Unknown. Final rule
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/register/2013/05/10/2013-11147·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2013-05-10.xml --- 78 91 Friday, May 10, 2013 Contents Antitrust Division Antitrust Division NOTICES Membership Changes under National Cooperative Research and Production Act: 3D PDF Consortium, Inc., 27431 2013-11113 Antitrust See Antitrust Division Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Consumer Financial Protection Bureau of Consumer Financial Protection PROPOSED RULES Loan Originator Compensation Requirements under the Truth In Lending Act:
Prohibition on Financing Credit Insurance Premiums; Delay of Effective Date, 27308-27310 2013-11223 Safety Enviromental Enforcement Bureau of Safety and Environmental Enforcement NOTICES Final Safety Culture Policy Statement, 27419-27421 2013-11117 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27390-27392 2013-11059 2013-11188 Meetings: Advisory Committee on Immunization Practices, 27392 2013-11112 Statements of Organization, Functions, and Delegations of Authority, 27392-27399 2013-11142 2013-11143 2013-11144 Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicare Programs:
FY 2014 Hospice Wage Index and Payment Rate; Hospice Quality Reporting Requirements; Payment Reform, 27823-27852 2013-10389 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Long Term Care Hospital Prospective Payment System, etc., 27486-27823 2013-10234 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27399-27402 2013-11033 2013-11035 Coast Guard Coast Guard RULES Safety Zones: Melrose Pyrotechnics Fireworks Display;
Chicago Harbor, Chicago, IL, 27304-27306 2013-11135 PROPOSED RULES Coast Guard Auxiliary, 27321-27335 2013-10882 Drawbridge Operation Regulations: Wolf River, Gills Landing and Winneconne, WI, 27336-27338 2013-11134 Transportation Worker Identification Credential Reader Requirements, 27335-27336 2013-11227 Commerce Commerce Department See Economic Development Administration See Foreign-Trade Zones Board See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List;
Additions and Deletions, 27368-27369 2013-11156 2013-11157 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Disclosure of Financial and Other Information by National Banks, 27480-27481 2013-11122 Corporation Corporation for National and Community Service NOTICES Meetings; Sunshine Act, 27369-27370 2013-11270 Defense Department Defense Department See Navy Department Drug Drug Enforcement Administration NOTICES Decisions and Orders:
Jose G. Zavaleta, M.D., 27431-27441 2013-11185 Economic Development Economic Development Administration NOTICES Petitions for Eligibility to Apply for Trade Adjustment Assistance, 27364 2013-11159 Energy Department Energy Department See Energy Information Administration See Federal Energy Regulatory Commission See National Nuclear Security Administration Energy Information Energy Information Administration NOTICES Proposed Change to Data Protection, 27370-27372 2013-11153 Environmental Protection Environmental Protection Agency NOTICES Environmental Impact Statements;
Availability, etc., 27374 2013-11189 Meetings: Initial Draft Materials for Nitrogen Oxides Integrated Science Assessment for Health Effects; Workshop, 27374-27375 2013-11198 Standards of Performance for New Stationary Sources, National Emission Standards for Hazardous Air Pollutants, and Stratospheric Ozone Protection Program: Applicability Determinations, Alternative Monitoring Decisions, and Regulatory Interpretations, 27375-27387 2013-11204 Workshops and Calls for Information:
Integrated Science Assessment for Oxides of Sulfur, 27387-27388 2013-11197 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Bombardier, Inc. Airplanes, 27314-27315, 27318-27321 2013-11067 2013-11169 The Boeing Company Airplanes, 27310-27313, 27315-27318 2013-11063 2013-11168 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Aircraft Situational Display to Industry Block Requests, 27472 2013-11187 Passenger Facility Charge Approvals and Disapprovals, 27472-27473 2013-11054 Surplus Property Releases:
Tupelo Regional Airport, Tupelo, MS, 27473 2013-10509 Federal Communications Federal Communications Commission RULES Establishment of Class A TV Service and Cable Television Rate Regulation: Cost of Service; Clarification; Correction, 27307 2013-10981 Radio Broadcasting Services: Dermott, AK, and Cleveland, MS, 27306-27307 2013-11123 PROPOSED RULES Radio Broadcasting Services: Moran, TX, 27342-27343 2013-11124 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 27388-27389 2013-11057 Federal Emergency Federal Emergency Management Agency NOTICES Emergencies and Related Determinations: Massachusetts, 27413 2013-11114 North Dakota, 27412 2013-11108 Texas, 27412-27413 2013-11110 Emergency Declarations: Texas; Amendment No. 1, 27414 2013-11119 Major Disasters and Related Determinations: Kansas, 27415-27416 2013-11118 Massachusetts, 27414 2013-11111 New York, 27414-27415 2013-11116 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 27372-27373 2013-11171 Federal Highway Federal Highway Administration NOTICES Final Federal Agency Actions:
Tappan Zee Hudson River Crossing Project, New York, 27473-27474 2013-11138 Federal Maritime Federal Maritime Commission NOTICES Meetings; Sunshine Act, 27389 2013-11219 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Medical Examiner's Certification Integration, 27343-27363 2013-11080 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 27389 2013-11148 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants:
Polk County, FL; Application for Incidental Take Permit; Availability of Proposed Low-Effect Habitat Conservation Plan and Associated Documents, 27421-27422 2013-11163 Food and Drug Food and Drug Administration RULES Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food: Electron Beam and X-Ray Sources for Irradiation of Poultry Feed and Poultry Feed Ingredients, 27303-27304 2013-11147 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; etc., 27404-27405 2013-11127 Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens, etc., 27404 2013-11125 Improving Food Safety and Defense Capacity of State and Local Level; Review of State and Local Capacities, 27404 2013-11128 Medicated Feed Mill License Application, 27402-27404 2013-11126 Meetings: Anesthetic and Analgesic Drug Products Advisory Committee, 27405-27406 2013-11133 Foreign Trade Foreign-Trade Zones Board NOTICES Reorganizations under Alternative Site Framework:
Foreign-Trade Zone 241, Fort Lauderdale, FL, 27364-27365 2013-11203 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See Health Resources and Services Administration See Inspector General Office, Health and Human Services Department See National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27389-27390 2013-11177 Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 27406-27407 2013-11092 Meetings: Council on Graduate Medical Education, 27407-27408 2013-11087 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S. Customs and Border Protection Housing Housing and Urban Development Department NOTICES Federal Properties Suitable as Facilities to Assist the Homeless, 27417-27419 2013-10865 Inspector General Health Inspector General Office, Health and Human Services Department NOTICES Revised OIG's Provider Self-Disclosure Protocol, 27408 2013-11050 Interior Interior Department See Bureau of Safety and Environmental Enforcement See Fish and Wildlife Service See Ocean Energy Management Bureau Justice Department Justice Department See Antitrust Division See Drug Enforcement Administration See Justice Programs Office NOTICES Consent Decrees:
Resource Conservation and Recovery Act, 27430-27431 2013-11107 Justice Programs Justice Programs Office NOTICES National Institute of Justice Evaluation Hand-Held Cell Phone Detector Devices, 27441-27442 2013-11049 Labor Department Labor Department See Mine Safety and Health Administration Legal Legal Services Corporation PROPOSED RULES Private Attorney Involvement, 27339-27341 2013-11071 Restrictions on Legal Assistance with Respect to Criminal Proceedings in Tribal Courts, 27341-27342 2013-11070 Mine Mine Safety and Health Administration NOTICES Coal Mine Dust Sampling Devices;
Correction, 27442 2013-11129 National Highway National Highway Traffic Safety Administration NOTICES Petitions for Decisions of Inconsequential Noncompliance: Fuji Heavy Industries USA, Inc., 27474-27476 2013-11089 Newell Coach Corp., 27478-27479 2013-11093 Pirelli Tire LLC, 27476-27478 2013-11091 National Institute National Institutes of Health NOTICES Meetings: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 27408 2013-11102 National Cancer Institute, 27408-27411 2013-11095 2013-11097 2013-11098 National Heart, Lung, and Blood Institute, 27411 2013-11099 National Institute of Allergy and Infectious Diseases, 27409-27410 2013-11100 2013-11101 National Institute of Environmental Health Sciences, 27410 2013-11105 National Institute on Drug Abuse, 27410-27412 2013-11103 2013-11104 Office of Research Infrastructure Programs, 27409 2013-11106 National Nuclear National Nuclear Security Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 27373-27374 2013-11154 National Oceanic National Oceanic and Atmospheric Administration NOTICES Meetings: Gulf of Mexico Fishery Management Council, 27365 2013-11151 New England Fishery Management Council, 27367 2013-11155 North Pacific Fishery Management Council, 27365-27367 2013-11149 2013-11150 Pacific Fishery Management Council, 27367-27368 2013-11083 Navy Navy Department NOTICES Meetings: Secretary of the Navy Advisory Panel, 27370 2013-11161 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Meetings:
Advisory Committee on Reactor Safeguards Subcommittee on Digital I and C, 27443 2013-11166 Advisory Committee on Reactor Safeguards Subcommittee on Fukushima, 27442-27443 2013-11162 Advisory Committee on Reactor Safeguards Subcommittee on Plant License Renewal, 27442 2013-11170 Advisory Committee on Reactor Safeguards Subcommittee on Reliability and PRA, 27443-27444 2013-11167 Ocean Energy Management Ocean Energy Management Bureau NOTICES Environmental Documents Prepared for Oil, Gas, and Mineral Operations:
Gulf of Mexico Outer Continental Shelf Region, 27422-27427 2013-11079 Outer Continental Shelf Geological and Geophysical Exploration Activities in the Gulf of Mexico, 27427-27430 2013-11226 Outer Continental Shelf Oil and Gas Lease Sales, 27430 2013-11076 Postal Service Postal Service NOTICES Meetings; Sunshine Act, 27444 2013-11216 Research Innovative Research and Innovative Technology Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Confidential Close Call Reporting System, 27479-27480 2013-11190 Securities Securities and Exchange Commission NOTICES Applications: Forum Investment Advisors, LLC, et al., 27444-27451 2013-11146 Meetings: Credit Ratings Roundtable, 27452 2013-11082 Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange LLC, 27453-27457 2013-11140 Miami International Securities Exchange LLC, 27462-27464 2013-11141 NASDAQ OMX BX, Inc., 27457-27459, 27464-27466 2013-11173 2013-11175 NASDAQ Stock Market LLC, 27466-27468 2013-11145 National Stock Exchange, Inc., 27461-27462 2013-11172 NYSE Arca, Inc., 27452-27453 2013-11174 NYSE MKT LLC, 27459-27460 2013-11176 Trading Suspension Orders:
CoreCare Systems, Inc., Forticell Bioscience, Inc., Michelex Corporation, and Rx for Africa, Inc., 27468 2013-11238 Small Business Small Business Administration NOTICES Disaster Declarations: Texas, 27468-27469 2013-11121 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evacuee Manifest and Promissory Note, 27469 2013-11178 Repatriation/Emergency Medical and Dietary Assistance Loan Application, 27469-27470 2013-11179 Culturally Significant Objects Imported for Exhibition:
Impressionists on the Water, 27470 2013-11181 Shaping Power: Luba Masterworks from the Royal Museum for Central Africa, 27470 2013-11180 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved for Consumptive Uses of Water, 27470-27471 2013-11160 Projects Rescinded for Consumptive Uses of Water, 27471 2013-11136 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See National Highway Traffic Safety Administration See Research and Innovative Technology Administration Treasury Treasury Department See Comptroller of the Currency Customs U.S.
Customs and Border Protection NOTICES Environmental Impact Statements; Availability, etc.: Northern Border Activities, 27416-27417 2013-11115 Veteran Affairs Veterans Affairs Department NOTICES Privacy Act; Systems of Records, 27481-27484 2013-11158 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 27486-27852 2013-10389 2013-10234 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 78 91 Friday, May 10, 2013 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 579 [Docket No. FDA-2012-F-0178] Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food;
Electron Beam and X-Ray Sources for Irradiation of Poultry Feed and Poultry Feed Ingredients AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the regulations for irradiation of animal feed and pet food to provide for the safe use of electron beam and x-ray sources for irradiation of poultry feed and poultry feed ingredients. This action is in response to a food additive petition filed by Sadex Corp. DATES: This rule is effective May 10, 2013. Submit either electronic or written objections and requests for a hearing by June 10, 2013. ADDRESSES: You may submit either electronic or written objections and requests for a hearing, identified by Docket No. FDA-2012-F-0178, by any of the following methods: Electronic Submissions Submit electronic objections in the following ways: *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. Written Submissions Submit written objections in the following ways: *Mail/Hand delivery/Courier (For paper, disk, or CD-ROM submissions):* Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. *Instructions:* All submissions received must include the Agency name and [Docket Number] for this rulemaking. All objections received will be posted without change to *http://www.regulations.gov,* including any personal information provided. For additional information on submitting objections, see the “Objections” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* For access to the docket to read background documents or objections received, go to *http://www.regulations.gov* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6853, *isabel.pocurull@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background In a notice published in the **Federal Register** of February 29, 2012 (77 FR 12226), FDA announced that a food additive petition (animal use) (FAP 2272) had been filed by Sadex Corp., 2650 Murray St., Sioux City, IA 51111. The petition proposed to amend Title 21 of the Code of Federal Regulations
(CFR)in part 579 *Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food* (21 CFR part 579) to provide for the safe use of electron beam and x-ray sources for irradiation of poultry feed and poultry feed ingredients. The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. One comment was received that was not substantive. II. Conclusion FDA concludes that the data establish the safety and utility of electron beam and x-ray sources for use as proposed with modification and that the regulations for irradiation of animal feed and pet food should be amended as set forth in this document. III. Public Disclosure In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve this petition are available for inspection at the Center for Veterinary Medicine by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 571.1(h), the Agency will delete from the documents materials that are not available for public disclosure before making the documents available for inspection. IV. Environmental Impact The agency has determined under 21 CFR 25.32(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment, nor an environmental impact statement is required. V. Objections and Hearing Requests Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES ) either electronic or written objections by (see DATES). Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provision of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. It is only necessary to send one set of documents. It is no longer necessary to send three copies of all documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 579 Animal feeds, Animal foods, Radiation protection. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 579 is amended as follows: PART 579—IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD 1. The authority citation for 21 CFR part 579 continues to read as follows: Authority: 21 U.S.C. 321, 342, 343, 348, 371. 2. In § 579.40, revise paragraph
(a)to read as follows: § 579.40 Ionizing radiation for the treatment of poultry feed and poultry feed ingredients.
(a)*Energy sources.* Ionizing radiation is limited to:
(1)Gamma rays from sealed units of cobalt-60 or cesium-137;
(2)Electrons generated from machine sources at energy levels not to exceed 10 million electron volts;
(3)X-rays generated from machine sources at energies not to exceed 5 million electron volts, except as permitted by § 179.26(a)(4) of this chapter; or
(4)X-rays generated from machine sources using tantalum or gold as the target material and using energies not to exceed 7.5 (MeV). Dated: April 22, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013-11147 Filed 5-9-13; 8:45 am]
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