[Federal Register Volume 78, Number 11 (Wednesday, January 16, 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. 11 / Wednesday, January 16, 2013 / 
Contents  

[[Page iii]]




Agriculture Department
See Food and Nutrition Service


Alcohol and Tobacco Tax and Trade Bureau
PROPOSED RULES
Establishment of the Ballard Canyon Viticultural Area, 3370-3377


Centers for Disease Control and Prevention
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 3429-3431


Children and Families Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Mother and Infant Home Visiting Program Evaluation; Follow-up Data 
            Collection on Family Outcomes, 3432-3433
    School Readiness Goals and Head Start Program Functioning, 3431-
            3432


Coast Guard
RULES
Safety Zones:
    Lower Portion of Anchorage 9, Mantua Creek Anchorage, 
            Paulsboro, NJ , 3326-3328


Commerce Department
See Industry and Security Bureau
See International Trade Administration
See National Oceanic and Atmospheric Administration


Commodity Futures Trading Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Financial Education Content Needs Survey, 3403-3407


Corporation for National and Community Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 3407-3408


Defense Department
See Navy Department
RULES
Appointing Authority for Military Commissions, 3325-3326
NOTICES
Meetings:
    U.S. Court of Appeals for Armed Forces Code Committee, 3408


Education Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Application for Client Assistance Program, 3409-3410
    Form for Maintenance of Effort Waiver Requests under Elementary and 
            Secondary Education Act of 1965, as Amended, 3410-3411
    Formula Grant for Electronic Application System for Indian 
            Education, 3411


Energy Department
See Federal Energy Regulatory Commission
NOTICES
Meetings:
    President's Council of Advisors on Science and Technology; Open 
            Teleconference; Correction, 3411-3412


Environmental Protection Agency
RULES
Pesticide Tolerances:
    Fluroxypyr, 3328-3333
    Spiromesifen, 3333-3337
PROPOSED RULES
Pesticide Petitions:
    Residues of Pesticide Chemicals in or on Various Commodities, 3377-
            3381
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    NSPS for Hospital/Medical/Infectious Waste Incinerators, 3414-3415
    NSPS for Surface Coating of Plastic Parts for Business Machines, 
            3413-3414
Applications for Emergency Exemptions:
    3-Decen-2-One, 3415-3417
Cancellations Orders for Pesticide Registrations and Labels:
    Iodomethane, 3417-3418
Draft Guidance for Pesticide Registrants on Web-Distributed Labeling 
          for Pesticide Products, 3418-3420
Draft Quality Standard for Environmental Data Collection, Production, 
          and Use:
    Non-EPA (External) Organizations and Two Associated QA Handbooks; 
            Correction, 3420
Pesticide Emergency Exemptions:
    Agency Decisions and State and Federal Agency Crisis Declarations, 
            3420-3422
Pesticide Products; Registration Applications, 3422-3423


Export-Import Bank
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Application for Long Term Loan or Guarantee , 3423-3424


Federal Aviation Administration
RULES
Safety Enhancements, Certification of Airports, 3311-3317
PROPOSED RULES
Airworthiness Directives:
    The Boeing Company Airplanes, 3363-3367
    Various Aircraft Equipped with Wing Lift Struts, 3356-3363


Federal Energy Regulatory Commission
NOTICES
Combined Filings, 3412

[[Page iv]]

Initial Market-Based Rate Filings Including Requests for Blanket 
          Authorizations:
    EnerPenn USA LLC, 3412-3413
    Texpo Power, LP, 3413
Meetings:
    Federal Energy Regulatory Commission, 3413


Federal Maritime Commission
NOTICES
Agreements Filed, 3424
Ocean Transportation Intermediary License Applicants, 3424
Ocean Transportation Intermediary Licenses:
    Rescission of Order of Revocation, 3424
    Revocations, 3425


Federal Reserve System
NOTICES
Changes in Bank Control:
    Acquisitions of Shares of a Bank or Bank Holding Company, 3425
Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 
          3425


Federal Trade Commission
NOTICES
Proposed Consent Orders:
    Filiquarian Publishing, LLC; Choice Level, LLC; and Joshua Linsk, 
            3425-3427
    Motorola Mobility LLC and Google Inc.; Correction, 3427-3429


Fish and Wildlife Service
NOTICES
Meetings:
    Migratory Bird Hunting; Service Regulations Committee, 3446


Food and Drug Administration
PROPOSED RULES
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based 
          Preventive Controls for Human Food, 3646-3824
Draft Qualitative Risk Assessment of Risk of Activity/Food 
          Combinations:
    Activities (Outside the Farm Definition) Conducted in Facility Co-
            Located on a Farm, 3824-3826
Standards for Growing, Harvesting, Packing, and Holding of Produce for 
          Human Consumption, 3504-3646
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Electronic Submission of Adverse Event Reports and Other Safety 
            Information Using Electronic Submission Gateway and Safety 
            Reporting Portal, 3433-3437


Food and Nutrition Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Performance Reporting System, Management Evaluation, 3394-3396
    Senior Farmers' Market Nutrition Program, 3393-3394
    Supplemental Nutrition Assistance Program Employment and Training 
            Program Activity Report, 3391-3393
    Worksheet for Supplemental Nutrition Assistance Program Quality 
            Control Reviews, 3390-3391


Foreign Claims Settlement Commission
NOTICES
Meetings; Sunshine Act, 3450


Health and Human Services Department
See Centers for Disease Control and Prevention
See Children and Families Administration
See Food and Drug Administration
See National Institutes of Health


Homeland Security Department
See Coast Guard
NOTICES
Privacy Act; Systems of Records, 3441-3446


Industry and Security Bureau
RULES
Entity List:
    Removal of Persons Based on Request; Implementation of Annual 
            Review Changes and Modifications and Corrections, 3317-3319
Validated End User Authorizations:
    Advanced Micro Devices China, Inc., et al., in the People's 
            Republic of China; Clarification of Scope of Entries in 
            Supplement, 3319-3325


Interior Department
See Fish and Wildlife Service
See Land Management Bureau
See Ocean Energy Management Bureau
See Surface Mining Reclamation and Enforcement Office


Internal Revenue Service
RULES
Disclosure or Use of Information by Preparers of Returns; Correction, 
          3325
Partners Distributive Share; Correction, 3325
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 3498-3499
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Customer Satisfaction Surveys, 3499
Meetings:
    Taxpayer Advocacy Panel Joint Committee, 3500-3501
    Taxpayer Advocacy Panel Notices and Correspondence Project 
            Committee, 3500
    Taxpayer Advocacy Panel Tax Forms and Publications Project 
            Committee, 3501
    Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements 
            Project Committee, 3500
    Taxpayer Advocacy Panel Taxpayer Communications Project Committee, 
            3501
    Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee, 
            3500


International Trade Administration
PROPOSED RULES
Extension of Time Limits, 3367-3370
NOTICES
Antidumping Duty Administrative Reviews; Results, Extensions, 
          Amendments, etc.:
    Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, 
            from People's Republic of China, 3396-3398
Meetings:
    United States Travel and Tourism Advisory Board, 3398

[[Page v]]




International Trade Commission
NOTICES
Investigations:
    Certain Microprocessors, Components Thereof, and Products 
            Containing Same; Statements on Public Interest, 3449-3450
    Silica Bricks and Shapes from China; Determination, 3449


Justice Department
See Foreign Claims Settlement Commission
See National Institute of Corrections


Land Management Bureau
NOTICES
Meetings:
    Western Montana Resource Advisory Council, 3446-3447


National Capital Planning Commission
NOTICES
Meetings:
    Comprehensive Plan for National Capital; Federal Elements, 3453


National Highway Traffic Safety Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 3496-3497


National Institute of Corrections
NOTICES
Solicitations for Cooperative Agreements:
    Development of Materials Specific to Lesbian, Gay, Bisexual, 
            Transgender and Intersex Offenders in Corrections, 3450-
            3453


National Institutes of Health
NOTICES
Government-Owned Inventions; Availabilities for Licensing, 3437-3441


National Oceanic and Atmospheric Administration
RULES
Fisheries of the Northeastern United States:
    Atlantic Mackerel, Squid, and Butterfish Fisheries; Specifications 
            and Management Measures, 3346-3355
High Seas Driftnet Fishing Moratorium Protection Act:
    Identification and Certification Procedures to Address Shark 
            Conservation, 3338-3346
PROPOSED RULES
Endangered and Threatened Species:
    Designation of a Nonessential Experimental Population of Spring-run 
            Chinook Salmon, San Joaquin River, CA, 3381-3389
NOTICES
Calls for Nominations:
    International Pacific Halibut Commission Appointments, 3399
Draft 2012 Marine Mammal Stock Assessment Reports, 3399-3401
Fisheries of the Northeastern United States:
    Atlantic Mackerel, Squid, and Butterfish Fisheries; Scoping 
            Process, 3401-3402
Meetings:
    Marine Fisheries Advisory Committee, 3402
Permits:
    Marine Mammals; File No. 16919, 3402-3403


National Science Foundation
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 3453-3454


Navy Department
NOTICES
Environmental Impact Statements; Availability, etc.:
    Gulf of Alaska Navy Training Activities, 3408-3409
Meetings:
    Board of Visitors of Marine Corps University, 3409


Nuclear Regulatory Commission
NOTICES
Docketing of Amendment Requests to Special Nuclear Materials:
    Independent Spent Fuel Storage Installation; License No. 2506, 
            3454-3458
Environmental Assessments; Availability, etc.:
    Florida Power Corp., Crystal River Unit 3; Proposed License 
            Amendment to Increase Maximum Reactor Power Level, 3458-
            3470
Environmental Impact Statements; Availability, etc.:
    DTE Electric Co.; Combined License for Unit 3 at Enrico Fermi 
            Atomic Power Plant Site, 3470
Hearings and to Petitions for Leave to Intervene:
    Aptuit, LLC; License Amendment Request, Opportunity to Provide 
            Comments, 3470-3473
Meetings:
    Advisory Committee on Reactor Safeguards, 3473-3474
    Advisory Committee on Reactor Safeguards Subcommittee on Materials, 
            Metallurgy and Reactor Fuels, 3474


Ocean Energy Management Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Southern Alaska Sharing Network and Subsistence Study, 3447-3448


Personnel Management Office
NOTICES
Privacy Act; Computer Matching Programs, 3474-3476


Postal Regulatory Commission
NOTICES
International Mail Contracts, 3476-3479


Presidio Trust
NOTICES
Meetings:
    Fort Scott Council, 3479


Securities and Exchange Commission
NOTICES
Self-Regulatory Organizations; Proposed Rule Changes:
    BATS Exchange, Inc., 3489-3494
    Chicago Board Options Exchange, Inc., 3486-3489
    Chicago Stock Exchange, Inc., 3485-3486
    NASDAQ Stock Market LLC, 3480-3482, 3485
    NYSE Arca, Inc., 3482
    Options Clearing Corp., 3479, 3483-3485
    Stock Clearing Corp. of Philadelphia, 3482


Small Business Administration
NOTICES
Disaster Declarations:
    Mississippi, 3494-3495

[[Page vi]]

    Puerto Rico, 3495
Exemptions under Small Business Investment Act; Conflicts of Interest:
    Claritas Capital Specialty Debt II, LP, 3495
Major Disaster Declarations:
    Maryland; Amendment 3, 3496
Surrenders of Licenses of Small Business Investment Companies, 3496


State Department
NOTICES
Specially Designated Global Terrorists:
    Michel Samaha, a.k.a. Saadah al-Naib Mishal Fuad Samahah, a.k.a. 
            Mishal Fuad Samahah, 3496


Surface Mining Reclamation and Enforcement Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 3448-3449


Surface Transportation Board
NOTICES
Acquisitions and Operation Exemptions:
    KM Railways, LLC from DTE Chicago Fuels Terminal, LLC and DTE Coal 
            Services, Inc., 3497-3498


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


Treasury Department
See Alcohol and Tobacco Tax and Trade Bureau
See Internal Revenue Service
NOTICES
Meetings:
    Debt Management Advisory Committee, 3498

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          3504-3826

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Reader Aids

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      CFR PARTS AFFECTED IN THIS ISSUE
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 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. 11 / Wednesday, January 16, 2013 / 
Contents  

  Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / 
Contents  

  Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / 
Contents  

[[Page vii]]



                          14 CFR
139...................................................3311
Proposed Rules:
39 (3 documents)..........................3356, 3363, 3365

                          15 CFR
744...................................................3317
748...................................................3319

                          19 CFR
Proposed Rules:
351...................................................3367

                          21 CFR
Proposed Rules:
1.....................................................3646
16 (2 documents)................................3504, 3646
106...................................................3646
110...................................................3646
112...................................................3504
114...................................................3646
117 (2 documents)...............................3646, 3824
120...................................................3646
123...................................................3646
129...................................................3646
179...................................................3646
211...................................................3646

                          26 CFR
1 (2 documents).......................................3325

                          27 CFR
Proposed Rules:
9.....................................................3370

                          32 CFR
18....................................................3325

                          33 CFR
165...................................................3326

                          40 CFR
180 (2 documents)...............................3328, 3333
Proposed Rules:
180...................................................3377

                          50 CFR
300...................................................3338
648...................................................3346
Proposed Rules:
223...................................................3381