[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Contents]
[Pages III-VII]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]



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                  CONTENTS
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  Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / 
Contents  

[[Page iii]]




Agency for Healthcare Research and Quality
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58346-58352


Agriculture Department
See Farm Service Agency
See Rural Business-Cooperative Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58313


Antitrust Division
NOTICES
Changes under the National Cooperative Research and Production Act:
    The Open Group, LLC, 58383


Antitrust
See Antitrust Division


Army Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58337


Centers for Disease Control and Prevention
NOTICES
Issuance of 10 Final Skin Notation Profile Publications, 58352-58353
Meetings:
    Advisory Committee to the Director, 58353
Requests for Nominations:
    Board of Scientific Counselors, Office of Infectious Diseases, 
            58353-58354


Centers for Medicare & Medicaid Services
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58354-58355


Coast Guard
RULES
Shipping and Transportation:
    Technical, Organizational, and Conforming Amendments, 58270-58289
PROPOSED RULES
Security Zones:
    Dignitary Arrival/Departure and United Nations Meetings, New York, 
            NY, 58298-58301


Commerce Department
See Economic Development Administration
See Foreign-Trade Zones Board
See International Trade Administration
See National Oceanic and Atmospheric Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58316-58317


Corporation for National and Community Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58331


Defense Department
See Army Department
PROPOSED RULES
Limitations on Terms of Consumer Credit Extended to Service Members and 
          Dependents, 58602-58641
NOTICES
Arms Sales, 58331-58337


Economic Development Administration
NOTICES
Trade Adjustment Assistance Eligibility; Petitions, 58317-58318


Education Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Application for Grants Under the Student Support Services Program 
            (1894-0001), 58338


Employment and Training Administration
NOTICES
Worker Adjustment Assistance Eligibility; Investigations; Corrections, 
          58383-58384


Energy Department
PROPOSED RULES
Energy Efficiency Program for Consumer Products:
    Energy Conservation Standards for Ceiling Fans; Meeting and 
            Preliminary Technical Support Document, 58290-58293
NOTICES
Meetings:
    Fusion Energy Sciences Advisory Committee; Open Teleconference, 
            58339
    State Energy Advisory Board; Open Teleconference, 58338-58339


Environmental Protection Agency
RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    California; Placer County Air Pollution Control District; 
            Stationary Source Permits, 58263-58266
Manufacturing (Import) Exemptions:
    Defense Logistics Agency; Polychlorinated Biphenyls (PCBs), 58266-
            58270
PROPOSED RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    California; Placer County Air Pollution Control District; 
            Stationary Source Permits, 58301-58302
    California; Regional Haze Progress Report, 58302-58309
    Montana; Prevention of Significant Deterioration, 58309-58312

[[Page iv]]

NOTICES
Meetings:
    Proposed List of Potential Peer Reviewers, Estimating Exposures and 
            Incremental Health Effects in Public and Commercial 
            Buildings, 58339-58341


Executive Office of the President
See Presidential Documents


Export-Import Bank
NOTICES
Applications for Final Commitments for Long-Term Loans or Financial 
          Guarantee in Excess of 100 Million Dollars, 58341


Farm Service Agency
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    United States Warehouse Act, 58313-58314


Federal Aviation Administration
RULES
Special Conditions:
    Boeing, Model 767-200/-300 Series Airplane, as Modified by Avionics 
            Support Group; Installed Rechargeable Lithium Batteries and 
            Battery Systems, 58243-58245
PROPOSED RULES
Airworthiness Directives:
    The Boeing Company Airplanes, 58294-58298


Federal Communications Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58341-58343
Meetings; Sunshine Act, 58343-58344
Termination of Dormant Proceedings, 58344-58345


Federal Maritime Commission
NOTICES
Ocean Transportation Intermediary License Applicants, 58345-58346


Federal Reserve System
NOTICES
Changes in Bank Control:
    Acquisitions of Shares of a Bank or Bank Holding Company, 58346


Federal Trade Commission
RULES
Advertising Allowances and Other Merchandising Payments and Services, 
          58245-58256


Fish and Wildlife Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Coastal Impact Assistance Program, 58374-58375


Food and Drug Administration
PROPOSED RULES
Food for Animals:
    Current Good Manufacturing Practice, Hazard Analysis and Risk-Based 
            Preventive Controls, 58476-58521
Foreign Supplier Verification Programs for Importers of Food for Humans 
          and Animals, 58574-58599
Human Foods:
    Current Good Manufacturing Practice, Hazard Analysis and Risk-Based 
            Preventive Controls, 58524-58572
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
          for Human Consumption, 58434-58473
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Records and Reports Concerning Experiences with Approved New Animal 
            Drugs: Adverse Event Reports, 58355-58357
    Voluntary Cosmetic Registration Program, 58357
Guidance:
    Establishing that a Tobacco Product was Commercially Marketed in 
            the United States as of February 15, 2007; Availability, 
            58358
    Internet/Social Media Platforms with Character Space Limitations: 
            Presenting Risk and Benefit Information for Prescription 
            Drugs and Medical Devices, 58357-58358
    Internet/Social Media Platforms: Correcting Independent Third-Party 
            Misinformation About Prescription Drugs and Medical 
            Devices, 58359


Foreign-Trade Zones Board
NOTICES
Reorganizations under Alternative Site Frameworks:
    Foreign-Trade Zone 58, Bangor, ME; Application, 58318
    Foreign-Trade Zone 93, Raleigh-Durham, NC, 58318


Health and Human Services Department
See Agency for Healthcare Research and Quality
See Centers for Disease Control and Prevention
See Centers for Medicare & Medicaid Services
See Food and Drug Administration
See Indian Health Service
See National Institutes of Health


Healthcare Research and Quality Agency
See Agency for Healthcare Research and Quality


Homeland Security Department
See Coast Guard
RULES
Commonwealth of the Northern Mariana Islands-Only Transitional Worker 
          Numerical Limitation for Fiscal Year 2015, 58241-58242


Housing and Urban Development Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Closeout Instructions for Community Development Block Grant 
            Programs Grants, 58369-58370
    Housing Opportunities for Persons with AIDS Program, Annual Grantee 
            Performance Reporting Requirements, etc., 58370-58371
    Planning Phase Evaluation of the LGBTQ Youth Homelessness 
            Prevention Initiative, 58368-58369
    Request for Prepayment of Section 202 or 202/8 Direct Loan Project, 
            58367-58368
    Survey Questions for Small Contractor Marketplace, 58371-58372
Privacy Act; Systems of Records, 58372-58374


Indian Health Service
See Indian Health Service

[[Page v]]

NOTICES
Final Policy on Conferring with Urban Indian Organizations, 58359-58363


Interior Department
See Fish and Wildlife Service
See Land Management Bureau
See National Park Service
See Surface Mining Reclamation and Enforcement Office
NOTICES
Charter Renewals:
    Exxon Valdez Oil Spill Public Advisory Committee, 58374


Internal Revenue Service
RULES
Employee Retirement Benefit Plan Returns Required on Magnetic Media, 
          58256-58261
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58430-58431


International Trade Administration
NOTICES
Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
    53-Foot Domestic Dry Containers from the People's Republic of 
            China, 58320-58322
    Certain Pasta from Italy, 58319-58320
    Low-Enriched Uranium from France, 58322-58324
Determinations of Sales at Less Than Fair Value:
    Grain-Oriented Electrical Steel from the Czech Republic, 58324-
            58326
    Monosodium Glutamate from the People's Republic of China, 58326-
            58329
    Monosodium Glutamate from the Republic of Indonesia, 58329-58330


International Trade Commission
NOTICES
Investigations; Determinations, Modifications, and Rulings, etc.:
    Certain Formatted Magnetic Data Storage Tapes and Cartridges 
            Containing the Same, 58382-58383


Justice Department
See Antitrust Division


Labor Department
See Employment and Training Administration


Land Management Bureau
NOTICES
Plats of Surveys:
    Montana, 58376
Public Lands; Temporary Closures:
    Dona Ana County, NM, 58376
Realty Actions:
    Proposed Non-Competitive Direct Sale of Public Lands, Washington 
            County, UT, 58376-58377


Legal Services Corporation
NOTICES
Meetings; Sunshine Act, 58384


National Highway Traffic Safety Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58402-58403


National Institutes of Health
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Formative Research, Pre-testing, Stakeholder Measures and Advocate 
            Forms at NCI, 58363-58364
Meetings:
    Center for Scientific Review, 58364-58367
    National Center for Advancing Translational Sciences, 58366-58367
    National Institute of Allergy and Infectious Diseases, 58364
    National Institute of Arthritis and Musculoskeletal and Skin 
            Diseases, 58364
    National Institute on Aging, 58366


National Oceanic and Atmospheric Administration
NOTICES
Meetings:
    Pacific Fishery Management Council, 58330-58331


National Park Service
RULES
Concession Contracts, 58261-58263
NOTICES
Environmental Impact Statements; Availability, etc.:
    Big Thicket National Preserve, TX; General Management Plan, 58378
    Lake Meredith National Recreation Area, Alibates Flint Quarries 
            National Monument, TX; General Management Plan, 58377-58378
National Register of Historic Places:
    Pending Nominations and Related Actions, 58378-58380
Repatriations of Cultural Items:
    U.S. Department of the Interior, Bureau of Indian Affairs, 
            Washington, DC, 58380-58381


Nuclear Regulatory Commission
NOTICES
Meetings:
    Advisory Committee on Reactor Safeguards, 58384-58385
Meetings; Sunshine Act, 58385-58386


Postal Regulatory Commission
NOTICES
New Postal Products, 58386


Postal Service
NOTICES
Product Changes:
    Priority Mail Negotiated Service Agreements, 58386-58387


Presidential Documents
PROCLAMATIONS
Pacific Remote Islands Marine National Monument; Expansion (Proc. 
          9173), 58643-58653


Rural Business-Cooperative Service
NOTICES
Applications:
    Advanced Biofuels Payment Program, 58314-58316


Securities and Exchange Commission
NOTICES
Self-Regulatory Organizations; Proposed Rule Changes:
    Financial Industry Regulatory Authority, Inc., 58390-58393

[[Page vi]]

    ISE Gemini Exchange, LLC, 58387-58388
    NASDAQ OMX BX, Inc., 58397-58399
    NASDAQ OMX PHLX LLC, 58393-58395
    NASDAQ Stock Market LLC, 58388-58390
    OneChicago, LLC, 58395-58397
Trading Suspension Orders:
    All Grade Mining, Inc., et al., 58399


Small Business Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58399-58400


State Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Training/Internship Placement Plan, 58400-58401
Certifications:
    Foreign Military Financing for Colombia, 58401
Culturally Significant Objects Imported for Exhibition:
    Madame Cezanne, 58401-58402
    Vodou -- Sacred Powers of Haiti, 58401


Surface Mining Reclamation and Enforcement Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58381-58382


Transportation Department
See Federal Aviation Administration
See National Highway Traffic Safety Administration


Treasury Department
See Internal Revenue Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 58403-58404
Funding Availability:
    Community Development Financial Institutions Fund, 58404-58430


Veterans Affairs Department
NOTICES
Meetings:
    Biomedical Laboratory Research and Development Service, Special 
            Emphasis Panel--Gulf War Veterans' Illnesses Biorepository, 
            58431-58432

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          58434-58473


Part III
Health and Human Services Department, Food and Drug Administration, 
          58476-58521


Part IV
Health and Human Services Department, Food and Drug Administration, 
          58524-58572


Part V
Health and Human Services Department, Food and Drug Administration, 
          58574-58599


Part VI
Defense Department, 58602-58641


Part VII
Presidential Documents, 58643-58653

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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. 188 / Monday, September 29, 2014 / 
Contents  

  Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / 
Contents  

  Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / 
Contents  

[[Page vii]]



                           3 CFR
Proclamations:
9173.................................................58645

                           8 CFR
214..................................................58241

                          10 CFR
Proposed Rules:
430..................................................58290

                          14 CFR
25...................................................58243
Proposed Rules:
39...................................................58294

                          16 CFR
240..................................................58245

                          21 CFR
Proposed Rules:
1 (2 documents)...............................58524, 58574
16 (2 documents)..............................58476, 58524
112..................................................58434
117 (2 documents).............................58476, 58524
507..................................................58476

                          26 CFR
301..................................................58256

                          32 CFR
Proposed Rules:
232..................................................58602

                          33 CFR
Proposed Rules:
165..................................................58298

                          36 CFR
51...................................................58261

                          40 CFR
52...................................................58263
761..................................................58266
Proposed Rules:
52 (3 documents).......................58301, 58302, 58309

                          46 CFR
1....................................................58270
4....................................................58270
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