[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[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. 78, No. 145 / Monday, July 29, 2013 / 
Contents  

[[Page iii]]




Agriculture Department
See Commodity Credit Corporation
See Forest Service
NOTICES
Meetings:
    Plant Breeding Listening Session, 45494


Antitrust Division
NOTICES
National Cooperative Research and Production Act; Membership Changes:
    tranSMART Foundation, 45565


Antitrust
See Antitrust Division


Civil Rights Commission
NOTICES
Meetings:
    New Hampshire Advisory Committee, 45496-45497


Coast Guard
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45545-45547


Commerce Department
See Industry and Security Bureau
See International Trade Administration


Commodity Credit Corporation
RULES
Feedstock Flexibility Program for Bioenergy Producers:
    Sugar Program, 45441-45447
NOTICES
Second Sugar Purchase and Exchange for Re-export Program Credits, 
          45494-45495


Community Development Financial Institutions Fund
NOTICES
Funding Opportunities:
    New Markets Tax Credit Program; Allocation Availability, 45604-
            45614


Defense Acquisition Regulations System
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45515


Defense Department
See Defense Acquisition Regulations System
See Navy Department
NOTICES
Privacy Act; Computer Matching Program, 45513-45515
Service Contracts Inventory, Fiscal Year 2012; Availability, 45515


Education Department
PROPOSED RULES
Student Assistance General Provisions, Federal Perkins Loan Program, 
          Federal Family Education Loan Program, and William D. Ford 
          Federal Direct Loan Program, 45618-45728
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Early Childhood Longitudinal Study, etc.; Correction, 45517
    Foreign Schools Eligibility Criteria Apply to Participate in Title 
            IV HEA Programs, 45516
    Student Assistance General Provisions; Subpart K; Cash Management, 
            45517
    William D. Ford Federal Direct Loan Program Repayment Plan 
            Selection Form, 45515-45516


Energy Department
See Federal Energy Regulatory Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    State Energy Program, 45517-45518
    Weatherization Assistance Program, 45518
Meetings:
    Environmental Management Site-Specific Advisory Board, Paducah, 
            45518-45519


Environmental Protection Agency
RULES
State Implementation Plans; Approvals and Promulgations:
    North Dakota; Interstate Transport of Pollution for the 2006 PM2.5 
            NAAQS, 45457-45459


Executive Office of the President
See Trade Representative, Office of United States


Federal Aviation Administration
PROPOSED RULES
Airworthiness Directives:
    Schempp-Hirth Flugzeugbau GmbH Gliders, 45471-45473
Amendment of Class E Airspace:
    St. George, UT, 45473-45474
Establishment of Class E Airspace:
    Akutan, AK, 45477-45478
    Cut Bank, MT, 45474-45475
    Rome, OR, 45475-45477
    Salmon, ID, 45478-45479
NOTICES
Surplus Property Releases:
    Huntsville International Airport, Huntsville, AL, 45598-45599


Federal Communications Commission
RULES
Broadband Data Improvement Act; Eligible Entities Aggregate Form 477 
          Data, 45464-45470
NOTICES
Auction of H Block Licenses in the 1915-1920 MHz and 1995-2000 MHz 
          Bands:
    Comment Sought on Competitive Bidding Procedures for Auction 96, 
            45524-45533
Data on Service Contracts Included in Record of Inmate Calling Service 
          Rates Proceeding, 45533-45534

[[Page iv]]




Federal Deposit Insurance Corporation
NOTICES
Receivership Termination:
    Western National Bank, Phoenix, AZ, 45534


Federal Emergency Management Agency
RULES
Suspension of Community Eligibility, 45460-45464
NOTICES
Emergency Declarations:
    Massachusetts; Amendment No. 2, 45547
Major Disaster and Related Determinations:
    Iowa, 45549
    Montana, 45548
    New York, 45549-45550
    North Dakota, 45547
    South Dakota, 45548-45549
Major Disaster Declarations:
    Oklahoma; Amendment No. 8, 45550


Federal Energy Regulatory Commission
RULES
Modeling, Data, and Analysis Reliability Standard, 45447-45451
PROPOSED RULES
Frequency Response and Frequency Bias Setting Reliability Standard, 
          45479-45490
NOTICES
Combined Filings, 45519-45521
Filings:
    David Marricle, 45521
Initial Market-Based Rate Filings Including Requests for Blanket 
          Section 204 Authorization:
    Desert Sunlight 250, LLC, 45521
Meetings:
    Centralized Capacity Markets in Regional Transmission Organizations 
            and Independent System Operators, 45521-45522
Petitions for Declaratory Orders:
    Catalina Solar, LLC, 45523
    Keys Energy Center, LLC, 45522-45523
Preliminary Permit Applications:
    Davis Hydro, LLC, 45523-45524


Federal Highway Administration
NOTICES
Memoranda of Understanding:
    Assigning Environmental Responsibilities to the State of Texas for 
            Categorical Exclusions, 45599-45600


Federal Reserve System
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45534-45535
Changes in Bank Control:
    Acquisitions of Shares of a Bank or Bank Holding Company, 45535-
            45536
Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 
          45536
Proposals to Engage in or to Acquire Companies Engaged in Permissible 
          Nonbanking Activities, 45536


Federal Trade Commission
NOTICES
Proposed Consent Agreements:
    Solera Holdings, Inc., 45536-45538


Fish and Wildlife Service
NOTICES
Establishment of the Advisory Council on Wildlife Trafficking, 45555-
          45556


Food and Drug Administration
PROPOSED RULES
Accreditation of Third-Party Auditors/Certification Bodies to Conduct 
          Food Safety Audits and to Issue Certifications, 45782-45839
Foreign Supplier Verification Programs for Importers of Food for Humans 
          and Animals, 45730-45779
NOTICES
Meetings:
    Patient Preference Initiative; Incorporating Patient Preference 
            Information Into the Medical Device Regulatory Processes; 
            Public Workshop, 45538-45540


Forest Service
NOTICES
Environmental Impact Statements; Availability, etc.:
    Conejos Peak Ranger District, Rio Grande National Forest, CO; 
            Cumbres Vegetation Management Project, 45495-45496
Meetings:
    Flathead Resource Advisory Committee, 45496


Health and Human Services Department
See Food and Drug Administration
See Health Resources and Services Administration
See National Institutes of Health
See Substance Abuse and Mental Health Services Administration


Health Resources and Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45540-45541


Homeland Security Department
See Coast Guard
See Federal Emergency Management Agency
See U.S. Immigration and Customs Enforcement


Housing and Urban Development Department
NOTICES
Rebuild by Design; Competition and Registration, 45551-45555


Indian Affairs Bureau
NOTICES
Environmental Impact Statements; Availability, etc.:
    Lac du Flambeau Band Fee-to-Trust Acquisition and Casino Project in 
            Shullsburg, WI, 45556


Industry and Security Bureau
NOTICES
Final Decisions and Orders:
    Chan Heep Loong, 45497-45502


Interior Department
See Fish and Wildlife Service
See Geological Survey
See Indian Affairs Bureau
See National Park Service
See Ocean Energy Management Bureau

[[Page v]]




Internal Revenue Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45614-45616
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Comment Request for Form 8960, 45616


International Trade Administration
NOTICES
Antidumping and Countervailing Duty Investigations; Results, 
          Extensions, Amendments, etc.:
    Oil Country Tubular Goods from India and Turkey, 45502-45505
    Oil Country Tubular Goods from India, the Republic of Korea, the 
            Republic of the Philippines, Saudi Arabia, Taiwan, 
            Thailand, the Republic of Turkey, Ukraine, and the 
            Socialist Republic of Vietnam, 45505-45512
    Polyethylene Terephthalate Film from India and Taiwan, 45512-45513


Judicial Conference of the United States
NOTICES
Meetings:
    Committee on Rules of Practice and Procedure, 45564


Justice Department
See Antitrust Division
NOTICES
Proposed Consent Decrees under the Clean Air Act, 45564-45565
Proposed Settlement Agreements under the Clean Water Act, 45565


Labor Department
See Labor Statistics Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Coal Mine Dust Sampling Devices, 45566-45567
    National Emergency Grant Assistance; Application and Reporting 
            Procedures, 45565-45566


Labor Statistics Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45567-45568


Legal Services Corporation
NOTICES
Meetings; Sunshine Act, 45568-45569


National Archives and Records Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45569


National Credit Union Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45569-45573


National Highway Traffic Safety Administration
NOTICES
Petitions for Decision of Inconsequential Noncompliance; Grants:
    Adrian Steel Co., 45600-45602


National Institutes of Health
NOTICES
Meetings:
    Center for Scientific Review, 45541-45542
    National Institute of Allergy and Infectious Diseases, 45541
    National Institute on Alcohol Abuse and Alcoholism, 45541
Requests for Information:
    National Institute of Environmental Health Sciences/National 
            Toxicology Program, 45542-45543


National Park Service
NOTICES
National Register of Historic Places:
    Pending Nominations and Related Actions, 45556-45557


Navy Department
RULES
Certifications and Exemptions Under the International Regulations for 
          Preventing Collisions at Sea, 45453-45454


Nuclear Regulatory Commission
NOTICES
Draft Guidance for Industry and Staff; Availability:
    Compensatory and Alternative Regulatory Measures for Nuclear Power 
            Plant Fire Protection, 45573-45574
Exemptions:
    Duke Energy Carolinas, LLC; Oconee Nuclear Station Units 1, 2, and 
            3; Independent Spent Fuel Storage Installation, 45575-45578
Radioactive Waste Export Licenses, 45578-45579
Radioactive Waste Import Licenses, 45579


Ocean Energy Management Bureau
NOTICES
Oil and Gas Lease Sales:
    Gulf of Mexico, Outer Continental Shelf, Western Planning Area, 
            Sale 233, 45557-45558
    Western Gulf of Mexico Planning Area, Outer Continental Shelf, Sale 
            233, 45558-45564


Office of United States Trade Representative
See Trade Representative, Office of United States


Personnel Management Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45579-45580
Meetings:
    Hispanic Council on Federal Employment, 45580


Securities and Exchange Commission
NOTICES
Self-Regulatory Organizations; Proposed Rule Changes:
    Chicago Board Options Exchange, Inc., 45584-45586
    International Securities Exchange, LLC, 45580-45584, 45590-45592
    Miami International Securities Exchange, LLC, 45586-45589
    NASDAQ OMX PHLX LLC, 45589-45590


Small Business Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45592
Conflicts of Interest; Exemptions:
    DeltaPoint Capital IV, LP, 45592

[[Page vi]]




Social Security Administration
RULES
Attorney Advisor Program:
    Extension of Sunset Date, 45459-45460
Mailing of Tickets Under the Ticket to Work Program, 45452-45453
Temporary Pilot Program Setting the Time and Place for a Hearing Before 
          an Administrative Law Judge:
    Extension of Effective Date, 45451-45452


State Department
PROPOSED RULES
Acquisition Regulations:
    Government-Furnished and Contractor-Acquired Property, 45490-45493
NOTICES
Meetings:
    Shipping Coordinating Committee, 45592-45593
Requests for Proposals:
    USA Pavilion/Exhibition at Universal Expo Milan Italy 2015; 
            Development, etc., 45593-45596


Substance Abuse and Mental Health Services Administration
NOTICES
Meetings:
    Advisory Committee for Women's Services, 45544-45545
    Center for Mental Health Services, 45543
    Center for Substance Abuse Prevention, 45545
    Center for Substance Abuse Treatment National Advisory Council, 
            45544
    National Advisory Council, 45545
    National Advisory Councils, 45543-45544


Trade Representative, Office of United States
NOTICES
Generalized System of Preferences:
    Initiation of the 2013 Annual GSP Product and Country Practices 
            Review; Deadlines for Filing Petitions, 45596-45597
Modification of the Harmonized Tariff Schedule of the United States for 
          Certain Cheeses, 45597-45598


Transportation Department
See Federal Aviation Administration
See Federal Highway Administration
See National Highway Traffic Safety Administration
NOTICES
Meetings:
    Industry Forums on the Next ITS Strategic Plan, 45598


Treasury Department
See Community Development Financial Institutions Fund
See Internal Revenue Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45602-45604


U.S. Immigration and Customs Enforcement
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 45550-45551


Veterans Affairs Department
RULES
Patient Access to Records, 45454-45457

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Separate Parts In This Issue
Part II
Education Department, 45618-45728


Part III
Health and Human Services Department, Food and Drug Administration, 
          45730-45779


Part IV
Health and Human Services Department, Food and Drug Administration, 
          45782-45839

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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. 78, No. 145 / Monday, July 29, 2013 / 
Contents  

  Federal Register / Vol. 78, No. 145 / Monday, July 29, 2013 / 
Contents  

  Federal Register / Vol. 78, No. 145 / Monday, July 29, 2013 / 
Contents  

[[Page vii]]



                           7 CFR
1435.................................................45441

                          14 CFR
Proposed Rules:
39...................................................45471
71 (5 documents).........45473, 45474, 45475, 45477, 45478

                          18 CFR
40...................................................45447
Proposed Rules:
40...................................................45479

                          20 CFR
404 (2 documents).............................45451, 45459
411..................................................45452
416 (2 documents).............................45451, 45459

                          21 CFR
Proposed Rules:
1 (2 documents)...............................45730, 45782
16...................................................45782

                          32 CFR
706..................................................45453

                          34 CFR
Proposed Rules:
668..................................................45618
674..................................................45618
682..................................................45618
685..................................................45618

                          38 CFR
1....................................................45454

                          40 CFR
52...................................................45457

                          44 CFR
64 (2 documents)..............................45460, 45462

                          47 CFR
1....................................................45464

                          48 CFR
Proposed Rules:
645..................................................45490
652..................................................45490