no later than to the service center by the payer. It is business to figure and report the credit. November 17, 2011 (at least 7 days used by IRS to summarize and The data is used to verify that the credit before the exemption becomes categorize the transmitted forms. claimed is correct. effective). Respondents: Private Sector: Respondents: Private Sector: An original and 10 copies of all Businesses or other for-profits. Businesses or other for-profits. pleadings, referring to Docket No. FD Estimated Total Burden Hours: Estimated Total Burden Hours: No. 35559, must be filed with the 1,016,812. 285,281. Surface Transportation Board, 395 E OMB Number: 1545–0120. OMB Number: 1545–0748. Street SW., Washington, DC 20423– Type of Review: Revision of a Type of Review: Extension without 0001. In addition, one copy of each currently approved collection. change of a currently approved pleading must be served on John D. Title: Certain Government Payments. collection. Heffner, Strasburger & Price, 1700 K Forms: 1099–G. Title: Employer Appointment of Street NW., Suite 640, Washington, DC Abstract: Form 1099–G is used by Agent. 20006. governments (primarily state and local) Form: 2678. Board decisions and notices are to report to the IRS (and notify Abstract: Title 26 U.S.C. 3504 available on our Web site at http:// recipients of) certain payments (e.g., authorizes an employer to designate a www.stb.dot.gov. unemployment compensation and fiduciary, agent, etc., to perform the Decided: November 4, 2011. income tax refunds). IRS uses the same acts as required of employers for information to insure that the income is By the Board. purposes of employment taxes. Form being properly reported by the Rachel D. Campbell, 2678 is used by an employer to notify recipients on their returns. the Director, Internal Revenue Service Director, Office of Proceedings. Respondents: State and local Center, of the appointment of an agent Jeffrey Herzig, governments. to pay wages on behalf of the employer. Clearance Clerk. Estimated Total Burden Hours: In addition, the completed form is an [FR Doc. 2011–29136 Filed 11–9–11; 8:45 am] 17,080,000. authorization to withhold and pay taxes BILLING CODE 4915–01–P OMB Number: 1545–0177. via Form 941, Employer’s Quarterly Type of Review: Extension without Federal Tax Return, for the employees change of a currently approved involved. collection. Respondents: Private Sector: DEPARTMENT OF THE TREASURY Title: Casualties and Thefts. Businesses or other for-profits, Not-for- Submission for OMB Review; Form: 4684. profit institutions. Comment Request Abstract: Form 4684 is used by Estimated Total Burden Hours: taxpayers to compute their gain or loss 13,731,200. November 4, 2011. from casualties or thefts, and to OMB Number: 1545–0877. The Department of the Treasury will summarize such gains and losses. The Type of Review: Extension without submit the following public information data is used to verify that the correct change of a currently approved collection requirements to OMB for gain or loss has been computed. collection. review and clearance under the Respondents: Individuals and Title: Acquisition or Abandonment of Paperwork Reduction Act of 1995, Households. Secured Property. Public Law 104–13 on or after the date Estimated Total Burden Hours: Form: 1099–A. of publication of this notice. A copy of 1,486,659. Abstract: Form 1099–A is used by the submissions may be obtained by OMB Number: 1545–0235. persons who lend money in connection calling the Treasury Bureau Clearance Type of Review: Revision of a with a trade or business, and who Officer listed. Comments regarding currently approved collection. acquire an interest in the property that these information collections should be Title: Monthly Tax Return for Wagers. is security for the loan or who have addressed to the OMB reviewer listed Forms: 730. reason to know that the property has and to the Treasury PRA Clearance Abstract: Form 730 is used to identify been abandoned, to report the Officer, Department of the Treasury, taxable wagers and collect the tax acquisition or abandonment. 1750 Pennsylvania Avenue NW., Suite monthly. The information is used to Respondents: Private Sector: 11010, Washington, DC 20220. determine if persons accepting wagers Businesses or other for-profits.

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Estimated Total Burden Hours: FOR FURTHER INFORMATION, CONTACT: Ms. Administrative Responsibility over 61,817. Anna Millikan, Program Analyst, Discipline, Suggested Adoption of Bureau Clearance Officer: Yvette National Public Liaison, CL: NPL, 7559, USPAP by OPR in Judging Appraiser Lawrence, Internal Revenue Service, 1111 Constitution Avenue NW., Conduct. Reports from the four IRSAC 1111 Constitution Avenue NW., Washington, DC 20224. Telephone: subgroups, Large Business and Washington, DC 20224; (202) 927–4374 (202) 622–6433 (not a toll-free number). International, Small Business/Self- _ OMB Reviewer: Shagufta Ahmed, Email address: *public [email protected]. Employed, Wage & Investment, and the Office of Professional Responsibility Office of Management and Budget, New SUPPLEMENTARY INFORMATION: Notice is will also be presented and discussed. Executive Office Building, Room 10235, hereby given pursuant to section 10(a) Washington, DC 20503; (202) 395–7873. Last minute agenda changes may (2) of the Federal Advisory Committee preclude advanced notice. The meeting Dawn D. Wolfgang, Act, 5 U.S.C. App. (1988), a public room accommodates approximately 80 Treasury PRA Clearance Officer. meeting of the IRSAC will be held on people, IRSAC members and Internal Wednesday, November 16, 2011, from [FR Doc. 2011–29099 Filed 11–9–11; 8:45 am] Revenue Service officials inclusive. Due 9 a.m. to 1:15 p.m. at the Embassy BILLING CODE 4830–01–P to limited seating, please call Anna Suites Hotel, 1250 22nd Street NW., Millikan to confirm your attendance. Consulate/Ambassador Room, Ms. Millikan can be reached at (202) DEPARTMENT OF THE TREASURY Washington, DC 20037. Issues to be 622–6433. Attendees are encouraged to discussed include, but not limited to: arrive at least 30 minutes before the Internal Revenue Service Remote Work, Commercial Awareness, meeting begins. Should you wish the Schedule UTP, Distance Learning, IRSAC to consider a written statement, Advisory Council to the Internal Empower Exam Managers as an please write to Internal Revenue Revenue Service; Meeting Alternative to SBSE Fast Track Service, Office of National Public Settlement Program, Enhance Worker Liaison, CL:NPL:7559, 1111 AGENCY: Internal Revenue Service (IRS), Classification Compliance with Treasury. Constitution Avenue NW., Washington, Voluntary Disclosure, Enhance DC 20224, or email ACTION: Notice. Collection by taking Unsecured Debt *[email protected]. into Consideration, Schedule D (Capital SUMMARY: The Internal Revenue Service Gains and Losses) Instructions and New Dated: October 26, 2011. Advisory Council (IRSAC) will hold a Reporting Requirements, Repeater Candice Cromling, public meeting on Wednesday, Balance Due Taxpayers, Refundable Director, National Public Liaison. November 16, 2011. Adoption Credit, Exclusive Authority [FR Doc. 2011–29304 Filed 11–8–11; 4:15 pm] DATES: November 16, 2011. over Discipline, Coordination of BILLING CODE 4830–01–P

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Part II

Department of Health and Human Services

Centers for Medicare & Medicaid Services 42 CFR Parts 413 and 414 Medicare Program; End-Stage Renal Disease Prospective Payment System and Quality Incentive Program; Ambulance Fee Schedule; Durable Medical Equipment; and Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies; Final Rule

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DEPARTMENT OF HEALTH AND published on April 6, 2011 (76 FR b. ESRD PPS Base Rate HUMAN SERVICES 18930). Additionally, effective January 2. ESRD Bundled Market Basket 12, 2012 the interim rule amending 42 a. Overview and Background Centers for Medicare & Medicaid CFR Part 414, published on January 16, b. Final Market Basket Update Increase Services Factor and Labor-Related Share for ESRD 2009 (74 FR 2873), is confirmed as final. Facilities for CY 2012 FOR FURTHER INFORMATION CONTACT: c. Productivity Adjustment 42 CFR Parts 413 and 414 Terri Deutsch, (410) 786–4533, for d. Calculation of the ESRDB Market Basket [CMS–1577–F] issues related to ESRD. Update, Adjusted for Multifactor Roechel Kujawa, (410) 786–9111, for Productivity for CY 2012 RIN 0938–AQ27 issues related to ambulance services. 3. Transition Budget-Neutrality Heidi Oumarou, (410) 786–7942, for Adjustment for CY 2011 Medicare Program; End-Stage Renal 4. Transition Budget-Neutrality issues related to the ESRD market Disease Prospective Payment System Adjustment for CY 2012 basket. and Quality Incentive Program; 5. Low-Volume Facility Provisions Shannon Kerr, (410) 786–3039, for Ambulance Fee Schedule; Durable 6. Update to the Drug Add-On to the issues related to the quality incentive Medical Equipment; and Competitive Composite Rate Portion of the ESRD program. Blended Payment Rate Acquisition of Certain Durable Medical Sandhya Gilkerson, (410) 786–4085, a. Estimating Growth in Expenditures for Equipment, Prosthetics, Orthotics and for issues related to DME MLR. Drugs and Biologicals in CY 2012 Supplies Hafsa Bora, (410) 786–7899 or Iffat b. Estimating per Patient Growth Fatima, (410) 786–6709, for DMEPOS c. Applying the Growth Update to the Drug AGENCY: Centers for Medicare & Add-On Adjustment Medicaid Services (CMS), HHS. Competitive Acquisition Program issues d. Update to the Drug Add-On Adjustment ACTION: Final rule. related to comments received on an for CY 2012 interim final rule that implemented 7. Updates to the Wage Index Values and SUMMARY: This final rule updates and provisions of MIPPA effective April 18, Wage Index Floor for the Composite Rate makes certain revisions to the End-Stage 2009. Portion of the Blended Payment and the Renal Disease (ESRD) prospective SUPPLEMENTARY INFORMATION: ESRD PPS Payment payment system (PPS) for calendar year a. Reduction to the ESRD Wage Index Floor (CY) 2012. We are also finalizing the Addenda Are Only Available Through b. Policies for Areas with no Hospital Data interim final rule with comment period the Internet on the CMS Web Site c. Wage Index Budget-Neutrality Adjustment published on April 6, 2011, regarding In the past, a majority of the Addenda d. ESRD PPS Wage Index Tables the transition budget-neutrality referred to throughout the preamble of 8. Drugs adjustment under the ESRD PPS,. This our proposed and final rules were a. Vancomycin final rule also sets forth requirements available in the Federal Register. b. Drug Overfill for the ESRD quality incentive program However, the Addenda of the annual 9. Revisions to Patient-Level Adjustment (QIP) for payment years (PYs) 2013 and proposed and final rules will no longer for Body Surface Area (BSA) 2014. In addition, this final rule revises be available in the Federal Register. 10. Revisions to the Outlier Policy the ambulance fee schedule regulations Instead, these Addenda to the annual a. Revisions Related to Outlier ESRD Drugs to conform to statutory changes. This proposed and final rules will be and Biologicals b. Exclusion of Automated Multi-Channel final rule also revises the definition of available only through the Internet on Chemistry (AMCC) Laboratory Tests durable medical equipment (DME) by the CMS Web site. The Addenda to the From the Outlier Calculation adding a 3-year minimum lifetime End-Stage Renal Disease (ESRD) c. Impact of Final Changes to the Outlier requirement (MLR) that must be met by Prospective Payment System (PPS) rules Policy an item or device in order to be are available at: http://www.cms.gov/ D. Technical Corrections considered durable for the purpose of ESRDPayment/PAY/list.asp. Readers 1. Training Add-On classifying the item under the Medicare who experience any problems accessing 2. ESRD-Related Laboratory Test benefit category for DME. Finally, this any of the Addenda to the proposed and E. Clarifications to the CY 2011 ESRD PPS final rule implements certain provisions final rules that are posted on the CMS 1. ICD–9–CM Diagnosis Codes 2. Emergency Services to ESRD of section 154 of the Medicare Web site identified above should Beneficiaries Improvements for Patients and contact Lisa Hubbard at (410) 786–4533. F. Miscellaneous Comments Providers Act of 2008 (MIPPA) related Table of Contents II. End-Stage Renal Disease Quality Incentive to the durable medical equipment, Program for Payment Years (PYs) 2013 prosthetics, orthotics and supplies To assist readers in referencing and 2014 (DMEPOS) Competitive Acquisition sections contained in this preamble, we A. Background for the End-Stage Renal Program and responds to comments are providing a Table of Contents. Some Disease Quality Incentive Program for PY received on an interim final rule of the issues discussed in this preamble 2013 and PY 2014 published January 16, 2009, that affect the payment policies, but do not B. Summary of the Proposed Provisions require changes to the regulations in the and Responses to Comments on the End- implemented these provisions of MIPPA Stage Renal Disease (ESRD) Quality effective April 18, 2009. (See the Table Code of Federal Regulations (CFR). Incentive Program (QIP) for PY 2013 and of Contents for a listing of the specific I. Calendar Year (CY) 2012 End-Stage Renal PY 2014 issues addressed in this final rule.) Disease (ESRD) Prospective Payment 1. PY 2013 ESRD QIP Requirements DATES: Effective dates: These regulations System (PPS) a. Performance Measures for the PY 2013 are effective on January 1, 2012. Also, A. Background on the End-Stage Renal ESRD QIP effective January 1, 2012, we are Disease Prospective Payment System b. Performance Period and Case Minimum B. Summary of the Proposed Provisions for the PY 2013 ESRD QIP finalizing the interim final rule with and Responses to Comments on the CY c. Performance Standards for the PY 2013 comment (‘‘Medicare Programs: Changes 2012 ESRD PPS ESRD QIP to the End-Stage Renal Disease 1. Updates to the Composite Rate and d. Methodology for Calculating the Total Prospective Payment System Transition ESRD PPS Base Rate Performance Score and Payment Budget-Neutrality Adjustment’’) a. Composite Rate Reduction for the PY 2013 ESRD QIP

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2. PY 2014 ESRD QIP 2. Application of the 3-Year MLR to Multi- CMS Centers for Medicare & Medicaid a. Performance Measures for the PY 2014 Component Devices Services ESRD QIP V. Interim Final Rule Regarding the CPM Clinical Performance Measure i. Anemia Management Measure Competitive Acquisition Program for CPT Current Procedural Terminology ii. Dialysis Adequacy Measure Certain Durable Medical Equipment, CROWNWeb Consolidated Renal iii. Vascular Access Type (VAT) Measure Prosthetics, Orthotics and Supplies Operations in a Web-Enabled Network iv. Vascular Access Infections Measure (DMEPOS) v. Standardized Hospitalization Ratio A. Background DFC Dialysis Facility Compare (SHR)-Admissions Measure 1. Legislative and Regulatory History of the DFR Dialysis Facility Report vi. Minimum Case Number for Clinical DMEPOS Competitive Bidding Program DME Durable Medical Equipment Measures and Other Considerations 2. The MIPPA and the Medicare DMEPOS ESA Erythropoiesis stimulating agent vii. National Healthcare Safety Network Competitive Bidding Program ESRD End-Stage Renal Disease (NHSN) Dialysis Event Reporting B. Overview of the Interim Final Rule ESRDB End-Stage Renal Disease Bundled Measure C. Summary of the Interim Final Rule FDA Food and Drug Administration viii. Patient Experience of Care Survey Provisions and Response to Comments FI/MAC Fiscal Intermediary/Medicare Usage Measure on Changes to the Competitive Administrative Contractor ix. Mineral Metabolism Reporting Measure Acquisition of Certain Durable Medical FY Fiscal Year 3. Performance Period for the PY 2014 Equipment, Prosthetics, Orthotics and GDP Gross Domestic Product ESRD QIP Supplies (DMEPOS) by Certain HAI Healthcare-associated Infections 4. Performance Standards and the Provisions of the Medicare Methodology for Calculating the Total Improvements for Patients and Providers HCPCS Healthcare Common Procedure Performance Score for the PY 2014 ESRD Act of 2008 (MIPPA) Coding System QIP 1. General Changes to the DMEPOS HD Hemodialysis i. Performance Standards for the PY 2014 Competitive Bidding Program HHD Home Hemodialysis ESRD QIP a. Temporary Delay of the Medicare ICD–9–CM International Classification of ii. Setting Performance Benchmarks and DMEPOS Competitive Bidding Program Diseases, 9th Edition, Clinical Thresholds b. Supplier Feedback on Missing Covered Modifications iii. Scoring Provider and Facility Documents ICH CAHPS In-Center Hemodialysis Performance on Clinical Measures Based c. Disclosure of Subcontractors and Their Consumer Assessment of Healthcare on Achievement Accreditation Status Under the Advisors iv. Scoring Provider/Facility Performance Competitive Bidding Program on Clinical Measures Based on IGI IHS Global Insight d. Exemption From Competitive Bidding IPPS Inpatient Prospective Payment System Improvement for Certain DMEPOS v. Calculating the VAT Measure Score KDIGO Kidney Disease: Improving Global e. Exclusion of Group 3 Complex vi. Calculating the NHSN Dialysis Event Outcomes Rehabilitative Power Wheelchairs Reporting Measure, Patient Experience KDOQI Kidney Disease Outcome Quality 2. Round 1 Changes to the Competitive Survey Usage Reporting Measure and Bidding Program Initiative Mineral Metabolism Reporting Measure a. Rebidding of the ‘‘Same Areas’’ as the Kt/V A measure of dialysis adequacy where Scores Previous Round 1, Unless Otherwise K is dialyzer clearance, t is dialysis time, vii. Weighting of the PY 2014 ESRD QIP Specified and V is total body water volume Measures and Calculation of the PY 2014 LDO Large Dialysis Organization ESRD QIP b. Rebidding of the ‘‘Same Items and MAP Medicare Allowable Payment viii. Examples for 2014 ESRD QIP Services’’ as the Previous Round 1, Performance Scoring Model Unless Otherwise Specified MCP Monthly Capitation Payment 6. Payment Reductions for the PY 2014 D. Other Public Comments Received on the MIPPA Medicare Improvements for Patients ESRD QIP January 16, 2009 Interim Final Rule and Providers Act of 2008 (Pub. L. 110– 7. Public Reporting Requirements VI. Collection of Information Requirements 275) 8. Future QIP Measures VII. Economic Analyses MMA Medicare Prescription Drug, 9. Process of Updating Measures VIII. Regulatory Flexibility Act Analysis Improvement and Modernization Act of III. Ambulance Fee Schedule IX. Unfunded Mandates Reform Act Analysis 2003 X. Federalism Analysis A. Summary of Proposed Provisions MMEA Medicare and Medicaid Extenders XI. Files Available to the Public via the 1. Section 106 of the Medicare and Act of 2010 Public Law 111–309 Medicaid Extenders Act of 2010 (MMEA) Internet Regulations Text MFP Multifactor Productivity a. Amendment to Section 1834(l)(13) of the NHSN National Healthcare Safety Network Act Acronyms NQF National Quality Forum b. Amendment to Section 146(b)(1) of PD Peritoneal Dialysis MIPPA Because of the many terms to which c. Amendment to Section 1834(l)(12) of the we refer by acronym in this final rule, PFS Physician Fee Schedule Act we are listing the acronyms used and PPS Prospective Payment System 2. Technical Correction their corresponding meanings in PSR Performance Score Report PY Payment Year B. Response to Comments alphabetical order below: IV. Durable Medical Equipment and Supplies QIP Quality Incentive Program A. Background for Durable Medical AMCC Automated Multi-Channel REMIS Renal Management Information Equipment (DME) and Supplies Chemistry System B. Current Issues ASP Average Sales Price RFA Regulatory Flexibility Act C. Overview of the Provisions of the AV Arteriovenous RUL Reasonable Useful Lifetime Proposed Durable Medical Equipment BLS Bureau of Labor Statistics SBA Small Business Administration BMI Body Mass Index (DME) Regulation SIMS Standard Information Management D. Summary of the Proposed Provisions BSA Body Surface Area System and Responses to Comments on the CY Calendar Year SHR Standardized Hospitalization Ratio Definition of Durable Medical CBSA Core-Based Statistical Area Equipment (DME) and the 3-Year CDC Centers for Disease Control and SSA Social Security Administration Minimum Lifetime Requirement (MLR) Prevention The Act Social Security Act 1. Application of the 3-Year MLR to Items CLABSI Central Line Access Bloodstream The Affordable Care Act The Patient Currently Covered as DME and to Infections Protections and Affordable Care Act Supplies and Accessories of Covered CFR Code of Federal Regulations URR Urea reduction ratio DME CIP Core Indicators Project VBP Value Based Purchasing

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I. Calendar Year (CY) 2012 End-Stage did not increase as a result of the a comment period that ended on August Renal Disease (ESRD) Prospective provision that permits ESRD facilities to 30, 2011 (76 FR 40498). In that proposed Payment System (PPS) be excluded from the 4-year transition. rule, for the ESRD PPS, we proposed to • Payment adjustments for dialysis (1) make a number of routine updates A. Background on the End-Stage Renal treatments furnished to adults for for CY 2012, (2) implement the second Disease Prospective Payment System patient age, body surface area (BSA), year of the transition, (3) make several On August 12, 2010, we published in low body mass index (BMI), onset of policy changes and clarifications, and the Federal Register, a final rule (75 FR dialysis, and six specified co- (4) technical changes with regard to the 49030 through 49214), entitled, ‘‘End- morbidities. CY 2011 ESRD PPS final rule. We Stage Renal Disease Prospective • A home or self-care dialysis training received approximately 40 public Payment System’’, hereinafter referred payment adjustment of $33.44 per comments on the ESRD PPS proposals, to as the CY 2011 ESRD PPS final rule. treatment paid in addition to the case- including comments from dialysis In the CY 2011 ESRD PPS final rule, we mix adjusted per treatment amount, facilities, the national organizations implemented a case-mix adjusted which is wage adjusted and applies to representing dialysis facilities, bundled PPS for Medicare outpatient claims for patients trained by ESRD nephrologists, patients, pharmaceutical ESRD dialysis patients beginning facilities certified to provide home manufacturers, hospitals and their January 1, 2011, in accordance with dialysis training. representatives, and MedPAC. In this • section 1881(b)(14) of the Social Payment adjustments for dialysis final rule, we provide a summary of Security Act (the Act), as added by treatments furnished to pediatric each proposed provision, a summary of section 153(b) of the Medicare patients for patient age and dialysis the public comments received, our Improvements for Patients and modality. responses to them, and what we are • Providers Act of 2008 (MIPPA). The A low-volume payment adjustment finalizing for the CY 2012 ESRD PPS in ESRD PPS replaced the basic case-mix for adult patients of 18.9 percent that this final rule. adjusted composite payment system and applies to the otherwise applicable case- the methodologies for the mix adjusted payment rate for facilities 1. Updates to the Composite Rate and reimbursement of separately billable that qualify as low-volume ESRD ESRD PPS Base Rate outpatient ESRD services. facilities. a. Composite Rate Also, section 1881(b)(14)(F) of the • An outlier payment policy that Act, as added by section 153(b) of provides an additional payment to Section 1881(b)(14)(E)(i) of the Act MIPPA and amended by section 3401(h) ESRD facilities treating high cost, requires a 4-year transition under the of Public Law 111–148, the Affordable resource-intensive patients. ESRD PPS. For CY 2012, under 42 CFR Care Act, established that beginning CY • The wage index adjustment that is 413.239(a)(2), ESRD facilities that 2012, and each subsequent year, the applied when calculating the ESRD PPS receive payment through the transition Secretary shall reduce the market basket payment rates in order to account for receive a blended rate equal to the sum increase factor by a productivity geographic differences in area wage of 50 percent of the ESRD PPS amount adjustment described in section levels. and 50 percent of the basic case-mix 1886(b)(3)(B)(xi)(II) of the Act. • An ESRD bundled (ESRDB) market adjusted composite payment amount. In the CY 2011 ESRD PPS final rule basket index used to project prices in Accordingly, we continue to update the (75 FR 49030), the Centers for Medicare the costs of goods and services used to composite rate portion of the blended & Medicaid Services (CMS) finalized the furnish outpatient maintenance dialysis. payment during the 4-year transition following: In addition, on April 6, 2011, we (that is, CYs 2011 through 2013). For a • A base rate of $229.63 per treatment published an interim final rule with historical perspective of the basic case- for renal dialysis services (but comment period in the Federal Register mix adjusted composite payment system postponed payment for oral-only renal (76 FR 18930), entitled ‘‘Changes in the for ESRD facilities, including the CY dialysis drugs under the ESRD PPS until End-Stage Renal Disease Prospective 2011 update to the composite rate January 1, 2014) that applies to both Payment System Transition Budget- portion of the blended rate, please see adult and pediatric dialysis patients Neutrality Adjustment’’, which revised the CY 2011 Physician Fee Schedule prior to the application of any case-mix the ESRD transition budget-neutrality (PFS) proposed rule, (75 FR 40164) and adjustments. This amount included the adjustment for CY 2011. In the interim the CY 2011 PFS final rule (75 FR 49031 2 percent reduction for budget final rule, we revised the 3.1 percent through 49033). In addition, we discuss neutrality required by MIPPA, a one transition budget-neutrality adjustment the CY 2012 drug add-on and the percent reduction for estimated outlier reduction to a zero percent transition updated wage index values for the payments, and a reduction to account budget-neutrality adjustment for renal composite rate portion of the blended for estimated payments for case-mix and dialysis services furnished on April 1, payment in sections I.C.6 and I.C.7, the low-volume payment adjustments. 2011 through December 31, 2011. respectively, of this final rule. • A 4-year transition period (for those Under section 1881(b)(14)(F)(ii) of the ESRD facilities that elected to receive B. Summary of the Proposed Provisions Act, for years during which the blended payments during the transition) and Responses to Comments on the CY transition applies, the composite rate during which ESRD facilities receive a 2012 ESRD PPS portion of the blend shall be annually blend of payments under the prior basic The proposed rule entitled, ‘‘Medicare increased by the ESRDB market basket, case-mix adjusted composite payment Program; Changes to the End-Stage which for CY 2012 and each subsequent system and the new ESRD PPS. Renal Disease Prospective Payment year, shall be reduced by the Although the statute uses the term System for CY 2012, End-Stage Renal productivity adjustment described in ‘‘phase-in’’, we use the term Disease Quality Incentive Program for section 1886(b)(3)(B)(xi)(II) of the Act. ‘‘transition’’ to be consistent with other PY 2013 and PY 2014; Ambulance Fee In section I.B.2.b of this final rule, we Medicare payment systems. Schedule; and Durable Medical are finalizing the CY 2012 ESRDB • A ¥3.1 percent transition budget- Equipment’’ (76 FR 40498) (the market basket update of 3.0 percent, neutrality adjustment to ensure that ‘‘proposed rule’’) appeared in the based on the third quarter 2011 IGI overall spending under the ESRD PPS Federal Register on July 8, 2011, with forecast of the ESRDB market basket. In

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section I.B.2.c of this final rule, we are such a large portion of the overall costs computation of factors used to adjust finalizing the CY 2012 MFP adjustment incurred by dialysis facilities. the ESRD PPS base rate for projected of 0.9 percent based on the third quarter Response: Beginning in 2012, section outlier payments and budget-neutrality 2011 IGI forecast of the MFP. 1881(b)(14)(F) of the Act, requires us to in accordance with sections We proposed to add the CY 2011 Part annually update the ESRD PPS payment 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) D per treatment amount (that is, $0.49) amounts and the composite rate portion of the Act, respectively (75 FR 49071 to the CY 2011 composite rate in order of the blended transition payment by an through 49082). Specifically, the ESRD to update the Part D amount for CY 2012 ESRD market basket increase that is PPS base rate was developed from CY using the ESRDB market basket minus reduced by the productivity adjustment 2007 claims (that is, the lowest per the productivity adjustment (76 FR described in section 1886(b)(3)(B)xi)(II) patient utilization year), updated to CY 40502). We believed this approach is of the Act. Given that the same update 2011, and represented the average per preferable to applying a growth factor to is used for both ESRD PPS and treatment Medicare allowable payment the $0.49 that is based on the rates for transition blended payments, and given (MAP) for composite rate and separately overall prescription drug prices that the ESRD PPS base rate includes a billable services. In addition, in were used in the National Health portion of former Part D drugs, we accordance with § 413.230, the ESRD Expenditure Projections, as we did for proposed to add the $0.49 part D drug PPS base rate is adjusted for the patient- the establishment of the CY 2011 ESRD amount to the composite rate portion of specific case-mix adjustments, PPS base rate, because it is consistent the blended payment because we applicable facility adjustments, with the update applied to the ESRD wanted to update it consistent with how geographic differences in area wage PPS base rate, which includes a per we update the ESRD PPS base rate. levels using an area wage index, as well treatment amount for former part D Further, because the statute requires an as any outlier payment or training add- drugs (that is, $0.49). We sought update using the ESRDB market basket on adjustments. For CY 2011, the ESRD comment on our proposal to add the CY less productivity and the ESRDB market PPS base rate was $229.63 (75 FR 2011 part D payment amount (that is, basket is comprised of the Producer 49082). $0.49) to the composite rate portion of Price Index (PPI) for prescription drugs As required by section 1881(b)(14)(F) the blended payment and update it as a proxy for measuring price growth of the Act, in this final rule, for CY using the ESRDB market basket minus in ESRD-related drugs, we believe that 2012, we applied the 2.1 percent productivity adjustment. The basis for our proposal to add the $0.49 to the increase (ESRDB market basket update composite rate and update it using the the first part of the transition budget- less productivity) to the CY 2011 ESRD ESRDB market basket less productivity neutrality adjustment (that is, the PPS base rate of $229.63, which results is appropriate. Therefore, for CY 2012, calculation of the $0.49 part D amount) in an ESRD PPS base rate for CY 2012 the composite rate payment, including was set forth in the CY 2011 ESRD PPS of $234.45 (229.63 × 1.021 = 234.45). the $0.49 Part D amount, will be final rule at 75 FR 49082. The comments The ESRD PPS base rate applies to the updated by the ESRDB market basket and our responses are set forth below. ESRD PPS portion of the blended less productivity. With regard to the Comment: Several commenters payments under the transition and to commenter’s concerns that the addition the ESRD PPS payments. In addition, as expressed concerns about the proposed of $0.49 to the composite rate would set methodology to add the former Part D discussed in section I.C.7.c of the a precedent that might affect access to proposed rule (76 FR 40509), we oral drug amount ($0.49) to the care for preferred agents when oral-only composite rate and then apply the proposed to apply the wage index drugs are included in the bundle in budget-neutrality adjustment factor to market basket reduced by the 2014, we note that we did not propose productivity adjustment. Some the ESRD PPS base rate in CY 2012. any payment policies for the oral-only We did not receive any comments on commenters believe that updating the drugs in the proposed rule. We will payment for oral equivalents of this proposal. Therefore, we are address in future rulemaking oral-only finalizing the policy to apply the wage injectable drugs by the ESRD market drugs and the bundled amount basket minus productivity could set a index budget-neutrality adjustment to established in CY 2011, and there will the ESRD PPS base rate. For CY 2012, precedent that might affect access to be an opportunity for public comment care for preferred agents when oral we apply the wage index budget- on any future proposals we may make. neutrality adjustment factor of 1.001520 drugs are included in the bundle in Consequently, for CY 2012, the to the updated base rate (that is, 2014. One commenter stated that it is composite rate portion of the ESRD PPS $234.45), yielding an ESRD PPS wage- inappropriate to apply the productivity blended payment is $141.94. The index budget-neutrality adjusted base adjustment to full transition blended $141.94 reflects the addition of the CY rate for CY 2012 of $234.81 ($234.45 × payment. Instead, they believe the 2011 part D per treatment amount 1.001520 = 234.81). blended payment amount, for CY 2012, ($0.49) to the CY 2011 composite rate of should be split with 50 percent of it $138.53, and application of the ESRDB 2. ESRD Bundled Market Basket paid at the PPI-inflated market basket market basket minus productivity a. Overview and Background rates and 50 percent of it adjusted using adjustment ($138.53 + 0.49 = $139.02; the update factors because the transition $139.02 × 1.021 = $141.94). In accordance with section blended payment rate is based on 50 1881(b)(14)(F)(i) of the Act, as added by percent of the PPS payment rate and 50 b. ESRD PPS Base Rate section 153(b) of MIPPA and amended percent on the old composite rate plus We described the development of the by section 3401(h) of the Affordable drug add-on rate. One commenter ESRD PPS per-treatment base rate in the Care Act, beginning in 2012, the ESRD acknowledged that by using the split CY 2011 ESRD PPS final rule (75 FR bundled payment amounts are required methodology, ESRD PPS would be 49071) and established Medicare to be annually increased by an ESRD updated differently than other payment regulations at 42 CFR 413.220 and market basket increase factor that is systems, but the commenter believed 413.230. The CY 2011 ESRD PPS final reduced by the productivity adjustment that this distinction was appropriate rule also provides a detailed discussion described in section 1886(b)(3)(B)(xi)(II) because of the unique nature of the of the methodology used to calculate the of the Act. The statute further provides program and because drugs represent ESRD PPS base rate and the that the market basket increase factor

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should reflect the changes over time in market basket), we would use that data, the BLS Web site. These two pieces of the prices of an appropriate mix of if appropriate, to determine the CY 2012 information, the cost weights and the goods and services used to furnish renal update in the final rule. Therefore, we price proxies, allow the public to dialysis services. Under section used the IGI’s third quarter 2011 replicate the historical time series of the 1881(b)(14)(F)(ii) of the Act, as added by forecast with history through the second ESRDB market basket. section 153(b) of MIPPA and amended quarter of 2011, and as discussed below, The forecasts of the individual price by section 3401(h) of the Affordable the projected market basket update for proxies used in a market basket are Care Act, the ESRD bundled (ESRDB) CY 2012 that we are finalizing is 3.0 developed independently by IGI, a rate market basket increase factor will percent based on the 2008-based ESRDB nationally recognized economic and also be used to update the composite market basket. financial forecasting firm. We purchase rate portion of ESRD payments during Additionally, we proposed to IGI’s detailed price proxy projections for the ESRD PPS transition period from continue to use a labor-related share of use in the Medicare market baskets. As 2011 through 2013; though beginning in 41.737 percent for CY 2012 for the ESRD a matter of practice, we publish all of 2012, such market basket increase factor PPS payment (76 FR 40503), which was the underlying detail for each price will be reduced by the productivity finalized in the CY 2011 ESRD final rule proxy for the historical period. adjustment. As a result of amendments (75 FR 49161). We also proposed to However, because the projections of by section 3401(h) of the Affordable continue to use a labor-related share of each individual price proxy are Care Act, a full market basket was 53.711 percent for the ESRD composite proprietary, we aggregate those applied to the composite rate portion of rate portion of the blended payment for projections into higher level categories the blended payment in CY 2011 during all years of the transition (76 FR 40503). and then publish the results with a one- the first year of the transition. This labor-related share was developed quarter lag on the CMS Web site. This from the labor-related components of is consistent with the level of data b. Final Market Basket Update Increase the 1997 ESRD composite rate market provided for other PPS payment system Factor and Labor-Related Share for basket that was finalized in the 2005 market baskets. The ESRDB market ESRD facilities for CY 2012 PFS final rule (70 FR 70168), and is basket data, including the detail as As required under section consistent with the mix of labor-related described above, is published on the 1881(b)(14)(F) of the Act, CMS services paid under the composite rate, CMS Web site at the following link: developed an all-inclusive ESRDB input as well as the method finalized in the (https://www.cms.gov/ price index (75 FR 49151 through CY 2011 ESRD PPS final rule (75 FR MedicareProgramRatesStats/04_ 49162). Although ‘‘market basket’’ 49116). MarketBasketData.asp#TopOfPage). technically describes the mix of goods The comments we received on these After considering the public and services used to produce ESRD care, proposals and our responses are set comments received and for the reasons this term is also commonly used to forth below. we previously articulated, we are denote the input price index (that is, Comment: Several commenters finalizing our proposals to continue to cost categories, their respective weights, believe that there should be more use the ESRDB market basket forecasts and price proxies combined) derived transparency in the calculation of the for the ESRD PPS and transition from that market basket. Accordingly, market basket update and are concerned payment updates. Therefore, we are the term ‘‘ESRDB market basket’’, as about the lack of data available to finalizing the ESRDB market basket used in this document, refers to the validate the calculations. update of 3.0 percent, based on the IGI ESRDB input price index. Response: We agree that the public third quarter forecast of the ESRDB We proposed to use the same should be able to replicate the market basket. We did not receive any methodology described in the CY 2011 methodology used to construct the public comments regarding our proposal ESRD PPS final rule (75 FR 49151 ESRDB market basket. We disagree, to continue to use the labor-related through 49162) to compute the CY 2012 however, that CMS has not been fully shares for the ESRD PPS portion and ESRDB market basket increase factor transparent in the calculation of the composite portion of the blended and labor-related share based on the market basket update. In the CY 2011 payment during the transition period. best available data (76 FR 40503). ESRD final rule (75 FR 49151 through Therefore, we are also finalizing the Consistent with historical practice, we 49161), we provided the public with the proposal to continue to use the labor- estimate the ESRDB market basket cost shares for the ESRDB market basket related share of 41.737 percent for the update based on IHS Global Insight and the data sources for the CY 2012 ESRD PPS payment and the (IGI), Inc.’s forecast using the most establishment of those cost shares. We labor-related share of 53.711 percent for recently available data. IGI is a also provided a detailed description of the CY 2012 ESRD composite rate nationally recognized economic and the data sources used to develop the portion of the blended payment, for financial forecasting firm that contracts ESRDB market basket cost weights and those facilities that elected to transition with CMS to forecast the components of the price proxies used in the ESRDB to the bundled ESRD PPS. the market baskets. market basket were listed for each cost Using this method and the IGI forecast category, which are based on data c. Productivity Adjustment for the first quarter of 2011 of the CY maintained and published by the The ESRDB market basket must be 2008-based ESRDB market basket (with Bureau of Labor Statistics (BLS). We annually adjusted by changes in historical data through the fourth refer the commenter to the BLS economy-wide productivity. quarter of 2010), and consistent with regarding any specific information on Specifically, under section our historical practice of estimating the detailed price proxies. In addition, 1881(b)(14)(F) of the Act, as amended by market basket increases based on the to assist the commenter and other section 3401(h) of the Affordable Care best available data, the proposed CY interested stakeholders in locating these Act, for CY 2012 and each subsequent 2012 ESRDB market basket increase price proxies on the BLS Web site, we year, the ESRD market basket percentage factor was 3.0 percent. We also have provided the individual BLS series increase factor shall be reduced by the proposed that if more recent data codes for the indexes in the price proxy productivity adjustment described in became subsequently available (for discussion of the final rule and the section 1886(b)(3)(B)(xi)(II) of the Act. example, a more recent estimate of the directions for obtaining the data through The statute defines the productivity

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adjustment to be equal to the 10-year applying the MFP adjustment to the underlying proxy components such as moving average of changes in annual ESRD payment update is similar to the gross domestic product (GDP), capital, economy-wide private nonfarm business methodology used in other payment and labor inputs required to estimate multifactor productivity (MFP) (as systems, as required by section 3401 of MFP and then combines those projected by the Secretary for the 10- the Affordable Care Act. projections according to the BLS year period ending with the applicable The projection of MFP is currently methodology. In Table 1 below, we fiscal year, year, cost reporting period, produced by IGI, an economic identify each of the major MFP or other annual period) (the ‘‘MFP forecasting firm. In order to generate a component series employed by the BLS forecast of MFP, IGI replicated the MFP adjustment’’). The BLS is the agency to measure MFP. We also provide the measure calculated by the BLS using a that publishes the official measure of corresponding concepts forecasted by private nonfarm business MFP. Please series of proxy variables derived from IGI and determined to be the best see http://www.bls.gov/mfp to obtain the IGI’s U.S. macroeconomic models. available proxies for the BLS series. BLS historical published MFP data. These models take into account a very CMS notes that the proposed and final broad range of factors that influence the methodology for calculating and total U.S. economy. IGI forecasts the

IGI found that the historical growth nongovernment, non-farm, real GDP,’’ to derive the nominal values of labor rates of the BLS components used to ‘‘hours of all persons in private nonfarm and capital inputs. IGI uses the calculate MFP and the IGI components establishments adjusted for labor ‘‘nongovernment total compensation’’ identified are consistent across all series composition,’’ and ‘‘real effective capital and ‘‘flow of capital services from the and therefore suitable proxies for stock’’ series (ranging from 2011 to total private non-residential capital calculating MFP. We have included 2021) are used to ‘‘grow’’ the levels of stock’’ series as proxies for the BLS’ below a more detailed description of the the ‘‘real value-added output,’’ ‘‘private income measures. These two proxy methodology used by IGI to construct a non-farm business sector labor input,’’ measures for income are divided by forecast of MFP, which is aligned and ‘‘aggregate capital input’’ series total income to obtain the shares of closely with the methodology employed published by the BLS. Projections of the labor compensation and capital income by the BLS. For more information ‘‘hours of all persons’’ measure are to total income. In order to estimate regarding the BLS method for estimating calculated using the difference between labor’s contribution and capital’s productivity, please see the following the projected growth rates of real output contribution to the growth in total link: http://www.bls.gov/mfp/ per hour and real GDP. This difference output, the growth rates of the proxy mprtech.pdf. is then adjusted to account for changes variables for labor and capital inputs are At the time of the development of this in labor composition in the forecast multiplied by their respective shares of CY 2012 final rule, the BLS published interval. total income. These contributions of a historical time series of private Using these three key concepts, MFP labor and capital to output growth is nonfarm business MFP for 1987 through is derived by subtracting the subtracted from total output growth to 2010, with 2010 being a preliminary contribution of labor and capital inputs calculate the ‘‘change in the growth value. Using this historical MFP series from output growth. However, in order rates of multifactor productivity:’’ and the IGI forecasted series, IGI has to estimate MFP, we need to understand ¥ developed a forecast of MFP for 2011 the relative contributions of labor and MFP = Total output growth ((labor through 2021, as described below. We capital to total output growth. input growth * labor compensation note that the historical MFP series and Therefore, two additional measures are share) + (capital input growth * the IGI forcasted series are updates from needed to operationalize the estimation capital income share)) those used at the time of the proposed of the IGI MFP projection: Labor The change in the growth rates (also rule (1987 through 2009, and 2010 compensation and capital income. The referred to as the compound growth through 2021, respectively). sum of labor compensation and capital rates) of the IGI MFP are multiplied by To create a forecast of BLS’ MFP income represents total income. The 100 in order to calculate the percent index, the forecasted annual growth BLS calculates labor compensation and change in growth rates (the percent rates of the ‘‘non-housing, capital income (in current dollar terms) change in growth rates are published by

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the BLS for its historical MFP measure). market basket drug cost share weight with both components of the calculation Finally, the growth rates of the IGI MFP accounts for all drugs included in the (the market basket and the productivity are converted to index levels based to ESRD bundled payment, including adjustment) to coincide so that changes 2005 to be consistent with the BLS’ ESRD-related oral drugs with injectable in market conditions are aligned. methodology. For benchmarking equivalents that were formerly covered Therefore, for the CY 2012 update, we purposes, the historical growth rates of under Medicare Part D as well as the proposed that the MFP adjustment be IGI’s proxy variables were used to costs associated with any other drugs as calculated as the 10-year moving estimate a historical measure of MFP, reported on the ESRD Medicare Cost average of changes in MFP for the which was compared to the historical Report. In 2014, any changes to the period ending December 31, 2012. We MFP estimate published by the BLS. bundle will be factored into a revised proposed to round the final annual The comparison revealed that the ESRDB market basket and be subject to adjustment to the one-tenth of one growth rates of the components were notice and comment rulemaking. percentage point level up or down as consistent across all series, and Therefore, although drugs account for a applicable according to conventional therefore validated the use of the proxy larger proportion of expenses in the rounding rules (that is, if the number we variables in generating the IGI MFP ESRDB market basket than in some are rounding is followed by 5, 6, 7, 8, projections. The resulting MFP index other provider-type PPS market baskets, or 9, we will round the number up; if was then interpolated to a quarterly we will continue to update the ESRD the number we are rounding is followed frequency using the Bassie method for payments as statutorily mandated by the by 1, 2, 3, or 4, we will round the temporal disaggregation. The Bassie Congress. As such, for CY 2012, the number down). technique utilizes an indicator (pattern) ESRD PPS payment rate and the Thus, in accordance with section series for its calculations. IGI uses the composite portion of the blended 1881(b)(14)(F)(i) of the Act, the index of output per hour (published by payment will be increased by the proposed market basket increase factor the BLS) as an indicator when estimated market basket update less for CY 2012 for the ESRDB market interpolating the MFP index. productivity, 2.1 percent (3.0 percent basket was based on the 1st quarter 2011 The comments we received on this ESRDB market basket less 0.9 forecast of the CY 2008-based ESRDB proposal and our response are set forth percentage point MFP adjustment), market basket update, which was below. which is described in more detail estimated to be 3.0 percent. This market Comment: One commenter stated that below. basket percentage was then reduced by the factors used in the productivity After careful consideration of the the MFP adjustment (the 10-year adjustor, which are mostly derived from public comments and to satisfy the moving average of MFP for the period capital and labor related economic statutory requirement for ESRD payment ending CY 2012) of 1.2 percent, which measures, are not appropriate for use to updates mentioned above, we are is calculated as described above and modify the market basket costs of drugs, finalizing our proposed method for based on IGI’s 1st quarter 2011 forecast. which are consumable items. One calculating and applying the MFP The resulting proposed MFP-adjusted commenter further believes that ESRD adjustment to the ESRDB market basket. ESRDB market basket update for CY PPS should be treated differently than 2012 was equal to 1.8 percent, or 3.0 d. Calculation of the ESRDB Market other PPS payment systems because percent less 1.2 percent. We proposed Basket Update, Adjusted for Multifactor drugs represent such a large portion of that if more recent data were Productivity for CY 2012 the overall costs incurred by dialysis subsequently available (for example, a services. One pharmaceutical company Under section 1881(b)(14)(F)(i) of the more recent estimate of the market expressed concern about the proposal to Act, beginning in 2012, ESRD PPS basket and MFP adjustment), we would apply the productivity adjustment to the payment amounts and the composite use such data, if appropriate, to Part D oral drug portion of the blended rate portion of the transition blended determine the CY 2012 market basket payment. payment amounts shall be annually update and MFP adjustment in the CY Response: In accordance with section increased by an ESRD market basket 2012 ESRD PPS final rule. Consistent 1881(b)(14)(F)(i) of the Act, beginning in percentage increase factor reduced by a with historical practice and our 2012, all renal dialysis services productivity adjustment. proposal, we update the market basket included in the ESRD bundle are We proposed to estimate the ESRDB increase factor estimate and the MFP required to be annually increased by an market basket percentage for CY 2012 adjustment in this final rule to reflect ESRD market basket increase factor that based on the CY 2008-based ESRDB the most recent available data (75 FR is reduced by the productivity market basket (76 FR 40504). In order to 40505). adjustment described in section calculate the MFP-adjusted update for We received no public comments 1886(b)(3)(B)(xi)(II) of the Act. the ESRDB market basket during the related to the proposed MFP-adjusted Therefore, CMS is statutorily required to transition period, we proposed that the ESRDB market basket update for CY update ESRD PPS payments by a market MFP percentage adjustment be 2012. Therefore, we are finalizing our basket update less productivity. We also subtracted from the CY 2012 market proposal to base the CY 2012 market note that CMS is statutorily required to basket update calculated using the CY basket update, which is used to update the ESRD composite rate portion 2008-based ESRDB market basket (75 FR determine the applicable percentage of the blended payment by the ESRDB 40504). We proposed that the end of the increase for the ESRD PPS and market basket less productivity. During 10-year moving average of changes in transition payments, on the most recent the transition, any items or services the MFP should coincide with the end data available, which is the third quarter included in the bundle have been of the appropriate CY update period. 2011 forecast of the CY 2008-based factored into the cost shares for the Since the market basket update is ESRDB market basket (estimated to be ESRDB market basket; as such, the costs reduced by the MFP adjustment to 3.0 percent). The MFP adjustment (the associated with oral drugs that were determine the annual update for the 10-year moving average of MFP for the formerly paid under Part D are included ESRD PPS and the ESRD composite rate period ending CY 2012) we are in the ESRDB market basket cost share portions of the blended payment during finalizing is 0.9 percent, which was weight for drugs. As finalized in the CY the transition, we believe it is calculated as described above and based 2011 ESRD final rule (75 FR 49156), the appropriate for the numbers associated on IGI’s third quarter 2011 forecast.

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Therefore, the final MFP-adjusted submitted on the interim final rule in transition. In the proposed rule, we ESRDB market basket update for CY the CY 2012 ESRD PPS final rule. addressed both parts of the transition 2012 is 2.1 percent (3.0 percent ESRDB We received four comments during budget-neutrality adjustment (76 FR market basket less 0.9 percentage point the IFC comment period and three 40505 and 40506). The first part of the MFP adjustment). comments in response to the CY 2012 transition budget-neutrality adjustment ESRD PPS proposed rule. All comments was addressed in section I.C.1. of this 3. Transition Budget-Neutrality were in support of the revised CY 2011 final rule where we address updates to Adjustment for CY 2011 transition budget-neutrality adjustment the composite rate and the ESRD PPS Section 1881(b)(14)(E)(iii) of the Act factor. Therefore, we are finalizing the base rate. requires that an adjustment to payments revised CY 2011 transition budget- For the second part of the transition be made for renal dialysis services neutrality adjustment factor of zero for budget-neutrality factor, we first provided by ESRD facilities during the ESRD claims for renal dialysis services determined the estimated increase in transition so that the estimated total furnished on April 1, 2011 through payments under the transition and then payments under the ESRD PPS, December 31, 2011. determined an offset factor, based on estimates of which facilities would including payments under the 4. Transition Budget-Neutrality choose to opt out of the transition (for transition, equal the estimated total Adjustment for CY 2012 amount of payments that would a detailed description, see the CY 2011 Section 1881(b)(14)(E)(i) of the Act otherwise occur under the ESRD PPS ESRD PPS proposed rule, 74 FR 49946). requires the Secretary to provide a four- without such a transition. In the CY We estimated the number of facilities year phase-in of the payments under the 2011 ESRD PPS final rule, we explained that would choose to opt out of the ESRD PPS for renal dialysis services that because we would not know the transition by comparing payment under furnished on or after January 1, 2011, actual number of ESRD facilities that the transition to payment under the PPS with payments under the ESRD PPS would elect to opt out of the transition and choosing the option that was fully implemented for renal dialysis prior to publishing the final rule, we financially beneficial to each facility. services furnished on or after January 1, would simulate payments under the Using that approach, we estimated that 2014. We use the term ‘‘transition’’ 43 percent of facilities would choose to existing basic case-mix adjusted rather than ‘‘phase-in’’ to be consistent composite payment system and under opt out of the transition and determined with other Medicare payment systems. the transition budget-neutrality the ESRD PPS to determine how many Section 1881(b)(14)(E)(ii) of the Act ESRD facilities we believed would elect adjustment to be a reduction of 3.1 permitted ESRD facilities to make a one- percent. In the April 6, 2011 interim to receive payment under 100 percent time election to be excluded from the ESRD PPS. Based on our simulations final rule with comment (76 FR 18930 transition. An ESRD facility that elected through 18934), however, we updated using 2007 data, we estimated that 43 to be excluded from the transition percent of ESRD facilities would the number of facilities that chose to opt would receive payment for renal out of the transition to 87 percent, based financially benefit from receiving full dialysis services provided on or after on actual election data that we received payment under the ESRD PPS. We January 1, 2011, based on 100 percent and recalculated a transition budget- indicated that based on the simulation of the payment rate under the ESRD PPS neutrality adjustment of zero percent. of estimated payments, a 3.1 percent rather than a blended payment based in Given that the transition budget- reduction would be applied to all part on the payment rate under the basic neutrality adjustment required under payments made to ESRD facilities for case-mix adjusted composite payment section 1881(b)(14)(A)(ii) of the Act renal dialysis services furnished on system and in part on the payment rate applies in each year of the transition, we January 1, 2011 through December 31, under the ESRD PPS. Section must update the transition budget- 2011 (75 FR 49082 through 49083). 1881(b)(14)(E)(iii) of the Act also neutrality adjustment for CY 2012. In On April 6, 2011, we published an requires that we make an adjustment to the proposed rule (76 FR 40506), we interim final rule with comment period payments during the transition so that noted that we were not proposing for CY in the Federal Register (76 FR 18930), the estimated total amount of payments 2012 to change the methodology used to entitled ‘‘Changes to the End-Stage under the ESRD PPS, including calculate the second part of the budget- Renal Disease Prospective Payment payments under the transition, equals neutrality adjustment. However, we System Transition Budget-Neutrality the estimated total amount of payments proposed to use more updated data. In Adjustment’’, which revised the ESRD that would otherwise occur under the order to ensure that total payments transition budget-neutrality adjustment ESRD PPS without such a transition. We under the transition equal total payment finalized for CY 2011. In the interim refer to this provision as the transition amounts without a transition, we would final rule, we indicated that based upon budget-neutrality adjustment. reduce all payments to ESRD facilities the election data submitted by ESRD As described in the CY 2011 ESRD in CY 2012 by a factor that is equal to facilities, 87 percent of ESRD facilities PPS final rule (75 FR 49082), the 1 minus the ratio of estimated payments elected to opt out of the transition. transition budget-neutrality adjustment under the ESRD PPS if there were no When we applied the actual number of is comprised of two parts. For the first transition to the total estimated ESRD facilities electing to receive part, we created a payment adjustment payments under the transition. payment under the ESRD PPS, the to the composite rate portion of the In the proposed rule, we explained transition budget-neutrality adjustment blended payment during the transition that we started with 2009 utilization was determined to be zero rather than to account for the per treatment costs of data from claims, as 2009 was the latest a 3.1 reduction in payments. We revised drugs that were paid under Part D. For complete year of claims data available of the 3.1 percent transition budget- the second part, we computed a factor complete claims data. In this final rule, neutrality adjustment reduction to a that would make the estimated total we used 2010 claims as it is the latest zero percent transition budget-neutrality amount of payments under the ESRD available year. Using price growth adjustment for renal dialysis services PPS, including payments under the factors for CY 2011 and CY 2012 that are furnished on April 1, 2011 through transition, equal to the estimated total discussed in the impact analysis in December 31, 2011. We also indicated amount of payments that would section I.VII.B.1 of this final rule, we that we would respond to comments otherwise occur without such a updated the CY 2010 utilization data to

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CY 2011 and CY 2012 payments. We status each year of the 3-year period. close of the cost reporting period (that then took the estimated CY 2012 This timeframe provided us with a is, there is a lag in the cost reporting payments under the full ESRD PPS and sufficient span of time to view submission). Thus, the FI/MACS may the blended payments under the consistency in business operations not have the cost report for the third transition based on actual facility through the data. Under 42 CFR year to determine eligibility and would election data and compared these 413.232(b), a low-volume facility is an need to rely on the attestation for that estimated payments to the total ESRD facility that: (1) Furnished less year. We proposed that if an ESRD estimated payments in CY 2012 as if all than 4,000 dialysis treatments in each of facility believes that it is eligible for the facilities had elected to receive payment the 3 years preceding the payment year low-volume adjustment, the ESRD under the full ESRD PPS. We then and (2) has not opened, closed, or facility would be required to submit an calculated the transition budget- received a new provider number due to attestation to its respective FI/MAC no neutrality factor to be 1 minus the ratio a change in ownership during the 3 later than November 1st of each year, of estimated payments under the ESRD years preceding the payment year. and proposed to amend the regulation PPS if there were no transition to the Under § 413.232(c), the number of text at § 413.232(f) (76 FR 40507). We total estimated payments under the treatments shall be equal to the noted that this timeframe provides 60 transition, which results in zero percent. aggregate number of treatments days for a FI/MAC to verify the cost Therefore, for CY 2012, we proposed furnished by other ESRD facilities that report information and update the that a zero percent reduction to all are both under common ownership and systems (76 FR 40507). We explained payments would be made to ESRD 25 road miles or less from the ESRD that if ESRD facilities are receiving the facilities (that is, the zero percent facility in question. This geographic low-volume adjustment for the CY 2011 adjustment would be applied to both the proximity criterion is only applicable to payment year, those ESRD facilities blended payments under the transition ESRD facilities that are Medicare should submit another attestation to and payments made under the 100 certified on or after January 1, 2011. their respective FI/MAC no later than percent ESRD PPS). We solicited Section 413.232(f) requires an ESRD November 1, 2011, to qualify for the comments on the proposed second part facility to provide an attestation low-volume adjustment for the CY 2012 of CY 2012 transition budget-neutrality statement to their respective fiscal payment year. An ESRD facility must adjustment methodology. The intermediary or Medicare administrative continue to attest that it is a low-volume comments and our responses are set contractor (FI/MAC) that the facility facility for each subsequent payment forth below. meets all the criteria in order to receive year it believes it is eligible for the low- Comment: Several national the low-volume adjustment. We note volume facility adjustment. associations and one dialysis that furnishing 4,000 treatments in a We explained that if the FI/MAC does organization supported the zero percent year equates to approximately 25 not receive an ESRD facility’s attestation transition budget-neutrality adjustment patients per year receiving three dialysis stating that the ESRD facility is eligible for CY 2012. One commenter indicated treatments a week (or hemo-equivalent for the low-volume adjustment on or that the proposed rule appropriately treatments). before November 1 prior to the payment reflected that a greater percentage of In the proposed rule, we discussed year, the ESRD facility would not ESRD facilities than estimated elected to § 413.232 and clarified that the receive the low-volume adjustment for receive payment under the ESRD PPS. ‘‘payment year’’ is the period of time that payment year. We also noted that Response: We thank the commenters that we use for determining payment to in the event a dialysis organization for their support. Therefore, in this final ESRD facilities, which is a calendar submits the low-volume attestation on rule, we are finalizing the proposed year, and that eligibility years mean the behalf of its ESRD facilities, the dialysis second part of the transition budget- 3 years preceding the payment year and neutrality adjustment and the zero are based on cost reporting years (76 FR organization will be required to identify percent budget-neutrality adjustment for 40506). We made this clarification to each ESRD facility by name and CY 2012. ensure that ESRD facilities and their provider number and submit them by the November 1 deadline. 5. Low-Volume Facility Provisions respective FI/MACs understand the distinction between eligibility (which is We solicited comment on our Section 1881(b)(14)(D)(iii) of the Act based on cost reporting years) and the proposal and the proposed regulation requires a low-volume payment payment year (when ESRD facilities can text changes at § 413.232(f). adjustment that ‘‘reflects the extent to begin to receive the low-volume We did not receive any comments which costs incurred by low-volume payment adjustment). and, therefore, in this final rule, we are facilities (as defined by the Secretary) in We did not seek comments on the finalizing a yearly November 1 deadline furnishing renal dialysis services exceed clarifications of the payment and cost for attestation submission and we are the costs incurred by other facilities in report years, however, we received three revising the regulation at § 413.232(f) to furnishing such services, and for comments indicating the clarifications reflect this date for CY 2012 and each payment for renal dialysis services were helpful. year thereafter. However, because the furnished on or after January 1, 2011, In the proposed rule (76 FR 40506 and CY 2012 final rule will not be effective and before January 1, 2014, such 40507), we proposed to establish the before November 1, 2011, we are payment adjustment shall not be less process for CY 2012 and each year finalizing a later low-volume attestation than 10 percent’’. We established the thereafter, that an ESRD facility would submission deadline of January 3, 2012, low-volume payment adjustment, be required to follow when submitting for attestations that pertain to the CY including the methodology we used to its attestation to notify its FI/MAC that 2012 low-volume adjustment. We develop the low-volume treatment it is eligible for the low-volume believe this due date provides facilities threshold in the CY 2011 ESRD PPS payment adjustment. We further sufficient time to submit an attestation final rule (75 FR 49117 through 49125). explained that the attestation is required and allows the agency (that is, the FI/ Because the analysis included data that because: (1) ESRD facility’s cost MACs) time to process submissions. In spanned a 3-year period, we defined a reporting periods vary and may not be addition, a later date is not possible low-volume ESRD facility as a facility based on the calendar year; and (2) the since the CY 2012 payment year will be that is able to maintain its low-volume cost reports are due 5 months after the underway. Accordingly, we also are

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revising the regulation at § 413.232(f) to consecutive month cost reporting making a technical correction to the reflect this change. periods) immediately preceding the regulation text at § 413.232(b)(2) to In the proposed rule, we indicated payment year, the ESRD facility is not reflect that a low-volume facility is an that the ESRD facility’s cost reports for eligible for the low-volume adjustment ESRD facility that has not open, closed, the cost reporting periods ending in the until it can demonstrate again that for 3 or received a new provider number due 3 years immediately preceding the years (12-consecutive month cost to a change in ownership in the 3 years payment year must report costs for 12- reporting periods) it has met the low- preceding the payment year. consecutive months (76 FR 40507). For volume criteria. The comments we Comment: One independent ESRD example, an FI/MAC should not received and our responses are set forth facility questioned the policy that ESRD consider a short period cost report (that below. facilities must remain low volume (that is, reporting costs for less than 12 Comment: One independent ESRD is, provide less than 4,000 dialysis months which may occur for new facility asked if an ESRD facility was treatments) for three years immediately facilities or facilities under new determined not to qualify for the low- preceding the payment year or risk not ownership), for low-volume eligibility. volume adjustment, would the low- qualifying for the low-volume Specifically, when an ESRD facility is volume adjustment be discontinued adjustment until it can once again assessing its eligibility for the low- without payment implication. demonstrate it is low volume for three volume adjustment and preparing its Response: Medicare is obligated to consecutive years. The commenter attestation, the ESRD facility should provide appropriate payment. If an further stated that many small or rural look at its 12-consecutive month cost ESRD facility has not met the eligibility dialysis facilities provide the only reports for the cost reporting periods requirements as described in 42 CFR access to care in a geographic area and that end in the 3 years immediately 413.232, the ESRD facility would not be this policy requires the established low- preceding the payment year. entitled to receive the low-volume volume facility to choose between As we indicated previously, the FI/ adjustment and the inappropriate low- providing access to care and significant, MAC may not have a final-settled cost volume payments made in that payment long term payment reductions. The report for all 3 years needed to complete year would be recouped. commenter further stated that this the ESRD facility’s verification and we Comment: One commenter indicated policy could result in dialysis facilities provided examples of such situations that in the CY 2011 ESRD PPS final rule, denying care to avoid crossing the 4,000 (76 FR 40507). Therefore, we proposed we defined a low-volume facility at threshold. The commenter suggested to amend the regulations at § 413.232(b)(2) as an ESRD facility that that CMS consider reducing the § 413.232(b)(1) and (b)(2) to clarify the has not opened, closed, or received a eligibility timeline for small facilities meaning of year with regard to the new provider number due to a change that have met the low-volume eligibility treatment threshold that is used for in ownership during the 3 years criteria so that they could re-qualify for determining low-volume eligibility and preceding the payment year (75 FR the low-volume adjustment in the how it relates to the payment year. This 49118). The commenter pointed out that following year if their treatments proposed change to the regulations in the CY 2011 ESRD PPS final rule we would make clear that the ESRD did not finalize the phrase, ‘‘or received returned to less than 4,000 per year. facility’s cost reports for the 3 years a new provider number due to a change Response: We do not agree with the immediately preceding the payment in ownership’’ in the regulation text at commenter’s assertion of the negative year must report costs for 12- § 413.232(b)(2) and in our discussion of effects of the low-volume eligibility consecutive months, and provide the definition of a low-volume facility criteria. The low-volume adjustment is clarification that in the absence of an in this year’s proposed rule we only intended for ESRD facilities that are ESRD facility’s final settled cost report, referred to the phrase, ‘‘or had a change located in areas that have a population an FI/MAC can review the ESRD in ownership’’ (76 FR 40507). The base resulting in less than 4,000 facility’s as-filed cost report when commenter is concerned that if we do treatments per year and is not intended determining if an ESRD facility meets not include the phrase, ‘‘or received a to account for fluctuations or business the low-volume criteria. We believe that new provider number due to a change decisions that increase or decrease the it is appropriate for the FI/MAC to in ownership’’ in the regulation text at number of treatments that can or would determine eligibility based upon an as- § 412.232(b)(2) that it will negatively be provided. We do not believe that filed cost report because the number of impact new owners of underperforming these fluctuations or changes in the total treatments should not change clinics that would otherwise wish to population from year to year would in between submission of the as-filed cost apply for the low-volume designation. most circumstances result in a facility report and the final settled cost report. Response: We agree with the not being eligible for the low-volume We solicited comment on the proposed commenter that in the CY 2011 final adjustment. As we indicated in the CY changes at § 413.232(b)(1) and (b)(2). We rule we inadvertently omitted the 2011 ESRD PPS final rule (75 FR 49118 did not receive any comments and, phrase, ‘‘or received a new provider and 49119), we believe the low-volume therefore, we are finalizing these number due to a change in ownership’’ adjustment should encourage small proposed changes to the regulation at in the regulation text finalized at ESRD facilities to continue to provide § 413.232(b)(1) and (b)(2). § 413.232(b)(2). In the preamble of both access to care, but are concerned about In the proposed rule, we explained the CY 2011 ESRD PPS proposed and potential disincentives that low-volume that if an FI/MAC receives an ESRD final rules (74 FR 49118 through 49919, facilities could have regarding patient facility’s attestation stating that the 74 FR 49975), we made clear that under care. We are monitoring the number of ESRD facility believes that it qualifies § 413.232(b), a low-volume facility is facilities that are receiving the low- for the low-volume payment adjustment defined as an ESRD facility that ‘‘has volume adjustment. Any changes in the and then finds that the ESRD facility did not opened, closed, or received a new low-volume methodology will be not meet the low-volume criteria, the FI/ provider number due to a change of discussed in future rulemaking. MAC will discontinue application of the ownership * * *’’; however, we As for allowing facilities that lose low-volume adjustment (76 FR 40508). inadvertently omitted language from the low-volume status to requalify for low- If the ESRD facility does not remain regulation (74 FR 50024, 74 FR 49200). volume status the next year, any low-volume for each of the 3 years (12- Therefore, in this final rule, we are changes in the low-volume eligibility

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criteria would be addressed in future and 2010. First, we estimated the total Thus, we projected a 2.7 percent rulemaking. drug expenditures for all ESRD facilities decrease (2.7 percent = .027 = 0.973¥1) in CY 2010. We used the final CY 2006 in per patient growth in drug 6. Update to the Drug Add-On to the through CY 2009 ESRD claims data and expenditures between 2011 and 2012. Composite Rate Portion of the ESRD the latest available CY 2010 ESRD Blended Payment Rate For this final rule, we estimate a 4.3 facility claims, updated through percent estimated growth in enrollment Section 1881(b)(14)(E)(i) of the Act December 31, 2010 (that is, claims with between CY 2011 and CY 2012. To requires a four-year transition under the dates of service from January 1 through obtain the per-patient estimated growth ESRD PPS. Under § 413.239, ESRD December 31, 2010, that were received, in expenditures, we divided the total facilities were permitted to make a one- processed, paid, and passed to the drug expenditure change between 2011 time election by November 1, 2011, to National Claims History File as of and 2012 (1.010) by enrollment growth be excluded from the transition and December 31, 2010). We indicated that of 4.3 percent (1.043) for the same receive full payment under the ESRD for this final rule, we intended to use timeframe. The result is a per-patient PPS. Under § 413.239, in CY 2012, additional updated CY 2010 claims with growth factor equal to 0.968 (1.010/ ESRD facilities that elected to receive dates of service for the same timeframe 1.043 = 0.968). Thus, in this final rule, payment under the transition will be (76 FR 40508). This updated CY 2010 for CY 2012 we are projecting a 3.2 paid a blended amount that will consist data file would include claims received, percent decrease (¥3.2 percent = 1.010/ of 50 percent of the basic case-mix processed, paid, and passed to the 1.043¥1 = 0.968¥1) in per patient adjusted composite payment system and National Claims History File as of June growth in drug expenditures between 50 percent on the ESRD PPS payment. 30, 2011. 2011 and 2012. Thus, we must continue to update the We inflated the CY 2010 drug composite rate portion of the blended expenditures to estimate the June 30, c. Applying the Growth Update to the payment amount during the ESRD PPS 2011 update of the 2010 claims file. The Drug Add-On Adjustment 4-year transition (CYs 2011 through net adjustment to the CY 2010 claims In the CY 2006 PFS final rule (71 FR 2013), which includes an update to the data was an increase of 11.62 percent to 69683), we applied the projected growth drug add-on. the 2010 expenditure data, which update percentage to the total amount of Under section 1881(b)(12) of the Act, allowed us to more accurately compare drug add-on dollars established for CY the basic case-mix adjusted composite the 2009 and 2010 drug expenditure 2005 to establish a dollar amount for the payment system includes the services data to estimate per patient growth. CY 2006 growth update. In addition, we comprising the composite rate and an Next, we calculated the average annual projected the growth in dialysis add-on to the composite rate component change in drug expenditures from 2006 treatments for CY 2006 based on the to account for the difference between through 2010. This average annual projected growth in ESRD enrollment. pre-MMA payments for separately billed change showed an increase of 1.4 We divided the projected total dollar drugs and the revised drug pricing percent in drug expenditures from 2006 amount of the CY 2006 growth by the specified in the statute. For the drug through 2010 (76 FR 40508). We used projected growth in total dialysis add-on for CY 2012 (76 FR 40508 and this 1.4 percent increase to project drug treatments to develop the per treatment 40509), we did not propose any changes expenditures for both 2011 and 2012. growth update amount. This growth to the methodology, but merely updated For the final rule, using the full-year update amount, combined with the CY the data used in computing the drug 2010 drug expenditure figure, we 2005 per treatment drug add-on amount, add-on as described below. calculated the average annual change in drug expenditure from 2006 through resulted in an average drug add-on a. Estimating Growth in Expenditures 2010. This average annual change amount per treatment of $18.88 (or a for Drugs and Biologicals in CY 2012 showed an increase of 1.0 percent in 14.5 percent adjustment to the Section 1881(b)(12)(F) of the Act drug expenditures from 2006 through composite rate) for CY 2006. specifies that the drug add-on increase 2010. We used this 1.0 percent increase In the CY 2007 PFS final rule with must reflect ‘‘the estimated growth in to project drug expenditures for both comment period (71 FR 69684), as a expenditures for drugs and biologicals 2011 and 2012. We note, the change in result of public comments, we revised (including erythropoietin) that are the drug expenditures increase is a our update methodology by applying separately billable * * *’’. By referring result of updated data. the growth update to the per treatment to ‘‘expenditures’’, we believe the drug add-on amount. That is, for CY b. Estimating per Patient Growth statute contemplates that the update 2007, we applied the growth update would account for both increases in In the proposed rule, we explained factor of 4.03 percent to the $18.88 per drug prices, as well as increases in that once we had the projected growth treatment drug add-on amount resulting utilization of those drugs. in drug expenditures from 2011 to 2012, in an updated per treatment drug add- To account for increases in drug we calculated per patient growth on amount of $19.64 per treatment (71 prices and utilization, we used the 5 between CYs 2011 and 2012 by FR 69684). For CY 2008, the per years of drug expenditure data based on removing the estimated growth in treatment drug add-on amount was ASP pricing and proposed to use this enrollment data between CY 2011 and updated to $20.33. In the CY 2009, 2010 data for trend analysis (76 FR 40508). CY 2012 (76 FR 40508). We estimate a and 2011 PFS final rule with comment We then removed growth in enrollment 4.2 percent estimated growth in period (73 FR 69755 through 69757, 74 for the same time period from the enrollment between CY 2011 and CY FR 61923, and 75 FR 73485, expenditure growth so that the residual 2012. To obtain the per-patient respectively), we applied a zero update reflects the per patient expenditure estimated growth in expenditures, we to the per treatment drug add-on growth (which includes price and divided the total drug expenditure amount resulting in a per treatment drug utilization combined). change between 2011 and 2012 (1.014) add-on amount of $20.33. As discussed To estimate drug expenditure growth by enrollment growth of 4.2 percent in detail below, in this final rule, for CY using trend analysis for CY 2012, we (1.042) for the same timeframe. The 2012, we are finalizing a zero update to looked at the average annual growth in result was a per-patient growth factor the per treatment drug add-on amount total drug expenditures between 2006 equal to 0.973 (1.014/1.042 = 0.973). of $20.33 established in CY 2008.

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d. Update to the Drug Add-On services to change after implementation 7. Updates to the Wage Index Values Adjustment for CY 2012 of a PPS. That is why we periodically and Wage Index Floor for the Composite We estimated a 1.4 percent increase in review our payment systems to Rate Portion of the Blended Payment drug expenditures between CY 2011 and determine if a refinement is warranted. and the ESRD PPS Payment CY 2012 (76 FR 40509). Combining this In addition, if we were to adjust for ESA Section 1881(b)(14)(D)(iv)(II) of the increase with a 4.2 percent increase in over usage in computing the drug add- Act provides that the ESRD PPS may enrollment, as described above, we on, this would lower the trend and the include such other payment projected a 2.7 percent decrease in per drug add-on would become more adjustments as the Secretary determines patient growth of drug expenditures negative. As we discussed above, appropriate, such as a payment between CY 2011 and CY 2012. section 1881(b)(12)(F) of the Act, adjustment by a geographic wage index, Therefore, we projected that the precludes a reduction of the drug add- such as the index referred to in section combined growth in per patient on because the statute requires that we 1881(b)(12)(D) of the Act. In the CY utilization and pricing for CY 2012 annually increase the drug add-on. 2011 ESRD PPS final rule (75 FR 49117 through 49117) and CY 2011 PFS final would result in a decrease to the drug In this final rule, for CY 2012, we add-on equal to 0.4 percentage points. rule (75 FR 73486), we finalized the estimate a 1.0 percent increase in drug This figure was derived by applying the wage index policy under the ESRD PPS. expenditures between CY 2011 and CY 2.7 percent decrease to the CY 2011 Specifically, under the ESRD PPS, we drug add-on of $20.33. This resulted in 2012. Combining this increase with a have adopted the same method and a revised drug add-on of $19.78, which 4.3 percent increase in enrollment, we source of wage index values used is 14.0 percent of the proposed CY 2012 project a 3.2 percent decrease in per previously for the basic case-mix base composite rate of $141.52. If we patient growth of drug expenditures adjusted composite payment system. were to apply no decrease to the drug between CY 2011 and CY 2012. We use the Office of Management and add-on of $20.33, this would result in a Therefore, we project that the combined Budget’s (OMB’s) Core Based Statistical 14.4 percent drug add-on. However, growth in per patient utilization and Area (CBSA)-based geographic area similar to last year and as indicated pricing for CY 2012 would result in a designations to define urban and rural above, we proposed a zero update to the decrease to the drug add-on equal to 0.4 areas and corresponding wage index drug add-on adjustment. We explained percentage points. This figure is derived values (76 FR 40509). In addition, the in the proposed rule that we believed by applying the 3.2 percent decrease to wage index values used under the ESRD this approach is consistent with the the CY 2011 drug add-on of $20.33. This PPS are the inpatient prospective language under section 1881(b)(12)(F) of results in a revised drug add-on of payment system (IPPS) wage index the Act, which states in part that ‘‘the $19.69, which is 13.9 percent of the values calculated without regard to Secretary shall annually increase’’ the final CY 2012 base composite rate of geographic reclassifications authorized drug add-on amount based on the $141.94. If we were to apply no decrease under sections 1881(d)(8) and (d)(10) of growth in expenditures for separately to the drug add-on of $20.33, this would the Act, and utilize pre-floor hospital billed ESRD drugs. Our understanding result in a 14.3 percent drug add-on. data that are unadjusted for of the statute contemplates ‘‘annually Similar to last year and as discussed occupational case mix. The CBSA-based increase’’ to mean a positive or zero above, for CY 2012, we are finalizing a geographic area designations are described in OMB Bulletin 03–04, update to the drug add-on. Therefore, zero update to the drug add-on and originally issued June 6, 2003, and are we proposed to apply a zero update and maintaining the $20.33 per treatment maintain the $20.33 per treatment drug available online at http:// drug add-on amount. add-on amount for CY 2012. The www.whitehouse.gov/omb/bulletins/ comments and our responses are set The current $20.33 per treatment drug b03–04.html. In addition, OMB has forth below. add-on reflected a 14.7 percent drug published subsequent bulletins Comment: Two commenters add-on adjustment to the composite rate regarding CBSA changes, including supported our proposed zero drug-add. in effect for CY 2011. Using the latest changes in CBSA numbers and titles. Response: We thank the commenters ESRDB market basket minus All ESRD rules and notices are for their support. productivity adjustment to update the considered to incorporate the CBSA Comment: One commenter indicated composite rate portion of the ESRD PPS changes published in the most recent that ESA usage is overstated in 2006 payment (forecast of 2.1 percent in 2012 OMB bulletin that applies to the through 2010 and that this would have effective January 1, 2012, as discussed hospital wage index used to determine an effect on the drug add-on and the in section I.B.2.b. of this final rule), the current ESRD wage index. The OMB ESRD PPS base rate calculations. The results in a decrease to the CY 2012 bulletins may be accessed online at commenter recommended that we drug add-on adjustment from 14.7 to http://www.whitehouse.gov/omb/ develop an ESA adjuster for the ESRD 14.3 percent in order to maintain the bulletins/index.html. PPS base rate. drug add-on at $20.33. This decrease Under the ESRD PPS, we adopted a Response: We used the best available wage index floor during the transition, occurs because the drug add-on data to compute the drug add-on and though we intended to gradually reduce adjustment is a percentage of the the base rate. We continue to believe the ESRD wage index floor (76 FR that the information on ESRD claims composite rate. Since the final CY 2012 40509, 75 FR 49117, 75 FR 73486). In represent the best information currently composite rate is higher than the CY the proposed rule (76 FR 40502–40503), available to the agency. Because we are 2011 composite rate, and since the drug we did not propose any changes to the required under section add-on remains at $20.33, the labor-related share for the ESRD PPS 1881(b)(14)(A)(ii) of the Act to use the percentage decreases. Therefore, we are and the composite rate portion of the lowest utilization year (which we finalizing for CY 2012 the drug add-on blend and proposed to continue to use determined to be 2007), we did not have adjustment of 14.3 percent to the a labor-related share of 41.737 percent discretion on the data we used in composite rate. for CY 2012 for the ESRD PPS. If an calculating the ESRD PPS base rate. We ESRD facility elected to transition to the note that it is common for utilization of PPS, the labor-related share for the

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composite rate portion of the blended compared to the CY 2011 variance, FR 73487). For CY 2012 and CY 2013, payment is 53.711 percent. We which was not anticipated by the we proposed to continue to reduce the proposed to continue to use the labor- commenter at the time the election was wage index floor by 0.05 for each of the related share of 53.711 percent for the made to transition into the ESRD PPS remaining years of the transition (that is, composite rate portion of the blended and stated that this is not beneficial for for CY 2012, the wage index value payment for all the years of the those dialysis facilities transitioning to would be reduced from 0.600 to 0.550, transition. As discussed in section I.2.b the ESRD PPS. and further reduced to 0.500 for CY of this final rule, we finalized the Response: The commenter is correct 2013) (76 FR 40510). The ESRD wage proposed labor-related share for the that the differences in the CY 2012 index floor value of 0.550 would be ESRD PPS and the composite rate composite rate and ESRD PPS wage applied to areas with wage index values portion of the blended payment. Finally, index values in the proposed rule are that are below the proposed wage index the wage data used to construct the not as significant as they were in the CY floor. Beginning January 1, 2014, we wage index under the ESRD PPS is 2011 ESRD PPS final rule. The principle proposed that the wage index floor updated annually, based on the most reason for the differences in the would no longer be applied because the current data available and based on composite rate and ESRD PPS wage wage index floor would be lower than OMB’s definitions and corresponding index values in the CY 2011 final rule areas with low wage index values. In the wage index values. is that the wage index budget neutrality CY 2012 ESRD PPS proposed rule, we As we previously indicated, because adjustment was applied to the stated that we continue to believe that ESRD facilities could elect to receive a composite rate values, while budget a gradual reduction in the floor is blended payment during the transition, neutrality for the ESRD PPS was needed to support continuing patient we continue to update the composite achieved through the overall 98 percent access to dialysis in areas that have low rate portion of the ESRD PPS blended budget-neutrality requirement (76 FR wage index values, especially in areas payment, including adjusting payments 40510). The reason the variances where the wage index values are below for geographic differences in area wage between the CY 2012 proposed the current wage index floor— levels (76 FR 40509, 75 FR 40163). We composite rate and ESRD PPS wage specifically, ESRD facilities located in did not propose any changes to the index values are less pronounced is Puerto Rico (76 FR 40510). We solicited methodology for the wage index used to because the proposed wage index comments on the proposal to continue adjust the composite rate portion of the budget-neutrality adjustment for CY to gradually reduce the wage index floor ESRD PPS blended payment. However, 2012 for the composite rate portion of in CYs 2012 and 2013 and, the we did propose to update the wage the blended payment is lower than the elimination of the floor in CY 2014. The index values and the wage index budget-neutrality adjustment factor for comments we received and our budget-neutrality adjustment factor for CY 2011. As we discussed above, in responses are set forth below. CY 2012. We did not receive any detail and in section I.C.1 of this final Comment: Three commenters comments pertaining to our proposal to rule, the wage index budget-neutrality responded regarding our proposal to update the wage index values and the adjustment for the ESRD PPS and the reduce and eventually eliminate the wage index budget-neutrality ESRD PPS portion of the blended wage index floor. One commenter adjustment factor for CY 2012 for the payment is not applied to the wage requested that the wage index floor be composite rate portion of the blended index values, but rather to the ESRD maintained for rural dialysis facilities payment under the transition. PPS base rate. Therefore, the variance due to their higher staffing costs, which Consequently, we are finalizing our described by the commenter is related could aggravate disparities in care and proposal. solely to the wage index budget- might impair access to care in rural Although we did not propose to make neutrality adjustment for the composite areas. One independent ESRD facility any changes to the methodology for rate portion of the blended payment. A indicated that the reduction of the wage updating the CY 2012 wage index under comparison to the ESRD PPS wage index floor threatens facilities with low the ESRD PPS (that is, for full ESRD PPS index value is not appropriate because wage index values and may result in payments and the ESRD PPS portion of the composite rate wage index has a access to care problems. One ESRD the blended payment under the wage index budget-neutrality organization requested that we transition), we did propose a wage adjustment applied while the ESRD PPS reconsider establishing a wage index index budget-neutrality adjustment wage index does not. floor after the transition because the factor to be applied in CY 2012 and in Since we did not receive any commenter believes that eliminating the subsequent years for the ESRD PPS (76 comments pertaining to our proposals floor would be detrimental to small FR 40509). regarding the method of applying the dialysis organizations (SDOs). The We received one comment as set forth wage index budget-neutrality commenter also stated that some small below. adjustment, that is, applying the wage facilities are located in a single Comment: One independent ESRD index budget-neutrality adjustment to community and, as such, are not able to facility indicated that it based its the wage index values for the composite spread their operating costs as larger decision to receive payment under the rate portion of the blended payment and organizations. The commenter further transition because the CY 2011 applying the wage index budget- stated that these facilities are in parts of composite rate wage index value for the neutrality adjustment to the ESRD PPS the country where the wage index is facility’s area was higher than the wage base rate for the PPS portion of the lowest, and the absence of a floor index value for the ESRD PPS. The blended payment and the ESRD PPS threatens their survival and negatively commenter stated that the higher payment, and for the reasons we impacts access to care. composite rate wage index would be discussed previously, we are finalizing Response: In the proposed rule, we beneficial to those facilities that opted those policies. proposed to reduce the floor by 0.05 for to receive payment under the transition. CYs 2012 and 2013 and to eliminate the The commenter indicated that the a. Reduction to the ESRD Wage Index floor beginning in 2014 (76 FR 40509 variances between the CY 2012 Floor through 40510). We have been reducing proposed composite rate and ESRD PPS The wage index floor for CY 2011 is the wage index floor since CY 2006 wage index values are not as great as 0.600 (75 FR 49116 and 49117 and 75 when ESRD facilities began to transition

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to the CBSAs and the wage index floor adjusted composite payment system, we index under the basic case-mix adjusted was 0.900 (70 FR 45799). We have identified a small number of ESRD composite payment system as an reduced the wage index floor by 0.05 facilities in both urban and rural areas example. We have previously each year since then. In CY 2011, the where there are no hospital data from interpreted the statute for the basic case- floor is 0.600 and only impacts ESRD which to calculate wage index values. mix adjusted composite payment system facilities located in Puerto Rico, because Since there were ESRD facilities in these (section 1881(b)(12)(D) of the Act) as no other ESRD facilities are located in areas, we developed policies for each of requiring that the geographic adjustment areas with a wage index value below these areas. In the CY 2011 ESRD PPS be made in a budget-neutral manner. In 0.600. This is also the case in CY 2012, final rule (75 FR 49117), we finalized CY 2011, we did not apply a wage index when the 0.05 reduction will bring the the methodology we have used for budget-neutrality adjustment factor floor to 0.550. We continue to believe urban areas with no hospital data, that under the ESRD PPS because budget- that artificially adjusting wage index is, we compute the average wage index neutrality was achieved through the values by substituting a wage index value of all urban areas within the State overall 98 percent budget-neutrality floor is not an appropriate method to and use that value as the wage index. requirement in section 1881(b)(14)(A)(ii) address low wages in certain geographic We also finalized the methodology of the Act. locations. However, we are willing to established for rural areas with no Given our authority to develop a wage take the points made by the commenters hospital data originally adopted in the index under section into consideration for future rulemaking CY 2008 PFS final rule (72 FR 66283), 1881(b)(14)(D)(iv)(II) of the Act, as well with regard to the issue of eliminating in which we computed the wage index as the authority to use the geographic the wage index floor in the future. using the average wage index values index under section 1881(b)(12)(D) of With regard to the comment that from all contiguous CBSAs to represent the Act, we proposed to apply the wage small facilities are located in areas with a reasonable proxy for that rural area. index in a budget-neutral manner under the lowest wage index values and the For rural Massachusetts, we determined the ESRD PPS using a wage index negative effects of eliminating the floor, that the borders of Dukes and Nantucket budget-neutrality adjustment factor (76 we note that the commenter is located Counties are continguous with FR 40510). However, as we discuss in in West Virginia and in CY 2011, has a Barnstable and Bristol counties. Under greater detail below, we proposed that wage index value of 0.7055, well above the methodology, the values for these under the ESRD PPS, we would apply the wage index floor of 0.600. Therefore, counties are averaged to establish the the wage index budget-neutrality the reduction of the floor does not wage index value for rural adjustment factor to the ESRD PPS base impact this provider. With regard to Massachusetts. For rural Puerto Rico, rate. areas that are impacted by the reduction we finalized a policy to use the wage Under the basic case-mix adjustment of the wage index floor (that is Puerto index floor as the wage index value, composite payment system, we began Rico), we note that the overall impact since all rural Puerto Rico areas were applying the wage index budget- (discussed in section VII.B of this final subject to the floor. neutrality adjustment factor in CY 2006 rule) of the changes in the outlier policy In the proposed rule, we did not (70 FR 70171). During the ESRD PPS discussed in section I.C.10 of this final propose to change these methodologies. transition, we proposed to continue to rule and the wage index results in a 0.3 We proposed for CY 2012 and for future apply the wage index budget-neutrality percent increase in estimated payments. years, to continue to use the adjustment to the wage index values for Therefore, we do not believe that ESRD methodologies we adopted for the composite rate portion of the ESRD facilities will be negatively impacted by establishing wage index values in both PPS blended payment for CYs 2012 and the reduction in the wage index floor. urban and rural geographic areas where 2013 (76 FR 40510). We noted that We note that the wage index values there are no hospital wage data from continuing to apply the budget- reflects\ hospital wages, unadjusted for which to calculate wage index values neutrality adjustment to the wage index occupational mix. Therefore, we believe for ESRD facilities (76 FR 40510). for the composite rate portion of the it reflects ESRD facility staff wages. We did not receive any comments on ESRD PPS blended payment allows With regard to the comment that some our proposed methodology for ESRD facilities going through the small facilities are located in a single computing a wage index value for areas transition to continue to use a community and, as such, are not able to without hospital data for urban and methodology to which they are spread their operating costs as larger rural geographic areas, or for Puerto accustomed. organizations can, we do not understand Rico. Therefore, for CY 2012 and future However, under the ESRD PPS, we the relationship between the wage index years, we are finalizing our believed that applying the wage index floor and limitations a facility may have methodologies for computing a wage budget-neutrality adjustment factor to to spread its operating costs. index value for areas without hospital the ESRD PPS base rate would be After considering the comments data for urban and rural geographic consistent with the application of the received, we are finalizing the 0.05 areas and for Puerto Rico. For urban wage index budget-neutrality reduction to the wage index floor for areas, we will compute the average wage adjustment factor in other prospective CYs 2012 and 2013, resulting in a wage index value of all urban areas within the payment systems. We also believed that index floor of 0.550 and a wage index State; for rural areas, we will compute applying the wage index budget- floor of 0.500, respectively. Although the wage index using the average wage neutrality adjustment factor to the ESRD we continue to believe that artificially index values from all contiguous PPS base rate is simpler and more adjusting the wage index value using a CBSAs; and for rural Puerto Rico, we straightforward in application and floor, which does not reflect actual will use the wage index floor. calculation. Applying the wage index wages paid in that area, we will budget-neutrality adjustment factor to c. Wage Index Budget-Neutrality reconsider the floor in CY 2014. the ESRD PPS base rate produces results Adjustment that are not measurably different from b. Policies for Areas With No Hospital We have broad discretion under applying the adjustment factor to the Data section 1881(b)(14)(D)(iv)(II) of the Act wage index, as is done for the composite In CY 2006, while adopting the CBSA to develop a geographic wage index. In rate portion of the blended payment designations for the basic case-mix addition, that section cites the wage during the transition. We sought

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comment on our proposal to apply the December 31, 2010), and geographic neutrality adjustment factor of 1.001520 wage index budget-neutrality location information for each facility which is applied to the ESRD PPS base adjustment factor to the ESRD PPS base which, may be found through Dialysis rate. Under the ESRD PPS, the wage rate for purposes of the ESRD PPS Facility Compare (76 FR 40510–40511). index floor for CY 2012 is 0.550 because payments and the ESRD PPS component Dialysis Facility Compare can be found the wage index budget-neutrality of the blended payments during the at the Dialysis Facility Compare Web adjustment factor is applied to the base transition. page on the CMS Web site at http:// rate. We did not receive any comments on www.cms.hhs.gov/ As we indicated in the proposed rule our proposal to apply the wage index DialysisFacilityCompare/. The FY 2012 (76 FR 40511), because we apply the budget-neutrality adjustment to the hospital wage index data for each urban wage index budget-neutrality ESRD PPS base rate and to continue to and rural locale by CBSA may also be adjustment factor to the wage index apply the wage index budget-neutrality accessed on the CMS Web site at values to ensure budget-neutrality under adjustment to the wage index values for http://www.cms.hhs.gov/ the composite rate portion of the the composite rate portion of the AcuteInpatientPPS/WIFN/list.asp. The blended payment, we also apply the blended payment. Therefore, for CY wage index data are located in the wage index budget-neutrality 2012 and subsequent years, we are section entitled, ‘‘FY 2012 Final Rule adjustment factor to the wage index finalizing our proposal to apply the Occupational Mix Adjusted and floor. We note this would apply to areas wage index budget-neutrality Unadjusted Average Hourly Wage and in Puerto Rico subject to the floor. adjustment factor to the ESRD PPS base Pre-Reclassified Wage Index by CBSA.’’ Therefore, for the composite rate portion rate for the purposes of the ESRD PPS We did not receive any comments on of the blended payment, we are payments and the ESRD PPS portion of the methodology used to compute the finalizing for CY 2012 to apply the wage the blended payment during the budget-neutrality adjustment factors. index budget-neutrality adjustment transition. We are also finalizing our Therefore, for CY 2012 and beyond, we factor to the wage index floor of 0.550 proposal to continue to apply the wage- are finalizing the methodology we which results in an adjusted wage index index budget-neutrality adjustment proposed for computing the CY 2012 floor of 0.552 (1.002830 × 0.550). factor directly to the ESRD wage index wage index budget-neutrality values for the composite rate portion of adjustment factors (76 FR 40510 and d. ESRD PPS Wage Index Tables the blended payment for CY 2012 and 40511). Using treatment counts from the The CY 2012 ESRD wage index tables, CY 2013. 2010 claims and facility-specific CY referred to as Addendum A (ESRD Because the ESRD wage index is only 2011 payment rates, we computed the facilities located in urban areas), and applied to the labor-related portion of estimated total dollar amount each Addendum B (ESRD facilities located in the composite rate, we computed the ESRD facility would have received in rural areas) are posted on the CMS Web wage index budget-neutrality CY 2011. The total of these payments site at: http://www.cms.gov/ adjustment factor based on that portion. became the target amount of ESRDPayment/PAY/list.asp. The wage That is, the labor-related share of the expenditures for all ESRD facilities for index tables list two separate columns composite rate portion of the blended CY 2012. Next, we computed the of wage index values. One column payment of 53.711 percent. This labor- estimated dollar amount that would represents the wage index values for the related share was developed from the have been paid for the same ESRD composite rate portion of the blended labor-related components of the 1997 facilities using the final ESRD wage payment to which the wage index ESRD composite rate market basket that index for CY 2012. The total of these budget-neutrality adjustment factor has was finalized in the 2005 PFS final rule payments becomes the new CY 2012 been applied. The other column lists the (70 FR 70168). The labor-related share amount of wage-adjusted payment rate wage index values for the ESRD PPS, of the ESRD PPS is 41.737 percent labor expenditures for all ESRD facilities. which does not reflect the application of (that is, the portion of the ESRD PPS After comparing these two dollar the wage index budget-neutrality payment rate and the ESRD PPS portion amounts (target amount divided by the adjustment factor, because as we of the blended payment). As discussed new CY 2012 amount), we calculated discussed above, we apply the wage in the CY 2011 ESRD PPS final rule (75 two wage index budget-neutrality index budget-neutrality adjustment FR 49161), we used the 2008-based adjustment factors that, when factor to the ESRD PPS base rate. ESRDB market basket cost weights to multiplied by the applicable CY 2012 determine the labor-related share for estimated payments, would result in 8. Drugs ESRD facilities under a bundled system. aggregate payments to ESRD facilities a. Vancomycin Under the ESRDB market basket, the that would remain budget-neutral when labor-related share for ESRD facilities is compared against the target amount of In the CY 2011 ESRD PPS final rule 41.737. These figures represent the sum payment rate expenditures. The first (75 FR 49050 through 49052), we stated of Wages and Salaries, Benefits, factor was applied to the ESRD PPS base that antibiotics used for the treatment of Housekeeping and Operations, All rate. The second factor was applied to venous access infections and peritonitis, Other Labor-related Services, 87 percent the wage index values for the composite are renal dialysis services under the of the weight for Professional Fees and, rate portion of the blended payment. ESRD PPS. Payments for anti-infective 46 percent of the weight for Capital- Therefore, in this final rule, we are drugs in injectable forms (covered under related Building and Equipment finalizing for CY 2012, the wage index part B) and oral or other forms of expenses. budget-neutrality adjustment factor for administration (formerly covered under To compute the proposed CY 2012 the composite portion of the ESRD PPS part D) used in the treatment of ESRD, wage index budget-neutrality blended payment of 1.002830, which is were included in computing the final adjustment factors, we proposed to use applied directly to the ESRD wage index ESRD PPS base rate and, would not be the fiscal year (FY) 2012 pre-floor, pre- values. For the ESRD PPS (that is, for separately paid under the ESRD PPS. reclassified, non-occupational mix- the full ESRD PPS payments and the We also noted that the oral versions of adjusted hospital data to compute the ESRD PPS portion of the blended vancomycin are not used for ESRD- wage index values, 2010 outpatient payments during the transition), we are related conditions and, therefore, would claims (paid and processed as of finalizing the wage index budget- not be considered a renal dialysis

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service. We further stated that any anti- Response: We thank the commenters ESRD PPS. One commenter stated that infective drug or biological used for the for their support. Consequently, in this the use of overfill is an efficient treatment of ESRD-related conditions final rule we are finalizing the proposal operation and expressed concern that would be considered a renal dialysis to eliminate the restriction on the new policy would lead to excessive service and, not eligible for separate vancomycin to allow ESRD facilities to wastage. A commenter disagreed with payment. We noted this policy also receive separate payment by placing the our assertion that overfill is provided by applies to any drug or biological that AY modifier on the claim for manufacturers without charge to the may be developed in the future. We vancomycin when furnished to treat provider and stated that there would be established edits to ensure that separate non-ESRD related conditions. In additional costs if facilities are not payment could not be made to ESRD accordance with ICD–9 guidelines as allowed to maximize drug usage. The facilities for vancomycin which has described in the CY 2011 ESRD PPS commenter believes the cost to traditionally been used by ESRD final rule (75 FR 49107), the ESRD providers includes the full amount of facilities to treat access infections. facility must indicate the diagnosis code drug in each vial. One commenter stated In the proposed rule (76 FR 40511), for which the vancomycin is indicated. that dialysis providers may and should we acknowledged that since the We reiterate that treatment of any skin administer overfill if clinically publication of the CY 2011 ESRD PPS infection that is related to renal dialysis appropriate to reduce costs and waste. final rule, we had received numerous access management would be The commenter cited the administration comments indicating that vancomycin is considered a renal dialysis service and of EPO as an example. One commenter indicated in the treatment of both ESRD would continue to be paid under the stated that, ‘‘* * * providers have been and non-ESRD conditions, such as skin ESRD PPS, and no separate payment purchasing drugs with overfill amounts infections. We further stated that after would be made. and use of the overfill amount has long consultation with our medical experts, been known by both the Office of b. Drug Overfill we concurred with the commenters. Inspector General (OIG) and CMS.’’ Therefore, we proposed to eliminate the In the CY 2011 PFS final rule (75 FR Response: We disagree with the restriction on vancomycin to allow 73466), we explained the methodology commenters that believe our proposal ESRD facilities to receive separate for Part B payment for drugs and would restrict the clinical use of payment by placing the AY modifier on biologicals that include intentional intentional overfill. As we indicated in the claim for vancomycin when overfill, and that the Medicare average the CY 2011 PFS final rule (75 FR furnished to treat non-ESRD-related sales price (ASP) payment limit is based 73467), our policy here is not intended conditions. In accordance with ICD–9 on the amount of drug conspicuously to limit the use of intentional overfill guidelines, as described in the ESRD indicated on the labeling approved by during the care of beneficiaries or in PPS final rule (75 FR 49107), the ESRD the Food and Drug Administration medical practice; such measures are facility would also be required to (FDA). We indicated that we had beyond CMS’ authority. Rather, the indicate the diagnosis code for which become aware of situations where proposed rule merely set forth how and the vancomycin is indicated. We noted manufacturers intentionally included a under what conditions we would make that treatment of any skin infection that small amount of overfill in drug payment under the ESRD PPS outlier is related to renal dialysis access containers, and that this overfill is policy. Consistent with prior management would be considered a provided at no extra charge to the rulemaking, under our authority in renal dialysis service and would provider. We also noted that we section 1881(b)(14)(D)(ii) of the Act, we continue to be paid under the ESRD understood the intent of the intentional are adopting the ASP policy on overfill PPS, and no separate payment would be overfill was to compensate for product for purposes of calculating the outlier made. We sought public comments on loss during the proper preparation and payment. We believe the use of the ASP our proposal to eliminate the restriction administration of a drug. We explained policy for purposes of calculating the on vancomycin to allow ESRD facilities that ASP calculations are based on data outlier payment is appropriate because, to receive separate payment for these reported by manufacturers, including for the reasons stated, we believe drugs when furnished to treat non- ‘‘volume per item’’. Therefore, providers overfill does not represent a cost to the ESRD-related conditions. The comments may only bill for the amount of drug facility; thus, overfill should not factor we received and our responses are set product actually purchased and the cost into our determination of outlier forth below: that the product represents (75 FR payments. This rule does not purport to Comment: Two commenters suggested 73467). regulate the use of overfill, only whether that we allow for separate payment for We stated in the proposed rule (76 FR it is reimbursed under our outlier policy daptomycin when furnished by ESRD 40511) that this part B provision applies and the composite rate portion of the facilities for non-ESRD related under the ESRD PPS. We explained that blended payment during the transition. conditions. ESRD facilities receiving blended Thus, whether we or the OIG had Response: We thank the commenter payments under the transition would information about certain providers’ for the suggestion to allow for separate receive payments based on ASP for purchase and use of overfill is payment of daptomycin when used for separately billable ESRD drugs and irrelevant. non-ESRD related conditions. As noted biologicals for the composite rate Comment: A large dialysis above, we had established system edits portion of the blend. In addition, under organization indicated that the drug to ensure that ESRD facilities could not the ESRD PPS outlier policy, the ESRD- overfill policy should not apply to ESRD be paid separately for both vancomycin related drugs that ESRD facilities report facilities because the ASP payment and daptomycin. We will consider on claims are priced for the outlier regulation applies to drugs ‘‘not paid on removing the system edit for policy using ASP prices. Therefore, a cost or prospective payment system daptomycin in future rulemaking. ESRD facilities may only report units basis.’’ The commenter contends it Comment: We received six comments and charges for drugs or biologicals would not apply under the ESRD PPS in support of our proposal to eliminate actually purchased. even though outlier eligible drugs are the restriction on vancomycin and allow Comment: Three commenters priced using the ASP prices established for separate payment when furnished expressed concern that the drug overfill under section 1847A of the Act. The for non-ESRD-related conditions. policy was not appropriate under the commenter stated that CMS cannot

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substitute the ASP method for a portion irrelevant to our proposal here. Our level adjustment for BSA that would be of the ESRD PPS. The commenter policy pertains only to how and applied to each 0.1 m2 change in BSA further contends that because dialysis whether we pay for drugs under our compared to the national average. providers may administer overfill, but outlier policy under authority of section In the proposed rule (76 FR 40511 and CMS’s proposal would prohibit them 1881(b)(14)(D)(ii) of the Act. 40512), we proposed to make one from submitting a claim that includes Third, we disagree with the change related to the use of the national overfill, it appears that CMS expects commenters that our policy will require BSA average value used in the providers either to inaccurately state the ESRD facilities to inaccurately reflect calculation of the BSA adjustment services furnished on the claims form or the services they furnish. We expect that applied to the composite rate portion of incur significant expense to separately providers will continue to maintain the blended payment during the track overfill amounts, which may be accurate medical records for all transition. This change was necessary used for thousands of patients daily, beneficiaries as well as accurate because we believe that the BSA resulting in unnecessary burden. The inventory records of all drugs that were national average used to compute commenter opined that applying the actually purchased and appropriately payment under the composite rate ASP payment rule under the ESRD PPS billed to Medicare. We acknowledge portion of the blended rate and under is inconsistent with the policy that separate tracking of overfill may the ESRD PPS should be both the most objectives of a PPS leading to wastage if increase burden on ESRD facilities that recent and consistent measurement facilities continue to use single-use vials were not doing so before. However, available. We further explained that for or extra expenses if facilities migrate to given that we have adopted ASP CY 2011, the BSA adjustment we multi-dose vials. policies generally for outliers under the calculated for the composite rate portion Response: We disagree with these ESRD PPS and we rely on data reported of the blended payment used the BSA comments. First, as noted above, we under the ASP methodology to national average of 1.84, which reflected proposed to incorporate into our outlier determine the outlier thresholds, even if the average among Medicare dialysis policy the policy for overfill under the we believed overfill were something patients in 2002. However, the BSA ASP methodology; however, our other than free product, we would have national average we used for computing authority to determine an outlier policy no ability to account for it separately. the BSA under the ESRD PPS was 1.87, is found in section 1881(b)(14) of the Finally, we disagree that our policy is which reflected the national average Act, which calls for a prospective inconsistent with waste reduction. As among Medicare dialysis patients in payment basis for renal dialysis services noted above, our policy does not apply 2007. We did not realize that we had and authorizes an outlier payment to the use of overfill; rather, it applies used 2 different national averages in CY adjustment. Thus, contrary to the only to whether we pay for overfill 2011, nor was it brought to our attention commenter’s assertion, we are paying under our outlier policy. ESRD facilities during the comment period. For CY for drugs subject to the ESRD PPS remain free to take steps to reduce drug 2012 and in subsequent years, we outlier policy under a prospective wastage and in doing so, reduce their proposed to use one national average for payment system, not under section costs in providing ESRD services—our computing the BSA under the 1847A of the Act. Under the outlier policy only prevents an ESRD facility composite rate portion of the blended policy, we use the ASP methodology, from accounting for something for payment during the transition and which is based upon manufacturer which it incurred no cost in under the ESRD PPS. reporting of the labeled amount of a determining whether it met the high In the CY 2004 PFS final rule (69 FR drug and not any other amount (that is, cost outlier policy. 66329), we explained that the BSA overfill amount). Therefore, we are We are finalizing our proposal to factor was defined as an exponent equal establishing that the ESRD PPS outlier incorporate the ASP overfill policy into to the value of the patient’s BSA minus policy does not include an amount for our outlier policy and for purposes of the reference. For example, for a overfill. Further, the outlier policy was the composite rate portion of the beneficiary with a BSA of 1.94, using designed to provide additional blended payment during the transition. the CY 2011 national average of 1.84 payments for high cost patients. To the Thus, ESRD facilities may only report under the composite rate would yield a extent a patient receives drug amounts units and charges for drugs and BSA adjustment factor of 1.0370. For the at no cost to the facility (that is, overfill biologicals actually purchased. same patient, using the national average of 1.87 used for the CY 2011 ESRD PPS amounts), that amount may not be 9. Revisions to Patient-Level BSA computation would yield a BSA attributed to the cost of that patient. Adjustment for Body Surface Area adjustment factor of 1.0258. A ratio or Finally, because we are continuing to (BSA) pay under the composite rate portion of proportional difference of 1.0258 the blended payment for separately Under section 1881(b)(14)(D)(i) of the divided by 1.0370 equals .9892 billable drugs using the ASP payment Act, the bundled ESRD PPS must difference the between the two BSA methodology, we should continue to include a payment adjustment based on adjustment factors. This corresponds to utilize the methodology for pricing case-mix that may take into account a reduction of 1.08 percent (1¥0.9892 = drugs for the outlier policy. patient weight, body mass index (BMI), 0.0108) in the composite rate payment Second, the commenter’s contention body surface area (BSA), and other for adult patients by increasing the BSA about the scope of the ‘‘incident to’’ appropriate factors. In the proposed rule reference value from 1.84 to 1.87. benefit reflects a misunderstanding of (76 FR 40511 and 40512), we explained In Table 3 of the proposed rule (76 FR our proposal. We refer the commenter to that we evaluated height and weight 40512), we showed the impact of discussion of the overfill policy in the because the combination of these two increasing the composite rate BSA CY 2011 PFS final rule (75 FR 73469), characteristics allows us to analyze two reference value from 1.84 to 1.87 for where we stated that our ASP overfill measures of body size: BSA and BMI. each year from 2011 to 2014, on facility policy is not based on the ‘‘incident to’’ We further explained that both body payments for ESRD facilities going rules, but rather applies to all drugs and size measures are strong predictors of through the transition. The impact on biologicals paid under section 1847A of variation in payment for ESRD patients. facility payments are greatest in 2011, the Act, regardless of setting. The As a result, in developing the ESRD where the blended payment during the ‘‘incident to’’ rules are similarly PPS, we established a case-mix patient transition period is weighted more

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heavily towards the basic case-mix 10. Revisions to the Outlier Policy exceeds a threshold. The MAP amount adjusted composite payment system, Section 1881(b)(14)(D)(ii) of the Act represents the average incurred amount and declines through 2014 when there requires that the ESRD PPS include a per treatment for services that were or is no impact on facility payments under payment adjustment for high cost would have been considered separately a fully implemented PPS. outliers due to unusual variations in the billable services prior to January 1, 2011. The threshold is equal to the Therefore, for CY 2012, we proposed type or amount of medically necessary ESRD facility’s predicted ESRD outlier to use the latest national average (that is, care, including variability in the amount services MAP amount per treatment 1.87) as the reference point for the of erythropoiesis stimulating agents (which is case-mix adjusted) plus the computation of the BSA adjustment for (ESAs) necessary for anemia management. In the CY 2011 ESRD PPS fixed dollar loss amount. In accordance both the composite rate portion of the with § 413.237(c) of the regulation, blended payment and for the ESRD PPS final rule, we stated that for purposes of determining whether an ESRD facility facilities are paid 80 percent of the per (76 FR 40512). We also proposed to treatment amount by which the imputed would be eligible for an outlier review the BSAs on CY 2012 claims MAP amount for outlier services (that is, payment, it would be necessary for the (and every 5 years thereafter) to the actual incurred amount) exceeds facility to identify the actual ESRD determine if any adjustment to the this threshold. ESRD facilities are outlier services furnished to the patient national average would be required in eligible to receive outlier payments for by line item on the monthly claim (75 the future. We sought comments on treating both adult and pediatric these proposals. The two comments we FR 49142). Medicare regulation § 413.237(a)(1) dialysis patients. received and our responses are set forth In the CY 2011 ESRD PPS final rule, provides that ESRD outlier services below: using 2007 data, we established the include: (1) ESRD-related drugs and outlier percentage at 1.0 percent of total Comment: One organization that biologicals that were or would have represents small dialysis organizations payments (75 FR 49142 through 49143). been, prior to January 1, 2011, We also established the fixed dollar loss supported the proposals to use the 1.87 separately billable under Medicare Part reference point for computing the BSA amounts that are added to the predicted B; (2) ESRD-related laboratory tests that outlier services MAP amounts. The and to review the BSA calculation every were or would have been, prior to five years. One independent ESRD outlier services MAP amounts and fixed January 1, 2011, separately billable dollar loss amounts are different for facility opposed the change in the under Medicare part B; (3) medical/ adult and pediatric patients due to reference point stating that it will surgical supplies, including syringes differences in the utilization of negatively impact facilities that opted to used to administer ESRD-related drugs, separately billable services among adult receive payment under the transition that were or would have been, prior to and pediatric patients (75 FR 49140). because it will reduce the composite January 1, 2011, separately billable rate payment. The commenter under Medicare Part B; and (4) renal a. Revisions Related to Outlier ESRD referenced the table in the proposed rule dialysis service drugs that were or Drugs and Biologicals that displays the negative effect. would have been, prior to January 1, Attachment 3 of Change Request 7064 Response: We thank the national 2011, covered under Medicare Part D, issued August 20, 2010 under organization for its support of our excluding ESRD-related oral-only drugs. Transmittal 2033, as modified by proposals and appreciate the concerns Drugs, laboratory tests, and medical/ Transmittal 2094 issued November 17, expressed by the ESRD facility. We surgical supplies that we would 2010 and Transmittal 2134 issued regret that we had not identified the recognize as outlier services were January 14, 2011, specified the former discrepancy in the values used in the specified in Attachment 3 of Change separately billable Part B drugs that are CY 2011 ESRD PFS and CY 2011 ESRD Request 7064, issued August 20, 2010 recognized as ESRD-related eligible PPS final rules. However, as we under Transmittal 2033. Transmittal outlier services and, the former Part D indicated in the CY 2012 proposed rule, 2033 was rescinded and replaced by drugs by National Drug Code (NDC) for we believe the change is necessary Transmittal 2094, dated November 17, the three vitamin D analogues because the BSA national average used 2010. The replacement document (calcitriol, paracalcitol, and to compute the composite rate portion involved the (1) Deletion of several doxercalciferol) and levocarnitine that of the blended payment and under the drugs; (2) identified drugs that may be are recognized as eligible outlier service eligible for ESRD outlier payment; (3) ESRD PPS should be both the most drugs. provided a list of laboratory tests that In the proposed rule (76 FR 40513), recent and consistent measurement comprise the AMCC tests; (4) deleted we indicated that we had intended to available. several laboratory tests; and (5) included update both the lists of former part B After considering the public the latest version of the ESRD PRICER drugs and biologicals and former part D comments and for the reasons noted layout file. Transmittal 2094 was drugs that are outlier services (75 FR above, in this final rule, for CY 2012, we subsequently rescinded and was 49138). However, we concluded that are finalizing our proposal to use the replaced by Transmittal 2134 issued any CMS prepared lists of drugs and BSA national average of 1.87, which is January 14, 2011. That transmittal was biologicals recognized as outlier the latest national average, as the issued to correct the subject on the services may be difficult to keep up-to- reference point for the computation of transmittal page and made no other date. We recognized that this is the BSA adjustment for both the changes. attributed to the lag in the receipt of composite rate portion of the ESRD PPS Medicare regulations at claims data; changes in ESRD practice blended payment and for the ESRD PPS. § 413.237(a)(2) through (a)(6), and (b) patterns; and inadvertent omissions and We are also finalizing our proposal to specify the methodology used to oversights. Because the regulation review the BSA national average on the calculate outlier payments. An ESRD defines eligible outlier service drugs, we CY 2012 claims and every 5 years facility is eligible for an outlier payment believe there is no need for CMS to thereafter to determine if any if its actual or imputed Medicare issue a list of former separately payable adjustment to the national average will Allowable Payment (MAP) amount per part B ESRD outlier services drugs. be required in the future. treatment for ESRD outlier services Furthermore, because the list of drugs is

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derived from paid ESRD claims, it outlier drugs and biologicals under the dialysis, would be considered as would not be comprehensive, ESRD PPS in the proposed rule, (76 FR separately billable under the composite completely represent drugs and 40513 and 40514) and our request for rate portion of the blended payment and biologicals furnished to ESRD patients, comments. eligible for outlier payments under the accurate, or up-to-date. We noted that, Under current policy, antibiotics ESRD PPS, while antibiotics used at consistent with current policy, all furnished in the home are considered to home by home patients for the same composite rate drugs, as defined in the be composite rate drugs and therefore, purpose would be considered to be Medicare Benefit Policy Manual, Pub. not eligible for outlier payment. In the included in the composite rate and not 100–02, chapter 11, section 30.4.1, proposed rule (76 FR 40513), we eligible for outlier payments. We would not be eligible for an outlier discussed that Pub. 100–02, chapter 11, proposed to eliminate the inclusion of payment, as these drugs would not have section 30.4.1 lists the drugs covered antibiotics when used in the home to been separately paid under Part B or under the composite rate. The list treat an infection of the catheter site or Part D prior to January 1, 2011, and do includes a statement that antibiotics peritonitis associated with peritoneal not meet the definition of outlier when used at home by a patient to treat dialysis as part of the composite rate services. Consequently, we proposed to an infection of the catheter site or drugs, and allow them to be separately eliminate the issuance of a list of former peritonitis associated with peritoneal paid under the composite portion of the separately payable Part B drugs and dialysis are considered composite rate blended payment for ESRD facilities biologicals that would be eligible for drugs. Because composite rate drugs and receiving payment during the transition. outlier payments. Accordingly, we their administration (both the staff time We also proposed that antibiotic drugs solicited public comments on our and the supplies) are covered under the used at home to treat catheter site proposal to eliminate the issuance of a composite rate, antibiotics furnished in infections or peritonitis associated with specific list of eligible outlier service the patient’s home used for the reasons peritoneal dialysis would be eligible as drugs which were or would have been noted above may not be billed and paid ESRD outlier services. Antibiotics separately billable under Medicare Part separately. However, antibiotics furnished in facility would continue to B prior to January 1, 2011. furnished in an ESRD facility are be recognized as ESRD outlier services. The comments on our proposal and considered separately payable in We solicited comments on our our responses are summarized below. accordance the Medicare Claims proposal. The comments and our Comment: Two national associations Processing Manual, Pub. 100–04, responses are summarized below. supported the proposal to eliminate the chapter 8, section 60.2.1.1. Comment: One national association drug and biological list. Both We also noted that Pub. 100–02, and one dialysis organization agreed commenters supported the creation of a chapter 11, section 50.9 states that an with the proposal that home antibiotics list through guidance. One commenter antibiotic used at home by a patient to to treat catheter site infections or indicated that the list would maintain treat an infection of the catheter site or peritonitis associated with peritoneal transparency, but recognized that this peritonitis associated with peritoneal dialysis would qualify as eligible for would create a rulemaking burden. The dialysis is covered as home dialysis outlier payment. commenter further requested that CMS supplies included in the Method II Response: We thank the commenter ensure that process remains transparent (Direct Dealing) payment cap for home for their support. and subject to input from stakeholders. dialysis supplies administered by the In this final rule, we are finalizing the Response: We thank the commenter’s Durable Medical Equipment (DME) proposal to recognize antibiotics for their support of our proposal. As we Supplier. Prior to January 1, 2011, under furnished in the home to treat catheter indicated, any CMS prepared lists of Method II, durable medical equipment site infections or peritonitis associated drugs and biologicals recognized as suppliers received direct payment from with peritoneal dialysis as eligible for outlier services may be difficult to keep Medicare for furnishing dialysis services outlier payment. We believe the up-to-date due to the factors described to home dialysis patients. Effective inclusion of antibiotics used by home above. January 1, 2011, as indicated in dialysis patients as outlier services will Because we are concerned that a § 413.210(b) of the regulations, CMS reduce confusion over drugs and failure to include a drug or biological on does not pay any entity or supplier biologicals that are eligible outlier the outlier services list will negatively other than ESRD facilities for covered services and eliminate the distinction in impact ESRD facilities by limiting the items and services furnished to a the eligibility of a drug for outlier drugs eligible for the outlier policy, in Medicare beneficiary. Therefore, eligibility based on where it is this final rule, we are finalizing the payment to DME suppliers for furnished. As new drugs emerge, we proposal to eliminate the issuance of a antibiotics under Method II can no intend to update the HCPCS codes specific list of eligible outlier service longer be made. Additionally, under the corresponding to new drugs and drugs which were or would have been ESRD PPS, the dialysis facility is biologicals for billing purposes, and to separately billable under Medicare part responsible for furnishing all renal determine whether any of those drugs B prior to January 1, 2011. However, dialysis services, regardless of the site of would have been considered to be under separate guidance, we plan to service. Under the ESRD PPS, there is composite rate drugs. Drugs and continue to identify renal dialysis no payment distinction made as to the biologicals which were or would have service drugs which were or would have site where a renal dialysis service is been considered composite rate drugs been covered under Part D for outlier provided (that is, in the home or in a are not eligible ESRD outlier services eligibility purposes in order to provide facility). under § 413.237. unit prices for calculating imputed Therefore, in the proposed rule, (76 In the proposed rule (76 FR 40514), outlier services. FR 40513 and 40514), we indicated that we proposed two modifications to the With respect to the comment we did not believe that it would be computation of the separately billable regarding transparency, we recognize appropriate to have a distinction in MAP amounts used to calculate outlier the need to be transparent and have which antibiotics administered in an payments for the reasons described sought input from stakeholders. We ESRD facility, used to treat an infection below. We explained that subsequent to believe that we have been transparent of the catheter or other access site, or the publication of the CY 2011 ESRD by the inclusion of proposed changes to peritonitis associated with peritoneal PPS final rule, our clinical review of the

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2007 ESRD claims used to develop the that when properly used, these agents treatment and, therefore, would be more ESRD PPS revealed that dialysis may help avoid unnecessary (and properly considered a composite rate facilities routinely used alteplase and expensive) access procedures and drug. other thrombolytic drugs for access interventions. The commenter further Comment: An independent ESRD management purposes. Under the ESRD believes that the outlier payment policy facility noted that alteplase was Benefit Policy Manual, Pub. 100–02, could adversely impact their proper use separately billable under the composite chapter 11, section 30.4.1, drugs used as and lead to greater vascular access rate and was not considered a substitute for any of the listed items, procedures outside of the dialysis unit ‘‘interchangeable with heparin’’. The or are used to accomplish the same and could be ‘‘detrimental to patients’ commenter further indicates that effect, are covered under the composite outcomes.’’ alteplase had been included in the CY rate. Because heparin is a composite rate Response: We do not understand the 2011 MAP. Finally, the commenter drug and could be used for access value that longer experience with the indicated that the decision made by this management, any drug or biological use of thrombolytics under a bundled facility to receive payment under the used for the same purpose may not be system before excluding them from the transition was made in part because separately paid. Because outlier outlier policy would provide. We alteplase was separately paid under the payments are restricted under believe that the determination the composite rate system and CMS § 413.237(a) to those items or services furnishing of a drug should be based included alteplase and other that were or would have been upon the patient’s needs and remain thrombolytics under the outlier policy. considered separately billable prior to independent of the outlier policy. We Response: The commenter is correct January 1, 2011, we proposed to believe that maintaining vascular access that alteplase was separately billable recalculate the average outlier services is a renal dialysis service and ESRD under the composite payment system MAP amounts to exclude these facilities would continue to be and was included in the CY 2011 MAP composite rate drugs (that is, we responsible for furnishing the service. amounts for the outlier policy. Because proposed to exclude thrombolytics from We also expect that ESRD facilities we did not propose to alter that policy the computation). would refer patients to another setting if with regard to the composite rate We also explained in the proposed medically necessary and we would not portion of the blended payment and the rule that in developing the outlier expect ESRD facilities to address any policy was only discussed in the context service MAP amounts for 2011, we and all vascular access complications if of the outlier policy, we do not believe excluded testosterone and anabolic doing so would be unsafe. it would be appropriate to make the steroids. We subsequently learned from With regard to the comment about change at this time. Therefore, as discussions with clinicians and ESRD proper use of thrombolytics, the efficacy indicated above, in CY 2012, facilities, that these drugs can be used or merit of thrombolytics is not in thrombolytics furnished by an ESRD for anemia management. Because drugs question with their exclusion from the facility will continue to receive separate used for anemia management in ESRD outlier policy. We believe that the ESRD payment under the composite rate patients were or would have been PPS provides an opportunity for ESRD portion of the blended payment. considered separately billable under facilities to make decisions based on the While we acknowledge that in the Medicare part B, these drugs would be medical need of patients and not on the development of the ESRD PPS, alteplase considered outlier services under basis of financial gain. That is, under was included in the computation of the § 413.237(a)(1). Consequently, we have current policy, a facility may choose to MAP amounts and eligible for outlier recomputed the outlier service MAP use a thrombolytic (alteplase) because payments, we proposed to rectify this amounts for CY 2012 to include these those drugs are eligible under the outlier situation in the proposed rule because drugs. As shown in Table 2, when policy, rather than using an we believe that making one access comparing the outlier service MAP anticoagulant (heparin) which is not management drug eligible for outlier amounts based on the current definition eligible. By no means are we implying payment while making another of ESRD outlier services to the revised that thrombolytics or any access ineligible should not exist. We also note ESRD outlier definition, the net effect of management drug should not be used that since heparin predated the use of these two revisions (the exclusion of when clinically indicated. But rather, thrombolytics in dialysis access patency thrombolytic drugs and inclusion of we are saying that payment policy is not and management and heparin was anabolic steroids) results in an decrease intended to dictate, determine, or included in the composite rate, we to the outlier service MAP amounts by influence clinical practice or favor one believe that any drug or biological $4.00 for adult patients and a decrease course of treatment over another. It is including other anticoagulants, of $0.50 for pediatric patients. intended to ensure that decisions are thrombolytics or any other type of drug We solicited comment on the two not made solely on the basis of financial that may be used in the future for access modifications to the computation of the gain but based on clinical judgment. patency and management would also be separately billable MAP amounts used Finally, as we discussed above, the considered a composite rate drug. to calculate outlier payments we Medicare Benefit Policy Manual, Pub. Comment: One pharmaceutical proposed. The comments received and 100–02, chapter 11, section 30.4.1, company indicated that it did not our responses are set forth below. states that drugs used as a substitute for promote the ‘‘off-label’’ use of alteplase Comment: We received several any of the listed items or are used to in the dialysis setting. The commenter comments opposing the proposal to accomplish the same effect are covered expressed concern that the proposed exclude thrombolytic drugs used for under the composite rate. Because change for outlier payments for access management from the outlier heparin is included in the composite alteplase will provide a disincentive for services MAP amounts and therefore, rate and is used to ensure patency of an appropriate vascular access practices not eligible for outlier payments. One access site and proper flow during the and management, resulting in a negative national organization believes that there dialysis treatment, as we discuss in effect on patients. The commenter stated should be a longer experience with the greater detail below, we interpret this that the manual cited in the proposed use of thrombolytics under a bundled provision to mean that any drug used to rule includes a list of specific drugs, system before excluding them from ensure patency of an access site and heparin is listed but does not include outlier payments. The commenter stated proper flow during the dialysis alteplase or other thrombolytic. The

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commenter further stated that the next different mode of action, with heparin not intended to dictate, determine, or section of the manual requires separate preventing thrombosis and influence clinical practice. We believe billing for thrombolytics used to declot thrombolytics lysing a thrombus after it that the policy that any drug or central venous catheters. The has formed. We are also aware that biological used for access management commenter acknowledged that heparin formation of a thrombus in or around would not be considered eligible under and alteplase are used for access the tip of central venous catheters used the outlier policy (that is, excluding management, but the commenter for dialysis is one reason for catheter thrombolytics from the outlier policy), maintained that does not mean that one dysfunction. Appropriate use of heparin would support decision-making based substitutes for the other. One example by dialysis facilities can prevent on medical need and not based upon provided by the commenter is that thrombus formation, thus reducing the financial incentives. We believe that heparin has been used for 30 years as an likelihood of catheter dysfunction. continuing to recognize expensive anticoagulant to prevent the blood from Heparin use in dialysis has long been thrombolytics as outlier services for clotting as it is being filtered through part of the ESRD composite payment purposes of computing outlier payments the dialyzer and states that the system, is relatively inexpensive, and is for ESRD facilities could create perverse substitute for heparin flushing is saline, widely used as an effective technique financial incentives to underutilize clot which may be contraindicated in the for primary prevention of hemodialysis prevention techniques and overutilize dialysis population due to potential catheter dysfunction. Thrombolytics clot lysis techniques in the course of blood pressure effects. The commenter (including alteplase), can be used to lyse vascular access maintenance by ESRD further stated that alteplase is used as a or dissolve thrombus, restoring catheter facilities. salvage therapy when a catheter function in some cases. These agents are The commenter is correct that becomes dysfunctional due to presumed very costly and, according to FDA Medicare Benefit Policy Manual, Pub. thrombosis. The commenter maintained package insert information, can result in 100–02, chapter 11, section 30.4.1, does that alteplase is the ‘‘only thrombolytic significant bleeding complications. not explicitly list alteplase or other currently marketed that can help lyse a From the perspective of achieving a thrombolytics as composite rate drugs; clot and potentially restore blood flow clinical result, maintenance of however, it does state that drugs used as to a poorly functioning catheter’’. The hemodialysis catheter function, either a substitute for any of the listed commenter included Kidney Dialysis inexpensive primary prevention or composite items or are used to Outcomes Quality Initiative (KDOQI) costly intervention produces accomplish the same effect (that is, guidelines that all catheters are interchangeable results. We believe that access patency) are covered under the ‘‘locked’’ with an anticoagulant such as payment policy should encourage composite rate. As we explained in heparin to prevent thrombosis. The achievement of the desired results in the previous responses, we believe that commenter provided the physiological most cost-effective manner, particularly alteplase and other thrombolytic drugs response to the heparin which they state when the prevention approach reduces are used for access management as is could result in thrombus formation and risk to Medicare beneficiaries. We heparin, though we acknowledge that further stated that the guidelines believe that the significant expenditures the physiological action is different. As recommend thrombolytic therapy for thrombolytics suggests that there are we explained above, we based our directed at salvaging the catheter before ESRD facilities that may not be decision to propose the elimination of access replacement. The commenter adequately applying established thrombolytic drugs from outlier cited the pharmacological and preventive methods (that is, use of eligibility because both thrombolytics indication differences between the two heparin) to maintain hemodialysis and anticoagulants are used to maintain drugs, as well as potential quality catheter access. Inclusion of the patency of the dialysis access site. problems that they believe will occur thrombolytics in the definition of outlier We note that, at this point, we are not with the proposed change Finally, the services and potentially making a aware of another ESRD-related drug commenter distinguished between facility eligible for outlier payments category which has some drugs covered heparin and alteplase by indicating that supports the continuation of this under the composite while others in the patient care technicians (PCTs) practice. category are separately billable. administer intravenous heparin while As for the statement about negative For example, for the category of bone alteplase is prescribed by a physician outcomes, we believe maintaining and mineral metabolism, there are and cannot be administered by PCTs. vascular access is a renal dialysis various drugs that can be used. These Response: We did not state in the service and therefore, is included in the drugs have the same outcome, but have proposed rule that alteplase was ESRD PPS. ESRD facilities are different physiological actions to sometimes used off-label in the dialysis responsible for furnishing the service. accomplish bone integrity; some are setting; however, we believe that the We expect that ESRD facilities would calcium or calcium analogues while commenter may be referring to our not refer patients to another healthcare others are phosphorus. The difference in statement that ESRD facilities routinely setting for the purpose of maintaining the bone and mineral metabolism used thrombolytic drugs for access vascular access. We expect patients to category is that all of the drugs were management purposes. be referred to another setting if separately billable and therefore, In the development of the ESRD PPS, medically necessary. We are not eligible under the outlier policy. we knew that alteplase and heparin suggesting that ESRD facilities are Another example is antihypertensives. were pharmacologically different (that expected to address any and all vascular There are many antihypertensive drugs is, one is a thrombolytic lysing clots and complications, if doing so would be which have the same clinical effect of the other is an anticoagulant preventing unsafe for the patient. Finally, as we lowering blood pressure, but how the clots, respectively). However, we indicated, we plan to monitor whether effect is achieved differs. Beta blockers believe that both drugs enable the ESRD facilities are continuing to by blocking beta adrenergic receptors catheter or graft to function either maintain vascular access as they slow the heart rate and thereby reduce through clot prevention or clot currently perform. the force in which the heart muscle degradation and provide effective With regard to the comment on the contracts leading to a decrease in blood dialysis vascular access. We are aware disincentive to use alteplase properly, pressure. Hydrochorothiazide increases that heparins and thrombolytics have a as we noted above, payment policy is the amount of water removed from the

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blood, causing a decrease in blood they should not be considered in the included in the 2007 claims (though the pressure. Ace inhibitors prevent the same category. We believe that any dollar amount was small) and as a conversion of ACE I and ACE II. ACE II medication or any protocol used for result, proposed to modify the outlier causes the blood vessels to constrict. By dialysis is prescribed by a medical policy. preventing the conversion, the blood practitioner and that differences in who Therefore, in this final rule, we are vessels dilate and lead to a decrease in may administer a drug is not an finalizing a policy to include blood pressure. Antihypertensives are in appropriate distinction that should testosterone and anabolic steroids that the composite rate. impact CMS payment determinations.. are used for anemia management as The commenter is also correct that the We are monitoring access management eligible outlier services and have Medicare Benefit Policy Manual, Pub. and will continue to do so. recomputed the outlier MAP amounts to 100–02, chapter 11, section 30.4.2 does We have not been convinced by the reflect this policy change. list thrombolytics for declotting central commenters that we should not b. Exclusion of Automated Multi- venous catheters as being separately implement the policy to exclude Channel Chemistry (AMCC) Laboratory paid. We cannot address why this thrombolytic drugs from the outlier Tests From the Outlier Calculation payment distinction was made under policy. Therefore, in this final rule, we the composite rate payment system. are finalizing our policy to exclude Medicare regulations at § 413.237 However, we do not believe that thrombolytic drugs from the outlier provide that ESRD-related laboratory allowing some drugs in a drug category policy and have recomputed the outlier tests that were or would have been (that is, for access management) to be MAP amounts to reflect this policy considered separately billable under eligible under the outlier policy while change. However, because we did not Medicare part B prior to January 1, other drugs in the category are not is propose to exclude separate payment of 2011, are eligible outlier services. Those sound payment policy. Because a drug thrombolytic drugs under the composite laboratory tests were specified in was paid separately under the rate portion of the blended payment, Attachment 3 of Change request 7064 composite rate system does not mean separate payment will be made for issued under Transmittal 2033, as that it has to be eligible under the thrombolytic drugs under the composite modified by Transmittals 2094 and outlier policy under the ESRD PPS. We rate portion of the blended payment in 2134. In the CY 2011 ESRD PPS final are not saying that thrombolytics should CY 2012. rule (75 FR 49135 through 49138), we or should not be used as their use is a Comment: One national organization indicated that in order to compute the medical determination. We are merely opposed the inclusion of testosterone outlier payment for laboratory tests, the saying that as a result of classifying and anabolic steroids in the anemia 50 percent rule is required. In addition, drugs and biologicals into categories (for management category citing that it is not because the 50 percent rule is necessary example, access management), recognized as the standard of care. The to calculate the composite rate portion thrombolytics would no longer be commenter indicated that the of the blended payment during the eligible under the outlier policy forthcoming Kidney Disease: Improving transition period, we retained the 50 beginning January 1, 2012. Global Outcomes (KDIGO) Clinical percent rule to determine whether As we discussed earlier and in the CY Practice Guidelines for Anemia and Automated Multi-Channel Chemistry 2011 ESRD PPS final rule (76 FR 49050), CKD makes a strong (level 1B) (AMCC) panel tests would be under the ESRD PPS, we did not recommendation that testosterone and considered composite rate or separately provide a specific ESRD-related drug list anabolic steroids not be used. The billable for the ESRD PPS portion of the because we recognized that drugs and commenter further states that the use of blended payment (75 FR 49137). The biologicals change over time. That is the these drugs is not the recognized AMCC panel tests and an explanation of reason that we categorized drugs and standard of care and the KDIGO the 50 percent rule are identified in Pub. biologicals based on function, such as guidelines would discourage the 100–2, chapter 11, section 30.2.2. ESRD access management. In that regard, financial incentives associated with laboratory billing rules can be found in heparin (and other clot prevention their use. Pub. 100.04, chapter 16, section 40.6. drugs) and thrombolytics such as Response: We appreciate the concerns The 50 percent rule provides that if 50 alteplase, despite their pharmacological expressed by the commenter. The percent or more of covered laboratory differences, are all categorized as access determination to include drugs in or tests comprising a panel of AMCC tests management drugs.). Because there may exclude drugs from a category is made are included under the composite rate be other drugs and biologicals that may based on the overall effect of the drug. payment, then all submitted tests are be used for access management in the Standards of care and appropriate use of included within the composite rate future that may also have different any item or service is not within the payment and, therefore, none of the physiological differences, we also stated scope of payment policy. As we have laboratory tests are considered that any drug or biological furnished for indicated in responses to comments separately billable. Conversely, if less the purpose of access management will above, we expect that ESRD facilities than 50 percent of the covered panel be considered a renal dialysis service will make decisions based on patient tests are composite rate tests, then all under the ESRD PPS. In other words, need and appropriateness of the items AMCC tests submitted for the date of even if a new drug has a physiological and services they furnish. That means service for that beneficiary are action that differs from anticoagulants we would not expect that a drug would considered separately billable. In (as heparin) or thrombolytics (as be furnished for financial purposes but addition, Pub. 100–2, chapter 8, section alteplase), but is used to maintain access rather that the drug is medically 60.1 provides that an AMCC test that is patency, we would not consider such necessary for the patient. We expect that a composite rate test, but is furnished drug to be eligible under the outlier medical practitioners will make beyond the normal frequency covered policy. prescribing decisions based on under the composite rate, is separately We disagree with the commenter’s appropriate medical decision making. billable based on medical necessity. argument that patient care techs (PCTs) Finally, we believe that the renal We explained in the CY 2012 ESRD can administer heparin as part of community will work towards achieving PPS proposed rule (76 FR 40514 and standing orders while alteplase is the best medical practice. Nonetheless, 40515), that after publication of the CY prescribed by a physician implies that we determined that such drugs were 2011 ESRD PPS final rule, we received

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numerous requests to eliminate the 50 ESRD payments would be based 100 because the transition period under the percent rule due to the commenters’ percent on the ESRD PPS and there ESRD PPS would be time limited, and assertions that they were confused about would no longer be a need to maintain will expire when the transition period its application. Unlike specific drugs the distinction between composite rate ends. which are classified as either composite and separately billable laboratory In the preamble of the proposed rule rate or separately billable for purposes services for purposes of applying the 50 (76 FR 40515), we proposed to revise of eligibility under the outlier policy as percent rule. The comments we received § 413.237(a)(1)(ii) of the regulations to discussed above, AMCC laboratory tests and our responses are set forth below: exclude these laboratory tests from the may be classified as either composite Comment: Two commenters definition of ESRD outlier services. rate or separately billable depending expressed support of the elimination of However, in the proposed regulation upon the application of the 50 percent the 50 percent rule under the outlier text of the proposed rule (76 FR 40550), rule or the frequency at which the policy. One renal dialysis organization we proposed revisions to § 413.237 by laboratory test is ordered. Therefore, the welcomed the elimination of the 50 adding paragraph (a)(1)(v) to exclude determination of ESRD-related percent rule. However, the commenter these laboratory tests from the definition laboratory tests as eligible outlier indicated that, of the 23 AMCC tests, of outlier services. In this final rule, we services depends upon the number of twelve were part of the composite rate are finalizing our proposal, but are panel tests furnished or their prior to January 1, 2011. The commenter finalizing the revision of § 413.237 by subsequent classification based on the believes that the other eleven tests adding paragraph (a)(1)(v) to indicate application of the 50 percent rule. should not be considered part of the that as of January 1, 2012, the laboratory composite rate as they are not routinely tests that comprise the AMCC panel are Because the AMCC laboratory tests performed for evaluation of ESRD. The included as eligible under the outlier excluded from the definition of outlier commenter further explained that it is services. policy are determined by the 50 percent rare to see all eleven tests ordered on rule, and in the interests of one patient. c. Impact of Final Changes to the Outlier administrative simplification and Response: We thank the commenters Policy minimizing confusion, we proposed to for their support of our proposal to In the proposed rule (76 FR 40515 and eliminate use of the 50 percent rule for eliminate the 50 percent rule under the 40516), we showed the impact of the the outlier policy and exclude the 23 outlier policy. As we discussed in the proposed changes in the outlier policy AMCC laboratory tests from the proposed rule (76 FR 40514 through which were to: (1) Exclude vascular definition of ESRD outlier services and 40515), all 23 laboratory tests were access management drugs and include from the computation of outlier included on the outlier list for the anabolic steroids as eligible outlier payments. We proposed that the purpose of the 50 percent rule only. elimination of the 50 percent rule for Under our proposal to eliminate the 50 service drugs; and (2) exclude the 23 the AMCC panel tests under the ESRD percent rule from the outlier policy, the AMCC laboratory tests from the ESRD PPS outlier payment policy would twelve composite rate laboratory tests in outlier services definition. In this final result in the de facto treatment of those the AMCC panel would no longer be rule, we are finalizing the revised ESRD tests as composite rate tests. considered eligible under the outlier outlier services definition and changes Accordingly, we proposed to revise policy. Of the remaining 11 laboratory to the outlier policy. The outlier § 413.237(a)(1)(ii) of the regulations to tests in the AMCC panel, the majority services MAP amounts and fixed dollar exclude these laboratory tests from the would not be considered ESRD related. loss amounts included in the proposed definition of ESRD outlier services. The Therefore, these tests are not eligible rule were based on 2009 data. In this 50 percent rule would continue to under the outlier policy. final rule, we are updating the outlier apply, however, to AMCC laboratory Because we did not propose to alter services MAP amounts and fixed dollar tests for classification as either that policy with regard to the composite loss amounts based on 2010 data. The composite rate or separately billable for rate portion of the blended payment and impact of this update is shown in Table the purpose of computing the composite the policy was only discussed in the 2, which compares the outlier services rate portion of the blended rate for context of the outlier policy, we do not MAP amounts and fixed dollar loss ESRD facilities that elected to receive believe it would be appropriate to make amounts in the proposed rule with the payments under the transition, because the change at this time. Therefore, in CY updated estimates for this final rule. All the transition period under the ESRD 2012, we are retaining the 50 percent estimates in Table 2 were inflation PPS would be time limited, and would rule and the 23 AMCC laboratory tests adjusted to reflect projected 2012 prices expire when the transition period ends. for the composite rate portion of the for outlier services. This would occur because all in 2014 blended payment during the transition, BILLING CODE 4120–01–P

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BILLING CODE 4120–01–C to determine the outlier thresholds are number of pediatric Medicare dialysis Based on the use of updated data for being updated from $145.25 to $141.21 patients overall (approximately 800 2010, the average outlier services MAP for adult patients and from $82.58 to patients nationally). This is especially per treatment amounts have decreased $71.64 for pediatric patients. We the case with the pediatric fixed dollar from $87.83 to $81.73 for adult patients estimate that the percentage of facilities loss amounts, since the magnitude of and slightly from $46.27 to $46.26 for with patient months qualifying for the pediatric fixed dollar loss amounts pediatric patients. These updates largely outlier payments under the current is basically determined by a relatively reflect changes in the utilization of policy will be slightly lower for adult small number of the highest cost outlier services for adult and pediatric patients (from 5.5 to 5.4 percent) and pediatric patients. The somewhat lower patients between 2009 and 2010. These higher for pediatric patients (from 5.0 to pediatric fixed dollar loss amounts changes result in a smaller outlier 5.7 percent) based on our use of 2010 based on data from 2010 (as compared services MAP amount for adult patients data. with 2009), reflect the tendency to have (decrease from $83.73 to $78.00) and The update based on 2010 data has a somewhat less extreme high cost cases very little change in the outlier services somewhat greater impact on the outlier for pediatric patients in the 2010 claims. MAP amount for pediatric patients. policy for pediatric patients compared The expected result based on this Similarly, the fixed dollar loss to adult patients. There is generally update is that a somewhat larger amounts which are added to the greater sensitivity in the pediatric percentage of pediatric claims are predicted MAP amounts per treatment results due to the relatively small expected to qualify for outlier payments

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based on 2010 data, but the average money on training and therefore their E. Clarifications to the CY 2011 ESRD outlier payment among the pediatric time should be compensated PPS outlier cases will be somewhat lower. appropriately. Another commenter believes that the home training add-on 1. ICD–9–CM Diagnosis Codes D. Technical Corrections adjustment did not come close to In the proposed rule, we discussed 1. Training Add-On capturing the costs of training. Several the ICD–9–CM diagnosis codes that are In the CY 2011 ESRD PPS final rule commenters maintained that training eligible for the co-morbidity payment (75 FR 49062 through 49063), we should be for more than one hour of adjustments (76 FR 40516). We explained the rationale for costs nursing time. Several commenters provided the list of ICD–9–CM codes believe that the training add-on associated with self-dialysis training. that are recognized for purposes of the adjustment is inadequate. On page 49063 of the CY 2011 ESRD co-morbidity payment adjustments in PPS final rule, the correct training add- Response: As we indicated in the Table E: ICD–9–CM Codes Recognized proposed rule (75 FR 40516), we were on amount of $33.44 is listed in our for a Co-morbidity Payment Adjustment providing a technical correction to note response in column. However, we of the Appendix of the CY 2011 ESRD the correct amount of $33.44 for training inadvertently listed an incorrect training PPS final rule (75 FR 49211). Although treatments furnished on or after January add-on amount of $33.38 in the third we discussed ICD–9–CM coding to be column of page 49063. The correct 1, 2011. We did not propose any change in the methodology or the training add- used to identify co-morbidity conditions training add-on amount is $33.44. on ESRD claims, we did not indicate Therefore, we are correcting the training on adjustment. Thus, the suggestions and comments received are beyond the that we would update the existing add-on amount to $33.44 in the third diagnostic categories and ICD–9–CM column on page 49063 of the CY 2011 scope of this final rule. However, we codes on an annual basis. ESRD PPS final rule, for costs associated will take these comments into account with self-dialysis training on or after in future rulemaking. Also note, the We clarified that the ICD–9–CM codes January 1, 2011. The geographic wage training add-on adjustment is adjusted are subject to the annual ICD–9–CM index is applied to the $33.44. As by geographic wage index to account for coding changes that occur in the described in the CY 2011 ESRD PPS a nurse’s salary for one-hour of home hospital inpatient PPS final rule and final rule (75 FR 49063), the training dialysis training. This adjustment effective October 1st of every year (76 add-on amounts after application of the applies to both hemodialysis and FR 40516). We explained that any wage index would range from $20.03 to peritoneal dialysis home training and is changes that affect the categories of co- $45.84. paid in addition to the ESRD PPS morbidities and the diagnoses within Although we did not propose any payment. That is, ESRD facilities receive the co-morbidity categories that are changes to the current training add-on a per-treatment payment, that accounts eligible for the co-morbidity payment (other than noting the technical for case-mix, geographic location, low- adjustments will be communicated to correction), we received 12 comments volume and outlier payments, regardless ESRD facilities through sub-regulatory from patients and a home training if the patient receives dialysis at home guidance. In the proposed rule, we also organization. The comments we or in a facility, plus the training add-on. explained that in response to comments received and our responses are set forth We also note that staff time is included we have received, we believed that it in the per treatment payment amount below: was important to reiterate the and, the training add-on is in addition Comment: Two commenters discussion of co-morbidities that was to that amount. supported the technical correction to detailed in the CY 2011 ESRD PPS final the training add-on amount. Some 2. ESRD-Related Laboratory Test rule (75 FR 49094 through 49107). comments recommended changes to the Therefore, we explained that ESRD training add-on which included In the proposed rule (76 FR 40516), facilities should continue to provide updating the training add-on to keep we noted that we inadvertently omitted documentation in the patient’s medical/ pace with inflation by applying the an ESRD-related laboratory test from clinical record to support any diagnosis update directly to the training add-on or Table F: ESRD-Related Laboratory Tests by re-calculating the hourly nurses time of the Appendix in the CY 2011 ESRD recognized for a payment adjustment, using the methodology employed in the PPS final rule. We explained that the because this is a requirement to receive CY 2011 ESRD PPS final rule. One ‘‘Assay of protein by other source,’’ the co-morbidity payment adjustment. commenter stated that the training add- which is identified by the Current As we discussed in the proposed rule, on is outside of the bundled base rate Procedural Terminology code 84157, we have been and will continue to and therefore, is not captured in the was a composite rate service under the monitor the prevalence of any co- annual market basket update. One home basic case-mix adjusted composite morbidity diagnoses recognized for the training organization stated that they payment system and, consequently, is co-morbidity payment adjustments were disappointed with home training considered a renal dialysis service under the ESRD PPS as compared to the reimbursement. The commenter also under the ESRD PPS effective January 1, prevalence of these categories over the indicated that the allowable home 2011. Therefore, the ‘‘Assay of protein past several years. Therefore, we would training payments cannot be billed by other source’’ should be furnished by be able to identify any changes in the because of issues with the submission the ESRD facility, either directly or prevalence of any of the co-morbidity requirements for the ESRD Medical under arrangement by another entity, to diagnoses recognized for purposes of the Evidence form for new patients. A home the ESRD patient and paid for under the co-morbidity payment adjustment as training organization, patients, families ESRD PPS payment. compared to previous trends. We are and a national association believe that We did not receive any comments. In monitoring the co-morbidities eligible training treatments should be paid at the this final rule, we are correcting Table for payment adjustment to determine if prescribed frequency and not limited to F of CY 2011 ESRD PPS final rule by the co-morbidity adjustments need to be three days per week, up to the allowable adding, ‘‘Assay of protein by other refined in future rulemaking. We did number of days. One commenter source’’ identified by the Current not receive any comments on this maintained that her clinic was losing Procedural Terminology code 84157. clarification.

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2. Emergency Services to ESRD hospital emergency departments or inappropriate for ESRD facilities to refer Beneficiaries emergency rooms, because these tests its patients to the emergency room or In the CY 2011 ESRD PPS final rule are usually administered as part of a emergency department for maintenance (75 FR 49056), we explained that patient’s clinical assessment of the of access sites (including treatment for inpatient services, emergency services, condition requiring emergency room access infections) which they had and outpatient services furnished in a admission, which we believe are not treated prior to the ESRD PPS for the hospital or in an ambulatory surgical generally related to the treatment of purpose of diverting costs of providing center furnished to ESRD beneficiaries ESRD. Therefore, laboratory tests that renal dialysis services to their patients, were not included in the ESRD PPS base are performed for Medicare ESRD or the administration of drugs that are rate, and none of these services are beneficiaries in an emergency situation considered renal dialysis services under considered renal dialysis services for in an emergency room or emergency the ESRD PPS. We also stated that we inclusion in the ESRD PPS payment department as part of the general work- are monitoring the provision of renal up of the patient, were excluded from dialysis services to ESRD patients in bundle. These services are reimbursed the ESRD PPS payment bundle, and emergency rooms or emergency under other Medicare payment systems. would not be considered renal dialysis departments. We also explained that certain services under the ESRD PPS. We did not solicit comments on outpatient procedures necessary to We acknowledged in the proposed emergency services to ESRD maintain vascular access (that is, those rule that laboratory tests that could be beneficiaries; however, we received four which cannot be addressed by the ESRD used during dialysis and ordered for the comments from national organizations. facilities using procedures that are treatment of ESRD also may be ordered A summary of the comments we considered part of routine vascular for ESRD patients in an emergency received and our responses to comments access care), are excluded from the department or emergency room for other are set forth below. definition of renal dialysis services and reasons (that is, as part of the Comment: Several commenters are not included in the ESRD PPS assessment of the patient to obtain a representing hospital organizations payment. However, we consider the diagnosis of the underlying condition endorsed CMS’ policy not to apply the furnishing of certain medications, such which required emergency consolidated billing rules to items and as those used to flush a vascular access intervention). Although such tests could services furnished to ESRD patients in site of an ESRD patient, to fall within also be used in dialysis treatment and in hospital emergency rooms or emergency the definition of renal dialysis services. the treatment of ESRD, because departments for reasons other than the As we discussed in the section on laboratory tests ordered for ESRD treatment of ESRD. One commenter consolidated billing rules and edits in patients treated in emergency supported CMS’s recognition that the the CY 2011 ESRD PPS final rule (75 FR departments or emergency rooms are ESRD PPS consolidated billing rules do 49168), the ESRD PPS payment is an all- needed to arrive at a diagnosis of the not apply to patients in the emergency inclusive payment for renal dialysis condition requiring emergency department. One commenter supported services and the ESRD facility is treatment, we did not consider the the exclusion of services provided in an responsible for all of the ESRD-related laboratory tests as renal dialysis services emergency room from the definition of services that a patient receives. Payment under the ESRD PPS. Accordingly, these renal dialysis services under the ESRD for renal dialysis services under the laboratory tests were not used to PPS. One commenter appreciated the ESRD PPS, including those that were develop the ESRD base rate. We clarification that’’‘‘legitimate’’ non- formerly paid separately under the basic indicated that we would not expect that ESRD laboratory tests in emergency case-mix adjusted composite payment the laboratory tests provided in that rooms, hospitals, and ambulatory care system, is no longer made to entities circumstance to be subject to centers are not part of the ESRD PPS. other than the ESRD facility (such as consolidated billing edits, resulting in Another commenter agreed that hospital laboratories and DME suppliers). denial of payment. That is, we would emergency department claims are In the proposed rule (76 FR 40517), not consider such tests to be renal excluded from the ESRD consolidated we noted that after the publication of dialysis services in those emergency billing edits. The commenter suggested the CY 2011 ESRD PPS final rule, we situation because they were not ordered modeling specific guidance from the received requests that we further clarify for the treatment of ESRD, but instead, skilled nursing facility (SNF) whether certain renal dialysis services furnished as part of the general work-up consolidated billing guidance. The furnished in an emergency room or of the patient necessary for diagnosis. commenter believed that that emergency department are considered We further explained in the proposed medication administration should not renal dialysis services covered under rule that the exclusion of laboratory be included in the ESRD PPS the ESRD PPS. Accordingly, we further tests ordered in hospital emergency consolidated billing stating that the clarified that renal dialysis services rooms or emergency departments from administration of medications other defined at § 413.171 of the regulations the consolidated billing edits did not than EPO or Aranesp would be directly include diagnostic laboratory tests. In mean that renal dialysis facilities should related to the emergency condition. The developing the ESRD PPS base rate, we attempt to circumvent the application of commenter stated that the application of included payments for outpatient the bundled ESRD PPS rate by directing the AY modifier is a huge operational laboratory tests billed on ESRD facility patients to emergency rooms or burden for hospitals and often they are claims, as well as laboratory tests emergency departments for obtaining unaware that patients have ESRD. ordered by monthly capitation payment ESRD-related laboratory tests, or the Response: We thank the commenters (MCP) physicians and billed on carrier provision of other renal dialysis who supported our clarification of claims (75 FR 49055), because we services. Because ESRD facilities are consolidated billing under the ESRD believe that these diagnostic laboratory financially responsible for all renal PPS. However, some commenters have tests furnished by ESRD facilities and dialysis laboratory tests, referring ESRD misunderstood our clarification. In the MCPs meet the definition of renal patients to the emergency room or proposed rule (76 FR 40517), we dialysis services. We did not include emergency department for ESRD-related explained that we understood that laboratory tests ordered for Medicare laboratory tests would be inappropriate. laboratory tests that could be used for ESRD patients undergoing treatment in We noted that it would also be dialysis could also be ordered for ESRD

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patients in an emergency room or under the transition or to receive outcomes. We encourage patients to emergency department for reasons other payment under the ESRD PPS was a contact their ESRD Network if they are than the treatment of ESRD in order to very important business decision for concerned about the care that they are arrive at a diagnosis. We stated that we ESRD facilities and that a reminder was receiving from their ESRD facilities. recognize that laboratory tests ordered not necessary. Comment: Several commenters for ESRD patients in emergency room or Comment: One national association requested that the rate-setting and emergency department that are needed urged CMS to consider the concerns of impact files at the provider level be to arrive at a diagnosis would not be facilities in the transition and make provided to allow for transparency. The considered renal dialysis services under adjustments to the proposed rule when commenters indicated that they did not the ESRD PPS and, therefore, would not it may impact their financial viability have the data to evaluate the proposed be subject to consolidated billing. We and ability to provide quality patient rule and offer suggestions to improve further explained that the exclusion of care. the bundled system. One commenter laboratory tests that are ordered in an Response: We always assess the cited the need for the rate-setting file to emergency room or emergency degree to which our proposed policies allow for evaluating the proposed department and excluded from negatively impact categories of ESRD changes to the low-volume adjuster. The consolidated billing edits does not mean facilities such as rural, independent, commenter further stated that their that renal dialysis facilities should pediatric, and transitioning ESRD findings differed from CMS and attempt to circumvent the ESRD PPS facilities and are committed to expressed concern that CMS may have bundled payment rate by directing developing payment policies that are overestimated the low-volume adjuster patients to the emergency room or fair and lead to increased payment in the standardization calculation emergency department for ESRD-related accuracy under the ESRD PPS. leading to funds being taken out of the laboratory tests. Comment: One independent ESRD payment system inappropriately. One We have not included drugs or any facility did not believe that ESRD dialysis organization expressed their other renal dialysis item or service in facilities should be held to the one-time concern that small providers may not the consolidated billing rule exemptions election if changes are made annually. have the resources to identify outliers when furnished in an emergency room The commenter proposed that the one- and place them on claims. The or emergency department. In other time election be made on an annual commenter urged CMS to show data words, the only services that we have basis or for those facilities that will be that outlier payments were helping excluded from the consolidated billing ‘‘disproportionately negatively small providers. The commenter further edits are laboratory tests that are impacted’’ by the proposed changes. stated that if small providers were not performed in an emergency room or The commenter further stated that the receiving outlier payments, then it may emergency department to determine a ability to rescind decisions made in be best for funds allocated for outliers diagnosis. We are not discussing any 2010 should be made available. be made part of the base rate. One other outpatient setting other than an Response: Section 1881(b)(14)(E)(ii) of commenter stated that they remain emergency room or emergency the Act prohibits us from allowing concerned that some proposed policies department. We will consider the facilities to submit annual elections or continue to result in a loss of funds from inclusion of renal dialysis drugs (that is, to rescind elections. Therefore, we are the ESRD program that exceeds the drugs used for ESRD-related conditions) unable to allow changes to the election Congressionally-mandated two percent furnished in the emergency room or under any circumstance. With regard to for CY 2011. emergency department exemption in annual changes to the ESRD PPS, we Response: We do not agree with the future rulemaking. did not state that CMS would not make assertions that CMS provided With regards to the suggestion that we any changes to the composite rate inadequate data to evaluate and follow the SNF consolidated billing portion of the blended payment or to the comment on the proposals described in guidelines, we will be issuing guidance ESRD PPS. We believe there are changes the proposed rule. We believe that the on the consolidated billing exemption of finalized in this rule (such as discussions and explanations in the laboratory tests ordered in an emergency eliminating a site of service distinction proposed rule are sufficiently detailed room or emergency department for the with regard to separate payment for to provide an adequate explanation as to purpose of establishing a diagnosis. antibiotics used for access infection and, how values were computed. In addition, Finally, with regard to the comment on eliminating the 50 percent rule under we posted a provider-level impact file the burden of using an AY modifier for the outlier policy) that will result in on the ESRD Payment Web site which non-ESRD-related items and services, positive effects to transitioning was used to create the proposed impact we believe it is important that we assure facilities. analysis. We acknowledge that we may that duplicate payments are not being Comment: One patient organization not have provided sufficient notification made for items and services that have stated that bundling has already that the files were available and, been included in the ESRD PPS bundled negatively impacted patients. The therefore, in the future, we plan to payment. At the current time, the use of commenter further states that providers provide a listserv notification to inform the AY modifier is the only means that have in large part changed prescribed stakeholders when these files are can be used in order to clearly identify medications to the detriment of patients. available on the ESRD Payment Web items and services that are not ESRD- The commenter cited changing practices site. As we did for CY 2011, we will related. of providing analog vitamin D and iron post the provider-level file that will as examples. allow further analysis of the impact of F. Miscellaneous Comments Response: We are concerned about the the final outlier and wage index changes Comment: One commenter expressed comments made by this organization. for CY 2012 on individual providers. disappointment that CMS did not We expect that ESRD facilities through We have not made the rate setting file remind ESRD facilities of the November their interdisciplinary teams and available because the release of patient 1, 2011 deadline to elect to be excluded through the patient’s nephrologist will identifiable data is not necessary to from the transition. ensure that patients receive the care that accomplish the purpose of analyzing Response: We believe that the they require. We are monitoring many our proposals. Applicable Federal decision to receive a blended payment aspects of the ESRD PPS, including privacy laws and regulations, including

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the Privacy Act and HIPAA Privacy through rulemaking rather than 49182 (August 12, 2010) (hereinafter Rule only permit us to disclose personal guidance and, requested that CMS referred to as the ‘‘CY 2011 ESRD PPS identifiable information when it is specify how future changes to the final rule’’)); and one that finalized necessary to administer the program, or system will be handled. One commenter other aspects of the 2012 ESRD QIP for health care operations and payment. supported a race/ethnicity adjuster and such as the scoring methodology and We believe that some of the concerns provided their rationale on its inclusion. payment reduction scale (76 FR 628 raised by the commenters are related to Another commenter urged CMS to through 646) (hereinafter referred to as the assumptions we made in computing examine time on machine, nutritional the ‘‘2012 ESRD QIP final rule’’). the final base rate for CY 2011 where we services, social work services and Section 1881(h) of the Act, as added by standardized the base rate to account for nursing services. One commenter section 153(c) of MIPPA, generally the projected payments for the ESRD requested that CMS explore broader requires that the Secretary establish an PPS adjustments. These concerns are ESRD bundles, such as integrated care ESRD QIP by (i) Selecting measures; (ii) beyond the scope of this final rule. models. Several commenters expressed establishing the performance standards With regard to the commenters’ difficulty of documenting co- that apply to the individual measures; claims that we had overstated the low- morbidities and suggested that CMS (iii) specifying a performance period volume adjustment in the provide the adjusters to the providers. with respect to a year; (iv) developing a standardization calculation leading to Finally, some commenters expressed methodology for assessing the total funds being inappropriately taken out of concerns about the ESRD cost report performance of each provider/facility the payment system, we explained the and with the anticipated funding of based on the performance standards low volume methodology in great detail oral-only drugs. with respect to the measures for a in the CY 2011 ESRD PPS proposed rule Response: Because these comments performance period; and (v) applying an (74 FR 49969 through 49978) and in the were not in response to any proposals appropriate payment reduction to CY 2011 ESRD PPS final rule (75 FR or discussions in the proposed rule, providers and facilities that do not meet 49117 through 49125). We did not they are beyond the scope of this final or exceed the established Total propose to change or modify the low- rule. However, we refer the commenters Performance Score. volume adjuster methodology for CY to the CY 2011 ESRD PPS final rule As we have stated, the first year for 2012. We note that we are monitoring where we believe that we addressed which the ESRD QIP payment reduction the extent to which the low-volume and many of these issues (75 FR 49030). We will be implemented is PY 2012, and we other ESRD PPS adjustments are also note that we will review all of the selected one measure for the PY 2012 consistent with the assumptions we comments and may address them in ESRD QIP of dialysis adequacy and two made in developing the ESRD PPS. We future rulemaking. measures of anemia management. The will address this issue in future Comment: One individual commenter following are the three measures rulemaking. supported the proposed rule. One (finalized in the CY 2011 ESRD PPS We do not understand the comment final rule) for the PY 2012 ESRD QIP: national association supported the case- • that suggested that the proposed mix adjusted PPS. Another national Percentage of Medicare patients policies continue to result in a loss of association expressed their pleasure with an average hemoglobin less than funds from the ESRD program that with the way in which CMS has 10.0 g/dL (Hemoglobin Less Than 10 g/ exceeds the Congressionally-mandated implemented the first year of the ESRD dL measure). two percent, because the two-percent • Percentage of Medicare patients PPS and the agency’s willingness to reduction only applied to CY 2011. with an average hemoglobin greater than Comment: Some commenters work with the ESRD community. Response: We thank the commenters 12.0 g/dL (Hemoglobin Greater Than 12 provided comments on issues that were for their support and willingness to g/dL measure). not addressed in the proposed rule. • Percentage of Medicare patients work with CMS in implementing the These are summarized as follows. Some with an average urea reduction ratio ESRD PPS. commenters suggested that the extra (URR) equal to or greater than 65 costs associated with patient non- II. End-Stage Renal Disease Quality percent (URR Hemodialysis Adequacy compliance should be addressed. Some Incentive Program for Payment Years measure). commenters advocated for inclusion of (PYs) 2013 and 2014 A full description of the their products in the ESRD bundled methodologies used for the calculation payment. Other commenters believed A. Background for the End-Stage Renal of the measures can be reviewed at: that there should be a new technology Disease Quality Incentive Program for http://www.dialysisreports.org/pdf/esrd/ adjustor and provided suggestions such PY 2013 and PY 2014 public/Guide_to_the_PY_2012_ as including new pharmaceutical agents For over 30 years, monitoring the ESRD_QIP_PSR.pdf (see the ‘‘Inclusion into the base rate; providing for quality of care provided to end-stage Criteria’’ and ‘‘Calculation Process’’ incremental payments for innovations renal disease (ESRD) patients and sections of the document). that improve clinical outcomes, but do provider/facility accountability have Other aspects of the 2012 ESRD QIP not reduce costs to dialysis facilities been important components of the finalized in the PY 2012 ESRD QIP final immediately; and a non-budget-neutral Medicare ESRD payment system. The rule include the establishment of pass-through for new technology. One ESRD Quality Incentive Program (QIP), performance standards for these commenter suggested that we include required by section 1881(h) of the Social measures (including applying the over-the-counter nutritional support in Security Act (the Act), is the next step special rule under section 1881(h)(4)(E) the PPS as of January 1, 2012. Several in the evolution of the ESRD quality of the Act) and establishing a scoring commenters maintained that oral drugs program that began more than three methodology for calculating individual for long term residents with ESRD decades ago. The first year for which the Total Performance Scores ranging from should be dispensed by the Long Term ESRD QIP payment reduction will be 0–30 points based on the three finalized Care pharmacy. Several commenters implemented is PY 2012. The PY 2012 measures. As part of our methodology declared that CMS provide a statement ESRD QIP was finalized in two for calculating the provider/facility indicating that future updates to items regulations: one that finalized the three Total Performance Score, we weighted and services in the bundle will be made performance measures (75 FR 49030, the Hemoglobin Less Than 10 g/dL

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Measure at 50 percent of the score, by assigning each provider/facility a FDA for the use of ESAs (http:// while the Hemoglobin Greater Than 12 Total Performance Score, ranging from www.fda.gov/Drugs/DrugSafety/ g/dl measure and the URR Hemodialysis 0–30 points, in accordance with its ucm259639.htm). We discussed with Adequacy measure were each weighted individual performance on the two the FDA our proposal to retire the at 25 percent of the score. We also proposed measures. We proposed that a Hemoglobin Greater Than 10 g/dL finalized a policy under which provider/facility that does not achieve a measure starting in PY 2013. Because providers/facilities that did not meet or Total Performance Score of 30 points this measure encourages providers/ exceed a Total Performance Score of 26 would receive a payment reduction in facilities to keep hemoglobin above 10 points would receive a payment PY 2013 ranging from 1.0 percent to 2.0 g/dL, the FDA agreed that retiring this reduction ranging from 0.5 percent to percent, depending upon how far below measure is consistent with the new 2.0 percent. this minimum Total Performance Score labeling for ESAs approved by the FDA. its performance falls. Our specific We proposed to maintain the B. Summary of the Proposed Provisions proposals, responses to comments, and Hemoglobin Greater Than 12g/dL and Responses to Comments on the finalized policies based on comments, measure as a measure of anemia End-Stage Renal Disease (ESRD) Quality are discussed below. management. As we explained in more Incentive Program (QIP) for PY 2013 detail in the proposed rule (76 FR and PY 2014 a. Performance Measures for the PY 40519), the studies continue to show On July 8, 2011, a proposed rule 2013 ESRD QIP that targeting hemoglobin levels above entitled ‘‘Medicare Program; Changes to Section 1881(h)(2)(A) of the Act 12 g/dL through the use of ESAs can the End-Stage Renal Disease Prospective requires that the measures specified for contribute to adverse patient outcomes.1 Payment System for CY 2012, End-Stage the ESRD QIP include measures on This measure, consistent with the Renal Disease Quality Incentive anemia management that reflect the requirement under section Program for PY 2013 and PY 2014; labeling approved by the FDA for such 1881(h)(2)(A)(i) of the Act, also Ambulance Fee Schedule; and Durable management; measures on dialysis continues to reflect the labeling Medical Equipment’’ (76 FR 40498) (the adequacy; to the extent feasible, a approved by the FDA for anemia ‘‘proposed rule’’) appeared in the measure or measures on patient management. Federal Register. In the proposed rule, satisfaction; and such other measures We also proposed to retain the URR we expanded upon the PY 2012 ESRD that the Secretary specifies, including Hemodialysis Adequacy measure, QIP framework by proposing to adopt (to the extent feasible) measures on iron which assesses the percentage of new ESRD QIP requirements for PYs management, bone mineral metabolism, Medicare patients with an average URR 2013 and 2014. and vascular access, including equal to or greater than 65 percent. We received approximately 88 public maximizing the placement of arterial Section 1881(h)(2)(A)(i) of the Act states comments on the proposed rule that venous fistula. In selecting measures for that the measures specified under the were related to the ESRD QIP. Interested the PY 2013 ESRD QIP, we examined ESRD QIP for a payment year shall parties that submitted comments whether it would be feasible to propose include measures on dialysis adequacy. included dialysis facilities, national to adopt any new measures for the We noted that, for the reasons stated in organizations representing dialysis program. In light of our proposal to the CY 2011 ESRD PPS final rule (75 FR facilities, nephrologists, nurses, select CY 2011 as the performance 49182), we believe that the URR nutritionists, home health agencies, period (discussed more fully below), we Hemodialysis Adequacy measure is an dialysis corporations, clinical determined that it is not feasible to appropriate and accurate measure of laboratories, pharmaceutical adopt any of the new measures hemodialysis adequacy. manufacturers, hospitals and their mentioned above until the PY 2014 The comments we received on these representatives, individual dialysis ESRD QIP. We also carefully proposals and our responses are set patients, advocacy groups, and the reexamined the three measures that we forth below. The comments on and the Medicare Payment Advisory adopted for the PY 2012 ESRD QIP, and responses to the Hemoglobin Greater Commission (MedPAC). In this section for the reasons discussed below, Than 12 g/dL measure also apply to the of the final rule, we provide a summary proposed to continue including only proposal to include this measure in the of each proposed requirement for the PY two of them, (i) The Hemoglobin Greater PY 2014 ESRD QIP. 2013 and PY 2014 ESRD QIP, a Than 12 g/dL measure and (ii) the URR Comment: Many commenters urged summary of the public comments Hemodialysis Adequacy measure, in the CMS to retire the URR Hemodialysis received on those requirements, our PY 2013 ESRD QIP measure set. Adequacy measure for PY 2013 in favor responses to these comments, and the We also proposed to retire the of a Kt/V measure because Kt/V is final policies that will apply to the PY Hemoglobin Less Than 10 g/dL measure widely accepted, is used extensively by 2013 and the PY 2014 ESRD QIP. beginning with the PY 2013 ESRD QIP. the renal community as a measure of As we explained in more detail in the dialysis adequacy, and is the basis for a 1. PY 2013 ESRD QIP Requirements proposed rule (76 FR 40519), we have measure endorsed by the National In the proposed rule, we outlined the recently reassessed the evidence for the Quality Forum (NQF). One commenter proposed requirements for the two use of erythropoiesis stimulating agents specifically noted that there are proposed measures for the PY 2013 (ESAs) in patients with kidney disease situations in which patients may have a ESRD QIP. We proposed that ESRD through a National Coverage Analysis Kt/V within an acceptable range, but not providers and facilities that do not meet (CAG–00413N) and, while we did not a URR equal to or greater than 65 these requirements would receive a seek to limit the coverage of these agents percent. One commenter suggested that, reduction, based on their Total at this time, we could not identify a if CMS does retire the URR dialysis Performance Score, to the payments specific hemoglobin lower bound level adequacy measure for the PY 2013 otherwise made under section that has been proven safe for all patients 1881(b)(14) with respect to PY 2013 treated with ESAs. In addition we 1 KDOQI Clinical Practice Guideline and Clinical services, in accordance with section believe that retiring the Hemoglobin Practice Recommendations for Anemia in Chronic Kidney Disease: 2007 Update of Hemoglobin Target, 1881(h)(1)(A) of the Act. We proposed Less Than 10 g/dL measure is reflective American Journal of Kidney Diseases, 50(3): Pages to calculate these payment reductions of the new labeling approved by the 471–530 (September 2007).

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ESRD QIP, the agency should consider Response: We thank commenters for discontinued. One commenter proposed allowing facilities to report either URR their input. As we stated in the that, in the event the Hemoglobin Less or Kt/V. proposed rule (76 FR 40519), we have Than 10 g/dL measure remains in the Response: We thank the commenters recently reassessed the evidence for the ESRD QIP, the weighting for this for their input on this issue. We agree use of ESAs in patients with kidney measure be decreased until an accurate that a Kt/V dialysis adequacy measure disease through a National Coverage baseline is determined reflecting current would more accurately measure how Analysis (CAG–00413N), and we could medical evidence and drug labeling. much urea is removed during dialysis not identify a specific hemoglobin lower One commenter suggested that this because the calculation takes into bound level that has been proven safe weighting decrease to zero. Commenters account the amount of urea removed for all patients treated with ESAs. We also asked CMS to continue to monitor with excess fluid. We asked providers/ are also not aware of, nor did the hemoglobin levels, perhaps through a facilities to begin submitting Kt/V data comments note, any studies that reporting measure or as a condition for on July 1, 2010, and plan to incorporate identify a specific hemoglobin level coverage, and publicly report low measure(s) based on Kt/V as soon as we which should be maintained to increase hemoglobin levels even if the measure can to ensure the validity and quality of life or minimize transfusions is retired from the ESRD QIP. consistency of these data. In the interim, or hospitalizations. However, if any new Response: As we noted above, we did for the reasons stated in the CY 2011 evidence or studies emerge, we will take not find scientific evidence to identify ESRD PPS final rule (75 FR 49182), we such evidence into consideration in an appropriate and safe quality standard believe that the URR Hemodialysis adopting future measures for the ESRD for a minimal achieved hemoglobin Adequacy measure is, overall, an QIP. We have discussed our proposal to level. Therefore, in the absence of this appropriate and accurate measure of retire the Hemoglobin Less Than 10 g/ evidence, we do not believe it is hemodialysis adequacy. dL measure with the FDA and they appropriate to simply decrease the lower bound. Additionally, continuing Comment: Many commenters voiced concur that retiring the measure is to employ the measure in the program, concern over CMS’ proposal to retire the consistent with the new labeling for but decreasing its weight to zero may Hemoglobin Less Than 10 g/dL ESAs. Factors that impact anemia signal to beneficiaries that this measure measure. One commenter specifically management, including optimal iron is valid, although less important, and stated that CMS should consider the stores, dialysis adequacy, avoidance of infections, reduction of inflammation, that it is, therefore based in scientific effects of retiring this measure on evidence. As noted above, we are pediatric patients. Commenters noted and other factors should be addressed by the health care team to improve actively monitoring trends in anemia that without a lower bound for management as well as patient hemoglobin in the ESRD QIP, the patient health. We urge patients and providers to work together to achieve outcomes, and we strongly encourage bundled payment system financially patients and providers to work together incentivizes providers/facilities to optimal hemoglobin levels for each individual patient. We will continue to to develop anemia management provide less ESAs, driving hemoglobin strategies appropriate for individual down. Commenters argued that monitor and evaluate practice patterns and outcomes for all segments of the patient circumstances. We note that the decreased hemoglobin will lead to a rise Hemoglobin Less Than 10 g/dL measure in transfusions, hospitalization, Medicare ESRD population as we develop and refine our measurement of results are currently reported on morbidity, and mortality, endanger Dialysis Facility Compare, and that we the quality of anemia management. vascular access due to the need for are exploring the options and feasibility Additionally, we note that pediatric additional venipuncture, and decrease of continuing to publicly report anemia patients are excluded from the anemia quality of life, appetite of patients, and management trends. consistency of care, shifting care to management measures we have thus far We agree with commenters that we hospitals and outpatient infusion adopted and are adopting in this final should consider anemia management centers. Further, one commenter argued rule for the ESRD QIP, so the retirement measures that apply to patients not on that dropping the hemoglobin floor will of this measure does not directly affect ESAs, and, under 42 CFR 494.180(h), we increase the burden of ESRD patients the pediatric population. asked providers/facilities to begin because, as a result of the negative Comment: As an alternative to retiring providing data for these patients on consequences, it will require more the measure, some commenters argued January 1, 2012. In addition, we are appointments and travel to receive that CMS should reduce the lower considering ways to incorporate transfusions; another commenter stated bound from 10 g/dL to 9 g/dL or 8 g/ achieved hemoglobin levels, ESA usage, that retiring the measure will have a dL or decrease the financial penalty. and other important factors in our ‘‘chilling effect’’ on the ability to pursue Commenters also suggested that the anemia measurement strategy for future innovation in the treatment of patients measure not be limited to those on ESAs years of the ESRD QIP; we welcome with chronic kidney disease (CKD). because there are other means of community input and would like to Commenters also noted that a rise in maintaining hemoglobin levels. Other encourage measure development in this transfusions could result in worse commenters suggested that the root area. transplant outcomes and a higher cause of health issues related to high Comment: Some commenters agreed likelihood of infection. They also argued hemoglobin is the overuse of ESAs, and, with our proposal to retire the that quality of life issues may cause therefore, CMS should create an anemia Hemoglobin Less Than 10 g/dL individuals to be less active and eat less management measure monitoring ESA measure. Commenters noted that such a nutritious foods, possibly resulting in usage or other outcomes such as proposal reflects the new labeling patients who are less healthy and need transfusion avoidance rather than approved by the FDA for the use of more care. Some commenters noted that hemoglobin levels. One commenter ESAs, is consistent with the lack of many of these consequences would be recommended that CMS set a range for scientific evidence for a lower bound, disproportionately suffered by the hemoglobin of 10–11 g/dL, and, if a and will allow providers more latitude, African-American community and patient’s hemoglobin is higher than 11 providing room for more patient- encouraged CMS to collect and analyze g/dL, CMS should require the ESA centered care. Several commenters also data on health disparities. dosage to be decreased and not suggested that, while CMS should retire

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the measure, the agency should also be reasonable for CMS to decrease the the Hemoglobin Greater Than 12 g/dL conduct additional clinical studies to weighting for the Hemoglobin Greater measure applies only to those patients establish optimal dose strategies, targets, Than 12 g/dL measure. on ESAs. Specifically, one commenter and the long term safety of various ESA Response: Studies continue to show inquired whether it is applied based on therapies, and reinstate a lower bound that targeting hemoglobin levels above one bill indicating ESA administration as soon as possible. 12 g/dL through the use of ESAs can after 90 days of dialysis and the Response: We thank commenters for contribute to adverse patient outcomes submission of four bills for dialysis their support. As we noted above, we including an increased risk of within a 12 month period for adult will continue to monitor practice myocardial infarction, stroke, venous patients. In addition, the commenter patterns in the area of anemia thromboembolism, thrombosis of asked how patients with untreated management and develop and evaluate vascular access, and overall mortality, Hemoglobin Greater Than 12 g/dL will additional measures for future years of and, in patients with a history of cancer, be identified and excluded from the the ESRD QIP. We will also continue to tumor progression or recurrence. Given measure calculation. work with our Federal partners and the significance of these outcomes, we Response: We assume that the external stakeholders to advance do not believe it is appropriate either to commenters are referring to data knowledge in this area. retire the measure or reduce the weight extracted from claims. As outlined in Comment: One commenter suggested of the measure. In addition, as the measure specification, ‘‘on ESA’’ that the agency include text in the ESRD explained further below, this measure is means that a patient is receiving ESAs QIP certificates to be posted in consistent with new labeling for ESAs during the month covered by a claim, as December 2011 to acknowledge the approved by the FDA that directs identified by the presence of an ESA changing guidance in anemia providers to reduce or interrupt the dose dose and hemoglobin on the claim. This management so patients and caregivers of ESAs if the hemoglobin level measure applies only to months for are aware that the data are dated and not approaches or exceeds 11 g/dL. which a patient has received an ESA necessarily relevant in today’s Comment: Some commenters argued agent. Patients are attributed to a facility environment. Another commenter stated that the only anemia management only after they have four months of that CMS should develop Performance measure should be Hemoglobin Greater eligible claims from that facility. To be Score Report (PSR) mechanisms to Than 11 g/dL, replicating the FDA eligible for the Hemoglobin Greater adjust for unusual patient demographics guidelines. Commenters suggested that Than 12 g/dL measure, among other and dialysis facility census. such a measure is consistent with criteria, (i) The beginning date of the Response: The PY 2012 ESRD QIP current scientific evidence, provides the claim must have been at least 90 days certificates will clearly state that ‘‘the best level of care for patients, and since the date of first ESRD service for information communicated * * * is lowers Medicare costs. the patient and (ii) the claim must based on 2010 data.’’ Our regulations do Response: New labeling approved by include a line item reporting the not preclude providers/facilities from the FDA for the use of ESAs addresses administration of an ESA in that month. providing patients with more targeted hemoglobin levels while we These inclusion criteria are unchanged explanatory detail, and we encourage measure achieved hemoglobin levels. from the PY 2012 ESRD QIP. The providers/facilities to engage patients in The achieved hemoglobin level is a measures specifications are available at discussions of this information. function of the target but also reflects http://www.dialysisreports.org/ As we have stated, we continue to patient factors such as the underlying ESRDMeasures.aspx. monitor the effects of the ESRD QIP on causes of anemia which determine how Comment: Some commenters believe all segments of the Medicare ESRD sensitive the patient is to ESAs and that the Hemoglobin Less Than 10 g/dL population, and we will continue to whether the target is actually achieved. measure should be retired from the PY evaluate our scoring and public These patient factors can vary 2012 measure set because it would be reporting methodology for any unpredictably over time even within an unfair to penalize dialysis providers/ necessary modifications. individual patient which means that facilities for their nephrologists’ Comment: Some comments suggested patients will sometime exceed (or fall interpretation of the medical literature. that the Hemoglobin Greater Than 12 g/ short of) the hemoglobin level target One commenter argued that CMS knew dL measure should be retired from the despite clinician diligence. The FDA of published studies in 2006 and 2009 PY 2013 and PY 2014 ESRD QIP label recognizes this hemoglobin which signaled that no lower bound measure set because some patients may variability and states that, if the could be identified and noted that these benefit from a higher hemoglobin level hemoglobin approaches or exceeds 11 studies changed behavior in the and there is a lack of scientific evidence g/dL, ESA dosing should be reduced or industry. One commenter also stated its for an upper hemoglobin bound. interrupted, but the label does not state belief that if CMS does not retire the Commenters argued that, generally, that hemoglobin levels should never measure for the PY 2012 ESRD QIP, the higher hemoglobin leads to better exceed this value. We believe that the public may erroneously conclude that quality of life and patients and doctors current anemia measure allows for some the provider’s/facility’s PY 2012 ESRD should be able to weigh risks and deviations of the achieved hemoglobin QIP total performance score reflects CY benefits, leading to a more patient- while highlighting that higher 2012 data, as opposed to the data centered definition of quality. These hemoglobin targets can result in adverse utilized for the performance period. commenters noted that CMS should patient outcomes. Commenters also argued that the only be regulating those providers/ Comment: Some commenters legislative language requiring the facilities that are clear outliers. Some supported the Hemoglobin Greater Than Secretary to reflect the FDA labeling commenters requested that, should CMS 12 g/dL measure. applies to the labeling in the payment retain the measure, the bound be raised Response: We thank commenters for year rather than the performance year. to Greater Than 12.5 or Greater Than 13 their support. Response: Based on the available g/dL. Another commenter stated that, Comment: One commenter requested evidence in 2006 regarding the given recent clinical practice changes clarification on the meaning of ‘‘on treatment of anemia in the ESRD already addressing the concern for high ESA,’’ and another commenter population, we developed a consensus- hemoglobin and high ESA doses, it may requested that CMS explicitly state that based measure which was endorsed by

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the NQF in 2008 (NQF #0370). This select all of CY 2011 as the performance Response: We acknowledge that measure formed the basis for the period for the PY 2013 ESRD QIP. section 1881(h)(4)(C) of the Act requires Hemoglobin Less Than 10 g/dl measure Consistent with what we finalized for the Secretary to establish performance which was adopted for the ESRD QIP the PY 2012 ESRD QIP, we also standards under subparagraph (A) prior (76 FR 628). This measure remained proposed to require that providers/ to the beginning of the performance consistent with clinical practice facilities have at least 11 cases that meet period for the year involved. However, guidelines and the labeling approved by the reporting criteria for a measure in we are establishing the performance the FDA for the use of ESAs in effect order to be scored on the measure. standard that will affect ESRD payments until June 2011. In June 2011, new The comments we received on these in PY 2013 in accordance with section labeling for ESAs was approved by the proposals and our responses are set 1881(h)(4)(E), which does not impose FDA. We will retire the Hemoglobin forth below. the limitation suggested by the Comment: Several commenters Less Than 10 mg/dL measure beginning commenters. We believe that setting a in PY 2013 in accordance with this new expressed concern that both the PY 2013 and PY 2014 programs will use CY 2011 performance period for the labeling. initial ESRD QIP will ensure that the Although measures are adopted for a data more than a year old and penalize facilities that have since improved; performance scores are based on a specific payment year, we evaluate robust set of data, and will allow us performance on those measures during commenters encouraged the use of methodologies that recognize changes in sufficient time to analyze that data, a performance period that precedes the determine whether provider/facilities payment year so that we can collect and performance over time and use the most recently available data as comparison met the performance standards, provide evaluate the data for these measures and data. Another commenter recommended providers/facilities with an opportunity allow providers/facilities adequate time that CMS establish CY 2012 as the to preview their performance scores and to review their scores before payment performance year for PY 2013 because it submit related inquiries, and implement reductions occur. Therefore, to the would allow dialysis facilities and the applicable payment reductions for extent that the anemia management providers to gauge their performance PY 2013. We also note that, beginning measures under section 1881(h)(2)(A)(i) using clinically relevant, timelier, and with the PY 2014 program, we will set reflect the labeling approved by the FDA prospective data. performance standards under section for such management, we believe that Response: For both PY 2013 and PY 1881(h)(4)(A) of the Act. those measures must reflect the labeling 2014, we have determined that data Comment: Commenters voiced and guidance in effect and the care derived from claims is the most provided during the performance period concerns about CMS’ approach to appropriate source on which to score including low-volume facilities in the which, with respect to the PY 2012 providers/facilities. Claims data allows program, was CY 2010. program because one patient could us to implement a variety of measures significantly affect a score for reasons Finally, as we noted above, the PY which can be used to evaluate the unrelated to quality of care, such as 2012 ESRD QIP certificates state that greatest number of facilities. In order to patient comorbidities, and decrease the ‘‘the information communicated * * * assure completeness of this claims data, ability of a provider/facility to score is based on 2010 data.’’ there is a lag between when the data is well on a measure. This scoring could, For the reasons discussed above, for generated and when we are able to use in turn, affect patient volume if the PY 2013 ESRD QIP, we finalize use it in the ESRD QIP. This time period is of the following two measures lengthened because we believe it is consumers judge facilities based on previously adopted for the PY 2012 important to allow providers/facilities a their scores. Commenters suggested ESRD QIP: period of time to review their scores different minimum case thresholds such • Hemoglobin Greater Than 12g/dL before the payment period. We are as 20 cases or 25 cases or that providers measure considering how we might be able to with fewer cases be scored differently; • URR Hemodialysis Adequacy shorten this timeline in the future, such some commenters also noted that their measure as by collecting data through studies showed that the sample size CROWNWeb or by some other method, rather than overall performance is b. Performance Period and Case such as the NHSN or electronic health driving the results for facilities and Minimum for the PY 2013 ESRD QIP records, and we will continue to take requested that CMS raise the case Section 1881(h)(4)(D) of the Act the commenters concerns into account minimum to 20. Another commenter requires the Secretary to establish a as we do so. urged CMS to research the reliability of performance period with respect to a Comment: Several commenters argued a measure to set the minimum number year, and for that performance period to that, under section 1881(h)(4)(C) of the of cases, publish minimum case occur prior to the beginning of such Act, the ESRD QIP performance periods reliability data, and use this data to set year. In the proposed rule, we discussed must be prospective, but nearly all of a minimum number of cases for all in detail the factors that we considered the PY 2013 performance period will value-based purchasing programs. One in determining what performance have ended by the time the performance commenter urged CMS to re-consider its period to select for the PY 2013 ESRD standards are finalized. Commenters scoring methodology to analyze for QIP (76 FR 40519). We also noted that, also argued that finalizing performance statistical significance. Another in light of the new ESRD PPS, we standards when the performance period commenter stated its belief that the believe that it is important to assess the is nearly complete impermissibly ESRD QIP methodology does not quality of care being furnished to ESRD creates a retroactive rule. Comments appropriately account for low patient patients and that basing this assessment also noted that a retrospective census, unusual treatment setting, or on a year of data will provide an performance period does not allow a patient case-mix, and recommended accurate and fair determination of provider/facility to change its practices that CMS develop a mechanism to whether a provider/facility has met or to meet standards, thereby increasing adjust for circumstances in which exceeded the proposed performance quality of care. Other commenters, facilities with an unusual care setting, standards with respect to the proposed however, voiced support for the atypical case-mix, or small patient measures. Therefore, we proposed to proposed PY 2013 performance period. census may be at high risk of incurring

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penalties for failure to meet 2007, we will assign a score of zero for laboratory tests. One commenter also performance standards. purposes of assessing which of the two stated that CMS should allow rounding Response: We appreciate the standards applies to the provider/ to the tenth to address ‘‘between commenters’ concerns regarding the facility. The provider/facility’s instrument variability within a single potential impact of patient case mix on performance in 2011 will then be laboratory.’’ smaller providers/facilities. The goal of compared against that initial Response: For Dialysis Facility the ESRD QIP is to accurately assess the performance standard. Compare (DFC) and Dialysis Facility quality of care provided by a provider/ For the reasons discussed above, we Reports (DFR), we have traditionally not facility. However, we recognize that a are finalizing all of CY 2011 as the rounded the average patient hemoglobin quality measure score could be performance period for the PY 2013 values or the values resulting from the impacted by one or more factors ESRD QIP. hematocrit to hemoglobin conversion. unrelated to the care furnished by the The final rule for the first year of the c. Performance Standards for the PY provider/facility, and that the potential ESRD QIP stated that we would 2013 ESRD QIP of such factors to greatly skew the calculate the hemoglobin measure rates calculation decreases as the number of In the proposed rule, we discussed in as they have been calculated for cases included in the measure increases. detail what performance standards we purposes of DFC and DFR in order to Similarly, a provider/facility with a planned to select for the PY 2013 ESRD maintain consistency (76 FR 629). In small number of patients could find that QIP. We noted that comparing provider/ light of this comment, however, we have one patient’s outcome determined its facility performance over time based on concluded that beginning with the PY score on a quality measure. Thus we data from successive years would be 2013 program, it is reasonable to round proposed that a provider/facility would beneficial as this method would allow the patient average hemoglobin value to need to have a minimum of eleven cases the public to most accurately gauge one decimal place to better reflect the that meet the eligibility criteria for a provider/facility improvement. As we precision of the original laboratory data measure in order to be scored on that discussed above, we also noted that due prior to determining performance on the measure. This eleven case minimum to operational issues, it is not feasible measure. We will also round the allows as many providers/facilities as for us to establish performance hematocrit to hemoglobin conversion to possible to participate in the program. standards prior to the beginning of the one decimal place. Using this new This minimum case number is also proposed performance period, as is rounding convention, the 2009 national consistent with the reporting of these required if the performance standards performance rate for the Hemoglobin measures on Dialysis Facility Compare. are established under section Greater Than 12 g/dL measure using this We will continue to closely monitor 1881(h)(4)(A). Therefore, we proposed new rounding convention rate is 14 beneficiary access to care, including to continue using the performance percent. evaluating the rate of facility closures. standard under section 1881(h)(4)(E) of Comment: One commenter suggested We will also continue to assess the the Act for the PY 2013 ESRD QIP. that CMS use a baseline period of 2009 impact of the program on facilities of all Under this proposed standard, for the Hemoglobin Greater Than 12 g/ sizes, and we will change the providers/facilities would be evaluated dL measure because data from 2009 is methodology if we believe it is based on the lesser of (i) the the most currently available data. This necessary to ensure that the program performance of the provider/facility in commenter also argued that, because of adequately measures quality. 2007, which is the year selected by the the change in FDA approved labeling Additionally, we continue to monitor Secretary under the second section of and guidance from the baseline period and evaluate the reliability of all of our section 1881(b)(14)(A)(ii), or (ii) a to the performance period, this measure value-based purchasing programs; we performance standard based on the will cause confusion and not accurately note, however, that each of these national performance rates for the measure quality and improvement. programs has its own set of measures in a period determined by the Response: We proposed to use CY requirements which must be considered Secretary. With respect to the second 2009 as the source of data for the during any assessment of reliability. prong, we proposed selecting CY 2009 national comparative performance Comment: One commenter expressed because that is the most recent year-long standard for scoring the PY 2013 ESRD concern that new facilities without a period for which data would be publicly QIP measures. Although we recognize complete data set available for the available prior to the beginning of the that the FDA-approved label for ESAs measures will be unfairly penalized. proposed performance period. At the changed in CY 2011, we note that this Response: Like all ESRD QIP time we published the proposed rule, change did not directly impact this providers/facilities, new facilities will the 2009 national performance rates for measure. The Hemoglobin Greater Than only be included in the program if they the Hemoglobin Greater Than 12 g/dL 12 g/dL measure reflects both the prior have the requisite amount of data. Any measure and the URR Hemodialysis and new labels for ESAs. provider/facility must have adequate Adequacy measure were: Comment: One commenter requested data to calculate performance rates on • For the Hemoglobin Greater Than that CMS employ the PY 2014 both PY 2013 measures to be included 12g/dL measure: 16 percent. achievement and improvement scoring in the PY 2013 ESRD QIP. For each of • For the URR Hemodialysis methodology for PY 2013. One these measures, there must be at least Adequacy measure: 96 percent. commenter voiced support for the eleven cases each with four claims, The comments we received on the change in methodology to equally regardless of whether the facility is new proposed selection of this performance weight the measures in PY 2013. One or established. standard and our responses are set forth commenter stated that performance Additionally, under the special rule below. standards for PY 2013 should be less in section 1881(h)(4)(E), we will be Comment: One commenter stringent to decrease the incentive to setting the initial performance standard recommended rounding the average game the system. as the lesser of the provider’s/facility’s hemoglobin to one decimal place Response: As explained above, we are performance during 2007 or the 2009 because this method is the industry using the special rule for PY 2013. national performance rates. If a standard and more decimal places Under this standard, providers/facilities provider/facility was not in existence in exaggerates the precision of the would be evaluated based on the lesser

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of (1) The performance of the provider/ strong incentives to meet or exceed measure scores together and rounding facility in 2007, which is the year anemia management and dialysis this number to the nearest integer (with selected by the Secretary under the adequacy performance standards, as 0.50 rounded-up), resulting in a 0–30 second section of section determined appropriate by the point range. 1881(b)(14)(A)(ii), or (2) a performance Secretary. Section 1881(h)(3)(A)(ii) of the Act For the PY 2012 ESRD QIP, we standard based on the national requires the Secretary to ensure that the finalized a scoring methodology under performance rates for the measures in a application of the scoring methodology which we calculated the performance of period determined by the Secretary (for results in an appropriate distribution of PY 2013, this is CY 2009). We do not each provider and facility by assigning reductions in payments among believe that the performance standards 0–10 points for each measure. The full providers and facilities achieving are too stringent; a provider/facility is rationale for this scoring methodology is different levels of Total Performance scored on the lesser of its own presented in detail in the PY 2012 ESRD Scores, with providers and facilities performance or the national QIP final rule (76 FR 629 through 634). performance rate. We will be monitoring For the PY 2013 ESRD QIP, we achieving the lowest Total Performance providers/facilities to assess any proposed to adopt the same Scores receiving the largest reductions. incentives to game the system. methodology for scoring provider/ For the PY 2012 ESRD QIP, we After considering the comments, and facility performance on each of the implemented a sliding scale of payment for the reasons stated above, we are measures. We noted that, we believe reductions, setting the minimum Total finalizing following performance that it is important to provide a clear- Performance Score that providers/ standards. For the PY 2013 ESRD QIP, cut method for calculating scores facilities will need to achieve in order providers/facilities will be evaluated initially while providers and facilities to avoid a payment reduction at 26 based on the lesser of (i) Their are becoming familiar with the program. points (76 FR 634). Providers/facilities individual performance on the measures We proposed to calculate the that score between 21–25 points will in 2007 or (ii) the national performance performance of each provider/facility on receive a 0.5 percent payment rates for the measures in 2009. We also each measure by assigning points based reduction; between 16–20 points, a 1.0 finalize that we will round the values on how well it performed on the percent payment reduction; between obtained when we convert hematocrit measure in CY 2011 relative to the 11–15 points, a 1.5 percent payment values to hemoglobin values and the proposed performance standard reduction; and for a score between 0–10 average patient hemoglobin values used (discussed above). If a provider or points, providers/facilities will receive in the Hemoglobin Greater Than 12 g/ facility meets the performance standard the full 2.0 percent payment reduction dL measure to one decimal place. for a measure, then it would receive 10 (76 FR 634). Based on our new rounding points for that measure. If a provider/ methodology and the most recent 2009 facility does not meet the performance To ensure that providers/facilities are data, the 2009 national performance standard for a measure, we would award properly incentivized to provide quality rates vary slightly from those in the points for each measure based on a 0 to care, we proposed to implement a more proposed rule. The national 10 point scale and would subtract 2 rigorous sliding scale of payment performance rate in 2009 for the points for every 1 percentage point the reductions for the PY 2013 ESRD QIP Hemoglobin Greater Than 12 g/dL provider or facility’s performance falls and raise the minimum Total measure is 14 percent, and the national below the performance standard during Performance Score that providers/ performance rate in 2009 for the URR CY 2011, the performance period for PY facilities would need to achieve in order Hemodialysis Adequacy measure is 97 2013. to avoid a payment reduction from 26 to percent. For the PY 2013 ESRD QIP, we 30 points. We noted that providers/ proposed to weight the Total facilities that score between 26–29 d. Methodology for Calculating the Total Performance Score for each provider/ points would receive a 1.0 percent Performance Score and Payment facility such that 50 percent would payment reduction; between 21–25 Reduction for the PY 2013 ESRD QIP reflect the Hemoglobin Greater Than points, a 1.5 percent payment reduction; Section 1881(h)(3)(A)(i) of the Act 12g/dL measure and 50 percent would and between 0–20 points, providers/ requires the Secretary to develop a reflect the URR Hemodialysis Adequacy facilities would receive the full 2.0 methodology for assessing the total measure. To be consistent with the percent payment reduction (see Table 3 performance of each provider and scoring methodology that we finalized below). We believe that applying a facility based on performance standards for the PY 2012 ESRD QIP, we proposed payment reduction of 2.0 percent to with respect to the measures selected for to award up to 30 points to a provider/ providers/facilities whose performance a performance period. Section facility based on its performance on the falls significantly below the 1881(h)(3)(A)(iii) of the Act states that proposed measures. However, because performance standards, coupled with the scoring methodology must include a we only proposed to adopt two applying two intermediate payment process to weight the performance measures for the PY 2013 ESRD QIP reduction levels to providers/facilities scores with respect to individual measure set, we proposed to calculate a based on lesser degrees of performance measures to reflect priorities for quality provider’s/facility’s Total Performance deficiencies, will provide proper improvement, such as weighting scores Score by multiplying each measure incentives for all providers/facilities to to ensure that providers/facilities have score (0–10 points) by 1.5, adding both improve the quality of their care.

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The comments we received on this to have implemented practices to Act. In specifying such measures, we proposed scoring, weighting, and improve their performance on these recognize that section 1881(h)(2)(B)(i) of payment methodologies and our measures. Additionally, because we are the Act requires that they must have responses are set forth below. using the special rule, providers/ been endorsed by the entity with a Comment: Several commenters facilities will be evaluated based on the contract under section 1890(a) of the expressed concern that the PY 2013 lesser of two standards, which should Act (that entity is currently the NQF) scoring methodology and resulting help alleviate the concerns expressed by unless the exception in clause (ii) payment reductions are too aggressive the commenters. applies. That provision provides that in and would overly penalize facilities, We designed the scoring based on a the case of a specified area or medical draining them of monetary resources scale similar to what we are using for topic determined appropriate by the and morphing the ESRD QIP into a cost- the PY 2012 ESRD QIP to make it easier Secretary for which a feasible and cutting program. Several commenters for Medicare beneficiaries to compare practicable measure has not been suggested either doubling the penalty or providers’/facilities’ performance in PY endorsed by the entity with a contract requiring more points to avoid a 2012 and PY 2013. Although we are under section 1890(a) of the Act, the penalty, but not both, stating that it is using one less measure and weighting Secretary may specify a measure that is unreasonable of CMS to expect facilities the measures differently in PY 2013, we not so endorsed as long as due to improve so rapidly from PY 2012 to believe that Medicare beneficiaries will consideration is given to measures that PY 2013. Commenters also argued that still be able to compare both the overall have been endorsed or adopted by CMS should reassess its PY 2013 quality of provider/facility performance consensus organizations identified by scoring because nearly all of the (for example, whether the performance the Secretary. performance period will have passed improved as a whole from PY 2012 to before the rule is finalized, not allowing PY 2013), and the degree to which i. Anemia Management Measure providers/facilities enough time to make provider/facility performance on each of Section 1881(h)(2)(A)(i) of the Act the necessary adjustments, and a facility the two PY 2013 measures may have requires that the measures specified for that does not meet the performance changed (because the certificates will the ESRD QIP include measures on standard for one measure may be display individual measure scores). anemia management that reflect the significantly and unduly penalized Comment: Some commenters voiced labeling approved by the FDA for such because the program only evaluates two their support for the PY 2013 scoring management. For the PY 2014 ESRD measures. Other commenters noted that methodology, including the more QIP, we proposed to retain the many other quality programs have a rigorous scale and the equal weighting Hemoglobin Greater Than 12g/dL broader sliding scale which gives more of the PY 2013 measures. measure that we adopted for the PY incentive for improvement and Response: We thank the commenters 2012 ESRD QIP and are finalizing in this suggested that the PY 2012 payment for their support. For the reasons stated final rule for the PY 2013 ESRD QIP. We scale of 0.5–2.0 percent also be used for above, we are finalizing the proposed made this proposal for the same reasons PY 2013. This broader range was also scoring, weighting, and payment that supported our proposal to retain suggested because it may take patients methodology for the PY 2013 ESRD QIP. this measure for the PY 2013 ESRD QIP a period of time to stabilize or larger 2. Proposed PY 2014 ESRD QIP measure set. penalties might result from outliers, and The comments we received on this the penalty structure should be more a. Proposed Performance Measures for proposed measure are discussed above forgiving of these patients. Other the PY 2014 ESRD QIP in the section discussing the PY 2013 commenters also stated that, because of For the PY 2014 ESRD QIP, we ESRD QIP. For the reasons stated above, the change in scoring from PY 2012, proposed to continue using the we finalize the Hemoglobin Greater patients will be unable to compare Hemoglobin Greater Than 12g/dL Than 12 g/dL measure for the PY 2014 facilities’ scores and note progress. measure, adopt seven new measures ESRD QIP. The specifications for this Response: We believe that providers/ (Kt/V Dialysis Adequacy, Vascular measure can be found at http:// facilities should always be striving to Access Type (VAT), Vascular Access www.dialysisreports.org/pdf/esrd/ improve the quality of care they provide Infections (VAI), Standard public-measures/AnemiaManagement- to patients. Therefore, we believe it is Hospitalization Ration (SHR)- HGB12-2013-2014-FR.pdf. appropriate, in the second year of the Admissions, National Healthcare and program, to set a higher standard to Safety Network (NHSN) Dialysis Event ii. Dialysis Adequacy Measure further encourage improvement. reporting, Patient Experience of Care Section 1881(h)(2)(A)(i) of the Act Because both of the measures that we (ICH CAHPS) reporting, and Mineral requires that the ESRD QIP include adopted for the PY 2013 ESRD QIP were Metabolism reporting) and to retire the measures on dialysis adequacy. For the included in the PY 2012 ESRD QIP URR Hemodialysis Adequacy measure. PY 2014 ESRD QIP, we proposed to measure set, we believe that it is We also proposed to adopt measures retire the URR Hemodialysis Adequacy reasonable to expect providers/facilities under section 1881(h)(2)(A)(iii) of the measure we adopted for the PY 2012

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ESRD QIP and are finalizing in this final values for performance standards commenter stated a belief that Kt/V is a rule to retain for the PY 2013 ESRD QIP. instead and/or wait until PY 2015 to substandard measure as it does not In its place, we proposed to adopt a implement the measure. Some adequately reflect the patient’s quality measure of dialysis adequacy based on commenters asked CMS to acknowledge of life. One commenter noted that CMS Kt/V (K = dialyzer clearance, t = dialysis that Daugirdas II or UKM formulas should also promote the understanding time, and V = volume of distribution) should be used for those patients that minimal Kt/V levels may not be for the PY 2014 ESRD QIP. Kt/V has receiving thrice weekly hemodialysis optimal levels and should develop a been advocated by the renal community care. One commenter urged CMS to method for assessing dialysis adequacy as a more widely accepted measure of rigorously validate comparison across all modalities; another dialysis adequacy. Specifically, Kt/V calculation methods to assure that if commenter argued that CMS should use more accurately measures how much different equations are used, they the last Kt/V value of the month for each urea is removed during dialysis, provide comparable results for Kt/V. patient to calculate the measure rate primarily because the Kt/V calculation Another commenter suggested that it because it is the best clinical indicator also takes into account the amount of would be extremely difficult, if not of the actual dialysis dose delivered to urea removed with excess fluid. Further, impossible, for the agency to correct the a patient during the month. Some the proposed measure assesses Kt/V lack of standardization in the base year commenters stated that the measure and asked instead that CMS take this levels in both hemodialysis (HD) specifications excluding Kt/V values patients (in-center and home (HHD)) into account in weighting this measure. Response: Beginning January 1, 2012, exceeding 2.5 for patients receiving and peritoneal dialysis (PD) patients, thrice weekly in-center nocturnal and is based on two Kt/V measures of we have asked providers and facilities hemodialysis may not be appropriate dialysis adequacy that have been to report Kt/V values on claims using because many patients achieve such endorsed by the NQF (#0249 2 and the Daugirdas II or UKM formulas, values and asked that this exclusion be #0318 3). Specifically, the proposed which are also the formulas specified in removed from the measure. Commenters measure assesses the percent of the NQF-endorsed hemodialysis also suggested that adjustments should Medicare dialysis patients (PD, HD and adequacy measures based on Kt/V (CR be made in the Kt/V measure for short HHD) meeting the modality specific Kt/ 7460). We have also stated that residual V threshold. For hemodialysis patients renal function should be included in the daily, more frequent, and nocturnal (HHD and in-center patients), we peritoneal dialysis Kt/V value but not treatments. Commenters asked CMS to proposed to measure the percentage of included in the hemodialysis Kt/V exclude residual renal function (RRF) adult (≥ 18 years old) Medicare patients value. We recognize the commenters’ because it could result in patients being dialyzing thrice weekly whose average concerns and agree that it would be under dialyzed, and it carries delivered dose of hemodialysis difficult, if not impossible, to create operational burdens such as requiring (calculated from the last measurements accurate, comparable Kt/V measure patients to collect urine during a 48- of the month using the Urea Kinetic scores for providers/facilities that might hour period. Some commenters, Modeling (UKM) or Daugirdas II not have used either the Daugirdas II or however, asked CMS to consider RRF in formula) was a Kt/V of at least 1.2 UKM formula in their Kt/V reporting or the calculation so that the Kt/V measure during the proposed performance that may have incorporated residual does not cause over-treatment. One period. For PD patients, we proposed to renal function differently. In light of this commenter asked for clarification of the measure the percentage of adult (≥ 18 concern, we are not finalizing our Kt/V specifications in two areas: (i) For years old) Medicare patients whose proposal to adopt the Kt/V dialysis PD patients, (a) does CMS require that average delivered PD dose was a weekly adequacy measure for the PY 2014 facilities report the average of all Kt/V urea of at least 1.7 (dialytic + ESRD QIP. We intend to propose to available values for the year; (b) should residual) during the proposed adopt a Kt/V dialysis adequacy measure the facilities record Kt/V every 3 or 4 performance period. The specifications for future years of the ESRD QIP and months; and (c) when should the RRF for the proposed measures exclude welcome public input as we proceed be measured; and (ii) for both HD and pediatric patients. The NQF has since with this process. PD, (a) What are the requirements We recognize that we are required endorsed a separate pediatric related to urea clearance; and (b) can under section 1881(h)(2)(A)(i) to include hemodialysis adequacy measure facilities use creatinine clearance as an measures on dialysis adequacy in the (#1423), and we are considering how to alternative? Although not specific, some ESRD QIP. For this reason, we are also best incorporate this measure into future commenters noted that some of the not finalizing our proposal to retire the measure specifications were not clear or years of the QIP. URR Hemodialysis Adequacy measure The comments we received on the were confusing and asked for for the PY 2014 ESRD QIP and will proposed Kt/V measure and our clarification. One commenter suggested continue to include this measure in the responses are set forth below. that the proposed Kt/V dialysis Comment: Several commenters PY 2014 measure set. For the reasons adequacy measure be calculated as the expressed concern that providers/ stated in the CY 2011 ESRD PPS final average of twelve months Kt/V values in rule (75 FR 49182) we believe that the facilities use different methodologies to an index year. One commenter URR Hemodialysis Adequacy measure calculate Kt/V and asked CMS to questioned the functionality of continues to be an appropriate and indicate which methodology should be CROWNWeb to collect Kt/V accurate measure of hemodialysis used. Several commenters noted that measurements in CY 2012. adequacy. this disparity in formulas and Comment: Many commenters strongly Response: For the reasons stated specifications may lead to disparate supported CMS’ proposal to use Kt/V to above, we will not finalize this measure baseline standards and requested that measure dialysis adequacy beginning for the PY 2014 ESRD QIP but we intend CMS standardize requirements for Kt/V with the PY 2014 ESRD QIP because it to propose to adopt a Kt/V dialysis is widely accepted, is used extensively adequacy measure for the program as 2 Note that in the proposed rule, we mistakenly referred to this measure as #0250. by the renal community as a measure of soon as possible. We will take the many 3 Note that in the proposed rule, we mistakenly dialysis adequacy, and is the basis for comments regarding the use of Kt/V and referred to this measure as #0321. measures endorsed by the NQF. One questions regarding the measure

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specifications into account as we provider’s/facility’s patients on measure under section 1881(h)(2)(B)(ii) develop this future proposal. hemodialysis using an autogenous AV of the Act. Comment: Some commenters urged fistula with two needles during the last We noted in the proposed rule that CMS to develop a dialysis adequacy HD treatment of the month (NQF since July 1, 2010, we have asked measure for hemodialysis patients who #0257); and (ii) the percentage of a dialysis providers/facilities to submit dialyze more or less than three times per provider’s/facility’s patients on VAT data on ESRD claims (CR 6782). week, either at home or in a clinic. hemodialysis using an intravenous We also proposed that hemodialysis Response: We agree with the catheter during the last HD treatment of patients with acute renal failure, commenter that a dialysis adequacy the month that have had an intravenous peritoneal dialysis patients, and patients measure for hemodialysis patients who catheter in use for 90 days or longer under 18 years of age would be dialyze more or less than three times per (NQF #0256). excluded from this proposed measure. week, either at home or in a clinic, is While catheter reduction and Finally, we stated our belief that an important quality indicator that increased use of AV fistula are both adoption of this measure would be should be part of the ESRD QIP. At this important steps to improve patient care, consistent with the efforts of the Fistula time there is no consensus within the we recognized that these two events are First initiative, which advances the use ESRD stakeholder community as to tightly interrelated and do not want to of fistulas proven to reduce the risk of what the correct formula or target value penalize providers/facilities twice for infection/morbidity and mortality.6 should be for this population. We are related outcomes. We therefore The comments we received on this committed to working with the proposed to combine these two separate proposed measure and our responses are stakeholder community to achieve measures into one measure to contribute set forth below. consensus on the correct formulas and jointly to the Total Performance Score. Comment: Many commenters target values for this population and to Because the rates and goals for each supported the proposed VAT measure, developing measures for future years of subcomponent measure are very noting the benefits of AV fistulas and the ESRD QIP that accurately assesses different, we proposed to calculate the problems with catheters. Many the adequacy of hemodialysis for this separate measure rates for each measure, commenters also stated that they population. based on a provider’s/facility’s support CMS’ decision to exclude For the reasons stated above, we are performance on each subcomponent hemodialysis patients with acute renal not finalizing the proposed Kt/V measure and to adopt a different failure, PD patients, and patients under Dialysis Adequacy measure for the PY methodology (discussed below) for age 18 from this proposed measure. 2014 ESRD QIP. We are also not purposes of setting performance Response: We thank commenters for finalizing our proposal to retire the URR standards and scoring providers/ their support. Hemodialysis Adequacy measure, but facilities on this measure. Comment: Some commenters are instead finalizing that this measure As explained above, section applauded CMS for proposing to adopt will be included in the PY 2014 ESRD 1881(h)(2)(B)(i) of the Act requires that, a VAT measure but noted certain QIP. The measure specifications for the unless the exception set forth in section ‘‘flaws.’’ Commenters noted that the URR measure can be found at: http:// 1881(h)(2)(B)(ii) of the Act applies, the measure (i) ignores grafts, which are www.dialysisreports.org/pdf/esrd/ measures specified for the ESRD QIP preferable to catheters and are available public-measures/DialysisAdequacy- under section 1881(h)(2)(A)(iii) of the to some patients who are not candidates URR65-2013-2014-FR.pdf. Act must have been endorsed by the for fistulas; (ii) is limited to Medicare entity with a contract under section beneficiaries; (iii) could prejudice iii. Vascular Access Type (VAT) 1890(a) of the Act (which is currently facilities with new patient populations Measure the NQF). Under the exception set forth who do not yet have a permanent access Section 1881(h)(2)(A)(iii) of the Act in section 1881(h)(2)(B)(ii), in the case type and those with patients who refuse states, in part, that the measures of a specified area or medical topic or are not eligible for fistulas, causing an specified for the ESRD QIP shall include determined appropriate by the Secretary access to care issue; and (iv) because of other measures as the Secretary for which a feasible and practical the 90 day requirement for the catheter specifies, including, to the extent measure has not been endorsed by the measure, will provide less than a year’s feasible, measures on vascular access, entity with a contract under section worth of data on which facilities will be including for maximizing the placement 1890(a) of the Act, the Secretary may evaluated. of arterial venous fistula. For the PY specify a measure that is not so Response: We thank commenters for 2014 ESRD QIP, we proposed to adopt endorsed as long as due consideration is their insights and will address each a VAT measure. We noted that given to measures that have been issue in turn. As we have noted arteriovenous (AV) fistulae are the endorsed or adopted by a consensus previously, VAT is critical to patient preferred type of vascular access for organization identified by the Secretary. care. Catheters are undesirable due to patients on maintenance hemodialysis. We stated in the proposed rule that we their high rate of complications, such as Because of the lower complication rates believe that assessing the type of infections, and we discourage their use (including reduced infections), vascular access used in hemodialysis through the proposed catheter patients is important because clinical decreased risk of patient mortality, and submeasure. The preferred type of evidence has shown that proper greater cost efficiency associated with vascular access is an AV fistula due to vascular access reduces the risk of this type of vascular access for eligible lower rates of complications, which we adverse outcomes such as infections. patients,4, 5 we proposed to adopt a VAT promote through the fistula submeasure. We also noted that we considered measure, based on two measures that Although grafts do decrease the risk of proposing to adopt the two NQF- are endorsed by the NQF. These infections and complications when endorsed measures noted above (#0256 measures assess (i) The percentage of a compared to catheters, grafts do not and #0257); however, in order to ensure decrease these risks as much as fistulae. that these measures fit the purposes of 4 http://www.kidney.org/professionals/kdoqi/ We, therefore, do not believe that grafts guideline_uphd_pd_va/va_guide2.htm. the ESRD QIP, we made modifications 5 http://www.fistulafirst.org/AboutAVFistulaFirst/ to these NQF-endorsed measures. 6 See http://www.fistulafirst.org/ for further History.aspx. Accordingly, we proposed to adopt this information regarding this initiative.

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are either beneficial enough to be facility’s some flexibility without still has a catheter in use providers/ specifically rewarded or harmful underplaying the risks associated with facilities should report the presence of enough to be specifically penalized. catheter infections. We believe that 90 both the catheter and the AV fistula/AV We agree that it would be beneficial days allows facilities a window of time graft. Accordingly, for purposes of the to measure vascular access type for all to stabilize patients and obtain a measure calculation during the ESRD patients, but, at this time, we are functional arteriovenous fistula. We performance period, in instances where unable to collect the needed data appreciate the role that vascular an AV fistula or AV graft is reported through Medicare claims. We believe surgeons play in obtaining vascular along with a catheter, we will only that when CROWNWeb becomes access, and we would expect providers/ count the AV fistula or AV graft as the available as a data collection vehicle for facilities and their staff to work closely patient’s access type. For purposes of all providers/facilities, we will be able together to ensure that proper care is the measure calculation during the to collect data on all patients, and we furnished. We note, however, that the baseline period, we exclude any claims anticipate proposing in future ESRD QIP applies only to providers/ reporting more than one access type rulemaking to change this measure facilities. because we assume this was reported in when these events occur. We are As we noted above, we are actively error since the guidance did not indicate actively monitoring access to care and monitoring access to care and issues that more than one access type should issues associated with ‘‘cherry-picking,’’ associated with ‘‘cherry-picking,’’ and be reported. Only Medicare patients are and it is our intent to engage the will consider proposing additional included in the proposed VAT measure community as we monitor these issues. policies in future rulemaking should we because we will be calculating it using Finally, we will be able to measure 1 conclude that they would improve the Medicare claims data. The year of catheter data despite the 90 day overall quality of the ESRD QIP. specifications for the catheter pre-requisite. The proposed measure Comment: One commenter suggested submeasure exclude catheters present specifications state that the catheter that CMS develop a measure to monitor for less than 90 days during calculation submeasure assesses the percentage of fistula flow. of the catheter measure rate in order to hemodialysis patients in whom (i) A Response: We thank the commenter allow time to establish another form of catheter was in use at the last for the suggestion. We continue to work vascular access. All catheters must be hemodialysis treatment of the month on developing measures appropriate for reported regardless of duration of use, and for each of the prior 90 days; and the ESRD QIP. the 90 day exclusion will be applied at (ii) a catheter was the only means of Comment: One commenter asked for the time of measure rate calculations. vascular access (that is, patient did not clarification of the VAT measure We thank commenters for requesting have an AV fistula or AV graft reported specifications, including the following: clarification, and we would clarify in at any time during the 90 days).7 The (i) What are the blood flow requirements this final rule that, for the catheter measure specifications state that through the AV fistula; (ii) when in the submeasure, a patient will only be patients with a catheter for at least 90 month is the access type to be reported; attributed to a facility if he or she was days will be counted in this measure. and (iii) are Medicare only patients at that facility for the 90 days during For example, if a patient was treated at counted? The commenter also asked for which he or she had a catheter so that a facility for all of October, November, clarification of the following catheter providers/facilities have adequate time and December of 2011 and has a submeasure specifications: (i) Are to facilitate placement of a permanent catheter for these months, this catheter Medicare only patients counted; (ii) do access and are not penalized for care would be counted in January 2012. facilities count catheters even if there is provided prior to the patient receiving Comment: One commenter another access in place; and (iii) how care at the facility. Because claims do recommended that CMS: (i) Consider should facilities report the ‘‘90 day’’ not specify the access type for each developing adjusters for unusual patient requirement if the V-codes do not match patient at every dialysis session, we also factors, facility census, and overall case- this criterion? Some commenters clarify that, if the last session of a month mix to discourage ‘‘cherry-picking’’; and generally commented that the measure indicates only a catheter, we consider (ii) develop a mechanism to more specifications are unclear and confusing that patient to have had the catheter for effectively engage, and hold and asked for clarification. the entirety of that month. accountable, vascular surgeons in Response: The proposed VAT We further clarify that we will use a creating successful vascular access. measure specifications for the AV fistula patient-month methodology calculating Another commenter suggested that the submeasure do not contain a blood flow the submeasure rates for the VAT measure be modified to only include requirement but rather require that the measures (i.e. each patient’s value for patients with catheters for at least 6 dialysis was performed with two each month will be included in the 9 months. needles. We do not require blood flow measure rate ).The NQF measures Response: We do not agree that only because we assume that, if a fistula is which we referred to in the proposed those patients who have catheters 6 used for dialysis treatment, the blood rule are calculated for a one month time months or longer should be included in flow achieved is adequate to meet period; however, our measure the measure. We note that the proposed treatment goals. Since July 1, 2010, specifications stated that the VAT catheter submeasure is based on an providers/facilities have been asked to measure can be calculated in a manner NQF-endorsed measure (#0256) which report the access that was used for similar to the PY 2012 ESRD QIP includes patients with a catheter longer dialysis during the last dialysis session measures which are calculated as a than 90 days.8 It is important to allow of the month covered by the claim (CR percent of patients (i.e. each patient’s 6782). These instructions were updated, mean or median value is calculated for 7 See http://www.dialysisreports.org/pdf/esrd/ effective January 1, 2012 (CR 7460), to the year at the facility and then the public-measures/ state that, if an AV fistula/AV graft is patient is classified as meeting the VascularAccess-Fistula-2014-FR.pdf and http:// used (both must be used with two www.dialysisreports.org/pdf/esrd/public-measures/ 9 needles to be reported), but the patient For example, if one patient was treated every VascularAccess-Catheter-2014-FR.pdf. month, his/her claim inputs would account for 8 See http://www.kidney.org/professionals/ twelve, individual inputs for calculating the kdoqi/pdf/12-50-0210_JAG_DCP_ http://www.qualityforum.org/WorkArea/ measure rate. Whereas a patient that is only seen Guidelines-VA_Oct06_SectionC_ofC.pdf; linkit.aspx?LinkIdentifier=id...67692. for four months would be counted as four inputs.

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requirement or not). We believe that nor do they provide information in a measure which is calculated based on patient-months would provide a more timely manner to effectively drive the substance of the data collected accurate picture of the care provided to quality improvement. Additionally, through the NHSN Dialysis Event a patient by weighting the VAT by the several commenters noted or asked for reporting system for future years if the number of months that access was clarification regarding whether claims data indicates a need for financial present. For instance, if a patient had a can result in duplicative counting of a incentives to drive improvement. catheter for seven months out of the patient with a recurrent infection, Comment: One commenter argued year and an AV fistula for 5 months, the penalizing a facility twice (or more) for that, because of the prevalence and costs patient’s ‘‘average’’ access would be a the same event. Commenters also stated associated with catheter related catheter and the facility would get no that CMS has not issued specific infections, catheter measures should be credit for the presence of an AV fistula. guidance for uniformity in reporting the in the PY 2012 ESRD QIP and, because By using patient-months, we can more V8/V9 modifiers and requested a the ESRD QIP can only penalize a accurately assess these patients by workable definition of VAI to account facility by up to two percent, a new counting seven of 12 months towards for cases where it is difficult to program should be implemented to the catheter submeasure and five of 12 accurately identify the source of penalize facilities further for catheter months towards the AV fistula infection. One commenter argued that infections. Additionally, this submeasure. This would also weight infection measures should not be a commenter stated that ESRD facilities each patient’s contribution to the composite so that facilities can should be required to educate patients facility measure rate by the amount of individualize areas of concern. Some on appropriate homecare and supplies time a patient received care in that commenters noted the measure’s lack of to help prevent infection. facility.10 precedent and NQF endorsement, Response: We thank the commenter After considering the comments, we suggesting instead that CMS use the for the input and concern. CMS finalize the VAT measure for the PY NHSN-endorsed measure (NQF #1460) continues to consider programs within 2014 ESRD QIP with the clarifications (which would also prevent redundancy) its statutory authority which will lead to and changes discussed above. This or change the measure to a reporting an increase in the quality of care measure is comprised of two measure only. provided to Medicare ESRD submeasures, one of which measures beneficiaries. The PY 2012 ESRD QIP, Response: We agree that reducing catheters and one of which measures however, has been finalized, and we vascular access infections is critical to AV fistulas. The VAT measure have calculated and will shortly be specifications can be found at http:// improving quality of care because implementing the resulting payment www.dialysisreports.org/pdf/ infections are one of the leading causes reductions. We note that the ESRD esrd/public-measures/ of morbidity and mortality among the Conditions for Coverage require that the VascularAccess-Fistula-2014-FR.pdf Medicare ESRD population. patient be included as a member of the and http://www.dialysisreports.org/ Furthermore, many of these infections dialysis multidisciplinary team, and pdf/esrd/public-measures/ can be prevented through evidence- that providers/facilities educate patients VascularAccess-Catheter-2014-FR.pdf. based practices. However, in response to and promote appropriate patient care these comments, we reassessed our (for example 42 CFR 494.90(d)).11 iv. Vascular Access Infections (VAI) proposal and concluded that the claims- For the reasons discussed above, we Measure based data that we proposed to use to are not finalizing the VAI measure for We proposed to measure dialysis calculate this measure is not detailed use in the PY 2014 ESRD QIP. We will access-related infection rates by enough and, as a result, could lead to consider proposing in future rulemaking assessing the number of months in inaccurate assessments and to adopt a CDC NHSN-based clinical which a monthly hemodialysis claim comparisons of quality. In addition, we measure that assesses infection rates reports a dialysis access-related are also proposing that providers/ related to dialysis. infection using HCPCS modifier V8, and facilities begin reporting similar we noted that since July 1, 2010, we information via the CDC NHSN Dialysis v. Standardized Hospitalization Ratio have asked dialysis providers/facilities Event reporting system and recognize (SHR)-Admissions Measure to code all Medicare claims for dialysis the burden that may result from In the proposed rule, we proposed to access-related infections using this requiring reporting to two separate adopt the SHR-Admissions measure to modifier (CR 6782). As discussed more systems for purposes of the ESRD QIP. measure hospitalizations for Medicare fully in the proposed rule, we proposed We note that commenters were much dialysis patients. We proposed to adopt to adopt this measure under section more supportive of the CDC infection this measure under section 1881(h)(2)(B)(ii) of the Act. tracking system and the associated 1881(h)(2)(A)(iii) of the Act. The The public comments we received on NHSN-based blood stream infection proposed SHR-Admissions measure is a the VAI measure and our responses are measure which is NQF-endorsed risk-adjusted measure of set forth below. (#1460) and upon which we based the hospitalizations for Medicare dialysis Comment: Many commenters NHSN Dialysis Event reporting measure. patients. The data needed to calculate commended CMS for moving towards Given the overall quality of the data the proposed SHR-Admissions measure measuring infections. However, some obtained through the NHSN system and is based on claims and has been commenters noted that infections the general support expressed by the regularly reported to DFR since 1995 should not be measured through claims ESRD community, we believe that (previously known as Unit-Specific because claims data are unable to patients’ needs will be best served if Reports). We noted that the measure is provide precise identification of providers/facilities focus efforts on an ‘‘all-cause’’ measure, meaning that healthcare-associated infections (HAIs), reporting infection data via the CDC NHSN system. We recognize that the 11 We also encourage providers/facilities to utilize 10 For example, if one patient was treated every proposed PY 2014 NHSN Dialysis Event other clinical practice guidelines regarding patient month, his/her claim inputs would account for education. See, for example, http://www.kidney.org/ twelve, individual inputs for calculating the reporting measure would not be professionals/kdoqi/pdf/12-50- measure rate. Whereas a patient that is only seen calculated using actual infection data, 0210_JAG_DCP_Guidelines- for four months would be counted as four inputs. but we will consider incorporating a VA_Oct06_SectionC_ofC.pdf.

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hospitalizations related to other medical the commenters, and we welcome based on their scores. Commenters conditions outside of ESRD are included public input on the composition of such suggested different minimum case in the measure. We refer readers to the a measure. thresholds such as 20 cases or 25 cases, proposed rule for further information on Comment: One commenter supported or that providers with fewer cases be this proposed measure (76 FR 40524). tracking hospitalization rates among scored differently; some commenters The public comments we received on dialysis clinic patients. Another also noted that their studies showed that the SHR-Admissions measure and our commenter suggested that the SHR- the sample size rather than overall responses are discussed below. Admissions measure could be used as a performance is driving the results for Comment: Many commenters voiced balancing measure once CMS retires the facilities and requested that CMS raise concern that the SHR-Admissions Hemoglobin Less Than 10 g/dL measure the case minimum to 20. Another measure does not reflect issues that to ensure that patients do not commenter urged CMS to research the dialysis facilities can control, may lead experience hospitalizations due to reliability of a measure to set the to untimely or inappropriate care, and is hemoglobin levels that are too low. minimum number of cases, publish not adequately transparent in its Response: We thank the commenters minimum case reliability data, and use calculation. Commenters also stated that for their support, but, for the reasons this data to set a minimum number of the measure may lead to ‘‘cherry- stated above, we will not include this cases for all value-based purchasing picking’’ of patients based on their risk measure in the program at this time. programs. One commenter urged CMS of hospitalizations, causing access to While the SHR-Admissions measure to re-consider its scoring methodology care issues for patients with more severe would include hospitalizations due to to analyze for statistical significance. illness. Commenters suggested that, anemia, the SHR-Admissions is an all- Another commenter stated the belief instead, CMS measure hospitalizations cause measure, and it is uncertain how that the ESRD QIP methodology does resulting from the care, or lack of care, sensitive it would be in detecting not appropriately account for low provided by ESRD facilities. Other practice changes and patient outcomes patient census, unusual treatment commenters disapproved of the SHR- related to anemia management alone. As setting, or patient case-mix, and Admissions measure because there is we have stated, we will continue to recommended that CMS develop a currently no mechanism either for work with the ESRD community to mechanism to adjust for circumstances correcting or updating patient develop appropriate measures reflecting in which facilities with an unusual care comorbidity data on CMS’ Medical hospitalizations and will specifically setting, atypical case-mix, or small Evidence Reporting Form 2728, and consider measures which account for patient census may be at high risk of these comorbidities affect the hospitalizations related to inappropriate incurring penalties for failure to meet calculation of the measure. Another anemia management. performance standards. commenter stated that, because patients For the reasons discussed above, we Response: We appreciate the in nursing homes are more likely to are not finalizing the SHR-Admissions commenters’ concerns regarding the have a greater number and severity of measure for use in the PY 2014 ESRD potential impact of patient case mix on comorbidities, the metrics for QIP. We intend to work with the smaller providers/facilities. One goal of independent living patients and nursing community to adopt a measure for the ESRD QIP is to accurately assess the home patients should be compared to future years of the program that more quality of care provided by a provider/ determine if the established goals place accurately measures quality of care in facility. However, we recognize that a nursing homes at a disadvantage in this area. quality measure score could be achieving such goals. Another impacted by one or more factors vi. Minimum Case Number for Clinical commenter suggested that, because of unrelated to the care furnished by the Measures and Other Considerations the issues mentioned above, if CMS provider/facility, and that the potential retains the measure, it should weight it We proposed that a provider/facility of such factors to greatly skew the less than the other clinical measures. would need to report a minimum calculation decreases as the number of Some commenters suggested that CMS number of eleven cases for a proposed cases included in the measure increases. use a longer baseline period, such as clinical performance measure in order Similarly, a provider/facility with a four years. to receive a score on that measure (76 small number of patients could find that Response: After reviewing these FR 40533). As stated above, we believe one patient’s outcome determined its comments, we have decided, for the that this minimum threshold will help score on a quality measure. Thus we reasons articulated by commenters, to reduce the possibility that a small proposed that a provider/facility would not finalize our proposal to adopt the number of poor outcomes artificially, need to have a minimum of eleven cases SHR-Admissions measure for the PY and for reasons unrelated to the quality that meet the eligibility criteria for a 2014 ESRD QIP. We recognize concerns of care, skew a small provider’s/ measure in order to be scored on that that this measure may not promote facility’s performance score. measure. This eleven case minimum improved patient care and may not The comments we received regarding allows as many providers/facilities as accurately reflect hospitalizations which this proposal and our responses are set possible to participate in the program. can be controlled by dialysis facilities, forth below. We also address other This minimum case number is also and we are concerned about the comments regarding the measures we consistent with how we have potential for ‘‘cherry-picking.’’ We are proposed to adopt for the PY 2014 ESRD traditionally reported measures on additionally concerned that we do not QIP below. Dialysis Facility Compare. We will yet have the necessary data to more Comment: Commenters voiced continue to closely monitor beneficiary accurately risk-adjust the measure. concerns about CMS’ approach to access to care, including evaluating the Therefore, after considering the including low-volume facilities in the rate of facility closures. comments, we agree that the measure as program because one patient could We recognize, however, that we are proposed should not be included in the significantly affect a score for reasons introducing new measures and scoring PY 2014 ESRD QIP. We intend, unrelated to quality of care, such as methodologies for the PY 2014 program. however, to work to develop a measure comorbidities. This scoring could, in As additional data becomes available for for future years of the ESRD QIP that turn, affect patient volume if patients these measures, we will conduct does not raise the issues identified by and their care-givers judge facilities additional analysis to assess our case

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minimum. If we determine that a Response: Two of the measures apply required by the CDC; and (ii) submit different threshold is more appropriate, to PD patients and, therefore, PD-only three or more consecutive months of we will propose an alternative scoring facilities will be evaluated on these dialysis event data to the NHSN. approach in future rulemaking for the measures. According to the Section 1881(h)(2)(B)(i) of the Act ESRD QIP to ensure that smaller or low- specifications, adult PD patients would requires that unless the exception set volume facilities are not unfairly be included in the calculations for the forth in section 1881(h)(2)(B)(ii) applies penalized. following measures: Hemoglobin to the Act, the measures specified for Comment: One commenter urged Greater Than 12 g/dL, and the Mineral the ESRD QIP under section CMS to use only NQF-endorsed Metabolism reporting measure. Pediatric 1881(h)(2)(A)(iii) of the Act must have measures for the ESRD QIP because of PD patients qualify for the mineral been endorsed by the entity with a the NQF’s high level of review. Because metabolism reporting measure. contract under section 1890(a) of the none of the PY 2014 measures are NQF- For the reasons stated above, we are Act (which is currently the NQF). endorsed, this commenter does not finalizing our proposal that a provider/ Section 1881(h)(2)(B)(ii) of the Act support their adoption. facility must have a minimum of eleven states that, in the case of a specified area Response: We believe that, when cases for a measure, each with four or medical topic determined appropriate evaluating measures for the ESRD QIP, claims, in order to receive a score for by the Secretary for which a feasible and it is important to consider measures that measure. practical measure has not been endorsed endorsed by NQF and other consensus- by the entity with a contract under vii. National Healthcare Safety Network based entities and we have based our section 1890(a) of the Act, the Secretary (NHSN) Dialysis Event Reporting measures on available endorsed may specify a measure that is not so Measure measures where possible. We note, endorsed as long as due consideration is however, that under Section 1881(h) of As we noted in the proposed rule, given to measures that have been the Act, the Secretary has discretion to healthcare-associated infections (HAI) endorsed or adopted by a consensus adopt measures that are not NQF- are a leading cause of preventable organization identified by the Secretary. endorsed in certain circumstances. We mortality and morbidity across different Although a measure calculated using refer readers to our discussions of our settings in the healthcare sector, NHSN Dialysis Event data is currently rationale for adopting the individual including dialysis facilities. In a endorsed by the NQF, the measure for measures, above. national effort to reduce this outcome, reporting purposes only has not been Comment: Commenters noted that the Department of Health and Human NQF-endorsed. We noted that because same data sent to multiple laboratories Services agencies, including CMS, are HAIs are a significant patient safety can yield different results from each partnering with the Centers for Disease concern, we intend to propose to adopt laboratory. They noted that this Control and Prevention (CDC) to one or more measures that assess actual variability, rather than the actual care encourage providers to report to the dialysis event rates in the future if delivered, may affect provider’s/ NHSN as a way to track and facilitate necessary. facility’s rates and, ultimately, their action for reducing HAIs. The public comments we received on Total Performance Scores. These The NHSN is currently a secure, the proposed NHSN Dialysis Event commenters suggested that CMS Internet-based surveillance system that reporting measure and our responses are incorporate an acceptable standard integrates patient and healthcare discussed below. deviation value into the measure rate personnel safety surveillance systems Comment: Many of the commenters calculations in order to mitigate this managed by the Division of Healthcare voiced general approval of the proposed variability. One commenter also stated Quality Promotion at the CDC. NHSN NHSN reporting measure, but voiced that CMS should allow rounding to the has been operational since 2008 with concern that the required training, tenth to address ‘‘between instrument acute care hospitals, long term acute enrolling, and reporting will unduly variability within a single laboratory.’’ care hospitals, psychiatric hospitals, burden many facilities, diminishing the Response: The proposed PY 2014 rehabilitation hospitals, outpatient amount of time staff can focus on scoring methodology allows providers/ dialysis centers, ambulatory surgery patients. One commenter suggested that facilities some latitude to account for centers, and long term care facilities. We CMS more clearly study and define issues such as laboratory variability. For believe that reporting dialysis events to what is needed of staff before moving example, as further explained below, the NHSN by all providers/facilities forward with the measure. Other providers/facilities need not score at the would support national goals for patient commenters noted that CROWNWeb performance standard for each measure safety, and particularly goals for the will be collecting similar data upon its in order to avoid a payment reduction. reduction of HAIs. Accordingly, for the implementation, leading to redundancy We believe that such flexibility PY 2014 ESRD QIP we proposed to in reporting and further burdening mitigates concerns about details such as adopt a measure that would assess providers/facilities, and requested that laboratory variability. We do agree that whether providers/facilities enroll and CMS delay an infection reporting it is important to account for the report dialysis event data to the NHSN. measure until it can be recorded via precision of the data that we use to We stated our belief that, by CROWNWeb. Commenters also noted calculate rates and scores, and, as measuring only whether providers/ that this measure is redundant because explained above with regard to the facilities report dialysis event data to it captures data already being captured Hemoglobin Greater Than 12 g/dl the NHSN, providers/facilities would be by other measures. Other commenters measure, we will specify the number of given time to become familiar with the expressed concern that the CDC does decimal places for measure calculations NHSN reporting process. We also noted not have infrastructure to be able to to reflect the precision of the data our intention in the future to propose to support the high volume of new reports submitted by providers/facilities. adopt a measure that would score and facilities will not have the Comment: One commenter requested providers/facilities based on actual necessary reporting mechanisms in clarification that the PY 2014 measures dialysis events reported to the NHSN if place to submit these reports. They do not apply to providers/facilities that necessary. Specifically, we proposed suggested that providers/facilities only only treat patients receiving peritoneal that providers/facilities: (i) Enroll in the be scored on enrolling and training for dialysis (PD). NHSN and complete any training PY 2014, delaying actual reporting of

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data to allow providers/facilities to burden and to further align our been administered if the provider/ prepare to meet the NHSN requirements reporting requirements with those of facility administered it in accordance and the NHSN to prepare for receiving NHSN, we will allow all facilities until with the current specifications for the these reports. One commenter noted March 31, 2013 at 11:59 EST to report survey. These specifications can be that the CDC reporting requires manual these data as allowed by the NHSN accessed at: https:// entry which can lead to data entry error system. www.cahps.ahrq.gov/content/products/ and suggested the CMS arrange an Comment: One commenter suggested ICH/ alternative mechanism for collection; that, if CMS requires this burdensome PROD_ICH_Intro.asp?p=1022&s=222.12 another commenter suggested that this reporting, CMS should increase its base We proposed to measure whether a mechanism be CROWNWeb. rate for dialysis care. Another provider/facility has attested that it Response: The CDC has informed us commenter noted that this measure does successfully administered the ICH that it is preparing for the additional not increase quality because it only CAHPS survey during the performance volume of new system enrollees and requires reporting. period for the PY 2014 program. We data reporting that will result from the Response: Section 1881(h) of the Act proposed that providers/facilities would ESRD QIP and is enhancing the NHSN’s does not authorize the Secretary to be required to submit this attestation technical infrastructure. Additionally, increase the base rate for dialysis care. through CROWNWeb (which will be our proposal that providers/facilities Furthermore, we do not agree that this implemented nationally in 2012) by submit, at a minimum, only three measure does not incentivize quality. In January 30, 2013 at 11:59 p.m. EST. consecutive months of data in CY 2012 order for providers/facilities to The public comments we received is expected to lessen the demand on the successfully report at least 3- regarding the proposed ICH CAHPS NHSN’s infrastructure. Thus, we believe consecutive months of data to the reporting measure and our responses are that the CDC will be able to NHSN, the provider/facility must either discussed below. accommodate the additional data that have or must implement processes to Comment: Many of the commenters will be reported to the NHSN as a result record dialysis infection events. This were generally supportive of a patient of this measure. implementation will require providers/ experience measure, but stated that the Furthermore, we do not believe that facilities to begin monitoring dialysis ICH CAHPS survey is too burdensome this reporting requirement will unduly events and could draw their attention to for patients to complete and for burden providers/facilities. For facilities areas in need of improvement. In future providers/facilities to implement. that are currently enrolled in the NHSN, years of the ESRD QIP, we will consider Several of these commenters suggested CDC has studied what is required of incorporating a measure based on that, instead, either providers/facilities staff in order to comply with this providers’/facilities’ infection rates. be allowed to field any type of patient reporting. In addition, we believe that For the reasons stated above, we are experience survey or CMS adopt a more this reporting requirement will not be adopting the NHSN reporting measure simplistic patient experience measure. burdensome because, reporting this data for the PY 2014 ESRD QIP. Other commenters suggested that the 57 will only take five to ten minutes per viii. Patient Experience of Care Survey question survey be split into three patient, or a total of two hours and ten Usage Measure independently verified domains, each minutes, of staff time per month for a Section 1881(h)(2)(A)(ii) of the Act given to one-third of the patient facility of average size. Although we population and each including a set of stated in the proposed rule that we states that the measures specified for the ESRD QIP shall include, to the extent core questions, to lessen patient burden believed that enrolling and training and prevent incomplete surveys. One would take a total of 48 hours per feasible, a measure (or measures) of patient satisfaction as the Secretary commenter believes the survey should facility (76 FR 40540), based on data we more adequately address the range of have since received from the CDC, we shall specify. Information on patient experience with care at a facility is an care a patient may receive and suggested have revised that analysis in the final that CMS develop a process measure to rule and now believe that both enrolling important quality indicator to help allow patients to voice individual and training, each a one-time event, will providers/facilities improve services to dialysis experiences. Some commenters take approximately 8 total hours, spread their patients and to assist patients in asked CMS to implement a survey that across a period of several weeks, to choosing a provider/facility at which to is validated across all treatment complete. Although the NHSN currently seek care. We proposed to adopt a modalities and settings; another requires manual entry of data, CDC is measure for the PY 2014 ESRD QIP that commenter asked CMS to clarify moving towards an electronic system assesses provider/facility usage of the whether the survey applies to PD and that will further reduce the time In-Center Hemodialysis (ICH) Consumer HHD. One commenter also noted that required for data entry and reduce the Assessment of Healthcare Providers and this measure alone is not sufficient opportunity for error. Systems (CAHPS) Survey. The intent of Finally, we, as we noted above, we including this reporting measure is to because it requires providers/facilities agree with this measure’s possible assess the degree to which providers/ to attest to administration of the survey, redundancy and we are no longer facilities are providing their patients but it does not base payment reductions adopting the VAI measure for PY 2014. with a voice in the quality of their upon the results of these surveys. Thus, the NHSN measure will be the hemodialysis care. Response: We thank commenters for only measure related to infections. We proposed to measure whether a their support and suggestions. As we Furthermore, we do not intend to provider/facility administers the survey, noted in the proposed rule (76 FR require reporting of the same data but we did not propose to measure a 40525), we believe empowering patients elements to both the NHSN and provider’s/facility’s actual performance to voice their concerns is a critical part CROWNWeb. It is our intent to require based on the survey results. We expect of quality improvement. Patient surveys providers/facilities to report dialysis to adopt such a measure for the ESRD can, and should, draw provider/facility event data to only one system. QIP in future rulemaking. For purposes 12 In order to successfully field the survey, the Despite our belief that this measure of reporting this proposed measure for facility/provider must follow the recommendations will not unduly burden providers/ the ESRD QIP, we stated that we will found at: https://www.cahps.ahrq.gov/CAHPSkit/ facilities, to decrease any perceived consider the ICH CAHPS survey to have files/53_Fielding_the_ICH_Survey.pdf.

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attention to insights that can only be a paper attestation would be overly recognizing patients’ experience of care. provided by those receiving care. Given burdensome. They encouraged CMS to For the reasons discussed above, we are the importance of this survey, we do not work with the community to offer an finalizing the use of the ICH CAHPS believe the burden to patients or alternative solution. reporting measure in the PY 2014 ESRD providers/facilities outweighs the Response: CROWNWeb is on QIP. importance of this measure. Many of the schedule for national release in CY 2012 concerns the commenters voiced can be which will allow providers/facilities to ix. Mineral Metabolism Reporting mitigated without decreasing the report their attestations by the January Measure number of questions on the survey or 2013 deadline. We do recognize, Section 1881(h)(2)(A)(iii) of the Act how the survey is administered. For however, that unanticipated delays may states that the measures specified for the occur. Therefore, if CROWNWeb will example, as the specifications ESRD QIP shall include other measures 13 not be available in time for the January indicate, patients may take a break as the Secretary specifies, including, to 30, 2013 attestation deadline, we will during the administration of the survey the extent feasible, measures of bone adopt an alternative, electronic mode of or take the survey in multiple sittings if mineral metabolism. Abnormalities of attestation and notify providers/ they feel that the number of questions bone mineral metabolism are facilities of this method through the is too great to answer at one time. exceedingly common and contribute Additionally, the survey requires third- ESRD Networks. Comment: One commenter noted significantly to morbidity and mortality party administration, taking no in patients with advanced CKD. additional dialysis staff time. discrepancies between the ICH CAHPS Numerous studies have associated We note that the ICH CAHPS survey specifications and the proposed disorders of mineral metabolism with was developed through the study of regulation, including (i) ICH CAHPS surveys used by dialysis providers. The requires survey administration to all or morbidity, including fractures, CAHPS tool went through extensive a random sample of patients (depending cardiovascular disease, and mortality. testing during development including on how many patients the facility Overt symptoms of these abnormalities focus groups and one-on-one patient serves), whereas the proposed often manifest in only the most extreme sessions. Thus, we believe that this regulation requires surveying in-center states of calcium-phosphorus survey is the best method available at hemodialysis patients, and (ii) ICH dysregulation, which is why we believe this time to measure patient experience. CAHPS recommends using third-party that routine blood testing of calcium survey administrators, whereas the and phosphorus is necessary to detect We also note that we intend to develop 15 a measure that evaluates providers/ proposed regulation seems to expect abnormalities. facilities based on patient responses to facilities to survey their own patients. The Kidney Disease: Improving the ICH CAHPS survey and use of a This commenter noted concern that Global Outcomes (KDIGO) 2009 uniform survey tool will allow us to requiring a third-party survey guideline recommends that the serum more accurately compare providers/ administrator will unequally burden phosphorus level in a dialysis patient facilities in future years of the program. small clinics. Another commenter generally be lowered toward the normal Furthermore, we disagree that this requested that facilities be allowed to range, but does not recommend a reporting measure does not improve administer their own surveys, provided specific target level that would apply to quality. In order to successfully report that those fielding the surveys are not all patients.16 The guideline also the measure, providers/facilities must center staff. recommends that therapy to correct for attest that they have successfully Response: As outlined in the abnormal levels be administered based administered the ICH CAHPS survey. specifications,14 the ICH CAHPS survey on the health needs of the individual The results of these surveys will be was developed for adult, in-center patient. Accordingly, we noted in the reported to the provider/facility by the hemodialysis patients and, therefore, proposed rule that we do not feel it is third-party administrator, and these this is the population to which it must appropriate at this time to propose to results can draw providers’/facilities’ be administered. Specifically, it must be adopt a measure that would penalize attention to areas in need of administered to all patients meeting providers/facilities if they did not improvement. these criteria or, if a facility cares for achieve a specific target serum Finally, we thank commenters for over 200 such patients, a random phosphorus level in all patients. We their suggestions in developing new sample of 200. This administration must also noted that there is currently no measures. The ICH CAHPS survey was be completed by a third-party; https:// NQF-endorsed measure dealing with the developed for adult in-center HD www.cahps.ahrq.gov/content/products/ achievement of specific target patients and this measure therefore does ICH/ phosphorus levels. In the time since this not apply to HHD, PD, or pediatric PROD_ICH_Intro.asp?p=1022&s=222. rule was proposed, the NQF has patients. Further, at this time, we are Even if the surveys were not endorsed a mineral metabolism measure not aware of a tool which allows administered by staff with whom the based on calcium levels (NQF #1454) patients to rate their experiences for patient had a direct relationship, a which we will consider proposing for every dialysis experience. We continue patient could still feel pressure to to evaluate opportunities to accurately refrain from responding candidly. It is 15 Kidney Disease: Improving Global Outcomes capture patient experience for all crucial that patients feel comfortable (KDIGO) CKD–MBD Work Group. KDIGO clinical modalities. answering honestly and openly, and, practice guideline for the diagnosis, evaluation, Comment: Some commenters therefore, it is vital that this survey be prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD–MBD). expressed concern that CROWNWeb administered by a third-party. As we Kidney International 2009; 76 (Suppl 113): S1– will not be available or will be noted above, although we are aware of S130. unreliable for submitting the ICH the burden associated with this 16 Kidney Disease: Improving Global Outcomes CAHPS survey attestations. These administration, we do not believe it (KDIGO) CKD–MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, commenters, however, also thought that outweighs the importance of prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD–MBD). 13 See https://www.cahps.ahrq.gov/content/ 14 https://www.cahps.ahrq.gov/content/products/ Kidney International 2009; 76 (Suppl 113): S1– products/ICH/PROD_ICH_Intro.asp?p=1022&s=222. ICH/PROD_ICH_Intro.asp?p=1022&s=222. S130.)

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future years of the ESRD QIP.17 We also submitted by January 30, 2013 at 11:59 Response: We thank this commenter noted that the NQF has previously p.m. E.S.T. for the support. We will consider endorsed phosphorus and calcium We also noted that we anticipate commenters’ suggestion as we develop a monitoring measures (NQF #0261 and adopting, for future years of the ESRD mineral metabolism measure for future NQF #0255) and, in 2008, we adopted QIP, one or more mineral metabolism years of the ESRD QIP. serum calcium and serum phosphorus clinical measures in addition to or in Comment: Some commenters monitoring as CPMs (http:// replacement of the proposed Mineral expressed concern that CROWNWeb www.dialysisreports.org/ Metabolism reporting measure. will not be available or will be ESRDMeasures.aspx). Despite the The public comments regarding the unreliable for submitting the Mineral current lack of consensus on specific proposed Mineral Metabolism reporting Metabolism attestations. These target ranges for both phosphorus and measure and our responses are commenters, however, also thought that calcium levels in dialysis patients, we discussed below. a paper attestation would be overly stated our belief that there is consensus Comment: Several commenters burdensome. They encouraged CMS to that monthly monitoring of calcium and expressed support for this measure, but work with the community to offer an phosphorus is important for early requested that CMS also develop an alternative solution. detection of abnormalities. outcomes measure for phosphorus for Response: CROWNWeb is on Section 1881(h)(2)(B)(i) of the Act submission to the NQF for endorsement schedule for national release in CY 2012 requires that unless the exception set as soon as feasible. Several commenters which will allow providers/facilities to forth in section 1881(h)(2)(B)(ii) of the urged CMS to also adopt a parathyroid report their attestations by the January Act applies, the measures specified for hormone (PTH) measure in order to 2013 deadline. We do recognize, however, that unanticipated delays may the ESRD QIP under section encompass all areas of bone mineral occur. Therefore, if CROWNWeb will 1881(h)(2)(A)(iii) of the Act must have metabolism. One commenter noted the not be available in time for the January been endorsed by the entity with a morbidity and mortality risks associated 30, 2013 attestation deadline, we will contract under section 1890(a) of the with extreme PTH values and stated that provide an alternative, electronic mode Act (which is currently the NQF). Under it is important to monitor the number of of attestation and notify providers/ the exception set forth in section patients with PTH below 100 pg/mL and facilities of this method through the 1881(h)(2)(B)(ii) of the Act, in the case above 400 pg/mL who are not on ESRD Networks. of a specified area or medical topic therapy. Another commenter suggested determined appropriate by the Secretary For the reasons discussed above, we that CMS consider the addition of a for which a feasible and practical are finalizing the Mineral Metabolism statement in the attestation to indicate measure has not been endorsed by the reporting measure for the PY 2014 ESRD that a treatment plan is in place for any entity with a contract under section QIP. We note that, as we proposed, a abnormalities in bone mineral 1890(a) of the Act, the Secretary may provider/facility must attest that it metabolism; one commenter also specify a measure that is not so measured the calcium and phosphorous expressed concern that the reporting endorsed as long as due consideration is of each Medicare ESRD patient at least measure alone would not improve given to measures that have been once per month. quality. endorsed or adopted by a consensus 3. Performance Period for the PY 2014 organization identified by the Secretary. Response: We do not agree that this ESRD QIP Although we gave due consideration measure does not incentivize quality. In to the NQF-endorsed measures on order to successfully report the measure, Having decided to propose to adopt phosphorus and calcium level providers/facilities must attest that they all of CY 2011 as the performance monitoring in dialysis patients, we have monitored calcium serum and period for the PY 2013 ESRD QIP, we noted that it is not feasible for us to phosphorous serum at least once a examined what performance period propose to adopt either of them at this month for each Medicare ESRD patient, would be most appropriate for the PY time as we do not currently collect data and to do that, the provider/facility 2014 ESRD QIP. We noted that we on whether these levels are checked for must either have or implement believe that a 12-month performance each patient each month to allow processes to collect and monitor this period is most appropriate for the ESRD calculation of the measure rates. We are data. This monitoring could draw QIP at this point in the program. We also not aware that any other consensus provider/facility attention to areas in also noted that a period of a year building entity has endorsed or adopted need of improvement and mineral accounts for seasonal variations, but measures on this topic. Therefore, we metabolism concerns for individual also provides a timely incentive and proposed to adopt a Mineral Metabolism patients. feedback for providers/facilities, as well reporting measure that is based on the We continue to explore new measures as timely performance information for two NQF-endorsed measures, but in the area of bone mineral metabolism; Medicare beneficiaries. We have also requires providers/facilities to attest to we will consider commenters’ determined that CY 2012 is the first compliance with monthly monitoring, suggestions for additional measures for feasible period during which we can and we proposed to adopt it under future years of the ESRD QIP, including collect sufficient performance period section 1881(h)(2)(B)(ii) of the Act. outcomes-based bone mineral data for all of the proposed measures. We proposed that providers/facilities metabolism measures and measures that Therefore, we proposed to select all of would be required to submit an indicate whether a treatment plan is in CY 2012 as the performance period for attestation through CROWNWeb that place for identified abnormalities. the PY 2014 ESRD QIP. they have conducted the appropriate Comment: One commenter agreed that The comments we received on the monitoring. We further proposed that the Mineral Metabolism measure should proposed selection of CY 2012 as the this reporting must be electronically be a reporting measure only and performance period and on the use of discouraged CMS from instituting a shorter performance periods in future 17 See http://www.qualityforum.org/Projects/e-g/ clinical measure unless and until years, and our responses are set forth _ _ _ _ End Stage Renal Disease 2010/ studies prove a causal relationship End_Stage_Renal_Disease_2010.aspx for more below. information regarding the National Voluntary between certain values and morbidity Comment: Commenters applauded Consensus Standards for ESRD. and mortality. CMS for adopting a prospective

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performance period of CY 2012 for the for the PY 2014 ESRD QIP because it would enable us to calculate national PY 2014 ESRD QIP and noted their will enable us to differentiate between performance rate values for these disapproval of any performance period providers/facilities that simply meet the proposed clinical measures before the of less than a full year. performance standards, those that beginning of the performance period. Response: We thank commenters for exceed the performance standards by We indicated that we would specify their support of the proposed PY 2014 varying amounts, and those that fall these values in the final rule. performance period. We also believe short of the performance standards. We With respect to the proposed VAT that it is most appropriate and helpful further believe that the proposed measure, we proposed to set for providers/facilities to be scored on a methodology will better incentivize performance standards using the same full year of data at this point in the providers and facilities to both achieve methodology and baseline period that program. high Total Performance Scores and we proposed to use for the other For the reasons stated above, we are improve the quality of care they proposed clinical measures; however, finalizing CY 2012 as the performance provide. we proposed to set performance period for all of the finalized measures standards for each of the subcomponent for the PY 2014 ESRD QIP. i. Performance Standards for the PY measures rather than for the overall 2014 ESRD QIP combined measure. 4. Performance Standards and the For the PY 2014 ESRD QIP, we We proposed to establish the Methodology for Calculating the Total proposed to establish performance achievement performance standard for Performance Score for the PY 2014 standards under section 1881(h)(4)(A) of the proposed NHSN Dialysis Event ESRD QIP the Act. This section of the Act reporting measure as the successful Section 1881(h)(3)(A)(i) of the Act generally provides that, subject to completion by providers/facilities of: (i) requires the Secretary to develop a subparagraph (E), the Secretary shall Enrollment in the NHSN and methodology for assessing the total establish performance standards with completion of the required training performance of each provider and respect to measures selected for the during the performance period (as facility based on the performance ESRD QIP for a performance period with verified by a digital certificate obtained standards with respect to the measures respect to a year. Furthermore, under from CDC), or, in the case of providers/ selected for the performance period. section 1881(h)(4)(B) of the Act, the facilities that have previously enrolled, The final rule entitled, ‘‘Medicare performance standards established continued enrollment throughout the Programs; Hospital Inpatient Value- under subparagraph (A) must include entirety of the performance period; and Based Purchasing Program,’’ appeared levels of achievement and improvement, (ii) submission to the NHSN of at least in the Federal Register on May 6, 2011 as determined appropriate by the three-consecutive months of dialysis (76 FR 26490) and set forth our view Secretary. To establish performance event data gathered during the that value-based purchasing represents standards under section 1881(h)(4)(A) of performance period. an important step in revamping how we the Act, the Secretary must also comply We proposed to establish the pay for care and services, allowing CMS with section 1881(h)(4)(C) of the Act, achievement performance standard for to move increasingly toward rewarding which requires the Secretary to establish the ICH CAHPS reporting measure as an better value, outcomes, and innovations performance standards prior to the attestation by the provider/facility that instead of merely paying for volume (76 beginning of the performance period for it successfully administered the ICH FR 26491). The final rule also set forth the year involved. CHAPS survey during the performance principles guiding the development of With respect to the anemia period. performance scoring methodologies, management and dialysis adequacy We proposed to establish the including: measures, we proposed to set the achievement performance standard for • Providers should be scored on their achievement performance standard the proposed Mineral Metabolism overall achievement relative to national under section 1881(h)(4)(A) of the Act reporting measure as whether a or other appropriate benchmarks. In as the national performance rate on each provider/facility submitted an addition, scoring methodologies should measure during a proposed baseline attestation stating that it measured the consider improvement as an period. We proposed that the national serum calcium and serum phosphorus independent goal. performance rate for each measure levels of Medicare patients treated by • Measures or measurement domains would be calculated at the national the provider/facility at least once within need not be given equal weight, but over aggregate level as the number of the month throughout the duration of time, scoring methodologies should be Medicare patients for whom the the performance period. more weighted towards outcome, measure was achieved divided by the As noted above, section 1881(h)(4)(B) patient experience, and functional total number of Medicare patients of the Act provides that the performance status measures. eligible for inclusion in the measure. We standards established under section • Scoring methodologies should be also proposed to set the improvement 1881(4)(A) of the Act must include reliable, as straightforward as possible, performance standard as the national levels of achievement and improvement, and stable over time and enable performance rate on each measure as determined appropriate by the consumers, providers, and payers to during the same proposed baseline Secretary. We determined that an make meaningful distinctions among period. We noted that our goal is to improvement performance standard is providers’ performance. incentivize providers/facilities to not appropriate for the proposed For the PY 2014 ESRD QIP, we achieve these national performance reporting measures because it is not proposed to adopt a new performance rates, whether they do so by attaining feasible to measure improvement on scoring methodology to replace the achievement points or improvement these measures at this time because we methodology we are using for the PY points under our proposed scoring do not have any existing data we can 2012 and are finalizing in this final rule methodology (76 FR 40527). We use to compare provider/facility for the PY 2013 ESRD QIP. We believe proposed to use a baseline period from performance. that this scoring methodology will more July 1, 2010 to June 30, 2011 to calculate We also noted that we do not interpret accurately reflect a provider’s/facility’s the national performance rate. We stated section 1881(h)(1)(B) of the Act to performance on the measures proposed our belief that this baseline period require that providers/facilities meet or

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exceed the performance standards we performing providers/facilities reached all of the clinical measures except the establish with respect to each individual during the baseline period. VAT measure based on how much their ESRD QIP measure. Rather, we In determining an improvement score performance on the measure during the proposed to implement a scoring for the clinical measures, we proposed performance period improved from their methodology that enables a provider/ that providers/facilities would receive performance on the measure during the facility to avoid a payment reduction as points along an improvement range, proposed individual facility baseline long as it achieves a minimum Total defined as a scale running between the period. A unique improvement range for Performance Score that, as discussed provider’s/facility’s performance on the each measure would be established for more fully below, is equal to the Total measure (the improvement threshold) each provider/facility. The following Performance Score it would have during the twelve-month baseline formula is used when the provider’s/ received if it had met the performance period and the benchmark. The facility’s performance rate is equal to or standards for all of the proposed provider/facility’s improvement score greater than the improvement threshold measures. would be calculated by comparing its (but below the benchmark). Using this Additionally, we noted that, performance on the measure during the formula, the provider/facility would beginning in PY 2015, we intend to performance period (CY 2012) to its receive a score of 0 to 9 improvement propose to establish floors for performance on the measure during the points based on equally spaced intervals performance such that performance baseline period (July 1, 2010–June 30, between the improvement threshold and standards would never be lower than 2011). the benchmark. those set for the previous year, even if iii. Scoring Provider and Facility [10 * ((Provider performance period provider/facility performance fails to Performance on Clinical Measures rate—provider baseline period improve, or even declines, over time. Based on Achievement rate)/(Benchmark—provider We also noted that, although we would baseline period rate))]—.5, where consider continuing to set the national We proposed to award between 0 and the provider performance score falls performance rate as the achievement 10 points for achievement for all of the in the range from the provider’s and/or improvement performance clinical measures except the VAT baseline period score to the standard, we would also consider measure based on where a provider’s/ benchmark. facility’s performance falls relative to establishing future performance We proposed that all improvement the achievement threshold and the standards that reflect performance goals points be rounded to the nearest integer, benchmark for that measure. The widely recognized by the ESRD medical with 0.5 rounded up). If a provider’s/ following formula is used when the community as demonstrating high facility’s score on the measure during provider’s/facility’s performance rate is quality care for ESRD patients, should the performance period was equal to or equal to or greater than the achievement such a consensus be reached. lower than its baseline period score on threshold (but below the benchmark). the measure, the provider/facility would ii. Setting Performance Benchmarks and Using this formula, a provider/facility receive 0 points for improvement. Thresholds would receive a score of 1 to 9 points Under the proposed scoring based on a linear scale disturbing all v. Calculating the VAT Measure Score methodology for the PY 2014 ESRD QIP, points proportionately between the We proposed to calculate the VAT a provider’s/facility’s performance on achievement threshold and the measure score by first calculating the each of the finalized clinical measures benchmark so that the interval in measure rate according to measure would be determined based on the performance between the score needed specifications for each of the two higher of (i) an achievement score or (ii) to receive a given number of measure subcomponents. We proposed an improvement score. In determining achievement points and one additional that these two rates would then be the achievement score, we proposed achievement point is the same converted into separate achievement that providers/facilities would receive throughout the range of performance and improvement scores, using the points along an achievement range, from the achievement threshold to the above methodology, for each defined as a scale that runs from the benchmark. subcomponent using achievement and achievement threshold to the [9* ((Provider’s performance period improvement ranges specific to each benchmark. We proposed to define the rate—achievement threshold)/ subcomponent measure. The higher of achievement threshold for each of these (benchmark—achievement the achievement or improvement score proposed measures as one standard threshold))] + .5. for each measure component would deviation below the achievement We proposed that all achievement then be averaged to produce one overall performance standard for the measure points would be rounded to the nearest score for the VAT measure. We believe (which we proposed to set as the integer, with 0.5 rounded up). If a that this method of calculating this national performance rate on the provider’s/facility’s score was: measure stresses the importance of both measure during the baseline period). We • Equal to or greater than the vascular access sub-measures without stated our belief that this achievement benchmark, the provider/facility would penalizing providers/facilities for two threshold will provide an incentive for receive 10 points for achievement similar measures or unduly weighting a providers/facilities to continuously • Less than the achievement provider’s/facility’s Total Performance improve their performance while not threshold (that is, the lower bound of Score in favor of VAT measures. reducing the payments made to the achievement range), the provider/ vi. Calculating the NHSN Dialysis Event providers/facilities that score at or facility would receive 0 points for Reporting Measure, Patient Experience above the national performance rate. We achievement. proposed to define the benchmark as the Survey Usage Reporting Measure and mean of the top decile of provider/ iv. Scoring Provider/Facility Mineral Metabolism Reporting Measure facility performance during the baseline Performance on Clinical Measures Scores period because it represents a Based on Improvement We proposed to adopt a different demonstrably high but achievable We proposed that providers/facilities scoring methodology for the proposed standard of excellence that the best would earn between 0 and 9 points for NHSN Dialysis Event reporting measure,

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Patient Experience Survey Usage performance standards, as determined report a minimum of eleven cases or reporting measure, and Mineral appropriate by the Secretary. more would be included in determining Metabolism reporting measure. In determining how to appropriately this score, with each such measure With respect to the proposed NHSN weight the PY 2014 ESRD QIP measures being weighted equally. We stated our Dialysis Event Reporting measure, we for purposes of calculating Total belief that this approach achieves that proposed to assign providers/facilities a Performance Scores, we considered a goal of including as many providers/ score of 0, 5, or 10 points as follows: number of criteria. Specifically, we facilities as possible, while ensuring the • Providers/facilities that enrolled in considered the number of measures we reliability of the measure scores. the NHSN during or before the have proposed to include in the PY Similarly, we proposed to assign performance period, completed the 2014 ESRD QIP as well as CMS and equal weight to the proposed NHSN required training, and successfully HHS quality improvement priorities. We Dialysis Event reporting measure, reported at least three-consecutive stated our belief that weighting the Patient Experience Survey reporting months of dialysis event data to the finalized clinical measures equally will measure, and Mineral Metabolism NHSN before January 30, 2013, for the incentivize providers/facilities to reporting measure, with those equal period of January 1, 2012–December 31, improve and achieve high levels of weights adding up to 10 percent of the 2012 would receive 10 points. performance across all of the measures, Total Performance Score. Applying the • Providers/facilities that enrolled in resulting in overall improvement in the proposed weighting criteria to a the NHSN and completed the required quality of care provided to ESRD provider/facility that receives a score on training during or before the patients. For these reasons, we proposed all of the proposed measures, we performance period, but did not report to assign equal weight to the five proposed to calculate the provider/ at least 3-consecutive months of dialysis proposed clinical measures, with those facility Total Performance Score using event data to the NHSN before January equal weights adding up to 90 percent the following formula: 30, 2013, for the period January 1, 2012 of the Total Performance Score. We Total Performance Score = [(.18 * through December 31, 2012, would stated our belief that, while the Hemoglobin Greater Than 12g/dL receive 5 points. reporting measures are valuable, the Measure) + (.18 * Kt/V Dialysis • Providers/facilities that failed to clinical measures measure actual patient enroll in the NHSN and/or complete the Adequacy Measure) + (.18 * outcomes and therefore, justify a Vascular Access Type Measure) + required training during or before the combined weight of 90 percent. We (.18 * Vascular Access Infection proposed performance period would proposed that the remaining 10 percent Measure) + (.18 * SHR–Admissions receive 0 points. of the Total Performance Score would Measure) + (.0333 * NHSN We proposed to assign providers/ be comprised of the proposed reporting Reporting Measure) + (.0333 * facilities a score of 10 points if they measures, with each measure weighted Patient Experience Survey attest that they successfully equally. We recognize that reporting is Reporting Measure) + (.0333 * administered the ICH CAHPS survey an important component in quality Mineral Metabolism Reporting during the performance period improvement, and that this type of Measure)] * 10. according to the specifications measure should also be included in the referenced above. Providers/facilities ESRD QIP, although at a substantially We proposed that the Total Performance that did not provide such an attestation lower weight. Score be rounded-up to the nearest would receive 0 points. We also considered whether and how integer (and any individual measure We proposed to assign providers/ we could award a Total Performance values ending in .5 would be rounded- facilities that measured the serum Score to providers/facilities that do not up). calcium and serum phosphorus levels of report data on at least eleven cases with We solicited public comment on the all Medicare ESRD patients treated by respect to one or more of the finalized proposed performance scoring the provider/facility at least once within clinical measures. As we stated above, methodology as detailed above. The the month throughout the duration of we proposed that this minimum number comments we received and our the proposed performance period a of cases must be reported with respect responses are summarized below. score of 10 points, while providers/ to each clinical measure in order for the Comment: One commenter urged that facilities that did not do so would provider/facility to receive a score on CMS should give greater weight to those receive 0 points. We will measure this that measure. We stated that because we measures over which facilities have the by requiring a facility to furnish an are proposing to adopt additional greatest control and asked for attestation at the end of the performance measures, we believe that it is clarification of the process that will be period. Those facilities that do not appropriate to calculate Total used to weight measures in future years provide this attestation will receive Performance Scores for all providers/ of the ESRD QIP. Another commenter 0 points. facilities. In the case of a provider/ suggested that CMS weight measures facility that has sufficient data from the that detect underutilization of services vii. Weighting of the PY 2014 ESRD QIP performance period, but lacks sufficient more than those that detect Measures and Calculation of the PY data from the baseline period, we overutilization. Another commenter 2014 ESRD QIP Total Performance Score proposed to only calculate its suggested that CMS weight each Section 1881(h)(3)(A)(iii) of the Act achievement score, because it would not measure based on its potential to provides that the methodology for be possible to calculate its improvement improve quality. assessing provider/facility total score. We believe that this approach is Response: We believe, at this time, performance must include a process to necessary to ensure that as many that it is appropriate to weight all of the weight the performance scores with providers/facilities receive a score as clinical measures equally and all of the respect to individual measures to reflect possible. We proposed that the reporting measures equally in order to priorities for quality improvement, such combined weight of the clinical equally incentivize quality in all of as weighting scores to ensure that measures that are scored would still be these areas of care. Additionally, we providers and facilities have strong equal to 90 percent of the Total believe that providers/facilities can, incentives to meet or exceed anemia Performance Score, but only those overall, impact the outcomes of these management and dialysis adequacy measures for which providers/facilities measures by providing high-quality,

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patient-centered care in accordance clinical measures. Furthermore, we do facilities, that do not successfully satisfy with the specified measures. Finally, we not believe it is in the best interest of the requirements for the reporting do not believe it is appropriate to patients to weight the fistula VAT measures, their Total Performance Score penalize underutilization more than submeasure more than the catheter VAT will be calculated based solely on the overutilization. Whether care is submeasure because of our goal to applicable clinical measures that apply substandard due to underutilization or promote fistula use. Although we agree to them. overutilization, it is still substandard that catheters pose a greater risk to However, we also recognize that care and should be recognized as such. patients, we do not believe this under our scoring methodology, a We seek to be as transparent as possible necessitates weighting the catheter provider/facility’s score on a reporting in all aspects of the ESRD QIP, and we subcomponent measure twice as much measure could help it achieve the will outline the weighting methodology as the AV fistula subcomponent minimum Total Performance Score for future years of the program through measure as both are equally important needed to avoid a payment reduction rulemaking. in promoting the best clinical practices that it would otherwise receive based Comment: Several commenters argued with respect to VAT. Therefore, as solely on its clinical measure score(s). In that the clinical measures should not be stated below, we finalize that the three order to balance these competing weighted equally. Some commenters clinical measures will be weighted concerns, we will allow a new provider/ suggested that the VAT catheter equally to comprise 90 percent of a facility (defined above as one that submeasure comprise a larger weight in providers/facilities Total Performance receives a new CCN on or after July 1, the final VAT measure score because of Score. 2012) the option to report one or more the literature suggesting that a reduction As we have also stated, we believe of the reporting measures. If the new in catheters will also reduce infections that the Patient Experience Survey is provider/facility chooses to take and mortality. One commenter voiced one of the most important tools in advantage of this option by successfully support for CMS’ proposal that the impacting clinical practices because it is satisfying the reporting requirement for clinical measures compose 90 percent of the only measure that gives patients a one or more of these measures, we will the Total Performance Score, but argued voice that may otherwise go score the new provider/facility on those that, because of the importance of unrecognized. Therefore, we do not measures and include those scores in vascular access to overall health and believe the ICH CAHPS measure should the calculation of that provider/facility’s cost reduction, the VAT measure should have a lesser weight than the other Total Performance Score. be weighted at 50 percent with the other reporting measures. We believe that we should include as clinical measures comprising the Comment: One commenter expressed many providers/facilities in the program equally weighted remainder of the concern that new facilities without a as possible. In the proposed rule, we clinical measure score. One commenter complete data set available for the proposed to calculate Total Performance suggested that CMS weight the VAT measures will be unfairly penalized. Scores for all providers/facilities and measure less than the other clinical Response: Like all ESRD QIP did not specifically state any minimum measures. Other commenters suggested providers/facilities, new facilities will number of clinical and reporting that, if CMS retains the VAT measure, only be included in the program if they measures a provider/facility would need the catheter submeasure be weighted have the requisite amount of data. For to receive a Total Performance Score. greater than the fistula submeasure, each of the clinical measures, there Thus, we clarify in this final rule that perhaps at a 2:1 ratio. Some commenters must be at least eleven cases each with a provider/facility will receive a Total also suggested that the Patient four claims, regardless of whether the Performance Score for PY 2014 if it is Experience Survey measure be weighted facility is new or established, in order eligible for at least one measure. We half as much as the other reporting for such measure to be included in the finalize that, if a provider/facility is measures because of the greater clinical Total Performance Score. For the eligible for at least one clinical measure impact of the Mineral Metabolism and reporting measures, however, we and at least one reporting measure, the NHSN reporting measures. acknowledge that we did not specify clinical measures will be equally Response: We believe that all of the any data requirements, and we weighted to sum 90 percent of the Total clinical measures improve care and are recognize that new facilities may be Performance Score, and the reporting important to the program. For the unfairly penalized if they do not have a measures will be equally weighted to measures finalized for PY 2014, we do sufficient amount of time to fulfill the sum 10 percent of the Total Performance not believe any one area of care should requirements for the reporting measure. Score. If a provider/facility is only be promoted over another, and we Accordingly, we finalize that a eligible for clinical but not reporting believe that providers/facilities should provider/facility that receives a new measures or vice versa, we will compute be equally incentivized to achieve high CCN on or after July 1, 2012 will have its Total Performance Score based solely standards in all of the areas evaluated the option to not be scored on the on the measures for which it is eligible. by the clinical measures. Thus, although reporting measures. We believe that Comment: Some commenters we have finalized only three of the five these new providers/facilities need a commended CMS for proposing proposed clinical measures, we still reasonable amount of time to put the measures, proposing timeframes, and believe that is appropriate to evenly necessary infrastrucure into place in proposing the weight each measure weight the clinical measures. order to be able to satisfy these would have in the PY 2014 program Additionally, we continue to believe measures. For example, with respect to within one regulation. that the clinical measures are vital to the ICH CAHPS patient survey Response: We thank commenters for improving care and should be weighted experience measure, a new facility their support. more substantially than those measures would need to, at a minimum, hire a Comment: Commenters noted that which to not score providers/facilities third party vendor, treat at least one in- establishing the achievement threshold based upon actual outcomes. We also center hemodialysis patient for 3 as one standard deviation below the believe that appropriate VAT is critical months, and field the survey (which, national performance rate might lead to to ensuring optimal patient outcomes. depending on the responsiveness of the inappropriate achievement thresholds Thus, we do not agree that we should patient, could take an additional period as a result of skewed performance weight this measure less than the other of months). For these new providers/ distributions. Some commenters

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suggested that, instead, CMS base on the following Web site: http:// methodology to ensure that performance standards on the median www.dialysisreports.org/pdf/esrd/ improvement standards do not diminish performance of providers/facilities, with public-measures/UpdatedBaseline- incentives for achievement (for the achievement threshold being at the 2014-FR.pdf. We are publishing in this example, facilities should be required to 15th percentile. Other commenters final rule numbers based on data from meet minimum thresholds prior to urged CMS to establish the achievement July 1, 2010 through March 30, 2011, or having improvement rewarded). threshold as the mean performance of nine of the 12 months of baseline data. Commenters noted that CMS should facilities performing in the lowest third. We will publish numbers based on 12 adjust its scoring methodology to ensure Response: In the proposed rule, we months, July 1, 2010 through June 30, that facilities performing consistently defined the performance standards as 2011, on or before January 31, 2012 at above the achievement threshold are not the national performance rate, the the following Web site: http:// penalized. Under the proposed scoring achievement threshold as one standard www.dialysisreports.org/pdf/esrd/ system, these facilities would not be deviation below the achievement public-measures/UpdatedBaseline- eligible for improvement points and threshold, and the benchmark as the 2014-FR.pdf. We do not anticipate that could perform worse in the long run mean of the top decile of providers/ the final numbers will differ than those who performed less well in facilities. After receiving public substantially from these numbers. baseline years. These commenters comment, we have found that the We believe that this approach suggested that CMS establish a distribution of facility performance on complies with section 1881(h)(4) of the consistency multiplier. Another several measures is skewed, we have Act, including the requirement in commenter proposed that CMS set a determined that the median is a better subparagraph (C) that the Secretary fixed achievement threshold in order to measure of central tendency, which was establish performance standards under prevent penalizing facilities that have our original intent for these standards. subparagraph (A) prior to the beginning improved (that is, improvement will If the measures had had a more even of the performance period. However, we raise the standard which will cause the distribution, one standard deviation recognize that providers/facilities are achievement threshold to rise which below the mean would have been very interested in these numbers and will cause the provider to have to calculated to be at approximately 35 have a legitimate need to learn what improve more). One commenter stated percentage points below the mean or the they will be with respect to a payment that the performance standards for both 15th percentile. Thus, we agree with the year as soon as possible. Although we PY 2013 and PY 2014 should be less commenters who suggested that the are not able to provide them in this final stringent to decrease the incentive to performance standard should be set at rule for the reasons discussed above, we game the system. the median performance of providers/ anticipate that beginning with the PY Response: We believe that the scoring facilities during the baseline period. In 2015 ESRD QIP, we will be able to select methodology we are finalizing for the order to more accurately access the a baseline period that ends early enough PY 2014 ESRD QIP provides appropriate achievement threshold, we will set the to make these numbers available in the incentives to providers/facilities to both performance standards (both final rule that applies to that program. achieve and improve. We acknowledge achievement and improvement) as the The estimated actual values that apply that under the methodology, it might be median of facility/provider performance to the PY 2014 performance standards, possible for a provider/facility to attain and establish the achievement threshold based on nine of the twelve months of a lower measure rate on one or more at the 15th percentile because the 15th baseline data, are shown in Table 5 measures than the measure rate attained percentile represents approximately one below. by other providers/facilities but receive standard deviation below the median Comment: One commenter suggested more points overall in the form of had the distributions been even. that CMS modify the payment reduction improvement points. However, we Comment: Several commenters argued scale to encourage providers to perform believe it is appropriate to incentivize that the performance standards must be well on all of the measures. lower-achieving facilities to continue to published and commenters must be Response: As we noted in the improve, even if their measure rates do allowed to comment on these standards proposed rule, we do not interpret not meet the achievement threshold and and the related scoring methodology section 1881(h)(1)(B) of the Act to even if their improvement points would before the beginning of the performance require that providers/facilities meet or be higher than their achievement points. period. exceed the performance standards we For these providers/facilities, our Response: Our proposal set forth the establish with respect to each individual scoring methodology allows us to performance standards that would apply ESRD QIP measure. Rather, we believe reduce the amount of a payment to the PY 2014 clinical measures and that our proposed approach best reduction that they might otherwise assigned example numerical values to balances the goal of incentivizing receive because they have improved each of those proposed measures using providers/facilities to provide quality over their baseline rates. Additionally, data from July 1, 2010 through care across all of the measures while because providers/facilities can score 1– November 30, 2010, which was the most still recognizing the higher quality of 10 points for achievement and only 0– current data that was available at the care provided by those providers/ 9 points for improvement, providers/ time that overlapped with the proposed facilities that exceed the performance facilities can always be rewarded more performance period. Because of data standards on certain measures. for achieving at higher levels. We agree limitations related to the claims Additionally, we believe that this with the commenters that the verification process which allows approach will give providers/facilities performance standard will likely providers/facilities a period of time to the flexibility they need to become continue to rise if we continue to utilize review and contest claims, we are able familiar with the new scoring this scoring methodology in future in this final rule to finalize the methodology. years, and we will take these comments performance standards that will apply Comment: Several commenters into consideration as we gain to the PY 2014 ESRD QIP but cannot yet commended CMS for recognizing both experience with the ESRD QIP. assign actual numbers to those finalized achievement and improvement in its Additionally, we do not believe that standards based on a full year of data. scoring methodology. Some commenters the performance standards for PY 2013 However, we will post these numbers suggested that CMS implement a or PY 2014 are too stringent. For PY

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2014, the performance standard is at the to reflect a more attainable standard, deviations. Due to skewed distributions midpoint of providers’/facilities’ and because we are changing the of facility performance, we are finalizing performance. Thus, this standard has achievement threshold to a fixed point, the performance standards (both been achieved by half of all facilities. To we also believe it is appropriate to achievement and improvement) as the begin scoring achievement points, modify our methodology for calculating median (50th percentile), the providers/facilities need only be at or the benchmark. To more accurately achievement threshold as the 15th above the 15th percentile. Thus, we represent the top of all performers, we percentile, and the benchmark as the believe that the performance standards will calculate the benchmark at the 90th 90th percentile. We agree with have been and will continue to be percentile instead of as the mean of the commenters that this better reflects the attainable. We will be monitoring top decile of performers; while the mean central tendency and spread of these outcomes and practice patterns in the of the top decile will vary depending performance distributions. ESRD setting to determine whether any upon the rates of the top ten percent of We are finalizing the proposed ESRD QIP policies might be encouraging performers for each measure, the 90th baseline period of July 1, 2010–June 30, activities that could be described as percentile is a fixed place on all 2011. We are also finalizing our ‘‘gaming,’’ and, to the extent necessary, measure performance distributions, thus proposal that providers/facilities that do we will make changes to the ESRD QIP allowing a more consistent calculation not have enough data in the baseline to lessen the potential that such throughout various distributions for all period to calculate a rate for a measure activities occur. measures. We believe that this change but do have enough data to calculate a Comment: Some commenters conforms the benchmark to the new measure rate in the performance period suggested that there was an error in performance standards and achievement will receive a score on that measure CMS’ proposed scoring methodology threshold while still accomplishing the based solely on achievement. We also because, if a facility does not improve benchmark’s intent to incentivize finalize that the clinical measures for at all, it is possible for that facility to providers/facilities to provide the which a provider/facility is eligible will receive a negative improvement score; highest achievable level of care. be equally weighted to comprise 90 these commenters asked CMS to clarify For the reasons discussed above, we percent of its Total Performance Score, that facilities with the same or lower are finalizing the PY 2014 ESRD QIP and the reporting measures for which a improvement score compared to their scoring methodology to score each provider/facility is eligible will be baseline score will have an clinical measure rate as the higher of the equally weighted to comprise 10 percent improvement score of zero. measure’s achievement or improvement of its Total Performance Score. If a Response: Under the proposed scoring score, as explained above. We are also provider/facility is only eligible for one methodology, scores would be rounded finalizing the proposed scoring type of measure, the provider’s/facility’s to the nearest integer, with a score of 0.5 methodology for calculating the Total Performance Score will be rounded up to the next highest integer. reporting measure scores and the calculated based on that measure(s) Accordingly, the lowest improvement requirement that a provider/facility alone. score a provider/facility could receive is must have received a CCN on or before Because of the data limitations (¥) 0.5, and this score would be July 1, 2012 in order to automatically be explained above, we are unable at this rounded to zero. The commenter is scored on the reporting measures. We time to assign final numbers to the correct in that the lowest score a facility note that, as discussed above, for the performance standards, achievement can receive for both improvement or NHSN Dialysis Event measure, we will thresholds, and benchmarks. We will achievement is zero. now allow providers/facilities until publish these numbers at the following Comment: One commenter expressed March 31, 2013 at 11:59 EST to report Web site: http:// concern that, by setting the benchmark the required three consecutive months www.dialysisreports.org/pdf/esrd/ score at the mean of the top decile of of data from the performance period. We public-measures/UpdatedBaseline- provider/facility performance, many are also finalizing our proposal to 2014-FR.pdf on or before January 31, facilities will be unfairly penalized and calculate the VAT measure score as the 2012. Below, in Table 4 and 5, we have requested that CMS set a benchmark average of the submeasure scores. provided estimates based upon data closer to the national performance rate. Based on public comments, we are from July 1, 2010 through March 30, Response: As noted, one of the goals not finalizing the proposed definition of 2011. We do not believe that these of the ESRD QIP is to incentivize the performance standards, achievement estimates will vary significantly from highest quality care. However, we agree thresholds, or benchmarks which were our finalized numbers. that the benchmark should be lowered based on means and standard BILLING CODE 4120–01–P

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BILLING CODE 4120–01–C Facility A’s performance on the URR exceeds the benchmark, so Facility A vii. Examples for 2014 ESRD QIP measure. The example benchmark (90th would earn 10 points (the maximum) for Performance Scoring Model percentile) calculated for this measure achievement for this measure. (Because, in this case is 100 percent, while the in this example, Facility A has earned Below, we provide examples to example achievement threshold (15th the maximum number of points possible illustrate the performance scoring percentile) is 91 percent. Facility A’s for this measure, its improvement score model. Figures 1–4 illustrate the scoring performance rate of 100 percent during is irrelevant.) for a clinical measure. Figure 1 shows the performance period meets or

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Figure 2 and 3 show the scoring for performance on the URR measure went to 95 percent during the performance another facility, Facility B. As from 80 percent in the baseline period period. illustrated below, the facility’s

Applying the achievement scale, However, because Facility B’s the benchmark), it would be scored Facility B would earn 5 points for performance during the performance based on improvement as well, as achievement, calculated as follows: period is also greater than its baseline shown by Figure 3, below. 9 * [(95 ¥ 91)/(100 ¥ 91)] + .5 = 4.5, period performance (but Facility B’s which is rounded to 5 points. performance period score is less than

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Applying the improvement scale, based 10 * [(95 ¥ 80)/(100 ¥ 80)] ¥ .5 = 7.5 In Figure 4 below, Facility C’s on Facility B’s period-to-period ¥ .5 = 7.0, which would be performance on the URR measure drops improvement, from 80 percent to 95 rounded to 7 points. from 80 percent in the baseline period percent, Facility B would earn 7 Because the higher of the two scores is to 75 percent in the performance period, improvement points, calculated as used for determining the measure a decline of 5 percent. follows: score, Facility B would receive 7 points for this measure.

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Because Facility C’s performance Hemodialysis Adequacy Measure) + receive the largest payment reductions, during the performance period falls (.300 * Vascular Access Type we proposed to increase the payment below the achievement threshold of 91 Measure) + (.05 * NHSN Reporting reduction from 1.0 percent to 1.5 percent, it would receive zero points for Measure) + (.05 * Mineral percent for all providers/facilities that achievement. Facility C would also Metabolism Reporting Measure)] * fail to achieve a Total Performance receive zero points for improvement 10. Score that is 10 points below the because its performance during the minimum Total Performance Score 6. Payment Reductions for the PY 2014 performance period was lower than its (described above). Additionally, we ESRD QIP performance during the baseline period. proposed to increase the payment In this example, Facility C would Section 1881(h)(3)(A)(ii) of the Act reduction to 2.0 percent for all receive zero points for the URR requires the Secretary to ensure that the providers/facilities that fail to achieve a Measure. application of the scoring methodology Total Performance Score that is 20 The method illustrated above would results in an appropriate distribution of points below the minimum Total be applied to each clinical measure in payment reductions across providers Performance Score (described above). order to obtain a score for each measure. and facilities such that providers and We stated our belief that such a sliding Scores for reporting measures are facilities achieving the lowest Total scale will incentivize providers/ calculated based upon the methodology Performance Scores receive the largest facilities to meet the performance as proposed. payment reductions. We have adopted a standards and continue to improve their Applying the weighting criteria to a sliding scale of payment reductions for performance because even if a provider/ provider/facility that receives a score on the PY 2012 ESRD QIP (76 FR 634) and facility fails to achieve the minimum all finalized measures, we calculate the have finalized a sliding scale in this Total Performance Score, such provider/ provider’s/facility’s Total Performance final rule for PY 2013 ESRD QIP. In facility will still be incentivized to Score using the following formula: developing a payment reduction scale strive for, and attain, better performance Total Performance Score = [(.300 * for the PY 2014 ESRD QIP, we sought in order to reduce the amount of its Hemoglobin Greater Than 12g/dL to create an approach that would retain payment reduction. Measure) + (.300 * URR aspects of the tiered sliding scale The comments we received on the Hemodialysis Adequacy Measure) + selected for the PY 2012 ESRD QIP, but proposed payment reductions are set (.300 * Vascular Access Type also reflect the change in provider/ forth below. Measure) + (.0333 * NHSN facility scores under the new scoring Comment: One commenter opposed Reporting Measure) + (.0333 * methodology. Under the proposed the elimination of the 0.5% payment Patient Experience Survey approach, a provider/facility would not reduction level and suggested that there Reporting Measure) + (.0333 * be required to meet or exceed the be at least five tiers in the payment Mineral Metabolism Reporting performance standards with respect to reduction scale because, in addition to Measure)] * 10. each of the finalized measures in order allowing comparisons between years, to avoid receiving a payment reduction The Total Performance Score be five-tiers in the payment reduction scale under the ESRD QIP. Rather, even if a is more consistent with the literature rounded to the nearest integer (and provider/facility failed to meet or supporting value-based purchasing any individual measure values exceed the performance standards with programs. ending in .5 would be rounded to respect to one or more of these Response: We agree with the the next higher integer)). measures, the provider/facility could commenter’s concern and will include However, if, for example, a provider/ avoid a payment reduction if it achieved the 0.5 percent payment reduction level facility did not receive a score on the a minimum Total Performance Score as an additional level in the PY 2014 proposed VAT measure, the provider’s/ that is equal to or greater than the ESRD QIP payment reduction scale. facility’s Total Performance Score minimum Total Performance Score it Thus, the payment reductions for PY would be calculated as follows: would receive if it had met the 2014 will range on a sliding scale from Total Performance Score = [(.4500 * performance standards for each 0.5 percent to 2.0 percent with the Hemoglobin Greater Than 12g/dL finalized measure, or, in the case of the provider/facility moving down a tier for Measure) + (.4500 * URR VAT measure, for the two every ten points its Total Performance Hemodialysis Adequacy Measure) + subcomponent measures. At the time we Score falls below the minimum Total (.0333 * NHSN Reporting Measure) issued the proposed rule, we were Performance Score. We are finalizing + (.0333 * Patient Experience unable to calculate the minimum Total new measures, a new scoring Survey Reporting Measure) + (.0333 Performance Score because we did not methodology, and rigorous performance * Mineral Metabolism Reporting have the data for the baseline period. standards which are not familiar to the Measure)] * 10, (the Total We estimated, however, that the community. We believe that including Performance Score will be rounded minimum Total Performance Score that this additional payment reduction level to the nearest integer (and any a provider/facility would have to will allow time for us as well as values ending in .5 would be achieve to avoid a payment reduction providers/facilities to become familiar rounded to the next higher integer)). would be 60 points, and we stated that with this new structure. Finally, if, for example, a provider/ we would specify the exact number in Comment: One commenter facility qualified for two of the reporting the final rule. We proposed to disapproved of setting 10 points as a measures,18 the provider’s/facility’s implement at least a 1.0 percent threshold for each reduction in payment Total Performance Score would be payment reduction for all providers/ for PY 2014 when CMS cannot yet calculated as follows: facilities that fail to meet or exceed this estimate the minimum Total Total Performance Score = [(.300 * minimum Total Performance Score. Performance Score because the Hemoglobin Greater Than 12g/dL To ensure that the proposed payment distribution in payment reductions is Measure) + (.300 * URR reduction methodology complies with not yet known and will not be known the section 1881(h)(3)(A)(ii) requirement until the performance period has ended. 18 This could occur, for example, if a provider/ that providers and facilities achieving Instead, the commenter suggested that facility is a pediatric and/or peritoneal facility only. the lowest Total Performance Scores CMS allow for a sufficient period of

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time for the quality measure scores to be the score a provider/facility would and plan to consistently use the 100 made publicly available and data to be receive if it had met the performance point scale going forward. collected to assess the potential impact standards for each of the finalized Based on the public comments we of the QIP on the facilities. Another clinical measures. Recognizing many received, we are finalizing most of the commenter suggested that CMS score commenters’ concerns regarding the payment reduction methodology that we the PY 2014 measures on a 30 point new reporting measures, and our lack of proposed; however, we are adding an scale consistent with PY 2012 so that data on which to approximate likely additional payment reduction level of facilities and consumers can provider/facility performance, we will 0.5 percent, with the scale now ranging meaningfully compare performance exclude them from the calculation of the from 0.5 percent to 2.0 percent. For from year to year. minimum Total Performance Score. We every ten points a provider/facility’s Response: We appreciate the believe this policy will balance our Total Performance Score falls below the commenter’s concern regarding how we desire to appropriately incentivize minimum Total Performance Score, it establish the minimum Total improvements in clinical quality while will receive an additional 0.5 percent Performance Score and each successive ensuring that providers/facilities are not reduction. We are modifying our payment reduction level. Although we unduly penalized. will not know the distribution of Based on our analysis of the data from definition of the minimum Total payment reductions based on the July 1, 2010 through March 30, 2011, we Performance Score to be equal to the minimum Total Performance Score until estimate that the PY 2014 minimum score a provider/facility would receive we have the data at the end of the Total Performance Score will be 56 if it performed at the performance performance period, given our current points. We will publish the final standards for each of the clinical estimates of the data, we believe that, minimum Total Performance Score at measures. the payment reductions will be the following Web site: http:// As noted above, we are unable to appropriate to incentivize providers/ www.dialysisreports.org/pdf/esrd/ publish a finalized minimum Total facilities to improve patient care. We public-measures/UpdatedBaseline- Performance Score until we assign a have calculated these estimates based 2014–FR.pdf on or before January 31, final number to each finalized on the data currently available to us, as 2012. performance standard. We will publish further explained in the Regulatory Additionally, although we generally a finalized minimum Total Performance Impact Statement, and they are similar believe that the ESRD QIP should Score at the following Web site: to the reductions for PY 2012 and our provide a means for patients to evaluate http://www.dialysisreports.org/pdf/esrd/ estimates for PY 2013. However, in light their providers/facilities over time, we public-measures/UpdatedBaseline- of the commenter’s concern, we will do not believe that, even if we set 2014–FR.pdf on or before January 31, further adjust how we set the minimum performance on a 30 point scale, PY 2012. Based upon the performance Total Performance Score. Rather than 2014 would be comparable to previous standard examples we provided above, set the minimum Total Performance years of the ESRD QIP because of the we estimate that the minimum Total Score as the score a provider/facility significant changes to scoring Performance Score will be 56. We do would receive if it had met the methodology and measures. We believe not anticipate that this estimate will performance standards for each a 100 point scale will accommodate a substantially change. Using this finalized measure, we will define the growing number of measures that may estimation, the payment reduction scale minimum Total Performance Score as be adopted in future years of the QIP would be as detailed below in

7. Public Reporting Requirements that a provider or facility have an For both the PY 2013 and PY 2014 opportunity to review the information to ESRD QIP, we proposed no change in Section 1881(h)(6)(A) of the Act be made public with respect to that the implementation of these statutory requires the Secretary to establish provider/facility prior to such provisions (section 1881(h)(6)(A) procedures for making information information’s publication. through section 1881(h)(6)(D) of the Act) regarding performance under the ESRD In addition, section 1881(h)(6)(C) of from the proposals finalized in the 2012 QIP available to the public, including the Act requires the Secretary to provide ESRD QIP final rule (76 FR 636 through information on the Total Performance each provider and facility with a 639), wherein we finalized the Score (as well as appropriate certificate containing its Total establishment of procedures for comparisons of providers and facilities Performance Score to post in patient providers/facilities to review the to the national average with respect to areas within the facility. Finally, section such scores) and performance scores for 1881(h)(6)(D) of the Act requires the information to be made public and the individual measures achieved by each Secretary to post a list of providers/ procedures for informing the public provider and facility. Section facilities and performance-score data on through facility-posted certificates. 1881(h)(6)(B) of the Act further requires a CMS-maintained Web site.

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The comments we received on the serum phosphorus management address these issues in future public reporting proposals are set forth measures for future years of the ESRD rulemaking, as needed. below. QIP. Specifically, we sought public Comment: One commenter suggested Comment: Some commenters noted comment on: that the ESRD QIP should focus more on that information reported to the public • Measurement of Serum Calcium mitigating patient non-compliance. should be meaningful and requested Concentration. Response: We thank the commenter that CMS include language on the ESRD • Measurement of Serum Phosphorus for the suggestion and will consider it QIP certificates stating (i) The date range Concentration. as we further develop measures and of the performance period; (ii) the date • Assessment of Iron Stores. policies for the ESRD QIP. We also note ranges used to compute the performance These measures are currently that there are mechanisms currently in standards; and (iii) a statement that the collected through CROWNWeb as part place under the ESRD Conditions for data may not reflect current medical of the CPM set. The full specifications Coverage that require that providers/ standards or facility/provider for these measures may be accessed at: facilities educate patients and promote performance. http://www.dialysisreports.org/ appropriate patient care (e.g. 42 CFR Response: The certificates for PY 2012 ESRDMeasures.aspx. 494.90(d)). will indicate the year of the The comments we received on future Comment: Some commenters urged performance period. We will monitor measures are set forth below. CMS to require reporting of the ESRD whether beneficiaries find the Comment: Many commenters QIP measures for all applicable patient certificates to be effective in conveying suggested measures and/or domains for populations, including both Medicare performance, and we will continue to future ESRD QIP payment years. These and non-Medicare populations, because evaluate the information they should suggestions included (i) Iron measures, providers will then have a better include for PY 2013 and PY 2014. We perhaps measuring trends in ferritin; (ii) understanding of their overall believe that the intent of the certificates upper serum phosphorus limit performance. is to convey information about facility measures; (iii) hypercalcemia measures Response: We intend to propose to performance in an understandable, (e.g. NQF #1454); (iv) PTH measures; require reporting of measure data on all clear, and concise manner. We do not (iv) albumin measures; (v) ESRD patient populations after the believe that details about the baseline immunization measures; (vi) fluid launch of CROWNWeb. We have thus data used to compute the performance management measures; (vii) quality of far not required reporting on all patient standards, or disclaimers about the life measures; (x) measures focusing populations because our measures have limitations of the data, are required to upon the nurse-patient relationship; been claims-based and have thus been convey this basic message, but we (viii) measures assessing the number of restricted to Medicare patients. We encourage providers/facilities to discuss HHD and PD patients; (ix) blood adopted claims-based measures to these certificates with their patients and pressure measures; and (x) standardized reduce the burden of reporting for provide any further explanatory mortality rate measures. Other providers/facilities in the initial years of information they feel is necessary. commenters suggested that we make the the program. Comment: Several comments reporting measures clinical measures as Comment: Some commenters requested that CMS address procedural soon as feasible. Commenters also requested that we clearly provide the issues related to facility Performance encouraged us to consider domains and criteria which we will use to select Score Reports. measures in which the pediatric future measures and their weight and Response: Performance Score Reports community, HHD patients, and PD suggested that measures be ‘‘phased-in.’’ (PSRs) are distributed to providers/ patients can more actively participate. Commenters also suggested the CMS use facilities for their review after the end Response: We thank commenters for criteria similar to that used by the NQF of the performance period but before these suggestions. We continue to to adopt measures and employ the payment reductions are assessed. For monitor measure development and valid feedback of the Measure Applications PY 2012, PSRs were sent to providers/ and available data sources and look Partnership in selecting measures facilities in July 2011, and provider/ forward to working with the ESRD appropriate for the program. facilities were permitted to preview the community to choose future measures Response: We believe that we have reports and ask us any questions. We are which drive quality of care. outlined the criteria we used to select currently reviewing our PSR process, Comment: One commenter stated a measures and their weights for the and we will consider commenters’ belief that that CMS should not adopt ESRD QIP, and we will continue to do suggestions as we develop the PSRs for any current or future measures that do so in the future. We will also consider PY 2013 and PY 2014. not indicate a causal relationship NQF criteria, as well as feedback of For the reasons set forth above, we are between the measure and morbidity and other consensus-based entities, such as finalizing the public reporting mortality and requested that CMS the Measures Application Partnership, requirements as proposed. conduct more scientific tests on these as we select measures for the ESRD QIP. measures. Therefore, this commenter We also believe that, in some cases, it 8. Future QIP Measures believes that an iron stores measure might be appropriate to ‘‘phase-in’’ As part of our effort to continuously should be a reporting measure only measures, and we will continue to improve the ESRD QIP, we are working until further scientific evidence can be consider the best methods of to adopt additional robust measures that obtained. This commenter also introducing measures to the program. provide valid assessments of the quality expressed concern that a ‘‘one size fits Comment: One commenter suggested of care delivered to ESRD beneficiaries. all’’ system will lead to ‘‘cherry- that CMS impose a method for ensuring To that end, we are developing picking.’’ that the data provided by facilities/ measures that apply to all modalities Response: We thank the commenter providers is accurate. (including home and in-center dialysis) for the input. We continue to analyze Response: We currently have the and the pediatric population. We also and develop measures that we believe ability to cross check the accuracy of sought public comment on the inclusion best reflect quality in care. We also some of the data reported via of iron management measures, serum continue to monitor access to care CROWNWeb. If a provider/facility calcium management measures, and issues and will adjust the ESRD QIP to reports information via CROWNWeb,

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we can see if this information reflects Comment: Some commenters section 1834(l)(13)(A) of the Act to that submitted for the ESRD QIP. We requested that CMS use the rulemaking extend the payment add-ons described will continue to monitor provider/ process to update and/or modify above for an additional year, such that facility compliance with the ESRD QIP measures. these add-ons also applied to covered reporting requirements, and we will Response: We believe that the ground ambulance transports furnished propose to implement a validation measure updating process that the on or after January 1, 2010 and before methodology in future rulemaking if we Secretary establishes under section January 1, 2011. In the CY 2011 conclude that this would be appropriate 1881(h)(2)(B) can be a subregulatory physician fee schedule final rule (75 FR for the program. process, as long as it is established in 73385 and 73386, 73625), we revised Comment: Some commenters consultation with interested parties. We § 414.610(c)(1)(ii) to conform the encouraged CMS to implement a also believe that we have met this regulations to this statutory program or conduct demonstration statutory requirement by proposing in requirement. programs for incentive bonus payments rulemaking to implement a process to Subsequently, section 106(a) of the rather than payment reductions. These update measures. Generally, we will use MMEA again amended section commenters suggested that these the rulemaking process as often as 1834(l)(13)(A) of the Act to extend the bonuses could be funded by the money possible to updated and/or modify payment add-ons described above for an saved in payment reductions under the measures. But the process we proposed additional year, such that these add-ons ESRD QIP. Another commenter to adopt balances our need, in some also apply to covered ground ambulance suggested that CMS make more of the circumstances, to expeditiously update transports furnished on or after January payment amount contingent upon measures to address changes in science 1, 2011 and before January 1, 2012. In quality, and one commenter urged CMS or issues related to patient safety while the CY 2012 ESRD PPS proposed rule to encourage innovation in the ESRD still allowing the public to express its (76 FR 40535), we proposed to revise field. critiques, concerns, and approval of § 414.610(c)(1)(ii) to conform the Response: Section 1881(h) does not such updates. regulations to this statutory provide us with the authority to issue After considering the comments, we requirement. This statutory requirement bonus payments to providers/facilities are finalizing our process for updating is self-implementing. A plain reading of based on their performance under the measures as proposed. the statute requires only a ministerial ESRD QIP or to make reductions of more application of the mandated rate than 2.0 percent. We have conducted III. Ambulance Fee Schedule increase, and does not require any quality incentive ESRD demonstration A. Summary of Proposed Provisions substantive exercise of discretion on the projects in the past, and we intend to do part of the Secretary. For further so in the future; we will consider In the CY 2012 ESRD PPS proposed information regarding the extension of commenters’ suggestions as we develop rule (76 FR 40535 through 40536), we these payment add-ons, please see future projects. We believe that the proposed to revise the regulations at Transmittal 706 (Change Request 6972) ESRD QIP will encourage innovation in § 414.610 to conform with section 106 of dated May 21, 2010 and the CMS Web the ESRD field as providers/facilities the Medicare and Medicaid Extenders site, http://www.cms.gov/ seek to reach the highest quality Act of 2010 (MMEA), and to incorporate AmbulanceFeeSchedule/02_afspuf.asp. standards through better and more a technical correction. efficient methods of care. b. Amendment to Section 146(b)(1) of 1. Section 106 of the Medicare and MIPPA 9. Process of Updating Measures Medicaid Extenders Act of 2010 (MMEA) Section 146(b)(1) of the MIPPA Section 1881(h)(2)(C) of the Act amended the designation of rural areas enables the Secretary to establish a a. Amendment to Section 1834(l)(13) of for payment of air ambulance services. process for updating the measures the Act This section specified that any area that specified under subparagraph (A) in Section 146(a) of the Medicare was designated as a rural area for consultation with interested parties. Improvements for Patients and purposes of making payments under the Occasionally there are changes in Providers Act of 2008 (Pub. L. 110–275) ambulance fee schedule for air science or new issues arise related to (MIPPA) amended section ambulance services furnished on patient safety that may impact the 1834(l)(13)(A) of the Act to specify that, December 31, 2006, shall continue to be measures that have been adopted effective for ground ambulance services treated as a rural area for purposes of through the rulemaking process. furnished on or after July 1, 2008 and making payments under the ambulance Therefore, for such cases where new before January 1, 2010, the ambulance fee schedule for air ambulance services information is available that specifically fee schedule amounts for ground furnished during the period July 1, 2008 relates to patient safety concerns, we ambulance services shall be increased as through December 31, 2009. proposed that we would post a notice of follows: Sections 3105(b) and 10311(b) of the the updates we intend to make to the For covered ground ambulance Affordable Care Act amended section measure(s) in the Federal Register. We transports which originate in a rural 146(b)(1) of MIPPA to extend this proposed to specify in the notice a time area or in a rural census tract of a provision for an additional year, period during which we would accept metropolitan statistical area, the fee through December 31, 2010. In the CY comments from the public. We also schedule amounts shall be increased by 2011 physician fee schedule final rule proposed to consider these comments 3 percent. (75 FR 73385 through 86, 73625 through and post a notice in the Federal Register For covered ground ambulance 26), we revised § 414.610(h) to conform finalizing any updates that we make to transports which do not originate in a the regulations to this statutory the measure(s). We stated our belief that rural area or in a rural census tract of requirement. Subsequently, section this process will enable us to make a metropolitan statistical area, the fee 106(b) of the MMEA amended section necessary updates to the ESRD QIP schedule amounts shall be increased by 146(b)(1) of MIPPA to extend this measures to ensure that the measures 2 percent. provision again through December 31, are based on the best available scientific Sections 3105(a) and 10311(a) of the 2011. Therefore, in the CY 2012 ESRD data. Affordable Care Act further amended PPS proposed rule (76 FR 40536), we

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proposed to revise § 414.610(h) to the regulations to this statutory B. Response to Comments conform the regulations to this statutory requirement. We did not receive any comments requirement. This statutory requirement Subsequently, section 106(c) of the regarding the proposed revisions to is self-implementing. A plain reading of MMEA again amended section § 414.610 discussed above. (We received the statute requires only a ministerial 1834(l)(12)(A) of the Act to extend the one ambulance-related comment during application of a rural indicator, and rural bonus described above for an the comment period which was beyond does not require any substantive additional year, through December 31, the scope of the proposed rule, and exercise of discretion on the part of the 2011. Therefore, as directed by the thus, it is not addressed in the final Secretary. Accordingly, for areas that MMEA, we are continuing to apply the rule). Therefore, we are finalizing the were designated as rural on December rural bonus described above (in the revisions to § 414.610 as proposed. 31, 2006, and were subsequently re- same manner as in previous years), to designated as urban, we have re- ground ambulance services with dates IV. Durable Medical Equipment and established the ‘‘rural’’ indicator on the of service on or after January 1, 2011 Supplies ZIP Code file for air ambulance services and before January 1, 2012 where A. Background for Durable Medical through December 31, 2011. transportation originates in a qualified Equipment (DME) and Supplies For further information regarding the rural area. extension of this MIPPA provision, This rural bonus is sometimes Title XVIII of the Social Security Act please see Transmittal 706 (Change referred to as the ‘‘Super Rural Bonus’’ (the Act) governs the administration of Request 6972) dated May 21, 2010 and and the qualified rural areas (also the Medicare Program. The statute the CMS Web site, http://www.cms.gov/ known as ‘‘super rural’’ areas) are provides coverage for broad categories AmbulanceFeeSchedule/02_afspuf.asp. identified during the claims of benefits, including inpatient and adjudicative process via the use of a outpatient hospital care, skilled nursing c. Amendment to Section 1834(l)(12) of data field included on the CMS facility care, home health care, the Act supplied ZIP Code File. physician services, and durable medical Section 414 of the Medicare In the CY 2012 ESRD PPS proposed equipment (DME). DME is covered by Prescription Drug, Improvement and rule (76 FR 40536), we proposed to Medicare based, in part, upon section Modernization Act of 2003 (MMA) revise § 414.610(c)(5)(ii) to conform the 1832(a) of the Act, which describes the added paragraph (12) to section 1834(l) regulations to the statutory requirement scope of benefits under the of the Act, which specified that in the set forth at section 106(c) of the MMEA. supplementary medical insurance case of ground ambulance services This statutory requirement is self- program (Medicare Part B). Section furnished on or after July 1, 2004, and implementing. The statute requires a 1861(s)(6) of the Act defines ‘‘medical before January 1, 2010, for which one-year extension of the rural bonus and other health services’’ to include transportation originates in a qualified (which was previously established by DME as a separate benefit for which rural area (as described in the statute), the Secretary), and does not require any payment is authorized by section 1832 the Secretary shall provide for a percent substantive exercise of discretion on the of the Act. Section 1861(m)(5) of the Act increase in the base rate of the fee part of the Secretary. For further specifically includes DME in the schedule for such transports. The statute information regarding the extension of definition of the term ‘‘home health requires this percent increase to be this rural bonus, please see Transmittal services.’’ based on the Secretary’s estimate of the 706 (Change Request 6972) dated May In accordance with section 1861(n) of average cost per trip for such services 21, 2010 and the CMS Web site, http:// the Act, the term ‘‘durable medical (not taking into account mileage) in the www.cms.gov/AmbulanceFeeSchedule/ equipment’’ includes iron lungs, oxygen lowest quartile of all rural county 02_afspuf.asp. tents, hospital beds, and wheelchairs populations as compared to the average used in the patient’s home whether 2. Technical Correction cost per trip for such services (not furnished on a rental basis or taking into account mileage) in the In the CY 2011 physician fee schedule purchased. The patient’s home includes highest quartile of rural county final rule (75 FR 73386, 73625), CMS an institution used as his or her home populations. Using the methodology made technical changes to reformat other than an institution that meets the specified in the July 1, 2004 interim § 414.610(c)(1). However, in making requirements of section 1861(e)(1) or final rule (69 FR 40288), we determined these revisions, language related to the section 1819(a)(1) of the Act. Besides that this percent increase was equal to ambulance fee schedule conversion being subject to this provision, the 22.6 percent. As required by the MMA, factor (CF) was inadvertently left out of coverage of DME must also meet the this payment increase was applied to this regulation. Specifically, the requirements of section 1862(a)(1)(A) of ground ambulance transports that following sentence was inadvertently the Act, which in general excludes from originated in a ‘‘qualified rural area’’; omitted from revised § 414.610(c)(l): payment any items or services that are that is, to transports that originated in ‘‘The CF is multiplied by the applicable not reasonable and necessary for the a rural area included in those areas RVUs for each level of service to diagnosis or treatment of illness or comprising the lowest 25th percentile of produce a service-level base rate.’’ Prior injury or to improve the functioning of all rural populations arrayed by to the changes made in the CY 2011 a malformed body member, and section population density. For this purpose, physician fee schedule final rule, this 1862(a)(6) of the Act, which (except for rural areas included Goldsmith areas (a was the first sentence under certain specified exceptions) precludes type of rural census tract). § 414.610(c)(l)(i). We did not intend to payment for personal comfort items. Sections 3105(c) and 10311(c) of the delete this language in making the CY Section 1834(a) of the Act, as added Affordable Care Act amended section 2011 formatting changes. Therefore, in by section 4062 of the Omnibus Budget 1834(l)(12)(A) of the Act to extend this the CY 2012 ESRD PPS proposed rule Reconciliation Act of 1987 (OBRA 87), rural bonus for an additional year (76 FR 40536), we proposed to revise Public Law 100–203, sets forth the through December 31, 2010. In the CY § 414.610(c)(1) to reinstate this sentence payment rules for most DME furnished 2011 physician fee schedule final rule which was inadvertently deleted in the on or after January 1, 1989. Historically, (75 FR 73385 through 73386 and 73625), CY 2011 physician fee schedule final the Medicare payment amount for a we revised § 414.610(c)(5)(ii) to conform rule. DME item is generally equal to 80

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percent of the lesser of the actual charge processing contractor’s individual normally be rented’’ and excludes items or the fee schedule amount for the item, consideration and judgment of a that are ‘‘of an expendable nature.’’ The less any unmet Part B deductible. The reasonable payment amount for each instructions do not specify exactly how beneficiary coinsurance for such items item. Payment for oxygen equipment set long an item must last to be considered is generally equal to 20 percent of the forth at § 414.226 is made on a monthly a durable item that would normally be lesser of the actual charge or the fee basis for up to 36 months of continuous rented as opposed to a disposable item schedule amount for the item once the use. The supplier retains ownership of or an item that would not normally be deductible is met. The fee schedule the oxygen equipment following the 36- rented. amounts are generally calculated using month cap, but must continue to furnish CMS has provided program average allowed charges from a base the equipment for the remainder of the instructions for coverage of supplies and period and then updated by annual equipment’s 5-year RUL, at which point accessories at Section 110.3 in Chapter update factors. Sections 1834(a)(2) the beneficiary can elect to obtain new 15 of the Medicare Benefit Policy through (a)(7) of the Act set forth six equipment. Payment for capped rental Manual. The instructions provide that separate classes of DME and separate items set forth at § 414.229(f) is made on payment may be made for supplies that payment rules for each class. The six a monthly rental basis for up to 13 are necessary for the effective use of classes of items are: inexpensive and months of continuous use. The supplier DME, such as lancets used to draw other routinely purchased DME; items must transfer title to the equipment to blood for use with a home blood glucose requiring frequent and substantial the beneficiary on the first day monitor. The lancet itself is disposable servicing; customized items; oxygen and following the 13th month of continuous and would not be covered as DME, but oxygen equipment; other covered items use. it is a covered item that falls under the (other than DME); and capped rental In establishing regulations for the general DME benefit because it is items. For DME in general, § 414.210(f) purpose of implementing the payment necessary for the effective use of DME— specifies that payment can be made for rules mandated by OBRA 87, 42 CFR the home blood glucose monitor. replacement of DME that is lost, stolen, 414.202 sets forth the basic definition of Supplies necessary for the effective use irreparably damaged, or has been in DME that was originally established and of DME also include oxygen and those continuous use for the equipment’s elaborated upon in program instructions drugs and biologicals which must be reasonable useful lifetime (RUL). In discussed below. Section 414.202 inserted directly into the equipment for general, the RUL for DME is established defines DME as equipment furnished by the effective use of DME. as 5 years. Computation of the RUL is a supplier or a home health agency The Healthcare Common Procedure that— Coding System (HCPCS) is a based on when the equipment is • delivered to the beneficiary, not the age Can withstand repeated use; standardized coding system used to • Is primarily and customarily used of the equipment. The 5-year standard is process claims submitted to Medicare, to serve a medical purpose; set forth in section 1834(a)(7)(C)(iii) of Medicaid, and other health insurance • Generally is not useful to an programs by providers, physicians, and the Act for capped rental DME, but was individual in the absence of an illness applied to all DME through the other suppliers. The HCPCS Code Set is or injury; and divided into two principal subsystems, regulations. The RUL is used to • Is appropriate for use in the home. referred to as level I and level II of the determine how often it is reasonable to The benefit for DME as it was initially pay for replacement of DME under the HCPCS: defined at section 1861(s)(6) of the Act Level I of the HCPCS codes is program and is not specifically set forth was a benefit for ‘‘rental of durable comprised of Current Procedural as a minimum lifetime standard. medical equipment.’’ The owner of Terminology (CPT) codes, which are Therefore, we are using our discretion to rented equipment is paid for the use of copyrighted by the American Medical establish a rule regarding how long the equipment. When the equipment is Association (AMA), and are used equipment must withstand repeated use no longer needed, it is returned to the primarily to identify medical services to be considered DME. owner and can then be rented by and procedures furnished by physicians Payment for inexpensive or routinely another customer. Items that are and other healthcare professionals that purchased DME is made on a purchase disposable cannot be rented and items are billed to public or private health or rental basis, with total payments that last for short periods of time are not insurance programs. being limited to the purchase fee likely to be items that would be rented. Level II of HCPCS is a standardized schedule amount for the item. The The Act was amended by section 16 of coding system used primarily to identify regulation at 42 CFR 414.220 provides the Medicare-Medicaid Anti-Fraud and products and supplies that are not that inexpensive DME have an average Abuse Amendments of 1977 (Pub. L. included in the CPT codes, such as purchase price of $150 or less and 95–142) to allow for purchase of DME DME, orthotics, prosthetics, and routinely purchased DME are items that in cases where purchase is less costly or supplies when used outside a have historically been acquired on a more practical than rental. In 1978, physician’s office. Assignment of a purchase basis 75 percent of the time or program instructions were added to the HCPCS code is not a coverage more. Accessories used with DME are Medicare Part B Carriers Manual determination and does not imply that also included in the inexpensive or (HCFA–Pub. 14–3, Rev. 3–669) to any payer will cover the items in the routinely purchased DME class. further define DME and durability of an code category. In October 2003, the Payment is generally made on a item, that is, when an item is considered Secretary delegated authority under the monthly rental basis with no cap on the durable. The instructions are now Health Insurance and Portability Act of number of rental payments made for included in section 110.1 of chapter 15 1996 to CMS to maintain and distribute items such as ventilators that require of the Medicare Benefit Policy Manual HCPCS Level II codes. frequent and substantial servicing. (CMS–Pub. 100–02). In specifying Payment for items meeting the which items satisfy the durability B. Current Issues definition of customized DME set forth criteria, these program instructions The regulation and program at § 414.224 is made on a lump sum provide that ‘‘an item is considered instructions do not lend guidance purchase basis in an amount established durable if it can withstand repeated use, regarding the specific period of time based on the Medicare claims that is, the type of item which could that equipment must function in order

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to be considered ‘‘durable.’’ In addition, anticipating how their products would Income and Accounts estimates.19 the regulation does not provide specific be treated under coding classification Furthermore, economics dictionaries,20 guidance or criteria regarding how to and benefit category determinations. various encyclopedias,21 and economics determine if new devices consisting of textbooks 22 define durable goods as C. Overview of the Provisions of the a system of durable and non durable Proposed Durable Medical Equipment goods that are expected to last longer components that together serve a (DME) Regulation than 3 years. medical purpose fall within the DME In addition, information gathered benefit category. Therefore, we believe it On July 8, 2011, we published in the from various sources such as is necessary to revise the regulation at Federal Register a proposed rule Rehabilitative Engineering and Assistive this time to include a definition of DME entitled, ‘‘Medicare Program; Changes to Technology Society of North America that uses more specific language to the End-Stage Renal Disease Prospective (RESNA),23 product catalogs, product define the term ‘‘durable’’ for the Payment System for CY 2012, End-Stage warranty documents, and consumer purpose of determining whether Renal Disease Quality Incentive product reviews indicate that Program for PY 2013 and PY 2014; equipment is DME. The issue of linking conventional DME items such as Ambulance Fee Schedule; and Durable durability to the lifetime of equipment wheelchairs, hospital beds, and Medical Equipment’’ (76 FR 40498). In and where to draw the line has come to ventilators specified in section 1861(n) that rule, we proposed revising the our attention in light of the recent of the Act typically have a useful life of definition of DME by adding a 3-year technology and engineering in the field 3 or more years before they need to be MLR that must be met by an item or of medical devices and equipment. replaced or need major repairs. device in order to be considered durable Establishing a minimum lifetime Therefore, we proposed establishing a 3- for the purpose of classifying the item requirement (MLR) would help facilitate year MLR for items to meet the under the Medicare benefit category for the benefit category determination durability criterion for DME. DME. process for items that clearly last longer The 3-year MLR was proposed to or shorter than the minimum lifetime D. Summary of the Proposed Provisions increase the clarity of the current threshold. and Responses to Comments on the definition and give regulatory weight to In cases where it is not clear that the Definition of Durable Medical a reasonable benchmark for a minimum equipment can function for the Equipment (DME) 3-Year Minimum period of durability or repeated use that specified minimum period of time, we Lifetime Requirement (MLR) an item would be expected to meet in proposed that reviewing additional We received approximately 35 order for the equipment to be information and evidence consistent comments on our proposal. Interested considered DME. In addition, the rule with the present benefit category parties that submitted comments was proposed to provide clear guidance determination process would be included several medical device and to CMS and other stakeholders for necessary to determine the expected life equipment manufacturers, a healthcare making consistent informal benefit of the equipment. CMS and CMS provider, RESNA (Rehabilitation category determinations and national contractors would base the decision on Assistive Technology Standards Board) coverage determinations for DME. It was various sources of information and national organizations for HCPCS also proposed to assist manufacturers in including but not limited to the HCPCS coding, disability, medical technology designing and developing new medical request form, pre-market clearance innovators and beneficiaries. In this equipment to have a better documents from the Food and Drug final rule we provide a summary of each understanding of how long an item must Administration (FDA), product warranty proposed provision, a summary of the be able to withstand repeated use in documents, product Web site, product public comments received, and our order to be considered DME for marketing materials, product user responses to them. Medicare purposes. It is important to guides, product operating manuals, We proposed making changes to the note that the 3-year MLR does not consumer product reviews, subject definition of DME at 42 CFR 414.202 in replace the RUL standard established by matter expert reviews, industry product order to clarify the meaning of the term section 1834(a)(7)(C) of the Act for standards data, and product data created ‘‘durable’’ in order to reflect our current payment purposes. The RUL rules are as a result of clinical studies or interpretation of the statutory provisions used to determine how often payment standardized test results. A minimum discussed above consistent with the can be made for replacement items and lifetime standard for DME may also help DME payment provisions. Specifically, is not a MLR for DME. Although the facilitate the HCPCS process. The we proposed establishing a 3-year MLR proposed 3-year MLR is a requirement current application form used to request that equipment will be expected to meet for determining whether an item will be new HCPCS codes for items includes in order to be considered DME. Based considered durable, it is not an the question regarding whether upon the statute and current indication of the typical or average equipment is durable and, if so, regulations, equipment would not lifespan of DME, which in many cases instructs the applicant to provide an qualify as DME if it could not withstand may last for much longer than 3 years. explanation of how the item can repeated use. Although the capacity for withstand repeated use. We have reuse is in itself a fundamental 19 The NIPA Handbook (Concepts and Methods of received requests from several entities characteristic of durability, it is not the U.S National Income and Product Accounts, including DME stakeholders for clear how many months or years an item Chapter 5–Personal Care Expenditures. The handbook is available at http://www.bea.gov/ additional clarification regarding the must withstand repeated use in order to national/pdf/NIPAhandbookch5.pdf. durability standard for DME. Comments be considered durable. 20 The McGraw Hill Dictionary of Modern from some of these entities indicate that The Merriam Webster dictionary Economics by Douglas Greenwald & Associates, there is limited direction on what is defines ‘‘durable’’ as the ability to exist Economics dictionary by Donald Moffat, Dictionary required for an item to be considered for a long time without significant of Business and Economics by Christine Ammer deterioration. The United States and Dean Ammer. ‘‘durable’’ in the current regulation. 21 Encyclopedia of Business, Britannica Additional clarification of the term Department of Commerce uses a Encyclopedia and Gale Encyclopedia. ‘‘durable’’ would be helpful to industry durability standard of 3 years for 22 A Lexicon of Economics by Kenyon A. Knopf. stakeholders such as manufacturers in consumer durable goods for National 23 http://resna.org/.

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1. Application of the 3-Year MLR to through rule making rather than repeated use for at least 3 years. As we Items Currently Covered as DME and to providing this clarification through discussed in our equipment Supplies and Accessories of Covered Manual provisions and program replacement payment rule, we expect DME instructions to provide an opportunity that equipment furnished by suppliers We proposed that the 3-year MLR be for input given that the definition of will function for a reasonable period of prospective only and not apply to DME is set forth in regulations. time. See 71 FR 65884, 65920 (Nov. 9, Comment: Several commenters stated equipment classified as DME before the 2006). We believe that a 3-year MLR that the proposed 3-year MLR was proposed rule is implemented. Based on would provide sufficient flexibility to arbitrary and inappropriate. our experience with the program, we cover new technology items that could Response: We disagree. As discussed be considered durable, but that may not believe that most items that are previously, the 3-year MLR for last for 5 years before having to be currently classified as DME function for durability reflects the standard used by replaced. As noted previously, the 3 or more years. We also proposed not various Federal agencies to define Congress, in drafting section to apply the standard to supplies and durable consumer goods such as cars, 4152(c)(2)(F) of the Omnibus Budget accessories used with DME that are paid refrigerators, air conditioning units, as Reconciliation Act of 1990 (Pub. L. 101– for under the DME benefit or blood well as hospital beds, walkers, crutches, 508), selected 5 years as the default RUL glucose monitors and blood testing scooters, wheelchairs, oxygen for capped rental DME. The RUL was strips to allow for continued coverage of equipment, etc. Federal agencies such as specified to be 5 years for each capped such items, supplies and accessories the Department of Commerce and the rental DME item unless prior experience that are necessary for the effective use Department of Labor have been applying in making payment for the item resulted of DME. In the proposed rule we also this standard to durable goods including in the establishment of an alternative solicited public comments on methods DME. Furthermore, the 3-year durability RUL for the item. As part of the interim for determining when multi-component standard is widely supported in the final rule (57 FR 57675) implementing devices are durable. We requested industry. See for example, Simon this provision on December 7, 1992, we comments only and did not propose any Kuznet’s ‘‘National Income and Capital extended the RUL provision to other regulation changes regarding this issue. Formation’’ published by the National items of DME and specified that, in the The comments received on this issue Bureau of Economic Research (1937), absence of program instructions, the will be taken into consideration in defining durable commodities as those carrier may determine that the RUL of determining whether changes on this whose period of utilization is more than equipment is greater than, but not less issue should be proposed in future 3 years, and references in a wide variety than, 5 years. See 57 FR 57675, 57686 rulemaking. of more recent literature, textbooks, (Dec. 7, 1992). Furthermore, such Comment: Several commenters dictionaries and encyclopedias, which standards are consistent with the DME acknowledged that it is necessary to specifically reference a 3-year period of payment methodology, mandated by establish a MLR for use in determining time in defining or classifying items as Section 4062(b) of the Omnibus Budget if medical equipment is durable for durable.24 We see no reason why a Reconciliation Act of 1987, Public Law purposes of Medicare payment. different standard for durability should 100–203, and section 5101(b) of the Response: We agree and thank the be used for the equipment covered as Deficit Reduction Act of 2005, Public commenters for their support and DME under the Medicare program. Law 109–171, which authorized the feedback that it is necessary to establish Therefore, we believe it is reasonable for changes in the payment for oxygen a MLR for use in determining if medical the Department of Health and Human equipment and mandated a cap on equipment is durable. Services to apply this 3-year standard to payments for all rented equipment other Comment: Several commenters argued DME. than a few frequently serviced items that the proposed rule is unnecessary Additionally, in light of the statutory such as ventilators. The following are and the current criteria for determining 5-year RUL requirement and the DME some examples of changes in payment whether equipment is durable are clear, payment rules, which support the fact rules that were made to avoid excessive with one commenter stating that that equipment paid for under the DME payments for durable items needed and Medicare payment rules and benefit is intended to be used over many used by patients for extended periods of manufacturer warranties already years, we believe that it is reasonable to time lasting for several years. provide beneficiaries with appropriate require that such equipment be • The rental payments for protection. Two commenters suggested functional or capable of withstanding inexpensive equipment such as canes that CMS should publish a MLR for and crutches that the beneficiary elects DME through subregulatory guidance. 24 The NIPA Handbook (Concepts and Methods of to rent rather than purchase is capped Response: We appreciate the the U.S National Income and Product Accounts, at the purchase fee for the equipment. comments; however, we believe there is Chapter 5—Personal Care Expenditures,The • The payment for oxygen equipment handbook is available at http://www.bea.gov/ a need to make changes to the definition national/pdf/NIPAhandbookch5.pdf, U.S. is currently capped at 3 years and of DME at 42 CFR 414.202 to clarify the Department of Labor/Bureau of Labor Statistics. suppliers are mandated to continue meaning of the term ‘‘durable’’ to reflect http://www.bls.gov/ppi/ppiwholesale.htm, The furnishing the equipment after the cap our current interpretation of the statute, McGraw Hill Dictionary of Modern Economics by for up to 2 additional years. Douglas Greenwald & Associates, Economics • consistent with the DME payment rules dictionary by Donald Moffat, Dictionary of Business Title to other expensive equipment previously discussed. Manufacturers of and Economics by Christine Ammer and Dean such as wheelchairs and hospital beds new technology medical devices have Ammer, Encyclopedia of Business, Britannica is transferred to the beneficiary after 13 specifically asked how long an item Encyclopedia and Gale Encyclopedia, Lexicon of continuous rental payments. Economics by Kenyon A. Knopf, Fiscal Policy and must withstand repeated use in order to Business Cycles by Alvin H. Hansen, Economics: The 5-year RUL and payment rules be considered durable equipment, and Principles in Action by Steven M. Sheffrin, apply to durable equipment that can be therefore our objective is to establish a Durability of Output and Expected Stock Returns by used for many years. See 71 FR at clear expected MLR for equipment in Joao F. Gomes, Leonid Kogan, & Motohiro Yogo, 65920, (regarding the expectation that Economics Fluctuations and Forecasting by Vincent order to facilitate consistent benefit Su, Macroeconomics by Roger A. Arnold, and suppliers furnish a quality item that will category determinations. We also National Income and Capital Formation by Simon last over a 5-year period). CMS wanted to publish the 3-year MLR Kuznet. continues to expect that in light of these

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RUL provisions, equipment covered establish an expected 3-year threshold based on our experience in making under the DME benefit should be standard consistent with these benefit category determinations and capable of withstanding repeated use for requirements and other Federal agencies analyzing the types of equipment that a minimum time period. Consistent and industry standards. In addition, are covered under the DME benefit over with these standards, we believe that a while we understand that exact periods the years, the majority of the categories 3-year durability threshold is of longevity will vary, the purpose of of DME items already last for 3 years or reasonable, especially given our history the rule is to establish a MLR in order longer. As noted earlier, we already with the program and the vast majority for the equipment to be considered expect items will function consistent of categories of DME that already last for durable for purposes of Medicare with the 5-year RUL and DME payment at least a 3-year period. payment determinations. The 3-year rules. For all the reasons discussed, we Comment: One commenter suggested MLR is intended to be a minimum believe that it is appropriate to apply that CMS should refrain from adding a threshold that equipment will be the 3-year MLR as a threshold for 3-year MLR and instead define what is expected to meet in order to be defining durability for equipment under meant by repeated use. considered durable under Medicare the program. Response: We appreciate the regulations We expect that equipment Comment: One commenter comment; however, we believe it is furnished under the benefit will be recommended that CMS create a necessary to establish a reasonable quality items that will function rebuttable presumption that a DME item expectation regarding durability by consistent with industry standards for a should last for 3 years but provide that adding a 3-year MLR to the definition of 3 year threshold period. a manufacturer can rebut that DME. Manufacturers of new technology Furthermore, a vast majority of the presumption with convincing evidence medical devices have specifically asked categories of DME last for 3 years or that the 3-year MLR should not be how long an item must withstand longer. Therefore, consistent with these applied automatically in a particular repeated use in order to be considered RUL and payment provisions, we instance. durable equipment, and therefore we believe that a 3-year MLR would Response: We disagree with the believe it is necessary to establish a continue to provide the flexibility to commenter’s recommendation for clear expected MLR for equipment in cover new technology items. creating a rebuttable presumption that a order to assure payment for quality We also appreciate the comment that DME item should last for 3 years. As items of DME, and facilitate consistent engineering a device for a guaranteed stated earlier, manufacturers of new benefit category and national coverage lifetime is virtually impossible; technology medical devices have determinations. however, given the industry standards, specifically asked how long an item Comment: One commenter suggested we expect that equipment should must withstand repeated use in order to establishing 6 months as the MLR for function for a minimum threshold be considered durable equipment, and DME. period of time. Based on our experience therefore our objective is to establish an Response: We appreciate the in making benefit category expected MLR for equipment in order to comment, however, as discussed earlier, determinations and analyzing the types assure payment for quality items and 3 years is a standard used by Federal of equipment that are covered under the facilitate consistent benefit category and agencies and the industry for classifying DME benefit over the years; we believe national coverage determinations. The durable goods, which include that the 3-year MLR is a reasonable issue of linking durability to the lifetime equipment typically covered under the threshold standard for the types of of equipment and where to draw the DME benefit. Therefore, we believe that equipment paid for under the DME line has come to our attention in light adopting a standard of 3 years for benefit. Therefore, we believe that for of the recent technology and purposes of the Medicare program purposes of Medicare payment, it is engineering in the field of medical would be reasonable and assure reasonable to establish a threshold of 3 devices and equipment. We are payment for equipment consistent with years which is consistent with other establishing a MLR for DME to clarify industry standards. Furthermore, as Federal agencies and industry our expectation regarding durability. An noted previously, in light of the standards. option to rebut the 3-year MLR in some statutory 5-year RUL requirement we do Comment: Two commenters suggested instances would undermine this not believe it is reasonable to establish that the MLR should be based upon a objective. a 6-month standard. As discussed specific code set, natural therapeutic Comment: Several commenters earlier, consistent with the statute, the requirements, and normal length of recommended that CMS collaborate payment rules support the fact that needs and medical necessity as dictated with industry stakeholders to develop equipment included in the DME benefit by the prescriber, rather than a additional requirements related to is intended to be used over many years. universally applied standard. determining durability of items. For all the reasons stated above, we do Response: We thank the commenters Response: We appreciate the not believe that a 6-month MLR for DME for their input that the MLR should be comment. The current processes is a reasonable option. based upon a specific code set, natural including Benefit Category Comment: Several commenters added therapeutic requirements, and normal Determination (BCD), National Coverage that using a universal 3-year MLR for all length of needs and medical necessity as Determination (NCD), Local Coverage types of products is inflexible and dictated by the prescriber, rather than a Determinations (LCD), and Healthcare nonfeasible. One commentator indicated universally applied standard. However, Common Procedure Coding System that engineering a device for a we have established a standard (HCPCS) include meetings with guaranteed lifetime is virtually applicable to the Medicare benefit that manufacturers in addition to the public impossible. is designed to be consistent with criteria where we seek input from the Response: We do not believe that established in the statute and payment stakeholders. We will continue to establishing an expected 3-year MLR is provisions. We have interpreted the receive input from stakeholders inflexible and nonfeasible. As noted benefit consistent with the standards in consistent with the BCD and NCD earlier, the regulations already provide the statute, Medicare payment process when determining whether an a requirement for repeated use and a 5- regulations, industry standards, and item is durable. See 68 FR 55634, year RUL standard. We proposed to Federal agency standards. Furthermore, (September 26, 2003); and http://www.

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cms.gov/DeterminationProcess/ http://www.cms.gov/Med previously, the 5-year RUL is well Downloads/FR09262003.pdf. HCPCSGenInfo/Downloads/2013_ established since 1992 and we have not See also, information on the HCPCS HCPCS_Application.pdf and http:// found that the RUL standard has stifled Level II coding process at: http://www. www.cms.gov/MedHCPCSGenInfo/08_ innovation or prevented entry of new cms.gov/MedHCPCSGenInfo/ HCPCSPublicMeetings.asp#TopOfPage. devices in the market. Therefore, in Downloads/2013_HCPCS_Application. Furthermore, the 3-year MLR will be light of these provisions, we believe that pdf. http://www.cms.gov/ prospective and will not be applied on 3 years is a reasonable threshold MedHCPCSGenInfo/08_ a retroactive basis; it will be used for consistent with Medicare payment HCPCSPublicMeetings.asp#TopOfPage. making benefit category decisions for rules, industry standards and Federal Comment: Several commenters stated new items. As noted previously, we agency standards. However, while we that the rule would create burdensome believe that a vast majority of the expect that equipment will meet our 3 testing requirements to verify the 3-year categories of DME already last for at year standard, we will continue to MLR for a device. One commenter least 3 years, consistent with the RUL monitor the issue and undertake stated that testing standards cannot and payment provisions. The 3-year additional rulemaking if necessary. validate the lifetime of a device and it MLR is designed to be a minimum Comment: One commenter requested is unclear how a manufacturer would threshold for determining if an item is clarification on the applicability and prove an item meets the 3-year MLR. considered durable and we expect that scope of the rule. Some commenters One commenter noted that added new DME products in general will requested clarification on how the MLR testing for durability will increase the continue to meet or exceed this MLR. would be applied to new generations of cost for manufacturers in addition to For reasons discussed above, we have products that are currently classified as designing new 3-year versions of DME no reason to believe that the 3-year MLR DME or how the standard would apply products that currently function for a will increase the cost for manufacturers. to an existing DME item that is modified shorter period of time. Comment: One commenter supported in the future to improve functionality. Response: We did not intend to create the grandfathering provision. One commenter recommended that the burdensome testing requirements. As Response: We thank the commenter new rule not apply if an existing DME noted previously, our objective is to for the input and support. item is just upgraded. Some commenters establish a reasonable minimum lifetime Comment: Several commenters voiced questioned if the rule would be standard for DME for purposes of concerns that the new requirement will applicable to only products that apply Medicare payment, consistent with stifle innovation and prevent the entry for a new HCPCS code. Some other Federal agencies and industry of new devices in the market. Several practice. As stated in the proposed commenters stated that the commenters questioned if the new rule regulation, in cases where it is not clear grandfathering provision would create would apply to items that are billed that the equipment can function for the disparities among manufacturers and be using existing HCPCS codes or any item specified minimum period of time, we disadvantageous to new product that fits into an existing product will review information and evidence manufacturers and advantageous to category or existing HCPCS codes and consistent with the current benefit existing DME product manufacturers. how miscellaneous codes would be category determination process to Some commenters stated that applying handled. determine the expected life of the the rule prospectively and not applying Response: We will apply the revised equipment. As discussed previously, the the rule to items currently classified as definition for DME on a prospective benefit category determination process DME makes the rule unclear and basis. That is, we will not redetermine typically involves reviewing nontransparent. for payment as DME any product that is information from various sources Response: We did not intend to create currently paid under the DME benefit. including but not limited to information disparities. As noted in the proposed The revised definition would only apply related to Food and Drug regulation and a response to an earlier to new products. To the extent that a Administration (FDA) pre-market comment, we are making changes to the modified product is not a new product clearance, product manuals, operating definition of DME to reflect our current (including an item that has been guides, warranty documents, and interpretation of the statute consistent upgraded), the 3-year MLR will not be standardized test results. The NCD with the RUL and general DME payment applicable. We will consider issuing process is available at http:// provisions. The 3-year MLR is designed additional guidance to provide further www.cms.gov/DeterminationProcess/ to be applied on a prospective basis and clarification if necessary. Downloads/FR09262003.pdf. See also, would represent a minimum threshold Comment: One commenter questioned 68 FR 55638 (September 23, 2003). for determinations regarding equipment how CMS would validate that a device Additionally, we routinely collect durability. As noted earlier, in light of lasts fewer than 3 years. One commenter information regarding durability of new the statutory 5-year RUL requirement requested clarification on whether the products as part of the HCPCS editorial and DME payment rules which support MLR would be calculated from the date process in order to identify categories of the fact that DME items should be able the manufacturer sells the item to the new DME subject to the procedures to withstand repeated use for many provider or date first provided to the established in accordance with the years; we believe that it is reasonable to patient. mandate of section 531(b) of the require that equipment be capable of Response: We are not proposing a Medicare, Medicaid and SCHIP Benefit withstanding repeated use consistent new process and as noted previously, Improvement and Protection Act of with the industry 3 year standard. We we will continue to follow the current 2000 (BIPA 2000), Public Law 106–554. believe that a 3-year MLR would benefit category determination process Based on our experience with the provide the flexibility to cover new to determine whether a product meets program, this information has been technology items that can be considered the standards for DME set forth in the readily available from the manufacturers durable, but may not last for 5 years rule. As noted earlier, the expected life of these items and other entities before having to be replaced. of an item will be estimated based upon submitting requests for changes to the We also believe that the 3-year MLR information gathered from various HCPCS. Information on the HCPCS is reasonable given the general payment sources consistent with the current Level II coding process is available at: and RUL requirements. As discussed benefit category determination process

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and will be calculated based upon use, with regard to these types of systems at the component that performs the not when it is sold to a supplier. this point, we solicited public medically necessary function of the Comment: One commenter voiced comments on this topic. Specifically, we device. concern that there would be no process solicited public comments on various We requested comments only and did for appealing decisions that items are ways we might consider applying the 3- not propose any regulation changes. not durable. year MLR to multi-component devices Therefore, the comments received will Response: A manufacturer or supplier consisting of both durable and non- be taken into consideration for future can request a reconsideration of an durable components. Various options proposed rulemaking. informal BCD determination or a might include the following: V. Interim Final Rule Regarding the reconsideration of a formal NCD 1. Apply the 3-year MLR to the Competitive Acquisition Program for consistent with the statute. See (68FR component(s) that performs the entire Certain Durable Medical Equipment, 55638, September 26, 2003) available at: medically necessary function of the Prosthetics, Orthotics and Supplies http://www.cms.gov/ device. DeterminationProcess/Downloads/ 2. Apply the 3-year MLR to the (DMEPOS) FR09262003.pdf. component(s) that performs a vital part A. Background Comment: One commenter stated that of the medically necessary function of the current testing standards for certain the device. 1. Legislative and Regulatory History of types of equipment that are currently 3. Consider a device/system to be the DMEPOS Competitive Bidding classified as DME require a much durable only if the cost of the durable Program shorter lifespan than 3 years. component(s) over a period of time (for Section 1847 of the Act, as amended Response: We appreciate the example, 5 years) makes up greater than by section 302(b)(1) of the Medicare comment; however, as stated 50 percent of the overall cost of the Prescription Drug, Improvement, and previously, the 3-year MLR would not device/system over the same period. Modernization Act of 2003 (MMA)(Pub. apply to any items currently classified In the proposed rule we solicited L. 108–173), requires the Secretary to as DME. In addition, the 3-year MLR public comments on the application of establish and implement a Medicare would not apply to blood testing strips, various options to multi-component DMEPOS Competitive Acquisition accessories and supplies used with DME devices to determine whether the device Program (‘‘competitive bidding that are necessary for the effective use is durable. We received approximately program’’ or ‘‘program’’). Under the of the DME item. For example: A blood 20 comments pertaining to the topic of competitive bidding program, Medicare glucose monitor and lancets used to applying the 3-year MLR to multi- sets payment amounts for selected obtain blood samples for use in a blood component devices consisting of both DMEPOS items and services furnished glucose monitor are covered under the durable and non-durable components. to beneficiaries in competitive bidding DME benefit. The blood glucose monitor One commenter disagreed with option areas (CBAs) based on bids submitted by is covered as DME and the lancets are one because this option requires that the qualified suppliers and accepted by covered as supplies necessary for the whole device meet the MLR as many Medicare. For competitively bid items, effective use of the DME item. devices will not be able to function the payment amounts, referred to as After reviewing all the comments, we without even minor elements, such as ‘‘single payment amounts’’, replace the are finalizing the regulation to revise the accessories and supplies. This fee schedule payment methodology set definition of durable medical equipment commenter noted that for the option forth in section 1834 of the Social at § 414.202 by adding a 3-year MLR two, it is not clear what is meant by Security Act (the Act) and 42 CFR part that must be met by an item or device ‘‘performs a vital part of the medically 414, Subpart D of our regulations. in order to be considered durable for the necessary function.’’ This commenter The competitive bidding program purpose of classifying the item under further stated that for option three it is guarantees savings to both the Medicare the Medicare benefit category for DME. unclear what is meant by ‘‘cost.’’ The program and beneficiaries under the This will be effective with respect to commenter noted that option 3 could be program. The program also includes items classified as DME after January 1, considered if the Medicare provisions to ensure beneficiary access 2012. reimbursement rate for the durable and to quality DMEPOS items and services. non-durable components is used as the Section 1847 of the Act limits 2. Application of the 3-Year MLR to ‘‘cost’’ for calculating the ratio of the participation in the program to Multi-Component Devices cost for durable and non-durable suppliers who have met applicable In some cases, a device may be a components. One commenter supported quality and financial standards and system consisting of durable and non- the 3-year MLR and endorsed option 2 requires the Secretary to maintain durable components that together serve which applies the 3-year MLR to the beneficiary access to multiple suppliers. a medical purpose. Currently, a multi- component(s) that performs a vital part On May 1, 2006, we issued a component device consisting of durable of the medically necessary function for proposed rule (72 FR 25654) in the and non-durable components is multi-component devices. Federal Register that would implement considered non-durable if the Several commenters endorsed the the competitive bidding program for component that performs the medically coverage of a specific multi-component certain DMEPOS items and services and necessary function of the device is non- device for Medicare beneficiaries. One solicited public comment on our durable, even if other components that commenter stated that medical proposals. On April 10, 2007, we issued are part of the device are durable. equipment comprised of durable and a final rule (72 FR 17992) in the Federal Therefore, if the proposed regulation to non-durable components should be Register addressing the comments on establish a minimum 3-year MLR for considered durable if any one the proposed rule and establishing the DME is applied to these devices, the component of the equipment is able to regulatory framework for the Medicare component(s) of a multi-component meet the MLR as determined in the DMEPOS competitive bidding program device that performs the medically HCPCS application process and CMS in accordance with section 1847 of the necessary function of the device would should evaluate the medically necessary Act. need to meet the 3-year MLR. Although, function performed by the device in its Consistent with the requirements of we did not propose to change our policy totality rather than basing durability on section 1847 of the Act and the

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competitive bidding regulations, we subcontracting relationships they have standard process for updating fee began implementing the program by entered into for the purpose of schedule amounts. conducting the first Round of furnishing items and services under the On February 10, 2009, we published competition in 2007 in 10 of the largest competitive bidding program. Contract a notice (74 FR 6557) in the Federal metropolitan statistical areas (MSAs) for suppliers must also inform CMS Register proposing to delay the effective 10 product categories and implemented whether each subcontractor meets the date of the interim final rule by 60 days the competitive bidding program on July accreditation requirement set forth in to allow Department officials the 1, 2008. section 1834(a)(20)(F)(i) of the Act, if opportunity for further review of the issues of law and policy raised by the 2. The MIPPA and the Medicare applicable to the subcontractor. Section 154(d) of the MIPPA excludes interim final rule. On February 19, 2009, DMEPOS Competitive Bidding Program from the competitive bidding program we published another notice (74 FR On July 15, 2008, section 154 of the certain DME furnished by a hospital to 7653) in the Federal Register that Medicare Improvements for Patients and the hospital’s patients during an implemented the temporary delay Providers Act (MIPPA) amended section admission or on the date of discharge. proposed on February 10, 2009. As 1847 of the Act to make certain limited On January 16, 2009, we published in specified by the February 19, 2009 changes to the Medicare DMEPOS the Federal Register (74 FR 2873) an notice, the interim final rule became competitive bidding program. Section interim final rule with comment period effective on April 18, 2009. 154(a) of the MIPPA delayed to incorporate into regulations at 42 CFR competition under the program and 414 Subpart F the MIPPA provisions B. Overview of the Interim Final Rule terminated the competitive bidding discussed above. On January 16, 2009, we published in contracts effective June 30, 2008. In addition to the changes the Federal Register an interim final The MIPPA required the Secretary to implemented through the interim final rule (74 FR 2873 through 2881) entitled conduct a second competition for rule, section 154 of the MIPPA made ‘‘Changes to the Competitive Round 1 in 2009 (‘‘Round 1 rebid’’) that other changes to the competitive Acquisition of Certain Durable Medical included the ‘‘same items and services’’ bidding program which included: Equipment, Prosthetics, Orthotics and in the ‘‘same areas’’ as the 2007 Round • Exclusions of certain areas in Supplies (DMEPOS) by Certain 1 competition, with certain limited subsequent rounds that are not already Provisions of the Medicare exceptions. Specifically, the Round 1 selected under Rounds 1 and 2; Improvements for Patients and rebid excluded negative pressure wound • Extension of the Program Advisory Providers Act of 2008 (MIPPA)’’. In the therapy (NPWT) items and services and and Oversight Committee; interim final rule, we revised current excluded Puerto Rico. In addition, • Exemption for Off-the-Shelf provisions at 42 CFR part 414, Subpart section 154(a) of the MIPPA Orthotics from Competitive Bidding F, to incorporate certain self- permanently excluded group 3 complex when provided by Certain Providers; implementing MIPPA provisions. The rehabilitative wheelchairs from the and interim final rule addressed the • competitive bidding program by Evaluation of certain Healthcare following changes made by the MIPPA: amending the definition of ‘‘items and Common Procedure Coding System General Changes to the DMEPOS services’’ in section 1847(a)(2) of the (HCPCS) codes. Competitive Bidding Program: Act. Suppliers, including suppliers that These provisions have been addressed • Temporary Delay of the Medicare previously were awarded a competitive through subsequent rulemaking or DMEPOS Competitive Bidding Program. bidding contract, had to resubmit bids subregulatory guidance, as appropriate. • Supplier Feedback on Missing to be considered for a contract under the For additional information about Covered Documents. Round 1 rebid. exclusions of certain areas in • Disclosure of Subcontractors and Section 154(a) of the MIPPA also subsequent rounds that are not already their Accreditation Status under the delayed competition for Round 2 of the selected under Rounds 1 and 2 and the Competitive Bidding Program. competitive bidding program from 2009 exemption for off-the-shelf orthotics • Exemption from Competitive to 2011 and subsequent competition from competitive bidding when Bidding for Certain DMEPOS. under the program from 2009 until after provided by certain providers, please • Exclusion of Group 3 Complex 2011. A competition for a national mail refer to the November 29, 2010, Federal Rehabilitative Wheelchairs. order competitive bidding program may Register (75 FR 73574). Round 1 Changes of the Competitive occur after 2010 as a result of the The following administrative Bidding Program: MIPPA. requirements were also not addressed in • Rebidding of the ‘‘same areas’’ as The MIPPA mandated certain changes the interim final rule: the previous Round 1, unless otherwise to the bidding process, starting with the • A post-award audit by the Office of specified. Round 1 rebid. Section 154(a) of the Inspector General; • Rebidding of the ‘‘same items and MIPPA added a new paragraph (F) to • Establishment of a Competitive services’’ as the previous Round 1, section 1847(a)(1) of the Act, which sets Acquisition Ombudsman; and unless otherwise specified. forth a process for supplier feedback on • A Government Accountability missing financial documents. Pursuant Office report on the results of the C. Summary of the Interim Final Rule to this requirement, we notify suppliers competitive bidding program. Provisions and Response to Comments that submit their bids within a specific The MIPPA mandated a nationwide on Changes to the Competitive time period if their bid submission is 9.5 percent reduction in the fee Acquisition of Certain Durable Medical missing any of the required financial schedule payment amounts for all items Equipment, Prosthetics, Orthotics and documents. We allow suppliers to and services that were competitively bid Supplies (DMEPOS) by Certain submit missing financial documents during the prior round of competition Provisions of the Medicare within 10 business days after this regardless of any exclusion such as Improvements for Patients and notice. group 3 complex rehabilitative Providers Act of 2008 (MIPPA) Section 154(b) of the MIPPA amended wheelchairs. This provision was not The interim final rule was published section 1847(b)(3) of the Act to require addressed in the interim final rule in the Federal Register on January 16, contract suppliers to notify us of because it was administered through the 2009 with a comment period that ended

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on March 17, 2009. We received competition for the Round 1 rebid to After consideration of the public approximately 793 timely pieces of occur in 2009; therefore, we could not comments received, we are finalizing comments from the interim final rule. delay the program further. We note that this provision without modification. Various parties submitted comments we made numerous process b. Supplier Feedback on Missing including DMEPOS manufacturers, improvements to the competitive Covered Documents suppliers, national associations bidding program for the Round 1 rebid. representing the supplier community, For example, we implemented an Section 1847(b)(2)(A) of the Act and pharmacies. upgraded on-line bid submission prohibits the Secretary from awarding a We note that we received many system, early bidder education, and contract under the program to a supplier comments on a wide range of issues that increased oversight of bidders that are unless the supplier meets applicable were not addressed in the interim final new to product categories or financial standards specified by the rule. We thank commenters for sharing competitive bidding areas to ensure they Secretary, taking into account the needs their views on these issues; however, meet our requirements. These of small providers. We have because these comments were outside improvements, combined with the implemented this requirement at the scope of the interim final rule, we MIPPA reforms discussed in this final § 414.414(d) of the competitive bidding do not address those comments in this rule, resulted in a smoother experience regulations, which requires suppliers to final rule. In this final rule we provide for bidders and contributed to the submit, as part of their bids, financial a summary of each proposed provision, successful implementation of the Round documents specified in the request for a summary of the public comments 1 rebid contracts and prices on January bids (RFB). received, our responses to them, and 1, 2011. The RFB issued for the Round 1 rebid any changes to the interim final rule we Consistent with our expectations, the required suppliers to submit the same are implementing in this final rule as a Round 1 rebid results so far have been categories of financial documents as we result of comments received. very positive. The program is fulfilling requested for the previous Round 1 its promise as an effective tool to help competition. In the previous round of 1. General Changes to the DMEPOS Medicare set appropriate payment rates competition, we required suppliers to Competitive Bidding Program for DMEPOS items and services: submit financial documents from the a. Temporary Delay of the Medicare payment amounts from the supplier most recent 3 years. As stated in 42 CFR DMEPOS Competitive Bidding Program competition for the Round 1 rebid of the 414.414(d), the required financial Section 154(a) of the MIPPA amended program resulted in average savings of documents have been specified in the section 1847(a)(1) of the Act to delay 35 percent as compared to the current RFB. Based on experience from the competition under Rounds 1 and 2 of fee schedule prices. The program is previous round of competition, we the Competitive Bidding Program from expected to save more than $17 billion modified the required financial 2007 and 2009 to 2009 and 2011, in Medicare expenditures over 10 years. documents to lessen the burden on respectively. It also delayed competition In addition to this positive impact on suppliers; instead of 3 years of for a national mail order program until the Medicare Part B trust fund balance, documentation, we required only 1 year. after 2010 and competition in additional the program is expected to save We believe that we can determine areas, other than mail order, until after beneficiaries more than $11 billion over whether a supplier demonstrates 2011. the next ten years as a result of lower financial soundness by reviewing one We revised § 414.410(a)(1) and (2) to coinsurance payments and the year of documentation. indicate that competition under Round downward effect on monthly premium Section 154(a) of the MIPPA added a 1 of the competitive bidding program payments. The overall combined new paragraph (F) to section 1847(a)(1) occurred in 2009 and competition under savings to Medicare and beneficiaries is of the Act, which established a detailed Round 2 of the program would occur in therefore expected to total more than process by which we must notify 2011. In addition, we have revised $28 billion over the first ten years of the suppliers of missing ‘‘covered § 414.410(a)(3) to indicate that program. documents’’—defined by MIPPA as competition in additional MSAs will As anticipated, beneficiaries are financial, tax or other documents occur after 2011 (or, in the case of receiving quality products from contract required to be submitted by a bidder as national mail order for items and suppliers in their CBAs. 76 percent of part of an original bid submission in services, after 2010). contracts were awarded to suppliers order to meet required financial The comments we received on already furnishing contract items in the standards—if such documents are Temporary Delay of the Medicare local area. Additional contract suppliers submitted within a specified time DMEPOS Competitive Bidding Program have furnished other items in the local period. The MIPPA details the specific and our responses are set forth below. area or furnished contract items in other steps of this process and provides a Comment: Several commenters areas: fully 97 percent of contracts were timeline for each stage of this covered disagreed with starting competition for awarded to suppliers already document submission review. We have the Round 1 rebid in 2009 and wanted established in the competitive bidding implemented this provision of the CMS to delay the program further. Some area, the product category, or both. Also, MIPPA consistent with its detailed commenters suggested that CMS spend CMS exceeded the the 30 percent small requirements. more time determining the impact and supplier target. For the Round 1 rebid, Consistent with section 1847(a)(1)(F) improving the quality of the DMEPOS small suppliers, those with gross of the Act, in the case of a bid in which Competitive Bidding Program for revenues of $3.5 million or less as one or more covered documents in suppliers and beneficiaries by defined for the program, make up about connection with such a bid has been considering comments received on the 51 percent of the contract suppliers. As submitted not later than the covered interim final rule and evaluating the discussed later in this preamble, our document review date, we would notify effects from Round 1 of the competitive comprehensive monitoring program has suppliers of each covered document that bidding program before starting the shown a very smooth effective is missing from the bidder’s submission Round 1 rebid. implementation with few inquiries and as of the covered document review date. Response: Section 154(a) of the complaints and no changes in As set out in the Act the ‘‘covered MIPPA 2009 required the supplier beneficiary health status outcomes. document review date’’ is the later of—

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(1) The date that is 30 days before the • CMS to review the submitted apply to the accuracy or completeness final date specified by the Secretary for covered documents and notify bidders of individual documents. submission of bids; or (2) the date that of any missing covered documents; and After consideration of the public is 30 days after the first date specified • Suppliers to submit the missing comments received, we are finalizing by the Secretary for submission of bids. covered documents. this provision without modification. For example, if a bid window opens on We also added a definition for c. Disclosure of Subcontractors and January 1st and closes on April 30th, the ‘‘covered document’’ and ‘‘covered Their Accreditation Status Under the ‘‘covered document review date’’ would document review date’’ to § 414.402. Competitive Bidding Program be the later of: (1) March 31st (30 days Comment: Several commenters before the final date specified by the suggested that the decision to change Section 154(b)(2) of the MIPPA added Secretary); or (2) January 31st (30 days financial document requirements from 3 a new paragraph (C) to section 1847 after the first date specified by the years to 1 year should have been (b)(3) of the Act. This new paragraph requires contract suppliers to disclose Secretary). Therefore, in this case, the subjected to notice and comment information on: (1) Each subcontracting ‘‘covered document review date’’ would rulemaking. Commenters believed that arrangement the supplier has in be March 31st. Suppliers that submit this would ensure that quality suppliers furnishing items and services under the their financial documents after the are selected as contract suppliers, taking contract; and (2) whether each such covered document review date would into consideration historical subcontractor meets the accreditation not receive notice of any missing demonstrated financial stability. Some requirement of section 1834(a)(20)(F)(i) financial documents. commenters also believed that it would of the Act, if applicable to such Section 1847(a)(1)(F)(i) of the Act be easier to falsify 1 year worth of subcontractor. The contract supplier requires that we notify bidders of any financial documents as opposed to 3 must make this disclosure not later than missing covered documents within 45 years. 10 days after the date a supplier enters days after the covered document review Response: As noted in the interim into a contract with CMS. If the contract date for the Round 1 rebid. In final rule, regulations at 42 CFR supplier subsequently enters into a subsequent rounds of competition, we 414.414(d) state that required financial subcontracting relationship, the have 90 days after the covered documents will be specified in the RFB. supplier must disclose this information document review date to provide such Based on our experience from the initial to CMS no later than 10 days after notice. For all rounds of competition, Round 1 competition, we determined entering into the subcontracting bidders that are notified of the missing that one year of financial documents relationship. covered document(s) have 10 business provides sufficient information for Section 154(b) of the MIPPA added days after the date of notice to submit determining whether suppliers meet the section 1834(a)(20)(F)(i) to the Act, the missing covered document(s). If a required financial standards. In the which mandates that the Secretary supplier submits the missing covered interest of lessoning the burden on require suppliers furnishing items and document(s) within this time period, we suppliers and ensuring compliance with services under a competitive bidding may not reject the supplier’s bid on the program requirements, we therefore program on or after October 1, 2009, basis that any covered document is decided to revise the financial directly or as a subcontractor for another missing or has not been submitted on a documentation requirements from three entity, to submit evidence of timely basis. years to one year. We also sought public accreditation by a CMS-designated Section 1847(a)(1)(F)(iii) of the Act comment on the RFB for the Round 1 accreditation organization. Both places certain limitations on the covered rebid through the Paperwork Reduction contract suppliers and their document review process. First, the Act (PRA) process, and the Office of subcontractors that furnish items and covered document review process Management and Budget (OMB) services under the competitive bidding applies only to the timely submission approved the RFB (OMB Control program must do so in accordance with (prior to the covered document review Number 0938–1016). the applicable supplier standards found date) of covered documents. Second, the Comment: One commenter reflected in Part 424, subpart D and other Federal process does not apply to any that, in Round 1 of the competitive regulations. determination as to the accuracy or bidding program, many bidders lost We have amended § 414.422, by completeness of the covered documents because they did not have the required revising paragraph (f) to set forth these submitted or whether such documents documents and CMS did not allow requirements for disclosing meet applicable financial requirements. suppliers to resend the documents after subcontracting arrangements. We have Third, the process does not prevent us the close of the bid window. also addressed subcontracting from rejecting a bid for reasons other Response: The MIPPA-mandated relationships and the method for than those not described in section covered document review process was disclosure of the subcontracting 1847(a)(1)(F)(i)(II) of the Act. Fourth, the incorporated into our regulations relationships in subregulatory guidance. covered document review process shall through the interim final rule addressed Comment: Some commenters stated not be construed as permitting a bidder this issue. Many Round 1 rebid bidders that subcontracting relationships should to change bidding amounts or to make took advantage of this process, and we not be allowed after contract suppliers other changes in a bid submission. believe it greatly helped these bidders have been selected. Commenters We have amended § 414.414 by ensure that they submitted all required believed that companies that did not adding paragraphs (d)(2)(i) through (iii) financial documents. win a contract would contact the to set forth the required covered Comment: One commenter suggested contract supplier and form an document review process. These that the rule needs to address not only arrangement in which the contract paragraphs identify the timeframes missing documents but missing and supplier would bill for an item established by the MIPPA for— incorrect contents in documents. furnished by a non-contract supplier. • Suppliers to submit covered Response: We appreciate this Several commenters also mentioned that documents in order to be eligible to comment; however, the statute adding subcontractors after contract receive notice of any missing covered specifically indicates that the covered suppliers have been selected could documents; document review process does not mean that the contract suppliers are not

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able to furnish items to beneficiaries in suppliers and subcontractors prior to subcontractor. One commenter did not the CBA and that they need awarding contracts. believe that disclosing the subcontractor subcontractors to provide items for the Response: Regulations at § 414.414 was a part of the MIPPA statute. contract supplier. specify that suppliers must be licensed Response: MIPPA sections 154(b)(1) Response: The MIPPA specifically and accredited to be selected for and (2) explicitly require subcontractors indicates that contract suppliers must contract award. We carefully check all to meet applicable accreditation disclose subcontracting relationships bidders during bid evaluation and reject requirements and require contract they establish after contract award; any bidders that are not fully licensed suppliers to disclose their therefore, we do not have discretion to and accredited. As specified by MIPPA, subcontracting arrangements within prohibit subcontracting after contract contract suppliers must disclose any specific time frames. We do not have the suppliers have been selected. Under the subcontractors within set time frames authority to eliminate this requirement. competitive bidding program, contract after contract award; disclosures must After consideration of the public suppliers are permitted to subcontract indicate if the subcontractors meet comments received, we are finalizing under the same rules that apply to all applicable accreditation requirements. this provision without modification. DMEPOS suppliers. Thus, the extent to We check all subcontractor disclosures d. Exemption From Competitive which contract suppliers subcontract is and verify that all applicable Bidding for Certain DMEPOS not a valid measure of contract accreditation requirements have been suppliers’ ability to furnish items. met. If we find that a contract supplier Section 414.404(b) previously We note that we have implemented a has subcontracted with an entity that exempted from competitive bidding robust monitoring program to track and does not meet applicable accreditation certain DME items when furnished by a resolve any issues that might occur with requirements, we will take appropriate physician or treating practitioner to his program implementation and have not action to ensure that the contract or her own patients as part of his or her identified any concerns about contract supplier stops using the subcontractor professional services. This exception is suppliers’ ability to furnish items. To until the subcontractor becomes limited to crutches, canes, walkers, date, the data show that Round 1 rebid properly accredited. Although MIPPA folding manual wheelchairs, blood implementation is going very smoothly does not require specific disclosure of glucose monitors, and infusion pumps with very few inquiries or complaints. subcontractors’ licensure status, that are considered DME. Section 154(d) For example, the competitive bidding contract suppliers, like all suppliers, of MIPPA amended section 1847(a) of call volume at the 1–800–MEDICARE must comply with all State regulatory the Act to exclude from the competitive call center for the first calendar quarter and licensure requirements (see bidding program these same items when they are furnished by hospitals to the of 2011was less than 0.9 percent of 1– § 424.57(c)(1)((ii)). This would include hospital’s own patients during an 800–MEDICARE’s total call volume. any State regulatory requirements admission or on the date of discharge. Most inquiries were about routine regarding applicable subcontractor We interpreted this exclusion to include matters like selecting a contract licensure. only DMEPOS paid for under Part B of supplier. Also, no changes in Comment: Many commenters wanted the Medicare program because section beneficiary health outcomes resulting CMS to clarify what is considered to be 1847 does not apply to items that are from the competitive bidding program a subcontracting relationship between paid for under Part A. As discussed in have been observed to date. The the contract supplier and a the April 10, 2007 final rule, in monitoring program includes: subcontractor with respect to • Local, on-the-ground presence in accreditation. One commenter wanted accordance with § 414.404(b)(3) each competitive bidding area through CMS to provide the industry with a payment for items furnished under the the CMS regional offices and local framework for entering into exceptions in § 414.404(b) will be made ombudsmen; subcontracts. in accordance with § 414.408(a). • A complaint process for Response: Contract suppliers may We have revised § 414.402 to include beneficiaries, caregivers, providers and subcontract to the same extent as any a definition for hospitals and have suppliers to use for reporting concerns other DMEPOS suppliers. The supplier revised § 414.404(b)(1) to incorporate about contract suppliers or other standards at § 424.57 set forth the mandated exemption from the competitive bidding implementation requirements regarding subcontracting competitive bidding program for issues; arrangements for purchase of inventory, hospitals that furnish certain types of • Contract supplier quarterly reports delivery and instruction on the use of competitively bid DME to their own identifying the brands of products they Medicare-covered items, and patients during an admission or on the furnish; maintenance and repair of rented date of discharge. In addition, we • Real-time claims analysis to equipment. The quality standards are a amended subparagraph (b)(1)(iii) to identify utilization trends, monitor helpful reference tool in distinguishing address the billing requirements for health outcomes and beneficiary access, the role of a primary supplier versus the hospitals under this exemption. address aberrancies in services, and role of a subcontractor as described in Comment: Some commenters target potential fraud and abuse; the supplier standards. We note that expressed concern that the MIPPA • A CMS Competitive Acquisition guidance about subcontracting, hospital exemption was not more Ombudsman who will respond to including guidance about accreditation expansive. Several commenters complaints and inquiries from of subcontractors, may be found on the suggested that CMS reconsider beneficiaries and suppliers about the National Supplier Clearinghouse Web including hospital-based suppliers in application of the program and will site, http://www.palmettogba.com/nsc the competitive bidding program. One issue an annual Report to Congress; and the Competitive Bidding commenter suggested that although • Secret shopping; and Implementation Contractor Web site at there is a hospital exemption, hospitals • Beneficiary surveys. http://www.dmecompetitivebid.com. may have trouble finding DME Comment: Some commenters Comment: One commenter believed equipment, such as oxygen, for recommended that CMS obtain and that the accreditation status of a snowbird beneficiaries. A few verify disclosures of both accreditation subcontractor is irrelevant to the commenters believed that quality of care and licensing status of contract contract supplier’s relationship with the and efficient operations of hospitals

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would be impacted if they were allowed Response: The statute explicitly (Texas) to furnish some items directly to their excludes Group 3 complex rehabilitative • Kansas City (Missouri and Kansas) patients while having to arrange with power wheelchairs from the competitive • Miami—Fort Lauderdale—Miami contract suppliers for furnishing other bidding program, and therefore, we do Beach (Florida) • items not covered by the exemption. not believe we have any discretion to Orlando (Florida) • Pittsburgh (Pennsylvania) One commenter suggested that a include these items in the program. • separate competitive bidding process Comment: Some commenters suggest Riverside—San Bernardino— should be established for hospital-based that Group 2 complex rehabilitative Ontario (California) DME suppliers. power wheelchairs be excluded from Section 154(a) of MIPPA mandated Response: Section 154(d) of MIPPA the competitive bidding program for that we conduct the Round 1 ‘‘rebid’’ in explicitly described the scope of the several reasons. One commenter the ‘‘same areas’’—except for Puerto hospital exemption, so we do not suggested that, if the Group 2 complex Rico—as the previous competition in believe we have discretion to provide a rehabilitative power wheelchairs are not 2007. As stated in the Federal Register broader exemption. We do not believe excluded, suppliers should be able to (72 FR 18016), we identified CBAs in that separate competitions for suppliers bid above the fee schedule amount. the 2007 Round 1 competition by that only furnish items to patients in Another commenter stated that the counties and zip codes to clearly hospitals is necessary or would result in inclusion of Group 2 complex identify the boundaries of a CBA. Therefore, we believe it is reasonable to efficient implementation of the rehabilitative power wheelchairs in the implement the ‘‘same areas’’ mandate by requirements of section 1847 of the Act. Round 1 rebid is not envisioned by the conducting the Round 1 rebid in those After consideration of the public statute; this commenter did not believe that this product category has the same zip codes. Certain zip codes comments received, we are finalizing changed since the first competition. We this provision without modification. potential for significant savings. Response: The MIPPA excludes therefore reviewed zip code changes e. Exclusion of Group 3 Complex Group 3 complex rehabilitative power made since 2007 and incorporated Rehabilitative Power Wheelchairs wheelchairs from the competitive applicable updates to the zip codes for the Round 1 rebid. For example, if a Section 1847(a)(2) of the Act defines bidding program but also mandates rebidding of the ‘‘same items and particular zip code had been split into the items and services subject to two new zip codes, we included the competitive bidding. Section services’’ as the previous Round 1. Therefore, we had no discretion to new zip codes in the CBA. We did not 1847(a)(2)(A) of the Act includes DME add any new zip codes that expanded and supplies as items and services exclude 2 complex rehabilitative power wheelchairs from the Round 1 rebid the geographic area of the CBAs. subject to competitive bidding. Section Accordingly, we have amended because these wheelchairs were 154(a) of the MIPPA amended this § 414.410(a)(1) to reflect the areas for included in the Round 1 competition. definition to exclude group 3 complex competition set forth in section After consideration of the public rehabilitative power wheelchairs (and 1847(a)(1) of the Act, as amended by the comments received, we are finalizing related accessories when furnished in MIPPA. connection with such wheelchairs) from this provision without modification. Comment: Several commenters competitive bidding. For Medicare 2. Round 1 Changes to the Competitive recommended various changes to the coding, coverage, and payment Bidding Program areas for the Round 1 rebid competition. purposes, power wheelchairs are For example, several commenters a. Rebidding of the ‘‘Same Areas’’ as the classified under several groups based on suggested that a few MSAs have rural Previous Round 1, Unless Otherwise performance and durability test results, areas and should be excluded from the Specified patient weight capacity, and equipment program to prevent patient access and handling capabilities. For a description Section 1847(a)(1)(D)(i)(II) of the Act, quality issues. Some also felt that small of the components, performance as amended by section 154(a) of the suppliers would not be able to provide requirements and coding guidelines for MIPPA, required us to conduct the items to the rural parts of the MSAs, group 3 power wheelchairs, see supplier competition for the Round 1 especially with lower reimbursements. https://www.dmepdac.com/resources/ rebid in 2009. Pursuant to section One commenter suggested that the articles/2006/08_14_06.pdf. Group 2 1847(a)(1)(D)(i)(II) of the Act, we Dallas MSA is too large and should be complex rehabilitative power conducted the competition for the split into two separate CBAs. One wheelchairs were included in Round 1 Round 1 rebid in a manner ‘‘so that it commenter recommended that CBAs rebid of the competitive bidding occurs in 2009 with respect to the same should be limited to large cities and not program because they were not items and services and the same areas’’ divided at a county level. One excluded by the MIPPA. as the first Round 1 competition, except commenter suggested that CMS choose We amended § 414.402 to revise the as provided by section different MSAs for the Round 1 rebid definition of ‘‘item’’ to exclude group 3 1847(a)(1)(D)(i)(III) and (IV) of the Act. competition because the original MSAs’ complex rehabilitative wheelchairs from Under section 1847(a)(1)(D)(i)(III), as suppliers have been affected financially the competitive bidding program. amended by the MIPPA, we excluded from Round 1 and because the suppliers Comment: One commenter agreed that Puerto Rico so that the Round 1 rebid that bid in the first round know the the exclusion was good policy because of the competitive bidding program single payment amounts that were the equipment needs to be properly occurred in 9 of the largest MSAs. selected for those areas and may cause designed or it would result in additional Therefore, the Round 1 rebid occurred bids to be skewed. costs for the government. Another in the following MSAs: Response: MIPPA explicitly required commenter believed that the exclusion • Cincinnati—Middletown (Ohio, the Round 1 rebid competition to occur should not be implemented because Kentucky and Indiana) in the same areas as in the initial Round having some power wheelchair • Cleveland—Elyria—Mentor (Ohio) 1 competition except for Puerto Rico, equipment options subject to • Charlotte—Gastonia—Concord therefore we do not have any discretion competitive bidding while others are (North Carolina and South Carolina) to change the areas for the Round 1 not would promote Medicare fraud. • Dallas—Fort Worth—Arlington rebid.

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After consideration of the public www.dmecompetitivebidcom. prior to Because there are no significant comments received, we are finalizing opening of the bid window. differences among NPWT products, the this provision without modification. Comment: Some commenters current HCPCS codes are adequate and suggested that several items should be do not need to be updated or changed. b. Rebidding of the ‘‘Same Items and excluded from competitive bidding for a The study results are available on the Services’’ as the Previous Round 1, variety of reasons. AHRQ Web site at: http:// Unless Otherwise Specified Response: The MIPPA specifically www.ahrq.gov/clinic/ta/negpresswtd/ Section 1847(a)(1)(D)(i)(II) of the Act, required us to conduct the Round 1 npwtd01.htm. as amended by the MIPPA, required that rebid competitive bidding program for After consideration of the public we conduct the Round 1 rebid the ‘‘same items and services’’ as were comments received, we are finalizing competitive bidding program with previously bid in Round 1 except this provision without modification. respect to the ‘‘same items and services’’ negative pressure wound therapy and group 3 complex rehabilitative power D. Other Public Comments Received on as were previously bid in Round 1 the January 16, 2009 Interim Final Rule except as provided in section wheelchairs, and therefore, we had no 1847(a)(1)(D)(i)(IV) of the Act, which discretion to exclude these items from We ordinarily publish a notice of excludes negative pressure wound the Round 1 rebid. proposed rulemaking in the Federal therapy. The Round 1 rebid also Comment: One commenter agreed Register to provide for public comment excludes group 3 complex rehabilitative with the statutory exclusion of negative before the provisions of a rule take effect power wheelchairs as noted previously. pressure wound therapy (NPWT) for the in accordance with section 553(b) of the Therefore, the Round 1 rebid included Round 1 rebid and suggested that it be Administrative Procedure Act (APA) the following categories of items and excluded entirely from competitive and section 1871 of the Act. This services: bidding. process may be waived, however, if an • Oxygen Supplies and Equipment. Response: Although MIPPA excluded agency finds good cause that a notice • Standard Power Wheelchairs, NPWT from the Round 1 rebid, it did and comment procedure is Scooters, and Related Accessories. not provide a permanent exclusion from impracticable, unnecessary, or contrary • Complex Rehabilitative Power the competitive bidding program. The to the public interest. We found good Wheelchairs and Related Accessories statute mandates competitive bidding cause to waive notice and comment (Group 2). for most items of DME, including NPWT rulemaking because we simply • Mail-Order Diabetic Supplies. equipment and supplies. CMS has conformed the competitive bidding • Enteral Nutrients, Equipment and decided to utilize the flexibility regulations to specific, detailed, and Supplies. provided by the statute to phase in proscriptive statutory provisions. • Continuous Positive Airway items under the program beginning with The comments we received on the Pressure (CPAP), Respiratory Assist high cost or high volume items. The waiver of proposed rulemaking and our Devices (RADs), and Related Supplies average monthly rental fee schedule responses are set forth below. and Accessories. amount for the NPWT pump is currently Comment: Several commenters • Hospital Beds and Related $1,558, meaning the beneficiary pays at believed that CMS should have engaged Accessories. least $312 per month on average for in notice and comment rulemaking to • Walkers and Related Accessories. rental of this device. By comparison, the implement MIPPA provisions rather • Support Surfaces (Group 2 average monthly fee and corresponding than issuing an interim final rule with mattresses and overlays) in Miami. coinsurance amount for a respiratory comment period for several reasons. In the April 10, 2007 Federal Register suction pump is $46 (monthly fee) and One reason was so that stakeholders (72 FR 18084), we define an item, in $9 (monthly coinsurance). A study would have sufficient time and part, as a product included in a conducted in 2009 by the Office of opportunity to give input on the competitive bidding program that is Inspector General for the Department of program. The second reason was identified by a HCPCS code. Health and Human Services found that because commenters wanted to ensure Therefore, consistent with our suppliers purchase these pumps for that comments received during the understanding of the MIPPA and the significantly less, $3,604 on average, comment period would be taken into mandate that bidding in the Round 1 than Medicare pays over 13 months, account before any final rule was rebid occur with respect to the ‘‘same currently $16,359. The savings potential published. The third reason commenters items and services’’ as the previous for the Medicare program and wanted CMS to conduct a notice and round of competition, we conducted the beneficiary for this item is therefore comment rulemaking was because competition for the Round 1 rebid for very significant. Medicare allowed commenters felt that important issues essentially the same codes for which we charges for NPWT equipment and were left unaddressed in the interim bid in 2007. We have made certain supplies were approximately $178 final rule such as how the program adjustments to reflect changes in the million in 2010, making this a high would be impacted by the changes that HCPCS codes consistent with 42 CFR volume and high cost item as well. were made by MIPPA, lessons learned 414.426. We excluded obsolete codes We note that section 154 (c) (3) of from Round 1, and supplier and and codes which, in light of the MIPPA MIPPA required the Secretary of the beneficiary concerns and suggestions amendments, are no longer separately Department of Health and Human from Round 1. Commenters felt that payable. For example, under the MIPPA, Services (DHHS) to perform an CMS should address major issues in the transfer of title provision was evaluation of the Healthcare Common notice and comment rulemaking instead deleted, thus oxygen accessories are no Procedure Coding System (HCPCS) of using of subregulatory guidance and longer separately payable because the coding decisions for NPWT devices. Web site postings. supplier maintains ownership of the CMS requested this report from The Response: As we explained in the equipment. The final list of HCPCS Technology Assessment Program (TAP) interim final rule, under the waiver of codes for the Round 1 rebid was at the Agency for Healthcare Research proposed rulemaking, we ordinarily published on the Competitive Bidding and Quality (AHRQ). AHRQ determined publish a notice of proposed rulemaking Implementation Contractor (CBIC) Web that there are no significant therapeutic to provide for public comment before site at http:// distinctions among NPWT devices. provisions of a rule take effect, but the

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process may be waived if the agency • Recommendations to minimize the is $2.61 per ESRD facility and a total of finds good cause that a notice and information collection burden on the $1,044 for all 400 facilities. These costs comment procedure is impracticable, affected public, including automated are estimated using the 2010 estimate unnecessary, or contrary to public collection techniques. for the occupational code 43–0000 interest. Because CMS issued the rule to Because we did not receive any Office and Administrative Support conform to the specific statutory comments for the ESRD PPS, we are Occupation mean hourly wage of $15.66 requirements contained in section 154 finalizing the collection of information as stated by the U.S. Bureau of Labor of the MIPPA it was impractical, section as proposed. Statistics. unnecessary, and contrary to public B. Requirements in Regulation Text C. Additional Information Collection interest to use notice and comment Requirements rulemaking to incorporate these We solicited public comment on the provisions into regulations. As issues below for the following sections This final rule imposes collection of indicated earlier in this preamble, we of this document that contain information requirements as outlined in also made process improvements to information collection requirements the regulation text and specified above. ensure compliance with the statute that (ICRs): However, this final rule also makes As discussed in section I.B.3 of this did not require notice and comment reference to several associated final rule, to receive the low-volume rulemaking before we conducted the information collections that are not adjustment, an ESRD facility would Round 1 rebid. Finally, we agree that discussed in the regulation text need to provide an attestation to their substantive issues should be addressed contained in this document. The Fiscal Intermediary or Medicare through notice and comment following is a discussion of these Administrative Contractor (FI/MAC) rulemaking consistent with the information collections, some of which that it has met the criteria to qualify as Administrative Procedure Act and note have already received OMB approval. a low-volume facility no later than that we used notice and comment November 1st of each year preceding the 1. Display of Certificates for the PY 2013 rulemaking to implement non-self- applicable low-volume adjustment and PY 2014 ESRD QIP implementing provisions of MIPPA (see payment year (except for the 2012 low- Section II.B of this rule discusses a 75 FR 73170 (November 29, 2010). volume payment year, which has an disclosure requirement for both the PY Comment: A few commenters attestation submission deadline of 2013 and the PY 2014 ESRD QIP. As disagreed with the statement in the January 3, 2012). The FI/MAC would stated earlier in this final rule, section interim final rule that MIPPA ‘‘did not verify the ESRD facility’s attestation of 1881(h)(6)(C) of the Act requires the alter fundamental requirements * * * their low-volume status for the 3- Secretary to provide certificates to used by us in * * * selecting suppliers consecutive years immediately dialysis care providers and facilities under the program’’. Some of the preceding the payment year, using the about their total performance scores commenters believed that the interim ESRD facility’s most recent final-settled under the ESRD QIP. This section also final rule is not self-implementing and or as-filed 12-month cost reports. requires each provider and facility that was not clear or understandable. The burden associated with the receives a QIP certificate to display it Response: We continue to believe as requirement is the time and effort prominently in patient areas. discussed in the interim final rule that necessary for an ESRD facility attesting To comply with this requirement, we the provisions of MIPPA included in the as a low-volume facility to develop an proposed to issue a PY 2013 and PY interim final rule were self- attestation and submit it to their FI/ 2014 ESRD QIP certificate to providers implementing. The language in these MAC. In the proposed rule, we and facilities via a generally accessible provisions was highly detailed and estimated that it would require an electronic file format. We proposed that proscriptive and did not provide administrative staff member from each each provider and facility would be options for discretionary revisions. low-volume facility 10 minutes to required to prominently display the V. Collection of Information obtain the total number of treatments in applicable ESRD QIP certificate in Requirements the cost reports necessary for eligibility patient areas. In addition, we proposed determination, develop the attestation, that each provider and facility would A. Legislative Requirement for and submit it to their FI/MAC. For this take the necessary measures to ensure Solicitation of Comments final rule, using 2010 claims our the security of the certificate in the Under the Paperwork Reduction Act contractor, UM–KECC, identified 963 patient areas. Finally, we proposed that of 1995, we are required to provide 60- ESRD facilities as providing treatments each provider/facility would be required day notice in the Federal Register and below the low-volume threshold of to have staff available to answer solicit public comment before a 4,000 treatments in 2010. Of these 963 questions about the certificate in an collection of information requirement is facilities, we estimated that 378 met the understandable manner, taking into submitted to the Office of Management additional low-volume criteria as account that some patients might have and Budget (OMB) for review and specified in § 413.232. Further, due to limited English proficiency. These approval. In order to fairly evaluate the historical trend of increase in the proposals represent no change from the whether an information collection number of small dialysis facilities, we policy finalized for the PY 2012 ESRD should be approved by OMB, section believe that several dozen additional QIP, and we are finalizing them in this 3506(c)(2)(A) of the Paperwork ESRD facilities may meet the criteria of final rule. Reduction Act of 1995 requires that we a low-volume facility prior to the CY The burden associated with the solicit comment on the following issues: 2012 payment year. To take these aforementioned requirements is the time • The need for the information facilities into account, we have rounded and effort necessary for providers and collection and its usefulness in carrying the total number of estimated low- facilities to print the applicable ESRD out the proper functions of our agency. volume facilities to 400. Therefore, for QIP certificate, display the certificate • The accuracy of our estimate of the CY 2012, we estimate that the total prominently in patient areas, ensure the information collection burden. initial ESRD facility burden would be 67 safety of the certificate, and respond to • The quality, utility, and clarity of hours. The estimated cost associated patient inquiries in reference to the the information to be collected. with compliance with this requirement certificates. We estimate that

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approximately 5,503 providers and rule that approximately 5,503 providers measure for the PY 2014 ESRD QIP. The facilities will receive an ESRD QIP and facilities will enroll in the NHSN burden associated with this requirement certificate in PY 2013 and PY 2014 and and submit the necessary data. We also is the time and effort necessary for will be required to display it. We also estimated that it would take each providers and facilities to administer estimate that it will take each provider/ provider or facility 48 hours per year to the ICH CAHPS survey and submit an facility 10 minutes per year to print, enroll in the NHSN and complete the attestation to CMS that they successfully prominently display, and secure the required training, for a total estimated administered the survey. ESRD QIP certificate, for a total annual burden of 264,144 hours [5,503 We estimate that approximately 5,503 estimated annual burden of 917 hours providers × 48 hours]. Upon further providers and facilities will administer [(10/60) hours × 5503 facilities] at a cost consultation with the CDC, we have the ICH CAHPS survey and submit an of $31, 755 [917 hours × $34.63 per now revised this estimate. We now attestation to that affect. We estimate hour]. We estimate that approximately believe that it will take each provider/ that it will take each provider or facility one-third of ESRD patients (estimated to facility approximately 8 hours to enroll 16 hours per year to be trained on the be 119,686 out of 395,058) will ask a in the NHSN and complete the required survey features. We further estimate that question about the ESRD QIP certificate. training, for a total estimated burden of it will take each provider/facility We further estimate that it will take 44,024 hours (8 hours × 5,503 facilities). approximately 5 minutes to submit the each provider/facility approximately 5 Based on the Bureau of Labor Statistics attestation each year. The estimated minutes to answer each patient question we estimate the average salary to be total annual burden on providers/ about the applicable ESRD QIP $34.63 per hour. Thus, average cost for facilities is estimated to be 88,507 hours certificate, or 1.8 hours per provider or each provider/facility will be $277.04 (8 [(5,503 providers × 16 hours) + (5,503 facility each year. The total estimated hours × $34.63 per hour). Across all providers × (5/60) hours)] which is annual burden associated with this 5,503 providers/facilities, this will equal valued at $3 million [88,507 hours × requirement is 9,905 hours [1.8 hours × approximately $1.5 million ($277.04 × $34.63 per hour], or $556.97 per 5503 providers]. The total estimated 5,503 facilities). However, we further provider/facility [$3 million/5,503 annual burden for both displaying the estimate that the number of dialysis providers]. We estimate that ESRD QIP certificates and answering events in a 3-month period will be administering the survey would take a patient questions about the certificates 125,680 for the 2014 ESRD population. third-party entity 45 minutes per patient is 10,822 hours [10,822 hours + 9,905 We estimate it will require 2 hours of (to account for variability in education hours] (for each of PY 2013 and PY staff time per month to collect and levels) and 200 surveys per year which 2014). While the total estimated annual submit data on these events and the equals 150 hours [(45/60) hours × 200 burden associated with both of these estimated burden for submitting 3 surveys] or $2,707.32 [150 hours × requirements as discussed is 10,822 months of data will be 33,018 hours (6 $17.58 per hour] per facility-year to hours, we do not believe that there will hours times 5,503 facilities). If the administer the ICH CAHPS survey for be a significant cost associated with dialysis events are distributed evenly an estimated annual burden of 825,450 these requirements because we are not across all 5,503 providers/facilities, that hours (150 hours × 5,503 providers) proposing to require providers/facilities will result in an additional 6-hour which is valued at $14.5 million to complete new forms. As discussed in burden ($218.58 (6 hours times $36.43)) ($2,637.00 × 5,503 providers). As section A.1.3 of this final rule, we for each provider/facility. Based upon discussed in section A. of this final rule, estimate that the total cost for all ESRD our updated analysis, the total estimated we estimate that the total cost for ESRD providers/facilities to comply with the annual burden for enrolling in the providers/facilities to comply with the collection of information requirements NHSN, conducting the required collection of information requirements associated with the certificate each year training, and submitting 3-consecutive associated with administering the ICH would be less than $400,000. months of data is 77,042 hours (44,024 CAHPS survey each year will be We did not receive any public + 33,018). We estimate that the total cost approximately $3,193.97 [$556.97 + comments regarding our analysis of the for all ESRD providers/facilities to $2,637.00] or $17.5 million [$3 million economic impact of the collection of comply with the collection of + $14.5 million] across all ESRD information requirement for this information requirements associated providers/facilities. proposal. with NHSN reporting requirement each We did not receive any public comments regarding the proposed 2. NHSN Reporting Requirement for the year will be less than $2.8 million (77,042 × $36.43), with the total average collection of information requirements PY 2014 ESRD QIP cost per provider/facility approximately associated with our adoption of this As stated above in section II.B.2.b.vi $508.80 ($2.8 million/5,503 facilities). measure for the PY 2014 ESRD QIP. of this final rule, we are finalizing a We did not receive any public proposal to include reporting dialysis comments regarding our proposed 4. Mineral Metabolism Reporting events to the National Healthcare Safety analysis of the economic impact of the Requirement for the 2014 ESRD QIP Network (NHSN) as a reporting measure collection of information requirements As stated above in section B.A.2 of for the PY 2014 ESRD QIP. Specifically, related to the adoption of an NHSN this final rule, we are finalizing our we are requiring providers/facilities to: reporting measure for the PY 2014 ESRD proposal to include a Mineral (1) Enroll in the NHSN and complete QIP. Metabolism reporting measure as part of required training as verified by a digital the PY 2014 ESRD QIP. The burden certificate obtained from CDC; and (2) 3. Patient Experience Survey Usage associated with this requirement is the submit at least 3-consecutive months of Requirement for the PY 2014 ESRD QIP time and effort necessary for providers dialysis event data to the NHSN. As stated above in section B.A.2. of and facilities to review their records and The burden associated with these this final rule, we are finalizing our submit an attestation to CMS that they requirements is the time and effort proposal to include a measure that had monitored on a monthly basis the necessary for providers and facilities to assesses provider/facility usage of the serum calcium and serum phosphorus enroll in the NHSN and conduct the In-Center Hemodialysis (ICH) Consumer levels of all patients each month. required training and submit 3 months Assessment of Healthcare Providers and We estimate that approximately 5,503 of data. We estimated in the proposed Systems (CAHPS) Survey as a reporting providers and facilities will submit the

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attestation. We estimate that it will take suppliers. Therefore, we approximated several policy and technical changes to each provider or facility approximately fewer than 400 winning suppliers for the CY 2011 ESRD PPS final rule. This 18 hours to review its records and the Round 1 rebid. Also, we estimated includes updates to the ESRD PPS and submit the attestation each year. The it will take each of the winning composite rate base rates, wage index estimated total annual burden on suppliers that use subcontractors on values, wage index budget-neutrality providers/facilities is estimated to be average approximately 1.5 hours to adjustment factors, outlier payment 99,054 hours [18 hours × 5,503 submit information on each policy, low-volume adjustment and providers] which is valued at $3.43 subcontracting arrangement to furnish transition budget-neutrality adjustment. million [99,054 hours × $34.63 per items and services under the contract Failure to publish this final rule would hour], or $623 per provider/facility and whether each subcontractor meets result in ESRD facilities not receiving [$3.43 million/5,503 providers]. the accreditation requirements in appropriate payments in CY 2012. We did not receive any public § 424.57, if applicable. Those that do not In addition, this rule will implement comments regarding our proposed use subcontractors will not have a a QIP for Medicare ESRD dialysis collection of information requirements reporting burden. The total estimated providers and facilities with payment associated with the adoption of a burden associated with these reductions beginning January 1, 2013. mineral metabolism reporting measure requirements is approximately 600 Under section 1881(h) of the Act, after for the PY 2014 ESRD QIP. hours (1.5 hours × 400 winning selecting measures, establishing suppliers). performance standards that apply to 5. Competitive Acquisition Program for We did not receive any comments on each of the measures, specifying a Certain Durable Medical Equipment, the information collection requirements performance period, and developing a Prosthetics, Orthotics and Supplies of the interim final rule. We sought methodology for assessing the total (DMEPOS) Collection of Information comments on these information performance of each provider and Requirements collection requirements again in the facility based on the specified We solicited public comment on the May 19, 2009 Federal Register (74 FR performance standards, the Secretary is following information collection 23415), and the Office of Management required to apply an appropriate requirements (ICRs): and Budget (OMB) approved the reduction to ESRD providers and collection (OMB Control Number 0938– facilities that do not meet or exceed the i. ICRs Regarding Round 1 Rebid 1016). established total performance score. Our We previously estimated that the vision is to continue to implement a VII. Economic Analyses burden associated with Round 1 would robust, comprehensive ESRD QIP that be 1,086,164 hours (68 hours × 15,973 A. Regulatory Impact Analysis builds on the foundation that has bids). Our estimate was that on average already been established in providing 1. Introduction it would take a supplier 68 hours to incentives to providers/facilities to complete and submit a bid and that we We examined the impacts of this final improve the quality of care they provide would receive 15,973 bids. Although we rule as required by Executive Orders to Medicare beneficiaries. expect the amount of hours to generally 12866 (September 30, 1993, Regulatory Also, this final rule will revise the remain the same (68 hours) for the Planning and Review) and Executive ambulance fee schedule regulations to Round 1 rebid, based on our Round 1 Order 13563 on Improving Regulation conform to the requirements of section experience we anticipated fewer bids. and Regulatory Review (January 18, 106 of the Medicare and Medicaid For the 2007 Round 1 of the competitive 2011). Executive Orders 12866 and Extenders Act of 2010 Public Law 111– bidding program, we received 13563 direct agencies to assess all costs 309 (MMEA). This final rule also revises approximately 6,500 bids. Therefore, the and benefits of available regulatory the definition of durable medical total estimated burden associated with alternatives and, if regulation is equipment. The revision adds a 3-year the Round 1 rebid was approximately necessary, to select regulatory MLR that must be met by an item or 442,000 hours (68 hours × 6,500). approaches that maximize net benefits device in order to be considered durable (including potential economic, for the purpose of classifying the item ii. ICRs Regarding Disclosure of environmental, public health and safety under the Medicare benefit category for Subcontracting Arrangements effects, distributive impacts, and DME. The proposed rule would not Section 414.422(f) states that equity). Executive Order 13563 impact items classified and covered as suppliers entering into a contract with emphasizes the importance of DME before the new rule takes effect or CMS must disclose information on each quantifying both costs and benefits, of supplies and accessories used with subcontracting arrangement that the reducing costs, of harmonizing rules, covered DME. Finally, this final rule supplier has to furnish items and and of promoting flexibility. This rule incorporates into regulations certain services under the contract and whether has been designated an ‘‘economically’’ self-implementing provisions of section each subcontractor meets the significant rule, under section 3(f)(1) of 154 of MIPPA that affect the DMEPOS accreditation requirements in section Executive Order 12866. Accordingly, Competitive Bidding Program. 424.57, if applicable. Section 414.422(f) the rule has been reviewed by the Office 3. Overall Impact also requires that the required of Management and Budget. We have disclosure be made no later than 10 prepared a Regulatory Impact Analysis We estimate that the final revisions to days after the date a supplier enters into that to the best of our ability presents the ESRD PPS will result in an increase a contract with CMS or 10 days after a the costs and benefits of the final rule. of approximately $240 million in supplier enters into a subcontracting We solicited comments on the payments to ESRD facilities in CY 2012. arrangement after entering into a regulatory impact analysis provided. Furthermore, as a result of contract with CMS. implementing the ESRD QIP for The burden associated with the 2. Statement of Need Medicare outpatient ESRD dialysis requirements in § 414.422(f) is the time This rule finalizes a number of providers and facilities, we estimate and effort necessary to disclose the routine updates for renal dialysis aggregate payment reductions in information to CMS. In the 2007 Round services in CY 2012, implementing the payment years 2013 and 2014 would be 1 competition, there were 329 winning second year of the transition, and makes $23.7 million and $22.1 million,

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respectively. However, given the lack of and do not change fundamental program ESRD PPS blended payment during the data for several measures, the actual requirements. transition. These rates of price growth impact of the PY 2014 ESRD QIP may are briefly outlined below, and are B. Detailed Economic Analysis vary significantly from the values described in more detail in the CY 2011 provided herein. Lastly, the aggregate 1. CY 2012 End-Stage Renal Disease ESRD PPS final rule (75 FR 49078 costs associated with the QIP collection Prospective Payment System through 49080). of information requirements described a. Effects on ESRD Facilities We used the CY 2010 amounts for the in section III.1 of this final rule (Display CY 2011 and CY 2012 amounts for of Certificates for the 2013 ESRD QIP) As explained in the proposed rule (76 Supplies and Other Services, since this are estimated to be $400,000 for all FR 40542), to understand the impact of category primarily includes the $0.50 ESRD providers/facilities in PY 2013. the changes affecting payments to administration fee for separately billable The additional estimated aggregate costs different categories of ESRD facilities, it part B drugs and this fee is not associated with the collection of is necessary to compare estimated increased; thus we used no price information requirements described in payments (that is, payments made under update. Because some ESRD facilities sections III.1. (Display of Certificates for the 100 percent ESRD PPS and those will receive blended payments during the PY 2013 and PY 2014 ESRD QIP), under the blended payment during the the transition and receive payment for III.2 (NHSN Reporting Requirement for transition) in CY 2012 to estimated ESRD drugs and biologicals based on the PY 2014 ESRD QIP), III.3 (Patient payments (that is, payments made under their average sales price plus 6 percent Experience Survey Usage Requirement the 100 percent ESRD PPS and those (ASP+6), we estimated price growth for for the PY 2014 ESRD QIP) and III.4 under the ESRD PPS blended payment these drugs and biologicals based on (Mineral Metabolism Reporting during the transition) in CY 2011. To ASP+6 percent. We updated the last Requirement for the PY 2014 ESRD QIP) estimate the impact among various available quarter of actual ASP data for in this final rule are expected to be classes of ESRD facilities, it is the top twelve drugs (the fourth quarter approximately less than $24 million for imperative that the estimates of of 2011) thru 2012 by using the all participating ESRD facilities. payments in CY 2011 and CY 2012 quarterly growth in the Producer Price contain similar inputs. Therefore, we The impact of section 106 of the Index (PPI) for Drugs, consistent with simulated payments only for those MMEA, requiring the extension of the method for addressing price growth ESRD facilities that we are able to certain add-on payments for ground in the ESRDB market basket. This calculate both current payments and ambulance services, and the extension resulted in 1.7 percent, 1.4 percent, 1.1 new payments. of certain rural area designations for percent, and 0.8 percent increase, purposes of air ambulance payment, For this final rule, we used the June respectively, for the first thru the fourth through CY 2011, is estimated to be $20 2011 update of CY 2010 National Claims quarter of 2012. Since the top twelve million (for CY 2011). History file as a basis for Medicare drugs account for over 99 percent of dialysis treatments and payments under total former separately billable Part B The fiscal impact of the proposed 3- the ESRD PPS. We updated the 2010 drug payments, we used a weighted year MLR cannot be estimated because claims to 2011 and 2012 using various average growth of the top twelve drugs, it is difficult to predict how many updates. The updates to the ESRD PPS for the remainder. Table 7 below shows different types of devices will be base rate and the base composite rate the updates used for the drugs. introduced in the market in the future portion of the blended rate during the We updated payments for laboratory that may or may not qualify as DME transition are described in section I.B of tests paid under the laboratory fee items as a result of the new rule. We this final rule. In addition, in order to schedule to 2011 and 2012 using the would expect that this final rule would prepare an impact analysis, since some statutory required update of the CPI–U have a small, if any, savings impact on providers opted to be paid the blended increase with any legislative the program. payment amount during the transition, adjustments. For this final rule, the Finally, we believe that the changes to we made various assumptions about growth from 2010 to 2011 is ¥1.8 the Medicare DMEPOS Competitive price growth for the formerly separately percent and the growth from 2010 to Bidding Program have a minimal fiscal billable drugs and laboratory tests with 2012 is ¥1.2 percent. impact because they are very limited regard to the composite portion of the BILLING CODE 4120–01–P

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Table 8 shows the impact of the compared to estimated payments to estimated CY 2012 ESRD payments ESRD facilities in CY 2011.

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BILLING CODE 4120–01–C and BSA national average changes, the c. Effects on the Medicare Program Column A of the impact table wage index, the effect of the ESRDB indicates the number of ESRD facilities We estimate that Medicare spending market basket increase minus (total Medicare program payments) for for each impact category and column B productivity adjustment, and the effect ESRD facilities in 2012 will be indicates the number of dialysis of the change in the blended payment approximately $8.2 billion. This treatments (in millions). The overall percentage from 75 percent of payments estimate is based on various price effect of the final changes to outlier based on the composite rate system and update factors discussed in section VII.B payment policy and the final changes 25 percent based on the ESRD PPS in in this final rule. In addition, we for the BSA national average described 2011, to 50/50, respectively, for 2012, estimate that there will be an increase in section I.C.10 and section .I.C.9, in fee-for-service Medicare beneficiary respectively, of this final rule, are for those facilities that opted to be paid enrollment of 4.3 percent in CY 2012. shown in column C. For CY 2012, the under the transition). We expect that impact on all facilities as a result of the overall, ESRD facilities will experience d. Effects on Medicare Beneficiaries changes to outlier payment policy and a 2.5 percent increase in estimated payments in 2012. ESRD facilities in Under the ESRD PPS, beneficiaries are the BSA national average would be a 0.3 responsible for paying 20 percent of the Puerto Rico are expected to receive a 0.3 percent increase in estimated payments. ESRD PPS payment amount or blended percent increase in their estimated The estimated impact of the changes to payment amount for patients treated in outlier payment policy and the BSA payments in CY 2012. This negligible ¥ facilities going through the ESRD PPS national average ranges from 0.1 increase is primarily due to the negative transition. As a result of the projected percent decrease to a 0.5 percent impact of the wage index. The 2.5 percent overall increase in the ESRD increase. Most ESRD facilities are remainder of ESRD facilities are PPS payment amounts in CY 2012, we anticipated to experience a positive expected to be positively impacted estimate that there will be an increase effect in their estimated CY 2012 ranging from an increase of 1.7 percent in beneficiary co-insurance payments of payments as a result of the outlier to 3.6 percent in their 2012 estimated 2.5 percent in CY 2012, which translates policy and BSA national average payments. to approximately $50 million. changes being finalized. Column D shows the effect of the b. Effects on Other Providers e. Alternatives Considered wage index on ESRD facilities and Under the ESRD PPS, ESRD facilities As we explained in the proposed rule reflects the CY 2012 wage index values are paid directly for the renal dialysis (76 FR 40544), we considered for the composite rate portion of the bundle and other provider types such as eliminating all laboratory tests from the blended payment during the transition laboratories, DME suppliers, and outlier policy, but instead we proposed and the ESRD PPS payments. Facilities to eliminate only the Automated Multi- pharmacies, may no longer bill located in the census region of Puerto Channel Chemistry (AMCC) panel tests. Medicare directly for renal dialysis Rico and the Virgin Islands would We indicated that we believed this receive a 2.4 percent decrease in services. Rather, effective January, 1, approach would continue to recognize estimated payments in CY 2012. Since 2011, such other providers can only expensive laboratory tests in the outlier most of the facilities in this category are furnish renal dialysis services under policy while reducing the burden located in Puerto Rico, the decrease is arrangements with ESRD facilities and associated with the 50 percent rule. We primarily due to the reduction in the must seek payment from ESRD facilities also considered alternatives for applying wage index floor (which only affects rather than Medicare. Under the ESRD the wage index budget-neutrality facilities in Puerto Rico in CY 2012). PPS, Medicare pays ESRD facilities one adjustment factor under the ESRD PPS Renal dialysis facilities outside of payment for renal dialysis services, for purposes of the full ESRD PPS Puerto Rico would experience changes which may have been separately paid to payments and ESRD PPS portion of the in estimated payments ranging from a suppliers by Medicare prior to the blended payment during the transition, 0.4 percent decrease to a 0.9 percent implementation of the ESRD PPS. such as applying the wage index budget- increase due to the update of the wage Therefore, in CY 2012, the second year neutrality adjustment factor to the ESRD index. of the ESRD PPS, we estimate that the PPS wage index values. We chose to Column E reflects the overall impact ESRD PPS will have zero impact on apply the wage index budget-neutrality (that is the effects of the outlier policy these other providers. adjustment factor to the ESRD PPS base

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rate and ESRD PPS portions of the begin on January 1, 2014 for services its inclusion in the PY 2014 program. transition blended payment to be furnished on or after January 1, 2014 for Third, our estimate now uses data from consistent with how these adjustments the PY 2014 ESRD QIP. the Fistula First Breakthrough Initiative are applied in other Medicare payment As a result, based on the ESRD QIP to approximate provider/facility systems. Finally, we considered outlined in this final rule, we estimate performance on the Vascular Access retaining the current BSA adjustment that approximately 19 percent or 1,014 Type (VAT) measure proposed for the under the composite rate potion of the of total ESRD dialysis providers/ 2014 QIP. The 2014 QIP will use data blended payment amount. facilities would likely receive a payment from Medicare claims based on HCPCS modifier V-codes that indicate fistula or 2. End-Stage Renal Disease Quality reduction for PY 2013. In PY 2014, we catheter use. Because sufficient Incentive Program estimate that approximately 30.3 percent or 1,665 of total ESRD facilities historical data are not yet available from a. Effects of the PY 2013 and PY 2014 would likely receive some type of Medicare claims for the fistula and ESRD QIP payment reduction. We note that these catheter rates that will be used to This final rule is intended to mitigate estimates differ significantly from the calculate the VAT, historical data possible reductions in the quality of estimates that were included in the regarding fistula and catheter use were ESRD dialysis facility services provided proposed rule. We believe that the obtained from the Fistula First to beneficiaries as a result of payment difference in our PY 2013 estimates is Breakthrough Initiative dataset for use changes under the ESRD PPS by attributable to two changes. First, we in this impact analysis. For more implementing an ESRD QIP that would determined that our previous estimates information on the Fistula First Dataset, reduce ESRD payments by up to 2 for PY 2013 had mistakenly included please see http://www.fistulafirst.org.. percent to dialysis providers/facilities the Hemoglobin Less Than 10 g/dL Lastly, our estimates incorporate the that fail to meet or exceed a Total measure, which resulted in lower changes to the proposed payment Performance Score with respect to provider/facility scores and greater reduction methodology that have been performance standards established by payment reductions. Second, we are finalized in this final rule. the Secretary with respect to certain now able to update our PY 2013 The ESRD QIP impact assessment specified measures. estimates using newly available data, assumes an initial count of 5,596 The methodology that we are such that we are now using 2009 data dialysis providers/facilities with paid finalizing to determine a provider/ as the baseline period and 2010 data as Medicare dialysis claims in 2010. The facility’s Total Performance Score is the performance period. We believe that PPS analysis, presented earlier, described in section IV.A.3 the difference in our PY 2014 estimates excludes 93 facilities for PPS-specific (Methodology for Calculating the Total is attributable to four changes that were reasons thereby narrowing the final Performance Score for the PY 2013 made to how we calculated the estimate. analytic sample to 5,503. The most ESRD QIP) and section IV.A.2.e First, as previously mentioned, we are common reason for exclusion was that (Methodology for Calculating the Total now able to update our estimates using facilities closed during 2010. As a Performance Score for the PY 2014 newly available data, such that we are result, Table 9 shows the overall ESRD QIP) of this final rule. Any now using 2009 data as the baseline estimated distribution of payment reductions in ESRD payment would period and 2010 data as the reductions resulting from the PY 2013 begin on January 1, 2013 for services performance period. Second, our ESRD QIP. Table 10 shows the overall furnished on or after January 1, 2013 for estimates no longer include estimated distribution of payment the PY 2013 ESRD QIP and any performance on the proposed SHR reductions resulting from the PY 2014 reductions in ESRD payment would measures, because we are not finalizing ESRD QIP.

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To estimate the total payment percent payment reduction level creates in sections III.1. (Display of Certificates reductions in PY 2013 and PY 2014 for a more gradual payment reduction scale, for the PY 2013 and PY 2014 ESRD each provider/facility resulting from and therefore benefits providers by QIP), III.2 (NHSN Reporting this final rule, we multiplied the total lessening the reduction impacts that Requirement for the PY 2014 ESRD Medicare payments to the facility in would have been received under the QIP), III.3 (Patient Experience Survey 2010 by the provider’s/facility’s original proposed scale. Usage Reporting Requirement for the PY estimated payment reduction percentage For PY 2013, totaling all of the 2014 ESRD QIP) and III.4 (Mineral expected under the ESRD QIP, yielding payment reductions for each of the Metabolism Reporting Requirement for a total payment reduction amount for 1,014 providers/facilities expected to the PY 2014 ESRD QIP) of this final rule each provider/facility: (Total ESRD receive a reduction leads to a total would be less than $25 million for all payment in 2010 × estimated payment payment reduction of approximately ESRD providers/facilities. reduction percentage). $23.7 million. Further, we estimate that As a result, we estimate that ESRD The PY 2014 payment reduction the total costs associated with the providers/facilities will experience an levels will include the 0.5 percent collection of information requirements aggregate impact of $24.1 million for PY payment reduction level as an described in section III.1, of this final 2013 and $47.1 million for PY 2014. additional level within the payment rule (Display of Certificates for the PY Table 11 below shows the estimated reduction scale. We are finalizing new 2013 ESRD QIP) would be less than impact of the finalized ESRD QIP measures, a new scoring methodology, $400,000 for all ESRD providers/ payment reductions to all ESRD and rigorous performance standards facilities in PY 2013. facilities for PY 2013. The table details which are not familiar to the For PY 2014, totaling all of the the distribution of ESRD providers/ community. We believe that including payment reductions for each of the facilities by facility size (both among this additional payment reduction level 1,665 facilities expected to receive a facilities considered to be small entities will allow time for providers/facilities reduction leads to a total payment and by number of treatments per to become familiar with this new reduction of approximately $22.1 facility), geography (both urban/rural structure and for CMS to acquire million. Further, we estimate that the and by region), and by facility type additional data on the impact of these total costs associated with the collection (hospital based/freestanding facilities). changes. The inclusion of the 0.5 of information requirements described BILLING CODE 4120–01–P

25 PY 2014 QIP Scores estimated using the 65 percent measures, as well as data from the Fistula First initiative as a proxy for the VAT Hemoglobin > 12 g/dl and Urea Reduction Ratio ≥ measure.

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We note that for the PY 2014 ESRD the Hemoglobin Greater Than 12g/dL Fistula First data, the actual impact of QIP we lack performance data on the measure and the Dialysis Adequacy the PY 2014 ESRD QIP may vary Vascular Access Type measure to Measure (URR). significantly from the values provided conduct an analysis at this time. We Using these conditions, we calculated here. conducted a simulation using the latest estimated national achievement Using the above assumptions, Table available performance data on the threshold and benchmark values for the 12 below shows the estimated impact of Hemoglobin Greater Than 12 g/dL Hemoglobin Greater Than 12 g/dL, URR the ESRD QIP payment reductions to all measure, and the Dialysis Adequacy Hemodilaysis Adequacy, and VAT ESRD facilities for PY 2014. The table (URR) measure and fistula and catheter measures using all facilities present in details the distribution of ESRD rates based on Fistula First data to the data set. Equal weighting was providers/facilities by facility size (both estimate the impact of this final rule as applied in calculating Total among facilities considered to be small accurately as possible. These simulated Performance Scores. Facilities were entities and by number of treatments per analyses were performed using 2010 required to have data on at least one of facility), geography (both urban/rural claims data as the performance year and the measures. Given the lack of data for and by region), and by facility type 2009 claims data as the baseline year for the reporting measures, and the use of (hospital based/freestanding facilities).

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BILLING CODE 4120–01–C 1881(h) of the Act, after selecting a new scoring approach for the PY 2014 b. Alternatives Considered for the PY measures, establishing performance ESRD QIP, we aimed to design a scoring 2013 and PY 2014 ESRD QIP standards that apply to each of the methodology that was straightforward measures, specifying a performance and transparent to providers/facilities, In developing the final PY 2013 ESRD period, and developing a methodology patients, and other stakeholders. During QIP, we carefully considered the size of for assessing the total performance of the public comment period, we received the incentive to providers and facilities each provider and facility based on the comments on the Total Performance to provide high-quality care. We also specified performance standards, the Score as proposed, and in light of those selected the measures adopted for the PY 2013 ESRD QIP because these Secretary is required to apply an concerns, we have adjusted how we set measures are important indicators of appropriate reduction to ESRD the minimum Total Performance Score. patient outcomes and quality of care. providers and facilities that do not meet Rather than set the minimum Total For example, inadequate dialysis can or exceed the established Total Performance Score as the score a lead to avoidable hospitalizations, Performance Score. In developing the provider/facility would receive if it had decreased quality of life, and death. final ESRD QIP, we carefully considered met the performance standards for each Thus, we believe the measures selected the size of the incentive to providers finalized measure, we will define the will allow CMS to continue focusing on and facilities to provide high-quality minimum Total Performance Score as improving the quality of care that care. We also considered finalizing all of the score a provider/facility would Medicare beneficiaries receive from the measures proposed for the PY 2014 receive if it had met the performance ESRD dialysis providers and facilities. ESRD QIP because these measures are standards for each of the finalized Additionally, for PY 2013 we important indicators of patient clinical measures. In recognition of considered whether to leave the outcomes and quality of care. Poor commenter concerns regarding the Hemoglobin Measure Less Than 10g/dL management of anemia and inadequate proposed reporting measures, and our in the program. Ultimately we decided dialysis, for example, can lead to lack of data on which to approximate that the clinical evidence shows that avoidable hospitalizations, decreased likely provider/facility performance, we this measure is not conducive to quality of life, and death. Infections are will exclude these measures from the improving the patient quality of care for also a leading cause of death and calculation of the minimum Total which the ESRD QIP strives. The ESA hospitalization among hemodialysis Performance Score. We believe this labeling approved by the FDA on June patients, but there are proven infection policy balances our desire to 24, 2011 states that no trial has control methods that have been shown appropriately incentivize improvements identified a hemoglobin target level that effective in reducing morbidity and to clinical quality of care while ensuring does not increase risks, and that ‘‘in mortality. However, after considering that providers/facilities are not unduly controlled trials, patients experienced public comments, we decided not to penalized. greater risks for death, serious adverse finalize all the measures we proposed. Furthermore, although we believe that cardiovascular reactions, and stroke While we intend to adopt additional the ESRD QIP should provide a means when administered ESAs to target a measures in future payment years, we for patients to evaluate their providers/ hemoglobin level of greater than believe that the measures finalized will facilities over time, we do not believe 11 g/dL.’’ We decided to retire the allow us to continue focusing on that PY 2014 will be comparable to Hemoglobin Less Than 10g/dL measure improving the quality of care that previous years of the ESRD QIP because from the program and are finalizing that Medicare beneficiaries receive from of the significant changes to the scoring proposal in this final rule. ESRD dialysis providers and facilities. methodology and measures. We believe This final rule implements an ESRD In finalizing the scoring methodology the 100 point scale will accommodate QIP for Medicare ESRD dialysis for the PY 2014 ESRD QIP, we the growing number of measures that providers and facilities with payment considered a number of alternatives, may be adopted in future years of the reductions beginning January 1, 2013 including continuing to use the existing ESRD QIP and plan to consistently use and January 1, 2014. Under section scoring model. In proposing to move to the 100 point scale going forward.

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Additionally, we believe that all 2014, we believe this is appropriate MMEA section 106(a) and (b), the scoring methodologies for Medicare given that providers/facilities will be number and level of services that might Value-Based Purchasing programs adjusting to a dramatically different occur during CY 2011 in rural and should be aligned as appropriate given program with new measures. urban areas generally is unknown at this their specific statutory requirements, time. While many elements may factor 3. Ambulance Fee Schedule and that the changes made to the into the final impact of section 106 of proposed methodology in this final rule Section 106 of the Medicare and the MMEA, our Office of the Actuary are in keeping with this approach. Medicaid Extenders Act of 2010 (OACT) estimates the impact of this The comments we received on this (MMEA) section to be $20 million for CY 2011. analysis and our responses are set forth As discussed in section III of this final 4. Durable Medical Equipment (DME) below. rule, section 106 of the MMEA requires Comment: One commenter asked and Supplies the extension of certain add-on CMS to explain why rural and urban The fiscal impact of the final 3-year payments for ground ambulance facilities will be affected differently by MLR for DME will be minimal because services, and the extension of certain the PY 2013 and PY 2014 ESRD QIP. we believe that this standard is rural area designations for purposes of This commenter specifically asked why consistent with our current those providers/facilities not receiving air ambulance payment, through CY interpretation of the payment and scores because of, for example, 2011. As further discussed in section III repeated use provisions for DME. It is inadequate data varied from PY 2013 to of this final rule, we are amending the difficult to predict how many different PY 2014. This commenter urged CMS to Medicare program regulations to types of new devices will be introduced change its methodology to encompass as conform the regulations to this section in the market in the future that may or many facilities as possible in the ESRD of the MMEA. This MMEA section is may not meet the 3-year MLR. However, QIP. This commenter also requested the essentially prescriptive and does not even absent the final rule, it is likely CMS explain why more payment allow for discretionary alternatives on that new products which do not meet reductions will likely result from PY the part of the Secretary. the 3-year MLR will not qualify as DME 2014. As discussed in the July 1, 2004 based upon our current interpretation of Response: The estimates of the impact interim final rule (69 FR 40288), in the criteria for DME. It is possible that for both PY 2013 and PY 2014 of the determining the super-rural bonus with the clarification of the 3-year MLR, proposed rule we developed were amount under section 1834(l)(12) of the we will limit what can be covered as created by modeling how providers/ Act, we followed the statutory guidance DME compared to what we would have facilities would have scored on the of using the data from the Comptroller covered as DME absent this regulatory ESRD QIP using data from 2008 and General (GAO) of the U.S. We obtained clarification. To the extent the 2009. While these estimates did show a the same data that were used in the regulatory change is binding to some slight difference in the average payment GAO’s September 2003 Report titled, new products, there may be reduced reduction between urban and rural ‘‘Ambulance Services: Medicare program cost. Also, the final revised facilities for PY 2013 and PY 2014, we Payments Can Be Better Targeted to regulation does not apply to items that believe that these differences are Trips in Less Densely Populated Rural were classified as DME before the relatively minor. While these estimates Areas’’ (GAO report number GAO–03– effective date of the amended have changed since we used more 986) and used the same general regulation, which tends to lessen the recent data (2009 and 2010) and methodology in a regression analysis as overall impact to the program. In adjusted the model to account for was used in that report. The result was general, we expect that this final will changes to the program in this final rule, that the average cost per trip in the have a small, if any, savings impact on we still believe that the differences will lowest quartile of rural county the program. We are finalizing the rule be relatively minor. We expect all populations was 22.6 percent higher with no modifications. facilities to provide quality care, than the average cost per trip in the 5. The Competitive Acquisition Program particularly in the important areas of highest quartile. As required by section for Certain Durable Medical Equipment, anemia management and dialysis 1834(l)(12) of the Act, this percent adequacy, regardless of size or increase is applied to the base rate for Prosthetics, Orthotics and Supplies geographic location. We will continue to ground ambulance transports that (DMEPOS) monitor and evaluate the impact of the originate in qualified rural areas, which As discussed in section V of this final ESRD QIP on access to and quality to were identified using the methodology rule, section 154 of MIPPA amended care and the quality of care received by set forth in the statute. Payments for section 1847 of the Act to make limited Medicare ESRD beneficiaries, including ambulance services under Medicare are changes to the Medicare DMEPOS indicators of facility financial health, to determined by the point of pick-up (by Competitive Bidding Program. These identify any disruptions or to make zip code area) where the beneficiary is changes were incorporated into future improvements in the program. In loaded on board the ambulance. regulations through an interim final rule light of our finalized proposal that every We determined that ground with comment period published in the provider/facility will receive a Total ambulance transports originating in Federal Register on January 16, 2009 Performance Score as long as at least 7,842 zip code areas (which were (74 FR 2873). The interim final rule one measure applies to it, we believe determined to be in ‘‘qualified rural merely incorporated limited statutory that nearly all providers/facilities will areas’’) out of 42,879 zip code areas, changes to the Medicare DMEPOS be included in the ESRD QIP. Lastly, we according to the July 2010 zip code file, Competitive Bidding Program and did do not believe that payment reductions will realize increased base rate not change the fundamental will be significantly greater in PY 2014. payments under section 106(c) of the requirements of the program. As seen from the estimates above, we MMEA for CY 2011; however, the Specifically, this final rule cites the new believe that payment reductions will be number and level of services that might timeframes for competition under the $23.7 million for PY 2013 and $22.1 occur in these areas for CY 2011 is program. In addition, the rule million for PY 2014. To the extent that unknown at this time. Similarly, for implements the MIPPA provisions that this number decreases somewhat in PY purposes of assessing the impact of mandated limited changes that affected

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competition under the program services. These changes are not www.whitehouse.gov/omb/ including a process for providing economically significant. Furthermore, circulars_a004_a-4), in Table 13 below, feedback to suppliers regarding missing because the regulation simply codifies we have prepared an accounting financial documentation, requiring the MIPPA provisions, we do not have statement showing the classification of contractors to disclose to CMS the authority to consider alternatives. the transfers and costs associated with information regarding subcontracting C. Accounting Statement the various provisions of this final rule. relationships, and exempting from BILLING CODE 4120–01–P As required by OMB Circular A–4 competitive bidding certain items and (available at http://

BILLING CODE 4120–C entities include small businesses, Individuals and States are not included VIII. Regulatory Flexibility Act nonprofit organizations, and small in the definitions of a small entity and Analysis governmental jurisdictions. 17 percent of dialysis facilities are Approximately 20 percent of ESRD nonprofit organizations. For more The Regulatory Flexibility Act dialysis facilities are considered small information on SBA’s size standards, (September 19, 1980, Pub. L. 96– entities according to the Small Business see the Small Business Administration’s 354)(RFA) requires agencies to analyze options for regulatory relief of small Administration’s size standards, which Web site at http://sba.gov/idc/groups/ classifies small businesses as those public/documents/sba_homepage/ entities, if a rule has a significant impact _ _ on a substantial number of small dialysis facilities having total revenues serv sstd tablepdf.pdf (Kidney Dialysis entities. For purposes of the RFA, small of less than $34.5 million in any 1 year.

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Centers are listed as 621492 with a size payment reduction (ranging from 0.5 analysis must conform to the provisions standard of $34.5 million). percent up to 2.0 of total payments), as of section 604 of the RFA. For purposes The claims data used to estimate presented in Table 11 above. We of section 1102(b) of the Act, we define payments to ESRD facilities in this RFA anticipate the payment reductions to a small rural hospital as a hospital that and RIA do not identify which dialysis average approximately $22,934 per is located outside of a metropolitan facilities are part of a large dialysis facility, with an average of $23,807 per statistical area and has fewer than 100 organization (LDO), regional chain, or small entity. Using our projections of beds. We do not believe this final rule other type of ownership. Each provider/facility performance, we then will have a significant impact on individual dialysis facility has its own estimated the impact of anticipated operations of a substantial number of provider number and bills Medicare payment reductions on ESRD small small rural hospitals because most using this number. Therefore, in entities, by comparing the total payment dialysis facilities are freestanding. previous RFAs and RIAs presented in reductions for the 385 small entities While there are 178 rural hospital-based proposed and final rules that updated expected to receive a payment dialysis facilities, we do not know how the basic case-mix adjusted composite reduction, with the aggregate ESRD many of them are based at hospitals payment system, we considered each payments to all small entities. For the with fewer than 100 beds. However, ESRD to be a small entity for purposes entire group of 1,054 ESRD small entity overall, the 178 rural hospital-based of the RFA. However, we conducted a facilities, a decrease of 0.57 percent in dialysis facilities will experience an special analysis for this final rule that aggregate ESRD payments is observed. estimated 2.3 percent increase in enabled us to identify the ESRD Furthermore, based on the finalized payments. As a result, this final rule is facilities that are part of an LDO or QIP payment reduction impacts to ESRD estimated to not have a significant regional chain and therefore, were able facilities for PY 2014, we estimate that impact on small rural hospitals. to identify individual ESRD facilities, of the 737 ESRD entity facilities Therefore, the Secretary has determined regardless of ownership, that would be expected to receive a payment that this proposed rule will not have a considered small entities. reduction, 132 small entities are significant impact on the operations of We do not believe ESRD facilities are expected to experience a payment a substantial number of small rural operated by small government entities reduction (ranging from 1.0 percent up hospitals. such as counties or towns with to 2.0 of total payments), as presented populations 50,000 or less and in Table 11 above. We anticipate the IX. Unfunded Mandates Reform Act therefore, they are not enumerated or payment reductions to average Analysis included in this estimated RFA. approximately $18,820 per facility, with Section 202 of the Unfunded Individuals and States are not included an average of $20,436 per small entity Mandates Reform Act of 1995 (UMRA) in the definition of a small entity. facility. Using our projections of (Pub. L. 104–4) also requires that For purposes of the RFA, we estimate provider/facility performance, we then agencies assess anticipated costs and that approximately 20 percent of ESRD estimated the impact of anticipated benefits before issuing any rule whose facilities are small entities as that term payment reductions on small entities, mandates require spending in any 1 year is used in the RFA (which includes by comparing the total payment $100 million in 1995 dollars, updated small businesses, nonprofit reductions for the 132 small entities annually for inflation. In 2011, that organizations, and small governmental expected to receive a payment threshold is approximately $136 jurisdictions). This amount is based on reduction, with the aggregate ESRD million. This final rule does not include the number of ESRD facilities shown in payments to all small entities. For the any mandates that would impose the ownership category in the impact entire group of 1,054 small entity spending costs on State, local, or Tribal Table 12. Using the definitions in this facilities, a decrease of 0.16 percent in governments in the aggregate, or by the ownership category, we consider the aggregate ESRD payments is observed. private sector, of $136 million. 663 facilities that are independent and Therefore, the Secretary has the 437 facilities that are shown as determined that this final rule will not X. Federalism Analysis hospital-based to be small entities. The have a significant economic impact on Executive Order 13132 on Federalism ESRD facilities that are owned and a substantial number of small entities. (August 4, 1999) establishes certain operated by LDOs and regional chains We solicit comment on the RFA analysis requirements that an agency must meet would have total revenues more than provided. when it promulgates a final rule (and $34.5 million in any year when the total Finally, based on data from the Small subsequent final rule) that imposes revenues for all locations are combined Business Administration (SBA), we substantial direct requirement costs on for each business (individual LDO or estimate that 85 percent of the suppliers State and local governments, preempts regional chain) are not included as of the items and services affected by the State law, or otherwise has Federalism small entities. changes to the Medicare DMEPOS implications. We have reviewed this For the ESRD PPS updates finalized Competitive Bidding Program would be final rule under the threshold criteria of in this rule, a hospital-based ESRD defined as small entities with total Executive Order 13132, Federalism, and facility (as defined by ownership type) revenues of $6.5 million or less in any have determined that it will not have is estimated to receive a 2.3 percent 1 year. This final rule merely codifies substantial direct effects on the rights, increase in payments for CY 2012. An MIPPA provisions, so there are no roles, and responsibilities of States, independent facility (as defined by options for regulatory relief for small local or Tribal governments. ownership type) is estimated to receive suppliers. The RFA therefore does not a 2.3 percent increase in payments for require that we analyze regulatory XI. Files Available to the Public via the 2012. options in this instance. Internet Based on the finalized QIP payment In addition, section 1102(b) of the Act This section lists the Addenda reduction impacts to ESRD facilities for requires us to prepare a regulatory referred to in the preamble of this final. PY 2013, we estimate that of the 2,059 impact analysis if a rule may have a Beginning in CY 2012, the Addenda for ESRD facilities expected to receive a significant impact on the operations of the annual ESRD PPS proposed and payment reduction, 385 ESRD small a substantial number of small rural final rulemakings will no longer appear entity facilities would experience a hospitals. Any such regulatory impact in the Federal Register. Instead, the

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Addenda will be available only through reports, whichever is most recent) Subpart F—Competitive Bidding for the Internet. We will continue to post preceding the payment year. Certain Durable Medical Equipment, the Addenda through the Internet. * * * * * Prosthetics, Orthotics, and Supplies Readers who experience any problems (DMEPOS) accessing the Addenda that are posted (f) Except as provided below, to on the CMS Web site at http:// receive the low-volume adjustment an ■ 6. Section 414.402 is amended by— www.cms.gov/ESRDPayment/PAY/ ESRD facility must provide an ■ A. Revising the definitions of list.asp, should contact Lisa Hubbard at attestation statement, by November 1st ‘‘covered document’’ and ‘‘covered (410) 786–4533. of each year preceding the payment document review date’’ and ‘‘hospital’’. year, to its Medicare administrative ■ B. Revising the introductory text of List of Subjects contractor that the facility has met all paragraph (1) of the definition of 42 CFR Part 413 the criteria established in paragraphs ‘‘item’’. (a), (b), (c), and (d) of this section. For Health facilities, Kidney diseases, calendar year 2012, the attestation must § 414.402 Definitions. Medicare, Reporting and recordkeeping be provided by January 3, 2012. * * * * * requirements. * * * * * Covered document means a financial, 42 CFR Part 414 tax, or other document required to be ■ 3. Section 413.237 is amended by Proposed Rule to revise the definition submitted by a bidder as part of an adding a new paragraph (a)(1)(v) to read original bid submission under a of durable medical equipment (DME) to as follows: incorporate a minimum lifetime competitive acquisition program in standard of 3 years and further refine § 413.237 Outliers. order to meet the required financial the meaning of the term durable. standards. (a) * * * Covered document review date means For the reasons set forth in the the later of— preamble, under the authority at 42 (1) * * * (1) The date that is 30 days before the U.S.C. 1395hh section 1871 of the Act, (v) As of January 1, 2012, the final date for the closing of the bid the Centers for Medicare & Medicaid laboratory tests that comprise the window; or Services confirms as final, the interim Automated Multi-Channel Chemistry (2) The date that is 30 days after the final rules published on January 16, panel are excluded from the definition opening of the bid window. 2009 (74 FR 2873), and April 6, 2011 (76 of outlier services. FR 18930), and further amends 42 CFR * * * * * * * * * * chapter IV as set forth below: Hospital has the same meaning as in PART 414—PAYMENT FOR PART B section 1861(e) of the Act. PART 413—PRINCIPLES OF MEDICAL AND OTHER HEALTH Item *** REASONABLE COST SERVICES (1) Durable medical equipment (DME) REIMBURSEMENT; PAYMENT FOR other than class III devices under the END-STAGE RENAL DISEASE ■ 4. The authority citation for part 414 Federal Food, Drug and Cosmetic Act, SERVICES; OPTIONAL continues to read as follows: as defined in § 414.202 of this part and PROSPECTIVELY DETERMINED group 3 complex rehabilitative PAYMENT RATES FOR SKILLED Authority: Secs. 1102, 1871, and 1881(b)(l) wheelchairs and further classified into of the Social Security Act (42 U.S.C. 1302, the following categories: NURSING FACILITIES 1395hh, and 1395rr(b)(l)). * * * * * ■ 1. The authority citation for part 413 Subpart D—Payment for Durable ■ 7. Section 414.404 is amended by continues to read as follows: Medical Equipment and Prosthetic and revising paragraphs (b)(1) introductory Authority: Secs. 1102, 1812(d), 1814(b), Orthotic Devices text, (b)(1)(ii), and (b)(1)(iii) to read as 1815, 1833(a), (i), and (n), 1861(v), 1871, follows: 1881, 1883, and 1886 of the Social Security ■ 5. Section 414.202 is amended by Act (42 U.S.C. 1302, 1395d(d), 1395f(b), § 414.404 Scope and applicability. 1395(g), 1395I(a), (i), and (n), 1395x(v), revising the definition of ‘‘durable 1395hh, 1395rr, 1395tt, and 1395ww); and medical equipment’’ to read as follows: * * * * * sec. 124 of Public Law 106–113 (133 stat. (b) * * * 1501A–332). § 414.202 Definitions. (1) Physicians, treating practitioners, * * * * * and hospitals may furnish certain types ■ 2. Section 413.232 is amended by Durable medical equipment means of competitively bid durable medical revising paragraphs (b)(1), (b)(2), and (f) equipment without submitting a bid and to read as follows: equipment, furnished by a supplier or a home health agency that meets the being awarded a contract under this § 413.232 Low-volume adjustment. following conditions: subpart, provided that all of the following conditions are satisfied: (a) * * * (1) Can withstand repeated use. (b) * * * * * * * * (1) Furnished less than 4,000 (2) Effective with respect to items (ii) The items are furnished by the treatments in each of the 3 cost classified as DME after January 1, 2012, physician or treating practitioner to his reporting years (based on as-filed or has an expected life of at least 3 years. or her own patients as part of his or her final settled 12-consecutive month cost (3) Is primarily and customarily used professional service or by a hospital to reports, whichever is most recent) to serve a medical purpose. its own patients during an admission or on the date of discharge. preceding the payment year; and (4) Generally is not useful to an (2) Has not opened, closed, or (iii) The items are billed under a individual in the absence of an illness received a new provider number due to billing number assigned to the hospital, or injury. a change in ownership in the 3 cost physician, the treating practitioner (if reporting years (based on as-filed or (5) Is appropriate for use in the home. possible), or a group practice to which final settled 12-consecutive month cost * * * * * the physician or treating practitioner

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has reassigned the right to receive requirements of § 424.58 of this disclose information on both of the Medicare payment. subchapter, unless a grace period is following: * * * * * specified by CMS. (i) The subcontracting arrangement ■ 8. Section 414.408 is amended by (d) Financial standards. (1) General that the supplier has in furnishing items revising paragraph (e)(2)(iv) to read as rule. Each supplier must submit along and services under the contract. follows: with its bid the applicable covered (ii) Whether the subcontractor meets documents (as defined in § 414.402) the requirement of section § 414.408 Payment rules. specified in the request for bids. 1834(a)(20)(F)(i) of the Act, if applicable * * * * * (2) Process for reviewing covered to such subcontractor. (e) * * * documents. (i) Submission of covered * * * * * (2) * * * documents for CMS review. To receive (iv) A physician, treating practitioner, notification of whether there are missing Subpart H—Fee Schedule for physical therapist in private practice, covered documents, the supplier must Ambulance Services occupational therapist in private submit its applicable covered practice, or hospital may furnish an documents by the later of the following ■ 12. Section 414.610 is amended by item in accordance with § 414.404(b) of covered document review dates: revising paragraphs (c)(1) introductory this subpart. (A) The date that is 30 days before the text, (c)(1)(ii), (c)(5)(ii), and (h) to read as follows: * * * * * final date for the closing of the bid window; or ■ 9. Section 414.410 is amended by § 414.610 Basis of payments. (B) The date that is 30 days after the revising paragraphs (a)(1) through (3) to opening of the bid window. * * * * * read as follows: (ii) CMS feedback to a supplier with (c) * * * § 414.410 Phased-in implementation of missing covered documents. (A) For (1) Ground ambulance service levels. competitive bidding programs. Round 1 bids. CMS has up to 45 days The CF is multiplied by the applicable RVUs for each level of service to (a) Phase-in of competitive bidding after the covered document review date produce a service-level base rate. programs. CMS phases in competitive to review the covered documents and to bidding programs so that competition notify suppliers of any missing * * * * * under the programs occurs— documents. (ii) For services furnished during the (1) In CY 2009, in Cincinnati— (B) For subsequent Round bids. CMS period July 1, 2008 through December Middletown (Ohio, Kentucky and has 90 days after the covered document 31, 2011, ambulance services originating Indiana), Cleveland—Elyria—Mentor review date to notify suppliers of any in— (Ohio), Charlotte—Gastonia—Concord missing covered documents. * * * * * (North Carolina and South Carolina), (iii) Submission of missing covered (5) * * * Dallas—Fort Worth—Arlington (Texas), documents. Suppliers notified by CMS (ii) For services furnished during the Kansas City (Missouri and Kansas), of missing covered documents have 10 period July 1, 2004 through December Miami—Fort Lauderdale—Miami Beach business days after the date of such 31, 2011, the payment amount for the (Florida), Orlando (Florida), Pittsburgh notice to submit the missing documents. ground ambulance base rate is increased (Pennsylvania), and Riverside—San CMS does not reject the supplier’s bid by 22.6 percent where the point of Bernardino—Ontario (California). on the basis that the covered documents pickup is in a rural area determined to (2) In CY 2011, in an additional 91 are late or missing if all the applicable be in the lowest 25 percent of rural MSAs (the additional 70 MSAs selected missing covered documents identified population arrayed by population by CMS as of June 1, 2008, and the next in the notice are submitted to CMS not density. The amount of this increase is 21 largest MSAs by total population later than 10 business days after the date based on CMS’s estimate of the ratio of based on 2009 population estimates, of such notice. the average cost per trip for the rural and not already phased in as of June 1, * * * * * areas in the lowest quartile of 2008). CMS may subdivide any of the 91 ■ 11. Section 414.422 is amended by population compared to the average cost MSAs with a population of greater than revising paragraph (f) to read as follows: per trip for the rural areas in the highest 8,000,000 into separate CBAs, thereby quartile of population. In making this resulting in more than 91 CBAs. § 414.422 Terms of contracts. estimate, CMS may use data provided (3) After CY 2011, additional CBAs * * * * * by the GAO. (or, in the case of national mail order for (f) Disclosure of subcontracting * * * * * items and services, after CY 2010). arrangements. (1) Initial disclosure. Not (h) Treatment of certain areas for * * * * * later than 10 days after the date a payment for air ambulance services. ■ 10. Section 414.414 is amended by supplier enters into a contract under Any area that was designated as a rural revising paragraph (c) and (d) as this section the supplier must disclose area for purposes of making payments follows: information on both of the following: under the ambulance fee schedule for (i) Each subcontracting arrangement air ambulance services furnished on § 414.414 Conditions for awarding that the supplier has in furnishing items December 31, 2006, must be treated as contracts. and services under the contract. a rural area for purposes of making * * * * * (ii) Whether each subcontractor meets payments under the ambulance fee (c) Quality standards and the requirement of section schedule for air ambulance services accreditation. Each supplier furnishing 1834(a)(20)(F)(i) of the Act if applicable furnished during the period July 1, items and services directly or as a to such subcontractor. 2008, through December 31, 2011. subcontractor must meet applicable (2) Subsequent disclosure. Not later (Catalog of Federal Domestic Assistance quality standards developed by CMS in than 10 days after the date a supplier Program No. 93.773, Medicare—Hospital accordance with section 1834(a)(20) of enters into a subcontracting Insurance; and Program No. 93.774, the Act and be accredited by a CMS- arrangement subsequent to contract Medicare—Supplementary Medical approved organization that meets the award with CMS, the supplier must Insurance Program)

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Dated: October 26, 2011. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. Approved: October 31, 2011. Kathleen Sebelius, Secretary, Department of Health and Human Services. [FR Doc. 2011–28606 Filed 11–1–11; 4:15 pm] BILLING CODE 4120–01–P

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Part III

The President

Notice of November 9, 2011—Continuation of the National Emergency With Respect to Weapons of Mass Destruction

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Federal Register Presidential Documents Vol. 76, No. 218

Thursday, November 10, 2011

Title 3— Notice of November 9, 2011

The President Continuation of the National Emergency With Respect to Weapons of Mass Destruction

On November 14, 1994, by Executive Order 12938, the President declared a national emergency with respect to the unusual and extraordinary threat to the national security, foreign policy, and economy of the United States posed by the proliferation of nuclear, biological, and chemical weapons (weapons of mass destruction) and the means of delivering such weapons. On July 28, 1998, the President issued Executive Order 13094 amending Executive Order 12938 to respond more effectively to the worldwide threat of weapons of mass destruction proliferation activities. On June 28, 2005, the President issued Executive Order 13382 which, inter alia, further amend- ed Executive Order 12938 to improve our ability to combat proliferation. The proliferation of weapons of mass destruction and the means of delivering them continues to pose an unusual and extraordinary threat to the national security, foreign policy, and economy of the United States; therefore, the national emergency first declared on November 14, 1994, and extended in each subsequent year, must continue. In accordance with section 202(d) of the National Emergencies Act (50 U.S.C. 1622(d)), I am continuing for 1 year the national emergency declared in Executive Order 12938, as amend- ed. This notice shall be published in the Federal Register and transmitted to the Congress.

THE WHITE HOUSE, November 9, 2011. [FR Doc. 2011–29458 Filed 11–9–11; 2:00 pm] Billing code 3295–F2–P

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Reader Aids Federal Register Vol. 76, No. 218 Thursday, November 10, 2011

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING NOVEMBER

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. 381...... 69146 Presidential Documents 3 CFR Executive orders and proclamations 741–6000 Proclamations: 10 CFR The United States Government Manual 741–6000 8742...... 68273 40...... 69120 8743...... 68611 431...... 69122 Other Services 8744...... 68613 Electronic and on-line services (voice) 741–6020 8745...... 68615 Proposed Rules: 51...... 70067 Privacy Act Compilation 741–6064 8746...... 68617 429...... 69870 Public Laws Update Service (numbers, dates, etc.) 741–6043 8747...... 68619 430...... 69147, 69870 8748...... 68621 TTY for the deaf-and-hard-of-hearing 741–6086 609...... 67622 8749...... 68623 950...... 67622 8750...... 68625 ELECTRONIC RESEARCH 8751...... 69081 12 CFR World Wide Web Executive Orders: 204...... 68064 13588...... 68295 Full text of the daily Federal Register, CFR and other publications 243...... 67323 is located at: www.fdsys.gov. Administrative Orders: 381...... 67323 Federal Register information and research tools, including Public Memorandums: 701...... 67583 Inspection List, indexes, and links to GPO Access are located at: Memorandums of 705...... 67583 www.ofr.gov. October 28, 2011 ...... 68049 741...... 67583 Notices: Proposed Rules: E-mail Notice of November 1, 44...... 68846 2011 ...... 68055 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 248...... 68846 Notice of November 7, an open e-mail service that provides subscribers with a digital 351...... 68846 2011 ...... 70035 form of the Federal Register Table of Contents. The digital form 1290...... 70069 of the Federal Register Table of Contents includes HTML and Notice of November 9, PDF links to the full text of each document. 2011 ...... 70319 13 CFR To join or leave, go to http://listserv.access.gpo.gov and select 5 CFR Proposed Rules: Online mailing list archives, FEDREGTOC-L, Join or leave the list 530...... 68631 121...... 69154 (or change settings); then follow the instructions. 531...... 68631 124...... 69154 PENS (Public Law Electronic Notification Service) is an e-mail 536...... 68631 125...... 69154 service that notifies subscribers of recently enacted laws. 731...... 69601 126...... 69154 127...... 69154 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html Ch. III ...... 70037 and select Join or leave the list (or change settings); then follow 6 CFR 14 CFR the instructions. Proposed Rules: 39 ...... 67341, 67343, 67346, FEDREGTOC-L and PENS are mailing lists only. We cannot 5...... 67621 67591, 67594, 68297, 68299, respond to specific inquiries. 68301, 68304, 68306, 68634, 7 CFR Reference questions. Send questions and comments about the 68636, 69123, 70040, 70042, Federal Register system to: [email protected] 275...... 67315 70044, 70046 319...... 67581, 68057 71 ...... 67596, 69608, 70051 The Federal Register staff cannot interpret specific documents or 958...... 67317 73...... 69125 regulations. 984...... 67320 97...... 70053, 70055 Reminders. Effective January 1, 2009, the Reminders, including 1205...... 69083 Proposed Rules: Rules Going Into Effect and Comments Due Next Week, no longer 1214...... 69094, 69110 39 ...... 67625, 67628, 67631, appear in the Reader Aids section of the Federal Register. This 2502...... 69114 67633, 68366, 68368, 68660, information can be found online at http://www.regulations.gov. Proposed Rules: 68661, 68663, 68666, 68668, CFR Checklist. Effective January 1, 2009, the CFR Checklist no 205...... 69141 68671, 69155, 69157, 69159, longer appears in the Federal Register. This information can be 319...... 67379 69161, 69163, 69166, 69168, found online at http://bookstore.gpo.gov/. 930...... 69673 69685 987...... 69678 71...... 68674 183...... 69171 FEDERAL REGISTER PAGES AND DATE, NOVEMBER 2502...... 69146 8 CFR 15 CFR 67315–67580...... 1 67581–68056...... 2 103...... 69119 748...... 69609 902...... 68310 68057–68296...... 3 9 CFR 922...... 67348 68297–68624...... 4 93...... 70037 Proposed Rules: 68625–69082...... 7 94...... 70037 738...... 68675 69083–69600...... 8 98...... 70037 740...... 68675 69601–70036...... 9 381...... 68058 742...... 68675 70037–70320...... 10 Proposed Rules: 770...... 68675 319...... 69146 772...... 68675

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774...... 68675 31...... 67384 52 ...... 67366, 67369, 67600, Proposed Rules: 301...... 67384 68103, 68106, 68317, 68638, 73 ...... 67397, 68124, 69222 16 CFR 602...... 68119 69052, 69135, 69896, 69928 79...... 67397 1107...... 69586 180 ...... 69636, 69642, 69648, 27 CFR 1109...... 69546 69653, 69659, 69662 48 CFR Proposed Rules: Proposed Rules: 300...... 70057 Ch. 1...... 68014, 68044, 70037 303...... 68690 4...... 68373 372...... 69136 1 ...... 68015, 68017, 68043 Ch. II ...... 69596 9...... 69198 Proposed Rules: 2...... 68015, 68026 1107...... 69482 52 ...... 67396, 67640, 68378, 3...... 68017 29 CFR 68381, 68385, 68698, 68699, 4 ...... 68027, 68028, 68043 17 CFR 1980...... 68084 69214, 69217, 70078, 70091 8...... 68032, 68043 1...... 69334 81...... 70078, 70091 12...... 68017, 68032 21...... 69334 30 CFR 180 ...... 69680, 69692, 69693 16...... 68032 39...... 69334 Proposed Rules: 300...... 70105 140...... 69334 75...... 70075 19...... 68026, 68032 200...... 67597 902...... 67635 41 CFR 22...... 68015 25 ...... 68027, 68028, 68037, 948...... 67637 101–26...... 67370 Proposed Rules: 68039 255...... 68846 102–39...... 67371 31 CFR 31...... 68040 38...... 68032 19 CFR Proposed Rules: 42 CFR 52 ...... 68015, 68026, 68027, 4...... 68066 1010...... 69204 Ch. IV...... 67992 68028, 68032, 68039 10...... 68067 1030...... 69204 409...... 68526 24...... 68067 413...... 70228 Proposed Rules: 204...... 70106 162...... 68067 32 CFR 414...... 70228 252...... 70106 163...... 68067 706...... 68097 424...... 68526 178...... 68067 1701...... 67599 425...... 67802 Proposed Rules: Proposed Rules: 484...... 68526 49 CFR 101...... 69688 165...... 68376 Ch. V...... 67992 242...... 69802 21 CFR 33 CFR 44 CFR 384...... 68328 Proposed Rules: Proposed Rules: 100 ...... 68314, 69613, 69622 64...... 67372 633...... 67400 866...... 69034 117 ...... 68098, 69131, 69632, 65...... 68322, 68325 69633 67...... 68107, 69665 22 CFR 165 ...... 68098, 68101, 69131, 50 CFR 42...... 67361 69613, 69622, 69634 45 CFR 300 ...... 67401, 68332, 70062 123...... 68311 Proposed Rules: 1307...... 70010 622 ...... 67618, 68310, 68339, 126...... 68313, 69612 135...... 67385 69136 Proposed Rules: 136...... 67385 46 CFR 635 ...... 69137, 69139, 70064 121...... 68694 167...... 67395 160...... 70062 648...... 68642, 68657 180...... 70062 660...... 68349, 68658 24 CFR 37 CFR 199...... 70062 679...... 68354, 68658 17...... 69044 2...... 69132 680...... 68358 7...... 69132 47 CFR Proposed Rules: 26 CFR 1...... 68641 17...... 67401, 68393 20...... 69126 38 CFR 2...... 67604 21 ...... 67650, 69223, 69225 31...... 67363 Proposed Rules: 43...... 68641 92...... 68264 301...... 67363, 70057 51...... 70076 64 ...... 68116, 68328, 68642 223...... 67652 Proposed Rules: 73...... 67375, 68117 224...... 67652 1 ...... 68119, 68370, 68373, 40 CFR 79 ...... 67366, 67377, 68117 226...... 68710 69172, 69188 9...... 69134 80...... 67604 622 ...... 67656, 68711, 69230

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GPO’s Federal Digital System H.R. 1975/P.L. 112–48 Office Building’’. (Nov. 7, (FDsys) at http://www.gpo.gov/ To designate the facility of the 2011; 125 Stat. 544) LIST OF PUBLIC LAWS fdsys. Some laws may not yet United States Postal Service Last List October 25, 2011 be available. This is a continuing list of located at 281 East Colorado public bills from the current H.R. 489/P.L. 112–45 Boulevard in Pasadena, California, as the ‘‘First session of Congress which To clarify the jurisdiction of Lieutenant Oliver Goodall Post Public Laws Electronic have become Federal laws. It the Secretary of the Interior Office Building’’. (Nov. 7, may be used in conjunction with respect to the C.C. Notification Service 2011; 125 Stat. 542) with ‘‘P L U S’’ (Public Laws Cragin Dam and Reservoir, (PENS) Update Service) on 202–741– and for other purposes. (Nov. H.R. 2062/P.L. 112–49 6043. This list is also 7, 2011; 125 Stat. 535) available online at http:// To designate the facility of the H.R. 765/P.L. 112–46 United States Postal Service PENS is a free electronic mail www.archives.gov/federal- notification service of newly register/laws. Ski Area Recreational located at 45 Meetinghouse enacted public laws. To Opportunity Enhancement Act Lane in Sagamore Beach, The text of laws is not subscribe, go to http:// of 2011 (Nov. 7, 2011; 125 Massachusetts, as the published in the Federal listserv.gsa.gov/archives/ Stat. 538) ‘‘Matthew A. Pucino Post Register but may be ordered Office’’. (Nov. 7, 2011; 125 publaws-l.html H.R. 1843/P.L. 112–47 in ‘‘slip law’’ (individual Stat. 543) pamphlet) form from the To designate the facility of the Note: This service is strictly Superintendent of Documents, United States Postal Service H.R. 2149/P.L. 112–50 for E-mail notification of new U.S. Government Printing located at 489 Army Drive in To designate the facility of the laws. The text of laws is not Office, Washington, DC 20402 Barrigada, Guam, as the United States Postal Service available through this service. (phone, 202–512–1808). The ‘‘John Pangelinan Gerber Post located at 4354 Pahoa PENS cannot respond to text will also be made Office Building’’. (Nov. 7, Avenue in Honolulu, Hawaii, specific inquiries sent to this available on the Internet from 2011; 125 Stat. 541) as the ‘‘Cecil L. Heftel Post address.

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