[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[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. 80, No. 180 / Thursday, September 17, 2015 / 
Contents  

[[Page iii]]




Agency for International Development
RULES
USAID Uniform Administrative Requirements, Cost Principles, and Audit 
          Requirements for Federal Awards, 55721-55726
NOTICES
Meetings:
    Board for International Food and Agricultural Development, 55826


Agriculture Department
See Animal and Plant Health Inspection Service
See Forest Service
See Rural Utilities Service


Animal and Plant Health Inspection Service
RULES
Importation of Kiwi from Chile into the United States, 55739-55741
NOTICES
Environmental Assessments; Availability, etc.:
    Oral Rabies Vaccine Trial; Supplement, 55826-55827


Census Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals; Correction, 55829


Centers for Medicare & Medicaid Services
NOTICES
Approvals for Exception to Prohibition Against Expansion of Facility 
          Capacity, 55851-55853


Children and Families Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 55853-55854


Coast Guard
RULES
Drawbridge Operations:
    Delaware River, Burlington County, NJ, 55763
    Mantua Creek, Paulsboro, NJ and Raccoon Creek, Bridgeport, NJ, 
            55762
    New Jersey Intracoastal Waterway, Atlantic City, NJ and Delaware 
            River, Delair, NJ, 55761-55762


Commerce Department
See Census Bureau
See First Responder Network Authority
See International Trade Administration
See National Institute of Standards and Technology
See National Oceanic and Atmospheric Administration
See National Telecommunications and Information Administration
NOTICES
Privacy Act; Systems of Records, 55829-55833


Defense Department
See Navy Department
RULES
Background Checks on Individuals in DoD Child Care Services Programs, 
          55752-55761


Education Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Borrower Defenses Against Loan Repayment, 55839
    Middle Grades Longitudinal Study of 2017-2018 Recruitment for 2017 
            Operational Field Test, 55839-55840
Meetings:
    National Board for Education Sciences, 55840-55841


Energy Department
See Federal Energy Regulatory Commission
PROPOSED RULES
Energy Conservation Program:
    Test Procedures for Small, Large, and Very Large Air-Cooled 
            Commercial Package Air Conditioning and Heating Equipment, 
            55797-55798
NOTICES
Meetings:
    Environmental Management Site-Specific Advisory Board, 55842
    National Coal Council, 55841-55842
    Secretary of Energy Advisory Board; Correction, 55841


Environmental Protection Agency
RULES
Pesticide Tolerances:
    Halosulfuron-methyl, 55768-55773
PROPOSED RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    Nevada; Regional Haze Progress Report, 55805-55819


Federal Aviation Administration
RULES
Class E Airspace; Amendments:
    Tracy, CA, 55741-55742
Discontinuation of Airport Advisory Service in the Contiguous U.S., 
          Puerto Rico, and Hawaii, 55742
PROPOSED RULES
Airworthiness Directives:
    Airbus Airplanes, 55798-55801


Federal Communications Commission
RULES
Assessment and Collection of Regulatory Fees for Fiscal Year 2015, 
          55775-55795
Expanding the Economic and Innovation Opportunities of Spectrum through 
          Incentive Auctions, 55795-55796
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 55847-55851


Federal Deposit Insurance Corporation
NOTICES
Terminations of Receivership:
    Progress Bank of Florida, Tampa, Fl, 55851


Federal Emergency Management Agency
RULES
Suspensions of Community Eligibility, 55773-55775

[[Page iv]]




Federal Energy Regulatory Commission
NOTICES
Applications:
    Alcoa Power Generating, Inc., 55843-55844
    Greenwood County, SC, 55846-55847
Initial Market-Based Rate Filings Including Requests for Blanket 
          Section 204 Authorizations:
    Little Elk Wind Project, LLC, 55844
    Odell Wind Farm, LLC, 55844-55845
    Robison Energy (Commercial), LLC, 55845
Preliminary Permit Applications:
    Empire State Hydro 303, LLC, 55842-55843
Proposed Restricted Service List for Programmatic Agreements for 
          Managing Properties Included in or Eligible for Inclusion in 
          the National Register of Historic Places:
    Beverly Lock and Dam Water Power Project No. 13404-002, et al., 
            55845-55846


Federal Transit Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 55899-55900


First Responder Network Authority
NOTICES
Meetings:
    First Responder Network Authority Board, 55834


Fiscal Service
RULES
Offset of Tax Refund Payments to Collect Certain Debts Owed to States, 
          55751-55752


Fish and Wildlife Service
NOTICES
Permits:
    Endangered Species; Applications, 55868-55869
    Endangered Species; Marine Mammals, 55867-55868


Food and Drug Administration
RULES
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
          Preventive Controls for Food for Animals, 56170-56356
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
          Preventive Controls for Human Food, 55908-56168
Qualitative Risk Assessment of Risk of Activity/Animal Food 
          Combinations for Activities (Outside the Farm Definition) 
          Conducted in a Facility Co-Located on a Farm; Availability, 
          56360
Qualitative Risk Assessment of Risk of Activity/Food Combinations for 
          Activities (Outside the Farm Definition) Conducted in a 
          Facility Co-Located on a Farm; Availability, 56358
PROPOSED RULES
User Fee Program to Provide for Accreditation of Third-Party Auditors/
          Certification Bodies to Conduct Food Safety Audits and to 
          Issue Certifications; Correction, 55802
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Guidance on Meetings with Industry and Investigators on the 
            Research and Development of Tobacco Products, 55855-55857
    Medical Device User Fee Small Business Qualification and 
            Certification, 55854-55855
    Substances Generally Recognized as Safe, Notification Procedure, 
            55857-55859
Meetings:
    Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 
            Committee, 55859


Forest Service
NOTICES
Meetings:
    National Advisory Committee for Implementation of the National 
            Forest System Land Management Planning Rule, 55827-55828
    Pacific Northwest National Scenic Trail Advisory Council, 55828


Health and Human Services Department
See Centers for Medicare & Medicaid Services
See Children and Families Administration
See Food and Drug Administration
See Health Resources and Services Administration
See National Institutes of Health


Health Resources and Services Administration
NOTICES
Funding Availability:
    Bridging the Word Gap Competition Challenge, 55861-55864
Single-Case Deviation from Competition Requirement for Program 
          Expansion:
    Alliance for Innovation on Maternal and Child Health Cooperative 
            Agreement, 55859-55860
    Centers of Excellence in Maternal and Child Health in Education, 
            Science, and Practice Program, 55860-55861


Homeland Security Department
See Coast Guard
See Federal Emergency Management Agency


Housing and Urban Development Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Legal Instructions Concerning Applications for Full Insurance 
            Benefits Assignment of Multifamily Mortgages to the 
            Secretary Correction of Website Address for Form, 55866-
            55867


Interior Department
See Fish and Wildlife Service
See National Park Service
See Surface Mining Reclamation and Enforcement Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Alternatives in Hydropower Licensing, 55869-55870


Internal Revenue Service
PROPOSED RULES
Substantiation Requirement for Certain Contributions, 55802-55805


International Trade Administration
NOTICES
Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
    Corrosion-Resistant Carbon Steel Flat Products from the Republic of 
            Korea, 55834-55836

[[Page v]]




International Trade Commission
NOTICES
Investigations; Determinations, Modifications, and Rulings, etc.:
    Cold-Rolled Steel Flat Products from Brazil, China, India, Japan, 
            Korea, Netherlands, Russia, and the United Kingdom, 55872
    Marine Sonar Imaging Systems, Products Containing the Same, and 
            Components Thereof, 55872-55874


Labor Department
See Mine Safety and Health Administration


Maritime Administration
NOTICES
Requests for Administrative Waivers of the Coastwise Trade Laws:
    Vessel ADRENALINE, 55900
    Vessel ALANA MCCREE, 55900-55901
    Vessel KING OF HEARTS, 55901-55902
    Vessel THE LONG RUN, 55902
    Vessel WAVE DANCER, 55901


Mine Safety and Health Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Respirable Coal Mine Dust Sampling, 55874-55878


National Highway Traffic Safety Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 55903-55904


National Institute of Standards and Technology
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Generic Clearance for Usability Data Collections, 55836


National Institutes of Health
NOTICES
Meetings:
    Center for Scientific Review, 55864-55866


National Oceanic and Atmospheric Administration
PROPOSED RULES
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic:
    Dolphin and Wahoo Fishery Off the Atlantic States and Snapper-
            Grouper Fishery of the South Atlantic Region; Amendments 7/
            33, 55819-55821
    Reef Fish Fishery of the Gulf of Mexico; Greater Amberjack 
            Management Measures, 55821-55825
Initiation of Review of Management Plan and Regulations of the Monterey 
          Bay National Marine Sanctuary:
    Scoping and Draft Environmental Impact Statement and Management 
            Plan; Correction, 55801-55802
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Mail Survey to Collect Economic Data from Federal Gulf of Mexico 
            and South Atlantic For-Hire Permit Holders, 55838
    Vessel Monitoring System Requirements under the Western and Central 
            Pacific Fisheries Convention, 55836-55837
Meetings:
    Pacific Island Fisheries, 55837-55838


National Park Service
NOTICES
National Register of Historic Places:
    Pending Nominations and Related Actions, 55870-55872


National Telecommunications and Information Administration
NOTICES
Meetings:
    First Responder Network Authority Board, 55834


Navy Department
NOTICES
Environmental Impact Statements; Availability, etc.:
    Guam and Commonwealth of the Northern Mariana Islands Military 
            Relocation, 55838-55839


Nuclear Regulatory Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Destinations of Released Patients Following Treatment with Iodine-
            131 and Estimation of Doses to Members of the Public at 
            Locations other than Conventional Residences Receiving Such 
            Patients, 55879-55880
Guidance:
    Independent Assessment of Nuclear Material Control and Accounting 
            Systems, 55880-55881
    Seismic Design Classification for Nuclear Power Plants, 55878-55879


Pension Benefit Guaranty Corporation
RULES
Multiemployer Plans; Electronic Filing Requirements, 55742-55745


Personnel Management Office
RULES
Federal Employees Health Benefits Program Self Plus One Enrollment 
          Type, 55726-55739


Postal Service
RULES
Rules of Practice before the Judicial Officer, 55766-55768


Presidential Documents
PROCLAMATIONS
Special Observances:
    National Grandparents Day (Proc. 9321), 55719-55720
    National Hispanic Heritage Month (Proc. 9322), 56361-56364
    National Hispanic-Serving Institutions Week (Proc. 9320), 55717-
            55718
ADMINISTRATIVE ORDERS
Foreign Assistance Act of 1961; Delegation of Authority (Memorandum of 
          August 28, 2015), 55715


Rural Utilities Service
NOTICES
Environmental Impact Statements; Availability, etc.:
    Energy Answers Arecibo, LLC, 55828-55829


Securities and Exchange Commission
NOTICES
Applications:
    Pomona Investment Fund, et al., 55885-55887
Self-Regulatory Organizations; Proposed Rule Changes:
    BATS Exchange, Inc., 55882-55883

[[Page vi]]

    C2 Options Exchange, Inc., 55887-55888
    NASDAQ OMX BX, Inc., 55888-55891
    National Securities Clearing Corp., 55883-55885
    NYSE Arca, Inc., 55892-55899


Surface Mining Reclamation and Enforcement Office
RULES
Pennsylvania Regulatory Program, 55746-55751


Surface Transportation Board
NOTICES
Abandonment Exemptions:
    Norfolk Southern Railway Co., Nottoway County, VA, 55904-55905


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


Treasury Department
See Fiscal Service
See Internal Revenue Service


Veterans Affairs Department
RULES
Loan Guaranties:
    Specially Adapted Housing Assistive Technology Grant Program, 
            55763-55766

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          55908-56168


Part III
Health and Human Services Department, Food and Drug Administration, 
          56170-56356


Part IV
Health and Human Services Department, Food and Drug Administration, 
          56358


Part V
Health and Human Services Department, Food and Drug Administration, 
          56360


Part VI
Presidential Documents, 56361-56364

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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. 80, No. 180 / Thursday, September 17, 2015 / 
Contents  

  Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / 
Contents  

  Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / 
Contents  

[[Page vii]]



                           2 CFR
700..................................................55721

                           3 CFR
Proclamations:
9320.................................................55717
9321.................................................55719
9322.................................................56363
Administrative Orders:
Memorandums:
Memorandum of August 28, 2015........................55715

                           5 CFR
890..................................................55726
892..................................................55726

                           7 CFR
319..................................................55739

                          10 CFR
Proposed Rules:
429..................................................55797
431..................................................55797

                          14 CFR
Ch. I................................................55742
71...................................................55741
Proposed Rules:
39...................................................55798

                          15 CFR
Proposed Rules:
922..................................................55801

                          21 CFR
1....................................................55908
11 (2 documents)..............................55908, 56170
16 (2 documents)..............................55908, 56170
106..................................................55908
110..................................................55908
114..................................................55908
117 (3 documents)......................55908, 56170, 56358
120..................................................55908
123..................................................55908
129..................................................55908
179..................................................55908
211..................................................55908
225..................................................55908
500..................................................55170
507 (2 documents).............................55170, 56360
579..................................................55170
Proposed Rules:
1....................................................55802

                          26 CFR
Proposed Rules:
1....................................................55802

                          29 CFR
4000.................................................55742
4041A................................................55742
4281.................................................55742

                          30 CFR
938..................................................55746

                          31 CFR
285..................................................55751

                          32 CFR
86...................................................55752

                          33 CFR
117 (3 documents)......................55761, 55762, 55763

                          38 CFR
36...................................................55763

                          39 CFR
957..................................................55766

                          40 CFR
180..................................................55768
Proposed Rules:
52...................................................55805

                          44 CFR
64...................................................55773

                          47 CFR
1....................................................55775
27...................................................55795
74...................................................55795

                          50 CFR
Proposed Rules:
622 (2 documents).............................55819, 55821