[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)] [Contents] [Pages III-VI] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] CONTENTS Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Contents [[Page iii]] Actuaries, Joint Board for Enrollment See Joint Board for Enrollment of Actuaries Agricultural Marketing Service PROPOSED RULES Avocados Grown in South Florida: Continuance Referendum, 71031 Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Commodity Credit Corporation See Food Safety and Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71084-71085 Animal and Plant Health Inspection Service RULES Highly Pathogenic Avian Influenza, 70997-71007 Census Bureau NOTICES 2014 Company Organization Survey, 71085 Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71102-71105 Fee Schedule: Reference Biological Standards and Biological Preparations, 71105 Statements of Organization, Functions, and Delegations of Authority, 71105-71106 Centers for Medicare & Medicaid Services PROPOSED RULES Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies, 71081-71082 Coast Guard RULES Safety Zones: Upper Mississippi River between Mile 44 and 46, Thebes, IL, 71020- 71022 Security Zones: USCGC Hamilton Commissioning Ceremony, Charleston Harbor, Charleston, SC, 71022-71025 PROPOSED RULES Great Lakes Pilotage Rates: 2015 Annual Review and Adjustment, 71082-71083 Commerce Department See Census Bureau See Economic Development Administration See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Commodity Credit Corporation RULES Clarification of Bales Made Available for Shipment by Approved Warehouses, 70995-70997 Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 71095 Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71095-71096 Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71096-71097 Meetings: Uniform Formulary Beneficiary Advisory Panel, 71097 Defense Nuclear Facilities Safety Board RULES Procedures for Safety Investigations, 71009-71013 Economic Development Administration NOTICES Meetings: National Advisory Council on Innovation and Entrepreneurship, 71085-71086 Energy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71097-71098 Emergency Preparedness and Response: DOE Response to Recommendation 2014-1 of the Defense Nuclear Facilities Safety Board, 71098-71099 Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Iowa, 71025-71029 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Massachusetts; Transit System Improvements, 71061-71065 Montana Second 10-Year Carbon Monoxide Maintenance Plan for Great Falls, 71057-71061 South Dakota; Infrastructure Requirements for the 1997 and 2006 PM2.5, 2008 Lead, 2008 Ozone, and 2010 NO2 National Ambient Air Quality Standards, 71040-71057 NPDES Electronic Reporting Rule, 71066-71081 Executive Office of the President See National Drug Control Policy Office See Science and Technology Policy Office See Trade Representative, Office of United States [[Page iv]] Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Airplanes, 71033-71037 Pratt and Whitney Canada Corp. Turboprop Engines, 71031-71033 The Boeing Company Airplanes, 71037-71040 Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71099-71101 Federal Mine Safety and Health Review Commission NOTICES Meetings; Sunshine Act, 71101 Federal Railroad Administration NOTICES Roadway Worker Authority Limits: Safety Advisory: Importance of Clear Communication, Compliance with Applicable Rules and Procedures, and Ensuring that Appropriate Safety Redundancies are in Place in the Event of Miscommunication or Error; Correction, 71152 Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 71101 Proposals to Engage in or to Acquire Companies Engaged in Permissible Nonbanking Activities, 71101-71102 Food and Drug Administration RULES Food Labeling: Calorie Labeling of Articles of Food in Vending Machines, 71259- 71293 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 71156-71259 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food Allergen Labeling and Reporting, 71107-71109 Medical Devices; Humanitarian Use Devices, 71110-71111 Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program, 71109-71110 Meetings: Seventh Annual Sentinel Initiative; Public Workshop; Amendment, 71111-71112 Food Safety and Inspection Service RULES Uniform Compliance Date for Food Labeling Regulations, 71007-71009 Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71102 Homeland Security Department See Coast Guard See U.S. Customs and Border Protection NOTICES Privacy Act; Systems of Records, 71112-71117 Industry and Security Bureau RULES Export Administration Regulations: Updated Statements of Legal Authority, 71013-71014 Validated End-User Authorizations: People's Republic of China; Lam Research Service Co., Ltd., 71014- 71019 Interior Department See National Park Service Internal Revenue Service NOTICES Publications: Tier 2 Tax Rates, 71153 International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Initiation of Five-Year Sunset Reviews, 71091-71093 Lightweight Thermal Paper from Germany, 71086-71087 Seamless Refined Copper Pipe and Tube from the People's Republic of China, 71089-71091 Vehicle and Light Truck Tires from the People's Republic of China, 71093-71095 Welded Carbon Steel Standard Pipe and Tube Products from Turkey, 71087-71089 International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Oil Country Tubular Goods from China, 71121-71124 Complaints: Certain Wireless Devices, Including Mobile Phones and Tablets III, DN 3043, 71124-71125 Joint Board for Enrollment of Actuaries NOTICES Meetings: Advisory Committee on Actuarial Examinations, 71125 Justice Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application and Permit for Permanent Exportation of Firearms, 71125-71126 Application to Transport Interstate or Temporarily Export Certain National Firearms Act Firearms, 71127-71128 Bureau of Justice Assistance Application Form; State Criminal Alien Assistance Program, 71126-71127 Claims Filed under the Radiation Exposure Compensation Act, 71126 Consent Decrees under the Clean Water Act, 71128 Labor Department See Mine Safety and Health Administration See Workers Compensation Programs Office [[Page v]] NOTICES List of Goods Produced by Child Labor or Forced Labor, 71128-71129 Mine Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Roof Control Plans for Underground Coal Mines, 71129-71130 Mine Safety and Health Federal Review Commission See Federal Mine Safety and Health Review Commission National Drug Control Policy Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Drug-Free Communities Support Program National Evaluation, 71131- 71132 National Institutes of Health NOTICES Meetings: National Eye Institute, 71112 National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Commercial Aggregated Large Coastal Sharks and Hammerhead Sharks in the Atlantic Region, 71029-71030 NOTICES Meetings: New England Fishery Management Council, 71095 National Park Service NOTICES Inventory Completions: Carnegie Museum of Natural History, Pittsburgh, PA, 71119-71120 U.S. Department of Defense, Army, Fort Sill National Historic Landmark and Museum, Fort Sill, OK, 71120-71121 Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71132-71134 Applications: License to Export Deuterium, 71134 Guidance: Tribal Policy Statement, 71136-71141 Tribal Protocol Manual, 71134-71136 Office of United States Trade Representative See Trade Representative, Office of United States Pension Benefit Guaranty Corporation RULES Allocation of Assets in Single-Employer Plans: Valuation of Benefits and Assets; Expected Retirement Age, 71019- 71020 Science and Technology Policy Office NOTICES Requests for Information: Microsatellite Technologies for Civil Earth Observations, 71141- 71143 Securities and Exchange Commission NOTICES Applications: Deregistration under the Investment Company Act, 71145-71146 MUFG Union Bank, N.A., 71143-71145 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 71150-71152 The NASDAQ Stock Market, LLC, 71146-71150 Trade Representative, Office of United States NOTICES Memberships to the Performance Review Board, 71152 Transportation Department See Federal Aviation Administration See Federal Railroad Administration Treasury Department See Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71152-71153 U.S. Customs and Border Protection NOTICES Commercial Gaugers and Laboratories; Accreditations and Approvals: NMK Resources, Inc., Roselle, NJ, 71118 NMK Resources, Inc., Thorofare, NJ, 71117-71118 Thionville Surveying Co., Inc., Harahan, LA, 71119 Veterans Affairs Department NOTICES Loan Guaranties: Assistance to Eligible Individuals in Acquiring Specially Adapted Housing; Cost-of-Construction Index, 71153-71154 Workers Compensation Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71130-71131 ----------------------------------------------------------------------- Separate Parts In This Issue Part II Health and Human Services Department, Food and Drug Administration, 71156-71293 ----------------------------------------------------------------------- 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. 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. Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Contents Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Contents Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Contents [[Page vi]] 7 CFR 1423.................................................70995 Proposed Rules: 915..................................................71031 9 CFR 93...................................................70997 94...................................................70997 95...................................................70997 317..................................................71007 381..................................................71007 10 CFR 1708.................................................71009 14 CFR Proposed Rules: 39 (3 documents).......................71031, 71033, 71037 15 CFR 730..................................................71013 734..................................................71013 736..................................................71013 742..................................................71013 744..................................................71013 745..................................................71013 748..................................................71014 21 CFR 11 (2 documents)..............................71156, 71259 101 (2 documents).............................71156, 71259 29 CFR 4044.................................................71019 33 CFR 165 (2 documents).............................71020, 71022 40 CFR 52...................................................71025 Proposed Rules: 52 (3 documents).......................71040, 71057, 71061 122..................................................71066 123..................................................71066 127..................................................71066 403..................................................71066 501..................................................71066 503..................................................71066 42 CFR Proposed Rules: 409..................................................71081 410..................................................71081 418..................................................71081 440..................................................71081 484..................................................71081 485..................................................71081 488..................................................71081 46 CFR Proposed Rules: 401..................................................71082 50 CFR 635..................................................71029