[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

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          71156-71293

-----------------------------------------------------------------------



Reader Aids

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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.


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