Federal Register Vol. 81, No.64,

Federal Register Volume 81, Issue 64 (April 4, 2016)

Page Range19021-19466
FR Document

81_FR_64
Current View
Page and SubjectPDF
81 FR 19136 - Certain Steel Nails From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2013-2014PDF
81 FR 19463 - Csar Chávez Day, 2016PDF
81 FR 19246 - Regular Board of Directors Meeting; Sunshine ActPDF
81 FR 19239 - Notice of Intent To Reschedule Public Meetings for the Draft Programmatic Environmental Impact Statement for the Outer Continental Shelf (OCS) Oil and Gas Leasing Program: 2017-2022PDF
81 FR 19178 - Sunshine Act NoticePDF
81 FR 19063 - Importation of Lemons From Chile Into the Continental United StatesPDF
81 FR 19173 - Proposed Information Collection Request; Comment Request; Clean Water Act State Revolving Fund ProgramPDF
81 FR 19234 - 60-Day Notice of Proposed Information Collection: Energy and Performance Information Center (EPIC)PDF
81 FR 19233 - Request for Specific Policy Proposals and Methods of Research and Evaluation for MTW Demonstration ExpansionPDF
81 FR 19094 - Drawbridge Operation Regulation; Norwalk River, Norwalk, CTPDF
81 FR 19040 - Drawbridge Operation Regulation; Three Mile Slough, Rio Vista, CAPDF
81 FR 19097 - Safety Zone, Block Island Wind Farm; Rhode Island Sound, RIPDF
81 FR 19216 - Prince William Sound Regional Citizens' Advisory Council Charter RenewalPDF
81 FR 19041 - Safety Zone; Hudson River, Tarrytown, NYPDF
81 FR 19041 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CAPDF
81 FR 19171 - Pesticide Product Registration; Receipt of Applications for New UsesPDF
81 FR 19188 - Administration on Disabilities, President's Committee for People With Intellectual DisabilitiesPDF
81 FR 19060 - Importation of Fresh Cherimoya Fruit From Chile Into the United StatesPDF
81 FR 19187 - Award of a Single Source Non-Competing Continuation Cooperative Agreement for One National Activities Grant Project Under Section 6 of the Assistive Technology Act of 1998, as Amended (ATAct)PDF
81 FR 19282 - Louisiana Disaster Number LA-00062PDF
81 FR 19282 - Georgia Disaster Number GA-00066PDF
81 FR 19176 - Recommended Aquatic Life Ambient Water Quality Criteria for Cadmium-2016PDF
81 FR 19110 - Waste Prevention, Production Subject to Royalties, and Resource ConservationPDF
81 FR 19162 - Proposed Subsequent ArrangementPDF
81 FR 19098 - Approval and Promulgation of Implementation Plans; Kentucky; Infrastructure Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality StandardPDF
81 FR 19161 - Environmental Management Site-Specific Advisory Board ChairsPDF
81 FR 19169 - Boulder Canyon ProjectPDF
81 FR 19246 - Entergy Nuclear Operations, Inc.; James A. FitzPatrick Nuclear Power PlantPDF
81 FR 19117 - Notice of Funds Availability: Inviting Applications for the Emerging Markets ProgramPDF
81 FR 19113 - Notice of Funds Availability: Inviting Applications for the Foreign Market Development Cooperator ProgramPDF
81 FR 19115 - Notice of Funds Availability: Inviting Applications for the Market Access ProgramPDF
81 FR 19122 - Notice of Funds Availability: Inviting Applications for the Quality Samples ProgramPDF
81 FR 19236 - Grant Availability to Federally Recognized Indian Tribes To Implement Traffic Safety Programs and Projects on Indian ReservationsPDF
81 FR 19120 - Notice of Funds Availability: Inviting Applications for the Technical Assistance for Specialty Crops ProgramPDF
81 FR 19236 - Indian Gaming; Extension of Tribal-State Class III Gaming Compact (Flandreau Santee Sioux Tribe and the State of South Dakota)PDF
81 FR 19185 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
81 FR 19186 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
81 FR 19186 - Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)PDF
81 FR 19137 - Takes of Marine Mammals Incidental to Specified Activities; Sand Quality Study Activities at the Children's Pool Beach, La Jolla, CaliforniaPDF
81 FR 19235 - Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of New MexicoPDF
81 FR 19161 - Agency Information Collection Activities; Comment Request; Teacher Follow-Up Survey (TFS 2016-17) to the National Teacher and Principal Survey (NTPS 2015-16)PDF
81 FR 19236 - Indian Gaming; Notice of Tribal-State Class III Gaming Compact Taking Effect in the State of New MexicoPDF
81 FR 19285 - Shipping Coordinating Committee; Amended Notice of Public MeetingPDF
81 FR 19021 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1; CorrectionsPDF
81 FR 19285 - 60-Day Notice of Proposed Information Collection: Application for a U.S. PassportPDF
81 FR 19112 - National Organic Standards Board (NOSB): Notice of Intent To Renew Charter and Call for NominationsPDF
81 FR 19285 - Culturally Significant Objects Imported for Exhibition Determinations: “Court and Cosmos: The Great Age of the Seljuqs” ExhibitionPDF
81 FR 19058 - Fisheries of the Exclusive Economic Zone Off Alaska; Northern Rockfish in the Bering Sea and Aleutian Islands Management Area.PDF
81 FR 19069 - Food and Drug Administration Review and Action on Over-the-Counter Time and Extent ApplicationsPDF
81 FR 19194 - Labeling for Biosimilar Products; Draft Guidance for Industry; AvailabilityPDF
81 FR 19190 - Determination That PRONESTYL (Procainamide Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
81 FR 19242 - Agency Information Collection Activities; Proposed eCollection eComments Requested; National Institute of Justice Compliance Testing ProgramPDF
81 FR 19241 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Public Safety Officers Permanent and Total DisabilityPDF
81 FR 19240 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Public Safety Officers Death BenefitsPDF
81 FR 19240 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Claim for Death BenefitsPDF
81 FR 19283 - Texas Disaster Number TX-00465PDF
81 FR 19283 - Mississippi Disaster #MS-00084PDF
81 FR 19282 - Pennsylvania Disaster #PA-00069PDF
81 FR 19032 - Extension of the Workers' Compensation Offset From Age 65 to Full Retirement Age-Achieving a Better Life Experience (ABLE) ActPDF
81 FR 19026 - Revisions to the Export Administration Regulations Based on the 2015 Missile Technology Control Regime Plenary AgreementsPDF
81 FR 19250 - Securities Investor Protection Corporation; Order Approving the Determination of the Board of Directors of the Securities Investor Protection Corporation Not To Adjust for Inflation the Standard Maximum Cash Advance Amount and Notice of the Standard Maximum Cash Advance AmountPDF
81 FR 19059 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of AlaskaPDF
81 FR 19220 - Michigan; Amendment No. 1 to Notice of an Emergency DeclarationPDF
81 FR 19288 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Lending LimitsPDF
81 FR 19229 - Proposed Flood Hazard Determinations for Coconino County, Arizona and Incorporated AreasPDF
81 FR 19221 - Final Flood Hazard DeterminationsPDF
81 FR 19224 - Changes in Flood Hazard DeterminationsPDF
81 FR 19205 - Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory CommitteePDF
81 FR 19287 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Examination QuestionnairePDF
81 FR 19289 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Community and Economic Development Entities, Community Development Projects, and Other Public Welfare InvestmentsPDF
81 FR 19216 - Agency Information Collection Activities: Administrative RulingsPDF
81 FR 19036 - Special Local Regulation; Charleston Race Week, Charleston Harbor, Charleston, SCPDF
81 FR 19038 - Special Local Regulation; Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway; Bucksport, SCPDF
81 FR 19269 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Adopting Requirements for the Collection and Transmission of Data Pursuant to Appendices B and C of the Regulation NMS Plan to Implement a Tick Size Pilot ProgramPDF
81 FR 19162 - Challenges and Opportunities for Pumped Storage HydropowerPDF
81 FR 19283 - Agency Information Collection Activities: Proposed RequestPDF
81 FR 19044 - Fisheries of the Northeastern United States; Atlantic Herring Fishery; Framework Adjustment 4PDF
81 FR 19183 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 19195 - Comparability Protocols-Chemistry, Manufacturing, and Controls Information for New Animal Drugs; Guidance for Industry; AvailabilityPDF
81 FR 19125 - Ashley Resource Advisory CommitteePDF
81 FR 19108 - World Trade Center Health Program; Petition 010-Peripheral Neuropathy; Finding of Insufficient EvidencePDF
81 FR 19286 - CSX Transportation, Inc.-Discontinuance of Service Exemption-in Greenbrier and Fayette Counties, W. Va.PDF
81 FR 19136 - New England Fishery Management Council; Public MeetingPDF
81 FR 19211 - Prospective Grant of Exclusive License: Development of 5T4 Antibodies in Human Cancer Therapeutics and DiagnosticsPDF
81 FR 19249 - New Postal ProductPDF
81 FR 19246 - Section 512 Study: Extension of Time To Submit Requests To Participate in RoundtablePDF
81 FR 19214 - National Institute on Aging; Notice of Closed MeetingsPDF
81 FR 19208 - Center For Scientific Review; Notice of Closed MeetingsPDF
81 FR 19179 - Proposed Agency Information Collection Activities; Comment RequestPDF
81 FR 19178 - Proposed Agency Information Collection Activities; Comment RequestPDF
81 FR 19181 - Proposed Agency Information Collection Activities; Comment RequestPDF
81 FR 19208 - Office of the Director, National Institutes of Health; Notice of MeetingPDF
81 FR 19169 - Review of Cost Submittals by Other Federal Agencies for Administering Part I of the Federal Power Act; Notice of Postponing Technical ConferencePDF
81 FR 19164 - Alaska Energy Authority; Notice of Availability of Draft Environmental AssessmentPDF
81 FR 19166 - Commission Information Collection Activities (FERC Form 6-Q); Comment Request; ExtensionPDF
81 FR 19167 - PennEast Pipeline Company, LLC; Notice of Schedule for Environmental Review of the Penneast Pipeline ProjectPDF
81 FR 19163 - Combined Notice of Filings #1PDF
81 FR 19168 - Energy Resources USA, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To IntervenePDF
81 FR 19168 - City of Wadsworth, Ohio; Notice of TeleconferencePDF
81 FR 19164 - Notice of Technical ConferencePDF
81 FR 19165 - Energy Resources USA, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To IntervenePDF
81 FR 19169 - Energy Resources USA, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To IntervenePDF
81 FR 19186 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Health Disparities Subcommittee (HDS)PDF
81 FR 19245 - Agricultural Worker Population Estimates for Basic Field-Migrant GrantsPDF
81 FR 19152 - Proposed Collection; Comment RequestPDF
81 FR 19066 - Administrative Actions for Noncompliance; Lesser Administrative ActionsPDF
81 FR 19033 - Administrative Actions for Noncompliance; Lesser Administrative ActionsPDF
81 FR 19250 - New Postal ProductPDF
81 FR 19247 - New Postal ProductPDF
81 FR 19248 - New Postal ProductPDF
81 FR 19153 - Annual Updates to the Income Contingent Repayment (ICR) Plan Formula for 2016-William D. Ford Federal Direct Loan ProgramPDF
81 FR 19054 - Fisheries Off West Coast States; Comprehensive Ecosystem-Based Amendment 1; Amendments to the Fishery Management Plans for Coastal Pelagic Species, Pacific Coast Groundfish, U.S. West Coast Highly Migratory Species, and Pacific Coast SalmonPDF
81 FR 19275 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Article 20, Rule 13 To Implement the Regulation NMS Plan To Implement a Tick Size Pilot Program (“Plan”)PDF
81 FR 19260 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Instituting Proceedings To Determine Whether to Approve or Disapprove Proposed Rule Change To Adopt FINRA Rule 2030 and FINRA Rule 4580 to Establish “Pay-To-Play” and Related RulesPDF
81 FR 19252 - Self-Regulatory Organizations; BATS Exchange, Inc., BATS Y-Exchange, Inc., EDGX Exchange, Inc., EDGA Exchange, Inc.; Order Approving Proposed Rule Changes To Amend and Restate the Certificate of Incorporation and Bylaws of the Exchanges' Ultimate Parent Company, BATS Global Markets, Inc.PDF
81 FR 19255 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change, as Modified by Amendment Nos. 1, 2, 3, and 4 Thereto, To List and Trade Shares of the REX Gold Hedged S&P 500 ETF and the REX Gold Hedged FTSE Emerging Markets ETF Under NYSE Arca Equities Rule 8.600PDF
81 FR 19157 - Deadline Dates for Reports and Other Records Associated With the Free Application for Federal Student Aid (FAFSA®), the Federal Pell Grant Program, the William D. Ford Federal Direct Loan Program, the Teacher Education Assistance for College and Higher Education Grant Program, and the Iraq and Afghanistan Service Grant Program for the 2016-2017 Award YearPDF
81 FR 19220 - Pennsylvania; Major Disaster and Related DeterminationsPDF
81 FR 19228 - Georgia; Amendment No. 1 to Notice of a Major Disaster DeclarationPDF
81 FR 19233 - Mississippi; Major Disaster and Related DeterminationsPDF
81 FR 19125 - Information Collection Activity; Comment RequestPDF
81 FR 19217 - Changes in Flood Hazard DeterminationsPDF
81 FR 19228 - Proposed Flood Hazard DeterminationsPDF
81 FR 19210 - National Human Genome Research Institute; Notice of Closed MeetingPDF
81 FR 19214 - National Heart, Lung, and Blood Institute; Amended Notice of MeetingPDF
81 FR 19210 - National Eye Institute; Notice of Closed MeetingPDF
81 FR 19212 - National Institute on Aging Amended Notice of MeetingPDF
81 FR 19209 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
81 FR 19207 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
81 FR 19213 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingsPDF
81 FR 19213 - Prospective Grant of Start-Up Exclusive License: Therapeutics for Multiple Sclerosis, Amyotrophic Lateral Sclerosis and Certain Other CNS DisordersPDF
81 FR 19230 - Proposed Flood Hazard DeterminationsPDF
81 FR 19222 - Proposed Flood Hazard DeterminationsPDF
81 FR 19238 - Request for Nominations for the Preservation Technology and Training BoardPDF
81 FR 19175 - Proposed Consent Decree, Clean Air Act Citizen SuitPDF
81 FR 19172 - Agency Information Collection Activities; Proposed Renewal of an Existing Collection (EPA ICR No. 0278.12); Comment RequestPDF
81 FR 19207 - Center for Scientific Review; Notice of Closed MeetingPDF
81 FR 19207 - Proposed Collection; 60 Day Comment Request; Women's Health Initiative (NHLBI)PDF
81 FR 19097 - Promulgation of Implementation Plans; Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation Plan; Reopening of Comment Period and Notice of AvailabilityPDF
81 FR 19212 - Center for Scientific Review; Notice of Closed MeetingPDF
81 FR 19210 - National Cancer Institute; Notice of MeetingPDF
81 FR 19211 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 19243 - MET Laboratories, Inc.: Grant of Expansion of Recognition and Modification to the NRTL Program's List of Appropriate Test StandardsPDF
81 FR 19209 - National Cancer Institute; Notice of Closed MeetingsPDF
81 FR 19213 - Center for Scientific Review; Amended Notice of MeetingPDF
81 FR 19212 - National Institute on Deafness and Other Communication Disorders; Notice of MeetingPDF
81 FR 19191 - Emergency Use Authorization of Medical Products and Related Authorities; Draft Guidance for Industry and Public Health Stakeholders; AvailabilityPDF
81 FR 19188 - Determination of Regulatory Review Period for Purposes of Patent Extension; BRINTELLIXPDF
81 FR 19243 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; H-2A Temporary Employment Certification ProgramPDF
81 FR 19183 - Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)PDF
81 FR 19131 - BE-150: Quarterly Survey of Payment Card and Bank Card Transactions Related to International TravelPDF
81 FR 19135 - BE-185: Quarterly Survey of Financial Services Transactions Between U.S. Financial Services Providers and Foreign PersonsPDF
81 FR 19128 - BE-577: Quarterly Survey of U.S. Direct Investment Abroad-Transactions of U.S. Reporter With Foreign AffiliatePDF
81 FR 19129 - BE-605: Quarterly Survey of Foreign Direct Investment in the United States-Transactions of U.S. Affiliate With Foreign ParentPDF
81 FR 19128 - BE-125: Quarterly Survey of Transactions in Selected Services and Intellectual Property With Foreign PersonsPDF
81 FR 19132 - BE-45: Quarterly Survey of Insurance Transactions by U.S. Insurance Companies With Foreign PersonsPDF
81 FR 19127 - BE-37: Quarterly Survey of U.S. Airline Operators' Foreign Revenues and ExpensesPDF
81 FR 19196 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 041PDF
81 FR 19214 - Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal AgenciesPDF
81 FR 19130 - BE-30: Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of U.S. CarriersPDF
81 FR 19133 - BE-9: Quarterly Survey of Foreign Airline Operators' Revenues and Expenses in the United StatesPDF
81 FR 19134 - BE-11: Annual Survey of U.S. Direct Investment AbroadPDF
81 FR 19132 - BE-29: Annual Survey of Foreign Ocean Carriers' Expenses in the United StatesPDF
81 FR 19126 - BE-15: Annual Survey of Foreign Direct Investment in the United StatesPDF
81 FR 19291 - Proposed Information Collection (The Veterans Metrics Initiative: Linking Program Components to Post-Military Well-Being); Activity: Comment RequestPDF
81 FR 19290 - Proposed Information Collection (Complaint of Employment Discrimination, VA Form 4939; Information for Pre-Complaint Processing, VA Form 08-10192); Activity: Comment RequestPDF
81 FR 19293 - Agency Information Collection (Application for VA Education Benefits, Application for Family Member to Use Transferred Benefits, Application for VA Education Benefits Under the National Call to Service (NCS) Program and Application for Veterans Retraining Assistance Program) Activity Under OMB ReviewPDF
81 FR 19291 - Proposed Information Collection-Department of Housing and Urban Development (HUD)/Department of Veterans Affairs (VA) Addendum to Uniform Residential Loan Application (VA Form 26-1802A); Activity: Comment RequestPDF
81 FR 19292 - Proposed Information Collection (Request for Determination of Loan Guaranty Eligibility-Unmarried Surviving Spouses); Activity: Comment RequestPDF
81 FR 19043 - Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Correction and Technical AmendmentsPDF
81 FR 19022 - Airworthiness Directives; General Electric Company Turbofan EnginesPDF
81 FR 19024 - Airworthiness Directives; Technify Motors GmbH Reciprocating EnginesPDF
81 FR 19086 - Amendments to the Definition of Broker or Dealer in SecuritiesPDF
81 FR 19353 - Federal Agency Final Regulations Implementing Executive Order 13559: Fundamental Principles and Policymaking Criteria for Partnerships With Faith-Based and Other Neighborhood OrganizationsPDF
81 FR 19325 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Pier Construction and Support Facilities Project, Port Angeles, WAPDF
81 FR 19295 - Miscellaneous Changes to Trademark Trial and Appeal Board Rules of PracticePDF
81 FR 19431 - Promoting Diversification of Ownership in the Broadcasting ServicesPDF

Issue

81 64 Monday, April 4, 2016 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Requests for Nominations: U.S. Preventive Services Task Force, 19183-19185 2016-07475 Agency Agency for International Development RULES Fundamental Principles and Policymaking Criteria for Partnerships with Faith-Based and Other Neighborhood Organizations, 19355-19430 2016-07339 Agricultural Marketing Agricultural Marketing Service NOTICES Charter Renewals: National Organic Standards Board; Request for Nominations, 19112-19113 2016-07616 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Animal and Plant Health Inspection Service

See

Commodity Credit Corporation

See

Forest Service

See

Rural Utilities Service

RULES Fundamental Principles and Policymaking Criteria for Partnerships with Faith-Based and Other Neighborhood Organizations, 19355-19430 2016-07339
Animal Animal and Plant Health Inspection Service PROPOSED RULES Importation of Fresh Cherimoya Fruit from Chile into the United States, 19060-19063 2016-07653 Importation of Lemons from Chile into the Continental United States, 19063-19066 2016-07673 Centers Disease Centers for Disease Control and Prevention NOTICES Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 19185-19186 2016-07628 2016-07625 2016-07626 2016-07627 Health Disparities Subcommittee, 19186 2016-07527 Subcommittee for Dose Reconstruction Reviews, Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health, 19186-19187 2016-07624 Coast Guard Coast Guard RULES Drawbridge Operations: Sacramento River, Sacramento, CA, 19041 2016-07656 Three Mile Slough, Rio Vista, CA, 19040-19041 2016-07660 Safety Zones: Hudson River, Tarrytown, NY, 19041-19043 2016-07657 Special Local Regulations: Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway, Bucksport, SC, 19038-19040 2016-07588 Charleston Race Week, Charleston Harbor, Charleston, SC, 19036-19038 2016-07589 PROPOSED RULES Drawbridge Operations: Norwalk River, Norwalk, CT, 19094-19097 2016-07662 Safety Zones: Block Island Wind Farm; Rhode Island Sound, RI, 19097 2016-07659 NOTICES Charter Renewals: Prince William Sound Regional Citizens' Advisory Council, 19216 2016-07658 Commerce Commerce Department See

Economic Analysis Bureau

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Commodity Credit Commodity Credit Corporation NOTICES Funding Availability: Emerging Markets Program, 19117-19120 2016-07638 Foreign Market Development Cooperator Program, 19113-19115 2016-07637 Market Access Program, 19115-19117 2016-07636 Quality Samples Program, 19122-19125 2016-07635 Technical Assistance for Specialty Crops Program, 19120-19122 2016-07633 Community Living Administration Community Living Administration NOTICES Meetings: Administration on Disabilities, President's Committee for People with Intellectual Disabilities, 19188 2016-07654 Single-Source, Non-Competitive Awards: National Activities Grant Project, 19187 2016-07652 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Community and Economic Development Entities, Community Development Projects, and Other Public Welfare Investments, 19289-19290 2016-07591 Examination Questionnaire, 19287-19288 2016-07592 Lending Limits, 19288-19289 2016-07597 Copyright Office Copyright Office, Library of Congress NOTICES Meetings: Section 512 Study, 19246 2016-07550 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19152-19153 2016-07525 Economic Analysis Bureau Economic Analysis Bureau NOTICES Surveys: Financial Services Transactions Between U.S. Financial Services Providers and Foreign Persons, 19135-19136 2016-07473 Foreign Airline Operators' Revenues and Expenses in the United States, 19133-19134 2016-07464 Foreign Direct Investment in the United States, 19126-19127 2016-07460 Foreign Direct Investment in the United States -- Transactions of U.S. Affiliate With Foreign Parent, 19129-19130 2016-07471 Foreign Ocean Carriers' Expenses in the United States, 19132-19133 2016-07462 Insurance Transactions by U.S. Insurance Companies with Foreign Persons, 19132 2016-07469 Ocean Freight Revenues and Foreign Expenses of U.S. Carriers, 19130-19131 2016-07465 Payment Card and Bank Card Transactions Related to International Travel, 19131-19132 2016-07474 Transactions in Selected Services and Intellectual Property with Foreign Persons, 19128-19129 2016-07470 U.S. Airline Operators' Foreign Revenues and Expenses, 19127 2016-07468 U.S. Direct Investment Abroad, 19134-19135 2016-07463 U.S. Direct Investment Abroad -- Transactions of U.S. Reporter With Foreign Affiliate, 19128 2016-07472 Education Department Education Department RULES Fundamental Principles and Policymaking Criteria for Partnerships with Faith-Based and Other Neighborhood Organizations, 19355-19430 2016-07339 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Teacher Follow-up Survey to the National Teacher and Principal Survey, 19161 2016-07621 Free Application for Federal Student Aid, the Federal Pell Grant Program, the William D. Ford Federal Direct Loan Program, the Teacher Education Assistance for College and Higher Education Grant Program, and the Iraq and Afghanistan Service Grant Program for the 2016-2017 Award Year; Deadline Dates, 19157-19161 2016-07510 William D. Ford Federal Direct Loan Program; Income Contingent Repayment Plan Formula for 2016, 19153-19157 2016-07517 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

See

Western Area Power Administration

NOTICES Meetings: Environmental Management Site-Specific Advisory Board Chairs, 19161-19162 2016-07642 Proposed Subsequent Arrangement, 19162 2016-07643 2016-07645
Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Meetings: Challenges and Opportunities for Pumped Storage Hydropower, 19162-19163 2016-07585 Environmental Protection Environmental Protection Agency PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation Plan; Reopening of Comment Period, 19097-19098 2016-07486 Kentucky; Infrastructure Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard, 19098-19108 2016-07644 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19172-19173 2016-07490 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Clean Water Act State Revolving Fund Program, 19173-19174 2016-07667 Pesticide Product Registration; Receipt of Applications for New Uses, 19171-19172 2016-07655 Proposed Consent Decrees under the Clean Air Act Citizen Suit, 19175-19176 2016-07491 Recommended Aquatic Life Ambient Water Quality Criteria for Cadmium - 2016, 19176-19178 2016-07647 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: General Electric Company Turbofan Engines, 19022-19024 2016-07377 Technify Motors GmbH Reciprocating Engines, 19024-19025 2016-07376 Federal Communications Federal Communications Commission RULES Promoting Diversification of Ownership in the Broadcasting Services, 19432-19461 2016-04838 Federal Emergency Federal Emergency Management Agency NOTICES Changes in Flood Hazard Determinations, 19217-19220, 19224-19228 2016-07505 2016-07594 Emergency Declarations: Michigan; Amendment No. 1, 19220 2016-07598 Final Flood Hazard Determinations, 19221-19222 2016-07595 Major Disaster Declarations: Georgia; Amendment No. 1, 19228 2016-07508 Major Disasters and Related Determinations: Mississippi, 19233 2016-07507 Pennsylvania, 19220-19221 2016-07509 Proposed Flood Hazard Determinations, 19222-19224, 19228-19233 2016-07494 2016-07495 2016-07504 Proposed Flood Hazard Determinations: Coconino County, AZ and Incorporated Areas, 19229-19230 2016-07596 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19166-19167 2016-07537 Combined Filings, 19163 2016-07535 Environmental Assessments; Availability, etc.: Alaska Energy Authority, 19164-19165 2016-07538 Environmental Impact Statements; Availability, etc.: PennEast Pipeline Co., LLC, 19167-19168 2016-07536 Meetings: Agencies for Administering Part I of the Federal Power Act; Postponement of Technical Conference, 19169 2016-07539 Review of Generator Interconnection Agreements and Procedures American Wind Energy Association, 19164 2016-07532 Wadsworth, OH, 19168 2016-07533 Preliminary Permit Applications: Energy Resources USA, Inc., 19165-19166, 19168-19169 2016-07528 2016-07529 2016-07530 2016-07531 2016-07534 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Meetings; Sunshine Act, 19178 2016-07690 2016-07691 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19178-19183 2016-07543 2016-07544 2016-07545 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 19183 2016-07581 Financial Crimes Financial Crimes Enforcement Network PROPOSED RULES Definition of Broker or Dealer in Securities, 19086-19094 2016-07345 Food and Drug Food and Drug Administration RULES Administrative Actions for Noncompliance; Lesser Administrative Actions, 19033-19036 2016-07523 PROPOSED RULES Administrative Actions for Noncompliance; Lesser Administrative Actions, 19066-19069 2016-07524 Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications, 19069-19086 2016-07612 NOTICES Determination of Regulatory Review Period for Purposes of Patent Extension: BRINTELLIX, 19188-19189 2016-07477 Determinations That Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: PRONESTYL (Procainamide Hydrochloride) Injectable and Other Drug Products, 19190 2016-07610 Guidance: Comparability Protocols -- Chemistry, Manufacturing, and Controls Information for New Animal Drugs, 19195-19196 2016-07573 Emergency Use Authorization of Medical Products and Related Authorities, 19191-19194 2016-07478 Labeling for Biosimilar Products, 19194-19195 2016-07611 Modifications to the List of Recognized Standards, 19196-19205 2016-07467 Forest Forest Service NOTICES Meetings: Ashley Resource Advisory Committee, 19125 2016-07568 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Disease Control and Prevention

See

Community Living Administration

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

RULES Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Correction and Technical Amendments, 19043-19044 2016-07401 Fundamental Principles and Policymaking Criteria for Partnerships with Faith-Based and Other Neighborhood Organizations, 19355-19430 2016-07339 PROPOSED RULES World Trade Center Health Program: Peripheral Neuropathy Petition; Finding of Insufficient Evidence, 19108-19110 2016-07567 NOTICES Requests for Nominations: Chronic Fatigue Syndrome Advisory Committee, 19205-19206 2016-07593
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Customs and Border Protection

RULES Fundamental Principles and Policymaking Criteria for Partnerships with Faith-Based and Other Neighborhood Organizations, 19355-19430 2016-07339
Housing Housing and Urban Development Department RULES Fundamental Principles and Policymaking Criteria for Partnerships with Faith-Based and Other Neighborhood Organizations, 19355-19430 2016-07339 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Energy and Performance Information Center, 19234-19235 2016-07665 Specific Policy Proposals and Methods of Research and Evaluation for MTW Demonstration Expansion, 19233-19234 2016-07663 Indian Affairs Indian Affairs Bureau NOTICES Grant Availability to Federally Recognized Indian Tribes to Implement Traffic Safety Programs and Projects on Indian Reservations, 19236-19238 2016-07634 Indian Gaming: Extension of Tribal-State Class III Gaming Compact; Flandreau Santee Sioux Tribe and the State of South Dakota, 19236 2016-07632 Tribal-State Class III Gaming Compact Taking Effect in the State of New Mexico, 19235-19236 2016-07620 2016-07622 Industry Industry and Security Bureau RULES Revisions to the Export Administration Regulations Based on the 2015 Missile Technology Control Regime Plenary Agreements, 19026-19032 2016-07601 Interior Interior Department See

Indian Affairs Bureau

See

Land Management Bureau

See

National Park Service

See

Ocean Energy Management Bureau

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81 64 Monday, April 4, 2016 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0156] RIN 3150-AJ63 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1; Corrections AGENCY:

Nuclear Regulatory Commission.

ACTION:

Correcting amendments.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) published a direct final rule in the Federal Register on January 6, 2016, amending its spent fuel storage regulations by revising the Holtec International (Holtec) HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to include Amendment No. 9, Revision 1, to Certificate of Compliance (CoC) No. 1014. The direct final rule inadvertently omitted Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012), to CoC No. 1014. This document is necessary to correct this omission.

DATES:

This rule is effective on April 4, 2016.

ADDRESSES:

Please refer to Docket ID NRC-2015-0156 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0156. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]

NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:

Robert D. MacDougall, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-5175, email: [email protected]; U.S. Nuclear Regulatory Commission, Washington DC 20555-0001.

SUPPLEMENTARY INFORMATION: I. Discussion

The NRC published a direct final rule in the Federal Register on January 6, 2016 (81 FR 371), that amended its spent fuel storage regulations by revising the Holtec HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to include Amendment No. 9, Revision 1, to CoC No. 1014. The direct final rule inadvertently omitted Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012) to CoC No. 1014. In a final rule published in the Federal Register on August 18, 2015 (80 FR 49887), the NRC amended its spent fuel storage regulations by revising the Holtec HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to add Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012) to the CoC No. 1014. This document restores Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012) to CoC No. 1014.

II. Rulemaking Procedure

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(B), the NRC finds good cause to waive notice and opportunity for comment on the amendments because it will have no substantive impact and is of a minor and administrative nature. Specifically, these amendments are to restore Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012) to CoC No. 1014. These amendments do not require action by any person or entity regulated by the NRC. Also, the final rule does not change the substantive responsibilities of any person or entity regulated by the NRC. Furthermore, for these reasons, the NRC finds, pursuant to 5 U.S.C. 553(d)(3), that good cause exists to make this rule effective upon publication of this document.

List of Subjects for 10 CFR Part 72

Administrative practice and procedure, Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Manpower training programs, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 72:

PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183,184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

2. In § 72.214, Certificate of Compliance No. 1014 is revised to read as follows:
§ 72.214 List of approved spent fuel storage casks.

Certificate Number: 1014.

Initial Certificate Effective Date: May 31, 2000.

Amendment Number 1 Effective Date: July 15, 2002.

Amendment Number 2 Effective Date: June 7, 2005.

Amendment Number 3 Effective Date: May 29, 2007.

Amendment Number 4 Effective Date: January 8, 2008.

Amendment Number 5 Effective Date: July 14, 2008.

Amendment Number 6 Effective Date: August 17, 2009.

Amendment Number 7 Effective Date: December 28, 2009.

Amendment Number 8 Effective Date: May 2, 2012, as corrected on November 16, 2012 (ADAMS Accession No. ML12213A170); superseded by Amendment Number 8, Revision 1, on February 16, 2016.

Amendment Number 8, Revision 1, Effective Date: February 16, 2016.

Amendment Number 9 Effective Date: March 11, 2014, superseded by Amendment Number 9, Revision 1, on March 21, 2016.

Amendment Number 9, Revision 1, Effective Date: March 21, 2016.

Safety Analysis Report (SAR) Submitted by: Holtec International.

SAR Title: Final Safety Analysis Report for the HI-STORM 100 Cask System.

Docket Number: 72-1014.

Certificate Expiration Date: May 31, 2020.

Model Number: HI-STORM 100.

Dated at Rockville, Maryland, this 30th day of March, 2016.

For the Nuclear Regulatory Commission.

Cindy Bladey, Chief, Rules, Announcements, and Directives Branch, Division of Administrative Services, Office of Administration.
[FR Doc. 2016-07618 Filed 4-1-16; 8:45 am] BILLING CODE 7590-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-4023; Directorate Identifier 2015-NE-29-AD; Amendment 39-18445; AD 2016-06-14] RIN 2120-AA64 Airworthiness Directives; General Electric Company Turbofan Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all General Electric Company (GE) CF6-80E1 turbofan engines with rotating compressor discharge pressure (CDP) seal, part number (P/N) 1669M73P02, installed. This AD was prompted by reports from the manufacturer of cracks in the teeth of two rotating CDP seals found during engine shop visits. This AD requires stripping of the coating, inspecting, and recoating the teeth of the affected rotating CDP seals. We are issuing this AD to prevent cracking of the CDP seal teeth, uncontained part release, damage to the engine, and damage to the airplane.

DATES:

This AD is effective May 9, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 9, 2016.

ADDRESSES:

For service information identified in this final rule, contact General Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215; phone: 513-552-3272; email: [email protected]. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4023.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4023; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Herman Mak, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7147; fax: 781-238-7199; email: [email protected].

SUPPLEMENTARY INFORMATION: Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all GE CF6-80E1 turbofan engines with rotating CDP seal, P/N 1669M73P02, installed. The NPRM published in the Federal Register on November 17, 2015 (80 FR 71747). The NPRM was prompted by reports of cracks in the teeth of two rotating CDP seals found during engine shop visits. The NPRM proposed to require stripping of the coating, inspecting, and recoating the teeth of the affected rotating CDP seals. We are issuing this AD to prevent cracking of the CDP seal teeth, uncontained part release, damage to the engine, and damage to the airplane.

Comments

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 71747, November 17, 2015) (“the NPRM”) and the FAA's response to each comment.

Request To Clarify Definition

Qantas, Air France, KLM Royal Dutch Airlines (KLM), and GE Aviation requested that the shop visit definition be clarified to allow for randomly occurring exemptions. Including exemptions would not increase the time between full shop visits.

We agree. We changed the shop visit definition to include specific conditions that do not qualify as shop visits.

Request To Clarify the Shop Visit Definition

KLM and Air France requested we clarify the phrase “separation of pairs of major mating engine flanges”.

We agree. We changed the definition for engine shop visit.

Request To Change Compliance Time

Qantas requested a more restrictive compliance time for engines that experience blade-out events and a less restrictive compliance time of next part exposure for all other affected engines. Only engines that experience blade-out conditions require urgent compliance times.

We disagree. The compliance times in the NPRM were derived from analysis that includes the risks associated with engines with and without blade-out events. We did not change this AD.

Request To Clarify Compliance

Qantas requested that we clarify the specific type of stationary CDP seal repair and that we clarify what is considered a replaced stationary CDP seal.

We agree. We modified the Compliance section to specify the repair as `honeycomb'. We also added a definition to define a replaced CDP seal.

Request To Change Applicability

KLM requested that the applicability be expanded to include spare parts.

We partially agree. We agree with the concern for accidental installation of borazon-nickel coated rotating CDP seals because the NPRM does not preclude this scenario. We disagree with expanding this AD to include spare parts because ADs address unsafe conditions of engines, not spare parts. We changed this AD by adding an installation prohibition paragraph to address this concern.

Request To Change Credit for Previous Action

KLM requested the Credit for Previous Action paragraph allow for other approved original equipment manufacturer approved procedures for stripping and recoating rotating CDP seal teeth. KLM recoated two CDP seals using a procedure approved by GE.

We disagree. It is unknown whether previous recoating procedures are equivalent to the procedures specified in the Credit for Previous Action paragraph of this AD. Any party may submit a request for an Alternative Method of Compliance using the procedures listed in this AD. We did not change this AD.

Additional Changes

We clarified paragraphs (e)(2)(i) and (e)(2)(ii) of this AD.

We updated the cost estimate. We changed the Costs of Compliance paragraph of this AD by increasing the number of affected engines by four and updating the costs accordingly.

Conclusion

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

We reviewed GE Service Bulletin (SB) CF6-80E1 S/B 72-0529, Revision 01, dated August 21, 2015. The SB describes procedures for stripping, inspecting, and replacing the seal tooth coating on the affected rotating CDP seals. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Other Related Service Information

We reviewed GE CF6-80E1 (GEK99376) Engine Manual, Revision 42, dated March 15, 2014. The engine manual describes acceptable repair procedures for the seal teeth.

Costs of Compliance

We estimate that this AD will affect 10 engines installed on airplanes of U.S. registry. We also estimate that it will take about 7.15 hours per engine to comply with this AD. The average labor rate is $85 per hour. Parts would cost about $7,835 per engine. Based on these figures, we estimate the total cost of this AD to U.S. operators to be $84,428.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

Adoption of the Amendment

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-06-14 General Electric Company: Amendment 39-18445; Docket No. FAA-2015-4023; Directorate Identifier 2015-NE-29-AD. (a) Effective Date

This AD is effective May 9, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to all General Electric Company (GE) CF6-80E1 turbofan engines with rotating compressor discharge pressure (CDP) seals, part number (P/N) 1669M73P02, installed.

(d) Unsafe Condition

This AD was prompted by reports from the manufacturer of cracks in the teeth of two rotating CDP seals found during engine shop visits. We are issuing this AD to prevent cracking of the CDP seal teeth, which can lead to uncontained part release, damage to the engine, and damage to the airplane.

(e) Compliance

(1) Comply with this AD within the compliance times specified, unless already done.

(2) Strip coating, inspect, and recoat the teeth of the rotating CDP seal, P/N 1669M73P02. Use paragraph 3.C.(2) of GE Service Bulletin (SB) CF6-80E1 S/B 72-0529, Revision 01, dated August 21, 2015 to do the strip coating, inspecting, and recoating, as follows:

(i) For engines that have had stationary CDP seal, P/N 1347M28G02, replaced or stationary CDP seal honeycomb repaired; strip coating, inspect, and recoat the teeth of the rotating CDP seal at the next engine shop visit.

(ii) For engines that have not had stationary CDP seal, P/N 1347M28G02, replaced or stationary CDP seal honeycomb repaired; strip coating, inspect, and recoat the teeth of the rotating CDP seal at the next part exposure of the rotating CDP seal.

(f) Installation Prohibition

After the effective date of this AD, do not install any rotating CDP seal, P/N 1669M73P02, that has not had its seal teeth recoated using procedures specified in ESM 72-31-10, REPAIR 002 of GE CF6-80E1 (GEK99376) Engine Manual, Revision 42, dated March 15, 2014, into any engine.

(g) Definitions

(1) For the purpose of this AD, exposure of the rotating CDP seal is defined as removal of the compressor rear frame from the high-pressure compressor (HPC) module.

(2) For the purpose of this AD, an engine shop visit is defined as the induction of an engine into the shop for maintenance involving the separation of any major mating engine flanges, except that the separation of engine flanges solely for the following purposes is not considered a shop visit:

(i) Transportation without subsequent engine maintenance.

(ii) Removing the turbine rear frame (TRF) for repair of TRF cracking.

(iii) Removing the top or bottom HPC case, or both, for HPC airfoil maintenance.

(iv) Removing only the accessory gearbox and/or transfer gearbox.

(v) Replacing the high-pressure turbine (HPT) stage 1 blades per CF6-80E1 SB 72-0504 “Quick-Turn Workscope Procedure to Replace CF6-80E1 Stage 1 HPT Blades”.

(3) For the purpose of this AD, a stationary CDP seal is replaced if at any previous shop visit, the seal has been removed and a different seal is installed.

(h) Credit for Previous Action

You may take credit for the actions that are required by paragraph (e) of this AD if the actions were performed before the effective date of this AD using the procedures in ESM 72-31-10, REPAIR 002 of the GE CF6-80E1 (GEK99376) Engine Manual, Revision 42, dated March 15, 2014, or earlier versions.

(i) Alternative Methods of Compliance (AMOCs)

The Manager, Engine Certification Office, FAA, may approve AMOCs to this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to: [email protected].

(j) Related Information

(1) For more information about this AD, contact Herman Mak, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7147; fax: 781-238-7199; email: [email protected].

(k) Material Incorporated by Reference

(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.

(i) General Electric Company Service Bulletin CF6-80E1 S/B 72-0529, Revision 01, dated August 21, 2015.

(ii) Reserved.

(3) For GE service information identified in this AD, contact General Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215; phone: 513-552-3272; email: [email protected].

(4) You may view this service information at FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

(5) You may view this service information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

Issued in Burlington, Massachusetts, on March 16, 2016. Ann C. Mollica, Acting Manager, Engine & Propeller Directorate, Aircraft Certification Service.
[FR Doc. 2016-07377 Filed 4-1-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-5193; Directorate Identifier 2015-NE-35-AD; Amendment 39-18464; AD 2016-07-19] RIN 2120-AA64 Airworthiness Directives; Technify Motors GmbH Reciprocating Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Technify Motors GmbH (type certificate previously held by Thielert Aircraft Engines GmbH) TAE 125-02-99 and TAE 125-02-114 reciprocating engines. This AD requires removal of affected fuel feed pumps. This AD was prompted by reports of in-flight shutdowns on TAE 125-02 engines. We are issuing this AD to prevent failure of the fuel feed pump, damage to the engine, and damage to the airplane.

DATES:

This AD becomes effective May 9, 2016.

ADDRESSES:

For service information identified in this AD, contact Technify Motors GmbH, Platanenstrasse 14, D-09356 Sankt Egidien, Germany; phone: +49-37204-696-0; fax: +49-37204-696-2912; email: [email protected] You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5193.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5193; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the mandatory continuing airworthiness information (MCAI), the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email: [email protected]gov.

SUPPLEMENTARY INFORMATION: Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The NPRM was published in the Federal Register on January 4, 2016 (81 FR 27). The NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

In-flight shut down occurrences have been reported on aeroplanes equipped with TAE 125-02 engines. The initial results of the investigations showed that a defective fuel feed pump was the probable cause of the engine failure.

You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5193.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 27, January 4, 2016).

Conclusion

We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed.

Related Service Information

Technify Motors GmbH has issued Operation & Maintenance Manual, CD-135/CD-155, OM-02-02, Issue 4, Revision No. 5, dated September 18, 2015. The service information describes procedures for removing and replacing the fuel feed pump.

Costs of Compliance

We estimate that this AD affects 190 engines installed on airplanes of U.S. registry. We also estimate that it will take about 0.5 hours per engine to comply with this AD. The average labor rate is $85 per hour. Pro-rated cost of the life limit reduction is about $160 per part. Based on these figures, we estimate the cost of this AD on U.S. operators to be $38,475.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

Adoption of the Amendment

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-07-19 Technify Motors GmbH (Type Certificate previously held by Thielert Aircraft Engines GmbH): Amendment 39-18464; Docket No. FAA-2015-5193; Directorate Identifier 2015-NE-35-AD. (a) Effective Date

This AD becomes effective May 9, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to all Technify Motors GmbH TAE 125-02-99 and TAE 125-02-114 reciprocating engines with a fuel feed pump, part number (P/N) 05-7312-K0073xx, or P/N 05-7312-K0133xx, where “xx” can be any number, installed.

(d) Reason

This AD was prompted by reports of in-flight shutdowns on TAE 125-02 engines. We are issuing this AD to prevent failure of the fuel feed pump, damage to the engine, and damage to the airplane.

(e) Actions and Compliance

Comply with this AD within the compliance times specified, unless already done. Remove from service each affected fuel feed pump before it exceeds 600 operating hours (OH) time in service (TIS) or within 110 OH after the effective date of this AD, whichever occurs later.

(f) Installation Prohibition

After the effective date of this AD, do not install onto any engine, any fuel feed pump, P/N 05-7312-K0073xx or P/N 05-7312-K0133xx, where “xx” can be any number, if the fuel feed pump has 600 hours or more TIS. If TIS of a fuel feed pump is unknown or has exceeded 600 hours TIS, then the fuel feed pump is not eligible for installation. Rebuilt, overhauled, or repaired fuel feed pumps or fuel feed pumps that lack a serial number, are not eligible for installation.

(g) Related Information

(1) For more information about this AD, Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email: [email protected]

(2) Refer to MCAI European Aviation Safety Agency AD 2015-0189, dated September 21, 2015, for more information. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2015-5193.

(3) For service information identified in this AD, contact Technify Motors GmbH, Platanenstrasse 14, D-09356 Sankt Egidien, Germany; phone: +49-37204-696-0; fax: +49-37204-696-2912; email: [email protected]

(4) You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

(h) Material Incorporated by Reference

None.

Issued in Burlington, Massachusetts, on March 25, 2016. Colleen M. D'Alessandro, Manager, Engine & Propeller Directorate, Aircraft Certification Service.
[FR Doc. 2016-07376 Filed 4-1-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 742, 750 and 774 [Docket No. 160204079-6079-01] RIN 0694-AG77 Revisions to the Export Administration Regulations Based on the 2015 Missile Technology Control Regime Plenary Agreements AGENCY:

Bureau of Industry and Security, Commerce.

ACTION:

Final rule.

SUMMARY:

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to reflect changes to the Missile Technology Control Regime (MTCR) Annex that were agreed to by MTCR member countries at the October 2015 Plenary in Rotterdam, Netherlands, and the April 2015 Technical Experts Meeting (TEM) in Bern, Switzerland. This final rule makes conforming changes to correlate the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) and other EAR provisions with the current MTCR Annex. This final rule revises six Export Control Classification Numbers (ECCNs) to implement the changes that were agreed to at the meetings and to better align the MT controls on the CCL with the MTCR Annex. In addition, this final rule makes a change to MT licensing policy to be consistent with the MTCR Annex General Minimum Software Note and the MTCR Annex General Technology Note that specify that a license for MT controlled items should also authorize certain minimum “software” and “technology.” This final rule also adds a new paragraph to the section of the EAR that specifies which changes to a license are considered “non-material.” This amendment will facilitate this rule's revised MT licensing policy, which will apply to all licenses for MT controlled items, except when excluded by a license condition.

DATES:

This rule is effective April 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Sharon Bragonje, Nuclear and Missile Technology Controls Division, Bureau of Industry and Security, Phone: (202) 482-0434; Email: [email protected]

SUPPLEMENTARY INFORMATION: Background

The Missile Technology Control Regime (MTCR) is an export control arrangement among 34 nations, including most of the world's suppliers of advanced missiles and missile-related equipment, materials, software and technology. The regime establishes a common list of controlled items (the Annex) and a common export control policy (the Guidelines) that member countries implement in accordance with their national export controls. The MTCR seeks to limit the risk of proliferation of weapons of mass destruction by controlling exports of goods and technologies that could make a contribution to delivery systems (other than manned aircraft) for such weapons.

In 1993, the MTCR's original focus on missiles for nuclear weapons delivery was expanded to include the proliferation of missiles for the delivery of all types of weapons of mass destruction (WMD), i.e., nuclear, chemical and biological weapons. Such proliferation has been identified as a threat to international peace and security. One way to address this threat is to maintain vigilance over the transfer of missile equipment, material, and related technologies usable for systems capable of delivering WMD. MTCR members voluntarily pledge to adopt the Regime's export Guidelines and to restrict the export of items contained in the Regime's Annex. The Regime's Guidelines are implemented through the national export control laws, regulations and policies of the regime members.

Amendments to the Export Administration Regulations

This final rule revises the Export Administration Regulations (EAR) to reflect changes to the MTCR Annex agreed to at the October 2015 Plenary in Rotterdam, Netherlands, and changes resulting from the April 2015 Technical Experts Meeting (TEM) in Bern, Switzerland.

Corresponding MTCR Annex references are provided below for the MTCR Annex changes agreed to at the meetings. This rule also makes two conforming changes to correlate the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) and other EAR provisions with the current MTCR Annex. These conforming changes are made to better align the MT controls on the CCL and other parts of the EAR with the MTCR Annex. In the explanation below for the revisions made in this rule, BIS identifies these changes as follows: “Rotterdam 2015 Plenary,” “Bern 2015 TEM,” and “Conforming Change to MTCR Annex” to assist the public in understanding the origin of each change included in this final rule.

In § 742.5 (Missile technology), this final rule adds a new paragraph (b)(3), and redesignates paragraphs (b)(3) and (b)(4), as paragraphs (b)(4) and (b)(5). This paragraph specifies that BIS licenses for MT controlled items also authorize the minimum “software” and “technology” for MT controlled items authorized under the same license, unless such minimum “software” and “technology” are specifically excluded by BIS on the license. This final rule also amends § 750.7(c)(1), which identifies “non-material changes [to a license that] do not require submission of a `Replacement' license or any other notification to BIS.” BIS has determined that a license applicant who does not seek a license for minimum “software” or “technology” for an MT controlled item need not seek a “Replacement” license if the applicant subsequently wishes to export such software or technology under the authority of the previously issued license. Such a use of the license would amount to a non-material change because the basic purpose of the license would be substantially undermined if the exporter could not promptly provide minimum necessary software or technology for the previously licensed MT item, an outcome that would be especially problematic in view of the 2015 regime changes referred to above. Moreover, in many instances, such exports of minimum necessary software and technology may already be made pursuant to License Exception TSU, set forth at § 740.13(a) and (c) (referring to minimum necessary operation software and technology), and notwithstanding the general prohibition against the use of License Exceptions for MT controlled items in § 740.2(a)(5)(i), which excludes a substantial number of MT items from the general prohibition under specified circumstances. Because BIS has previously determined that many such exports can be made pursuant to a License Exception, it stands to reason that the substantially similar MT “minimum necessary” software and technology exports at issue in this rule should be eligible for “non-material” treatment under § 750.7(c)(1). Accordingly, in this rule BIS establishes a new paragraph (c)(1)(x) to § 750.7 that applies to all MT licenses, except when a condition is placed on the license that excludes such minimum “software” and “technology.” These changes are also consistent with the boilerplate text on BIS licenses, because the § 750.7(c)(1)(x) revision identifies the export, reexport or transfer (in-country) of minimum necessary MT controlled software and technology as a non-material change to a license.

BIS makes this change to MT licensing policy to be consistent with the MTCR Annex General Minimum Software Note and the MTCR Annex General Technology Note that specify that a license for MT controlled items should also authorize certain minimum “software” and “technology,” which is being implemented by adding paragraph (c)(1)(x) to § 750.7 (which allows licensees to make such exports, reexports and transfers (in-country) pursuant to licenses for MT items) and paragraph (b)(3) to § 742.5 (which specifies this MT licensing policy) of the EAR. (MTCR Annex Change, General Minimum Software Note, Rotterdam 2015 Plenary; and MTCR Annex, General Technology Note, Conforming Change to MTCR Annex). The MTCR General Minimum Software Note, MTCR Annex General Technology Note, and the provisions this final rule adds to § 742.5 are consistent with the General Software Note and General Technology Note in Supplement No. 2 to part 774 and License Exception TSU under § 740.13, paragraphs (a) and (c). Note, however, that the implementation of these provisions is being done through the MT licensing policy, and the addition of paragraph (c)(1)(x) to § 750.7 described below, instead of through the use of a license exception.

BIS is presumptively including such minimum “software” and “technology” as part of the authorized scope for each license that includes MT controlled items. Therefore, applicants are not required to identify or provide any support documentation for such minimum “software” and “technology” on a license application for MT controlled items because such minimum “software” and “technology” is authorized within the scope of the license, pursuant to § 750.7(c)(1)(x), absent a license condition to the contrary. Applicants will be informed when such minimum “software” and/or “technology” in § 750.7(c)(1)(x) is excluded from the license by a BIS condition on the license, which will state the following: “This license does not authorize the export, reexport or transfer (in-country) of the minimum “software” and/or “technology” specified in paragraph (b)(3) of § 742.5.” Absent this condition on the license for MT controlled items, the licensee may assume, consistent with § 750.7(c)(1)(x) and the licensing policy in § 742.5, that the approved license also authorizes the export (or reexport, or transfer (in-country) as applicable) to the same ultimate consignee(s) and end user(s) specified on the license of the minimum “software,” excluding source code, controlled for MT reasons that is required for the installation, operation, maintenance or repair of the item and the “technology” required for the installation, operation, maintenance, or repair of the item in order to ensure the item's safe operation as originally intended. It is important to note that this licensing policy in paragraph (b)(3) of § 742.5 is only available for licensed exports (or reexports, or transfers (in-country)). For example, if an exporter wishes to export such minimum “software” and “technology” for a machine tool controlled for MT reasons, but there is not a license in place authorizing the export of the machine tool, then the export of such minimum “software” and “technology” would require a separate authorization under the EAR. This final rule adds a new Note to paragraph (b)(3), as described below, to make this clear.

This final rule also specifies in § 742.5, paragraph (b)(3) that a license for MT controlled items authorizes pursuant to § 750.7(c)(1)(x) the later export (or reexport, or transfer (in-country) as applicable) of “software” controlled for MT reasons intended to correct defects (bug fixes) in a previously legally exported item under a BIS license to the same ultimate consignee(s) and end user(s) specified on the license, provided that the capability and/or performance of the item are not otherwise enhanced and such “software” is not excluded from the license by a BIS condition on the license.

Lastly, for the changes to § 742.5, this final rule adds a Note to paragraph (b)(3) to clarify that for the limited number of ECCNs that are identified in § 740.2, paragraph (a)(5), License Exception TSU is available, and therefore exporters do not need to apply for a license from BIS for such minimum “software” or “technology.” License Exception TSU is available provided such minimum “software” or “technology” is for an end use specified in that paragraph and meets the requirements of License Exception TSU and is not otherwise restricted under § 740.2 of the EAR. This Note to paragraph (b)(3) also clarifies that the licensing policy in paragraph (b)(3) is only available for licensed exports (or reexports, or transfers (in-country)), as noted above in the example for what minimum “software” and “technology” would require a separate authorization under the EAR. BIS took into account that certain minimum “software” and “technology” was already eligible for License Exception TSU when deciding to add paragraph (b)(3) to § 742.5 for the MT licensing policy and paragraph (c)(1)(x) to § 750.7 to allow for such changes to a license for MT items.

In § 750.7(c) (Changes to the license), this rule adds a new paragraph (c)(1)(x), as referenced above in the description of the changes this final rule makes to § 742.5. This paragraph (c)(1)(x) specifies that the export, reexport or transfer (in-country) of missile technology (MT) controlled minimum “software” and/or “technology permitted pursuant to the missile technology licensing policy in § 742.5(b)(3) does not require a new license. This final rule also includes a parenthetical phrase in § 750.7(c)(1)(x) to cross reference § 742.5(b)(3)(i) to define the scope of eligible minimum “software” and “technology” and other limitations for licenses for MT controlled items.

Also in § 750.7, this final rule adds two notes to paragraph (c)(1)(x). The new Note 1 provides context for why BIS is implementing the MT licensing policy pursuant to § 750.7(c)(1)(x). Note 1 explains that the MT licensing policy is being implemented pursuant to paragraph (c)(1)(x) because it applies to all MT licenses. This new Note 1 also explains that this MT licensing policy does not apply when BIS places a condition on the specific license(s) which excludes the use of paragraph (c)(1)(x). This final rule also adds a Note 2 to paragraph (c)(1)(x) to provide guidance on the relationship between License Exception TSU and § 750.7(c)(1)(x), as well as § 742.5(b)(3). Note 2 is the same as the Note to paragraph (b)(3) to § 742.5, described above in this final rule, except for minor changes to reflect that the note is in § 750.7.

In addition, this final rule amends the Commerce Control List (CCL) to reflect changes to the MTCR Annex. Specifically, the following six ECCNs are affected by the changes set forth in this final rule:

ECCN 1B101. This final rule amends ECCN 1B101 by revising paragraph a and the introductory text of paragraph b in the List of Items Controlled section. (MTCR Annex Change, Category II: Item 6.B.1.a. and b., Bern 2015 TEM). Specifically, this final rule amends paragraph a to revise the term `fiber-placement machines' to add the term “/tow” after the term “fiber” to clarify that the scope of the control parameter extends to placement machines regardless of whether they are named fiber-placement machines or tow-placement machines. This final rule revises the term “fiber-placement machines” to “fiber/tow-placement machines” in order to clarify that both these similar machines (two types of placement machines) are classified under this control parameter, regardless of the naming convention. This final rule revises paragraph b to add single quotation marks around the term `tape-laying machines' to indicate that this term is defined for purposes of ECCN 1B101. This final rule also revises paragraph b to remove the phrase “and sheets,” because it is no longer needed as part of the control parameter because the definition of tape now encompasses sheets. Lastly, this final rule adds four new Technical Notes to paragraphs a and b. The addition of these four Technical Notes provides a clear technical definition for `fiber/tow-placement machines' and `tape-laying machines' under new Technical Note 1, which is based on the minimum width of material that these machines are capable of laying (as specified further in the new Technical Notes 3 and 4 this final rule adds to ECCN 1B101). This final rule also adds a Technical Note 2 to provide an ECCN-specific definition of `filament band,' which is also used as part of the definition of `fiber/tow-placement machines' and `tape-laying machines.' The purpose of this change to ECCN 1B101 is to more clearly define and differentiate between fiber/tow-placement machines and tape-laying machines. The only increase in license applications will be due to the clarification that tow-placement machines are definitively controlled by the MTCR.

ECCN 1C111. This final rule amends ECCN 1C111 by revising paragraphs b.4, b.9, d.9, and d.12 in the List of Items Controlled section to add CAS (Chemical Abstract Service) Numbers. CAS Numbers are numerical identifiers assigned by the Chemical Abstracts Service (CAS) to every chemical substance described in open scientific literature, including organic and inorganic compounds, minerals, isotopes and alloys. The inclusion of CAS Numbers will make it easier to identify the materials controlled under these “items” paragraphs of 1C111.

This final rule revises paragraph b.4 to add the CAS Number (CAS 25265-19-4/CAS 68891-50-9) after the material “polybutadiene acrylic acid acrylonitrile (PBAN).” (MTCR Annex Change, Category II: Item 4.C.5.e., Rotterdam 2015 Plenary). This change is not expected to have any impact on the number of license applications received by BIS. This final rule revises paragraph d.9 to add the CAS Number (CAS 6068-98-0) after the material “ethylene dihydrazine.” (MTCR Annex Change, Category II: Item 4.C.2.b.8., Rotterdam 2015 Plenary). This change is not expected to have any impact on the number of license applications received by BIS.

This final rule revises paragraph d.12 to add the material “1,1-Dimethylhydrazinium azide (CAS 227955-52-4),” which is an alternative structure of the same chemical (Dimethylhydrazinium azide) classified under d.12. This final rule also revises paragraph d.12 to add “1,2-” before the material “Dimethylhydrazinium azide” and adds the CAS Number (CAS 299177-50-7) after the material “1,2-Dimethylhydrazinium azide.” These changes will aid exporters and licensing officers by making it clear that both structures of the chemical are caught under paragraph d.12. (MTCR Annex Change, Category II: Item 4.C.2.b.12., Rotterdam 2015 Plenary). These changes are not expected to have any impact on the number of license applications received by BIS.

Lastly, for the changes to ECCN 1C111, this final rule revises paragraph d.19, to add the material “1,1-Diethylhydrazine nitrate (DEHN),” which is an alternative structure of the same chemical (Diethylhydrazine nitrate (DEHN)) classified under d.19. This final rule also revises paragraph d.19 to add “1,2-” before the material “Diethylhydrazine nitrate (DEHN)” and adds the CAS Number (CAS 363453-17-2) after the material “1,2-Dimethylhydrazinium nitrate.” These changes will aid exporters and licensing officers and make clear that both structures of the chemical are caught under paragraph d.19. (MTCR Annex Change, Category II: Item 4.C.2.b.19., Rotterdam 2015 Plenary). These changes are not expected to have any impact on the number of license applications received by BIS.

ECCN 7A116. This final rule amends ECCN 7A116 to revise the heading to add the term “pneumatic” to the beginning of the control parameter to specify that pneumatic flight control systems are also controlled under ECCN 7A116. In addition, this final rule adds the phrase “and fly-by-light” to the parenthetical phrase “(including fly-by-wire systems)” to specify that the flight control systems classified under this ECCN include fly-by-wire and fly-by-light systems. (MTCR Annex Change, Category II: Item 10.A.1., Rotterdam 2015 Plenary). These changes are not expected to have any impact on the number of license applications received by BIS, because the commodities described in ECCN 7A116 are “subject to the ITAR.”

ECCN 9A012. This final rule amends ECCN 9A012 by adding paragraph b.5 in the List of Items Controlled section to control pneumatic, hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by ECCN 9A012, and capable of delivering at least 500 kilograms payload to a range of at least 300 km. (MTCR Annex Change, Category II: Item 10.A.1., Rotterdam 2015 Plenary). New paragraph b.5 is not intended to control UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a. This change is made to conform to the MTCR Annex and to address that certain MTCR Category I UAVs are on the CCL as a result of Export Control Reform.

This final rule also makes two conforming changes to ECCN 9A012 for the addition of paragraph 9A012.b.5. Specifically, this final rule is revising the “MT” paragraph in the License Requirements section to add an MT control for the new paragraph 9A012.b.5. This final rule is revising the Related Control Paragraph to include a reference to also see ECCN 9A610, because as noted above, similar types of systems and equipment are controlled under ECCN 9A610.w. This change is expected to result in an increase of 1-3 applications received annually by BIS.

ECCN 9A610. This final rule amends ECCN 9A610 by revising paragraph w in the List of Items Controlled section to add the term “pneumatic” to the beginning of the control parameter to specify that pneumatic flight control systems are also classified under this paragraph w. In addition, this final rule adds the phrase “and fly-by-light” to the parenthetical phrase “(including fly-by-wire systems)” to specify that the flight control systems classified under this paragraph w include fly-by-wire and fly-by-light systems. (MTCR Annex Change, Category II: Item 10.A.1., Rotterdam 2015 Plenary). These changes are a slight expansion of the control parameter by extending the control to include pneumatic flight control systems that are designed or modified for “missiles.” This expansion of the control parameter is needed because state-of-the-art flight control systems may use optical fibers to provide digital communication between the flight control components. This change is expected to result in an increase of 1-3 applications received annually by BIS.

ECCN 9B106. This final rule amends ECCN 9B106 by revising paragraphs a.1 and the introductory text of paragraph a.2 in the List of Items Controlled section. The introductory text of paragraph a previously referred to both paragraphs a.1 and a.2 as flight conditions, which was not entirely accurate. Therefore, this final rule revises the introductory text of paragraph a by removing the phrase “simulating all of the following flight conditions” and adding in its place the phrase “having all of the following characteristics.” (MTCR Annex Change, Category II: Item 15.B.4.a., Bern 2015 TEM). The altitude and temperature requirements specified in paragraphs a.1.a and a.2.a are flight conditions, but the incorporation or ability to incorporate a shaker unit or other vibration test equipment specified in paragraph a.2 is not strictly a flight condition, but a means of simulating a flight condition, so the introductory text of paragraph a needed to be updated for clarity. This clarification to the introductory text of paragraph a reflects the way this control has previously been interpreted by BIS. This final rule revises the control parameter in paragraph a.1.b to clarify the temperature range goes from below −50° C to above 125° C. The revision to paragraph a.1.b does not change the scope of control of 9B610 and this revision will better reflect the control text of the MTCR Annex. (MTCR Annex Change, Category II: Item 15.B.4.a.1.b., Conforming Change to MTCR Annex).

Lastly, as a non-substantive formatting change, this final rule revises paragraph a.2 to move the comma inside of the single quotation marks for the term `bare table.' These changes are not expected to have any impact on the number of license applications received by BIS.

Savings Clause

Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting or reexporting carrier, or enroute aboard a carrier to a port of export or reexport, on April 4, 2016, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR) so long as they are exported or reexported before May 4, 2016. Any such items not actually exported or reexported before midnight, on May 4, 2016, require a license in accordance with this rule.

Export Administration Act

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.

Regulatory Requirements

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866.

2. Notwithstanding any other provision of law, no person may be required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and carries a burden estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are expected to increase slightly as a result of this rule. The expected increase in total burden hours is expected to be minimal and to not exceed the existing estimates for burden hours associated with the PRA and OMB control number 0694-0088. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to [email protected], or by fax to (202) 395-7285.

3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Immediate implementation of these amendments fulfills the United States' international commitments to the MTCR. The MTCR contributes to international peace and security by promoting greater responsibility in transfers of missile technology items that could make a contribution to delivery systems (other than manned aircraft) for weapons of mass destruction. The MTCR consists of 34 member countries that act on a consensus basis and the changes set forth in this rule implement agreements reached by MTCR member countries at the October 2015 Plenary in Rotterdam, Netherlands and pursuant to the April 2015 Technical Experts Meeting in Bern, Switzerland. Since the United States is a significant exporter of the items in this rule, implementation of this provision is necessary for the MTCR to achieve its purpose. Moreover, it is in the public interest to waive the notice and comment requirements, as any delay in implementing this rule will disrupt the movement of affected items globally because of disharmony between export control measures implemented by MTCR members. Export controls work best when all countries implement the same export controls in a timely manner. If this rulemaking were delayed to allow for notice and comment and a 30 day delay in effectiveness, it would prevent the United States from fulfilling its commitment to the MTCR in a timely manner, would injure the credibility of the United States in this and other multilateral regimes, and may impair the international communities' ability to effectively control the export of certain potentially national- and international-security-threatening materials.

Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Therefore, this regulation is issued in final form.

List of Subjects 15 CFR Part 742

Exports, Terrorism.

15 CFR Part 750

Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.

15 CFR Part 774

Exports, Reporting and recordkeeping requirements.

Accordingly, parts 742, 750 and 774 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:

PART 742—[AMENDED] 1. The authority citation for 15 CFR part 742 continues to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of August 7, 2015, 80 FR 48233 (August 11, 2015); Notice of November 12, 2015, 80 FR 70667 (November 13, 2015).

2. Section 742.5 is amended: a. By redesignating paragraphs (b)(3) and (4) as paragraphs (b)(4) and (5), respectively; and b. By adding a new paragraph (b)(3) to read as follows:
§ 742.5 Missile technology.

(b) * * *

(3)(i) Consistent with the MTCR Annex General Minimum Software Note, MTCR Annex General Technology Note and § 750.7(c)(1)(x) of the EAR, the approval of any item controlled for MT reasons on a BIS license also authorizes the export, reexport, or transfer (in-country) to the same ultimate consignee(s) and end user(s) specified on the license of the minimum “software,” excluding source code, controlled for MT reasons that is required for the installation, operation, maintenance or repair of the item and the “technology” required for the installation, operation, maintenance, or repair of the item in order to ensure the item's safe operation as originally intended. The approval of any item controlled for MT reasons on a BIS license also authorizes the later export, reexport, or transfer (in-country) of “software” controlled for MT reasons intended to correct defects (bug fixes) in a previously legally exported item under a BIS license to the same ultimate consignee(s) and end user(s) specified on the license, provided that the capability and/or performance of the item are not otherwise enhanced. This MT licensing policy is implemented concurrent with § 750.7(c)(1)(x) because it applies to all MT licenses, except when a condition is placed on the license which excludes the use of § 750.7(c)(1)(x), as described in paragraph (b)(3)(ii) of this section.

(ii) Applicants are not required to identify or provide any support documentation for such minimum “software” or “technology” on a license application for MT controlled items because such minimum “software” or “technology” is authorized within the scope of the license, consistent with § 750.7(c)(1)(x). Applicants will be informed when such minimum “software” and/or “technology” in § 750.7(c)(1)(x) is excluded from the license by a BIS condition on the license, which will state the following: “This license does not authorize the export, reexport or transfer (in-country) of the minimum “software” and/or “technology” specified in paragraph (c)(1)(x) of § 750.7 (See paragraph (b)(3) of § 742.5).”

Note to paragraph (b)(3):

License Exception TSU under § 740.13 of the EAR is available for the ECCNs controlled for MT reasons specified in paragraph (a)(5) in § 740.2, provided the software or technology is for an end use specified in that paragraph and meets the requirements of License Exception TSU. (See §§ 740.2(a)(5) and 740.13). The licensing policy in paragraph (b)(3) is only available for licensed exports (or reexports, or transfers (in-country)).

PART 750—[AMENDED] 3. The authority citation for 15 CFR part 750 continues to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; Sec 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2013 Comp., p. 223; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of August 7, 2015, 80 FR 48233 (August 11, 2015).

4. Section 750.7 is amended: a. By removing the period at the end of paragraph (c)(1)(ix) and adding in its place “; or”; and b. By adding paragraph (c)(1)(x) to read as follows:
§ 750.7 Issuance of licenses.

(c) * * *

(1) * * *

(x) Export, reexport or transfer (in-country) of missile technology (MT) controlled minimum necessary “software” and/or “technology” permitted pursuant to the missile technology licensing policy in § 742.5(b)(3) of the EAR. (See § 742.5(b)(3)(i) for the scope of eligible minimum “software” and/or “technology” and other limitations for licenses for MT controlled items).

Note 1 to paragraph (c)(1)(x):

This MT licensing policy is implemented pursuant to paragraph (c)(1)(x) of this section because it applies to all MT licenses, except when a condition is placed on the license which excludes the use of paragraph (c)(1)(x) of this section, as described in § 742.5(b)(3)(ii).

Note 2 to paragraph (c)(1)(x):

License Exception TSU under § 740.13 of the EAR is available for the ECCNs controlled for MT reasons specified in paragraph (a)(5) in § 740.2, provided the software or technology is for an end use specified in that paragraph and meets the requirements of License Exception TSU. (See §§ 740.2(a)(5) and 740.13). The licensing policy in § 742.5(b)(3) is only available for licensed exports (or reexports, or transfers (in-country)).

PART 774—[AMENDED] 5. The authority citation for 15 CFR part 774 continues to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 7, 2015, 80 FR 48233 (August 11, 2015).

6. In Supplement No. 1 to part 774 (the Commerce Control List), Category 1—Special Materials and Related Equipment, Chemicals, “Microorganisms” and “Toxins,” Export Control Classification Number (ECCN) 1B101 is amended: a. By revising “items” paragraphs a and b in the List of Items Controlled section; and b. By adding Technical Notes for paragraphs a and b at the end of the “items” paragraph b in the List of Items Controlled section to read as follows: Supplement No. 1 to Part 774—The Commerce Control List 1B101 Equipment, other than that controlled by 1B001, for the “production” of structural composites, fibers, prepregs or preforms, usable for rockets, missiles, or unmanned aerial vehicles capable of achieving a “range” equal to or greater than 300 km and their subsystems, as follows (see List of Items Controlled); and “specially designed” “parts,” “components” and “accessories” therefor. List of Items Controlled

Items:

a. Filament winding machines or `fiber/tow-placement machines,' of which the motions for positioning, wrapping and winding fibers can be coordinated and programmed in three or more axes, designed to fabricate composite structures or laminates from fibrous or filamentary materials, and coordinating and programming controls;

b. `Tape-laying machines' of which the motions for positioning and laying tape can be coordinated and programmed in two or more axes, designed for the manufacture of composite airframe and missile structures;

Technical Notes for paragraphs a and b:

For the purposes of 1B101.a. and 1B101.b., the following definitions apply:

1. `Fiber/tow-placement machines' and `tape-laying machines' are machines that perform similar processes that use computer-guided heads to lay one or several `filament bands' onto a mold to create a part or a structure. These machines have the ability to cut and restart individual `filament band' courses during the laying process.

2. A `filament band' is a single continuous width of fully or partially resin-impregnated tape, tow, or fiber. Fully or partially resin-impregnated `filament bands' include those coated with dry powder that tacks upon heating.

3. `Fiber/tow-placement machines' have the ability to place one or more `filament bands' having widths less than or equal to 25.4 mm. This refers to the minimum width of material the machine can place, regardless of the upper capability of the machine.

4. `Tape-laying machines' have the ability to place one or more `filament bands' having widths less than or equal to 304.8 mm, but cannot place `filament bands' with a width equal to or less than 25.4 mm. This refers to the minimum width of material the machine can place, regardless of the upper capability of the machine.

7. In Supplement No. 1 to part 774 (the Commerce Control List), Category 1—Special Materials and Related Equipment, Chemicals, “Microorganisms” and “Toxins,” Export Control Classification Number (ECCN) 1C111 is amended: a. By revising “items” paragraph b.4 in the List of Items Controlled section; and b. By revising “items” paragraphs d.9, d.12 and d.19 in the List of Items Controlled section to read as follows: 1C111 Propellants and constituent chemicals for propellants, other than those specified in 1C011, as follows (see List of Items Controlled). List of Items Controlled

Items:

b. * * *

b.4. Polybutadiene acrylic acid acrylonitrile (PBAN) (CAS 25265-19-4/CAS 68891-50-9);

d. * * *

d.9. Ethylene dihydrazine (CAS 6068-98-0);

d.12. 1,1-Dimethylhydrazinium azide (CAS 227955-52-4)/1,2-Dimethylhydrazinium azide (CAS 299177-50-7);

d.19. 1,1-Diethylhydrazine nitrate (DEHN)/1,2-Diethylhydrazine nitrate (DEHN) (CAS 363453-17-2);

8. In Supplement No. 1 to part 774 (the Commerce Control List), Category 7— Navigation and Avionics, Export Control Classification Number (ECCN) 7A116 is amended by revising the heading to read as follows: 7A116 Flight control systems (pneumatic, hydraulic, mechanical, electro-optical, or electro-mechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment) designed or modified for “missiles”. (These items are “subject to the ITAR”. See 22 CFR parts 120 through 130.) 9. In Supplement No. 1 to part 774 (the Commerce Control List), Category 9—Aerospace and Propulsion, Export Control Classification Number (ECCN) 9A012 is amended: a. By revising the “MT” paragraph in the table in the License Requirements section; b. By revising the Related Controls paragraph in the List of Items Controlled section; and c. By adding “items” paragraph b.5 in the List of Items Controlled section to read as follows: 9A012 Non-military “Unmanned Aerial Vehicles,” (“UAVs”), unmanned “airships”, related equipment and “components”, as follows (see List of Items Controlled). License Requirements

Reason for Control:

Control(s) Country Chart (see sup No. 1 to part 738) *    *    *    *    * MT applies to non-military Unmanned Air Vehicle (UAVs) and Remotely Piloted Vehicles (RPVs) that are capable of a maximum range of at least 300 kilometers (km), regardless of payload, and 9A012.b.5 MT Column 1. *    *    *    *    * List of Items Controlled

Related Controls: See the U.S. Munitions List Category VIII (22 CFR part 121). Also see ECCN 9A610 and § 744.3 of the EAR.

Items:

b. * * *

b.5. Pneumatic, hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by ECCN 9A012., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.

10. In Supplement No. 1 to part 774 (the Commerce Control List), Category 9—Aerospace and Propulsion, Export Control Classification Number (ECCN) 9A610 is amended by revising “items” paragraph w in the List of Items Controlled section to read as follows: 9A610 Military aircraft and related commodities, other than those enumerated in 9A991.a (see List of Items Controlled). List of Items Controlled

Items:

w. Pneumatic, hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.

11. In Supplement No. 1 to part 774 (the Commerce Control List), Category 9—Aerospace and Propulsion, Export Control Classification Number (ECCN) 9B106 is amended: a. By revising the introductory text of “items” paragraph a in the List of Items Controlled section; b. By revising “items” paragraph a.1 in the List of Items Controlled section; and c. By revising the introductory text of items paragraph a.2 to read as follows: 9B106 Environmental chambers usable for rockets, missiles, or unmanned aerial vehicles capable of achieving a “range” equal to or greater than 300 km and their subsystems, as follows (see List of Items Controlled). List of Items Controlled

Items:

a. Environmental chambers having all of the following characteristics:

a.1. Capable of simulating any of the following flight conditions:

a.1.a. Altitude equal to or greater than 15,000 m; or

a.1.b. Temperature range from below −50 °C to above 125 °C; and

a.2. Incorporating, or designed or modified to incorporate, a shaker unit or other vibration test equipment to produce vibration environments equal to or greater than 10 g rms, measured `bare table,' between 20 Hz and 2 kHz while imparting forces equal to or greater than 5 kN;

Dated: March 29, 2016. Kevin J. Wolf, Assistant Secretary for Export Administration.
[FR Doc. 2016-07601 Filed 4-1-16; 8:45 am] BILLING CODE 3510-33-P
SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 [Docket No. SSA-2015-0018] RIN 0960-AH85 Extension of the Workers' Compensation Offset From Age 65 to Full Retirement Age—Achieving a Better Life Experience (ABLE) Act AGENCY:

Social Security Administration.

ACTION:

Final rule.

SUMMARY:

This final rule adopts, with one additional change, the notice of proposed rulemaking (NPRM) that we published in the Federal Register on January 4, 2016. This final rule revises our rules by incorporating changes made by the ABLE Act to section 224(a) of the Social Security Act (Act). Under this final rule, the age at which disability insurance benefits (DIB) are no longer subject to reduction (offset) based on receipt of workers' compensation or public disability benefits (WC/PDB) changes from age 65 to the day the individual attains full retirement age.

DATES:

This final rule is effective April 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Dean Dwight, Office of Income Security Programs, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401, (410) 966-7161. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

This final rule adopts, with one additional change discussed below, the NPRM that we published in the Federal Register on January 4, 2016.1

1 81 FR 41 (2016) (https://www.thefederalregister.org/fdsys/pkg/FR-2016-01-04/pdf/2015-33036.pdf).

Background

We explained our reasons for proposing the rule that we are now adopting as a final rule in the preamble to the NPRM (81 FR at 41), and we incorporate that discussion here.

In addition to the changes we proposed in the NPRM, we are making one additional change to our rules. The fourth sentence of current section 404.317 states, “Your monthly benefit amount may be reduced if you receive workers' compensation or public disability payments before you become 65 years old as described in § 404.408.” For consistency with the other changes we are making to our rules, we are also revising the reference to “before you become 65 years old” in section 404.317 to “before you attain full retirement age.”

Public Comments

In the NPRM, we provided a 30-day comment period, which ended on February 3, 2016. We received one comment. The comment came from a member of the public. After carefully considering the comment, we are adopting our proposed rule (81 FR 41-42) as a final rule.

Comment: The one comment we received stated, “Not fair there are plenty who have worked very hard to retire perhaps when a certain group progresses then reconsider changing the policy.”

Response: We did not adopt the comment. The changes we are making are mandated by statute. We have no discretion to reconsider the policy in the absence of a statutory change.

Regulatory Procedures Good Cause for Effective Date

We find good cause for dispensing with the 30-day delay in the effective date of this final rule. 5 U.S.C. 553(d)(3). For the reasons discussed above and in the preamble to the NPRM (81 FR at 41), we are making minor changes to our current rules to incorporate changes made by section 201 of the ABLE Act 2 to section 224(a) of the Act. The provision in the ABLE Act applies to any individual whose DIB payment is offset for WC/PDB and who attains age 65 on or after December 19, 2015.3 Because the changes we are making in this final rule only reflect a statutory change that is already in effect, we find that it is unnecessary to delay the effective date of our final rule.

2 Public Law 113-295, Division B, § 201, 128 Stat. 4010, 4064.

3Id., § 201(b). Section 201(b) specifies that the amendment to section 224(a) of the Act “shall apply with respect to any individual who attains 65 years of age on or after the date that is 12 months after the date of the enactment of this Act.” Congress enacted the ABLE on December 19, 2014. Id. Consequently, the statutory amendment applies to an individual who attains age 65 on or after December 19, 2015. Id.

Executive Order 12866 as Supplemented by Executive Order 13563

We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order 12866 as supplemented by Executive Order 13563. Thus, OMB did not review the final rule.

Regulatory Flexibility Act

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it applies to individuals only. Thus, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.

(Catalog of Federal Domestic Assistance Program No. 96.006, Supplemental Security Income.) List of Subjects in 20 CFR Part 404

Administrative practice and procedure; Blind; Disability benefits; Government employees; Old-age, Survivors and Disability Insurance; Reporting and recordkeeping requirements; Social security.

Dated: March 25, 2016. Carolyn W. Colvin, Acting Commissioner of Social Security.

For the reasons set forth in the preamble, we amend subparts D and E of part 404 of title 20 of the Code of Federal Regulations as set forth below:

PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ). Subpart D—[Amended] 1. The authority citation for subpart D of part 404 continues to read as follows: Authority:

Secs. 202, 203(a) and (b), 205(a), 216, 223, 225, 228(a)-(e), and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 403(a) and (b), 405(a), 416, 423, 425, 428(a)-(e), and 902(a)(5)).

2. Amend § 404.317 by revising the fourth sentence to read as follows:
§ 404.317 How is the amount of my disability benefit calculated?

* * * Your monthly benefit amount may be reduced if you receive workers' compensation or public disability payments before you attain full retirement age (as defined in § 404.409) (see § 404.408). * * *

Subpart E—[Amended] 3. The authority citation for subpart E of part 404 continues to read as follows: Authority:

Secs. 202, 203, 204(a) and (e), 205(a) and (c), 216(l), 222(c), 223(e), 224, 225, 702(a)(5), and 1129A of the Social Security Act (42 U.S.C. 402, 403, 404(a) and (e), 405(a) and (c), 416(l), 422(c), 423(e), 424a, 425, 902(a)(5), and 1320a-8a); 48 U.S.C. 1801.

4. In § 404.401, revise paragraph (a)(4) to read as follows:
§ 404.401 Deduction, reduction, and nonpayment of monthly benefits or lump-sum death payments.

(a) * * *

(4) An individual under full retirement age (see § 404.409) is concurrently entitled to disability insurance benefits and to certain public disability benefits (see § 404.408);

5. In § 404.408, revise paragraph (a)(2)(ii) to read as follows:
§ 404.408 Reduction of benefits based on disability on account of receipt of certain other disability benefits provided under Federal, State, or local laws or plans.

(a) * * *

(2) * * *

(ii) The individual has not attained full retirement age as defined in § 404.409.

[FR Doc. 2016-07602 Filed 4-1-16; 8:45 am] BILLING CODE 4191-02-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 56 [Docket No. FDA-2015-N-5052] Administrative Actions for Noncompliance; Lesser Administrative Actions AGENCY:

Food and Drug Administration, HHS.

ACTION:

Direct final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.

DATES:

This rule is effective August 17, 2016. Submit electronic or written comments on this direct final rule or its companion proposed rule by June 20, 2016.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2015-N-5052 for “Subpart E—Administrative Actions for Noncompliance; Lesser Administrative Actions.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Sheila Brown, Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-6563.

SUPPLEMENTARY INFORMATION: I. Background

FDA is amending § 56.120(b) (21 CFR 56.120(b)), which describes lesser administrative actions that the Agency may impose on an IRB until the IRB takes appropriate action to correct the IRB's noncompliance. We are publishing this direct final rule because it is intended to clarify an existing regulation, and we do not anticipate any significant adverse comment regarding this amendment to § 56.120(b). Specifically, this direct final rule would amend § 56.120(b) by clarifying that FDA has authority to require the IRB to withhold approval of new FDA-regulated studies conducted at the institution or reviewed by the IRB, direct that no new subjects be added to ongoing studies, and terminate ongoing studies provided that doing so would not endanger study subjects.

This amendment also renumbers current paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and inserts “FDA may” into newly designated paragraph (c) so that it is a complete sentence.

FDA first proposed requirements for the composition and operations of institutional review committees in the “Proposed Investigational Device Exemptions,” published in the Federal Register of August 20, 1976 (41 FR 35282; “Proposed IDE Rule”). In that document, FDA proposed disqualification procedures for institutional review committees and requested comments on the proposed procedures and other possible administrative actions that FDA might take against a committee that is not in compliance with the regulations (41 FR 35282 at 35293). FDA also stated its intention to publish uniform, Agency-wide regulations governing clinical investigations at a later date, including requirements governing institutional review committees (41 FR 35282 at 35283).

Subsequently, FDA published “Standards for Institutional Review Boards for Clinical Investigations” on August 8, 1978 (43 FR 35186; “Proposed IRB Standards”). Comments on implementing institutional review requirements received in response to the Proposed IDE Rule were reviewed and utilized in preparing the Proposed IRB Standards (43 FR 35186 at 35187). In the Proposed IRB Standards, FDA proposed that disqualification would be used only if the Commissioner of Food and Drugs finds that: (1) The IRB failed to comply with one or more of the standards for IRBs in part 56 or other supplemental requirements in the investigational new drug or investigational device exemptions (IDE) regulations; (2) the noncompliance adversely affects the validity of the data or the rights or safety of the human subjects; and (3) other lesser regulatory actions (e.g., warnings or rejection of data from individual clinical investigations) have not been or probably will not be adequate in achieving compliance (43 FR 35186 at 35195).

FDA received numerous comments to the Proposed IRB Standards, and addressed those comments in the Federal Register of January 27, 1981 (46 FR 8958), “Protection of Human Subjects: Standards for Institutional Review Boards for Clinical Investigations, Final Rule.” Specifically, several comments suggested that any lesser regulatory actions should be listed (46 FR 8958 at 8973). FDA accepted these comments and revised § 56.120(b) to set forth the lesser administrative actions that the Agency may take if FDA finds deficiencies in the operation of an IRB and to describe the circumstances in which these lesser administrative actions may be used by the Agency. FDA's longstanding interpretation of § 56.120(b) is that FDA may impose these restrictions on a noncompliant IRB until the IRB takes appropriate corrective action. The text of the regulation, however, suggests that it is the Agency that would withhold approval of studies that have been reviewed by a noncompliant IRB, rather than authorizing FDA to direct the IRB to stop approving new studies until the IRB comes back into compliance.

This direct final rule amends § 56.120(b) to read, in addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to withhold approval of new studies, direct that no new subjects be added to ongoing studies, or terminate ongoing studies. This will ensure that those activities are suspended until the IRB takes appropriate corrective action to address its noncompliance. We believe revising § 56.120(b) as described in this document will improve the clarity and accuracy of the regulations. We are also renumbering § 56.120(b)(4) as § 56.120(c), and § 56.120(c) as § 56.120(d). We are inserting “FDA may” into newly designated § 56.120(c) so that it is a complete sentence.

FDA may notify relevant State and Federal regulatory Agencies when warranted to assure that organizations with a need to know about the IRB's apparent noncompliance are appropriately informed. The revision would eliminate confusion by stating clearly that FDA is authorized to notify others about the IRB's noncompliance. We believe these changes will ensure clarity and improve the accuracy of the regulations.

II. Procedures for Issuing a Direct Final Rule

In the Federal Register of November 21, 1997 (62 FR 62466), FDA announced the availability of the guidance document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures” 1 that described when and how we will employ direct final rulemaking. We believe that this rule is appropriate for direct final rulemaking because it is intended to clarify an existing regulation. We anticipate no significant adverse comment.

1http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.

Consistent with FDA's direct final rulemaking procedures, we are publishing a companion proposed rule elsewhere in this issue of the Federal Register. That proposed rule is identical in substance to this direct final rule. The companion proposed rule will serve the purpose of issuing a proposed rule under usual notice-and-comment procedures in the event we withdraw this direct final rule because we receive significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. We will consider any comments that we receive in response to the companion proposed rule to be comments also regarding this direct final rule and vice versa.

If FDA receives any significant adverse comment, we will withdraw this direct final rule before its effective date by publishing a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is one that explains why the rule would be inappropriate (including challenges to the rule's underlying premise or approach), or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, we consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule would not be considered adverse. A comment recommending a rule change in addition to the rule would not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment.

If we withdraw this direct final rule, FDA will consider all comments that we received regarding the companion proposed rule as we develop a final rule through the usual notice-and-comment procedures of the APA. If we receive no significant adverse comment during the specified comment period regarding this direct final rule, we intend to publish a confirmation notice in the Federal Register within 30 days after the comment period ends.

III. Legal Authority

This rule, if finalized, would amend § 56.120(b). FDA's authority to modify § 56.120(b) arises from the same authority under which FDA initially issued this regulation, the IRB regulations, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262).

IV. Analysis of Environmental Impact

We have determined under 21 CFR 25.30(h) and 25.34(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Economic Analysis of Impact

We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule does not add any additional regulatory burdens, we certify that this final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

The purpose of this final rule is to affirm FDA's longstanding interpretation of § 56.120(b), that FDA may impose these administrative actions on a noncompliant IRB until the IRB takes appropriate corrective action. The amendment will improve the clarity and accuracy of the regulations. Because this final rule is a clarification and would impose no additional regulatory burdens, this regulation is not anticipated to result in any compliance costs, and the economic impact is expected to be minimal.

VI. Paperwork Reduction Act of 1995

This direct final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Federalism

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 56

Human research subjects, Reporting and recordkeeping requirements, Safety.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 56 is amended as follows:

PART 56—INSTITUTIONAL REVIEW BOARDS 1. The authority citation for 21 CFR part 56 is revised to read as follows: Authority:

21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.

2. In § 56.120, redesignate paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and revise paragraph (b) and newly designated paragraph (c) to read as follows:
§ 56.120 Lesser administrative actions.

(b) On the basis of the IRB's or the institution's response, FDA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to:

(1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB;

(2) Direct that no new subjects be added to ongoing studies subject to this part; or

(3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects.

(c) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, FDA may notify relevant State and Federal regulatory agencies and other parties with a direct interest in the Agency's action of the deficiencies in the operation of the IRB.

Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-07523 Filed 4-1-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2015-1055] RIN 1625-AA08 Special Local Regulation; Charleston Race Week, Charleston Harbor, Charleston, SC AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a special local regulation on the waters of Charleston Harbor in Charleston, SC during the Charleston Race Week from April 15, 2016 through April 17, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.

DATES:

This rule is effective from April 15, 2016 through April 17, 2016.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-1055 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions about this rule, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone(843)740-3184, email [email protected]

SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

On November 18, 2015, the Charleston Ocean Racing Association notified the Coast Guard that it will sponsor a series of sailboat races in the Charleston Harbor, Charleston, SC. from 8:30 a.m. to 5 p.m. April 15, 2016 through April 17, 2016. In response, on February 5, 2016, the Coast Guard published a notice of proposed rulemaking titled Charleston Race Week. There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this special local regulation. During the comment period that ended March 7, 2016, we received no comments.

Under good cause provisions in 5 U.S.C. 553(d)(3), we are making this rule effective less than 30 days after its publication in the Federal Register. The Coast Guard finds that good cause exists for making this rule effective starting April 15, 2016 because this special local regulation is necessary to ensure the safety of life and property during this high speed boat race and it would be contrary to public interest not to make this rule effective by April 15, 2016. Also, this regulation will have a limited impact on the waterway for a limited time and designated representatives will be on scene to assist the public with compliance.

III. Legal Authority and Need for Rule

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to insure safety of life on navigable waters of the United States during three Charleston Race Week sailboat races. It was determined that potential hazards are associated with the areas used in the Charleston Race Week sailboat races that can be alleviated by prohibiting access to the regulated areas.

IV. Discussion of Comments, Changes, and the Rule

As noted above, we received no comments on our NPRM published February 5, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

From April 15, 2016 through April 17, 2016, Charleston Ocean Racing Association will host three sailboat races on Charleston Harbor in Charleston, South Carolina during Charleston Race Week. Approximately 300 sailboats will participate in the three races. This rule establishes a special local regulation on certain waters of Charleston Harbor in Charleston, South Carolina. The special local regulation will be enforced daily from 8:30 a.m. until 5 p.m. on April 15, 2016 through April 17, 2016. The special local regulation consists of the following three race areas.

1. Race Area #1. All waters encompassed within a 700 yard radius of position 32°46′10″ N. 79°55′15″ W.

2. Race Area #2. All waters encompassed within a 700 yard radius of position 32°46′02″ N. 79°54′15″ W.

3. Race Area #3. All waters encompassed within a 700 yard radius of position 32°45′55″ N. 79°53′39″ W.

Except for those persons and vessels participating in the sailboat races, persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the race areas unless specifically authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the race areas may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the race areas is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The economic impact of this rule is not significant for the following reasons: (1) Non-participant persons and vessels may enter, transit through, anchor in, or remain within the regulated area during the enforcement periods if authorized by the Captain of the Port Charleston or a designated representative; (2) vessels not able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative may operate in the surrounding areas during the enforcement period; and (3) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners; (4) the safety zone will impact only 3 small designated areas of Charleston Harbor for less than 9 hours per day for 3 days over the weekend of April 15, to 17, 2016, and thus is limited in time and scope.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which may be small entities: The owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. For the reasons discussed in Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction.

An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 100

Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority:

33 U.S.C. 1233

2. Add a temporary § 100.35T07-1055 to read as follows:
§ 100.35T07-1055 Special Local Regulation; Charleston Race Week, Charleston Harbor, Charleston, SC.

(a) Regulated Area. A special local regulation is established on waters of Charleston Harbor in Charleston, South Carolina. The special local regulations will be enforced daily from 8:30 a.m. until 5 p.m. from April 15, 2016 through April 17, 2016. The special local regulations consist of the following three race areas.

(1) Race Area #1. All waters encompassed within a 700 yard radius of position 32°46′10″ N. 79°55′15″ W.

(2) Race Area #2. All waters encompassed within a 700 yard radius of position 32°46′02″ N. 79°54′15″ W.

(3) Race Area #3. All waters encompassed within a 700 yard radius of position 32°45′55″ N. 79°53′39″ W.

(b) Definition. The term “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port Charleston in the enforcement of the regulated areas.

(c) Regulations. (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area, except persons and vessels participating in Charleston Race Week or serving as safety vessels. Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative.

(2) The Coast Guard will provide notice of the regulated area by Marine Safety Information Bulletins, Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

(d) Enforcement Date. This rule will be enforced daily from 8:30 a.m. until 5 p.m. from April 15 through April 17, 2016.

Dated: March 29, 2016. G.L. Tomasulo, Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2016-07589 Filed 4-1-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2016-0009] RIN 1625-AA08 Special Local Regulation; Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway; Bucksport, SC AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Lake Murray Drag Boat Spring Nationals, on June 4 and June 5, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.

DATES:

This rule is effective from June 4, 2016 through June 5, 2016.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0009 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions about this rule, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone (843) 740-3184, email [email protected]

SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

On December 27, 2015, the Bucksport Marina notified the Coast Guard that it will sponsor a series of drag boat races from 1 p.m. to 7 p.m. on June 4 and June 5, 2016. In response, on February 5, 2016, the Coast Guard published a notice of proposed rulemaking titled Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway; Bucksport, SC. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this special local regulation. During the comment period that ended March 7, 2016, we received no comments.

III. Legal Authority and Need for Rule

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to insure safety of life on navigable waters of the United States during the two days of drag boat races.

IV. Discussion of Comments, Changes, and the Rule

As noted above, we received no comments on our NPRM published February 5, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM. From June 4, 2016 through June 5, 2016, Bucksport Marina will host a series of drag boat races on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Lake Murray Drag Boat Spring Nationals. Approximately 50 powerboats are anticipated to participate in the races and approximately 35 spectator vessels are expected to attend the event. This rule establishes a special local regulation on certain waters on the Atlantic Intracoastal Waterway in Bucksport, South Carolina. The special local regulation will be enforced daily from 1 p.m. until 7 p.m. on June 4, 2016 and June 5, 2016.

Except for those persons and vessels participating in the drag boat races, persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the race areas unless specifically authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the race areas may contact the Captain of the Port Charleston by telephone at (843)740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the race areas is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The economic impact of this rule is not significant for the following reasons: (1) Non-participant persons and vessels may enter, transit through, anchor in, or remain within the regulated area during the enforcement periods if authorized by the Captain of the Port Charleston or a designated representative; (2) vessels not able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative may operate in the surrounding areas during the enforcement period; and (3) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners. (4) the safety zone will impact only a small designated area of the Atlantic Intracoastal Waterway for the 2 days of June 4, and 5, from 1p.m. to 7 p.m., and thus is limited in time and scope.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which may be small entities: The owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. For the reasons discussed in Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction.

An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 100

Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority:

33 U.S.C. 1233.

2. Add a temporary § 100.35T07-0009 to read as follows:
§ 100.35T07-0009 Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway; Bucksport, SC.

(a) Regulated Area. All waters of the Atlantic Intracoastal Waterway encompassed by a line connecting the following points: Point 1 in position 33°39′13″ N., 079°05′36″ W.; thence west to point 2 in position 33°39′17″ N., 079°05′46′ W.; thence south to point 3 in position 33°38′53″ N., 079°05′39″ W.; thence east to point 4 in position 33°38′54″ N., 079°05′31″ W.; thence north back to point 1. All coordinates are North American Datum 1983.

(b) Definition. As used in this section, “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port Charleston in the enforcement of the regulated areas.

(c) Regulations. (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area, except persons and vessels participating in Bucksport/Lake Murray Drag Boat Spring Nationals or serving as safety vessels. Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843)740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative.

(2) The Coast Guard will provide notice of the regulated area by Marine Safety Information Bulletins, Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

(d) Enforcement Date. This rule will be enforced daily on June 4 and June 5, 2016, from 1 p.m. until 7 p.m.

Dated: March 29, 2016. G.L. Tomasulo, Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2016-07588 Filed 4-1-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0239] Drawbridge Operation Regulation; Three Mile Slough, Rio Vista, CA AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulation.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Highway 160 drawbridge across Three Mile Slough, mile 0.1, at Rio Vista, CA. The deviation is necessary to allow the bridge owner to complete the necessary sand blasting and painting rehabilitation. This deviation allows the bridge to be secured in the closed-to-navigation position during the deviation period.

DATES:

This deviation is effective from 12:01 a.m. on April 11, 2016 to 11:59 p.m. on April 17, 2016.

ADDRESSES:

The docket for this deviation, [USCG-2016-0239], is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email [email protected]

SUPPLEMENTARY INFORMATION:

The California Department of Transportation has requested a temporary change to the operation of the Highway 160 drawbridge, mile 0.1, over Three Mile Slough, at Rio Vista, CA. The drawbridge navigation span provides 12 feet vertical clearance above Mean High Water in the closed-to-navigation position. In accordance with 33 CFR 117.5, the draw opens on signal. Navigation on the waterway is commercial, search and rescue, law enforcement, and recreational.

The drawbridge will be secured in the closed-to-navigation position from 12:01 a.m. on April 11, 2016 to 11:59 p.m. on April 17, 2016, to allow the bridge owner to complete the necessary sand blasting and painting rehabilitation after unforeseen events have caused project delays. A containment scaffolding system has been installed below low steel of the entire length of the bridge structure, reducing vertical clearance for navigation by not more than 4 feet, and is lighted at night with red lights. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies. The confluence of the San Joaquin and Sacramento rivers can be used as an alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform waterway users through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Dated: March 23, 2016. D.H. Sulouff, District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2016-07660 Filed 4-1-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0225] Drawbridge Operation Regulation; Sacramento River, Sacramento, CA AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulation.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the Pony Express Marathon. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

DATES:

This deviation is effective from 6:30 a.m. to 11 a.m. on May 1, 2016.

ADDRESSES:

The docket for this deviation, [USCG-2016-0225] is available at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email [email protected]

SUPPLEMENTARY INFORMATION:

California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The vertical lift bridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 6:30 a.m. to 11 a.m. on May 1, 2016, to allow the community to participate in the Pony Express Marathon. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Dated: March 23, 2016. D.H. Sulouff, District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2016-07656 Filed 4-1-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0226] RIN 1625-AA00 Safety Zone; Hudson River, Tarrytown, NY AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary moving safety zone for navigable waters of the Hudson River, in the vicinity of the Tappan Zee Bridge around a 100-yard radius of DECK BARGE WITTE 1406. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by salvage operations on the sunken vessel TUG SPECIALIST. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port New York.

DATES:

This rule is effective without actual notice from April 4, 2016 through May 17, 2016. For the purposes of enforcement, actual notice will be used from March 17, 2016 through April 4, 2016.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0226 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email MST1 Kristina Pundt, Waterways Management Division, U.S. Coast Guard; telephone 718-354-4352, email [email protected]

SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because immediate action is needed to respond to the potential safety hazards associated with the salvage operations of TUG SPECIALIST that sank in the Hudson River on March 12, 2016. Delaying the effective date of this rule would be contrary to the public interest of ensuring the safety of salvage workers, DECK BARGE WITTE 1406, other vessels, and mariners from the hazards associated with the salvage of TUG SPECIALIST.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register for the same reasons as discussed above.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port New York (COTP) has determined that potential hazards associated with emergency salvage operations starting March 17, 2016, will be a safety concern for anyone within a 100-yard radius of DECK BARGE WITTE 1406. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while DECK BARGE WITTE 1406 conducts salvage operations on the sunken vessel.

IV. Discussion of the Rule

This rule establishes a safety zone from March 17, 2016 through May 17, 2016. The safety zone will cover all navigable waters within 100 yards of DECK BARGE WITTE 1406 to salvage the sunken tug vessel. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while salvage operations are conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive order related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Hudson River in the vicinity of the Tappan Zee Bridge for 60 days and during a time of year when vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves: A safety zone lasting approximately 62 that will prohibit entry within 100 yards of DECK BARGE WITTE 1406 being used by personnel to salvage the sunken tug vessel. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165-REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T01-0226 to read as follows:
§ 165.T01-0226 Safety Zone; Salvage of TUG SPECIALIST, Hudson River, Tarrytown, NY.

(a) Location. The following area is a safety zone: All navigable waters within 100 yards of DECK BARGE WITTE 1406 while it is in the Hudson River.

(b) Definitions. As used in this section, designated representative means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port New York (COTP) in the enforcement of the security zone.

(c) Regulations. (1) Under the general security zone regulations in subpart D of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.

(2) To seek permission to enter, contact the COTP or the COTP's representative via VHF channel 16 or by phone at (718) 354-4353 (Sector New York Command Center). Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

(d) Enforcement period. This section will be enforced from March 17, 2016 through May 17, 2016, unless terminated sooner by the COTP.

Dated: March 17, 2016. M.H. Day, Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2016-07657 Filed 4-1-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 75 RIN 0991-ZA46 Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Correction and Technical Amendments AGENCY:

Department of Health and Human Services.

ACTION:

Interim final rule; correction and technical amendments.

SUMMARY:

The Department of Health and Human Services published a document containing technical amendments in the Federal Register on January 20, 2016, revising the Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards. That document inadvertently failed to update the following: A provision in Appendix II; an improper citation; a recent OMB change; and a grammatical error. This document makes correcting amendments to correct these sections.

DATES:

Effective on April 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Audrey E. Clarke, Ph.D., Division of Grants, Office of Grants and Acquisition Policy and Accountability, Office of the Assistant Secretary for Financial Resources, U.S. Department of Health and Human Services, email: [email protected]

SUPPLEMENTARY INFORMATION:

HHS is correcting its regulations in line with FR Doc. 2014-28697, published on December 19, 2014 (79 FR 75871), entitled “Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards”, the “Guidance for Reporting and Use of Information Concerning Recipient Integrity and Performance” to 2 CFR part 200, published on July 22, 2015 (80 FR 43301), and “Universal Identifier and System of Award Management; Corrections”, published on September 10, 2015 (80 FR 54407), made by the Office of Management and Budget (OMB). HHS adopts the correcting amendments made by OMB. HHS is also making amendments to address citation or grammatical inconsistencies, to amend incomplete statements in the regulation, and to update existing HHS regulations to incorporate 45 CFR part 75. The correcting amendments will go into effect at the time of publication.

This is the second set of corrections. The first set of corrections was published in the Federal Register on January 20, 2016 (81 FR 3004). This document augments the corrections which were published in the Federal Register on January 20, 2016 (81 FR 3004). This document includes a corresponding change made by OMB to 2 CFR 200 on November 9, 2015 (80 FR 69111) that was omitted from the first set of corrections. This document also removes instruction 197c on page 3018 in the Federal Register on January 20, 2016 (81 FR 3004), which as published attempted to amend the wrong appendix in 45 CFR part 75. Because that instruction cited the wrong appendix, that amendment could not be incorporated into the CFR.

Correction

In the Federal Register issue of January 20, 2016 (81 FR 3004), make the following correction:

On page 3018, in the third column, remove amendatory instruction 197c.

List of Subjects in 45 CFR Part 75

Accounting, Auditing, Administrative practice and procedure, Colleges and universities, Cost principles, Grant programs, Grant programs-health, Grants administration, Hospitals, Indians, Nonprofit organizations, Reporting and recordkeeping requirements, and State and local governments.

Accordingly, HHS makes the following technical amendments to 45 CFR part 75:

PART 75—UNIFORM ADMINISTRATIVE REQUIREMENTS, COST PRINCIPLES, AND AUDIT REQUIREMENTS FOR HHS AWARDS 1. The authority citation for part 75 continues to read as follows: Authority:

5 U.S.C. 301.

§ 75.2 [Amended]
2. In § 75.2: a. In the definition of “Federal Audit Clearinghouse (FAC)”, remove “(FAC)” in the second and third sentences and add “FAC” in its place; and b. In the introductory text of the definition of “Federal financial assistance”, add the word “means” before the colon.
§ 75.205 [Amended]
3. Amend § 75.205 paragraph (a)(2) by removing “publicly available information in” and adding, in its place “non-public segment of”.
Appendix II to Part 75—[Amended] 4. Amend Appendix II to Part 75 Section C by adding ” “Equal Employment Opportunity (30 FR 12319, 12935, 3 CFR 1964-1965 Comp., p. 339)” after “Executive Order 11246,”; and adding “amending Executive Order 11246 Relating to Equal Employment Opportunity,” after “Executive Order 11375”: Dated: March 24, 2016. Ellen Murray, Assistant Secretary for Financial Resources, Department of Health and Human Services.
[FR Doc. 2016-07401 Filed 4-1-16; 8:45 am] BILLING CODE 4150-24-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No.: 150304214-6231-02] RIN 0648-BE94 Fisheries of the Northeastern United States; Atlantic Herring Fishery; Framework Adjustment 4 AGENCY:

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Final rule.

SUMMARY:

NMFS implements approved measures in Framework 4 to the Atlantic Herring Fishery Management Plan. The New England Fishery Management Council developed Framework 4 to further enhance catch monitoring and address discarding in the herring fishery. The approved measures include: A requirement that vessels report slippage (i.e., catch discarded prior to sampling by an observer) via the vessel monitoring system; slippage consequences measures (i.e., requirement to move 15 nautical miles (27.78 km) or return to port following a slippage event); and clarifications to existing slippage measures and definitions. NMFS disapproved two measures in Framework 4. These measures would have required: Fish holds to be certified and observers to collect volumetric catch estimates of total catch; and fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized law enforcement officer. NMFS disapproved these measures because it determined that they are inconsistent with the Magnuson-Stevens Fishery Conservation and Management Act, the Administrative Procedure Act, and the Paperwork Reduction Act. Therefore, those two measures are not implemented in this action. Lastly, NMFS implements minor corrections to regulations to clarify their intent and ensure they are consistent with the Atlantic Herring Fishery Management Plan.

DATES:

Effective May 4, 2016.

ADDRESSES:

The New England Fishery Management Council (Council) developed an environmental assessment (EA) for this action that describes the proposed action and other considered alternatives and provides a thorough analysis of the impacts of the proposed measures and alternatives. Copies of the framework, the EA, and the Regulatory Impact Review (RIR)/Initial Regulatory Flexibility Analysis (IRFA), are available upon request from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Newburyport, MA 01950. The EA/RIR/IRFA is accessible via the Internet at www.greateratlantic.fisheries.noaa.gov.

Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted to NMFS, Greater Atlantic Regional Fisheries Office and by email to [email protected], or fax to (202) 395-7285.

FOR FURTHER INFORMATION CONTACT:

Carrie Nordeen, Fishery Policy Analyst, phone 978-281-9272, fax 978-281-9135.

SUPPLEMENTARY INFORMATION: Background

The Council adopted Framework Adjustment 4 to the Atlantic Herring Fishery Management Plan at its April 22, 2014, meeting. The Council submitted Framework 4 to NMFS for review on July 18, 2014, and resubmitted it to NMFS on February 27, 2015, and April 30, 2015. The proposed rule for Framework 4 published in the Federal Register on August 27, 2015 (80 FR 52005), with a 30-day public comment period that ended September 28, 2015. NMFS received four comment letters on the proposed rule.

NMFS implements approved measures in Framework 4 to the Atlantic Herring Fishery Management Plan (Herring FMP) and minor corrections to existing regulations in this final rule. The Council developed Framework 4 to build on catch monitoring improvements implemented in Amendment 5 to the Herring FMP (79 FR 8786, February 13, 2014) by further enhancing catch monitoring and addressing discarding in the herring fishery. The approved measures in Framework 4 clarify the slippage definition, require limited access herring vessels to report slippage events on the daily vessel monitoring system (VMS) catch report, and establish slippage consequences. Slippage consequence measures require vessels with All Areas (Category A) or Areas 2/3 (Category B) Limited Access Herring Permits to move 15 nautical miles (27.78 km) following an allowable slippage event (i.e., slippage due to safety, mechanical failure, or excess catch of spiny dogfish) and to terminate a fishing trip and return to port following a non-allowable slippage event (i.e., slippage for any other reason). NMFS also makes minor corrections to new and existing regulations. These revisions, identified and described below, are necessary to clarify current regulations or the intent of the Herring FMP, and do not change the intent of any regulations.

NMFS disapproved two measures recommended by the Council in Framework 4. Those measures would have required: Herring vessel fish holds to be certified and observers to collect volumetric catch estimates on herring trips as a cross-check of vessel and dealer data; and herring vessel fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized law enforcement officer. During the development of Framework 4, NMFS expressed its concern with the lack of support for these two measures in Framework 4. Specifically, NMFS commented that these measures are not likely to improve catch monitoring, but they would result in compliance and enforcement costs. Despite NMFS urging, the Council did not include sufficient support for these two measures in Framework 4. Framework 4 does not provide evidence of specific problems with catch monitoring or discarding that need to be addressed, nor does it demonstrate how these recommended measures would rectify problems with monitoring or discarding. NMFS described its concern with these measures in the proposed rule, and explained that that they appear inconsistent with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and other applicable law. Some public comments on the proposed rule expressed support for the approval and implementation of both measures, but the commenters did not provide evidence that the utility of these measures would outweigh costs. Therefore, NMFS determined that these two measures must be disapproved because they are inconsistent with the Magnuson-Stevens Act, the Administrative Procedure Act (APA), and the Paperwork Reduction Act (PRA).

Approved Measures

NMFS approves the following measures because it believes they will further enhance catch monitoring and address discarding in the herring fishery.

Clarification of Existing Slippage Measures

Framework 4 maintains the existing requirements that prohibit operational discards (i.e., small amounts of fish that cannot be pumped on board and remain in the codend or seine at the end of pumping operations) aboard midwater trawl vessels fishing in the Groundfish Closed Areas and allow operational discards to occur on board herring vessels fishing outside the Groundfish Closed Areas. Current observer protocols include documenting operational discards and existing regulations require vessel operators to assist the observer with this process. Because it can be time and labor intensive to bring these small amounts of fish on board the vessel, the Council and NMFS believe that compliance costs associated with prohibiting operational discards outside the Groundfish Closed Areas would likely outweigh any benefits to the catch monitoring program and the herring resource.

Framework 4 clarifies that a slippage event due to safety, mechanical failure, or excess catch of spiny dogfish is categorized as an “allowable” slippage event and clarifies that slippage for any other reason is categorized as a “non-allowable” slippage event. The Council recommended these categories to help distinguish between slippage types and the triggers for slippage consequence measures.

Framework 4 clarifies that catch not brought on board due to gear damage would be categorized as mechanical failure and, therefore, as an allowable slippage event. Although a gear failure that results in the release of catch from a codend is often beyond the control of the vessel operator, instances of catch released due to gear damage are similar to instances of catch released due to mechanical failure. Therefore, the Council and NMFS believe that catch released due to gear damage should be categorized as mechanical failure and an allowable slippage event. As an allowable slippage event, catch not brought on board due to gear damage would be subject to a slippage consequence measure.

Framework 4 clarifies that when catch that falls out of or off of gear and is not brought on board, the event would not be categorized as a slippage event. In general, only small amounts of catch fall out or off of gear during fishing and/or when catch is being brought aboard the vessel, unlike the potential for catch loss due to mechanical failure. Therefore, the Council and NMFS believe that fish that fall out of the gear should be categorized as discarded catch, but not slippage. For these reasons, instances of catch falling out or off of gear during fishing and/or when catch is being brought aboard the vessel would not be subject to existing slippage requirements or any slippage consequence measures.

Slippage Consequences

Building on the slippage restrictions established in Amendment 5, Framework 4 requires vessels to move following an allowable slippage event before resuming fishing. Specifically, vessels with Category A or B herring permits slipping catch due to safety, mechanical failure, or excess catch of spiny dogfish, are required to move at least 15 nautical miles (27.78 km) away from the slippage event location. The vessel is allowed to move 15 nautical miles (27.78 km) away in any direction, but it is prohibited from resuming fishing until it is at least 15 nautical miles (27.78 km) from the location of the allowable slippage event. Additionally, the vessel is required to remain at least 15 nautical miles (27.78 km) from the slippage event location for the duration of that fishing trip. In addition to moving and remaining at least 15 nautical miles (27.78 km) away from an allowable slippage event, vessels with Category A or B herring permits fishing with midwater trawl gear in the Groundfish Closed Areas must leave the Groundfish Closed Areas and remain outside of the Groundfish Closed Areas for the remainder of the fishing trip following an allowable slippage event.

Framework 4 also requires trip termination for non-allowable slippage events. Specifically, vessels with Category A or B herring permits, including those fishing with midwater trawl gear in the Groundfish Closed Areas, that slip catch for any reason other than safety, mechanical failure, or excess catch of spiny dogfish, are required to immediately stop fishing and return to port. After having returned to port and terminated the fishing trip, vessels are allowed to initiate another fishing trip, consistent with the existing pre-trip notification requirements (e.g., contact the Northeast Fisheries Observer Program (NEFOP) to request an observer, vessel monitoring system (VMS) trip/gear declaration) for limited access vessels participating in the herring fishery.

NMFS is implementing slippage consequences for both allowable and non-allowable slippage events to further discourage slippage in the herring fishery and enhance the catch monitoring program established through Amendment 5. The herring fishery is a relatively high-volume fishery capable of catching large quantities of fish in a single tow. Therefore, even a few slippage events have the potential to substantially affect species composition data, especially extrapolations of incidental catch. Additionally, slippage is a significant concern for many stakeholders because they believe it undermines the ability to collect unbiased estimates of herring catch, as well as other species, in the herring fishery. Stakeholders expressed support for the slippage consequence measures in Framework 4 to further ensure accountability for all catch in the herring fishery.

NMFS expects the requirement for vessels to move following slippage events will provide sufficient incentive for herring vessels to minimize slippage, while still promoting safety at sea and providing opportunities to utilize the herring optimum yield (OY). The requirement for vessels to move 15 nautical miles (27.78 km) following an allowable slippage event applies uniformly to all vessels that slip catch, unlike other considered alternatives (e.g., leaving a management area, leaving a statistical area) where the magnitude of the move would have depended upon the location of the allowable slippage event. NMFS expects that the requirement for vessels to move 15 nautical miles (27.78 km) following an allowable slippage event provides sufficient incentive (i.e., cost in time and fuel) for herring vessels to minimize slippage, and the requirement that vessels terminate their fishing trip and return to port following a non-allowable slippage event will further minimize slippage. NMFS believes that minimizing slippage events and better documentation of slipped catch may improve estimates of bycatch in the fishery. To the extent that the amount and species composition of slipped catch can be sampled and/or estimated, catch monitoring will be enhanced. To the extent that slippage events can continue to be reduced, bycatch can be further minimized.

The Mid-Atlantic Fishery Management Council recommended these same slippage consequences for allowable and non-allowable slippage events in the Atlantic mackerel fishery as part of Framework 9 to the Atlantic Mackerel, Squid, and Butterfish FMP. Many vessels participate in both the herring and mackerel fisheries, and NMFS expects that implementing consistent slippage consequences across these fisheries will improve compliance and enforcement of slippage requirements.

Reporting Slippage Events

Framework 4 requires vessels with limited access herring permits to report slippage events, including the reason for the slippage event, via the herring daily VMS catch report. NMFS expects that this VMS report, in combination with observer data, will help enhance the enforceability of existing slippage requirements, such as completing a released catch affidavit, as well as the slippage consequences.

Clarifications and Corrections

This final rule also contains minor clarifications and corrections to existing regulations. NMFS implements these adjustments under the authority of section 305(d) to the Magnuson-Stevens Act, which provides that the Secretary of Commerce may promulgate regulations necessary to ensure that framework adjustments to a FMPs are carried out in accordance with the FMP and the Magnuson-Stevens Act. These adjustments, identified and described below, are necessary to clarify current regulations and do not change the intent of any regulations.

NMFS is implementing a transiting provision for herring management areas with seasonal sub-ACLs. This provision allows vessels to transit herring management areas during periods when zero percent of the sub-ACL for those areas is available for harvest, with herring harvested from other herring management areas aboard, provided gear is stowed and not available for use. NMFS overlooked this provision during rulemaking for Framework Adjustment 2 to the Herring FMP and the provision is consistent with the intent of that action and the Herring FMP. NMFS is removing regulations at § 648.80(d)(7) describing requirements for midwater trawl vessels fishing in Groundfish Closed Area I because they are redundant with regulations at § 648.202(b) describing requirements for midwater trawl vessels fishing in any of the Groundfish Closed Areas. NMFS is adding the definition of operational discards at § 648.2 and clarifying that operational discards are not permitted aboard midwater trawl vessels fishing in Groundfish Closed Areas, unless those fish have first been made available to an observer for sampling. NMFS is revising references to individual years in regulations for carryover at § 648.201 to more correctly describe the timing of carryover. Lastly, NMFS is correcting coordinates for Herring Management Area 2 at § 648.200(f)(2).

Disapproved Measures

NMFS disapproved the following measures because it determined they are inconsistent with the Magnuson-Stevens Act, APA, and PRA.

Volumetric Catch Estimates

Framework 4 would have required vessels with limited access herring permits to have their fish holds certified and NEFOP observers to collect volumetric estimates of total catch by measuring the volume of the fish in hold prior to offloading. Observers would have converted the volumetric estimate to a weight and submitted the estimated weight to the Greater Atlantic Region Fisheries Office (GARFO) for a cross-check of vessel trip reports (VTRs) and dealer reports. The requirement for observers to estimate the amount of catch in the fish hold was intended to enhance catch monitoring in the herring fishery by providing an independent estimate of total catch.

This measure was developed to address stakeholder concerns with NMFS's reliance on industry-reported catch data to monitor the herring fishery. Specifically, some stakeholders, including environmental organizations, the groundfish industry, and recreational fishing groups, believe that herring catch is not accurately reported by the industry and that large discrepancies exist between vessel and dealer reports. The herring industry, in general, does not believe that herring catch is being misreported but, in an effort to address stakeholder concerns, supports the requirement for observers to collect an estimate of total catch.

Framework 4 does not provide evidence of misreporting by the herring industry, but it does highlight past differences, that have since been minimized, between the amount of herring reported by vessels and dealers. In past years, discrepancies between VTRs and dealer data have been as large as 54 percent. But recently, GARFO staff has improved the process for cross-checking and resolving differences between VTRs and dealer data. Now discrepancies between VTRs and dealer data are minimal, with differences averaging 1 percent. Because discrepancies between VTRs and dealer data are now minimal, NMFS does not believe that the proposed measure requiring volumetric estimates of total catch is necessary to help resolve discrepancies between VTR and dealer data.

Vessels and dealers report catch by species. VTRs, in combination with observer data, are used in herring stock assessments, while a combination of dealer data, VTR, and VMS, and observer data are used to track catch against herring annual catch limits and catch caps in the herring fishery. The measure requiring volumetric catch estimates would have provided an estimate of total catch, but would not have differentiated catch by species. Because the volumetric estimate would not have provided catch by species, it could not have been used to replace VTRs or dealer data nor could it have been used for catch monitoring or stock assessments.

Additionally, Framework 4 cautions whether the proposed measure would be more accurate than methods currently used by vessel operators or dealers to estimate catch. The volumetric conversion proposed in Framework 4 is based on herring harvested in other parts of the world. Using a volumetric conversion assumes consistency in the size, weight, and density of the catch, but there can be substantial variability in the catch composition of the herring fishery, depending on the area and season. Additionally, the proposed 5 percent deduction from total weight to account for water in the tanks is based on industry practices, but the Council did not rigorously evaluate the amount of the deduction. For these reasons, Framework 4 explains that converting a volume of total fish to pounds based on the proposed conversion could produce less accurate catch estimates than current vessel or dealer estimates.

The measure requiring a volumetric catch estimate is unlikely to improve catch monitoring in the herring fishery because that estimate cannot be used to replace VTR or dealer report to monitor catch and it is not necessary to resolve minimal discrepancies between VTR and dealer data. In contrast, the compliance costs associated with the measure may be high. If a vessel's fish holds are not already certified, the vessel owner would need to pay to have the fish holds certified. NMFS would need to significantly develop the measure prior to implementation, including generating a sampling protocol, approving volume to weight conversions and deductions to account for water in the fish hold, training observers, and evaluating how to use the data. Additionally, requiring observers to sample vessels in port would require modifications to the description of observer duties and contracts with observer service providers.

For these reasons, NMFS concluded that the measure requiring fish holds to be certified and observers to collect volumetric catch estimates is inconsistent with the requirements of the Magnuson-Stevens Act, APA, and PRA. The measure is inconsistent with the APA because there is insufficient support in Framework 4 documenting the need for this measure and how this measure would address the purported need. The measure is inconsistent with the requirements of Magnuson-Stevens Act National Standard 7 and the PRA because the benefit of the volumetric catch estimate is dubious and does not outweigh the additional burden on vessel owners of certifying their fish holds and making available a measuring stick for observers. The measure is inconsistent with Magnuson-Stevens Act National Standard 2 because the quality of the volumetric catch estimate is not sufficient for monitoring the fishery, facilitating inseason management, or judging the performance of the management regime. Finally, the measure is inconsistent with Magnuson-Stevens Act National Standard 5 because it does not allow the fishery to operate at the lowest possible administrative costs relative to any additional monitoring benefit provided by the measure.

Empty Fish Holds

Framework 4 would have required fish holds of vessels with Category A or B Limited Access Herring Permits to be empty of fish before leaving the dock on a herring trip. A waiver may have been issued by an authorized law enforcement officer when fish have been reported as caught but cannot be sold due to the condition of fish.

The Council recommended this measure to enhance catch monitoring and discourage wasteful fishing practices in the herring fishery. Some stakeholders are concerned that vessels are harvesting more fish than they can sell and then discarding the unsold fish on subsequent fishing trips. These stakeholders are also concerned that fish not purchased by a dealer, and discarded on subsequent trips, may not be reported on the VTR. The Council intended this measure to discourage the discarding of unreported fish, provide a mechanism to document when harvested fish become unmarketable, and prevent vessel operators from mixing fish from multiple trips in the hold, potentially biasing catch data.

While prohibiting the disposal of unsold fish at sea may discourage wasteful fishing practices, there is insufficient support in the record to conclude that herring vessels are harvesting excess fish and discarding unsold fish at sea. The costs associated with a herring trip, including fuel, crew wages, and insurance, are substantial, so it is unlikely that vessel operators are making herring trips to harvest fish that will ultimately be discarded. Additionally, if discarding of unsold fish at sea is occurring, Framework 4 explains that it is unclear whether unsold catch disposed of at sea on a subsequent trip is reported.

Initially, this measure requiring empty fish holds simply required that fish holds be empty of fish at the beginning of a herring trip. But recognizing that there may be unforeseen events making it difficult to sell fish (e.g., refrigeration failure, poor condition, lack of market), the Council recommended the waiver provision to mitigate the potential costs associated with disposing of unmarketable catch on land. The Council intended the waiver to provide a mechanism to verify that fish had been reported and document the nature and extent to which vessels are departing on trips with fish in their fish holds. Additionally, some vessels in the herring fishery land their catch in multiple ports, and the Council intended that the waiver provision would allow that practice to continue.

Part of the justification for the waiver provision is to provide a way to verify that fish have been reported and to document the extent to which vessels are departing on trips with fish in their fish holds. However, Framework 4's proposed waiver provides no way of verifying the amount of fish reported relative to the amount of fish left in the hold. Therefore, NMFS does not believe that this measure contains a viable mechanism to verify whether harvested fish that are left in the hold were reported by the vessel.

Because the measure lacks a mechanism to verify or correct the amount of fish reported on the VTR, the measure is unlikely to improve catch monitoring in the herring fishery. In contrast, the compliance and enforcement costs associated with the measure may be high. For example, vessel operators needing to dispose of fish at sea may lose time and money waiting for an authorized law enforcement officer to travel to their vessel, inspect the fish in the fish hold, and issue a waiver. Additionally, it would likely be time consuming for authorized officers to issue waivers and would divert resources from other law enforcement duties.

This measure is also intended to prevent vessel operators from mixing catch from multiple trips in the hold and biasing catch data. NEFOP observers sample the catch while it is on the deck, before it is placed in the fish hold, so there would be no chance that observers would be sampling fish from multiple trips that were mixed in the hold. The herring fishery is also sampled portside by the Massachusetts Department of Marine Fisheries (MA DMF) and Maine's Department of Marine Resources. Mixing of catch from multiple fishing trips, although unlikely, may have the potential to bias landings data used to inform herring stock assessments, state management spawning closures, and the river herring avoidance program operated by the University of Massachusetts' School of Marine Fisheries and MA DMF.

The Atlantic States Marine Fisheries Commission recently adopted a requirement that vessel fish holds be empty of fish before vessels depart on a herring trip, contingent on adoption in Federal waters, in Amendment 3 to the Interstate FMP for Atlantic Herring. Establishing a similar provision in this action would have promoted coordination between Federal and state management, but, for the reasons described above, it is unlikely to improve catch monitoring in the herring fishery.

For these reasons, NMFS concluded that the measure requiring fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized officer, is inconsistent with the requirements of the Magnuson-Stevens Act, APA, and PRA. The measure is inconsistent with the APA because there is insufficient support in Framework 4 documenting the need for this measure and how this measure would address the purported need. The measure is inconsistent with Magnuson-Stevens Act National Standard 7 and the PRA because the benefit of requiring empty fish holds when departing on a herring trip does not outweigh the additional reporting burden on vessel operators to request and obtain a waiver from an authorized officer. The measure is inconsistent with Magnuson-Stevens Act National Standard 7 because it does not provide fishermen with the greatest possible freedom of action in conducting business and imposes an unnecessary enforcement burden. Finally, the measure is inconsistent with Magnuson-Stevens Act National Standard 5 because it does not allow the fishery to operate at the lowest possible administrative and enforcement costs relative to any additional monitoring benefit provided by the measure.

Comments and Responses

NMFS received four comment letters on the proposed rule. Two letters were from environmental advocacy groups (Herring Alliance and CHOIR (Coalition for the Atlantic Herring Fishery's Orderly, Informed, and Responsible Long Term Development)) and two letters were from herring industry groups (Seafreeze Ltd. and the Sustainable Fisheries Coalition).

Comment 1: The Herring Alliance supports proposed measures in Framework 4 that would clarify the slippage definition and require slippage to be reported via the daily VMS catch report.

Response: NMFS is implementing measures to clarify the slippage definition and require slippage to be reporting via the daily VMS catch report.

Comment 2: CHOIR expressed concern with the potential for increased discarding of unsampled catch associated with the clarifications to existing slippage measures that allow for operational discards and catch that falls out of or off gear. Despite its concern, CHOIR supports the proposed clarifications to existing slippage measures, because it believes that the proposed slippage consequence measures will drastically improve management of herring fishery.

Response: NMFS agrees with CHOIR that slippage consequence measures will likely improve management of the herring fishery, but disagrees with CHOIR that continuing to allow for operational discards and fish that fall out of or off gear would increase the discarding of unsampled catch.

Framework 4 maintains the existing requirements that prohibit operational discards aboard midwater trawl vessels fishing in the Groundfish Closed Areas, but allows operational discards to occur on board herring vessels fishing outside the Groundfish Closed Areas. Framework 4 clarifies that operational discards are small amounts of fish that cannot be pumped on board and remain in the codend or seine at the end of pumping operations. Current observer protocols include estimating the amount and composition of operational discards. Because the fish cannot be pumped, it can be time and labor intensive to bring these small amounts of fish on board the vessel. There is no evidence in Framework 4 to suggest that continuing to allow operational discards would increase the discarding of unsampled catch. Rather, Framework 4 concludes that the compliance costs associated with requiring herring vessels fishing outside the Groundfish Closed Areas to bring operational discards on board would likely outweigh any benefits to the catch monitoring program and the herring resource.

Framework 4 clarifies that catch that falls out of or off of gear and is not brought on board would be categorized as discarded catch, but not slippage. In general, only small amounts of catch fall out or off of gear during fishing and/or when catch is being brought aboard the vessel, unlike the potential for catch loss due to mechanical failure. It would be very difficult for vessels to retrieve the small amounts of fish that fall out of or off gear and bring those fish on board the vessel. Again, there is no evidence in Framework 4 suggesting that this measure would increase the discarding of unsampled catch and the compliance costs associated with requiring these fish be brought on board the vessel for sampling would likely outweigh any benefit to herring catch monitoring.

Comment 3: The Sustainable Fisheries Coalition supports minor clarifications and corrections to existing measures because it believes they are not a substantive change to current regulations and are consistent with the Herring FMP. The Sustainable Fisheries Coalition also supports categorizing catch not brought on board due to gear damage as an allowable slippage event and catch that falls out of or off gear as a discard event. The Sustainable Fisheries Coalition supports continuing to allow operational discards in the herring fishery, except on board herring vessels fishing in the Groundfish Closed Areas, noting that the costs of prohibiting operational discards would likely outweigh any benefits. Lastly, the Sustainable Fisheries Coalition has no objection to the proposed requirement to report slippage via the VMS daily catch report.

Response: NMFS agrees with the Sustainable Fisheries Coalition and the measures implemented in this final rule are consistent with the Sustainable Fisheries Coalition recommendations.

Comment 4: The Sustainable Fisheries Coalition supports including the definition of operational discards in the regulations, but suggests that the operational discards definition, as well as the slippage definition, be revised to acknowledge that releasing small amounts of fish from the codend or seine at the end of pumping operations is also operationally discarding catch.

Response: This final rule adds the definition of operational discards to regulations at § 648.2. Operational discards are defined as small amounts of fish that cannot be pumped on board the vessel and remain in the codend or seine at the end of pumping operations. Leaving small amounts of fish in the codend or seine at the end of pumping operations is operationally discarding catch. This final rule also categorizes instances of catch falling out or off of gear during fishing and/or when catch is being brought aboard the vessel as discarding, rather than slippage. Framework 4 explains that, in general, only small amounts of catch fall out or off of gear during fishing and/or when catch is being brought aboard the vessel. NMFS believes that categorizing catch that falls out of gear as discarding addresses the Sustainable Fisheries Coalition's recommendation to acknowledge releasing small amounts of fish from the codend or seine at the end of pumping operations is a discard event and not slippage.

Comment 5: CHOIR and the Herring Alliance support the proposed slippage consequence measures. CHOIR commented that proposed slippage consequence measures are vital to provide vessels with incentive to avoid slippage and the Herring Alliance commented that the proposed slippage consequence measures are reasonable, safe, and necessary to further deter slippage events on observed trips.

Response: NMFS is implementing the slippage consequence measures to help improve catch monitoring and further deter slippage in the herring fishery.

Comment 6: Seafreeze Ltd. and the Sustainable Fisheries Coalition do not support the proposed measure requiring vessels to move and remain at least 15 nautical miles (27.78 km) away from an allowable slippage event for the duration of that fishing trip.

Seafreeze Ltd. and the Sustainable Fisheries Coalition commented that because no scientific analysis supports the requirement to move 15 nautical miles (27.78 km), the measure is inconsistent with the requirement that measures be based on the best available science. Seafreeze Ltd. noted that fishing effort is often already spatially limited by regulations, oceanographic features, or fish distribution. Both Seafreeze Ltd. and the Sustainable Fisheries Coalition commented that requiring vessels to move 15 nautical miles (27.78 km) following an allowable slippage event may result in lost fishing opportunities and will not rectify the problem that caused the slippage event. Additionally, the Sustainable Fisheries Coalition commented that the measure raises concerns with the ability of the herring fleet to achieve the herring OY, the need to minimize adverse impacts on fishing communities, and the measure having a limited conservation benefit as bycatch has already been minimized to the extent practicable.

Seafreeze Ltd. noted that as spiny dogfish populations continue to increase, herring fishery interactions with dogfish will also likely increase. Seafreze Ltd. also noted that vessels typically move from an area following interactions with dogfish, but they do not move as far as 15 nautical miles (27.78 km).

Seafreeze Ltd. and the Sustainable Fisheries Coalition commented that needing to slip catch for safety or mechanical failure is often beyond the control of the vessel operator. Seafreeze Ltd. also commented that requiring vessels to move 15 nautical miles (27.78 km) following allowable slippage events may pressure vessel operators to possibly engage in unsafe fishing practices to avoid a penalty. Additionally, Seafreeze Ltd. commented that penalizing a vessel for safety concerns violates National Standard 10.

Lastly, Seafreeze Ltd. commented that its bottom trawl vessels have higher observer coverage rates than other gear types participating in the herring fishery and would, therefore, be disproportionately impacted by the proposed slippage consequence measure following an allowable slippage event.

Response: NMFS disagrees with Seafreeze Ltd. and the Sustainable Fisheries Coalition that the slippage consequence measure requiring vessels to move and remain at least 15 nautical miles (27.78 km) away from an allowable slippage event for the duration of that fishing trip should not be approved.

NMFS anticipates this slippage consequence measure will address concerns about bycatch and slippage by discouraging the occurrence of slippage throughout the fishery, while continuing to promote safe and efficient fishing practices on vessels participating in the herring fishery. Safety is an important consideration for all fishery management plans and Framework 4 acknowledges that slippage events due to safety concerns or mechanical failure may be beyond the control of the vessel operator. NMFS expects the requirement to move 15 nautical miles (27.78 km) following an allowable slippage event will accommodate any safety concerns because it allows vessels to continue fishing, when it is safe to do so, rather than requiring trip termination.

NMFS also expects that this slippage consequence measure will enhance the catch monitoring program established through Amendment 5 by further discouraging slippage in the herring fishery. The requirement for a vessel to move following an allowable slippage event is not based on the biology or distribution of a fish species, like the Groundfish Closed Areas, nor is it intended to rectify mechanical failures, unsafe weather conditions, or encounters with spiny dogfish. Instead, the measure was based on an analysis evaluating the distances vessels move during fishing operations and is intended to provide sufficient incentive (i.e., cost in time and fuel) for herring vessels to minimize slippage, while providing opportunities to utilize the herring OY. Options for moving 10 nautical miles (16.09 km) and 20 nautical miles (32.19 km) were also considered in Framework 4, but the 15-nautical mile (27.78-km) option was recommended by the Council because 15 nautical miles (27.78 km) is the median value between 10 nautical miles (16.09 km) and 20 nautical miles (32.19 km). Additionally, this measure applies uniformly to all vessels that slip catch, unlike other considered alternatives (e.g., leaving a management area, leaving a statistical area) in Framework 4 where the magnitude of the move would have depended upon the location of the allowable slippage event.

Framework 4 describes the impact of this slippage consequence measure as a low negative for the herring industry. This impact is not related to safety concerns, but to the potential for lost time and money associated with moving following an allowable slippage event. Analyses in Framework 4 show that midwater trawl and purse seine vessels participating in the herring fishery have the potential to be most affected by the requirement to move following an allowable slippage event. Small mesh bottom trawl vessels are expected to be least affected by the move requirement because documented slippage events by those vessels are low.

NMFS implemented this same slippage consequence measure in the mackerel fishery as part of the measures recommended by the Mid-Atlantic Fishery Management Council in Framework 9 to the MSB FMP. Many vessels participate in both the herring and mackerel fisheries, and NMFS expects that implementing consistent slippage consequences across these fisheries will improve compliance and enforcement of slippage measures.

Comment 7: The Sustainable Fisheries Coalition supports the proposed measure requiring vessels to terminate a fishing trip and return to port following a non-allowable slippage event. With the exception of the allowable slippage events, the Sustainable Fisheries Coalition commented that vessels should be able to bring catch aboard and make it available to the observer for sampling. The Sustainable Fisheries Coalition noted that if the condition of the fish results in catch being unmarketable, those fish would be discarded after they were sampled by the observer.

Response: NMFS is implementing the requirement to terminate a fishing trip and return to port following a non-allowable slippage event.

Comment 8: CHOIR and the Herring Alliance support the measure requiring vessel fish holds to be certified and NEFOP observers to collect volumetric estimates of total catch. CHOIR noted that the volumetric catch estimate is especially important to confirm industry catch reports, given past instances of misreporting and when vessels and dealers both work for the same company. Even if observers only sporadically collected catch estimates, CHOIR commented that having a mechanism to confirm catch reports could improve catch reporting. Herring Alliance commented that third-party catch verification is needed to needed ensure industry catch reports are accurate, complete, and credible and that catch limits are not exceeded. The Herring Alliance explained that accurate landings data will improve stock assessments and aid in monitoring fishery catch caps. Additionally, the Herring Alliance noted that logistical and operational challenges associated with observers collecting volumetric estimates of catch, such as modifying the description of observer duties and contracts with observer service providers to require observers to sample vessels in port, are solvable.

Response: NMFS agrees with the Herring Alliance that it is possible to make the necessary programmatic changes to enable observers to collect volumetric estimates in port, but disagrees with CHOIR and the Herring Alliance that the proposed volumetric catch estimate is a cost-effective measure that is necessary to confirm industry catch reports and will improve catch reporting and stock assessments.

Vessels and dealers report catch by species. VTRs, in combination with observer data, are used in herring stock assessments, while a combination of dealer data, VTR, and VMS, and observer data are used to track catch against herring annual catch limits and catch caps in the herring fishery. The proposed measure would provide an estimate of total catch, but not catch by species. Therefore, the volumetric estimate could not be used to replace either VTRs or dealer data and it could not be used for catch monitoring or stock assessments.

Framework 4 does not provide evidence of misreporting by the herring industry, but it does highlight past differences, that have since been minimized, between the amount of herring reported by vessels and dealers. In recent years, discrepancies between VTRs and dealer data have been minimal. VTRs were higher than dealer reports in 2009 (2 percent), 2010 (1.3 percent), 2011 (1.2 percent), and 2013 (0.1 percent) and less than dealer reports in 2012 (0.1 percent). GARFO staff use a rigorous process to match vessel and dealer reported data and make corrections to the appropriate data set. Given that discrepancies between VTR and dealer data are minimal as well as investigated and resolved, NMFS does not consider the proposed volumetric catch estimate necessary to help identify or resolve discrepancies between VTR and dealer data.

NMFS disapproved the requirement for volumetric catch estimates because it considers the measure inconsistent with the Magnusson-Stevens Act, APA, and PRA.

Comment 9: Seafreeze Ltd. does not support the proposed measure requiring fish holds to be certified and NEFOP observers to collect volumetric estimates of total catch. The Sustainable Fisheries Coalition noted that its members did not reach a consensus whether the volumetric catch estimate should be approved or disapproved, but it expressed concern with the potential inaccuracies associated with the proposed measure. Additionally, the Sustainable Fisheries Coalition recommended that if the proposed measure was implemented, that it only apply to vessels whose fish holds had already been certified to help minimize vessel compliance costs. Seafreeze Ltd. also questioned the accuracy of the proposed volumetric estimates and expressed concern that the proposed measure would increase observer workload. Seafreeze Ltd. commented that because discrepancies between vessel and dealer reports are minimal, the proposed measure is not warranted. Lastly, Seafreeze Ltd. noted that the proposed measure would not be applicable to the Seafreeze Ltd. vessels that offload frozen product.

Response: NMFS shares Seafreeze Ltd.'s and the Sustainable Fisheries Coalition's concern with the accuracy of the proposed volumetric catch estimates and disapproved this measure in Framework 4. The volumetric conversions proposed in Framework 4 are based on herring harvested in other parts of the world. Using a volumetric conversion assumes consistency in the size, weight, and density of the catch, but there can be substantial variability in the catch composition of the herring fishery, depending on the area and season. Additionally, the proposed 5 percent deduction from total weight to account for water in the tanks is based on industry practices, but the Council did not rigorously evaluate the amount of the deduction. For these reasons, Framework 4 questioned whether the proposed measure would be more accurate than methods currently used by vessel operators or dealers to estimate catch.

NMFS agrees with Seafreeze Ltd. that requiring observers to collect volumetric catch estimates would increase observer workload and that discrepancies between vessel and dealer reports are minimal. As described previously, volumetric estimates could not be used to replace either VTRs or dealer data and it could not be used for catch monitoring or stock assessments. Increasing observer workload with duties that are unlikely to improve herring catch monitoring is not an effective use of NMFS resources. As described previously, NMFS does not consider the proposed volumetric catch estimate necessary to help identify or resolve the minimal discrepancies between VTR and dealer data.

Lastly, the measure, as proposed, would have required all vessels with limited access herring permits to have their fish holds certified and observers to collect volumetric catch estimates. Limiting the measure to only apply to vessels whose fish holds had already been certified would have meant substantially revising the measure. NMFS can only approve or disapprove a proposed measure; therefore, NMFS cannot revise the measure to only apply to vessels whose fish holds have already been certified.

Comment 10: CHOIR and Herring Alliance support the proposed measure requiring fish holds to be empty of fish before a vessel departs on a herring trip, unless a waiver has been issued. CHOIR expressed concern with the perceived practice of fish being harvested without a confirmed buyer and unsold fish being discarded at sea, especially when discarded fish may not have been reported. CHOIR surmised that requiring empty fish holds would likely ensure that vessels do not harvest excess fish or discard unsold fish at sea.

Response: The proposed measure requiring empty fish holds was intended to enhance catch monitoring and discourage wasteful fishing practices in the herring fishery. While prohibiting the disposal of unsold fish at sea may discourage wasteful fishing practices, there is insufficient support in the record to conclude that herring vessels are harvesting excess fish and discarding unsold fish at sea. The costs associated with a herring trip, including fuel, crew wages, and insurance, are substantial, so it is unlikely that vessel operators are making herring trips to harvest fish that will ultimately be discarded. Additionally, if discarding of unsold fish at sea is occurring, Framework 4 explains that it is unclear whether unsold catch disposed of at sea on a subsequent trip is reported.

Part of the justification for the waiver provision is to provide a way to verify that fish have been reported and document the extent to which vessels are departing on trips with fish in their fish holds. However, Framework 4's proposed waiver provides no way of verifying the amount of fish reported relative to the amount of fish left in the hold. Therefore, NMFS does not believe this measure contains a viable mechanism to verify whether harvested fish that are left in the hold were reported by the vessel and is unlikely to improve catch monitoring in the herring fishery.

NMFS disapproved the requirement for empty fish holds because it considers the measure inconsistent with the Magnusson-Stevens Act, APA, and PRA.

Comment 11: Seafreeze Ltd. does not support the proposed measure requiring fish holds to be empty of fish before a vessel departs on a herring trip. Seafreeze Ltd. noted that its processing vessels produce a frozen, processed product that would not be discarded at sea. Additionally, Seafreeze Ltd. noted that fish cannot be pumped out of the fish hold of its harvesting vessel at sea, only in port. For these reasons, Seafreeze Ltd. commented that this measure is not applicable to its vessels and would impact the vessels unnecessarily.

Response: NMFS disapproved this measure in Framework 4, so the application to frozen fish is not relevant. However, had NMFS approved the measure, it would not have applied to a frozen product or fish stored in freezers.

Comment 12: The Sustainable Fisheries Coalition did not have consensus whether the empty fish hold requirement should be approved or disapproved, but it commented that Framework 4 does not provide evidence of the misreporting and wasteful fishing practices that the empty fish hold requirement is intended to rectify. The Sustainable Fisheries Coalition noted that rarely does a vessel leave port with fish in its hold unless it is offloading at multiple locations, storing fish for which there is no immediate market, or disposing of poor quality fish. Given the absence of a clearly documented problem, the Sustainable Fisheries Coalition commented that the cost of delaying a trip to obtain a waiver, in order to depart on a herring trip with fish in the hold, would be a hardship.

Response: As described previously, there is insufficient evidence in Framework 4 to support claims of misreporting and wasteful fishing practices. Additionally, because the proposed measure lacks a mechanism to verify or correct the amount of fish reported on the VTR, the proposed measure is unlikely to improve catch monitoring in the herring fishery. In contrast, the compliance and enforcement costs associated with the proposed measure may be high. For example, vessel operators needing to dispose of fish at sea may lose time and money waiting for an authorized law enforcement officer to travel to their vessel, inspect the fish hold, and issue a waiver. Additionally, it would likely be time consuming for authorized officers to issue waivers and would divert resources from other law enforcement duties.

Comment 13: The Herring Alliance and CHOIR also commented on initiatives to increase monitoring in the herring fishery that are related to this action, but are outside the scope of measures considered and approved as part of Framework 4. Specifically, the commenters recommended that slippage consequence measures should apply if electronic monitoring is to be used to monitor the herring fishery and that NMFS should provide reasonable cost estimates for electronic monitoring as soon as possible to prevent a delay in allowing industry-funded monitoring to increase monitoring of the herring fishery.

Response: NMFS is working with the Council to develop measures related to these issues. Although NMFS understands the connection between these measures and slippage consequence measures established in this action, these additional initiatives are outside the scope of Framework 4.

Changes From the Proposed Rule

The proposed rule for Framework 4 contained all the measures in that were adopted by the Council in April 2014. As described previously, NMFS disapproved the measures requiring fish holds to be certified and observers to collect volumetric catch estimates, and fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized law enforcement officer. Thus, the regulatory requirements associated with those two measures are not included in this final rule. Specifically, the following sections from the proposed rule have been removed: §§ 648.4(a)(10)(iv)(P), 648.11 (m)(5), 648.14(r)(1)(ii)(D), 648.14(r)(2)(xiii), and 648.204(c) are not being implemented in this rule. Additionally, proposed § 648.11(m)(3)(ii) was revised to remove provisions related to providing an observer with a NMFS-approved measuring stick when requested.

This final rule also contains minor clarifications to the slippage definition, slippage reporting requirements, and slippage consequence measures to ensure consistency with slippage requirements for the Atlantic mackerel fishery. Specifically, the following sections have been revised: §§ 648.2, 648.11(m)(4)(C)(iv), and 648.14(r)(2)(vii), (xi), and (xii). Many vessels participate in both the herring and mackerel fisheries and NMFS expects that implementing consistent requirements across these fisheries will improve compliance and enforcement of slippage requirements. NMFS is revising the regulations under the authority of section 305(d) to the Magnuson-Stevens Act, which provides that the Secretary of Commerce may promulgate regulations necessary to ensure that framework adjustments to FMPs are carried out in accordance with the FMP and the Magnuson-Stevens Act.

Classification

The Assistant Administrator for Fisheries, NOAA, has determined that this rule is consistent with the national standards and other provisions of the Magnuson-Stevens Act and other applicable laws.

The Office of Management and Budget has determined that this rule is not significant according to Executive Order 12866.

This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.

NMFS, pursuant to section 604 of the Regulatory Flexibility Act (RFA), has completed a final regulatory flexibility analysis (FRFA) in support of Framework 4 in this final rule. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, a summary of the analyses completed in the Framework 4 EA, and this portion of the preamble. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in Framework 4 and in the preamble to the proposed and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and a copy of the IRFA, the RIR, and the EA are available upon request (see ADDRESSES) or via the Internet at www.greateratlantic.fisheries.noaa.gov.

Summary of the Significant Issues Raised by the Public Comments in Response to the IRFA, a Summary of the Agency's Assessment of Such Issues, and a Statement of Any Changes Made in the Final Rule as a Result of Such Comments

NMFS received four comment letters on the proposed rule. Those comments, and NMFS' responses, are contained in the Comments and Responses section of this final rule and are not repeated here. None of the comments addressed the IRFA and NMFS did not make any changes in the final rule based on public comment.

Description and Estimate of Number of Small Entities to Which the Rule Would Apply

This action regulates the activity of vessels with limited access herring permits and vessels with Category A or B limited access herring permits. Therefore, the regulated entity is the business that owns at least one limited access herring permit.

In 2013, the most recent full year of fishery permit data, 93 fishing vessels were issued a limited access herring permit. Vessels and/or permits may be owned by entities affiliated by stock ownership, common management, identity of interest, contractual relationships, or economic dependency. For the purposes of this analysis, ownership entities are defined as those entities with common ownership personnel as listed on permit application documentation. Only permits with identical ownership personnel are categorized as an affiliated entity. For example, if five permits have the same seven personnel listed as co-owners on their application paperwork, those seven personnel form one ownership entity, covering those five permits. If one or several of the seven owners also own additional vessels, with sub-sets of the original seven personnel or with new co-owners, those ownership arrangements are deemed to be separate entities for the purpose of this analysis.

Based on this ownership criterion, NMFS dealer data for recent years (2010-2013), and the size standards for finfish and shellfish firms, there are 68 regulated fishing firms with a limited access herring permit. Of those 68 firms, there are 61 small entities and 7 large entities. Not all of these permitted firms are active: Only 32 small entities and 5 large entities were actively fishing for herring during the last 3 years. Additionally, there are 32 regulated fishing firms that hold Category A or B herring permits. Of those 32 firms, there are 27 small entities and 5 large entities. Not all of these permitted firms are active: Only 19 small entities and 5 large entities holding Category A or B herring permits were actively fishing for herring during the last 3 years.

Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements

This final rule contains collection-of-information requirements subject to the PRA that have been approved by the OMB under Control Number 0648-0202.

This action requires all limited access vessels to report slippage events via the daily VMS herring catch report. This information is intended to improve catch monitoring in the herring fishery. All limited access herring vessels are currently required to submit daily VMS catch reports, therefore, reporting slippage via VMS is not expected to cause any additional time or cost burden above that which was previously approved under OMB Control Number 0648-0202. Time burdens that were previously approved through OMB Control Number 0648-0202 include an estimated burden of 5 minutes to complete daily catch reports, with an additional 2 minutes if the vessel is also reporting all fish kept, and a total burden of 429 hours. Cost burdens that were previously approved through OMB Control Number 0648-0202 include an estimated burden of $0.60 per transmission of daily catch reports and a total burden of $2,323. In a given fishing year, NMFS estimates that the additional reporting requirements included in Framework 4 will not cause any additional time or cost burden from that which was previously approved. Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and by email to [email protected], or fax to (202) 395-7285.

Notwithstanding any other provisions of the law, no person is required to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of Applicable Statutes

NMFS disapproved two measures in Framework 4 because it determined the measures were inconsistent with the Magnuson-Stevens Act, APA, and PRA.

One of the disapproved measures in Framework 4 would have required owners of vessels with limited access herring permits to certify the capacity of their fish holds and purchase and carry a NMFS-approved measuring stick to estimate the volume of fish in the fish hold. Each fish hold certification done by a certified marine surveyor is estimated to cost $300-$400. The cost of the NMFS-approved measuring stick is unknown at this time, but expected to be minimal. Ninety-three vessels were issued a limited access herring permit in 2013. Therefore, an estimated 93 vessels would have been required to submit a fish hold certification at the time of permit issuance in 2016 and obtain and carry on board a NMFS-approved measuring stick. By disapproving this measure, vessel owners will not incur the costs associated with this measure.

The other disapproved measure in Framework 4 would have required vessels with Category A or B herring permits to have fish holds empty of fish prior to departing on a herring trip. A waiver may have been issued by an authorized law enforcement officer when fish had been reported as caught but could not be sold due to condition. Forty-three vessels were issued a Category A or B herring permit in 2013. Therefore, an estimated 43 vessels would have been required to obtain a waiver from an authorized officer prior to leaving the dock on a herring trip with fish in the hold. The burden to the vessel operator/owner associated with obtaining a waiver would be any loss of time and/or money waiting for an authorized officer to travel to their vessel, inspect the fish hold, and issue a waiver. By disapproving this measure, vessel owners will not incur the burden associated with this measure.

NMFS is implementing slippage consequence measures for vessels with Category A and B herring permits in this rule, including requirements to move 15 nautical miles (27.78 km) following an allowable slippage event and terminate a trip following a non-allowable slippage event. Because non-allowable slippage events are already prohibited in the herring fishery, NMFS expects that instances of vessels terminating a trip and returning to port following a non-allowable slippage event will be rare. Therefore, the requirement to terminate a trip following a non-allowable slippage event will not have a significant economic impact on vessels with Category A and B herring permits. NMFS also expects that the requirement to move 15 nautical miles (27.78 km) following an allowable slippage event will also not have a significant economic impact on Category A and B vessels. The measure is based on an analysis evaluating the distances vessels move during fishing operations and is intended to provide sufficient incentive (i.e., cost in time and fuel) for herring vessels to minimize slippage, while still promoting safety at sea and maximizing opportunities to utilize the herring OY. Options for moving 10 nautical miles (16.09 km) and 20 nautical miles (32.19 km) were also considered in Framework 4, but the 15-nautical mile (27.78-km) option is being implemented because 15 nautical miles (27.78 km) is the median value between 10 nautical miles (16.09 km) and 20 nautical miles (32.19 km). Additionally, this measure applies uniformly to all vessels that slip catch, unlike other considered alternatives (e.g., leaving a management area, leaving a statistical area) in Framework 4 where the magnitude of the move, and resulting economic impacts, would have depended upon the location of the allowable slippage event.

This rule also implements clarifications and minor corrections to existing regulations. These clarifications and minor corrections are intended to clarify existing slippage measures; allow vessels to transit herring management areas during periods when zero percent of the sub-ACL for those areas is available for harvest, provided gear was stowed and not available for use; and correcting coordinates for Herring Management Area 2 to more accurately define the area. NMFS expects these clarifications and corrections to facilitate operation of the herring fishery.

List of Subjects in 50 CFR Part 648

Fisheries, Fishing, Recordkeeping and reporting requirements.

Dated: March 29, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:

PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority:

16 U.S.C. 1801 et seq.

2. In § 648.2, the definition for “Slippage in the Atlantic herring fishery” is removed and the definitions for “Operational discards in the Atlantic herring fishery” and “Slip(s) or slipping catch in the Atlantic herring fishery” are added in alphabetical order to read as follows:
§ 648.2 Definitions.

Operational discards in the Atlantic herring fishery means small amounts of fish that cannot be pumped on board and remain in the codend or seine at the end of pumping operations. Leaving small amounts of fish in the codend or seine at the end of pumping operations is operationally discarding catch.

Slip(s) or slipping catch in the Atlantic herring fishery means discarded catch from a vessel issued an Atlantic herring permit that is carrying a NMFS-approved observer prior to the catch being brought on board or prior to the catch being made available for sampling and inspection by a NMFS-approved observer after the catch is on board. Slip(s) or slipping catch includes releasing fish from a codend or seine prior to the completion of pumping the fish on board and the release of fish from a codend or seine while the codend or seine is in the water. Slippage or slipped catch refers to fish that are slipped. Slippage or slipped catch does not include operational discards, discards that occur after the catch is brought on board and made available for sampling and inspection by a NMFS-approved observer, or fish that inadvertently fall out of or off fishing gear as gear is being brought on board the vessel.

3. In § 648.11, paragraph (m)(4) is revised to read as follows:
§ 648.11 At-sea sea sampler/observer coverage.

(m) * * *

(4) Measures to address slippage. (i) No vessel issued a limited access herring permit may slip catch, as defined at § 648.2, except in the following circumstances:

(A) The vessel operator has determined, and the preponderance of available evidence indicates that, there is a compelling safety reason; or

(B) A mechanical failure, including gear damage, precludes bringing some or all of the catch on board the vessel for inspection; or,

(C) The vessel operator determines that pumping becomes impossible as a result of spiny dogfish clogging the pump intake. The vessel operator shall take reasonable measures, such as strapping and splitting the net, to remove all fish which can be pumped from the net prior to release.

(ii) Vessels may make test tows without pumping catch on board if the net is re-set without releasing its contents provided that all catch from test tows is available to the observer to sample when the next tow is brought on board for sampling.

(iii) If a vessel issued any limited access herring permit slips catch, the vessel operator must report the slippage event on the Atlantic herring daily VMS catch report and indicate the reason for slipping catch. Additionally, the vessel operator must complete and sign a Released Catch Affidavit detailing: The vessel name and permit number; the VTR serial number; where, when, and the reason for slipping catch; the estimated weight of each species brought on board or slipped on that tow. A completed affidavit must be submitted to NMFS within 48 hr of the end of the trip.

(iv) If a vessel issued an All Areas or Areas 2/3 Limited Access Herring permit slips catch for any of the reasons described in paragraph (m)(4)(i) of this section, the vessel operator must move at least 15 nm (27.78 km) from the location of the slippage event before deploying any gear again, and must stay at least 15 nm (27.78 km) away from the slippage event location for the remainder of the fishing trip.

(v) If catch is slipped by a vessel issued an All Areas or Areas 2/3 Limited Access Herring permit for any reason not described in paragraph (m)(4)(i) of this section, the vessel operator must immediately terminate the trip and return to port. No fishing activity may occur during the return to port.

4. In § 648.14, paragraph (r)(1)(vii)(F) is added and paragraphs (r)(2)(v) through (xii) are revised to read as follows:
§ 648.14 Prohibitions.

(r) * * *

(1) * * *

(vii) * * *

(F) Transit or be in an area that has zero percent sub-ACL available for harvest specified at § 648.201(d) with herring on board, unless such herring were caught in an area or areas with an available sub-ACL specified at § 648.201(d), all fishing gear is stowed and not available for immediate use as defined in § 648.2, and the vessel is issued a vessel permit that authorizes the amount of herring on board for the area where the herring was harvested.

(2) * * *

(v) Fish with midwater trawl gear in any Northeast Multispecies Closed Area, as defined in § 648.81(a) through (e), without a NMFS-approved observer on board, if the vessel has been issued an Atlantic herring permit.

(vi) Slip or operationally discard catch, as defined at § 648.2, unless for one of the reasons specified at § 648.202(b)(2), if fishing any part of a tow inside the Northeast Multispecies Closed Areas, as defined at § 648.81(a) through (e).

(vii) Fail to immediately leave the Northeast Multispecies Closed Areas or comply with reporting requirements after slipping catch or operationally discarding catch, as required by § 648.202(b)(4).

(viii) Slip catch, as defined at § 648.2, unless for one the reasons specified at § 648.11(m)(4)(i).

(ix) For vessels with All Areas or Areas 2/3 Limited Access Herring Permits, fail to move 15 nm (27.78 km), as required by § 648.11(m)(4)(iv) and § 648.202(b)(4)(iv).

(x) For vessels with All Areas or Areas 2/3 Limited Access Herring Permits, fail to immediately return to port, as required by § 648.11(m)(4)(v) and § 648.202(b)(4)(iv).

(xi) Fail to complete, sign, and submit a Released Catch Affidavit as required by § 648.11(m)(4)(iii) and § 648.202(b)(4)(ii).

(xii) Fail to report or fail to accurately report a slippage event on the Atlantic herring daily VMS catch report, as required by § 648.11(m)(4)(iii) and § 648.202(b)(4)(iii).

§ 648.80 [Amended]
5. In § 648.80, paragraph (d)(7) is removed. 6. In § 648.200, paragraph (f)(2) is revised to read as follows:
§ 648.200 Specifications.

(f) * * *

(2) Management Area 2 (South Coastal Area): All state and Federal waters inclusive of sounds and bays, bounded on the east by 70°00′ W. long. and the outer limit of the U.S. Exclusive Economic Zone; bounded on the north and west by the southern coastline of Cape Cod, Massachusetts, and the coastlines of Rhode Island, Connecticut, New York, New Jersey, Delaware, Maryland, Virginia, and North Carolina; and bounded on the south by a line following the lateral seaward boundary between North Carolina and South Carolina from the coast to the Submerged Lands Act line, approximately 33°48′46.37″ N. lat., 78°29′46.46″ W. long., and then heading due east along 33°48′46.37″ N. lat. to the outer limit of the US Exclusive Economic Zone.

7. In § 648.201, paragraphs (e) and (f) are revised and paragraph (g) is added to read as follows:
§ 648.201 AMs and harvest controls.

(e) A vessel may transit an area that has zero percent sub-ACL available for harvest specified in paragraph (d) of this section with herring on board, provided such herring were caught in an area or areas with sub-ACL available specified in paragraph (d) of this section, that all fishing gear is stowed and not available for immediate use as defined in § 648.2, and the vessel is issued a permit that authorizes the amount of herring on board for the area where the herring was harvested.

(f) Up to 500 mt of the Area 1A sub-ACL shall be allocated for the fixed gear fisheries in Area 1A (weirs and stop seines) that occur west of 67°16.8′ W. long (Cutler, Maine). This set-aside shall be available for harvest by fixed gear within the specified area until November 1 of each fishing year. Any portion of this allocation that has not been utilized by November 1 shall be restored to the sub-ACL allocation for Area 1A.

(g) Carryover. Subject to the conditions described in this paragraph (g), unharvested catch in a herring management area in a fishing year (up to 10 percent of that area's sub-ACL) shall be carried over and added to the sub-ACL for that herring management area for the fishing year following the year when total catch is determined. For example, NMFS will determine total catch from Year 1 during Year 2, and will add carryover to the applicable sub-ACL(s) in Year 3. All such carryover shall be based on the herring management area's initial sub-ACL allocation for the fishing year, not the sub-ACL as increased by carryover or decreased by an overage deduction, as specified in paragraph (a)(3) of this section. All herring landed from a herring management area shall count against that area's sub-ACL, as increased by carryover. For example, if 500 mt of herring is added as carryover to a 5,000 mt sub-ACL, catch in that management area would be tracked against a total sub-ACL of 5,500 mt. NMFS shall add sub-ACL carryover only if the ACL, specified consistent with § 648.200(b)(3), for the fishing year in which there is unharvested herring, is not exceeded. The ACL, consistent with § 648.200(b)(3), shall not be increased by carryover specified in this paragraph (g).

8. In § 648.202, paragraphs (b)(2) introductory text, (b)(2)(ii), (b)(4) introductory text, and (b)(4)(ii) are revised, and paragraphs (b)(4)(iii) and (iv) are added to read as follows:

§ 648.202 Season and area restrictions.

(b) * * *

(2) No vessel issued an Atlantic herring permit and fishing with midwater trawl gear, when fishing any part of a midwater trawl tow in the Closed Areas, may slip or operationally discard catch, as defined at § 648.2, except in the following circumstances:

(ii) A mechanical failure, including gear damage, precludes bringing some or all of the catch on board the vessel for inspection; or,

(4) If catch is slipped or operational discarded by a vessel, the vessel operator must:

(ii) Complete and sign a Released Catch Affidavit detailing: The vessel name and permit number; the VTR serial number; where, when, and for what reason the catch was released; the estimated weight of each species brought on board or released on that tow. A completed affidavit must be submitted to NMFS within 48 hr of the end of the trip.

(iii) Report slippage events on the Atlantic herring daily VMS catch report and indicate the reason for slipping catch if the vessel was issued a limited access herring permit.

(iv) Comply with the measures to address slippage specified in § 648.11(m)(4)(iv) and (v) if the vessel was issued an All Areas or Areas 2/3 Limited Access Herring Permit.

[FR Doc. 2016-07583 Filed 4-1-16; 8:45 am] BILLING CODE 3510-22-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No.: 150629565-6224-02] RIN 0648-BF15 Fisheries Off West Coast States; Comprehensive Ecosystem-Based Amendment 1; Amendments to the Fishery Management Plans for Coastal Pelagic Species, Pacific Coast Groundfish, U.S. West Coast Highly Migratory Species, and Pacific Coast Salmon AGENCY:

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Final rule.

SUMMARY:

NMFS issues regulations to implement Comprehensive Ecosystem-Based Amendment 1 (CEBA 1), which includes amendments to the Pacific Fishery Management Council's (Council's) four fishery management plans (FMPs): the Coastal Pelagic Species (CPS) FMP, the Pacific Coast Groundfish FMP, the FMP for U.S. West Coast Highly Migratory Species (HMS), and the Pacific Coast Salmon FMP. CEBA 1 amended the Council's FMPs to bring new ecosystem component species (collectively, “Shared EC Species”) into each of those FMPs, and prohibits directed commercial fisheries for Shared EC Species within the U.S. West Coast Exclusive Economic Zone (EEZ). This final rule defines and prohibits directed commercial fishing for Shared EC Species, and prohibits, with limited exceptions, at-sea processing of Shared EC Species.

DATES:

Effective May 4, 2016.

ADDRESSES:

Electronic copies of CEBA 1 may be obtained from the Council Web site at http://www.pcouncil.org. Electronic copies of the environmental assessment and final regulatory flexibility analysis for this action may be obtained from the West Coast Regional Office Web site at http://www.westcoast.fisheries.noaa.gov/fisheries/ecosystem/index.html.

FOR FURTHER INFORMATION CONTACT:

Yvonne deReynier, 206-526-6129, [email protected].

SUPPLEMENTARY INFORMATION: Background

NMFS published a notice of availability of CEBA 1 in the Federal Register (80 FR 76924, December 11, 2015) to notify the public of the availability of the FMP amendments and invite comments. NMFS published a proposed rule to implement CEBA 1 on January 5, 2016 (81 FR 215). NMFS accepted public comments on the FMP amendments and proposed rule through February 9, 2016.

CEBA 1, through its implementing FMP amendments and regulations, prohibits the development of fisheries for a suite of ecosystem component species (collectively, “Shared EC Species”) within the U.S. West Coast EEZ until the Council has had an adequate opportunity to both assess the scientific information relating to any proposed directed fishery and consider potential impacts to existing fisheries, fishing communities, and the greater marine ecosystem. CEBA 1 includes these FMP amendments: Amendment 15 to the CPS FMP, Amendment 25 to the Pacific Coast Groundfish FMP, Amendment 3 to the FMP for U.S. West Coast HMS, and Amendment 19 to the Pacific Coast Salmon FMP. CEBA 1 adds the following species as Shared EC Species to each of the four West Coast FMPs: round herring (Etrumeus teres) and thread herring (Opisthonema libertate and O. medirastre); mesopelagic fishes of the families Myctophidae, Bathylagidae, Paralepididae, and Gonostomatidae; Pacific sand lance (Ammodytes hexapterus); Pacific saury (Cololabis saira); silversides (family Atherinopsidae); smelts of the family Osmeridae; and pelagic squids (families: Cranchiidae, Gonatidae, Histioteuthidae, Octopoteuthidae, Ommastrephidae except Humboldt squid (Dosidicus gigas,) Onychoteuthidae, and Thysanoteuthidae).

This final rule revises 50 CFR 660.1(a) to clarify that the regulations in Part 660 of Title 50 of the Code of Federal Regulations are not limited to fishing for management unit species, but are applicable generally to vessels fishing within the U.S. West Coast EEZ. This rule also adds new regulations at 50 CFR part 660, subpart B, that: 1) identify Shared EC Species as including the unfished forage species listed earlier in the preamble to this rule; 2) define what is meant by “directed commercial fishing” for Shared EC Species within the U.S. West Coast EEZ; 3) prohibit directed commercial fishing for Shared EC Species; and 4) prohibit at-sea processing of Shared EC Species, except while otherwise lawfully processing groundfish in accordance with 50 CFR part 600, subpart D. This action is needed to proactively protect unmanaged, unfished forage fish of the U.S. West Coast EEZ, in recognition of the importance of these forage fish to the species managed under the Council's FMPs and to the larger California Current Ecosystem. Shared EC Species have not historically been targeted or processed in EEZ fisheries, and the limits provided in this final rule are intended to recognize that low levels of incidental catch of Shared EC Species may continue to occur. This action does not supersede tribal or state fishery management for these species.

Public Comments and Responses

NMFS received 63 letters and emails supporting the finalization of CEBA 1 and its implementing regulations during the public comment period. Within the letters of support, NMFS received a letter from the U.S. Department of the Interior requesting clarification on whether essential fish habitat (EFH) would be defined for Shared EC Species. Several letters from environmental organizations included petitions supporting the action, with signatures or comments from 91,966 people supporting the action. Two of the letters of support were received from organizations of fishermen and vessel owners asking for clarifications of or revisions to the regulations language. In addition to the letters and emails supporting the action, NMFS also received a letter from an organization of fishermen and vessel owners recommending clarifications to the final rule. NMFS appreciates the broad public interest in this rulemaking and has taken the strong public support it received during the comment period into account in its approval of this final rule. Comments requesting clarification on regulatory issues, or suggesting revisions to regulatory language implementing this action are summarized below, with NMFS's responses to those comments.

Comment 1: The Department of the Interior requests clarification on whether NMFS will designate EFH for Shared EC Species.

Response: NMFS will not designate EFH for Shared EC Species. Under Federal regulations at 50 CFR 600.805(b), EFH must be designated for all species within an FMP's fishery management unit. In contrast, federal regulations at 50 CFR 600.310(d)(5) characterize ecosystem component species as species that are: not in the fishery or fishery management unit, not the target of Federal fisheries, not overfished or approaching an overfished condition, and not generally retained for sale. Occasional retention of ecosystem component species does not preclude their characterization as ecosystem component species. The species identified by this action as within the Shared EC Species group meet the guidance at 50 CFR 600.310(d)(5) for classification as ecosystem component species, rather than as fishery management species. Therefore, NMFS does not need to designate EFH for Shared EC Species.

Comment 2: Some of the letters or emails supporting this action asked that NMFS also prohibit fishing for krill, either off the West Coast or elsewhere in the U.S., in addition to the prohibitions on fishing for species classified as Shared EC Species by this action.

Response: Under Federal regulations at 50 CFR 660.505(o), fishing for krill has been prohibited in the EEZ off the U.S. West Coast since 2009 (74 FR 33372, July 13, 2009). This action does not address fisheries occurring outside of the U.S. West Coast EEZ; furthermore there is no known fishing for krill by U.S. vessels on the high seas.

Comment 3: An organization representing fishermen and fishing vessel owners described upheavals in West Coast salmon and Dungeness crab fisheries resulting from recent unusual environmental conditions. The organization asked that NMFS or the Council provide guidance to the fishing industry on whether there are avenues for developing future sustainable fisheries on Shared EC Species, should the need arise.

Response: The Council explicitly considered this issue in developing CEBA 1 and made provisions for allowing future fishing interests to experiment with directed fishing for Shared EC Species, to provide the Council with scientific information that would allow it to consider opening a fishery for these species, considering potential impacts to existing fisheries, fishing communities, and the greater marine ecosystem. Although this action revises Federal regulations to prohibit directed fishing for Shared EC Species, some future Council could recommend revising those regulations to accommodate a sustainable directed fishery for a species now classified as a Shared EC Species. NMFS and the Council have a regular practice for existing West Coast fisheries of encouraging innovative gear types or fishing methods that may not be allowed in Federal regulations by considering exempted fishing permits (EFPs) for the proposed new gear type or fishing method. To ensure that the Council receives consistent and thoughtfully-designed EFP proposals, it maintains Operating Procedures outlining its requirements for considering EFPs for new or experimental fisheries or gear. As part of its work on CEBA 1, the Council adopted its Operating Procedure 24, a Protocol for Consideration of Exempted Fishing Permits for Shared Ecosystem Component Species. Ultimately, to allow a directed fishery for a species now classified as a Shared EC Species, the Council and NMFS would have to review the potential fishery and species for inclusion in an FMP as a fishery management unit species, and would then have to consider Federal regulations to implement that fishery. This process of considering revisions to fishing regulations by using information gained in EFP fisheries is common in the West Coast Federal fisheries management process. NMFS supports the Council's thorough work on the CEBA 1 package of FMP amendments, implementing regulations, and operating procedure for future potential EFPs. Together, the elements of CEBA 1 reflect an understanding of the current state of science on West Coast marine species and of the Federal fisheries laws and regulations that affect those species, while also leaving flexibility for future fishermen and fisheries managers to work with changes in the ecosystem and updates in fisheries and ocean science.

Comment 4: An organization representing companies that own whiting vessels noted that the Council described the purpose of CEBA 1 as prohibiting new directed commercial fishing in Federal waters on unmanaged, unfished forage fish species until the Council has had an adequate opportunity to both assess the scientific information relating to any proposed directed fishery and consider potential impacts to exiting fisheries, fishing communities, and the greater marine ecosystem. The commenter asks why the proposed rule implementing CEBA 1 appears to prohibit any directed fisheries for Shared EC species, rather than prohibiting only new directed fisheries for Shared EC Species.

Response: There are no existing directed fisheries for Shared EC Species in the U.S. West Coast EEZ; therefore, any future directed fishing for Shared EC Species would be new directed fishing. Adding the word “new” to the regulation would be confusing and superfluous.

Comment 5: An organization representing CPS fishermen and fishing vessel owners recommended that, in the preamble to this final rule, NMFS reiterate the Council's full purpose and need statement for CEBA 1. This organization also expressed concern that the proposed definition of directed fishing for Shared EC Species did not allow for high enough levels of incidental landings to account for unique historic events where Shared EC Species were taken incidentally with species managed under a Council FMP, and suggested that only the historically highest landings of 52 mt per day with an annual vessel limit of 225 mt per year would account for unique historic events. Finally, the organization noted that climate change could bring shifts in the composition of species occurring off the U.S. West Coast and asked that, in the final rule for this action, NMFS establish a two-year review period for this action to assess the impacts of the action.

Response: As discussed in the preamble to the proposed rule for this action, and as quoted by the commenter who submitted Comment 4, the purpose of this action, according to the environmental assessment for the action, is to “prohibit new directed commercial fishing in Federal waters on unmanaged, unfished forage fish species until the Council has had an adequate opportunity to both assess the scientific information relating to any proposed directed fishery and consider potential impacts to existing fisheries, fishing communities, and the greater marine ecosystem.”

In the analysis that NMFS conducted to review potential limits for allowable incidental landings levels of Shared EC Species, NMFS noted that the highest daily landing level for the 2005-2014 period of groups of species that were predominantly Shared EC Species, but which could also have included Humboldt squid, was 52 mt. NMFS also noted that a daily incidental landing level of 10 mt would account for 99 percent of all historic daily landings levels. For annual total landings of species groups that were predominantly Shared EC Species, but which could also have included Humboldt squid, the highest historic annual landing level was 225 mt, while an annual limit of 30 mt would account for 97 percent of all historic annual landings levels. Between approximately 2006 and 2010 and peaking in 2008, the waters off the U.S. West Coast were inundated with large schools of Humboldt squid, which is not a Shared EC Species. Due to the somewhat surprising nature of this mass squid migration and population explosion, West Coast fisheries data collection programs were not initially equipped to separately identify Humboldt squid from other squid species on fish landings tickets. For these regulations, the Council recommended a Shared EC Species daily incidental landing limit of 10 mt and an annual cumulative landing limit of 30 mt, knowing that historic landings at those levels could possibly have included some Humboldt squid, also known as “jumbo” squid for its large size. NMFS believes that the limits recommended by the Council, provided in the proposed rule for this action, and finalized with this final rule, strike an appropriate balance between being high enough to account for unique historic incidental catch of Shared EC Species, without being so high as to allow or encourage targeting of those species. The NMFS analysis of historic West Coast landings of Shared EC Species, including discussions explaining the constraints of the fisheries landings data, is available on the Council's Web site for its September 2015 meeting: http://www.pcouncil.org/wp-content/uploads/2015/08/D2a_SUP_NMFS_Rpt_forage_SEPT2015BB.pdf.

The Council can schedule a review of these regulations and their effects at any time. Regulations at 50 CFR part 660 govern the actions of fishermen, fishing vessel owners, and fisheries participants operating in the U.S. West Coast EEZ. The scope of this action did not include the activities of the Council itself, and therefore this final rule does not include any provisions governing the actions of the Council.

Changes From the Proposed Rule

There are no changes to the regulatory text from the proposed rule, except for a minor and non-substantive grammatical correction to 50 CFR 660.1(a), changing the word “of” to “by,” when referring to fishing activity by vessels of the United States.

Classification

The Administrator, West Coast Region, NMFS, determined that the FMP amendments implementing CEBA 1 are necessary for conservation and management of West Coast fisheries, and that they are consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

A final regulatory flexibility analysis (FRFA) was prepared pursuant to 5 U.S.C. 604(a), and incorporates the Initial Regulatory Flexibility Analysis (IRFA), and NMFS's responses to comments received on the IRFA, if any. NMFS did not receive any comments from the public on the IRFA for this action. The preamble to the proposed rule for this action included a detailed summary of the analyses contained in IRFA, and that discussion is not repeated here.

Final Regulatory Flexibility Analysis A Statement of the Need for, and Objectives of, the Rule

This rule prohibits new directed commercial fishing in Federal waters on unmanaged, unfished forage fish species until the Council has had an adequate opportunity to both assess the scientific information relating to any proposed directed fishery and consider potential impacts to existing fisheries, fishing communities, and the greater marine ecosystem. This action is needed to proactively protect unmanaged, unfished forage fish of the U.S. West Coast EEZ in recognition of the importance of these forage fish to the species managed under the Council's FMPs and to the larger CCE. This action is not intended to supersede tribal or state fishery management for these species, and coordination would still occur through the existing Council process. CEBA 1 brings new ecosystem component species into each of the Council's four FMPs through amendments to those FMPs, and protects those species by prohibiting the future development of new directed commercial fisheries for Shared EC Species within the U.S. West Coast EEZ. No existing fisheries will be eliminated by this action. Under this rulemaking, existing levels of incidental catch of Shared EC Species in current fisheries will be allowed to continue into the future.

A Summary of Significant Issues Raised by the Public in Response to the Summary of the Agency's Assessment of Such Issues, and a Statement of Any Changes Made in the Final Rule as a Result

No public comments were received by NMFS in response to the IRFA or the economic analyses summarized in the IRFA, and no changes were required to be made as a result of the public comments. A summary of the comments received, and our responses, can be found above in the “Comments and Responses” section of this rule's preamble.

Response of the Agency to any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration in Response to the Proposed Rule

The Small Business Administration did not provide any comments on the proposed rule for this action.

Description and Estimate of Number of Small Entities To Which the Rule Will Apply

This rule will have no direct impact on any small entities.

A Description of the Projected Reporting, Recordkeeping and Other Compliance Requirements of the Rule

This action does not contain any Federal reporting, record keeping, or any other compliance requirements for either small or large entities.

A Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of Applicable Statutes

Alternative 2, the selected alternative for this rule, accomplishes the stated objectives of applicable statutes without any significant economic impact on small entities. Alternative 1, the no-action alternative, also would not have had any direct economic impact on small entities, but did not accomplish the state objectives of applicable statutes. Alternative 3 was expected to have moderate, indirect and negative effects on coastal pelagic species, shrimp, bottom trawl, and whiting fisheries and fishery management practices and was thus rejected in favor of the selected alternative in order to minimize economic impact on small entities consistent with the stated objectives of applicable statutes. A copy of this analysis is available from NMFS (see ADDRESSES). Copies of the Small Entity Compliance Guide prepared for this final rule are available on the West Coast Region's Web site at http://www.westcoast.fisheries.noaa.gov/.

This final rule was developed after meaningful collaboration, through the Council process, with the tribal representative on the Council. NMFS is not aware of any Treaty Indian tribe or subsistence fisheries in the EEZ other than those listed in 50 CFR 600.725(v). This action does not supersede or otherwise affect exemptions that exist for Treaty Indian fisheries.

List of Subjects in 50 CFR Part 660

Administrative practice and procedure, Fisheries, Fishing.

Dated: March 29, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

For the reasons set out in the preamble, 50 CFR part 660 is amended as follows:

PART 660—FISHERIES OFF WEST COAST STATES 1. The authority citation for part 660 continues to read as follows: Authority:

16 U.S.C. 1801 et seq., 16 U.S.C. 773 et seq., and 16 U.S.C. 7001 et seq.

2. In § 660.1 revise paragraph (a) to read as follows:
§ 660.1 Purpose and scope.

(a) The regulations in this part govern fishing activity by vessels of the United States that fish or support fishing inside the outer boundary of the EEZ off the states of Washington, Oregon, and California.

3. Add subpart B to read as follows: Subpart B—All West Coast EEZ Fisheries Sec. 660.5 Shared Ecosystem Component Species. 660.6 Prohibitions.
§ 660.5 Shared Ecosystem Component Species.

(a) General. The FMPs implemented in this part 660 each contain ecosystem component species specific to each FMP, as well as a group of ecosystem component species shared between all of the FMPs. Ecosystem component species shared between all of the Pacific Fishery Management Council's FMPs, and known collectively as “Shared EC Species,” are:

(1) Round herring (Etrumeus teres) and thread herring (Ophisthonema libertate and O. medirastre).

(2) Mesopelagic fishes of the families Myctophidae, Bathylagidae, Paralepididae, and Gonostomatidae.

(3) Pacific sand lance (Ammodytes hexapterus).

(4) Pacific saury (Cololabis saira).

(5) Silversides (family Atherinopsidae).

(6) Smelts of the family Osmeridae.

(7) Pelagic squids (families: Cranchiidae, Gonatidae, Histioteuthidae, Octopoteuthidae, Ommastrephidae except Humboldt squid [Dosidicus gigas,] Onychoteuthidae, and Thysanoteuthidae).

(b) Directed commercial fishing for Shared EC Species. For the purposes of this section, “directed commercial fishing” means that a fishing vessel lands Shared EC Species without landing any species other than Shared EC Species, or lands Shared EC Species with other species and in amounts more than:

(1) 10 mt combined weight of all Shared EC Species from any fishing trip; or

(2) 30 mt combined weight of all Shared EC Species in any calendar year.

§ 660.6 Prohibitions.

In addition to the general prohibitions specified in § 600.725 of this chapter, and the other prohibitions specified in this part, it is unlawful for any person to:

(a) Directed commercial fishing. Engage in directed commercial fishing for Shared EC Species from a vessel engaged in commercial fishing within the EEZ off Washington, Oregon, or California. This prohibition does not apply to:

(1) Fishing authorized by the Hoh, Makah, or Quileute Indian Tribes, or by the Quinault Indian Nation, or

(2) Fishing trips conducted entirely within state marine waters.

(b) At-sea processing. At-sea processing of Shared EC Species is prohibited within the EEZ, except while processing groundfish in accordance with subpart D of this part.

4. In § 660.112, add paragraphs (d)(16) and (e)(10) to read as follows:
§ 660.112 Trawl fishery—prohibitions.

(d) * * *

(16) Retain and process more than 1 mt of Shared EC Species other than squid species in any calendar year; or, retain and process more than 40 mt of any Shared EC squid species in any calendar year.

(e) * * *

(10) Retain and process more than 1 mt of Shared EC Species other than squid species in any calendar year; or, retain and process more than 40 mt of any Shared EC squid species in any calendar year.

[FR Doc. 2016-07516 Filed 4-1-16; 8:45 am] BILLING CODE 3510-22-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150916863-6211-02] RIN 0648-XE551 Fisheries of the Exclusive Economic Zone Off Alaska; Northern Rockfish in the Bering Sea and Aleutian Islands Management Area. AGENCY:

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; modification of closure.

SUMMARY:

NMFS is opening directed fishing for northern rockfish in the Bering Sea and Aleutian Islands Management Area (BSAI). This action is necessary to fully use the 2016 total allowable catch (TAC) of northern rockfish in the BSAI.

DATES:

Effective 1200 hrs, Alaska local time (A.l.t.), March 30, 2016, through 2400 hrs, A.l.t., December 31, 2016. Comments must be received at the following address no later than 4:30 p.m., A.l.t., April 19, 2016.

ADDRESSES:

You may submit comments on this document, identified by NOAA-NMFS-2015-0118, by any of the following methods:

Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to: https://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2015-0118, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

Mail: Submit written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Ellen Sebastian. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.

Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

FOR FURTHER INFORMATION CONTACT:

Steve Whitney, 907-586-7228.

SUPPLEMENTARY INFORMATION:

NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

Pursuant to the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016), NMFS closed the directed fishery for northern rockfish under § 679.20(d)(1)(iii).

As of March 28, 2016, NMFS has determined that approximately 3,200 metric tons of northern rockfish initial TAC remains unharvested in the BSAI. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the 2016 TAC of northern rockfish in the BSAI, NMFS is terminating the previous closure and is opening directed fishing for northern rockfish in the BSAI. This will enhance the socioeconomic well-being of harvesters in this area. The Administrator, Alaska Region (Regional Administrator) considered the following factors in reaching this decision: (1) The current catch of northern rockfish in the BSAI and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels in participating in this fishery.

Classification

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) and § 679.25(c)(1)(ii) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of northern rockfish in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 28, 2016.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

Without this inseason adjustment, NMFS could not allow the fishery for northern rockfish in the BSAI to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until April 19, 2016.

This action is required by §§ 679.20 and 679.25 and is exempt from review under Executive Order 12866.

Authority:

16 U.S.C. 1801 et seq.

Dated: March 30, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
[FR Doc. 2016-07613 Filed 3-30-16; 4:15 pm] BILLING CODE 3510-22-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150818742-6210-02] RIN 0648-XE556 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska AGENCY:

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2016 Pacific cod total allowable catch apportioned to vessels using pot gear in the Central Regulatory Area of the GOA.

DATES:

Effective 1200 hours, Alaska local time (A.l.t.), March 31, 2016, through 1200 hours, A.l.t., June 10, 2016.

FOR FURTHER INFORMATION CONTACT:

Josh Keaton, 907-586-7228.

SUPPLEMENTARY INFORMATION:

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.

The A season allowance of the 2016 Pacific cod total allowable catch (TAC) apportioned to vessels using pot gear in the Central Regulatory Area of the GOA is 8,028 metric tons (mt), as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016) and reallocation (81 FR 15650, March 24, 2016).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2016 Pacific cod TAC apportioned to vessels using pot gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 8,018 mt and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

Classification

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod for vessels using pot gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 29, 2016.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

Authority:

16 U.S.C. 1801 et seq.

Dated: March 30, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
[FR Doc. 2016-07599 Filed 3-30-16; 4:15 pm] BILLING CODE 3510-22-P
81 64 Monday, April 4, 2016 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. APHIS-2015-0015] RIN 0579-AE13 Importation of Fresh Cherimoya Fruit From Chile Into the United States AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States, provided that fruit is produced in accordance with a systems approach, as an alternative to the currently required treatment. Commercial consignments of fresh cherimoya fruit are currently authorized entry into all ports of the United States from Chile subject to a mandatory soapy water and wax treatment. The proposed systems approach would include requirements for production site registration, low pest prevalence area certification, post-harvest processing, and fruit cutting and inspection at the packinghouse. The fruit would also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization of Chile with an additional declaration stating that the consignment was produced in accordance with the regulations. Fresh cherimoya fruit that does not meet the conditions of the systems approach would continue to be allowed to be imported into the United States subject to treatment. This action would allow for the importation of fresh cherimoya fruit from Chile while continuing to provide protection against the introduction of plant pests into the continental United States.

DATES:

We will consider all comments that we receive on or before June 3, 2016.

ADDRESSES:

You may submit comments by either of the following methods:

Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0015.

Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0015, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0015 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT:

Ms. Claudia Ferguson, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, Imports, Regulations, and Manuals, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2352.

SUPPLEMENTARY INFORMATION: Background

Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-74, referred to below as the regulations or the fruits and vegetables regulations), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.

Pursuant to 7 CFR 319.56-4(a), fresh cherimoya (Annona cherimola) fruit from Chile may be imported into the United States provided the shipment has undergone a soapy water and wax treatment in accordance with the Plant Protection and Quarantine (PPQ) Treatment Manual to mitigate against infestation by the false red mite (Brevipalpus chilensis), and is accompanied by a permit and subjected to inspection and shipping procedures.

The national plant protection organization (NPPO) of Chile has requested that APHIS amend the regulations in order to allow fresh cherimoya fruit that has been produced in accordance with an approved systems approach to be imported into the continental United States as an alternative option to the currently approved treatment.

As part of our evaluation of Chile's request, we prepared a pest risk assessment (PRA), “Importation of Fresh Cherimoya (Annona cherimola Mill.) Fruit from Chile into the Continental United States, A Qualitative, Pathway-Initiated Pest Risk Assessment” (May 2013), which evaluated the risk of permitting the importation of fresh cherimoya fruit from Chile into the continental United States.

The PRA identifies the false red mite as the one quarantine pest that could be introduced into the United States in consignments of fresh cherimoya fruit from Chile. A quarantine pest is defined in § 319.56-2 as “a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled.” In the PRA, the likelihood and consequences of introducing this pest to the United States are considered, and the false red mite is rated as having a medium pest risk potential. Pests receiving a rating within the medium range may necessitate specific phytosanitary measures in addition to standard port-of-entry inspection of the commodity being imported into the continental United States.

We also prepared a commodity import evaluation document (CIED) to determine what phytosanitary measures should be applied to mitigate the pest risk associated with the importation of fresh cherimoya fruit from Chile into the continental United States. Copies of the PRA and CIED may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web site (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room).

In the CIED, entitled, “Importation of Fresh Cherimoya (Annona cherimola Mill.) Fruit from Chile into the Continental United States using a systems approach,” (December 2014), we determined that phytosanitary measures could be applied as a systems approach to mitigate the risks of introducing or disseminating the false red mite into the continental United States. Therefore, we are proposing to allow the importation of fresh cherimoya fruit from Chile into the continental United States if it is produced under a systems approach, which is described below. Alternatively, fresh cherimoya fruit that do not meet the conditions of the systems approach would still be allowed to be imported into the United States if the fruit is treated in Chile in accordance with the current requirements of the PPQ Treatment Manual. The fruit would also have to be imported in commercial consignments only and accompanied by documentation to validate foreign site preclearance inspection after the required treatment is completed.

Based on the findings of the CIED and the PRA, we are proposing to add the systems approach to the regulations in a new § 319.56-75.

Commercial Consignments

Only commercial consignments of fresh cherimoya fruit from Chile would be allowed to be imported into the continental United States. Produce grown commercially is less likely to be infested with plant pests than noncommercial consignments. Noncommercial consignments are more prone to infestations because the commodity is often ripe to overripe, could be of a variety with unknown susceptibility to pests, and is often grown with little or no pest control. Commercial consignments, as defined in § 319.56-2, are consignments that an inspector identifies as having been imported for sale and distribution. Such identification is based on a variety of indicators, including, but not limited to: Quantity of produce, type of packing, identification of grower or packinghouse on the packaging, and documents consigning the fruits or vegetables to a wholesaler or retailer.

Production Site Registration

Under this proposed rule, the production site where the fruit is grown would be required to be registered with the NPPO of Chile. The official registration number of the production site would be marked on all field cartons and containers of harvested fresh cherimoya fruit. Production sites would be required to renew their registration annually.

Registration of production sites with the NPPO of Chile and marking of field cartons or containers with the registration numbers would allow traceback to the production site if pest problems were found on fruit shipped to the United States. Problem production sites could then be suspended until further mitigation measures were taken to address the pest populations.

Low-Prevalence Production Site Certification

Between 1 and 30 days prior to harvest, random samples of leaves would have to be collected from each registered production site under the direction of the NPPO of Chile. These samples would have to undergo a pest detection and evaluation method as follows: The leaves would have to be washed using a flushing method, placed in a 20-mesh sieve on top of a 200-mesh sieve, sprinkled with a liquid soap and water solution, washed with water at high pressure, and washed with water at low pressure. The process would then be repeated. The contents of the 200-mesh sieve would then be placed on a petri dish and analyzed for the presence of live false red mites. If a single live false red mite were found, the production site would not qualify for certification as a low-prevalence production site and would only be eligible to export fruit to the continental United States if the fruit is subsequently treated with an APHIS-approved quarantine treatment in Chile. Each production site would have only one opportunity per season to qualify as a low-prevalence production site, and certification of low prevalence would be valid for one harvest season only. The NPPO of Chile would be required to present a list of certified production sites to APHIS.

Production site low-prevalence certification would identify problem production sites and prevent the shipment of fruit with false red mites from such sites. This mite sampling method has been tested in Chile and found to be successful in identifying grape, citrus, baby kiwi, and pomegranate production areas with high and low populations of mites.

Post-Harvest Processing

After harvest, all damaged or diseased fruits would have to be culled at the packinghouse, and the remaining fruit would have to be packed into new, clean boxes, crates, or other APHIS-approved packing containers.

Post-harvest processing procedures, such as culling damaged fruit and sampling for mites, would remove fruit that could contain pests from consignments being shipped to the United States. Culling is a standard procedure to remove fruit that may contain pests or otherwise be of poor quality.

Phytosanitary Inspection

The fruit would have to be inspected in Chile at an APHIS-approved inspection site under the direction of APHIS inspectors in coordination with the NPPO of Chile following any post-harvest processing. In order to be eligible for shipment to the continental United States, the fruit in the consignment would have to pass inspection by meeting the following requirements:

• Fruit presented for inspection would have to be identified in the shipping documents accompanying each lot of fruit to specify the production site(s) where the fruit was produced and the packing shed(s) where the fruit was processed. This identification would have to be maintained until the fruit is released for entry into the United States.

• A biometric sample would have to be drawn from each consignment and examined for false red mite. If a single live false red mite were found during the inspection process, the certified low-prevalence production site where the fruit was grown would lose its certification for the remainder of the harvest season. Rejected consignments of fruit would still be eligible for export to all ports of the United States only after application of an APHIS-approved quarantine treatment in Chile as long as the fruit is imported in commercial consignments only and accompanied by documentation to validate foreign site preclearance inspection after the required treatment is completed.

The proposed requirements for the identification in shipping documents of the fresh cherimoya fruit to their production sites and packing sheds would aid in traceback if pests were discovered. The proposed requirements for visual inspection and biometric sampling of the fruit would provide additional layers of protection against the possibility of fresh cherimoya fruit infested with quarantine pests being shipped from Chile to the United States. These methods have proved effective when employed to inspect consignments of citrus, baby kiwi, and pomegranates from Chile.

Phytosanitary Certificate

Each consignment of fruit would have to be accompanied by a phytosanitary certificate issued by the NPPO of Chile that contains an additional declaration stating that the fruit in the consignment was inspected and found free of false red mite based on field and packinghouse inspections and was grown, packed, and shipped in accordance with the requirements of the regulations.

Requiring a phytosanitary certificate would ensure that the NPPO of Chile has inspected the fruit and certified that the fruit meets the conditions in the section for export to the United States.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

APHIS is proposing to allow the importation of fresh cherimoya fruit from Chile into the continental United States under a systems approach, in response to a January 2013 request from Chile's NPPO. This proposed rule provides the public with the opportunity to comment on APHIS' PRA and CIED that are the basis for this action. Currently, commercial consignments of fresh cherimoya are allowed into all of the United States subject to mandatory soapy water and wax treatment for Brevipalpus chilensis.

Over 80 percent of Chile's cherimoya exports are to the United States. APHIS welcomes information regarding cherimoya production within the United States. Regardless of the number of U.S. producers or their size, any impact of this proposed rule would be minor because the volume of cherimoya imported from Chile is not expected to change significantly.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

Executive Order 12988

This proposed rule would allow fresh cherimoya fruit to be imported into the continental United States from Chile under a systems approach. If this proposed rule is adopted, State and local laws and regulations regarding fresh cherimoya fruit imported under this rule would be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2015-0015. Please send a copy of your comments to: (1) APHIS, using one of the methods described under ADDRESSES at the beginning of this document, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250.

We are proposing to amend the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States, provided that fruit is produced in accordance with a systems approach, as an alternative to the currently required treatment. Commercial consignments of fresh cherimoya fruit are currently authorized entry into all ports of the United States from Chile subject to a mandatory soapy water and wax treatment.

The proposed systems approach would include requirements for production site registration, low pest prevalence area certification, post-harvest processing, and fruit cutting and inspection at the packinghouse. The fruit would also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the NPPO of Chile with an additional declaration stating that the consignment was produced in accordance with the regulations. Fresh cherimoya fruit that does not meet the conditions of the systems approach would continue to be allowed to be imported into the United States subject to treatment. This action would allow for the importation of fresh cherimoya fruit from Chile while continuing to provide protection against the introduction of plant pests into the continental United States.

Implementing this rule will require pre-clearance documentation, production site registration with low-prevalence level certification option, inspections, box markings, and phytosanitary certificates.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.12407 hours per response.

Respondents: Producers and importers of fresh cherimoya fruit and the NPPO of Chile.

Estimated annual number of respondents: 16.

Estimated annual number of responses per respondent: 202.5.

Estimated annual number of responses: 3,240.

Estimated total annual burden on respondents: 402 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the EGovernment Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

List of Subjects in 7 CFR Part 319

Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Rice, Vegetables.

Accordingly, we propose to amend 7 CFR part 319 as follows:

PART 319—FOREIGN QUARANTINE NOTICES 1. The authority citation for part 319 continues to read as follows: Authority:

7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

2. Section 319.56-75 is added to subpart Fruits and Vegetables to read as follows:
§ 319.56-75 Fresh cherimoya from Chile.

Fresh cherimoya (Annona cherimola) fruit must be imported into the United States under the conditions listed in paragraphs (a) and (b)(1) of this section. Fresh cherimoya fruit may also be imported into the continental United States from Chile under the conditions listed in paragraph (b)(2) of this section.

(a) Commercial consignments. The fresh cherimoya fruit may be imported in commercial consignments only.

(b) The risks presented by Brevipalpus chilensis mites must be addressed in one of the following ways:

(1) The fresh cherimoya fruit are subject to treatment and certification consisting of:

(i) A soapy water and wax treatment.

(ii) Each consignment of fresh cherimoya fruit must be accompanied by documentation to validate foreign site preclearance inspection after soapy water and wax treatment completed in Chile; or

(2) The fresh cherimoya fruit are subject to a systems approach consisting of the following:

(i) Production site registration. The production site where the fruit is grown must be registered with the national plant protection organization (NPPO) of Chile. Harvested cherimoya must be placed in field cartons or containers that are marked to show the official registration number of the production site. Registration must be renewed annually.

(ii) Low-prevalence production site certification. The fruit must originate from a low-prevalence production site to be imported under the conditions in this section. Between 1 and 30 days prior to harvest, random samples of leaves must be collected from each registered production site under the direction of the NPPO of Chile. These samples must undergo a pest detection and evaluation method as follows: The leaves must be washed using a flushing method, placed in a 20-mesh sieve on top of a 200-mesh sieve, sprinkled with a liquid soap and water solution, washed with water at high pressure, and washed with water at low pressure. The process must then be repeated. The contents of the 200-mesh sieve must then be placed on a petri dish and analyzed for the presence of live B. chilensis mites. If a single live B. chilensis mite is found, the production site will not qualify for certification as a low-prevalence production site. Each production site may have only one opportunity per season to qualify as a low-prevalence production site, and certification of low prevalence will be valid for one harvest season only. The NPPO of Chile will present a list of certified production sites to APHIS. Fruit from those production sites that do not meet the requirements for certification as low-prevalence production sites may still be imported into the continental United States subject to treatment as listed in paragraph (b)(1) of this section.

(iii) Post-harvest processing. After harvest, all damaged or diseased fruits must be culled at the packinghouse and remaining fruit must be packed into new, clean boxes, crates, or other APHIS-approved packing containers.

(iv) Phytosanitary inspection. Fruit must be inspected in Chile at an APHIS-approved inspection site under the direction of APHIS inspectors in coordination with the NPPO of Chile following any post-harvest processing. A biometric sample must be drawn and examined from each consignment. Fresh cherimoya fruit can be shipped to the continental United States under the conditions of this section only if the consignment passes inspection. Any consignment that does not meet the requirements for inspection can still be imported into the continental United States subject to treatment as listed in paragraph (b)(1) of this section. Inspection procedures are as follows:

(A) Fruit presented for inspection must be identified in the shipping documents accompanying each lot of fruit to specify the production site or sites in which the fruit was produced and the packing shed or sheds in which the fruit was processed. This identification must be maintained until the fruit is released for entry into the United States.

(B) A biometric sample of the boxes, crates, or other APHIS-approved packing containers from each consignment will be selected by the NPPO of Chile, and the fruit from these boxes, crates, or other APHIS-approved packing containers will be visually inspected for quarantine pests. If a single live B. chilensis mite is found during the inspection process, the certified low-prevalence production site where the fruit was grown will lose its certification for the remainder of the harvest season.

(v) Phytosanitary certificate. Each consignment of fresh cherimoya fruit must be accompanied by a phytosanitary certificate issued by the NPPO of Chile that contains an additional declaration stating that the fruit in the consignment was inspected and found free of Brevipalpus chilensis and was grown, packed, and shipped in accordance with the requirements of § 319.56-75(b)(2).

Done in Washington, DC, this 29th day of March 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-07653 Filed 4-1-16; 8:45 am] BILLING CODE 3410-34-P
DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. APHIS-2015-0051] RIN 0579-AE20 Importation of Lemons From Chile Into the Continental United States AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the fruits and vegetables regulations to list lemon (Citrus limon (L.) Burm. f.) from Chile as eligible for importation into the continental United States subject to a systems approach. Under this systems approach, the fruit would have to be grown in a place of production that is registered with the Government of Chile and certified as having a low prevalence of Brevipalpus chilensis. The fruit would have to undergo pre-harvest sampling at the registered production site. Following post-harvest processing, the fruit would have to be inspected in Chile at an approved inspection site. Each consignment of fruit would have to be accompanied by a phytosanitary certificate with an additional declaration stating that the fruit had been found free of Brevipalpus chilensis based on field and packinghouse inspections. This proposed rule would allow for the safe importation of lemons from Chile using mitigation measures other than fumigation with methyl bromide.

DATES:

We will consider all comments that we receive on or before June 3, 2016.

ADDRESSES:

You may submit comments by either of the following methods:

Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0051.

Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0051, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0051 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT:

Mr. George Balady, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, Plant Health Programs, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 851-2240.

SUPPLEMENTARY INFORMATION: Background

Under the regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-74, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.

The regulations in § 319.56-4(a) provide that fruits and vegetables that can be imported using one or more of the designated phytosanitary measures in § 319.56-4(b) to mitigate risk will be listed, along with the applicable requirements for their importation, on the Internet (currently in the Fruits and Vegetables Import Requirements [FAVIR] database at www.aphis.usda.gov/favir). Under those provisions, lemons from Chile (Citrus limon (L.) Burm. f.) are currently listed in the FAVIR database as enterable subject to treatment with methyl bromide for the pest Brevipalpus chilensis, the Chilean false red mite, applied either as a condition of entry treatment or applied in Chile under an APHIS preclearance program.

The regulations in § 319.56-4(a) also provide that commodities that require phytosanitary measures other than those measures cited in § 319.56-4(b) may only be imported in accordance with applicable requirements in § 319.56-3 and commodity-specific requirements contained elsewhere in the subpart. Under those provisions, other citrus fruits, including clementines (Citrus reticulata Blanco var. Clementine), mandarins (Citrus reticulata Blanco), and tangerines (Citrus reticulata Blanco) may be imported into the United States from Chile, and grapefruit (Citrus paradisi Macfad.) and sweet oranges (Citrus sinensis (L.) Osbeck) may be imported into the continental United States from Chile under a systems approach. The conditions applicable to the importation of citrus from Chile are listed in § 319.56-38.

In this document, we are proposing to amend § 319.56-38 to include lemons that are currently enterable into the United States subject to treatment, thereby making the lemons eligible for importation under the same systems approach as other citrus from Chile.

Our review of the information supporting the safe importation into the United States of citrus from Chile under the listed phytosanitary measures is examined in a commodity import evaluation document (CIED) titled “Importation of Fresh Lemons (Citrus limon (L.) Burm. F.), from Chile into the Continental United States Using a Systems Approach.” Copies of the CIED may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room).

In June 2010, APHIS recognized all of Chile as a pest-free area with respect to Ceratitis capitata, the Mediterranean fruit fly. Therefore, the CIED identifies one quarantine pest that could be introduced into the United States in consignments of lemon from Chile: B. chilensis. A quarantine pest is defined in § 319.56-2 as “a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled.” In the CIED, the likelihood and consequences of introducing this pest to the United States are considered, and B. chilensis is rated as having a medium pest risk potential. Pests receiving a rating within the medium range may necessitate specific phytosanitary measures in addition to standard port-of-entry inspection of the commodity being imported into the United States.

Based on the findings of our CIED, we are proposing to allow the importation of fresh lemons from Chile into the United States subject to the same systems approach in place for other citrus from Chile. Under a systems approach, a set of phytosanitary conditions, at least two of which have an independent effect in mitigating the pest risk associated with the movement of commodities, is specified, whereby fruits and vegetables may be imported into the United States from countries that are not free of certain plant pests. The systems approach for lemons from Chile would require the fruit to be grown in a place of production that is registered with the national plant protection organization (NPPO) of Chile. The fruit would have to undergo pre-harvest sampling at the registered production site under the direction of the NPPO of Chile. The NPPO of Chile would present a list of production sites certified as having a low prevalence of B. chilensis to APHIS. Following post-harvest processing, the fruit would have to be inspected in Chile at an APHIS-approved inspection site under the direction of APHIS inspectors in coordination with the NPPO of Chile. Each consignment of the fruit would have to be accompanied by a phytosanitary certificate with an additional declaration stating that the lemons in the consignment meet the conditions of the systems approach and are free of B. chilensis. The mitigation measures in the proposed systems approach are discussed in greater detail below.

Production Site Registration

The production site where the lemons are grown would have to be registered with the NPPO of Chile. To register, the production site must provide the NPPO of Chile with the following information: Production site name, grower name, municipality, province, region, area planted to each species, number of plants/hectares/species, and approximate date of harvest. Registration would have to be renewed annually.

Registration of production sites is required to manage production site requirements and to control access to the program to only qualified sites. Commercially grown shipments from registered production sites use good agricultural practices to reduce or eliminate pests.

Low-Prevalence Production Site Certification

Between 1 and 30 days prior to harvest, random samples of fruit would have to be collected from each registered production site under the direction of the NPPO of Chile. These samples would have to undergo a pest detection and evaluation method as follows: The fruit would have to be washed using a flushing method, placed in a 20-mesh sieve on top of a 200-mesh sieve, sprinkled with a liquid soap and water solution, washed with water at high pressure, and washed with water at low pressure. The washing process would then be repeated immediately after the first washing. The contents of the 200-mesh sieve would then be placed on a petri dish and analyzed for the presence of live B. chilensis mites. If a single live B. chilensis mite is found, the production site would not qualify for certification as a low-prevalence production site and would be eligible to export fruit to the United States only if the fruit is fumigated with methyl bromide either in Chile or at the port of first arrival in the United States. Each production site would have only one opportunity per season to qualify as a low-prevalence production site, and certification of low prevalence would be valid for one harvest season only. The NPPO of Chile would be required to present a list of certified production sites to APHIS annually.

Post-Harvest Processing

After harvest and before packing, the fruit would have to be washed, rinsed in a potable water bath, washed with detergent with brushing using bristle rollers, rinsed with a hot water shower with brushing using bristle rollers, predried at room temperature, waxed, and dried with hot air. These mitigations aid in removing any pests from the fruit.

Phytosanitary Inspection

The fruit would have to be inspected in Chile at an APHIS-approved inspection site under the direction of APHIS inspectors in coordination with the NPPO of Chile following any post-harvest processing. A biometric sample would be drawn from each consignment, which may represent multiple grower lots from different packing sheds. Consignments with mites will be rejected from the systems approach. Rejected lots may still be exported to the United States but would require fumigation with methyl bromide either in Chile or at the port of first arrival in the United States in accordance with § 305.5 of the regulations.

Phytosanitary Certificate

Each consignment of fruit would have to be accompanied by a phytosanitary certificate issued by the NPPO of Chile that contains an additional declaration stating that the lemons in the consignment meet the conditions of the systems approach and are free of B. chilensis. Requiring a phytosanitary certificate ensures that the NPPO of Chile inspects the lemons for pests.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

The Government of Chile submitted a market access request for lemon fruit to be approved for import into the continental United States using a systems approach as an alternative to methyl bromide fumigation, to mitigate the risk of introduction of the Chilean false red mite.

The United States is a net exporter of fresh lemon; over 5 seasons (2009/10-2013/14), annual exports averaged about 102,410 metric tons (MT) (19 percent of production), compared to annual imports that averaged about 46,270 MT. Based on the Small Business Administration small-entity standards, the majority of entities that comprise industries that may be affected by this rule are small. These entities include lemon producers, packers, wholesalers, retailers, and importers.

Chile supplies about one-third of U.S. fresh lemon imports. Chile's Ministry of Agriculture estimates that approximately 60 percent of their lemon consignments to the United States will switch from methyl bromide treatment to the systems approach. Chile currently exports about 15,000 MT per year to the United States, of which the systems approach is expected to be used for 8,500 to 9,000 MT. For this reason, the proposed rule is not expected to result in a significant increase in Chilean lemon exports to the United States or their competitiveness.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

Executive Order 12988

This proposed rule would allow lemon fruit to be imported into the continental United States from Chile. If this proposed rule is adopted, State and local laws and regulations regarding lemon fruit imported under this rule would be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2015-0051. Please send a copy of your comments to: (1) APHIS, using one of the methods described under ADDRESSES at the beginning of this document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250.

APHIS is proposing to amend the fruits and vegetables regulations to list lemon (Citrus limon (L.) Burm. f.) from Chile as eligible for importation into the continental United States subject to a systems approach. Under this systems approach, the fruit would have to be grown in a place of production that is registered with the Government of Chile and certified as having a low prevalence of B. chilensis. The fruit would have to undergo pre-harvest sampling at the registered production site. Following post-harvest processing, the fruit would have to be inspected in Chile at an approved inspection site. Each consignment of fruit would have to be accompanied by a phytosanitary certificate with an additional declaration stating that the fruit had been found free of B. chilensis based on field and packinghouse inspections. This proposed rule would allow for the safe importation of lemons from Chile using mitigation measures other than fumigation with methyl bromide.

Implementing this rule will require permits, production site registration with low-prevalence level certification option, phytosanitary inspections, phytosanitary certificates, and chemical treatment procedures.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.6917 hours per response.

Respondents: Producers and importers of lemons, and the NPPO of Chile.

Estimated annual number of respondents: 198.

Estimated annual number of responses per respondent: 6.71.

Estimated annual number of responses: 1,330.

Estimated total annual burden on respondents: 920 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

List of Subjects in 7 CFR Part 319

Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Rice, Vegetables.

Accordingly, we propose to amend 7 CFR part 319 as follows:

PART 319—FOREIGN QUARANTINE NOTICES 1. The authority citation for part 319 continues to read as follows: Authority:

7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

§ 319.56-38 [Amended]
2. Section 319.56-38 is amended as follows: a. In the introductory text, by adding the words “, lemons (Citrus limon (L.) Burm. f.),” between the words “(Citrus paradisi Macfad.)” and “and sweet oranges”. b. In paragraph (e), by adding the word “lemons,” between the words “grapefruit,” and “mandarins,”. c. In paragraph (f), by adding the word “lemons,” between the words “grapefruit,” and “mandarins,”. Done in Washington, DC, this 29th day of March 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-07673 Filed 4-1-16; 8:45 am] BILLING CODE 3410-34-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 56 [Docket No. FDA-2015-N-5052] Administrative Actions for Noncompliance; Lesser Administrative Actions AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Food and Drug Administration (FDA) is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions, until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.

DATES:

Submit electronic or written comments on this proposed rule or its companion direct final rule by June 20, 2016.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper comments as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2015-N-5052 for “Subpart E—Administrative Actions for Noncompliance; Lesser Administrative Actions.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Sheila Brown, Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-6563.

SUPPLEMENTARY INFORMATION: I. Background

FDA is proposing to amend the text of § 56.120(b) (21 CFR 56.120(b)), which describes lesser administrative actions that the Agency may impose on an IRB until the IRB takes appropriate action to correct the IRB's noncompliance. FDA is proposing this revision to clarify the language and improve the accuracy of the regulations. Specifically, this proposed rule would propose to amend § 56.120(b) by clarifying that FDA has authority to require the IRB to withhold approval of new FDA-regulated studies conducted at the institution or reviewed by the IRB, direct that no new subjects be added to ongoing studies, and terminate ongoing studies provided that doing so would not endanger study subjects.

This amendment also proposes to renumber current paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and inserts “FDA may” into newly designated paragraph (c) so that it is a complete sentence.

FDA first proposed requirements for the composition and operations of institutional review committees in the “Proposed Investigational Device Exemptions,” published in the Federal Register of August 20, 1976 (41 FR 35282; “Proposed IDE Rule”). In that document, FDA proposed disqualification procedures for institutional review committees and requested comments on the proposed procedures and other possible administrative actions that FDA might take against a committee that is not in compliance with the regulations (41 FR 35282 at 35293). FDA also stated its intention to publish uniform, Agency-wide regulations governing clinical investigations at a later date, including requirements governing institutional review committees (41 FR 35282 at 35283).

Subsequently, FDA published “Standards for Institutional Review Boards for Clinical Investigations” on August 8, 1978 (43 FR 35186; “Proposed IRB Standards”). Comments on implementing institutional review requirements received in response to the Proposed IDE Rule were reviewed and utilized in preparing the Proposed IRB Standards (43 FR 35186 at 35187). In the Proposed IRB Standards, FDA proposed that disqualification would be used only if the Commissioner of Food and Drugs finds that: (1) The IRB failed to comply with one or more of the standards for IRBs in part 56 or other supplemental requirements in the investigational new drugs or investigational device exemptions (IDE) regulations; (2) the noncompliance adversely affects the validity of the data or the rights or safety of the human subjects; and (3) other lesser regulatory actions (e.g., warnings or rejection of data from individual clinical investigations) have not been or probably will not be adequate in achieving compliance (43 FR 35186 at 35195).

FDA received numerous comments to the Proposed IRB Standards, and addressed those comments in the Federal Register of January 27, 1981 (46 FR 8958), “Protection of Human Subjects: Standards for Institutional Review Boards for Clinical Investigations, Final Rule.” Specifically, several comments suggested that any lesser regulatory actions should be listed (46 FR 8958 at 8973). FDA accepted these comments and revised § 56.120(b) to set forth the lesser administrative actions that the Agency may take if FDA finds deficiencies in the operation of an IRB and to describe the circumstances in which these lesser administrative actions may be used by the Agency. FDA's longstanding interpretation of § 56.120(b) is that FDA may impose these restrictions on a noncompliant IRB until the IRB takes appropriate corrective action. The text of the regulation, however, suggests that it is the Agency that would withhold approval of studies that have been reviewed by a noncompliant IRB, rather than authorizing FDA to direct the IRB to stop approving new studies until the IRB comes back into compliance.

This proposed rule would amend § 56.120(b) to read that, in addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to withhold approval of new studies, direct that no new subjects be added to ongoing studies, or terminate ongoing studies. This will ensure that those activities are suspended until the IRB takes appropriate corrective action to address its noncompliance. We believe revising § 56.120(b) will improve the clarity and accuracy of the regulations. We are also proposing to redesignate § 56.120(b)(4) as § 56.120(c), and § 56.120(c) as § 56.120(d).

FDA may notify relevant State and Federal regulatory Agencies when warranted to assure that organizations with a need to know about the IRB's apparent noncompliance are appropriately informed. The revision would eliminate confusion by stating clearly that FDA is authorized to notify others about the IRB's noncompliance. We believe these changes will ensure clarity and improve the accuracy of the regulations.

II. Why is FDA publishing this proposed rule?

This proposed rule is a companion to a direct final rule affirming FDA's longstanding interpretation of § 56.120(b), i.e., that FDA may impose these restrictions on a noncompliant IRB until the IRB takes appropriate corrective action. The direct final rule is published in the final rules section of this issue of the Federal Register. The direct final rule and this companion proposed rule are substantively identical. This companion proposed rule will serve the purpose of issuing a proposed rule under usual notice-and-comment procedures in the event we withdraw the direct final rule because we receive significant adverse comment. We are publishing the direct final rule because we believe it is noncontroversial, and we do not anticipate any significant adverse comments. If we do not receive any significant adverse comments in response to the direct final rule, we will not take any further action on this proposed rule. Instead, within 30 days after the comment period ends, we intend to publish a notice that confirms the effective date of the direct final rule.

If FDA receives any significant adverse comment regarding the direct final rule, we will publish a notice of significant adverse comment and withdraw the direct final rule within 30 days after the comment period ends. We will then proceed to final rulemaking using our usual notice-and-comment rulemaking procedures under the Administrative Procedure Act (APA). The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period. We will consider any comments that we receive in response to this companion proposed rule to be comments also regarding the direct final rule and vice versa. We do not intend to provide additional opportunity for comment.

A significant adverse comment is one that explains why the rule would be inappropriate (including challenges to the rule's underlying premise or approach), or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, we consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the APA (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered adverse. A comment recommending a rule change in addition to the rule would not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment.

You can find additional information about FDA's direct final rulemaking procedures in the guidance document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” 1 announced in the Federal Register of November 21, 1997 (62 FR 62466).

1http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.

III. Legal Authority

This proposed rule, if finalized, would amend § 56.120(b). FDA's authority to modify § 56.120(b) arises from the same authority under which FDA initially issued this regulation, the IRB regulations, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262).

IV. Analysis of Environmental Impact

We have determined under 21 CFR 25.30(h) and 25.34(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Economic Analysis of Impacts

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would not add any additional regulatory burdens, we propose to certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

The purpose of this proposed rule is to affirm FDA's longstanding interpretation of § 56.120(b), that FDA may impose these restrictions on a noncompliant IRB until the IRB takes appropriate corrective action. The amendment will improve the clarity and accuracy of the regulations. Because this proposed rule is a clarification and would impose no additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

VI. Paperwork Reduction Act of 1995

FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Federalism

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 56

Human research subjects, Reporting and recordkeeping requirements, Safety.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 56 is amended as follows:

PART 56—INSTITUTIONAL REVIEW BOARDS 1. The authority citation for 21 CFR part 56 is revised to read as follows: Authority:

21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.

2. In § 56.120, redesignate paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and revise paragraph (b) and newly designated paragraph (c) to read as follows:
§ 56.120 Lesser administrative actions.

(b) On the basis of the IRB's or the institution's response, FDA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to:

(1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB;

(2) Direct that no new subjects be added to ongoing studies subject to this part; or

(3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects.

(c) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, FDA may notify relevant State and Federal regulatory agencies and other parties with a direct interest in the Agency's action of the deficiencies in the operation of the IRB.

Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-07524 Filed 4-1-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 330 [Docket No. FDA-2016-N-0543] RIN 0910-AH30 Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). We are also proposing other changes to make the TEA process more efficient.

DATES:

Submit either electronic or written comments on the proposed rule by June 3, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by June 3, 2016, (see the “Paperwork Reduction Act of 1995” section of this document).

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2016-N-0543 for “Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit comments on information collection issues to the Office of Management and Budget in the following ways:

• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected] All comments should be identified with the title, Food and Drug Administration Review and Action on Over‐the‐Counter Time and Extent Applications.

FOR FURTHER INFORMATION CONTACT:

With regard to the proposed rule: Kristin Hardin, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-4246, [email protected]

With regard to the information collection: Ila Mizrachi, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., Rm. 14526, Silver Spring, MD 20993-0002, [email protected]

SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose and Scope of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations and Acronyms Commonly Used in This Document III. Background A. FDA Regulation of Over-The-Counter (OTC) Drugs B. The Sunscreen Innovation Act (SIA) IV. Legal Authority V. Description of the Proposed Rule A. Timelines for FDA Review and Action on Time and Extent Applications and Safety and Effectiveness Data Submissions (Proposed New § 330.15) B. Amendments to § 330.14 “Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded” VI. Proposed Effective Date VII. Economic Analysis of Impacts A. Introduction B. Summary VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995 X. Federalism XI. References I. Executive Summary A. Purpose and Scope of the Proposed Rule

This proposed rule is intended to implement part of the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9 sub. 5 part I, enacted November 26, 2014). Among other provisions, the SIA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 586F to the FD&C Act. Section 586F(b) directs FDA to issue regulations establishing timelines and related performance metrics for the review of certain submissions under FDA's regulation governing TEAs, which is codified at 21 CFR 330.14. The TEA regulation sets forth criteria and procedures by which OTC drugs initially marketed in the United States after the OTC Drug Review began in 1972 and OTC drugs without any U.S. marketing experience can be considered in the OTC drug monograph system. If a drug meets each of the conditions contained in any applicable OTC drug monograph, and other applicable regulations, it is considered generally recognized as safe and effective (GRASE) and not misbranded, and is not required by FDA to be approved in a new drug application (NDA) under section 505 of the FD&C Act. Drugs determined to be not GRASE (or non-monograph) must be approved under section 505 of the FD&C Act before being marketed in the United States (see section II.A. for more detail on the OTC Drug Review and the TEA process).

Section 586F(b) of the FD&C Act specifically requires FDA to issue regulations providing for the timely and efficient review of submissions under the TEA regulation, including establishing (1) reasonable timelines for reviewing and acting on such submissions for non-sunscreen OTC active ingredients and other conditions (non-sunscreen TEA conditions) and (2) measurable metrics for tracking the extent to which such timelines are met.

FDA is also proposing to amend the TEA regulation to make the TEA process more efficient and predictable for both product sponsors and FDA by adding filing determination requirements and criteria and by addressing the withdrawal of consideration of TEA and safety and effectiveness data submissions.

The timelines and metrics in this proposed rule would apply to non-sunscreen TEA conditions (see section V.A for more detail). FDA is addressing timelines for review of sunscreen active ingredients and other related topics regarding sunscreens separately, under other provisions of the SIA (see section II.B for more detail).

B. Summary of the Major Provisions of the Proposed Rule

The proposed rule implements the SIA requirements for non-sunscreen TEAs by adding proposed new § 330.15 to FDA's OTC drug monograph regulations (21 CFR part 330). The proposed new section has two major provisions regarding actions to be taken by FDA, consistent with requirements in the SIA. In particular, proposed § 330.15(c) establishes timelines for FDA to review and take action on non-sunscreen TEA conditions, and proposed § 330.15(b) describes measurable metrics that FDA will use for tracking the extent to which the timelines set forth in the regulations are met. Proposed § 330.15(a) generally limits the applicability of these timelines to non-sunscreen TEAs submitted after the enactment of the SIA, with one exception.

We are proposing to amend § 330.14 to:

• Add provisions concerning filing determinations regarding safety and effectiveness data submissions for eligible TEA conditions (i.e., determinations as to whether such submissions are sufficiently complete to permit a substantive review by FDA) (§ 330.14(j)),

• add provisions regarding the withdrawal of consideration of TEAs and safety and effectiveness data submissions (§ 330.14(k)),

• add certain definitions (§ 330.14(a)), and

• make minor conforming and clarifying changes.

C. Legal Authority

This rule is proposed under FDA's authority to regulate OTC drug products under the FD&C Act (see sections 201, 501, 502, 503, 505, 510, 586F, and 701(a) of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, and 371(a))). As stated in the Federal Register of January 22, 2002 (67 FR 3069), in which the final rule establishing the TEA process was published, submission of an NDA has been required before marketing a new drug since passage of the FD&C Act in 1938 (21 U.S.C. 355). To market a new drug, it must first be approved under section 505 of the FD&C Act. Section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. FDA's regulations in 21 CFR part 330 describe the conditions for a drug to be considered GRASE and not misbranded. If a drug meets each of the conditions contained in part 330, as well as each of the conditions contained in any applicable OTC drug monograph, and other applicable regulations, it is considered GRASE and not misbranded, and is not required by FDA to obtain approval under section 505 of the FD&C Act.

In addition, section 586F of the FD&C Act requires FDA to issue regulations providing for the timely and efficient review of certain submissions under the TEA regulation at 21 CFR 330.14. Section 586F of the FD&C Act specifically requires these regulations to include timelines and metrics associated with the review of those submissions under the TEA regulation. Proposed § 330.15 would add timeline and metrics provisions that are intended to implement section 586F of the FD&C Act.

D. Costs and Benefits

We expect that the proposed rule would make the TEA process more efficient and predictable, and improve communication between FDA and sponsors. Sponsors may benefit from knowing if additional data is needed and what optimal steps to take to receive a GRASE determination, and we would be able to bring resolution to TEA conditions. However, we do not know the monetary value of added predictability to sponsors.

We expect the rule would create a minimal burden on sponsors, primarily when they send a letter to request a meeting with us. Thus, we anticipate no increase in annual recurring costs for either small or large sponsors. We expect the six current sponsors of non-sunscreen TEAs covering conditions that have been found eligible to be considered for inclusion in the OTC drug monograph system would incur one-time costs to read and understand the proposed rule. We also estimate sponsors will submit two additional TEAs annually, and each of these sponsors would also spend time reading and understanding the proposed rule. The present value of the total costs over 10 years ranges from about $17,000 to $35,000 with a 7 percent discount rate and from about $19,000 to $38,000 with a 3 percent discount rate. With a discount rate of 7 percent and 3 percent, we estimate that on average affected sponsors would incur less than $150 of annualized costs per year.

II. Table of Abbreviations and Acronyms Commonly Used in This Document ANDA Abbreviated New Drug Application FDA Food and Drug Administration FD&C Act Federal Food, Drug, and Cosmetic Act GRASE Generally Recognized as Safe and Effective HHS U.S. Department of Health and Human Services NDA New Drug Application NOE Notice of Eligibility NPRM Notice of Proposed Rulemaking OMB Office of Management and Budget OTC Over-the-Counter PRA Paperwork Reduction Act SIA Sunscreen Innovation Act of 2014 TEA Time and Extent Application III. Background A. FDA Regulation of Over-the-Counter (OTC) Drugs

The OTC drug monograph system was established to evaluate the safety and effectiveness of all OTC drug products marketed in the United States before May 11, 1972, that were not covered by new drug applications (NDAs) and all OTC drug products covered by “safety” NDAs that were marketed in the United States before enactment of the 1962 drug amendments to the FD&C Act. In 1972, FDA began its OTC Drug Review to evaluate OTC drugs by categories or classes (e.g., sunscreens, antacids), rather than on a product-by-product basis, and to develop “conditions” under which classes of OTC drugs are GRASE and not misbranded.

FDA publishes these conditions in the Federal Register in the form of OTC drug monographs, which consist primarily of active ingredients, labeling, and other general requirements. Final monographs for OTC drugs that are GRASE and not misbranded are codified in 21 CFR part 330. Manufacturers of drugs that meet each of the conditions contained in part 330, including each of the conditions contained in any applicable OTC drug monograph, and other applicable regulations, need not seek FDA clearance before marketing.

Initially, OTC drug conditions not marketed in the U.S. prior to the inception of the OTC Drug Review were not eligible for review under the OTC drug monograph process. The TEA process, established by regulations finalized in 2002 (21 CFR 330.14), expanded the scope of the OTC Drug Review. A “condition,” for purposes of the TEA regulation, is an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration marketed for a specific OTC use. The TEA process provides a potential pathway for OTC conditions, including newer active ingredients that previously had no U.S. marketing history or that were marketed in the United States after the OTC Drug Review began, to be marketed under an OTC drug monograph.

Active ingredients and other conditions that satisfy the TEA eligibility requirements are subject to the same safety, effectiveness, and labeling standards that apply to other conditions under the OTC monograph process (see 21 CFR 330.14(g)). The TEA regulation requires multi-step, notice-and-comment rulemaking procedures before an active ingredient or other condition is added to an OTC drug monograph.

The TEA process begins with the submission of a TEA containing data documenting the OTC marketing history of the active ingredient, combination of active ingredients, or other condition(s) (e.g., a new dosage strength for an active ingredient already included in an OTC drug monograph). FDA reviews the application and determines whether the sponsor's marketing data establish that the condition or conditions have been marketed to a material extent and for a material time, as set forth in the TEA regulation's eligibility requirements. If the condition is not found eligible, FDA will send a letter to the sponsor explaining why the condition was not found acceptable. If the marketing data satisfy the TEA regulation's eligibility criteria, FDA publishes a notice of eligibility (NOE) in the Federal Register announcing that the active ingredient or other condition is being considered for inclusion in an OTC drug monograph and calling for submissions of safety and efficacy data for the proposed OTC use.

We note that although a TEA is the application regarding the time and extent of marketing, which leads to an eligibility determination (resulting in publication of an NOE or a letter of ineligibility), references to TEAs or applications under section 330.14 (including in the SIA) sometimes encompass FDA's review of the condition's eligibility and the GRASE determination for the condition. Thus, these references may be used to mean the TEA itself, the safety and effectiveness data submission, FDA's GRASE determination, associated order or rulemaking actions, or all of these. In this proposed rule and preamble, the terms “TEA” and “safety and effectiveness data submission” are used, where appropriate, to describe the two distinct submissions under the TEA regulation. However, the term “TEA process” may be used when referring to one or more actions under the TEA regulation.

If, after FDA reviews the safety and effectiveness data, the Agency initially determines that the active ingredient or other condition is GRASE, it will publish a proposed rule to include the condition in an appropriate OTC drug monograph.

If the condition is initially determined not to be GRASE, FDA will inform the sponsor and other interested parties that submitted data of its decision by letter, and will include the letter in the relevant public docket (§ 330.14(g)(4)). The Agency will also publish a notice of proposed rulemaking to include the condition in § 310.502. The sponsor and other interested parties will have an opportunity to submit comments and new data on FDA's initial determination and proposed rule (§ 330.14(g)(5)). After evaluation of any additional data submitted, FDA will either issue a final rule or a new proposed rule, if necessary, in the Federal Register.

B. The Sunscreen Innovation Act (SIA)

In November 2014, Congress passed the SIA to supplement the TEA process with regard to both sunscreen and non-sunscreen OTC drug products. Proposed § 330.15 addresses section 586F of the FD&C Act, which was added by the SIA and only applies to TEAs for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients (see sections 586 and 586F of the FD&C Act, as amended by the SIA). For FDA review of non-sunscreen TEA conditions, section 586F includes two main requirements, one regarding timelines for review of eligible TEA conditions pending before the date of enactment of the SIA, and the other regarding timelines and performance metrics for the TEA process going forward.

The first general requirement (see FD&C Act section 586F(a)) is that FDA provide the option of selecting one of four frameworks for review to each non-sunscreen TEA sponsor who (1) had submitted a TEA for a condition that had been deemed eligible to be considered for inclusion in the OTC monograph system before the date of enactment of the SIA, and (2) requested the framework option within 180 days after enactment. FDA was required to provide the framework options to requesting sponsors by no later than one year after enactment of the SIA (by November 26, 2015). Before the date of SIA enactment, there were six non-sunscreen TEAs for conditions that had been found eligible to be considered for inclusion in the OTC drug monograph system: (1) Piroctone olamine (for dandruff control) (69 FR 7652, 2/18/04; Docket 2004N-0050 (FDA-2004-N-0037)); (2) triclosan (for oral healthcare) (69 FR 40640, 7/6/04; Docket 1981N-0033P (FDA-1981-N-0015)); (3) triclosan (for acne treatment) (70 FR 72447, 12/5/05; Docket 2005N-0445 (FDA-2005-N-0454)); (4) climbazole (for dandruff control) (70 FR 72448, 12/5/05; Docket 2005N-0444 (FDA-2005-N-0021)); (5) sodium picosulfate (for laxative use) (71 FR 35917, 6/22/06; Docket 2006O-0232 (FDA-2006-O-0057)); and (6) sodium shale oil sulfonate (for dandruff control) (74 FR 15741, 4/7/09; Docket FDA-2009-N-0146).

The sponsors of three of those TEAs requested that FDA provide a review framework by the deadline established in section 586F(a) of the FD&C Act. The three TEAs are for: (1) Piroctone olamine (for dandruff control) (69 FR 7652, 2/18/04; Docket 2004N-0050 (FDA-2004-N-0037)); (2) sodium picosulfate (for laxative use) (71 FR 35917, 6/22/06; Docket 2006O-0232 (FDA-2006-O-0057)); and (3) sodium shale oil sulfonate (for dandruff control) (74 FR 15741, 4/7/09; Docket FDA-2009-N-0146). FDA provided the review framework options to the requesting sponsors on November 24, 2015. With regard to the three sponsors who did not request or elect a framework in accordance with section 586F(a) of the FD&C Act, the eligible conditions addressed by their TEAs will be reviewed under the timelines set forth in proposed § 330.15 (if finalized as proposed).

The second general requirement (see FD&C Act section 586F(b)) is that FDA issue a regulation that includes (1) timelines for review of non-sunscreen TEA conditions and (2) measurable metrics for tracking the extent to which the timelines are met. This proposed rule includes both timelines and metrics, as required by the SIA.

FDA has determined that with regard to non-sunscreen TEAs, the best way to both address the statutory requirements of the SIA and to make certain FDA-initiated modifications to the TEA process set forth in § 330.14 is to (1) establish a new section (proposed § 330.15) that is specific to non-sunscreen TEA conditions, and (2) amend § 330.14 with regard to process improvements for TEAs for all OTC drugs (such as providing format and content criteria for a filing determination and addressing withdrawal of consideration).

In addition to developing new § 330.15, which implements SIA requirements with regard to the TEA process for non-sunscreens, FDA proposes to make certain changes to the process set forth in § 330.14 that we believe will make the TEA process more clear and efficient for both sponsors and FDA. These proposed changes to § 330.14 are discussed in more detail in this document, but notably include provisions that address filing determination requirements with regard to safety and effectiveness data submissions (to allow FDA to determine, and sponsors to know, early on whether a submission is sufficiently complete to permit a substantive review) and provisions regarding withdrawal of consideration of a TEA or safety and effectiveness data submission.

IV. Legal Authority

This rule is being proposed under FDA's authority to regulate OTC drug products under the FD&C Act (see sections 201, 501, 502, 503, 505, 586F, and 701(a) of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 355, 360fff-6, and 371(a))). As stated in the Federal Register of January 22, 2002 (67 FR 3069), in which the final rule establishing the TEA process was published, submission of an NDA has been required before marketing a new drug since passage of the FD&C Act in 1938 (21 U.S.C. 355). To market a new drug, it must first be approved under section 505 of the FD&C Act. Section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. FDA's regulations in 21 CFR part 330 describe the conditions for a drug to be considered GRASE and not misbranded. If a drug meets each of the conditions contained in part 330, as well as each of the conditions contained in any applicable OTC drug monograph, and other applicable regulations, it is considered GRASE and not misbranded, and is not required by FDA to obtain approval under section 505 of the FD&C Act.

In addition, section 586F of the FD&C Act requires FDA to issue regulations providing for the timely and efficient review of certain submissions under the TEA regulation at 21 CFR 330.14. Section 586F of the FD&C Act specifically requires these regulations to include timelines and metrics associated with the review of certain submissions under the TEA regulation. Proposed § 330.15 would add timeline and metrics provisions that are intended to implement section 586F of the FD&C Act.

V. Description of the Proposed Rule

In this rule, we are proposing to establish new § 330.15 and to amend current § 330.14. In particular, we are proposing to: (1) Establish timelines and metrics for review of non-sunscreen TEA conditions, (2) add provisions concerning filing determination requirements with regard to the content and format of safety and effectiveness data submissions under § 330.14(f), (3) address withdrawal of consideration of TEAs and safety and effectiveness data submissions, (4v) add related definitions, and (5) make clarifying and conforming changes to the TEA regulation. These proposed changes are discussed in detail in this section.

A. Timelines for FDA Review and Action on Time and Extent Applications and Safety and Effectiveness Data Submissions (Proposed § 330.15)

The SIA mandates that FDA issue regulations to establish timelines and metrics regarding the review of non-sunscreen TEA conditions, and provides that the proposed timelines may vary based on the content, complexity, and format of the submission, and that they must (1) reflect FDA's public health priorities, including the potential public health benefits posed by the inclusion of additional drugs in the OTC drug monograph system, (2) take into consideration the availability of FDA resources for carrying out such priorities and the relevant review processes and procedures, and (3) be reasonable, taking into account the required consideration of priorities and resources (FD&C Act section 586F(b)(2)). Proposed § 330.15 is intended to implement these requirements.

1. Applicability (See Proposed § 330.15(a))

As a general matter, the timeline provisions in proposed § 330.15 apply to FDA and are triggered by specific actions by sponsors, such as submission of a TEA or submission of a safety and effectiveness data submission (as defined in proposed § 330.14(a)) and, in some cases, FDA (e.g., the date of filing). The metrics provisions also apply to FDA.

Proposed § 330.15(a) describes which TEA conditions are subject to the timelines for FDA review and action in this section and which are not. We invite comment on the proposed applicability of this section. In particular, FDA is proposing that the review of an active ingredient or other condition in a TEA submitted under § 330.14 for consideration in the OTC drug monograph system would be subject to the proposed timelines, with two exceptions.

First, in § 330.15(a)(1), FDA proposes that § 330.15 does not apply to a sunscreen active ingredient or a combination of sunscreen active ingredients or other conditions for such ingredients. Section 586F(b) of the FD&C Act directs the Agency to issue regulations establishing timelines for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients. The SIA recognizes that active ingredients can only be GRASE under specified conditions. For example, section 586A of the FD&C Act, which was added by the SIA to provide an alternative route for inclusion in the sunscreen monograph, states that a person may submit a request to FDA for a determination of whether a nonprescription sunscreen active ingredient or combination of ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is GRASE. Because the TEA regulation addresses active ingredients and other conditions, including dosage forms, and an active ingredient can only be GRASE under specified conditions, we understand the reference to TEAs for drugs other than sunscreen active ingredients in section 586F(b) of the FD&C Act to be distinguishing sunscreen active ingredients and related conditions from non-sunscreen active ingredients and related conditions. Furthermore, “pending requests” for sunscreen active ingredients under the SIA are subject to the provisions of section 586C(b) of the FD&C Act, as amended by the SIA (21 U.S.C. 360fff-3(b)), which include timeframes for FDA review and action. Therefore, under proposed § 330.15(a), § 330.15 would not apply to sunscreen active ingredients and related conditions.

Second, in § 330.15(a)(2), FDA proposes that § 330.15 generally does not apply to non-sunscreen active ingredients or other conditions submitted in TEAs under § 330.14 on or before the date of enactment of the SIA. Section 586F(b)(1) of the FD&C Act directs the Agency to issue regulations establishing timelines for the review of TEA conditions submitted after the date of enactment of the SIA. However, as provided in the SIA, any non-sunscreen TEA conditions determined to be eligible to be considered for inclusion in the OTC drug monograph system before the date of enactment of the SIA, for which the sponsor did not request a framework for review under section 586F(a)(1), will also be reviewed under the timelines set forth in § 330.15(c) of this proposed rule (see FD&C Act section 586F(a)(1)(C)) (if finalized as proposed). Accordingly, the scope of the exclusion in proposed § 330.15(a)(2) references section 586F(a)(1)(C) of the FD&C Act to account for such TEA conditions.

For sponsors of TEAs covering conditions that had been found eligible to be considered for inclusion in the OTC drug monograph system before the date of enactment of the SIA who elected to choose a framework for review, FDA was required to provide four optional frameworks that set forth timelines for FDA review (FD&C Act section 586F(a)((2)). The frameworks included timelines for review if the sponsors choose an order process with or without a filing determination, or a rulemaking process with or without a filing determination. A notification of optional frameworks was provided to each requesting sponsor on November 24, 2015. Before the date of enactment of the SIA, there were six non-sunscreen TEA conditions that were found by FDA to be eligible to be considered for inclusion in the OTC drug monograph system (listed in section II.B). Of these, three sponsors elected a framework for review, and three did not (listed in section II.B).

2. Timelines for FDA Review and Action (Proposed New § 330.15(c)).

As discussed in the introduction to section V.A, section 586F(b) of the FD&C Act, as amended by the SIA, directs FDA to establish timelines for the review of certain TEA conditions. As also discussed in section V.A.1, in addition to applying to new non-sunscreen TEAs, these timelines would apply to certain non-sunscreen TEA conditions that were found to be eligible before November 26, 2014. Section 586F(b) of the FD&C Act also requires timelines for internal procedures related to the review of safety and effectiveness data submissions.

FDA is proposing to establish the timelines described in this section of the document for FDA review and action, as described in proposed new § 330.15(c).

Note that terms for certain actions that begin review timelines for FDA are defined in proposed amendments to § 330.14 (e.g., “date of filing”). In addition to clarifying that its definitions apply to proposed § 330.15, proposed § 330.14(a) would clarify the applicability of the definitions in section 201 of the FD&C Act by expressly stating that any relevant definitions in that section, such as the definition of “person” at section 201(e), would apply to §§ 330.14 and 330.15.

a. Proposed Timelines

The proposed timelines are:

• FDA will issue a notice of eligibility or post to the docket a letter of ineligibility, in accordance with § 330.14(d) and (e), within 180 days of submission of a TEA under § 330.14(c).

• FDA will issue a filing determination in accordance with § 330.14(j) within 90 days of receipt by FDA of a safety and effectiveness data submission from the sponsor under § 330.14(f). Under proposed § 330.14(a)(5), a safety and effectiveness data submission is defined as a data package submitted by a sponsor that includes safety and effectiveness data and information under § 330.14(f) and that is represented by the sponsor as being a complete submission. Therefore, FDA will not start the 90-day filing determination period until the sponsor has confirmed that it considers the submission to contain all data and information required under § 330.14(f) by providing a statement that the submission is a complete safety and effectiveness data submission. If the sponsor submitted such a safety and effectiveness data submission at the same time as the sponsor submitted the TEA, and the condition addressed in the TEA is deemed eligible for consideration, FDA will issue a filing determination within 90 days after issuing the notice of eligibility.

• If the active ingredient or other condition is initially determined not to be GRASE, FDA will inform the sponsor and other interested parties who have submitted data of its determination by feedback letter in accordance with § 330.14(g)(4), within 730 days (generally 24 months) from the date of filing. FDA is considering whether to add a codified provision to address sponsor requests for additional time in response to a feedback letter and how that would affect the timeline for review. We welcome comments on this issue.

• FDA will issue a notice of proposed rulemaking within 1,095 days (generally 36 months) from the date of filing to either:

○ Include the active ingredient or other condition in an appropriate OTC monograph(s), either by amending an existing monograph(s) or establishing a new monograph(s), if necessary; or

○ Include the active ingredient or other condition in § 310.502 (which would require the sponsor to seek approval under section 505 of the FD&C Act before marketing).

• FDA will issue a final rule within 912 days (generally 30 months) of the closing of the docket of the proposed rulemaking under § 330.15(c)(4). If the docket is reopened, the final rule will be issued within 912 days of the closing of the re-opened docket.

For non-sunscreen TEA conditions that were found to be eligible before enactment of the SIA and that would be subject to the timelines in proposed § 330.15, FDA intends to treat the date of publication of the final rule for § 330.15 to be the date of filing for purposes of §§ 330.14 and 330.15. Therefore, upon the publication of the final rule, the timelines in proposed § 330.15(c)(3), if applicable, and § 330.15(c)(4) would begin for these eligible TEA conditions.

b. Development of Timelines

As required by the SIA (section 586F(b)(2) of the FD&C Act), FDA considered specific factors in developing the timelines in proposed new § 330.15(c). In particular, the SIA provides that the timelines for the review of non-sunscreen TEA conditions may vary based on the content, complexity, and format of the submission, and shall (1) reflect FDA public health priorities (including potential public health benefits of including additional drugs in the OTC drug monograph system), (2) take into consideration the resources available for carrying out such public health priorities and the relevant review processes and procedures, and (3) be reasonable, taking into account the required consideration of priorities and resources just described (section 586F(b)(2)(A) and (B) of the FD&C Act).

FDA is allowed (for the “may” factors) or required (for the “shall” factors) to take these factors into account in the timelines for review of non-sunscreen TEAs and related submissions. These SIA provisions recognized factors that could possibly affect how long it may take FDA to complete review of a particular TEA and related submissions. The timelines proposed in § 330.15 factored in the considerations that are required under the SIA; they reflect the projected time necessary for FDA to complete its review of marketing, filing, and scientific data and other information, as well as to make tentative and final determinations about the adequacy of the submissions to ultimately support a finding that the active ingredient or other condition is or is not GRASE and not misbranded for nonprescription use, based on the Agency's public health priorities and the resources available to carry them out. The timelines also include the projected time necessary to draft and finalize the letters or rules (proposed and final), and when applicable, prepare the document for publication in the Federal Register. In addition, the timelines take into account other activities that may occur during the review, such as convening an advisory committee meeting, meeting with sponsors, or both. FDA believes that the proposed timelines are reasonable, taking into consideration FDA's priorities and resources. More detail on how FDA took these factors into account is provided in this section.

i. FDA Public Health Priorities

Under section 586F(b)(2)(B)(i) of the FD&C Act, the timelines must reflect FDA's public health priorities, including the potential public health benefits posed by the inclusion of additional drugs in the OTC drug monograph system. FDA has a very broad mandate and multiple public health priorities, with limited resources to address these priorities.

FDA's Center for Drug Evaluation and Research (CDER) is responsible for regulating the safety and efficacy of both prescription and nonprescription human drugs. Like FDA as a whole, CDER must continually balance multiple important public health priorities, of which the OTC Drug Review is one. CDER does, and will continue to, consider the OTC Drug Review among its priorities as it endeavors to appropriately allocate staff and resources within the context of all CDER responsibilities.

Examples of how FDA public health priorities may affect the time required for the review of non-sunscreen TEA conditions under the proposed timelines include situations such as a public health emergency or competing high priority work that requires diversion of the staff assigned to a TEA or safety and effectiveness data submission.

ii. Resources Available for Carrying Out Such Priorities

Under section 586F(b)(2)(B)(ii), the timelines must take into consideration Agency resources available for carrying out its public health priorities and the processes and procedures related to the review of TEA conditions. Examples of resource constraints that may affect the time required for review include, but are not limited to: multiple TEAs arriving at or near the same time; general expected staff and budget constraints; unexpected staff and budget constraints; personnel turnover and lag times in hiring new staff; etc. For example, FDA has only a certain number of trained staff available to assign to TEA review work, and these staff generally have other assigned work in addition to TEA reviews.

iii. Reasonableness, Taking Into Consideration Agency Priorities and Resources

In developing the timelines set forth in proposed new § 330.15(c), FDA has attempted to set reasonable timelines that will be achievable in most circumstances, given our experience to date with TEAs and related safety and effectiveness data submissions. While FDA expects that the filing determination requirements we propose adding to § 330.14(j) will help to avoid major content and format deficiencies in incoming safety and effectiveness data submissions, there is likely still to be some variation in the formatting of incoming TEAs and safety and effectiveness data submissions, and a related variation in the ease and efficiency of review.

In determining reasonable timelines, FDA also considered the potential effect on stakeholders, including TEA sponsors and the public. In addition to considering the benefits that the proposed timelines and related metrics would provide to sponsors (e.g., more transparency regarding the TEA review process, increased predictability regarding how long each major process step is expected to take, and metrics on how long each step actually takes), FDA also considered other potential impacts of the proposed timelines on sponsors, including concerns regarding the time required to complete the review and rulemaking process. For each step in the TEA process, FDA attempted to determine a timeline that is achievable, consistent with timelines for similar FDA activities in other contexts to the extent possible (e.g., NDA process timelines, general rulemaking experience), consistent with the Agency's priorities and resources, and that reasonably takes into consideration the interests of the public (in safe and effective OTC drug products) and sponsors (in a timely and efficient review process). For some steps, this resulted in FDA setting a shorter timeline than it had previously estimated for the step. For example, the proposed timeline for the eligibility determination step (proposed new § 330.15(c)(1)) is 180 days from receipt of a TEA, which is roughly half the time estimated by FDA for this step in a 2011 guidance to industry (Ref. 1).

Eligibility Determination

With respect to the eligibility determination (§ 330.15(c)(1)), FDA is proposing to review and issue a notice of eligibility or post to the docket a letter of ineligibility within 180 days of receipt of a TEA, which FDA considers to be a reasonable timeline, taking into consideration Agency priorities and resources. As stated previously, in a 2011 final guidance to industry, FDA previously estimated a 1-year timeframe for taking this action (Ref. 1).

Filing Determination

FDA is proposing to issue a filing determination within 90 days of submission by the sponsor of a safety and effectiveness data submission, which is defined in proposed § 330.14(a), in part, as a submission that the sponsor has confirmed it considers to be complete (i.e., contains all data and information required under § 330.14(f)). While this timeline is 30 days longer than the filing provisions in 21 CFR 314.101 for NDAs and ANDAs, we anticipate that the filing review of a safety and effectiveness data submission for a nonprescription active ingredient or other condition may require more time than an NDA or ANDA review because the submission may consist of data and information from a wider variety of sources, with possibly a greater reliance on certain sources (e.g., published literature).

Rulemaking and Feedback Letter

Notice and comment rulemaking is generally a lengthy and multistep process (Ref. 2). The timelines in this proposed rule are consistent with the length of time typically required for other rulemaking, and reflect the amount of time FDA anticipates will be required for the reviews of safety and effectiveness data submissions and related rulemaking.

Major steps for FDA rulemaking generally include determination that a rule is needed and what the rule should say; drafting, reviewing, and finalizing the proposed rule; publishing the proposed rule; a public comment period and review of the comments; revising the proposed rule as appropriate; reviewing the draft final rule and finalizing it, and publishing the final rule in the Federal Register.

As noted previously, rulemaking is often a lengthy process, and the OTC Drug Review process (of which the TEA process is a part) offers additional rulemaking challenges, such as were discussed in a public meeting on OTC process reform held by FDA in 2014 (“Over-The-Counter Drug Monograph System—Past, Present and Future; Public Hearing,” 79 FR 10168, February 24, 2014; Docket No. FDA-2014-N-0202). Additional information, such as the hearing transcript, is available at http://www.fda.gov/Drugs/NewsEvents/ucm380446.htm. For TEA active ingredients and other conditions, the timelines for rulemaking involve conducting the scientific review, making a GRASE determination, and drafting and finalizing the rule for publication in the Federal Register. FDA estimates that initial scientific review of a complete safety and effectiveness data submission, including for new molecular entities that have never been marketed in the United States, will take approximately 730 days (generally 24 months). In addition to conducting this comprehensive review, the timeline may also include other activities, such as convening an advisory committee (or, under rare circumstances, an advisory review panel under § 330.10) and meeting with sponsors.

If the active ingredient or other condition is initially determined not to be GRASE for OTC use in the United States, FDA will also issue a feedback letter within this 730-day (generally 24-month) timeline. The feedback letter may identify the specific gaps in the data or information necessary to make a GRASE determination, and it provides the sponsor with time before the NPRM is published that could be used to begin collecting the data or information required for potential inclusion in a monograph. We note that a feedback letter reflects the Agency's initial determination. If FDA does not issue a feedback letter, it does not guarantee that we will ultimately determine that an ingredient is GRASE and not misbranded.

FDA proposes to issue an NPRM within 1,095 days (generally 36 months) from the date of filing (as defined in proposed § 330.15(a)(6)). For an active ingredient or other condition that is initially determined to be GRASE, FDA would issue a proposed rule to include the condition in the appropriate OTC monograph. For an active ingredient or other condition that is initially determined not to be GRASE, FDA would issue a proposed rule to include the condition in 21 CFR 310.502 (the regulation listing drugs that have been accorded new drug status through rulemaking and must be approved under section 505 of the FD&C Act before marketing). In general, FDA intends to close the public comment period for the proposed rule at 90 days, unless a request to defer further rulemaking to allow the submission of new safety or effectiveness data to the record is granted.

FDA is proposing to issue a final rule within 912 days (generally 30 months) of the closing of the comment period for the proposed rule. During this 912-day time period, FDA will review and consider any new data, information, and public comments submitted to the docket and draft and publish a final regulation.

Timelines for FDA review and action for sunscreen active ingredients under sections 586B and 586C of the FD&C Act, as amended by the SIA, are generally shorter than those in this proposed rule. The most notable differences are the timelines for proposed and final GRASE determinations which, under the SIA requirements for sunscreen active ingredients, are made through an order process rather than a rulemaking process. The order process eliminates some of the requirements of rulemaking that are time-consuming and resource intensive.

A 2009 Government Accountability Office (GAO) report (Ref. 3) examined, among other things, how long agencies, including FDA, take to issue rules. For the 16 case studies, the report found significant variation in time to complete rulemaking, with an average of about four years and a range of one to nearly 14 years. Factors that influenced the time needed to issue a rule included the complexity of the issues, Agency priorities, and the amount of internal and external review required (Ref. 3 at p. 19).

In summary, based on the type of data typically submitted in a TEA, along with the potential variability in the content and formatting of that submission, and because of the complex scientific review required to determine if an active ingredient or other condition is GRASE for OTC use, the possible use of an advisory committee, and the requirements for the rulemaking process itself, FDA considers the timelines put forth in this proposed rule to be reasonable, taking into consideration Agency priorities and resources. As described in further detail in the paragraphs that follow, if a TEA and the related safety and effectiveness data submission are straightforward, well-organized, and complete, FDA may be able to take action within shorter timeframes than proposed in this rule.

As stated previously, under section 586F(b)(2)(A) of the FD&C Act, the timelines established in the regulations required under that section could vary based on the content, complexity, and format of the submission. FDA considered a number of timeline options. Ultimately, FDA determined that instead of setting multiple proposed timelines for submissions of varying content, complexity, and format, it would be more efficient and sensible to set one general timeline for the review of non-sunscreen TEA conditions that accommodates anticipated variation among submissions. There is likely to be some variation in how quickly each submission is reviewed, because each will present a unique set of data and each review will occur in the context of multiple ongoing FDA activities and priorities. This may result in a review step taking less time than proposed in § 330.15(c) (for example, if a submission is well-organized, complete when submitted, and straightforward). In unusual circumstances, a review or rulemaking step may require a longer time than proposed in § 330.15(c) (e.g., an unusually high volume of TEAs submitted, an especially complex new ingredient or other condition, or a public health emergency that diverts Agency resources). However, FDA would endeavor to meet the proposed timelines in § 330.15(c) for all submissions, and any missed timelines would be reflected in the metrics set forth in proposed § 330.15(b). In summary, the provisions in § 330.15(c) provide sponsors and the public with consistent timeframes for expected Agency action. In the paragraphs that follow, we discuss some practical examples of how certain factors might be expected to impact FDA review of a non-sunscreen TEA condition:

○ Content

The quantity and quality of submitted data can generally impact FDA's review. If a TEA or safety and effectiveness data submission includes all the information that is required and all information that the sponsor wishes to have considered in the initial submission to FDA, it is likely possible to complete review of the TEA or safety and effectiveness data submission more quickly than if it has poor quality data, if FDA finds that clarification or additional data is needed, or if the sponsor submits additional spontaneous data supplements during the substantive review.

○ Complexity

Complexity, including, among other things, the nature of the active ingredient or other condition that is the subject of the TEA and the status of the monograph for the therapeutic category (i.e., final, tentative, or new) may also impact FDA's review. For example, review of a TEA and safety and effectiveness data submission for an active ingredient that has not previously been evaluated under the monograph for any use would likely be more complex than for an ingredient that is the subject of a GRASE determination in another monograph category. In addition, a review that involves a new technology would be more complex than one that does not.

The OTC monograph status for the therapeutic category (final, tentative, or new) and the U.S. Pharmacopeia (USP) monograph status (whether establishment of a USP monograph is required or not) may each affect the time required for review and rulemaking, in that addition of an active ingredient or other condition to a final OTC monograph once the GRASE determination is made would generally be faster than working with a tentative or new OTC monograph. Also, because a USP monograph for the ingredient is required before FDA can issue a final rule adding an active ingredient to an OTC monograph (§ 330.14(i)), the USP monograph status may lengthen the review and rulemaking time.

Finally, if FDA determines that an advisory committee or an advisory review panel is appropriate (e.g., for a particularly complex new issue), that process could increase the time required to complete the review, particularly if the committee's recommendations raised additional issues to review.

○ Format

The format including, among other things, whether a TEA or safety and effectiveness data submission is well-organized or poorly-organized, whether some or all of the information is submitted in electronic format, etc., could also impact FDA's review. We note that FDA recently issued draft guidance for industry regarding the format and content of data submissions for nonprescription sunscreen active ingredients (Ref. 4). A well-formatted TEA can generally be reviewed more quickly and efficiently than a poorly-organized TEA. In addition, review could take longer (or result in a refusal to file) if a safety and effectiveness data submission is disorganized with a structure that does not facilitate review for completeness, if there are electronic submissions that cannot be opened or that cannot be readily navigated (e.g., hyperlinks do not operate), or if there are data tabulations or graphic displays that are not interpretable, inadequately labeled, or do not indicate data sources. These issues may arise, in particular, with regard to safety and effectiveness data submissions that are filed over protest.

3. Metrics (Proposed New § 330.15(b))

Section 586F(b) of the FD&C Act requires FDA to establish measurable metrics for tracking the extent to which the timelines set forth in the regulations are met (see proposed timelines under § 330.15(c)). FDA is proposing to maintain a publicly available posting of metrics for the review of TEAs and safety and effectiveness data submissions submitted under § 330.14 that are subject to the timelines under proposed § 330.15(a), and update the posting annually. The posting will contain the metrics listed in this section, as proposed in § 330.15(b), for submissions received during the previous calendar year.

• Number and percent of eligibility notices or ineligibility letters issued within 180 days of submission of a TEA (i.e., for new TEAs submitted during the year, the number and percentage for which FDA issued either an eligibility notice or an ineligibility letter within 180 days).

• Number and percent of filing determinations issued within 90 days of submission of a safety and effectiveness data submission (i.e., for safety and effectiveness data submissions received during the year, the number and percentage for which FDA issued a filing determination within 90 days).

• If applicable, number and percent of feedback letters issued within 730 days (generally 24 months) from the date of filing (i.e., the number of feedback letters issued during the year, if any, and the number and percent of these that were issued within 730 days from the date of filing the safety and effectiveness data submission).

• Number and percent of notices for proposed rulemaking issued within 1,095 days (generally 36 months) from the date of filing (i.e., the number of notices of proposed rulemaking issued during the year, if any, and the number and percent of these that were issued within 1,095 days from the date of filing).

• Number and percent of final rules issued within 912 days (generally 30 months) of closing of the docket of the proposed rulemaking (i.e., the number of final rules issued during the year, if any, and the number and percent of these that were issued within 912 days of the closing of the docket of the proposed rulemaking). We note that if the docket is reopened, the 912 days will be measured from the date the reopened docket is closed.

• Total number of TEAs submitted under § 330.14; FDA may also post a total number of TEAs that have been submitted in all previous years.

For purposes of the metrics, a lack of FDA action in response to a triggering event in the previous calendar year will not be factored in unless the response was due in the previous calendar year. In other words, if a sponsor submits a TEA in October of the previous calendar year, and FDA has not yet issued a notice of eligibility or letter of ineligibility because 180 days has not elapsed by the end of the calendar year, under the proposed metrics, FDA would not consider the lack of response as missing the timeline. Whether FDA met the timeline or not would be reflected in the next year's metrics.

FDA intends to track these metrics and post them publically on the FDA Internet site. The Agency routinely uses its Internet site to post information and track progress and performance metrics on various initiatives (Ref. 5).

The Agency anticipates that the proposed metrics web posting will improve transparency by providing sponsors and the public with information that will enable them to quickly ascertain the number of TEAs that have been submitted to FDA, and the Agency's performance in meeting the proposed timelines. Over time, these measurements may also assist the Agency with resource planning and utilization.

B. Amendments to § 330.14 “Additional Criteria and Procedures for Classifying OTC Drugs as Generally Recognized as Safe and Effective and Not Misbranded”

FDA is proposing to revise § 330.14 to add new definitions and requirements. The new proposed definitions are primarily meant to clarify the beginning or ending of the timelines for FDA review and action as proposed in new § 330.15. The new proposed requirements include filing determination provisions under proposed new § 330.14(j) and “withdrawal of consideration” provisions under proposed new § 330.14(k), which are intended to make the TEA process more efficient for both sponsors and FDA.

1. Definitions (Proposed Revised § 330.14(a))

FDA is proposing new definitions that, in general, are intended to clarify the beginning or ending of the timelines for FDA review and action as proposed in § 330.15. FDA is adding these definitions to § 330.14 instead of proposed new § 330.15 because § 330.14 describes the TEA process to which these definitions apply. The definitions for “condition” and “botanical drug substance,” proposed under § 330.14(a)(1) and (2) respectfully, are unchanged from the current definitions under § 330.14(a). FDA is proposing to add the following new definitions of terms that apply to § 330.14.

• FDA is proposing that the term “sponsor” mean the person (as defined in section 201(e) of the FD&C Act) that submitted a TEA under § 330.14(c). Because the TEA process involves a public rulemaking process, comments from other interested parties, such as additional safety and effectiveness data, may be submitted to the docket for a TEA condition. FDA is proposing this definition to make clear that the sponsor is the person that submitted the TEA and related safety and effectiveness data submission, and will be the recipient of certain letters communicating FDA decisions. Because this is a public process, such letters will also be posted publicly to the relevant docket.

• FDA is proposing that the term “time and extent application (TEA)” mean a submission by a sponsor under § 330.14(c), which will be evaluated by the Agency to determine eligibility of a condition for consideration in the OTC drug monograph system. FDA is proposing this definition to make clear the difference between a submission to FDA for the purposes of establishing that the condition has been marketed for a material time and to a material extent versus a submission to FDA for the purposes of establishing that the condition is GRASE.

• FDA is proposing that the phrase “safety and effectiveness data submission” mean a data package submitted by a sponsor that includes safety and effectiveness data and information under § 330.14(f) and that is represented by the sponsor as being a complete submission. FDA is proposing this definition to differentiate this type of submission from the TEA. It also clarifies that FDA will not begin its filing determination under § 330.14(j) unless the sponsor first asserts that the submission is complete.

• FDA is proposing that the phrase “date of filing” mean the date of the notice from FDA informing the sponsor that FDA has made a threshold determination that the safety and effectiveness data submission is sufficiently complete to permit a substantive review. For submissions filed over protest in accordance with § 330.14(j)(3), the date of filing is the date of the notice from FDA informing the sponsor that FDA has filed the submission over protest. This date will be no later than 30 days after the sponsor's request that FDA file the submission over protest. FDA is proposing this definition to make clear the start of the timeframe for FDA review and action under § 330.15(c)(3) and (4).

• FDA is proposing that the term “feedback letter” mean a letter issued by the Agency in accordance with § 330.14(g)(4) that informs the sponsor and other interested parties who have submitted data under paragraph (f) of this section that a condition is initially determined not to be GRASE. FDA is proposing this definition to clarify the FDA action under § 330.14(g)(4) and the timeframe for such action under § 330.15(c)(3).

2. Filing Determination (Proposed New § 330.14(j))

FDA is proposing new requirements that specify certain filing determination requirements that are intended, in part, to help improve the content and format of a safety and effectiveness data submission. FDA is also proposing timelines related to these proposed new requirements. For example, submission criteria include factors such as whether the submission includes all required information, whether the submission is organized and formatted in a manner that allows FDA to readily determine if it is sufficiently complete to permit a substantive review, and whether the submission includes all required certifications.

The proposed new section also sets forth processes that apply whether the submission is accepted for filing, refused, or filed over protest. If the submission is filed, the date of filing, as defined in proposed § 330.14(a), represents the start of FDA's initial review for a GRASE determination, and triggers the start of timelines under proposed §§ 330.15(c)(3) and (4).

FDA believes that these proposed requirements would benefit both TEA sponsors and FDA, as well as potentially benefitting other interested parties. In FDA's experience, TEA-related submissions vary widely in their content and format and are sometimes difficult or extremely time-consuming and resource-intensive to review as submitted (e.g., missing data; copies of articles in foreign languages without an accompanying translation; hyperlinks that do not work; data submitted piecemeal; data not organized in any discernable manner, such as a submission with no listing of contents, page numbers, data categories, etc.). The proposed new requirements would provide more clarity and certainty to sponsors as to the content and format of a safety and effectiveness data submission and would provide for FDA to let sponsors know early on in the process if there is missing material or a problematic format that could delay review. For FDA, the proposed new requirements would be expected to result in more complete and clear data submissions from sponsors, to allow FDA to more easily and quickly determine whether the submission is sufficiently complete to permit FDA to go forward with a substantive review, and to ensure that once FDA begins its substantive review, the data and other information necessary for a complete review are available. If the submission is not sufficiently complete to allow substantive review, the new requirements would provide a clear pathway to communicate this issue to sponsors via a filing determination, and to communicate what additional information or format changes are required. Because safety and effectiveness data submissions are posted to the public docket, once filed, a more complete submission may also benefit other interested parties. Among other things, it may be easier for non-sponsor interested parties to determine whether there is information not otherwise reflected in the docket that they would like to submit for FDA to consider in the GRASE determination.

We note that while the SIA did not require FDA to issue a regulation regarding filing determination criteria for safety and effectiveness data submissions under § 330.14, it did require FDA to issue draft and final guidance on the format and content of information submitted by a sponsor in support of a “request” under section 586A of the FD&C Act and a “pending request,” which are related to sunscreens (see FD&C Act section 586D(a)(1)(A) and (B)). A notice of availability of the draft guidance on this topic was published in the Federal Register on November 23, 2015 (Ref. 4). When final, this guidance will provide the Agency's current thinking about the criteria for the content and format of the safety and effectiveness data submitted by the sponsor of a TEA for a nonprescription sunscreen active ingredient or related condition. As noted in the draft guidance, when finalized, parts of the general advice in that guidance about the content and format of sunscreen safety and effectiveness data submissions may also be useful to persons preparing submissions for non-sunscreen TEA conditions.

As stated earlier in this section, proposed § 330.14(j) sets forth criteria FDA would use in making a filing determination for a safety and effectiveness data submission, as well as timing and processes related to the determination. In particular, in § 330.14(j)(1), FDA proposes that after FDA receives a safety and effectiveness data submission, the Agency will determine whether the submission may be filed. The determination would be whether or not to accept the submission for filing, after an initial review of the submission regarding whether the submission contains the data and information required under § 330.14(f) in an acceptable format, and satisfies the other filing criteria under § 330.14(j)(4). The filing of a submission under proposed § 330.14(j)(2) would mean that FDA has made a threshold determination that the submission is sufficiently complete to permit a substantive review.

In § 330.14(j)(2), FDA proposes that the date of filing will begin the FDA timelines described in § 330.15(c)(3) and (4).

In § 330.14(j)(3), FDA proposes to describe the process for cases in which FDA refuses to file the safety and effectiveness data submission. If this happens, the Agency would notify the sponsor in writing and state the reason for the refusal under proposed § 330.14(j)(4). Proposed § 330.14(j)(3) provides the sponsor 30 days in which to request an informal conference with the Agency about whether the Agency should file the submission and sets forth the procedures if the sponsor wishes to file the submission over protest following the informal conference. Proposed § 330.14(j)(3) further provides that FDA will convene the informal conference within 30 days of the request from the sponsor. It also provides that if, within 120 days after the informal conference, the sponsor requests that FDA file the submission (with or without correcting the deficiencies), the Agency will file the safety and effectiveness data submission over protest under § 330.14(j)(2), notify the sponsor in writing, and review it as filed. The sponsor need not resubmit a copy of a safety and effectiveness data submission that is filed over protest.

In proposed § 330.14(j)(4), FDA describes the conditions under which FDA may refuse to file a safety and effectiveness data submission. These include a submission that:

○ Is incomplete because it does not contain information required under § 330.14(f) (if such information is not provided because it is not relevant, the submission must clearly identify and explain the omission);

○ Is not organized or formatted in a manner to enable the Agency to readily determine if it is sufficiently complete to permit a substantive review;

○ Does not contain a signed statement that the submission represents a complete safety and effectiveness data submission and that the submission includes all the safety and effectiveness data and information available to the sponsor at the time of the submission, whether positive or negative;

○ Does not contain an analysis and summary of the data and other supporting information, organized by clinical or nonclinical area;

○ Does not contain a supporting document summarizing the strategy used for literature searches, including search terms, sources, dates accessed and years reviewed;

○ Does not contain a reference list and copy of supporting information; or

○ Includes data or information relevant to the GRASE determination that is marked as confidential without a statement that the information may be released to the public (if the relevant data was produced and marked confidential by a third party, the sponsor would need to include a statement that the sponsor is authorized to make the information publicly available or include an authorization from the third party permitting the information to be publicly disclosed).

In addition, the following four filing determination factors relate to requirements under other sections of the regulations. FDA may refuse to file a safety and effectiveness data submission if the submission:

○ Does not contain either a complete environmental assessment or information supporting a categorical exclusion under part 25 (see 21 CFR part 25, “Environmental impact considerations”);

○ Does not contain a statement for each nonclinical laboratory study that it was conducted in compliance with part 58 requirements (see 21 CFR part 58, “Good laboratory practice for nonclinical laboratory studies”) (or a statement of reasons for the noncompliance);

○ Does not contain a statement for each clinical investigation involving human subjects that it was conducted in compliance with part 56 institutional review board regulations (see 21 CFR part 56, “Institutional Review Boards”) or was not subject to those regulations, and that it was conducted in compliance with part 50 informed consent regulations (see 21 CFR part 50, “Protection of human subjects”); or

○ Does not include required part 54 financial certification and disclosure statements (see 21 CFR part 54, “Financial disclosure by clinical investigators”).

3. Withdrawal of Consideration of a TEA or Safety and Effectiveness Data Submission (Proposed New § 330.14(k))

The Agency is also proposing to add withdrawal provisions to new § 330.14(k). These proposed provisions acknowledge that a sponsor may request withdrawal of consideration of a TEA or safety and effectiveness data submission. In addition, inaction by a sponsor in certain circumstances may be deemed by FDA as a request for withdrawal of consideration (e.g., prolonged failure of a sponsor to submit any safety and effectiveness data after receipt of an NOE, failure of a sponsor to respond to FDA communications). These proposed requirements are expected to help provide clarity on the status of TEAs and safety and effectiveness data submissions, and the effect of a withdrawal of consideration on the docket. They would also permit FDA to suspend work on those TEAs or safety and effectiveness data submissions that are no longer being pursued by the sponsor and for which FDA does not believe that the GRASE determination should go forward.

The Agency believes that the proposed provisions on withdrawal of consideration would allow the Agency to better allocate resources for the review of TEA conditions than the current process. Based on past experience with the OTC monograph process, FDA has found that following an Agency action, a sponsor may not respond to a request for data from FDA. For example, the Agency issued an NOE and request for safety and effectiveness data in 2005 for a TEA active ingredient (70 FR 72447, December 5, 2005) and to date, FDA has not received data or a response from the sponsor. Without an established deadline for submitting data or otherwise responding to an Agency request, a sponsor may never submit the requested data and a TEA condition may remain unresolved. To better utilize FDA resources as well as to address the withdrawal of consideration of a TEA or a safety and effectiveness data submission, the Agency is proposing to amend § 330.14 to add paragraph (k) to address such withdrawal of consideration.

In § 330.14(k)(1), we propose that FDA may withdraw consideration of a TEA or safety and effectiveness data submission if: (1) The sponsor requests that its submission be withdrawn from consideration, or (2) FDA deems the submission to be withdrawn from consideration due to the sponsor's failure to act on the submission or failure to respond to communications from FDA. For purposes of this provision, withdrawal of consideration of a TEA would include the withdrawal of consideration of a TEA condition that had been found to be eligible, but for which a safety and effectiveness data submission is not received by the Agency. If a sponsor requests withdrawal of consideration for its TEA or safety and effectiveness data submission, FDA generally intends to stop its review. However, we note that while FDA may withdraw consideration of a TEA or safety and effectiveness determination, we may determine not to do so in some cases. For example, if FDA has already issued a proposed rule that tentatively determines that the active ingredient or other condition is GRASE for OTC use, or is not GRASE for OTC use, FDA may continue to rely on the information submitted to the docket and proceed to issue a final rule.

In § 330.14(k)(2), we propose that FDA will notify the sponsor of a submission that FDA intends to deem withdrawn under paragraph (k)(1)(ii), and that the sponsor will then have 30 days from the date of the notice to request that FDA not withdraw consideration of the TEA or safety and effectiveness data submission and request additional time needed to submit relevant data and information. For example, a sponsor may request that FDA not withdraw consideration of a safety and effectiveness data submission to allow the submission of new safety or effectiveness data to the record if the sponsor needs additional time to conduct a study and submit the data. If, within 30 days of FDA's notice, the sponsor requests that FDA not withdraw consideration under proposed § 330.14(k)(1)(ii), we will continue to consider the submission. If we continue to consider the submission, that does not preclude the possibility of withdrawing consideration under § 330.14(k)(1) at a later time. FDA recommends that sponsors keep FDA apprised of the anticipated timing for submission of requested data to facilitate the review process and better utilize FDA resources.

In § 330.14(k)(3), FDA proposes to clarify that if consideration of a TEA or safety and effectiveness data submission is withdrawn, information that has been posted to the public docket for the TEA at the time of the withdrawal (such as an NOE or a safety and effectiveness data submission that has been accepted for filing and posted to the docket) will remain on the public docket. The TEA process is primarily a public process and withdrawal of consideration of a TEA or safety and effectiveness data submission will not cause previously public information to be removed from the docket. We also note that the original sponsor or other interested parties may wish to pursue review of the active ingredient or other condition at some point in the future. In that case, a new safety and effectiveness data submission may be submitted for the same active ingredient or other condition after consideration of the original submission has been withdrawn. If the Agency has already issued an NOE that determined that the active ingredient or other condition is eligible for review under the TEA process, another interested party may submit safety and effectiveness data for the eligible condition for the Agency's review.

In § 330.14(k)(4), FDA proposes that if a TEA or safety and effectiveness data submission being reviewed in accordance with § 330.15 is withdrawn, the timelines under § 330.15(c) and the metrics under § 330.15(b) no longer apply.

4. Minor Changes to § 330.14 for Clarity and Consistency

FDA is proposing to reorganize paragraph (a) of § 330.14 to create an introductory paragraph that includes the current text under § 330.14(a), except for the definitions of “condition” and “botanical drug substance,” which would be moved to the proposed definitions section in § 330.14(a). FDA is proposing to eliminate the paragraph heading “introduction,” and in its place, propose the paragraph heading “definitions” and a statement that the definitions that follow apply to this section and § 330.15. Under this new heading, FDA is proposing to include the definitions and current text for the terms “condition” and “botanical drug substance.” FDA is also proposing to add to the end of the introductory paragraph of § 330.14 a sentence stating that § 330.15 sets forth timelines for FDA review and action.

FDA is proposing several minor amendments to § 330.14(f) for clarity and for consistency with the OTC monograph regulations under § 330.10.

• FDA is proposing to revise paragraph (f) to use terminology consistent with the new definition in § 330.14(a)(5) for “safety and effectiveness data submission” when referring to the data package submitted by the sponsor.

• FDA is proposing to revise the first sentence and add the second sentence to differentiate between, in the NOE, requesting the safety and effectiveness data submission from the sponsor, and requesting data and views from other interested parties.

• FDA is proposing to add a sentence that references the new filing determination requirements at proposed new § 330.14(j) and makes clear that the safety and effectiveness data submission must be sufficiently complete to be filed by the Agency under proposed paragraph (j)(2).

• FDA is proposing to add a sentence that references the requirements for compliance with good laboratory practices, institutional review board, informed consent, and financial certification or disclosure statement requirements, under § 330.10(c), (e), and (f), and makes clear that those requirements also apply to the safety and effectiveness data and information submitted under this paragraph. This proposed sentence does not impose new requirements. The sentence was added for clarity and consistency with § 330.10.

FDA is proposing to add the word “feedback” prior to the word “letter” in the first sentence of § 330.14(g)(4) to use terminology consistent with the proposed new definition for “feedback letter” in § 330.14(a)(7).

VI. Proposed Effective Date

The SIA directs the Agency to issue a final rule regarding the timelines and metrics described in section 586F(b) of the FD&C Act within 27 months after the enactment of the SIA (by February 26, 2017). The SIA also requires that the final rule be published not less than 30 calendar days before the effective date of the regulation. Consequently, the final rule implementing the timeline and metrics provisions of section 586F(b) will become effective 30 calendar days after the date of the final rule's publication in the Federal Register.

Beginning on that date, the timelines and metrics set forth in the regulation will apply to the review of TEAs and safety and effectiveness data submissions to which that regulation is applicable, and any amended provisions of § 330.14 will apply to the TEA process under that regulation.

VII. Economic Analysis of Impacts A. Introduction

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule does not impose significant new economic burdens on any entity, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

In table 1, we provide the Regulatory Information Service Center/Office of Information and Regulatory Affairs Consolidated Information System accounting information.

Table 1—Economic Data: Costs and Benefits Statement Category Primary
  • estimate
  • Low
  • estimate
  • High
  • estimate
  • Units year
  • dollars
  • Discount rate
  • (%)
  • Period
  • covered
  • (yrs.)
  • Notes
    Benefits: Annualized 7 Monetized 3 $millions/year Annualized 7 Quantified 3 Qualitative The proposed rule would improve the TEA review process by establishing timelines and clarifying requirements and increase the predictability of the process. Costs: Annualized $0.00 $0.00 $0.00 2015 7 10 Monetized 0.00 0.00 0.00 2015 3 10 $millions/year Annualized 7 Quantified 3 Qualitative Transfers Federal 7 Annualized Monetized 3 $millions/year From/To From: To: Other 7 Annualized Monetized 3 $millions/year From/To From: To: Effects State, Local, and/or Tribal Government: No effects Small Business: No effects Wages: No effect Growth: No effect
    B. Summary 1. Baseline Conditions

    We regulate nonprescription drug products under two primary pathways: (1) The new drug application (NDA) process, described in 21 CFR part 314; or (2) the nonprescription (over-the-counter or OTC) drug monograph process, described in part 330. There are important differences between these two pathways. Under the NDA process, the sponsor of an application must submit to us nonclinical and clinical data that supports the safety and effectiveness of its drug product, and we must review and approve the application before the sponsor can market such product. By contrast, OTC drug monographs are regulations describing conditions (§ 330.14 defines condition as an active ingredient or botanical drug substance (or combination of both), dosage form, dosage strength, or route of administration marketed for a particular specific OTC use) that certain OTC drugs (such as antacids) must meet to be considered as GRASE and not misbranded. In contrast with the application pathway, once a sponsor submits safety and effectiveness data to amend a monograph (which is posted to a public docket), the data are public. Drug products that comply with an applicable OTC drug monograph and other applicable regulations may be marketed without an NDA.

    Initially, active ingredients and other conditions that were not marketed in the United States before the inception of the OTC Drug Review in 1972 were not eligible for review under the OTC drug monograph process. However, the TEA process, established by regulations finalized in 2002 (21 CFR 330.14), expanded the scope of this OTC drug review. The TEA process offers a pathway for OTC conditions to be marketed under an OTC drug monograph. OTC conditions can include newer active ingredients that previously had no U.S. marketing history, or that were marketed in the United States after the OTC drug review began. Active ingredients and other conditions that satisfy the TEA eligibility requirements are subject to the same safety, effectiveness, and labeling standards that apply to other conditions under the OTC monograph process.

    The TEA process requires multi-step, notice-and-comment rulemaking procedures before a new active ingredient or other condition is added to an OTC drug monograph. After determining that an active ingredient or other condition is eligible for consideration under the OTC monograph process, we issue a notice in the Federal Register announcing the TEA determination and requesting safety and effectiveness data for the proposed OTC use. Next, after reviewing data submitted to the docket, we issue a proposed rule to either include the condition in the appropriate OTC drug monograph or, if the condition is initially determined not to be GRASE for OTC use, include it in § 310.502, which would require the sponsor to seek approval under the NDA pathway to market the condition. The proposed rule allows for public comments and for sponsors and other interested parties to submit additional data for safety and effectiveness. If a monograph is amended, by publishing a final rule, an OTC condition that complies with the OTC monograph and the general requirements for OTC drugs may be marketed in the United States without an NDA (examples of other general requirements include requirements to comply with Current Good Manufacturing Practice, to register and list products, to use drug facts labeling, etc.).

    Although our multi-step TEA process allows sponsors to learn about the progress of our review of an application (for example when an NOE is issued, and if a feedback letter is issued), there are no established timelines to review applications or for sponsors to submit data. The lack of timelines can create unpredictability for interested parties because they may lack key information. For example, they may not know: (1) Whether the safety and effectiveness data submitted is sufficient or in the right format for us to conduct a substantive review; (2) when they need to submit new information; or (3) when to expect our determinations regarding eligibility or other feedback. The unpredictability in the process could result in sponsors not performing a required action within reasonable time for our review, performing unnecessary actions (examples of unnecessary actions may include collecting unnecessary or inadequate data, performing tests or studies that do not contribute to data needed by us to make a GRASE determination), or creating unnecessary effort for us and for them. For example, if a TEA remains inactive for a significant amount of time, scientific knowledge may evolve thus creating the need to amend the original TEA. Without specific timelines sponsors may not know whether their initial data submission was insufficient to review, was sufficient but is under review, or whether we require additional information. In addition, without specific timelines, we don't know if sponsors intend to submit additional data or whether they do not intend to pursue their application any further.

    2. Purpose of This Proposed Rule

    This proposed rule complies with certain mandates of the Sunscreen Innovation Act (Pub. L. 113-195), enacted in November 2014. In particular, the proposed rule would establish timelines and metrics for review of TEAs for non-sunscreen OTC drug products. Specific timelines applicable to non-sunscreen TEA conditions would be added in a new section to Title 21 of the CFR, § 330.15. The first proposed timeline is to issue a Notice of Eligibility or a post a letter of ineligibility to the TEA docket within 180 days of submission of a TEA. The second proposed timeline is to issue a filing determination within 90 days of receipt of a complete safety and effectiveness data submission from the sponsor once such sponsor has confirmed that it considers the submission to be complete. If we initially determine the active ingredient or other condition not to be GRASE, we will inform sponsors and interested parties within 730 days from the date of filing as defined in proposed § 330.14(a). The next proposed timeline is to issue a notice of proposed rulemaking (NPRM) within 1,095 days from the date of filing. Lastly, we propose to issue a final rule within 912 days of the closing of the docket of the proposed rulemaking.

    The proposed rule would also amend the existing § 330.14 by: (1) Setting forth clear filing determination requirements with regard to the content and format of safety and effectiveness data submissions for TEAs, and by (2) addressing withdrawal of consideration of a TEA or safety and effectiveness data submission. These amendments would apply to all TEAs, and their goal is to provide early notification to sponsors whether their applications meet the filing requirements and to provide more clarity regarding withdrawal of a TEA-related submissions. The proposed amendments are intended to provide us with feedback from sponsors whether they intend to actively pursue their applications, and specify that we may withdraw consideration of a TEA or safety and effectiveness data submission in certain circumstances (such as at a sponsor's request or after prolonged inaction and lack of response to FDA communications). Finally, the proposed rule would also add definitions and make clarifying changes to the TEA regulation in § 330.14.

    The proposed clarifications and establishment of timelines for the TEA process seek to dissipate uncertainties that may be preventing interested parties from submitting all the necessary data for us to grant final GRASE determination to existing TEA conditions that have been found to be eligible to be considered for inclusion in the OTC drug monograph system. Since the TEA review process became effective in 2002 (67 FR 3060 at 3074, January 23, 2002), we have received six TEAs for non-sunscreen active ingredients, including applications for dandruff, laxative, anti-gingivitis, and anti-acne products. However, we have not yet issued a proposed rule regarding whether any of these ingredients are GRASE under specified conditions of use. In fact, as of December 2015, the sponsor of one of these TEAs has not yet submitted safety and effectiveness data for our review.

    3. Benefits

    We lack data to quantify the potential benefits of the proposed rule. With the proposed rule, we expect the proposed timelines and data submission clarifications would make the TEA process, including establishing a new OTC drug monograph, more efficient and predictable, and improve communication between us and sponsors. Sponsors may benefit from knowing if additional data is needed and what optimal steps to take to receive a GRASE determination, and we would be able to bring resolution to TEA conditions. However, we do not know the monetary value of added predictability to sponsors. Also, because we have not yet issued tentative GRASE determinations for any of the non-sunscreen TEA conditions under review, as of December 2015, and because we do not know the increase in the probability of granting tentative GRASE determinations resulting from the proposed rule, we request comment on the potential benefits of the proposed rule.

    4. Costs

    This proposed rule supplements the TEA process. We expect the rule would create a minimal burden on sponsors from the possible cost associated with sending a meeting request letter to us in the event that we refuse to file a safety and effectiveness data submission and the sponsor would like to meet with us to discuss the decision, or the possible cost of calling or writing FDA to request that we not withdraw consideration of a submission in the event that we deem a submission withdrawn under proposed 330.14(k)(ii). Therefore, we anticipate no increase in annual recurring costs for either small or large sponsors.

    We expect the six current sponsors would spend time reading and understanding the proposed rule, and this would take from about 6.5 hours to 13 hours. With an hourly wage rate of $133 including 100 percent overhead, each sponsor would incur one-time costs ranging from about $865 to $1,730. We also estimate that we would receive two additional TEAs annually, and thus during a 10-year horizon we estimate potentially twenty additional applicants would spend the time to read and understand the proposed rule. The present value of the total costs over 10 years ranges from about $17,000 to $35,000 with a 7 percent discount rate and from about $19,000 to $38,000 with a 3 percent discount rate. With a discount rate of 7 percent and 3 percent, we estimate that on average sponsors would incur less than $150 of annualized costs per year.

    5. Impact on Small Entities

    The Regulatory Flexibility Act requires a Regulatory Flexibility Analysis (RFA) unless the Agency can certify that the proposed rule would have no significant impact on a substantial number of small entities. The proposed rule would affect few entities. Moreover, we estimate one-time costs under $2,000 per entity, costs well below 0.01 percent of annual revenues for the smallest entities, and we propose to certify that the rule would not have a significant economic impact on a substantial number of small entities.

    We invite comments on this analysis.

    VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection are given under this section with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

    We invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Title: Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications

    Description: The proposed rule would amend FDA's TEA regulations to establish timelines and performance metrics for FDA's review of non-sunscreen TEAs and safety and effectiveness data submissions, as required by the SIA. FDA also proposes other changes to make the TEA process more efficient.

    FDA has OMB approval (Control Number 0910-0688) for the information collection in 21 CFR 330.14, which specifies additional criteria and procedures by which OTC drugs that were initially marketed in the United States after the OTC Drug Review began and OTC drugs without any U.S. marketing experience may become eligible for consideration in the OTC drug monograph system.

    The proposed rule would amend the TEA regulations in § 330.14 to make the process more efficient and to make conforming and clarifying changes. Proposed § 330.14(j) would clarify the requirements on content and format criteria for a safety and effectiveness data submission, and would provide procedures for FDA's review of the submissions and determination of whether a submission is sufficiently complete to permit a substantive review. Proposed § 330.14(j)(3) would describe the process for cases in which FDA refuses to file the safety and effectiveness data submission. Under proposed § 330.14(j)(3), if FDA refuses to file the submission, the Agency will notify the sponsor in writing, state the reason(s) for the refusal, and provide the sponsor with 30 days in which to submit a written request for an informal conference with the Agency about whether the Agency should file the submission. A sponsor's submission of a written request for an informal conference is not already approved under OMB Control Number 0910-0688. We estimate that approximately one sponsor (“number of respondents” in table 2, row 1) will annually submit to FDA approximately one request for an informal conference (“total annual responses” in table 2, row 1), and that preparing and submitting each request will take approximately one hour for each sponsor (“average burden per response” in table 2, row 1).

    Under proposed § 330.14(j)(4)(iii), the safety and effectiveness data submission must contain a signed statement that the submission represents a complete safety and effectiveness data submission and that the submission includes all the safety and effectiveness data and information available to the sponsor at the time of the submission, whether positive or negative. A sponsor's signed statement is not already approved under OMB Control Number 0910-0688. We estimate that approximately two sponsors (“number of respondents” in table 2, row 2) will annually submit to FDA approximately two signed statements as described previously (“total annual responses” in table 2, row 2), and that preparing and submitting each signed statement will take approximately one hour for each sponsor (“average burden per response” in table 2, row 2).

    Under proposed § 330.14(k)(1), FDA, in response to a written request from a sponsor, may withdraw consideration of a TEA submitted under § 330.14(c) or a safety and effectiveness data submission submitted under § 330.14(f). A sponsor's request that FDA withdraw consideration of a TEA or safety and effectiveness data submission is not already approved under OMB Control Number 0910-0688. We estimate that approximately one sponsor (“number of respondents” in table 2, row 3) will annually submit to FDA approximately one request (“total annual responses” in table 2, row 3), and that preparing and submitting each request will take approximately one hour for each sponsor (“average burden per response” in table 2, row 3).

    Under proposed § 330.14(k)(2), a sponsor may request that FDA not withdraw consideration of a TEA or safety and effectiveness data submission. A sponsor's request for FDA to not deem its submission withdrawn from consideration is not already approved under OMB Control Number 0910-0688. We estimate that approximately one sponsor (“number of respondents” in table 2, row 4) will annually submit to FDA approximately one request (“total annual responses” in table 2, row 4), and that preparing and submitting each request will take approximately two hours for each sponsor (“average burden per response” in table 2, row 4).

    FDA estimates the burden of this information collection as follows:

    Table 2—Estimated Annual Reporting Burden 1 21 CFR Section Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    330.14(j)(3)—Sponsor request for informal conference on FDA's refusal to file 1 1 1 1 1 330.14(j)(4)(iii)—Sponsor's signed statement that the submission is complete 2 1 2 1 2 330.14(k)(1)—Sponsor request for FDA to withdraw consideration of a TEA or safety and effectiveness data submission 1 1 1 1 1 330.14(k)(2)—Sponsor request for FDA to not deem its submission withdrawn from consideration 1 1 1 2 2 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    In compliance with the PRA (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this proposed rule to OMB for review. Interested persons are requested to send comments on this information collection to the Office of Information and Regulatory Affairs, OMB (see ADDRESSES).

    X. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” The sole statutory provision giving preemptive effect to the proposed rule is section 751 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379r).

    We believe that the preemptive effect of this proposed rule, if finalized, would be consistent with Executive Order 13132. Through the publication of this proposed rule, we are providing notice and an opportunity for State and local officials to comment on this rulemaking.

    XI. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. FDA, Guidance for Industry, “Time and Extent Applications for Nonprescription Drug Products,” September 2011, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078902.pdf.

    2. Office of the Federal Register, “A Guide to the Rulemaking Process,” 2011, available at https://www.federalregister.gov/uploads/2011/01/the_rulemaking_process.pdf.

    3. GAO, “Federal Rulemaking, Improvements Needed to Monitoring and Evaluation of Rules Development as Well as to the Transparency of OMB Regulatory Reviews,” April 2009 (GAO-09-205), available at http://www.gao.gov/assets/290/288538.pdf.

    4. FDA, Draft Guidance for Industry, “Nonprescription Sunscreen Drug Products: Content and Format of Data Submissions To Support a GRASE Determination Under the Sunscreen Innovation Act,” November 2015, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM473772.pdf.

    5. Examples of FDA internet pages that include progress reports or other metrics include: FDA's FDA-TRACK Web page, http://www.fda.gov/AboutFDA/Transparency/track/ucm195010.htm; FDA's “Sunscreen Innovation Act (SIA)” Web page, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm434782.htm, and FDA's “Rulemaking History for OTC Time and Extent Applications” Web page, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm072455.htm.

    List of Subjects in 21 CFR Part 330

    Over-the-counter drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 330 be amended as follows:

    PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED 1. The authority citation for part 330 is revised to read as follows: Authority:

    21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, 371.

    2. Section 330.14 is amended as follows: a. Redesignate paragraph (a) as introductory text, revise the newly redesignated introductory text, and add new paragraph (a); b. Revise paragraphs (f) introductory text and (g)(4); c. Add paragraphs (j) and (k).

    The revisions and additions read as follows:

    § 330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.

    This section sets forth additional criteria and procedures by which over-the-counter (OTC) drugs initially marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered in the OTC drug monograph system. This section also addresses conditions regulated as a cosmetic or dietary supplement in a foreign country that would be regulated as OTC drugs in the United States. Section 330.15 sets forth timelines for FDA review and action.

    (a) Definitions. The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act and the following definitions of terms apply to this section and to § 330.15.

    (1) Condition means an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration, marketed for a specific OTC use, except as excluded in paragraph (b)(2) of this section.

    (2) Botanical drug substance means a drug substance derived from one or more plants, algae, or macroscopic fungi, but does not include a highly purified or chemically modified substance derived from such a source.

    (3) Sponsor means the person that submitted a time and extent application (TEA) under paragraph (c) of this section.

    (4) Time and extent application (TEA) means a submission by a sponsor under paragraph (c) of this section, which will be evaluated by the agency to determine eligibility of a condition for consideration in the OTC drug monograph system.

    (5) Safety and effectiveness data submission means a data package submitted by a sponsor that includes safety and effectiveness data and information under paragraph (f) of this section and that is represented by the sponsor as being a complete submission.

    (6) Date of filing means the date of the notice from FDA informing the sponsor that FDA has made a threshold determination that the safety and effectiveness data submission is sufficiently complete to permit a substantive review; or, if the submission is filed over protest in accordance with paragraph (j)(3) of this section, the date of filing is the date of the notice from FDA informing the sponsor that FDA has filed the submission over protest (this date will be no later than 30 days after the sponsor's request that FDA file the submission over protest).

    (7) Feedback letter means a letter issued by the agency in accordance with paragraph (g)(4) of this section that informs the sponsor and other interested parties who have submitted data under paragraph (f) of this section that a condition is initially determined not to be generally recognized as safe and effective (GRASE).

    (f) Safety and effectiveness data submission. The notice of eligibility shall request that the sponsor submit a safety and effectiveness data submission that includes published and unpublished data to demonstrate the safety and effectiveness of the condition for its intended OTC use(s). The notice of eligibility will also request data and views from other interested parties. These data shall be submitted to a docket established in the Division of Dockets Management and shall be publicly available for viewing at that office, except data deemed confidential under 18 U.S.C. 1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j). Data considered confidential under these provisions must be clearly identified. Any proposed compendial standards for the condition shall not be considered confidential. The safety and effectiveness data submission must be sufficiently complete to be filed by the agency under paragraph (j)(2) of this section. Safety and effectiveness data and other information submitted under this paragraph are subject to the requirements in § 330.10(c), (e), and (f). The safety and effectiveness data submission must include the following:

    (g) * * *

    (4) If the condition is initially determined not to be GRASE for OTC use in the United States, the agency will inform the sponsor and other interested parties who have submitted data of its determination by feedback letter, a copy of which will be placed on public display in the docket established in the Division of Dockets Management. The agency will publish a notice of proposed rulemaking to include the condition in § 310.502 of this chapter.

    (j) Filing determination. (1) After FDA receives a safety and effectiveness data submission, the agency will determine whether the submission may be filed. The filing of a submission means that FDA has made a threshold determination that the submission is sufficiently complete to permit a substantive review.

    (2) If FDA finds that none of the reasons in paragraph (j)(4) of this section for refusing to file the safety and effectiveness data submission apply, the agency will file the submission and notify the sponsor in writing. The date of filing begins the FDA timelines described in § 330.15(c)(3) and (4).

    (3) If FDA refuses to file the safety and effectiveness data submission, the agency will notify the sponsor in writing and state the reason(s) under paragraph (j)(4) of this section for the refusal. The sponsor may request in writing, within 30 days of the date of the agency's notification, an informal conference with the agency about whether the agency should file the submission, and FDA will convene the meeting within 30 days of the request. If, within 120 days after the informal conference, the sponsor requests that FDA file the submission (with or without correcting the deficiencies), the agency will file the safety and effectiveness data submission over protest under paragraph (j)(2) of this section, notify the sponsor in writing, and review it as filed. The sponsor need not resubmit a copy of a safety and effectiveness data submission that is filed over protest.

    (4) FDA may refuse to file a safety and effectiveness data submission if any of the following applies:

    (i) The submission is incomplete because it does not contain information required under paragraph (f) of this section. If the submission does not contain required information because such information or data are not relevant to the condition, the submission must clearly identify and provide an explanation for the omission.

    (ii) The submission is not organized or formatted in a manner to enable the agency to readily determine if it is sufficiently complete to permit a substantive review.

    (iii) The submission does not contain a signed statement that the submission represents a complete safety and effectiveness data submission and that the submission includes all the safety and effectiveness data and information available to the sponsor at the time of the submission, whether positive or negative.

    (iv) The submission does not contain an analysis and summary of the data and other supporting information, organized by clinical or nonclinical area, such as clinical efficacy data, clinical safety data, clinical pharmacology, adverse event reports, animal toxicology, chemistry data, and compendial status.

    (v) The submission does not contain a supporting document summarizing the strategy used for literature searches, including search terms, sources, dates accessed and years reviewed.

    (vi) The submission does not contain a reference list of supporting information, such as published literature, unpublished information, abstracts and case reports, and a copy of the supporting information.

    (vii) The submission includes data or information relevant for making a GRASE determination marked as confidential without a statement that the information may be released to the public.

    (viii) The submission does not contain a complete environmental assessment under § 25.40 of this chapter or fails to provide sufficient information to establish that the requested action is subject to categorical exclusion under § 25.30 or § 25.31 of this chapter.

    (ix) The submission does not contain a statement for each nonclinical laboratory study that it was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if it was not conducted in compliance with part 58 of this chapter, a brief statement of the reason for the noncompliance.

    (x) The submission does not contain a statement for each clinical investigation involving human subjects that it was conducted in compliance with the institutional review board regulations in part 56 of this chapter, or was not subject to those regulations, and that it was conducted in compliance with the informed consent regulations in part 50 of this chapter.

    (xi) The submission does not include financial certification or disclosure statements, or both, as required by part 54 of this chapter, accompanying any clinical data submitted.

    (k) Withdrawal of consideration. (1) FDA may withdraw consideration of a TEA submission or a safety and effectiveness data submission if:

    (i) The sponsor requests that its submission be withdrawn from consideration, or

    (ii) FDA deems the submission to be withdrawn from consideration due to the sponsor's failure to act on the submission or failure to respond to communications from FDA.

    (2) Before FDA deems a submission withdrawn under paragraph (k)(1)(ii) of this section, FDA will notify the sponsor of the submission. If, within 30 days from the date of the notice from FDA, the sponsor requests that FDA not withdraw consideration of the submission, FDA will not deem the submission to be withdrawn.

    (3) If FDA withdraws consideration of a submission under paragraph (k)(1) of this section, FDA will post a notice of withdrawal to the docket. Information that has been posted to the public docket for the TEA at the time of the withdrawal (such as a notice of eligibility or a safety and effectiveness data submission that has been accepted for filing and posted to the docket) will remain on the public docket.

    (4) If FDA withdraws consideration of a submission under paragraph (k)(1) of this section, the timelines under § 330.15(c) will no longer apply as of the date of withdrawal, and the submission will not be included in the metrics under § 330.15(b).

    3. Add § 330.15 to subpart B to read as follows:
    § 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.

    (a) Applicability. This section applies to the review of a condition in a time and extent application (TEA) submitted under § 330.14 for consideration in the over-the-counter (OTC) drug monograph system. This section does not apply to:

    (1) A sunscreen active ingredient or combination of sunscreen active ingredients, and other conditions for such ingredients, or

    (2) A non-sunscreen active ingredient or combination of non-sunscreen active ingredients and other conditions for such ingredients submitted in a TEA under § 330.14 prior to November 27, 2014, subject to section 586F(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act.

    (b) Metrics. FDA will maintain and update annually, a publicly available posting of metrics for the review of TEAs and safety and effectiveness data submissions that are subject to the timelines in this section. The posting will contain the following information for tracking the extent to which the timelines set forth in paragraph (c) of this section were met during the previous calendar year.

    (1) Number and percent of eligibility notices or ineligibility letters issued within 180 days of submission of a TEA;

    (2) Number and percent of filing determinations issued within 90 days of submission of a safety and effectiveness data submission;

    (3) If applicable, number and percent of feedback letters issued within 730 days from the date of filing;

    (4) Number and percent of notices for proposed rulemaking issued within 1,095 days from the date of filing;

    (5) Number and percent of final rules issued within 912 days of closing of the docket of the proposed rulemaking; and

    (6) Total number of TEAs submitted under § 330.14.

    (c) Timelines for FDA review and action. FDA will review and take an action within the following timelines:

    (1) Within 180 days of submission of a TEA under § 330.14(c), FDA will issue a notice of eligibility or post to the docket a letter of ineligibility, in accordance with § 330.14(d) and (e).

    (2) Within 90 days of submission by the sponsor of a safety and effectiveness data submission, FDA will issue a filing determination in accordance with § 330.14(j). The date of filing begins the FDA timelines in paragraphs (c)(3) and (4) of this section.

    (3) Within 730 days from the date of filing, if the condition is initially determined not to be GRASE for OTC use in the United States, FDA will inform the sponsor and other interested parties who have submitted data of its determination by feedback letter in accordance with § 330.14(g)(4).

    (4) Within 1,095 days from the date of filing of a safety and effectiveness data submission, FDA will issue a notice of proposed rulemaking to either:

    (i) Include the condition in an appropriate OTC monograph(s), either by amending an existing monograph(s) or establishing a new monograph(s), if necessary; or

    (ii) Include the condition in § 310.502 of this chapter.

    (5) Within 912 days of the closing of the docket of the proposed rulemaking under paragraph (c)(4) of this section, FDA will issue a final rule.

    Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-07612 Filed 4-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Financial Crimes Enforcement Network 31 CFR Parts 1010 and 1023 RIN 1506-AB29 Amendments to the Definition of Broker or Dealer in Securities AGENCY:

    Financial Crimes Enforcement Network (“FinCEN”), Treasury.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    FinCEN, a bureau of the Department of the Treasury, is proposing amendments to the definitions of “broker or dealer in securities” and “broker-dealer” under the regulations implementing the Bank Secrecy Act. This rulemaking would amend those definitions explicitly to include funding portals that are involved in the offering or selling of crowdfunding securities pursuant to section 4(a)(6) of the Securities Act of 1933. The consequence of those amendments would be that funding portals would be required to implement policies and procedures reasonably designed to achieve compliance with the Bank Secrecy Act requirements currently applicable to brokers or dealers in securities. The proposal to specifically require funding portals to comply with the Bank Secrecy Act regulations is intended to help prevent money laundering, terrorist financing, and other financial crimes.

    DATES:

    Written comments on this Notice of Proposed Rulemaking (“NPRM”) must be submitted on or before June 3, 2016.

    ADDRESSES:

    Comments may be submitted, identified by Regulatory Identification Number (RIN) 1506-AB29, by any of the following methods:

    Federal E-rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Include RIN 1506-AB29 in the submission. Refer to Docket Number FINCEN-2014-0005.

    Mail: FinCEN, P.O. Box 39, Vienna, VA 22183. Include RIN 1506-AB29 in the body of the text.

    Please submit comments by one method only. Comments submitted in response to this NPRM will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.

    Inspection of comments: The public dockets for FinCEN can be found at Regulations.gov. Federal Register notices published by FinCEN are searchable by docket number, RIN, or document title, among other things, and the docket number, RIN, and title may be found at the beginning of the notice. FinCEN uses the electronic, Internet-accessible dockets at Regulations.gov as their complete, official-record docket; all hard copies of materials that should be in the docket, including public comments, are electronically scanned and placed in the docket. In general, FinCEN will make all comments publicly available by posting them on http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    FinCEN Resource Center at 1-800-767-2825 or 1-703-905-3591 (not a toll free number) and select option 3 for regulatory questions. Email inquiries can be sent to [email protected].

    SUPPLEMENTARY INFORMATION: I. Statutory and Regulatory Provisions

    The Currency and Foreign Transactions Reporting Act of 1970, as amended by the Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (Public Law 107-56) (“USA PATRIOT Act”) and other legislation, which legislative framework is commonly referred to as the Bank Secrecy Act (“BSA”),1 authorizes the Secretary of the Treasury (“Secretary”) to require financial institutions to keep records and file reports that “have a high degree of usefulness in criminal, tax, or regulatory proceedings, or in the conduct of intelligence or counterintelligence activities, including analysis, to protect against international terrorism.” 2 In addition, the Secretary is authorized to impose anti-money laundering (“AML”) program requirements on financial institutions.3 The Secretary has delegated to the Director of FinCEN the authority to implement, administer, and enforce compliance with the BSA and its implementing regulations.4

    1 The BSA is codified at 12 U.S.C. 1829b and 1951-1959, and 31 U.S.C. 5311-5314 and 5316-5332 and notes thereto, with implementing regulations at 31 CFR Chapter X. See 31 CFR 1010.100(e).

    2 31 U.S.C. 5311.

    3 31 U.S.C. 5318.

    4 Treasury Order 180-01 (Jul. 1, 2014).

    The BSA was amended by the Annunzio-Wylie Anti-Money Laundering Act of 1992 (Pub. L. 102-550) (“Annunzio-Wylie”).5 Annunzio-Wylie authorizes the Secretary to issue regulations requiring financial institutions to implement programs to guard against money laundering, maintain records considered useful in criminal, tax, or regulatory investigations or proceedings, and report suspicious transactions.6 When prescribing minimum standards for AML programs, FinCEN must “consider the extent to which the requirements imposed under [the AML program requirement] are commensurate with the size, location, and activities of the financial institutions to which such regulations apply.” 7 Pursuant to these authorities, FinCEN has issued regulations requiring brokers or dealers in securities to report suspicious transactions and implement AML programs.8

    5 31 U.S.C. 5318(g) was added to the BSA by section 1517 of the Annunzio-Wylie Act; it was expanded by section 403 of the Money Laundering Suppression Act of 1994 (the “Money Laundering Suppression Act”), Title IV of the Riegle Community Development and Regulatory Improvement Act of 1994, Public Law 103-325, to require designation of a single government recipient for reports of suspicious transactions. As amended by the USA PATRIOT Act, subsection (g)(1) states generally that “the Secretary may require any financial institution, and any director, officer, employee, or agent of any financial institution, to report any suspicious transaction relevant to a possible violation of law or regulation.”

    6 Annunzio-Wylie Anti-Money Laundering Act, Title XV of the Riegle Community Development and Regulatory Improvement Act of 1994, Public Law 103-325; See also 31 U.S.C. 5318(g).

    7 See section 352(c) of Title III of the USA PATRIOT Act of 2001, Pub. L. 107-56, 115 Stat. 272, 322 (2001) (codified at 31 U.S.C. 5318(h)).

    8 31 CFR 1023.320.

    II. Background Information A. The Effect of the JOBS Act and the Securities and Exchange Commission Crowdfunding Rule on the Scope of the Definitions of Brokers or Dealers in Securities and Broker-Dealers Under the Implementing Regulations of the BSA

    The Jumpstart Our Business Startups Act (the “JOBS Act”), enacted on April 5, 2012, establishes the foundation for a regulatory structure for startups and small businesses to raise funds by offering and selling securities through crowdfunding 9 without having to register the securities with the Securities and Exchange Commission (“SEC” or “Commission”) or state securities regulators.10 Crowdfunding is a new and evolving method to raise money using the Internet by seeking small individual contributions from a large number of people. The crowdfunding provisions of the JOBS Act were designed to help startups and small businesses raise funds by making relatively low-dollar offerings of securities less costly. They also permit Internet-based platforms known as “funding portals,” acting as intermediaries, to facilitate the offer or sale of securities without having to register with the SEC as brokers.

    9 Crowdfunding is the use of the Internet to raise money through small contributions from a large number of investors. Not all crowdfunding involves the offering or selling of securities, though in some instances it does. This NPRM is meant to address only instances in which crowdfunding involves facilitating an offer or sale of securities to raise money for a business pursuant to section 4(a)(6) of the Securities Act. For example, this NPRM is not addressing instances where crowdfunding is utilized to solicit donations from the general public or a targeted group.

    10 Public Law 112-106, 126 Stat. 306 (2012).

    Title III of the JOBS Act amends the Securities Act of 1933 and the Securities Exchange Act of 1934 to create a new exemption for offerings of crowdfunded securities.11 Specifically, the JOBS Act amends section 4 of the Securities Act of 1933 to exempt issuers from the registration requirements of section 5 of that Act when they offer and sell up to $1 million in securities, provided that, among other things, individual investments do not exceed certain thresholds (e.g., $2,000 to $100,000 in a 12-month period) based on the investor's annual income or net worth. Additionally, issuers must use the services of an intermediary that is either a broker registered with the SEC or a “funding portal” registered with the SEC.12

    11Id. See also sections 4(a)(6) and 4A of the Securities Act of 1933 (15 U.S.C. 77a et seq.), and section 3(a)(80) of the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).

    12Id.

    The JOBS Act also amends the Securities Exchange Act of 1934 to include a definition of funding portals in section 3(a)(80).13 The JOBS Act defines a funding portal as any person acting as an intermediary in a transaction involving the offer or sale of securities for the account of others, solely pursuant to section 4(a)(6) of the Securities Act that does not: (i) Offer investment advice or recommendations; (ii) solicit purchases, sales, or offers to buy securities offered or displayed on its Web site or portal; (iii) compensate employees, agents, or other persons for such solicitation or based on the sale of securities displayed or referenced on its Web site or portal; (iv) hold, manage, possess, or otherwise handle investor funds or securities; or (v) engage in such other activities as the SEC, by rule, determines appropriate.14

    13See section 3(a)(80) of the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).

    14Id.

    In addition, the JOBS Act adds new section 3(h) to the Securities Exchange Act of 1934, which requires the SEC to exempt, by rule, conditionally or unconditionally, a registered funding portal from the requirement to register with the SEC as a broker.15 The funding portal would, however, remain subject to the SEC's examination, enforcement, and rulemaking authority. The funding portal also must become a member of a national securities association that is registered under section 15A of the Securities Exchange Act.16 As required by the JOBS Act, the SEC issued a notice of proposed rulemaking (“Crowdfunding NPRM”) on November 5, 2013 proposing the regulatory framework for intermediaries facilitating the offer or sales of crowdfunded securities,17 which it finalized largely as proposed on October 30, 2015.18

    15Id. Generally, a third party that operates a Web site to effect the purchase and sale of securities for the account of others generally would, under existing regulations, be required to register with the Commission as a broker-dealer and comply with the laws and regulations applicable to broker-dealers.

    16Id.

    17See 78 FR 66428 (Nov. 5, 2013).

    18See 80 FR 71387 (Nov. 16, 2015).

    Current BSA regulations at Part 1023 of Chapter X of Title 31 of the CFR (the Part that imposes the specific requirements to maintain an anti-money laundering program and to file suspicious activity reports) define “broker-dealers” by reference to persons “registered, or required to be registered, as a broker or dealer with the Commission under the Securities Exchange Act of 1934.” 19 As described above, a registered funding portal would not be a person required to be registered as a broker with the Commission because a funding portal would be exempt from broker registration, and thus would not be subject to BSA regulations under the current BSA definition of “broker-dealers.” In its Crowdfunding NPRM, the SEC sought to address this issue through its proposed rule 403(b). Specifically, the SEC proposed that “[n]otwithstanding [the exemption from registration as a broker or dealer in securities], for purposes of 31 CFR chapter X, a funding portal is `required to be registered' as a broker or dealer with the Commission under the Exchange Act.” 20 At the final stage of its Crowdfunding rulemaking, the SEC determined “that it would be more appropriate to work with other regulators to develop consistent and effective AML obligations for funding portals,” and chose not to adopt proposed rule 403(b).21 Now that the SEC has finalized its Crowdfunding rule exempting funding portals from having to register as brokers or dealers in securities, FinCEN is proposing this rulemaking to ensure that registered funding portals are subject to BSA regulations.

    19 31 CFR 1023.100.

    20See 78 FR 66428, 66484 (Nov. 5, 2013).

    21See 80 FR 71387, 71471 (Nov. 16, 2015).

    There are good reasons to ensure that funding portals are subject to BSA regulations. As the SEC has recognized, funding portals would continue to function as brokers regardless of the statutory provisions exempting them from registering as brokers under the Exchange Act.22 Specifically, although the JOBS Act prohibits a funding portal from holding, managing, possessing, or handling customer funds or securities, a funding portal's business activity is essentially similar to that of introducing brokers, which typically do not accept cash from customers or maintain custody of customer securities,23 but yet are subject to the BSA regulations. As such, funding portals raise at least the same degree of AML and counter financing of terrorism risk as some other broker-dealers registered with the SEC, and should be regulated commensurately under the BSA.

    22 See 78 FR 66428, 66483-66484.

    23See infra note 20.

    Moreover, as the SEC noted in its November 5, 2013 Crowdfunding NPRM, there is reason to “expect that funding portals would often facilitate offerings of microcap or low-priced securities, which may be more susceptible to fraud and market manipulation. We believe that imposing the monitoring and reporting requirements of the BSA on funding portals would establish a valuable oversight, prevention and detection mechanism.” 24 In a 2010 published report, the Financial Action Task Force also identified low-priced and privately-placed securities as potential vehicles for laundering money.

    24See78 FR 66428, 66490-66491 (Nov. 5, 2013).

    These securities pose a money laundering risk because they are often used to generate illicit assets through market manipulation, insider trading, and fraud.25 In addition, unlawfully acquired assets can be used to purchase these securities in order to resell them and create the appearance of legitimately sourced funds.26 It is also possible that issuers relying on the exemption in section 4(a)(6) may be shell companies, which have been associated with a high risk of money laundering.27 Congress recognized and expressed concern about these money laundering and financial crimes risks, which is why, in part, it chose to require that securities offered and sold in reliance on section 4(a)(6) be sold through a regulated intermediary.28

    25Id. See also Financial Action Task Force (“FATF”), Money Laundering and Terrorist Financing in the Securities Sector 20-21 (Oct. 2009) (“FATF Typology”) (discussing the money laundering risks associated with low priced securities, private issuers, and shell companies). As explained in the FATF Typology, illicit actors “can either use existing shares that are already publicly traded or start a shell company for the express purpose of engaging in those illicit activities. In addition, criminal organizations also have been known to use illicit assets generated outside the securities industry to engage in market manipulation and fraud.”

    26See 78 FR 66428, 66490-66491 (Nov. 5, 2013). “Moreover, criminal organizations can also initially invest in a private company that they can then use as a front company for commingling illicit and legitimate assets. They can then take this company public through an offering in the public securities markets, thus creating what appear to be legitimate offering revenues. Alternatively, criminal organizations can acquire a publicly traded company and use it to launder illicit assets.” The FATF Typology further highlighted the risk of shell companies that, for example, “can be established to accept payments from criminal organizations for non-existent services. These payments, which appear legitimate, can be deposited into depository or brokerage accounts and either wire transferred out of a jurisdiction or used to purchase securities products that are easily transferable or redeemable.”

    27See 78 FR 66428, 66490-66491 (Nov. 5, 2013). See also, e.g., Joint Release, Guidance on Obtaining and Retaining Beneficial Ownership Information, FIN-2010-G001 (Mar. 5, 2010) (noting that criminals, money launderers, tax evaders, and terrorists may exploit the privacy and confidentiality surrounding some business entities, including shell companies and other vehicles designed to conceal the nature and purpose of illicit transactions and the identities of the persons associated with them); Financial Crimes Enforcement Network, The Role of Domestic Shell Companies in Financial Crime and Money Laundering: Limited Liability Companies (Nov. 2006), available at http://www.fincen.gov/news_room/rp/files/LLCAssessment_FINAL.pdf.

    28See 78 FR 66428, 66490-66491 (Nov. 5, 2013). See also 158 Cong. Rec. S1781 (daily ed. Mar. 19, 2012) (statement of former Sen. Carl Levin) (“Senior citizens, state securities regulators, and others worry that this will give rise to money laundering and fraud risks.”).

    FinCEN believes that funding portals could play a critical role in detecting, preventing, and reporting money laundering and other illicit financing, such as market manipulation and fraud. As described above, funding portals should be subject to normal BSA obligations. A funding portal, like an introducing broker, is in the best position to know its customers, and to identify and monitor for suspicious and potentially illicit activity at the individual customer level, as compared to other required participants in the transaction such as the qualified third party, which may not see such activity given its less direct contact with individual customers.29 FinCEN understands that the JOBS Act was designed to provide regulatory relief and ease the funding gap that startups and small businesses often face, while providing significant investor protections. But in addition to investor protections, any regulatory structure for securities-based crowdfunding through the Internet must also address the risk of money laundering and other financial crimes presented by the misuse of crowdfunding transactions. FinCEN agrees with the SEC that a funding portal engaging in the business of effecting securities transactions for the accounts of others through crowdfunding is acting as a broker-dealer, despite the exemption from registration under the Exchange Act that Congress directed the SEC to implement, and that this new type of broker or dealer in securities should be subject to supervision under the BSA regulation.

    29See 78 FR 66428, 66490. See also, e.g., National Association Of Securities Dealers (“NASD”) (n/k/a “FINRA”), NASD Provides Guidance To Member Firms Concerning Anti-Money Laundering Compliance Programs Required by Federal Law, Special Notice to Members 02-21 (Apr. 2002), available https://www.finra.org/Industry/Regulation/Notices/2002/p003703 (stating that “introducing brokers generally are in the best position to `know the customer,' and thus to identify potential money laundering concerns at the account opening stage, including verification of the identity of the customer and deciding whether to open an account for a customer.”).

    For all of these reasons, in addition to the provisions finalized in the SEC's Crowdfunding rulemaking, FinCEN believes that it is further appropriate, in response to changes in the registration requirement in the JOBS Act, to amend the BSA definitions of a broker or dealer in securities and broker-dealer to explicitly include funding portals, registered or required to be registered as such, with the SEC. Explicitly requiring funding portals to comply with the BSA's requirements, consistent with registered brokers or dealers in securities, helps ensure consistent regulation of brokers or dealers in securities with fewer opportunities for regulatory gaps, which could be exploited by financial criminals. Because the BSA and its implementing rules are risk-based, we expect that funding portals would design programs commensurate with their limited business model and not the more comprehensive programs established by full service broker-dealers.

    B. Overview of the Current Regulatory Provisions Regarding Brokers or Dealers in Securities and Broker-Dealers

    On October 26, 2001, the President signed into law the USA PATRIOT Act of 2001. Title III of the USA PATRIOT Act makes a number of amendments to the anti-money laundering provisions of the BSA to promote the prevention, detection, and prosecution of international money laundering and the financing of terrorism. The statutory mandate that all financial institutions, which include brokers or dealers in securities, establish an AML program and comply with the BSA regulations is a key element in the nation's effort to detect and prevent money laundering and the financing of terrorism. If implemented, this proposal would explicitly incorporate a funding portal's activities within the existing definition of brokers or dealers in securities, and require funding portals to comply with the full range of requirements outlined in 31 CFR 1023 applicable to broker-dealers, including: (1) AML program; (2) Suspicious Activity Report; (3) Customer Identification Program; (4) Currency Transaction Report; (5) Recordkeeping and Travel rules; (6) Information Sharing (section 314); (7) Due Diligence for Correspondent Accounts for Foreign Financial Institutions and Private Banking Accounts; (8) Prohibition on Correspondent Accounts for Foreign Shell Banks; and (9) Special Measures (section 311).30 The following are brief descriptions of the regulations that would apply to funding portals if this rulemaking is finalized as proposed.

    30See 31 CFR 1023.210, 1023.220, 1023.310, 1023.320, 1023.410, 1023.520, 1023.610, and 1023.630.

    1. Anti-Money Laundering Program

    Section 352(a) of the USA PATRIOT Act amended section 5318(h) of the BSA. Section 5318(h)(1) requires every financial institution defined in 31 U.S.C. 5312(a)(2), which are also covered in 31 CFR, to establish an AML program that includes, at minimum, (1) the development of internal policies, procedures, and controls; (2) the designation of a compliance officer; (3) an ongoing employee training program; and (4) an independent audit function to test programs.31 The BSA defines the term “financial institution” to include, in part, “a broker or dealer in securities.” 32 Currently, a broker or dealer in securities that implements and maintains an AML program that complies with the rules, regulations, or requirements of its self-regulatory organization (“SRO”) is deemed to satisfy the requirement of section 5318 (h)(1) of the BSA.33

    31 31 U.S.C. 5318(h)(1)(A-D).

    32 31 U.S.C. 5312(a)(2)(G).

    33 31 CFR 1023.210. See also Notice of Proposed Rulemaking—Customer Due Diligence Requirements for Financial Institutions 79 FR 45151 (Aug. 4, 2014). Treasury proposed rules to clarify and strengthen customer due diligence requirements, to include a new requirement to identify beneficial owners of legal entity customers. The proposed changes in that notice of proposed rulemaking may have an impact on what is proposed in this notice.

    2. Suspicious Activity Report

    FinCEN has promulgated Suspicious Activity Report (“SAR”) regulations for a number of financial institutions. These include banks, casinos, money services businesses, brokers or dealers in securities, mutual funds, insurance companies, and futures commission merchants and introducing brokers in commodities.34 31 CFR 1023.320 contains the rules setting forth the obligation of broker-dealers in securities to report suspicious transactions. Specifically, brokers or dealers in securities are required to report a transaction that is conducted or attempted by, at, or through a broker-dealer and involves or aggregates to at least $5,000 in funds or other assets, and the broker-dealer knows, suspects, or has reason to suspect that the transaction (or a pattern of transactions of which the transaction is a part) (i) involves funds derived from illegal activity or is intended or conducted to hide or disguise funds or assets derived from illegal activity; (ii) is designed, whether through structuring or other means, to evade the requirements of the BSA; (iii) has no business or apparent lawful purpose, and the broker or dealer in securities knows of no reasonable explanation for the transaction after examining the available facts; or (iv) involves the use of the broker-dealer to facilitate criminal activity.

    34See 31 CFR 1020.210, 1020.320, 1021.210, 1021.320, 1022.210, 1022.320, 1023.210, 1023.320, 1024.210, 1024.320, 1025.210, 1025.320, 1026.210, and 1026.320, respectively.

    3. Currency Transaction Report

    The Secretary was granted authority in 1970, with the enactment of 31 U.S.C. 5313, to require financial institutions to report currency transactions exceeding $10,000. The information collected on the Currency Transaction Report is required to be provided pursuant to 31 U.S.C. 5313. The implementing regulation for brokers or dealers in securities can be found at 31 CFR 1023.310.

    4. Records To Be Made and Retained by Financial Institutions

    On January 3, 1995, FinCEN and the Board of Governors of the Federal Reserve System (“the Board”) jointly issued a rule that requires banks and nonbank financial institutions to collect and retain information on certain funds transfers and transmittals of funds (the “recordkeeping rule”).35 At the same time, FinCEN issued the “travel rule,” which requires banks and nonbank financial institutions to include with a transmittal order certain information on funds transfers and transmittals of funds sent to other banks or nonbank financial institutions.36

    35 31 CFR 1020.410(a) (recordkeeping requirements for banks); 31 CFR 1010.410(e) (recordkeeping requirements for nonbank financial institutions). The Board revised its Regulation S (12 CFR part 219) to incorporate by reference the recordkeeping rule codified in Title 31 of the CFR, as well as to impose a five-year record-retention requirement with respect to the recordkeeping requirements.

    36 31 CFR 1010.410(f).

    The recordkeeping and travel rules provide uniform recordkeeping and transmittal requirements for financial institutions, and are intended to help law enforcement and regulatory authorities detect, investigate, and prosecute money laundering and other financial crimes by preserving an information trail about persons sending and receiving funds through the funds transfer system.

    In general, the recordkeeping rule requires financial institutions to retain certain information on transmittals of funds of $3,000 or more, which must be retrievable and available upon request to FinCEN, to law enforcement, and to regulators to whom FinCEN has delegated the BSA compliance examination authority. Under the travel rule, a financial institution acting as the transmittor's financial institution must obtain and include in the transmittal order certain information on transmittals of funds of $3,000 or more.

    5. Customer Identification Program

    31 CFR 1023.220 sets forth the customer identification program (“CIP”) requirements for brokers or dealers in securities, which would include funding portals with the proposed amendments. Under the rule published jointly with the SEC,37 brokers or dealers in securities must establish a written CIP that, at a minimum, includes procedures for: (1) Obtaining customer identifying information from each customer prior to account opening; (2) verifying the identity of each customer to the extent reasonable and practicable, within a reasonable time before or after account opening; (3) making and maintaining a record of obtained information relating to identity verification; (4) determining, within a reasonable time after account opening or earlier, whether a customer appears on any list of known or suspected terrorist organizations designated by Treasury; and (5) providing each customer with adequate notice, prior to opening an account, that information is being requested to verify the customer's identity.38 Under certain defined circumstances, brokers or dealers in securities may rely on the performance of another financial institution that also is subject to an AML compliance program rule to fulfill some or all of the requirements of the broker-dealer's CIP.39

    37 68 FR 25113 (May 9, 2003).

    38 31 CFR 1023.220(a)(6).

    39Id.

    6. Special Information Procedures To Deter Money Laundering and Terrorist Activity

    31 CFR 1023.500 states generally that brokers or dealers in securities are covered by the special information procedures to detect money laundering and terrorist activity requirements.40 Sections 1010.520 and 1010.540 implement sections 314(a) and 314(b) of the USA PATRIOT Act, respectively.

    40 These requirements are set forth and cross referenced in sections 1023.520 (cross referencing to 31 CFR 1010.520) and 1023.540 of 31 CFR (cross-referencing to 31 CFR 1010.540).

    Under the section 314(a) requirements, brokers or dealers in securities must respond to requests for information made by FinCEN on behalf of Federal, state, and local law enforcement agencies, or a similar request from FinCEN on its own behalf, on behalf of certain components of Treasury, or on behalf of certain foreign law enforcement agencies.41 Upon receiving such a request, a broker or dealer in securities is required to search its records to determine whether it has accounts for, or has engaged in transactions with, any specified individual, entity, or organization.42 Under the regulation implementing section 314(b), brokers or dealers in securities are authorized to share information with one another, under a safe harbor that offers protections from liability, in order to better identify and report potential money laundering or terrorist activities.43

    41 31 CFR 1010.520(b).

    42 31 CFR 1010.520(b)(3).

    43 31 CFR 1023.540.

    7. Due Diligence Anti-Money Laundering Programs for Private Banking and Certain Foreign Accounts

    31 CFR 1023.600 generally states that brokers or dealers in securities are subject to the special standards of diligence, prohibitions, and special measures requirements.44 Sections 1010.610, 1010.620, and 1010.630 implement section 312 of the USA PATRIOT Act and generally apply to any financial institution listed in 31 U.S.C. 5312(a)(2). Sections 1023.610 and 1023.620 require U.S. financial institutions, including brokers or dealers in securities, to establish risk-based due diligence policies, procedures, and controls reasonably designed to detect and report money laundering through correspondent accounts and private banking accounts that U.S. financial institutions establish or maintain for non-U.S. persons.

    44 These requirements are set forth and cross referenced in sections 1023.610 (cross referencing to 31 CFR 1010.610), 1023.620 (cross-referencing to 31 CFR 1010.620), and 1023.630 of 31 CFR (cross-referencing to 31 CFR 1010.630).

    8. Prohibition on Correspondent Accounts for Foreign Shell Banks; Records Concerning Owners of Foreign Banks and Agents for Service of Legal Process

    Section 313 of the USA PATRIOT Act amended the BSA by adding subsection (j) to 31 U.S.C. 5318. Sections 1010.630 and 1023.630 implement this provision and set forth the requirements for brokers and dealers in securities. The regulations prohibit covered financial institutions from providing correspondent accounts in the United States to foreign shell banks (i.e., banks without a physical presence in any country) and to take reasonable steps to ensure that correspondent accounts provided to foreign banks are not being used to provide banking services to foreign shell banks indirectly.45 The statutory and regulatory definitions of covered financial institutions include a broker or dealer in securities.46 Brokers and dealers in securities must comply with this regulation with respect to any account they provide in the United States to a foreign bank that permits the foreign bank to engage in securities transactions, funds transfers, or other financial transactions through that account.

    45See 31 CFR 1010.630.

    46See 31 U.S.C. 5318(j)(1) and 5312(a)(2).

    Section 319(b) of the USA PATRIOT Act amended the BSA by adding subsection (k) to 31 U.S.C. 5318, which requires any covered financial institution that provides a correspondent account to a foreign bank to maintain records of the foreign bank's owners and any agent in the United States designated to accept service of legal process for records regarding the correspondent account. While the rule does not prescribe the manner in which a covered financial institution must obtain the required information, it does provide a safe harbor if a covered financial institution obtains from the foreign bank the model certification provided on FinCEN's public Web site.47 The rule requires covered financial institutions to verify the information previously provided by each foreign bank for which it maintains a correspondent account at least once every two years.

    47 Certification Regarding Correspondent Accounts for Foreign Banks, available at: http://www.fincen.gov/forms/files/Certification%20Regarding%20Correspondent%20Accounts%20for%20Foreign%20Banks.pdf; Certification Regarding Correspondent Accounts for Foreign Banks, available at: http://www.fincen.gov/forms/files/Recertification%20Regarding%20Correspondent%20Accounts%20for%20Foreign%20Banks.pdf.

    9. Special Measures Under Section 311 of the USA PATRIOT Act

    Section 311 of the USA PATRIOT Act (“section 311”) added section 5318A to the BSA, granting FinCEN the authority to require domestic financial institutions and financial agencies to take certain “special measures” upon finding that reasonable grounds exist for concluding that a foreign jurisdiction, institution, class of transaction, or type of account is of “primary money laundering concern.” To address the specific money laundering risks, section 311 provides a range of special measures that can be imposed individually, jointly, in any combination, and in any sequence.48

    48 Available special measures include requiring: (1) Recordkeeping and reporting of certain financial transactions; (2) collection of information relating to beneficial ownership; (3) collection of information relating to certain payable-through accounts; (4) collection of information relating to certain correspondent accounts; and (5) prohibition or conditions on the opening or maintaining of correspondent or payable through accounts. 31 U.S.C. 5318A(b)(l)-(5). For a complete discussion of the range of possible countermeasures, see 68 FR 18917 (April 17, 2003) (proposing special measures against Nauru).

    Under 31 CFR 1010.810(a), “[o]verall authority for enforcement and compliance, including coordination and direction of procedures and activities of all other agencies exercising delegated authority under this chapter, is delegated [by the Secretary] to the Director, FinCEN.” In turn, Federal functional regulators have been delegated authority to examine certain financial institutions they oversee for compliance with FinCEN's regulations. FinCEN has delegated to the SEC the authority to examine brokers or dealers in securities, which would include funding portals, for compliance with FinCEN regulations.49

    49 31 CFR 1010.810(b)(6).

    III. Section-by-Section Analysis

    This NPRM proposes to revise the regulations implementing the BSA by amending the definition of “broker or dealer in securities” and its synonymous term “broker-dealer” to specifically include funding portals that are involved in the offering or selling of crowdfunding securities pursuant to section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)). These terms are defined in three different places, and phrased slightly differently for each, but are substantively the same:

    • In 31 CFR 1010.100(h), a “broker or dealer in securities” is defined as “[a] broker or dealer in securities, registered or required to be registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934, except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934.”

    • 31 CFR 1010.605(e)(1)(viii) and (e)(2)(viii) refer to “[a] broker or dealer in securities registered, or required to be registered, with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.), except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934.”

    • In 31 CFR 1023.100(b), a “broker-dealer” is defined to mean “a person registered or required to be registered as a broker or dealer with the Commission under the Securities Exchange Act of 1934 (15 U.S.C. 77a et seq.), except persons who register pursuant to 15 U.S.C. 78o(b)(11).” 50

    50 FinCEN is also amending this section of the rule to reflect the correct citation of 15 U.S.C. 78a et seq. currently published as 15 U.S.C. 77a et seq.

    FinCEN proposes to amend these definitions by adding to each the phrase “a person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)).” FinCEN further proposes to make technical amendments to each definition to create one standard definition of the terms “broker or dealer in securities” and “broker-dealer” to be used throughout the regulations.

    IV. Request for Comment

    FinCEN invites comment on any and all aspects of the NPRM, and specifically seeks comments on the following questions:

    • Is the application of all BSA regulations currently covering brokers or dealers in securities to funding portals appropriate?

    • Are there exceptions to the regulations that should be granted to funding portals? If so, why would any such exceptions be appropriate?

    V. Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this proposed rule is a significant regulatory action, although not economically significant, for purposes of Executive Orders 12866 and 13563.

    VI. Unfunded Mandates Act of 1995 Statement

    Section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), Public Law 104-4 (March 22, 1995), requires that an agency prepare a budgetary impact statement before promulgating a rule that may result in expenditure by the state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 202 of the Unfunded Mandates Act also requires an agency to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. Since there is no change to the requirements imposed under existing regulations, FinCEN has determined that it is not required to prepare a written statement under section 202.

    VII. Regulatory Flexibility Act

    The Regulatory Flexibility Act (“RFA”) (5 U.S.C. 601 et seq.) requires that a regulation that has a significant economic impact on a substantial number of small entities, small businesses, or small organizations must include an initial regulatory flexibility analysis describing the regulation's impact on small entities. Such an analysis need not be undertaken if the agency has certified that the regulation will not have a significant economic impact on a substantial number of small entities (5 U.S.C. 605(b)).

    Section 601(3) of the RFA states that the term “small business” has the same meaning as the term “small business concern” under section 3 of the Small Business Act, unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate for the activities of the agency and publishes such definition(s) in the Federal Register. The Small Business Administration's (“SBA”) defines a broker dealer industry to be a small entity as having “annual receipts” of $38.5 million.51 However, FinCEN is concerned that using the SBA size standard rather than the SEC size standard may result in confusion. Accordingly, FinCEN consulted with the SBA's Office of Advocacy. After consultation, FinCEN is proposing to define the term small entity in accordance with definitions obtained from SEC rules implementing the Securities Exchange Act,52 in lieu of using the Small Business Administration's definition.53 The SEC defines an entity as a small broker or dealer, for purposes of the RFA, if it: (1) Had total capital (net worth plus subordinated liabilities) of less than $500,000 on the date in the prior fiscal year as of which its audited financial statements were prepared pursuant to Rule 17a-5(d) or, if not required to file such statements, a broker or dealer that had total capital (net worth plus subordinated debt) of less than $500,000 on the last business day of the preceding fiscal year (or in the time that it has been in business if shorter); and (2) is not affiliated with any person (other than a natural person) that is not a small business or small organization as defined in this release. The proposed rules would define broker or dealer in securities as: (1) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.), except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934 (15 U.S.C. 78o(b)(11)); or (2) a person, registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6). Based on FOCUS Report data, the SEC estimated that there are 871 broker-dealers that are classified as “small” entities for purposes of the RFA.54 The SEC applied comparable criteria to funding portals that would register under the SEC's Crowdfunding rule.

    51Id.

    52 17 CFR 240.0-10c.

    53 13 CFR 121.201.

    54 FOCUS Reports, or “Financial and Operational Combined Uniform Single” Reports, are monthly, quarterly, and annual reports that broker-dealer generally are required to file with the SEC and or self-regulatory organizations pursuant to Exchange Act Rule 17a-5 (17 CFR 240.17a-5).

    Relying on the SEC's definition has the benefit of ensuring consistency in the categorization of small entities for SEC examiners, as well as providing the broker or dealer industry with a uniform standard. In addition, FinCEN's proposed use of the SEC's definition of small entity will have no material impact upon the application of these proposed rules to the broker or dealer industry. FinCEN requests comment on the appropriateness of using the SEC's definition of small entity.

    The proposed changes are intended to amend the regulatory definition of broker or dealer in securities to include funding portals in light of the JOBS Act and the Final SEC Crowdfunding Rules. While these amendments do not alter a broker or dealer in securities existing obligations, they will expand the BSA regulations to create obligations for funding portals. Accordingly, FinCEN has prepared an initial regulatory flexibility analysis pursuant to the Regulatory Flexibility Act. A final regulatory flexibility analysis will be conducted after consideration of comments received during the public comment period.

    1. Statement of the Need for, and Objectives of, the Proposed Regulation

    The JOBS Act creates a comprehensive regulatory structure for startups and small businesses to raise capital through securities offerings using the Internet through crowdfunding. It also establishes the regulation of registered funding portals and brokers that are required to act as intermediaries in the offer and sale of crowdfunded securities. The JOBS Act amends the Federal securities laws to include certain funding portals, defined as any person acting as an intermediary in a transaction involving the offer or sale of securities for the account of others solely pursuant to section 4(a)(6) of the Securities Act, but that is exempted from the requirement to register as a broker-dealer with the SEC, and is instead required to be registered as a funding portal with the SEC. This proposed regulation is necessary to expand the scope of the regulatory definition of broker or dealer in securities to incorporate funding portals, to ensure consistent applicability of the BSA regulations to all brokers in securities.

    2. Small Entities Affected by the Proposed Regulation

    While the proposed BSA requirements would impose burdens on funding portals, the proposed rules would not impose any burden on funding portals in addition to those already imposed on broker-dealers. Consequently, we do not discuss those burdens here, and we would not be requesting any separate approval from OMB to impose the burdens associated with the information collection requirements to comply with the requirements of 31 CFR 1023, including the BSA/AML program, CTR, SAR, CIP, Recordkeeping and travel rules, Due Diligence Programs for Correspondent Accounts for Foreign Financial Institutions and Private Bank accounts, Prohibition on Correspondent Account for Shell Banks, section 311, and section 314 requirements.

    The requirements of this proposed regulation, which are consistent with the existing requirements for brokers or dealers in securities, would include funding portals regardless of size. Based on SEC analysis of the estimated 50 funding portals in the first year expected to register with the SEC, as a result of the JOBS Act and implementing regulations, 30 would be classified as “small” entities for purposes of the Regulatory Flexibility Act.55

    55See 80 FR 71387, 71533 (Nov. 16, 2015).

    3. Compliance Requirements

    Upon finalization of this proposal, registered funding portals would be required to comply with all of the requirements of the BSA, including the reporting, recordkeeping, and record retention requirements that apply to entities currently defined as brokers or dealers in securities. We recognize that the proposed rules would impose costs on funding portals to implement AML procedures, but we believe that the proposed amendments and requirements provide important benefits. As noted in the SEC NPRM, low-priced and privately-placed securities pose a money laundering risk because they are susceptible to market manipulation and fraud.56 Requiring funding portals to comply with BSA regulations, in particular the requirement to file SARs, helps identify potentially fraudulent activity for law enforcement and regulators. These AML requirements would therefore help to protect market participants from illegal activity that could potentially infiltrate new online investment opportunities. Requiring the implementation of AML procedures in turn provides potential investors with some degree of confidence that adequate protections against illegal activity exist for this new fundraising approach and could encourage more investors to participate, thus facilitating capital formation.

    56See 78 FR 66428, 66490-66491 (Nov. 5, 2013).

    The proposed regulations would require funding portals to develop programs reasonably designed to comply with the BSA and to collect and keep certain information, as well as report suspicious activity, among other reports. While the proposed regulations would not change the scope of compliance with the BSA requirements for brokers or dealers in securities that are not funding portals, the reporting, recordkeeping, and other compliance requirements of the proposed regulation would impact small entities that decide to register as funding portals. While the majority of these requirements would be performed by the funding portal's internal compliance personnel, some funding portals may choose to hire outside counsel and third-party service providers to assist in meeting the compliance requirements.

    4. Duplicative, Overlapping, or Conflicting Federal Rules

    FinCEN believes that there are no Federal rules that duplicate, overlap, or conflict with the proposed regulations or the proposed amendments.

    5. Significant Alternatives to the Proposed Regulations

    FinCEN considered whether it would be appropriate to establish different compliance or reporting obligations for small funding portals in the proposal, or whether small funding portals should be exempt from any parts of the proposed rules or even from the rules in their entirety. While the proposed rules are based on existing compliance requirements applicable to registered brokers or dealers in securities, FinCEN believes that it would not be necessary, nor would it be advisable, to establish different requirements for small funding portals that engage in crowdfunding. Eliminating or issuing different requirements for smaller funding portals would not be the most effective means of addressing the money laundering risk associated with securities crowdfunding as it would create a loophole and a path of least resistance that money launderers could exploit. The number of small funding portals that would be affected by the proposed rules would be limited. According to the SEC, an industry survey of crowdfunding platforms reported that 191 platforms were estimated to be operating in the United States as of 2012.57 Based on 135 participants in the survey both in the United States and international jurisdictions, 15% of funding portal platforms were engaged in securities-based crowdfunding.58 Although the number of intermediaries that may ultimately register as funding portal is uncertain, it is likely that three to four of the crowdfunding platforms that have the majority of market share in reward-based and donation-based crowdfunding would most likely obtain the majority of market share in the securities-based crowdfunding market based on section 4(a)(6).59 The BSA regulations are risk-based and are designed so that entities that are subject to the regulations can implement a program that is commensurate with the risks posed by their particular business. FinCEN expects that a small funding portal would implement a risk-based compliance program that takes into account the limited business activities in which the business participates. For example, a funding portal could implement a risk-based compliance program which reflects the fact that the business does not accept cash or securities from its customers. Therefore, we believe that the proposed rules are appropriate, and properly cover all brokers or dealers in securities, including funding portals. Furthermore, FinCEN believes that having different requirements for funding portals could undermine the objectives of the proposed requirements.

    57See 78 FR 66428, 66516 (Nov. 5, 2013).

    58 The survey further indicated that 11% were engaged in lending-based crowdfunding, 27% in donation-based crowdfunding, and 47% in reward-based crowdfunding.

    59See 78 FR 66428, 66516 (Nov. 5, 2013).

    FinCEN welcomes comment on any significant alternatives that would minimize the impact of the proposal on small funding portal entities.

    VIII. Paperwork Reduction Act

    The collection of information requirements have been reviewed and approved by the Office of Management and Budget (“OMB”) under section 3507 of the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3507(d). (OMB Control Number 1506-0004 for the CTR requirement, the OMB Control Number for the CTR report itself is 1506-0064, OMB Control Number 1506-0019 for the SAR regulatory requirement, the OMB Control Number for the BSA SAR report itself is 1506-0065, OMB Control Number 1506-0034 for the CIP requirement, OMB Control Number 1506-0043 for the Prohibitions on Correspondent Accounts for Foreign Shell Banks requirement, OMB Control Number 1506-0049 for the section 314 requirement, and OMB Control Number 1506-0053 for the Recordkeeping and travel rules requirements). Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Certain provisions of the proposed rules contain “collection of information” requirements within the meaning of the PRA. This proposal intends to expand the scope of financial institutions subject to the BSA regulations FinCEN issued for brokers or dealers in securities to include funding portals. The collections of information included under OMB Control Number 1506-0004 for the CTR requirement, OMB Control Number 1506-0019 for the SAR requirement, OMB Control Number 1506-0034 for the CIP requirement, OMB Control Number 1506-0043 for the Prohibitions on Correspondent Accounts for Shell Banks requirement, OMB Control Number 1506-0049 for the section 314 requirement, and OMB control number 1506-0053 for the Recordkeeping and travel rules requirements, respectively would be amended to reflect related burdens under the proposed rules.

    1. Description of Affected Financial Institutions

    Funding portals registered or required to be registered with the SEC.

    2. Estimated Number of Affected Financial Institutions

    According to the SEC, as of 2014, there are approximately 200 U.S.-based crowdfunding portals in existence. Approximately 15% of these crowdfunding portals would participate in securities-based crowdfunding. The SEC estimates that the number of crowdfunding portals would grow at 60% per year over the next three years and that approximately 50 entities would register as funding portals annually.60

    60See 80 FR 71387, 71523 (Nov. 16, 2015).

    For purposes of this analysis it should be noted that the actual number of funding portals that would participate in securities-based crowdfunding transactions is uncertain, as the rules governing securities-based crowdfunding transactions through funding portals have only recently been passed. Based on registration information currently available, the SEC estimates that approximately 10 intermediaries that are currently registered with the SEC may choose to register as brokers to act as intermediaries for transactions made in reliance on section 4(a)(6). In addition, approximately 50 intermediaries per year that are registered as brokers with the SEC would choose to add to their service offerings by also becoming crowdfunding intermediaries or funding portals.

    3. Estimated Average Annual Burden Hours Per Affected Financial Institutions, Estimated Total Annual Burden

    As this is a new requirement, the estimated average burden associated with the recordkeeping requirement in this proposed rule is three hours for development of a written program. A one hour per year burden is recognized for annual maintenance and update. FinCEN believes funding portals would establish policies and procedures to achieve compliance with the BSA requirements at the same time as it is establishing policies and procedures to comply with the JOBS Act. This would reduce the overall burden on funding portals as all issues concerning the establishment of policies and procedures could be addressed simultaneously. Nevertheless, the proposed rules would not impose any additional burden on funding portals to those currently imposed on brokers or dealers. Therefore, the burden on funding portals would be the same as the existing burden for broker-dealers, and would be included within those estimates FinCEN provided to OMB for brokers or dealers.

    List of Subjects in 31 CFR Parts 1010 and 1023

    Authority delegations (Government agencies), Banks and banking, Currency, Investigations, Law enforcement, Reporting and recordkeeping requirements.

    Authority and Issuance

    For the reasons set forth in the preamble, parts 1010 and 1023 of Chapter X of title 31 of the Code of Federal Regulations are proposed to be amended as follows:

    PART 1010—GENERAL PROVISIONS 1. The authority citation for part 1010 continues to read as follows: Authority:

    12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316-5332; title III, section 314, Pub. L. 107-56, 115 Stat. 307.

    2. Amend § 1010.100 by revising paragraph (h) to read as follows:
    § 1010.100 General definitions.

    (h) Broker or dealer in securities. A broker or dealer in securities means:

    (1) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.), except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934 (15 U.S.C. 78o(b)(11)); or

    (2) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6));

    3. Amend § 1010.605 by revising paragraphs (e)(1)(viii) and (e)(2)(viii) to read as follows:
    § 1010.605 Definitions.

    (e) * * *

    (1) * * *

    (viii) A broker or dealer in securities means:

    (A) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.), except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934 (15 U.S.C. 78o(b)(11)); or

    (B) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6));

    (2) * * *

    (viii) A broker or dealer in securities means:

    (A) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.), except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934 (15 U.S.C. 78o(b)(11)); or

    (B) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)).

    PART 1023—RULES FOR BROKERS OR DEALERS IN SECURITIES 4. The authority citation for part 1023 continues to read as follows: Authority:

    12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316-5332; title III, section 314, Pub. L. 107-56, 115 Stat. 307.

    5. Amend § 1023.100 by revising paragraph (b) to read as follows:
    § 1023.100 Definitions.

    (b) Broker or dealer in securities or broker-dealer means:

    (1) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.), except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934 (15 U.S.C. 78o(b)(11)); or

    (2) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)).

    Jennifer Shasky Calvery, Director, Financial Crimes Enforcement Network.
    [FR Doc. 2016-07345 Filed 4-1-16; 8:45 am] BILLING CODE 4810-02-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2014-1057] RIN 1625-AA09 Drawbridge Operation Regulation; Norwalk River, Norwalk, CT AGENCY:

    Coast Guard, DHS.

    ACTION:

    Supplemental Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to modify the operating schedule that governs the Metro-North WALK Bridge across the Norwalk River, mile 0.1, at Norwalk, Connecticut. The bridge owner submitted a request to require a greater advance notice for bridge openings and to increase time periods the bridge remains in the closed position during the weekday morning and evening rush hours. It is expected that this change to the regulations will create efficiency in drawbridge operations while continuing to meet the reasonable needs of navigation.

    DATES:

    Comments and related material must reach the Coast Guard on or before May 4, 2016.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2014-1057 using Federal eRulemaking Portal at http://www.regulations.gov.

    See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this supplemental proposed rule, call or email Mr. Chris Bisignano, Project officer, First Coast Guard District, telephone 212-514-4331, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive order FR Federal Register NPRM Notice of proposed rulemaking SNPRM Supplemental notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    On August 31, 2015, we published a notice of proposed rulemaking (NPRM) entitled, Drawbridge Operation Regulation; Norwalk River, Norwalk, CT, in the Federal Register (80 FR 52423), soliciting comments on the proposed rule through October 30, 2015. In addition, Commander (dpb), First Coast Guard District published Public Notice 1-149 dated September 21, 2015. We received four submissions on the proposed rule, which will be addressed in Section III, below.

    The Metro-North WALK Bridge, mile 0.1, across the Norwalk River at Norwalk, Connecticut, has a vertical clearance in the closed position of 16 feet at mean high water and 23 feet at mean low water. The drawbridge operation regulations are listed at 33 CFR 117.217(b). The waterway users are seasonal recreational vessels and commercial vessels of various sizes.

    The owner of the bridge, Connecticut Department of Transportation (CDOT), requested a change to the Drawbridge Operation Regulations because the volume of train traffic across the bridge during the peak commuting hours makes bridge openings impractical under the current schedule. As a result, bridge openings that occur during peak commuter train hours cause significant delays to commuter rail traffic.

    The NPRM published in August 2015 would have permanently changed the operating hours during the Monday-Friday, excluding holidays, timeframes to operate as follows:

    (1) The draw shall open on signal between 4:30 a.m. and 9 p.m. after at least a two hour advance notice is given; except that, from 4:30 a.m. through 9:30 a.m. and from 4 p.m. through 9 p.m., Monday through Friday excluding holidays, the draw need not open for the passage of vessel traffic unless an emergency exists.

    (2) From 9 p.m. through 4:30 a.m. the draw shall open on signal after at least a four hour advance notice is given.

    In response to the comments received and after further review of bridge logs and train schedules, the Coast Guard now proposes to modify the NPRM by adjusting when the draw will be available to open Monday through Friday, excluding holidays as follows:

    (1) The draw shall open on signal between 4:30 a.m. and 9 p.m. after at least a two hour advance notice is given; except that, from 5:45 a.m. through 9:45 a.m. and from 4 p.m. through 8 p.m., Monday through Friday excluding holidays, the draw need not open for the passage of vessel traffic unless an emergency exists.

    (2) From 9 p.m. through 4:30 a.m. the draw shall open on signal after at least a four hour advance notice is given.

    III. Discussion of Comments and Change

    We received four submissions commenting on the NPRM. Three submissions opposed and one submission supported the proposed changes. Some submissions commented on multiple aspects of the proposed regulation. The Coast Guard considered all comments and the responses from CDOT in creation of this supplemental alternative proposal.

    One comment suggested a meeting to deliberate the changes proposed in this rulemaking. The Coast Guard met with all parties that expressed interest in this rulemaking on May 11, 2015. The Coast Guard does not see a need to hold additional public meetings at this time.

    One comment requested that any modification to the existing rule should not be extended past the initiation of construction of a new replacement bridge. The Coast Guard disagrees. A replacement bridge is only in the planning stage at CDOT. Design and construction of a replacement project for a bridge of this scale typically takes several years. As the timeline of a potential bridge replacement is uncertain, the Coast Guard cannot consider it within this rulemaking.

    One comment suggested that any change in the operating regulations for the Metro-North WALK bridge should take into consideration the operating rule of the downstream SR136 (Washington Street) Bridge to facilitate the movement of waterborne commerce. The Coast Guard agrees that the operating schedule of the SR136 Bridge is relevant and considered the operating schedule for SR136 when drafting this supplemental rulemaking.

    One comment recommended that the Coast Guard consider revising the 4:30 a.m. to 9:30 a.m. opening schedule, Monday through Friday, as only two trains cross the bridge from 9 a.m. to 9:30 a.m. In response to this comment, the Coast Guard expanded its analysis of train traffic densities; this analysis contributed to the adjustments made in this supplemental rule compared to the proposed rule. These adjustments shorten from five to four hours the a.m. and p.m. periods provided for in the “except that” language in paragraph (b)(1) of the regulation, but also shifts the a.m. period to end later in the day.

    Two commenters noted that the added restrictions to opening times of the bridge would negatively impact aggregate deliveries and require alternative deliveries by truck, thereby stressing the road system in the area. Even under the more restrictive test deviation conducted from January 1, 2015, to June 28, 2015, as discussed in the NPRM, Metro-North was able to accommodate all of the requests for bridge openings. Further, review of the bridge logs revealed that in 2014, prior to the aforementioned test deviation and NPRM, as compared to 2015 during the test deviation and the NPRM, the difference in the number of requested bridge openings was negligible. The Coast Guard also reviewed tidal data for this area in consideration of the types of commercial traffic known to use this waterway. The combination of these factors contributed to the adjustments made in this supplemental rule compared to the proposed rule.

    The Coast Guard believes the supplemental changes balance the needs of rail and vessel traffic. The proposed changes enhance rail traffic without significantly affecting vessel traffic.

    In review of the proposed rule and stakeholder comments, the Coast Guard noted that the term “emergency,” as used within the existing and proposed regulation, was not specifically discussed. The term and associated required actions by the bridge owner are as defined within 33 CFR 117.31. This proposed rule makes no changes to regulations under that section. However, the Coast Guard notes that there may be instances in which emergent conditions beyond those explicitly listed therein could merit a special opening of the bridge for draft constrained vessels when tides and the bridge schedule interfere. For example, if the inventory of seasonally critical home heating oil or road salt at a facility upstream of the bridge that serves as the primary supply within the local area is or will soon be exhausted, and a commercial vessel transit to replenish inventory must occur during an allowed-closed period of the bridge, this condition may also reasonably be expected to require a special opening of the bridge to support public safety. In such cases, the Coast Guard expects that the bridge owner, and involved local municipality or commercial entity can make special arrangements as needed.

    IV. Discussion of Proposed Rule

    Based on further review of bridge logs and scheduled train crossings, the Coast Guard now proposes to modify the NPRM, specifically changing the “except that” language in paragraph (b)(1) of the regulation as indicated above in Section II. This slight modification would better serve the freedom of navigation without significantly impacted rail traffic.

    V. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders and discuss First Amendment rights of protestors.

    1. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the proposed rule has not been reviewed by the Office of Management and Budget.

    This regulatory action determination is based on the fact that vessels can still transit the bridge given advanced notice. The vertical clearance under the bridge in the closed position is relatively high enough to accommodate most vessel traffic during the time periods the draw is closed during the morning and evening commuter rush hours.

    2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    3. Collection of Information

    This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

    4. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

    Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

    5. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.

    6. Environment

    We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This proposed rule simply promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.

    Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    7. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

    VI. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:

    PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: Authority:

    33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.

    2. In § 117.217, revise paragraph (b) to read as follows:
    § 117.217 Norwalk River.

    (b) The draw of the Metro-North “WALK” Bridge, mile 0.1, at Norwalk, shall operate as follows:

    (1) The draw shall open on signal between 4:30 a.m. and 9 p.m. after at least a two hour advance notice is given; except that, from 5:45 a.m. through 9:45 a.m. and from 4 p.m. through 8 p.m., Monday through Friday excluding holidays, the draw need not open for the passage of vessel traffic unless an emergency exists.

    (2) From 9 p.m. through 4:30 a.m. the draw shall open on signal after at least a four hour advance notice is given.

    (3) A delay in opening the draw not to exceed 10 minutes may occur when a train scheduled to cross the bridge without stopping has entered the drawbridge lock.

    (4) Requests for bridge openings may be made by calling the bridge via marine radio VHF FM Channel 13 or the telephone number posted at the bridge.

    Dated: March 24, 2016. L.L. Fagan, Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
    [FR Doc. 2016-07662 Filed 4-1-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2016-0026] RIN 1625-AA00 Safety Zone, Block Island Wind Farm; Rhode Island Sound, RI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Proposed rule; reopening of comment period.

    SUMMARY:

    The Coast Guard is extending the comment period for the proposed safety zone. In response to public requests, the Coast Guard is extending the comment period until April 17, 2016.

    DATES:

    The comment period for the proposed rule published in the Federal Register on February 16, 2016 (81 FR 7718) is reopened. Comments must be received on or before April 17, 2016.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0026 using the Federal e-Rulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this rule, call or email Mr. Edward G. LeBlanc, Chief of the Waterways Management Division at Coast Guard Sector Southeastern New England, telephone 401-435-2351, email [email protected]

    SUPPLEMENTARY INFORMATION:

    On February 16, 2016, the Coast Guard published the proposed rule “Safety Zone, Block Island Wind Farm” in the Federal Register (81 FR 7718). The Coast Guard proposes to establish a 500-yard safety zone around each of five locations where the Block Island Wind Farm (BIWF) wind turbine generator (WTG) towers, nacelles, blades and subsea cables will be installed in the navigable waters of the Rhode Island Sound, RI, from April 1 to October 31, 2016. These safety zones are intended to safeguard mariners from the hazards associated with construction of the BIWF. Vessels would be prohibited from entering into, transiting through, mooring, or anchoring within these safety zones while construction vessels and associated equipment are present at any of the BIWF WTG sites, unless authorized by the Captain of the Port (COTP), Southeastern New England or the COTP's designated representative.

    The original deadline to submit comments was March 17, 2016. This action extends the deadline for 30 days. Written comments must now be received by April 17, 2016.

    Dated: March 22, 2016. J.T. Kondratowicz, Captain, U.S. Coast Guard, Captain of the Port Southeastern New England.
    [FR Doc. 2016-07659 Filed 4-1-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2015-0189; FRL-9944-42-Region 6] Promulgation of Implementation Plans; Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation Plan; Reopening of Comment Period and Notice of Availability AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule; reopening of comment period; availability of supplemental information.

    SUMMARY:

    The Environmental Protection Agency (EPA) is reopening the comment period for a proposed rule to establish a Clean Air Act (CAA) Federal Implementation Plan (FIP) to address regional haze and visibility transport requirements for the State of Arkansas. The reopening of the comment period is strictly limited to EPA's calculations of revised RPGs for Arkansas' Class I areas, which are presented in a supporting document being made available at this time in the docket. EPA is reopening the public comment period until May 4, 2016.

    DATES:

    The comment period for the proposed rule published on April 8, 2015 (80 FR 18944), extended at 80 FR 24872 (July 15, 2015), and reopened at 80 FR 43661 (July 23, 2015), is again reopened. Written comments must be received on or before May 4, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket No. EPA-R06-OAR-2015-0189, at http://www.regulations.gov or via email to [email protected] Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact Dayana Medina, 214-665-7241, [email protected] For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available at either location (e.g., CBI).

    FOR FURTHER INFORMATION CONTACT:

    Dayana Medina, (214) 665-7241; [email protected] To inspect the hard copy materials, please schedule an appointment with Dayana Medina or Mr. Bill Deese at 214-665-7253.

    SUPPLEMENTARY INFORMATION:

    On April 8, 2015, we published in the Federal Register a proposal to establish a FIP for the State of Arkansas addressing regional haze and visibility transport (80 FR 18944). The proposed FIP includes emission limits for sources in Arkansas. Comments on the proposed rule were required to be received by May 16, 2015. On May 1, 2015, we extended the comment period to July 15, 2015 (80 FR 24872). On July 23, 2015, we reopened the comment period until August 7, 2015 (80 FR 43661), in response to a request we received for an extension of the comment period.

    We are announcing the availability in the docket of supplemental information we relied on in our Arkansas FIP proposal, but which was inadvertently omitted from the docket at the time we proposed the FIP. In our proposed rule published on April 8, 2015, we proposed revised RPGs for the 20% worst days for Arkansas' Class I areas, the Caney Creek and Upper Buffalo Wilderness Areas (80 FR at 18998). Our revised RPGs and our methodology for calculating the revised RPGs were discussed in detail in our proposal and in our technical support documentation,1 which was made available in the docket when the proposed rule was published on April 8, 2015. However, a spreadsheet containing the actual calculations of our revised RPGs was inadvertently omitted from the docket. Therefore, the reopening of the comment period is strictly limited to our calculations of the revised RPGs, as presented in the spreadsheet we are making available at this time in the docket. The reopening of the comment period does not apply to our general methodology for calculating the revised RPGs, to the numerical values of the revised RPGs, or to any other aspects or portions of our proposed rule, for which we have previously provided opportunity for public comment. This action will allow interested persons time to prepare and submit comments on our calculations of the revised RPGs, as presented in the spreadsheet that we are making available in the docket at this time.

    1 See “Technical Support Document for EPA's Proposed Action on the Arkansas Regional Haze Federal Implementation Plan” at page 147.

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Best available control technology, Incorporation by reference, Intergovernmental relations, Interstate transport of pollution, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping, requirements, Sulfur dioxides, Regional haze, Visibility.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: March 23, 2016. Lisa Price, Acting Director, Multimedia Planning and Permitting Division, Region 6.
    [FR Doc. 2016-07486 Filed 4-1-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2014-0426; FRL-9944-52-Region 4] Approval and Promulgation of Implementation Plans; Kentucky; Infrastructure Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve portions of the State Implementation Plan (SIP) submission, submitted by the Commonwealth of Kentucky, Energy and Environment Cabinet, Department for Environmental Protection, through the Kentucky Division for Air Quality (KDAQ), on April 26, 2013, to demonstrate that the Commonwealth meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour sulfur dioxide (SO2) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure” SIP. KDAQ certified that the Kentucky SIP contains provisions that ensure the 2010 1-hour SO2 NAAQS is implemented, enforced, and maintained in Kentucky. EPA is proposing to determine that Kentucky's infrastructure submission, submitted on April 26, 2013, addresses certain infrastructure elements for the 2010 1-hour SO2 NAAQS.

    DATES:

    Written comments must be received on or before May 4, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2014-0426 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michele Notarianni, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Notarianni can be reached via electronic mail at [email protected] or the telephone number (404) 562-9031.

    Table of Contents I. Background and Overview II. What elements are required under sections 110(a)(1) and (2)? III. What is EPA's approach to the review of infrastructure SIP submissions? IV. What is EPA's analysis of how Kentucky addressed the elements of sections 110(a)(1) and (2) “Infrastructure” provisions? V. Proposed Action VI. Statutory and Executive Order Reviews I. Background and Overview

    On June 22, 2010 (75 FR 35520), EPA revised the primary SO2 NAAQS to an hourly standard at a level of 75 parts per billion (ppb), based on a 3-year average of the annual 99th percentile of 1-hour daily maximum concentrations. Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the applicable requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2010 1-hour SO2 NAAQS to EPA no later than June 2, 2013.1

    1 In these infrastructure SIP submissions states generally certify evidence of compliance with sections 110(a)(1) and (2) of the CAA through a combination of state regulations and statutes, some of which have been incorporated into the federally-approved SIP. In addition, certain federally-approved, non-SIP regulations may also be appropriate for demonstrating compliance with sections 110(a)(1) and (2). Throughout this rulemaking, unless otherwise indicated, the term “401 KAR XX:XXX” indicates that the cited regulation has either been approved, or submitted for approval into Kentucky's federally-approved SIP. The State statutes cited from the Kentucky Revised Statutes (also referred to as “KRS”) throughout this rulemaking are not approved into the Kentucky SIP, unless otherwise indicated.

    Today's action is proposing to approve Kentucky's infrastructure SIP submission for the applicable requirements of the 2010 1-hour SO2 NAAQS. With respect to the interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states and the visibility requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4), and the minor source program requirements of section 110(a)(2)(C), EPA is not proposing any action at this time regarding these requirements. For the aspects of Kentucky's submittal proposed for approval today, EPA notes that the Agency is not approving any specific rule, but rather proposing that Kentucky's already approved SIP meets certain CAA requirements.

    II. What elements are required under sections 110(a)(1) and (2)?

    Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains.

    More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As mentioned above, these requirements include basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. The requirements that are the subject of this proposed rulemaking are summarized below and in EPA's September 13, 2013, memorandum entitled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2).” 2

    2 Two elements identified in section 110(a)(2) are not governed by the three year submission deadline of section 110(a)(1) because SIPs incorporating necessary local nonattainment area controls are not due within three years after promulgation of a new or revised NAAQS, but rather due at the time the nonattainment area plan requirements are due pursuant to section 172. These requirements are: (1) Submissions required by section 110(a)(2)(C) to the extent that subsection refers to a permit program as required in part D, title I of the CAA; and (2) submissions required by section 110(a)(2)(I) which pertain to the nonattainment planning requirements of part D, title I of the CAA. Today's proposed rulemaking does not address infrastructure elements related to section 110(a)(2)(I) or the nonattainment planning requirements of 110(a)(2)(C).

    • 110(a)(2)(A): Emission Limits and Other Control Measures • 110(a)(2)(B): Ambient Air Quality Monitoring/Data System • 110(a)(2)(C): Programs for Enforcement of Control Measures and for Construction or Modification of Stationary Sources 3

    3 This rulemaking only addresses requirements for this element as they relate to attainment areas.

    • 110(a)(2)(D)(i)(I) and (II): Interstate Pollution Transport • 110(a)(2)(D)(ii): Interstate Pollution Abatement and International Air Pollution • 110(a)(2)(E): Adequate Resources and Authority, Conflict of Interest, and Oversight of Local Governments and Regional Agencies • 110(a)(2)(F): Stationary Source Monitoring and Reporting • 110(a)(2)(G): Emergency Powers • 110(a)(2)(H): SIP Revisions • 110(a)(2)(I): Plan Revisions for Nonattainment Areas 4

    4 As mentioned above, this element is not relevant to today's proposed rulemaking.

    • 110(a)(2)(J): Consultation with Government Officials, Public Notification, and Prevention of Significant Deterioration (PSD) and Visibility Protection • 110(a)(2)(K): Air Quality Modeling and Submission of Modeling Data • 110(a)(2)(L): Permitting fees • 110(a)(2)(M): Consultation and Participation by Affected Local Entities III. What is EPA's approach to the review of infrastructure SIP submissions?

    EPA is acting upon the SIP submission from Kentucky that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2010 1-hour SO2 NAAQS. The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.

    EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review (NNSR) permit program submissions to address the permit requirements of CAA, title I, part D.

    Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions, and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.5 EPA therefore believes that while the timing requirement in section 110(a)(1) is unambiguous, some of the other statutory provisions are ambiguous. In particular, EPA believes that the list of required elements for infrastructure SIP submissions provided in section 110(a)(2) contains ambiguities concerning what is required for inclusion in an infrastructure SIP submission.

    5 For example: Section 110(a)(2)(E)(i) provides that states must provide assurances that they have adequate legal authority under state and local law to carry out the SIP; section 110(a)(2)(C) provides that states must have a SIP-approved program to address certain sources as required by part C of title I of the CAA; and section 110(a)(2)(G) provides that states must have legal authority to address emergencies as well as contingency plans that are triggered in the event of such emergencies.

    The following examples of ambiguities illustrate the need for EPA to interpret some section 110(a)(1) and section 110(a)(2) requirements with respect to infrastructure SIP submissions for a given new or revised NAAQS. One example of ambiguity is that section 110(a)(2) requires that “each” SIP submission must meet the list of requirements therein, while EPA has long noted that this literal reading of the statute is internally inconsistent and would create a conflict with the nonattainment provisions in part D of title I of the Act, which specifically address nonattainment SIP requirements.6 Section 110(a)(2)(I) pertains to nonattainment SIP requirements and part D addresses when attainment plan SIP submissions to address nonattainment area requirements are due. For example, section 172(b) requires EPA to establish a schedule for submission of such plans for certain pollutants when the Administrator promulgates the designation of an area as nonattainment, and section 107(d)(1)(B) allows up to two years, or in some cases three years, for such designations to be promulgated.7 This ambiguity illustrates that rather than apply all the stated requirements of section 110(a)(2) in a strict literal sense, EPA must determine which provisions of section 110(a)(2) are applicable for a particular infrastructure SIP submission.

    6 See, e.g., “Rule To Reduce Interstate Transport of Fine Particulate Matter and Ozone (Clean Air Interstate Rule); Revisions to Acid Rain Program; Revisions to the NOX SIP Call; Final Rule,” 70 FR 25162, at 25163-65 (May 12, 2005) (explaining relationship between timing requirement of section 110(a)(2)(D) versus section 110(a)(2)(I)).

    7 EPA notes that this ambiguity within section 110(a)(2) is heightened by the fact that various subparts of part D set specific dates for submission of certain types of SIP submissions in designated nonattainment areas for various pollutants. Note, e.g., that section 182(a)(1) provides specific dates for submission of emissions inventories for the ozone NAAQS. Some of these specific dates are necessarily later than three years after promulgation of the new or revised NAAQS.

    Another example of ambiguity within sections 110(a)(1) and 110(a)(2) with respect to infrastructure SIPs pertains to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action.8 Similarly, EPA interprets the CAA to allow it to take action on the individual parts of one larger, comprehensive infrastructure SIP submission for a given NAAQS without concurrent action on the entire submission. For example, EPA has sometimes elected to act at different times on various elements and sub-elements of the same infrastructure SIP submission.9

    8 See, e.g., “Approval and Promulgation of Implementation Plans; New Mexico; Revisions to the New Source Review (NSR) State Implementation Plan (SIP); Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR) Permitting,” 78 FR 4339 (January 22, 2013) (EPA's final action approving the structural PSD elements of the New Mexico SIP submitted by the State separately to meet the requirements of EPA's 2008 PM2.5 NSR rule), and “Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Infrastructure and Interstate Transport Requirements for the 2006 PM2.5 NAAQS,” (78 FR 4337) (January 22, 2013) (EPA's final action on the infrastructure SIP for the 2006 PM2.5 NAAQS).

    9 On December 14, 2007, the State of Tennessee, through the Tennessee Department of Environment and Conservation, made a SIP revision to EPA demonstrating that the State meets the requirements of sections 110(a)(1) and (2). EPA proposed action for infrastructure SIP elements (C) and (J) on January 23, 2012 (77 FR 3213) and took final action on March 14, 2012 (77 FR 14976). On April 16, 2012 (77 FR 22533) and July 23, 2012 (77 FR 42997), EPA took separate proposed and final actions on all other section 110(a)(2) infrastructure SIP elements of Tennessee's December 14, 2007, submittal.

    Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise with respect to infrastructure SIP submission requirements for different NAAQS. Thus, EPA notes that not every element of section 110(a)(2) would be relevant, or as relevant, or relevant in the same way, for each new or revised NAAQS. The states' attendant infrastructure SIP submissions for each NAAQS therefore could be different. For example, the monitoring requirements that a state might need to meet in its infrastructure SIP submission for purposes of section 110(a)(2)(B) could be very different for different pollutants because the content and scope of a state's infrastructure SIP submission to meet this element might be very different for an entirely new NAAQS than for a minor revision to an existing NAAQS.10

    10 For example, implementation of the 1997 PM2.5 NAAQS required the deployment of a system of new monitors to measure ambient levels of that new indicator species for the new NAAQS.

    EPA notes that interpretation of section 110(a)(2) is also necessary when EPA reviews other types of SIP submissions required under the CAA. Therefore, as with infrastructure SIP submissions, EPA also has to identify and interpret the relevant elements of section 110(a)(2) that logically apply to these other types of SIP submissions. For example, section 172(c)(7) requires that attainment plan SIP submissions required by part D have to meet the “applicable requirements” of section 110(a)(2). Thus, for example, attainment plan SIP submissions must meet the requirements of section 110(a)(2)(A) regarding enforceable emission limits and control measures and section 110(a)(2)(E)(i) regarding air agency resources and authority. By contrast, it is clear that attainment plan SIP submissions required by part D would not need to meet the portion of section 110(a)(2)(C) that pertains to the PSD program required in part C of title I of the CAA, because PSD does not apply to a pollutant for which an area is designated nonattainment and thus subject to part D planning requirements. As this example illustrates, each type of SIP submission may implicate some elements of section 110(a)(2) but not others.

    Given the potential for ambiguity in some of the statutory language of section 110(a)(1) and section 110(a)(2), EPA believes that it is appropriate to interpret the ambiguous portions of section 110(a)(1) and section 110(a)(2) in the context of acting on a particular SIP submission. In other words, EPA assumes that Congress could not have intended that each and every SIP submission, regardless of the NAAQS in question or the history of SIP development for the relevant pollutant, would meet each of the requirements, or meet each of them in the same way. Therefore, EPA has adopted an approach under which it reviews infrastructure SIP submissions against the list of elements in section 110(a)(2), but only to the extent each element applies for that particular NAAQS.

    Historically, EPA has elected to use guidance documents to make recommendations to states for infrastructure SIPs, in some cases conveying needed interpretations on newly arising issues and in some cases conveying interpretations that have already been developed and applied to individual SIP submissions for particular elements.11 EPA most recently issued guidance for infrastructure SIPs on September 13, 2013 (2013 Guidance).12 EPA developed this document to provide states with up-to-date guidance for infrastructure SIPs for any new or revised NAAQS. Within this guidance, EPA describes the duty of states to make infrastructure SIP submissions to meet basic structural SIP requirements within three years of promulgation of a new or revised NAAQS. EPA also made recommendations about many specific subsections of section 110(a)(2) that are relevant in the context of infrastructure SIP submissions.13 The guidance also discusses the substantively important issues that are germane to certain subsections of section 110(a)(2). Significantly, EPA interprets sections 110(a)(1) and 110(a)(2) such that infrastructure SIP submissions need to address certain issues and need not address others. Accordingly, EPA reviews each infrastructure SIP submission for compliance with the applicable statutory provisions of section 110(a)(2), as appropriate.

    11 EPA notes, however, that nothing in the CAA requires EPA to provide guidance or to promulgate regulations for infrastructure SIP submissions. The CAA directly applies to states and requires the submission of infrastructure SIP submissions, regardless of whether or not EPA provides guidance or regulations pertaining to such submissions. EPA elects to issue such guidance in order to assist states, as appropriate.

    12 “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act sections 110(a)(1) and 110(a)(2),” Memorandum from Stephen D. Page, September 13, 2013.

    13 EPA's September 13, 2013, guidance did not make recommendations with respect to infrastructure SIP submissions to address section 110(a)(2)(D)(i)(I). EPA issued the guidance shortly after the U.S. Supreme Court agreed to review the D.C. Circuit decision in EME Homer City, 696 F.3d7 (D.C. Cir. 2012) which had interpreted the requirements of section 110(a)(2)(D)(i)(I). In light of the uncertainty created by ongoing litigation, EPA elected not to provide additional guidance on the requirements of section 110(a)(2)(D)(i)(I) at that time. As the guidance is neither binding nor required by statute, whether EPA elects to provide guidance on a particular section has no impact on a state's CAA obligations.

    As an example, section 110(a)(2)(E)(ii) is a required element of section 110(a)(2) for infrastructure SIP submissions. Under this element, a state must meet the substantive requirements of section 128, which pertain to state boards that approve permits or enforcement orders and heads of executive agencies with similar powers. Thus, EPA reviews infrastructure SIP submissions to ensure that the state's implementation plan appropriately addresses the requirements of section 110(a)(2)(E)(ii) and section 128. The 2013 Guidance explains EPA's interpretation that there may be a variety of ways by which states can appropriately address these substantive statutory requirements, depending on the structure of an individual state's permitting or enforcement program (e.g., whether permits and enforcement orders are approved by a multi-member board or by a head of an executive agency). However they are addressed by the state, the substantive requirements of section 128 are necessarily included in EPA's evaluation of infrastructure SIP submissions because section 110(a)(2)(E)(ii) explicitly requires that the state satisfy the provisions of section 128.

    As another example, EPA's review of infrastructure SIP submissions with respect to the PSD program requirements in sections 110(a)(2)(C), (D)(i)(II), and (J) focuses upon the structural PSD program requirements contained in part C and EPA's PSD regulations. Structural PSD program requirements include provisions necessary for the PSD program to address all regulated sources and new source review (NSR) pollutants, including greenhouse gases (GHGs). By contrast, structural PSD program requirements do not include provisions that are not required under EPA's regulations at 40 CFR 51.166 but are merely available as an option for the state, such as the option to provide grandfathering of complete permit applications with respect to the 2012 fine particulate matter (PM2.5) NAAQS. Accordingly, the latter optional provisions are types of provisions EPA considers irrelevant in the context of an infrastructure SIP action.

    For other section 110(a)(2) elements, however, EPA's review of a state's infrastructure SIP submission focuses on assuring that the state's SIP meets basic structural requirements. For example, section 110(a)(2)(C) includes, among other things, the requirement that states have a program to regulate minor new sources. Thus, EPA evaluates whether the state has an EPA-approved minor NSR program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (i.e., already in the existing SIP) for compliance with the requirements of the CAA and EPA's regulations that pertain to such programs.

    With respect to certain other issues, EPA does not believe that an action on a state's infrastructure SIP submission is necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP. These issues include: (i) Existing provisions related to excess emissions from sources during periods of startup, shutdown, or malfunction that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (ii) existing provisions related to “director's variance” or “director's discretion” that may be contrary to the CAA because they purport to allow revisions to SIP-approved emissions limits while limiting public process or not requiring further approval by EPA; and (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Thus, EPA believes it may approve an infrastructure SIP submission without scrutinizing the totality of the existing SIP for such potentially deficient provisions and may approve the submission even if it is aware of such existing provisions.14 It is important to note that EPA's approval of a state's infrastructure SIP submission should not be construed as explicit or implicit re-approval of any existing potentially deficient provisions that relate to the three specific issues just described.

    14 By contrast, EPA notes that if a state were to include a new provision in an infrastructure SIP submission that contained a legal deficiency, such as a new exemption for excess emissions during SSM events, then EPA would need to evaluate that provision for compliance against the rubric of applicable CAA requirements in the context of the action on the infrastructure SIP.

    EPA's approach to review of infrastructure SIP submissions is to identify the CAA requirements that are logically applicable to that submission. EPA believes that this approach to the review of a particular infrastructure SIP submission is appropriate, because it would not be reasonable to read the general requirements of section 110(a)(1) and the list of elements in 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. Because SIPs have grown by accretion over the decades as statutory and regulatory requirements under the CAA have evolved, they may include some outmoded provisions and historical artifacts. These provisions, while not fully up to date, nevertheless may not pose a significant problem for the purposes of “implementation, maintenance, and enforcement” of a new or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP submission. EPA believes that a better approach is for states and EPA to focus attention on those elements of section 110(a)(2) of the CAA most likely to warrant a specific SIP revision due to the promulgation of a new or revised NAAQS or other factors.

    For example, EPA's 2013 Guidance gives simpler recommendations with respect to carbon monoxide than other NAAQS pollutants to meet the visibility requirements of section 110(a)(2)(D)(i)(II), because carbon monoxide does not affect visibility. As a result, an infrastructure SIP submission for any future new or revised NAAQS for carbon monoxide need only state this fact in order to address the visibility prong of section 110(a)(2)(D)(i)(II).

    Finally, EPA believes that its approach with respect to infrastructure SIP requirements is based on a reasonable reading of sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues and mechanisms to address specific substantive deficiencies in existing SIPs. These other statutory tools allow EPA to take appropriately tailored action, depending upon the nature and severity of the alleged SIP deficiency. Section 110(k)(5) authorizes EPA to issue a “SIP call” whenever the Agency determines that a state's SIP is substantially inadequate to attain or maintain the NAAQS, to mitigate interstate transport, or to otherwise comply with the CAA.15 Section 110(k)(6) authorizes EPA to correct errors in past actions, such as past approvals of SIP submissions.16 Significantly, EPA's determination that an action on a state's infrastructure SIP submission is not the appropriate time and place to address all potential existing SIP deficiencies does not preclude EPA's subsequent reliance on provisions in section 110(a)(2) as part of the basis for action to correct those deficiencies at a later time. For example, although it may not be appropriate to require a state to eliminate all existing inappropriate director's discretion provisions in the course of acting on an infrastructure SIP submission, EPA believes that section 110(a)(2)(A) may be among the statutory bases that EPA relies upon in the course of addressing such deficiency in a subsequent action.17

    15 For example, EPA issued a SIP call to Utah to address specific existing SIP deficiencies related to the treatment of excess emissions during SSM events. See “Finding of Substantial Inadequacy of Implementation Plan; Call for Utah State Implementation Plan Revisions,” 74 FR 21639 (April 18, 2011).

    16 EPA has used this authority to correct errors in past actions on SIP submissions related to PSD programs. See “Limitation of Approval of Prevention of Significant Deterioration Provisions Concerning Greenhouse Gas Emitting-Sources in State Implementation Plans; Final Rule,” 75 FR 82536 (December 30, 2010). EPA has previously used its authority under CAA section 110(k)(6) to remove numerous other SIP provisions that the Agency determined it had approved in error. See, e.g., 61 FR 38664 (July 25, 1996) and 62 FR 34641 (June 27, 1997) (corrections to American Samoa, Arizona, California, Hawaii, and Nevada SIPs); 69 FR 67062 (November 16, 2004) (corrections to California SIP); and 74 FR 57051 (November 3, 2009) (corrections to Arizona and Nevada SIPs).

    17 See, e.g., EPA's disapproval of a SIP submission from Colorado on the grounds that it would have included a director's discretion provision inconsistent with CAA requirements, including section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344 (July 21, 2010) (proposed disapproval of director's discretion provisions); 76 FR 4540 (Jan. 26, 2011) (final disapproval of such provisions).

    IV. What is EPA's analysis of how Kentucky addressed the elements of the sections 110(a)(1) and (2) “Infrastructure” provisions?

    Kentucky's April 26, 2013, infrastructure submission addresses the provisions of sections 110(a)(1) and (2) as described below.

    1. 110(a)(2)(A) Emission Limits and Other Control Measures: Section 110(a)(2)(A) requires that each implementation plan include enforceable emission limitations and other control measures, means, or techniques (including economic incentives such as fees, marketable permits, and auctions of emissions rights), as well as schedules and timetables for compliance, as may be necessary or appropriate to meet the applicable requirements. These requirements are met through Kentucky Revised Statute (KRS) Chapter 224 Section 10-100 (KRS 224.10-100), which provides the KDAQ the authority to administer all rules, regulations, and orders promulgated under Chapter 224, and to provide for the prevention, abatement, and control of all water, land, and air pollution.

    KDAQ cited to chapters and associated Kentucky Administrative Regulations (KAR) under Title 401 to demonstrate that the Commonwealth meets the requirements of this element, including the following:

    • Chapter 50 General Administrative Procedures: 401 KAR 50:010. Definitions for 401 KAR Chapter 50; 401 KAR 50:012. General application; 401 KAR 50:015. Documents incorporated by reference; 401 KAR 50:020. Air quality control regions; 401 KAR 50:025. Classification of counties; 401 KAR 50:040. Air quality models; 401 KAR 50:042. Good engineering practice stack height; 401 KAR 50:045. Performance tests; 401 KAR 50:047. Test procedures for capture efficiency; 401 KAR 50:050. Monitoring; 401 KAR 50:055. General compliance requirements; and 401 KAR 50:060. Enforcement.

    • Chapter 51 Attainment and Maintenance of the National Ambient Air Quality Standards: 401 KAR 51:001. Definitions for 401 KAR Chapter 51; 401 KAR 51:005. Purpose and General Provisions; 401 KAR 51:010. Attainment Status Designations; 401 KAR 51:017. Prevention of significant deterioration of air quality; 401 KAR 51:052. Review of new sources in or impacting upon nonattainment areas.

    • Chapter 52 Permits, Registrations, and Prohibitory Rules: 401 KAR 52:001. Definitions for 401 KAR Chapter 52; 401 KAR 52:020. Title V permits; 18 401 KAR 52:030. Federally-enforceable permits for nonmajor sources; 401 KAR 52:090. Prohibitorv rule for hot mix asphalt plants; 401 KAR 53:005. General provisions; 401 KAR 53:010. Ambient air quality standards.

    18 This rule is not approved into Kentucky's federally-approved SIP.

    Collectively these regulations establish enforceable emissions limitations and other control measures, means or techniques, for activities that contribute to SO2 concentrations in the ambient air and provide authority for KDAQ to establish such limits and measures as well as schedules for compliance to meet the applicable requirements of the CAA. EPA has made the preliminary determination that the provisions contained in these regulations, and Kentucky's statute are adequate for enforceable emission limitations and other control measures, means, or techniques, as well as schedules and timetables for compliance for the 2010 1-hour SO2 NAAQS in the Commonwealth.

    In this action, EPA is not proposing to approve or disapprove any existing Commonwealth provisions with regard to excess emissions during SSM operations at a facility. EPA believes that a number of states have SSM provisions which are contrary to the CAA and existing EPA guidance, “State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown” (September 20, 1999), and the Agency is addressing such state regulations in a separate action.19

    19 On June 12, 2015, EPA published a final action entitled, “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown, and Malfunction.” See 80 FR 33840.

    Additionally, in this action, EPA is not proposing to approve or disapprove any existing state rules with regard to director's discretion or variance provisions. EPA believes that a number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to take action in the future to address such state regulations. In the meantime, EPA encourages any state having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.

    2. 110(a)(2)(B) Ambient Air Quality Monitoring/Data System: Section 110(a)(2)(B) requires SIPs to provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to (i) monitor, compile, and analyze data on ambient air quality, and (ii) upon request, make such data available to the Administrator. These requirements are met through KRS 224.10-100 (22), which provides KDAQ the authority to require the installation, maintenance, and use of equipment, devices, or tests and methodologies to monitor the nature and amount of any substance emitted into the ambient air and to provide the information to the cabinet.

    KDAQ cites the following regulations to demonstrate that the Commonwealth meets the requirements of this element: 401 KAR 50:050. Monitoring; 401 KAR 51:017. Prevention of significant deterioration of air quality; and 401 KAR 51:052. Review of new sources in or impacting upon nonattainment areas; 401 KAR 53:005. General provisions; 401 KAR 53:010. Ambient air quality standards.

    These SIP-approved rules and Kentucky's statute, along with Kentucky's Ambient Air Monitoring Network Plan, provide for the establishment and operation of ambient air quality monitors, the compilation and analysis of ambient air quality data, and the submission of these data to EPA upon request. Annually, states develop and submit to EPA for approval statewide ambient monitoring network plans consistent with the requirements of 40 CFR parts 50, 53, and 58. The annual network plan involves an evaluation of any proposed changes to the monitoring network, includes the annual ambient monitoring network design plan and a certified evaluation of the agency's ambient monitors and auxiliary support equipment.20 KDAQ's monitoring network plan was submitted on July 1, 2015, and approved by EPA on October 28, 2015. Kentucky's approved monitoring network plan can be accessed at www.regulations.gov using Docket ID No. EPA-R04-OAR-2014-0426. EPA has made the preliminary determination that Kentucky's SIP and practices are adequate for the ambient air quality monitoring and data system related to the 2010 1-hour SO2 NAAQS.

    20 On occasion, proposed changes to the monitoring network are evaluated outside of the network plan approval process in accordance with 40 CFR part 58.

    3. 110(a)(2)(C) Programs for Enforcement of Control Measures and for Construction or Modification of Stationary Sources: This element consists of three sub-elements: Enforcement, state-wide regulation of new and modified minor sources and minor modifications of major sources, and preconstruction permitting of major sources and major modifications in areas designated attainment or unclassifiable for the subject NAAQS as required by CAA title I part C (i.e., the major source PSD program). These requirements are met through 401 KAR 50:060. Enforcement; 401 KAR 51:017. Prevention of significant deterioration of air quality; and 401 KAR 51:052. Review of new sources in or impacting upon nonattainment areas. Collectively, these regulations enable KDAQ to regulate sources contributing to the 2010 1-hour SO2 NAAQS. EPA's analysis of how these provisions of Kentucky's SIP address each sub-element (with the exception of the minor source program requirements, as set forth below) is described below.

    Enforcement: KDAQ's SIP-approved regulation, 401 KAR 50:060. Enforcement, provides for enforcement of SO2 emission limits and control measures through permit and compliance schedule modifications and revocations, and authorizes administrative penalties and injunctive relief, citing to statutory civil penalty and injunctive relief provisions of KRS 224.99-010. EPA has made the preliminary determination that Kentucky's SIP is adequate for enforcement related to the 2010 1-hour SO2 NAAQS.

    PSD Permitting for Major Sources: EPA interprets the PSD sub-element to require that a state's infrastructure SIP submission for a particular NAAQS demonstrate that the state has a complete PSD permitting program in place covering the structural PSD requirements for all regulated NSR pollutants. A state's PSD permitting program is complete for this sub-element (and prong 3 of D(i) and J related to PSD) if EPA has already approved or is simultaneously approving the state's SIP with respect to all structural PSD requirements that are due under the EPA regulations or the CAA on or before the date of the EPA's proposed action on the infrastructure SIP submission. For the 2010 1-hour SO2 NAAQS, Kentucky's authority to regulate new and modified sources to assist in the protection of air quality in attainment or unclassifiable areas is established in KAR Chapter 51—Attainment and Maintenance of the National Ambient Air Quality Standards, which describes the permit requirements for new major sources or major modifications of existing sources in areas classified as attainment or unclassifiable under section 107(d)(1)(A)(ii) or (iii) of the CAA. These requirements are designed to ensure that sources in areas attaining the NAAQS at the time of designations prevent any significant deterioration in air quality. Chapter 51 also establishes the permitting requirements for areas in or around nonattainment areas and provides the Commonwealth's statutory authority to enforce regulations relating to attainment and maintenance of the NAAQS.

    Kentucky's infrastructure SIP submission demonstrates that new major sources and major modifications in areas of the Commonwealth designated attainment or unclassifiable for the specified NAAQS are subject to a federally-approved PSD permitting program meeting all the current structural requirements of part C of title I of the CAA to satisfy the infrastructure SIP PSD elements.21 EPA has made the preliminary determination that Kentucky's SIP is adequate for PSD permitting for major sources related to the 2010 1-hour SO2 NAAQS.

    21 For more information concerning how the Kentucky infrastructure SIP submission currently meets applicable structural PSD program requirements, see the technical support document in the docket for today's rulemaking.

    Regulation of minor sources and minor modifications: Section 110(a)(2)(C) also requires the SIP to include provisions that govern the minor source preconstruction program that regulates emissions of the 2010 1-hour SO2 NAAQS. EPA is not proposing any action in this rulemaking related to the regulation of minor sources and minor modifications under section 110(a)(2)(C) and will consider these requirements in relation to Kentucky's 2010 1-hour SO2 NAAQS infrastructure submission in a separate rulemaking.

    4. 110(a)(2)(D)(i)(I) and (II) Interstate Pollution Transport: Section 110(a)(2)(D)(i) has two components: 110(a)(2)(D)(i)(I) and 110(a)(2)(D)(i)(II). Each of these components has two subparts resulting in four distinct components, commonly referred to as “prongs,” that must be addressed in infrastructure SIP submissions. The first two prongs, which are codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (“prong 1”), and interfering with maintenance of the NAAQS in another state (“prong 2”). The third and fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality in another state (“prong 3”), or to protect visibility in another state (“prong 4”).

    110(a)(2)(D)(i)(I)—prongs 1 and 2: EPA is not proposing any action in this rulemaking related to the interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states of section 110(a)(2)(D)(i)(I) (prongs 1 and 2) because Kentucky's 2010 1-hour SO2 NAAQS infrastructure submission did not address prongs 1 and 2.

    110(a)(2)(D)(i)(II)—prong 3: With regard to section 110(a)(2)(D)(i)(II), the PSD element, referred to as prong 3, this requirement may be met by a state's confirmation in an infrastructure SIP submission that new major sources and major modifications in the state are subject to: A PSD program meeting all the current structural requirements of part C of title I of the CAA, or (if the state contains a nonattainment area that has the potential to impact PSD in another state) to a NNSR program. As discussed in more detail above under section 110(a)(2)(C), Kentucky's SIP contains the relevant SIP revisions necessary to satisfy the structural PSD requirements of prong 3. Kentucky's SIP-approved NNSR program is found at 401 KAR 51:052. Review of new sources in or impacting upon nonattainment areas. EPA has made the preliminary determination that Kentucky's SIP is adequate for interstate transport for permitting of major sources and major modifications related to the 2010 1-hour SO2 NAAQS for section 110(a)(2)(D)(i)(II) (prong 3).

    110(a)(2)(D)(i)(II)—prong 4: EPA is not proposing any action in this rulemaking related to the interstate transport provisions pertaining to visibility protection in other states of section 110(a)(2)(D)(i)(II) (prong 4) and will consider these requirements in relation to Kentucky's 2010 1-hour SO2 NAAQS infrastructure submission in a separate rulemaking.

    5. 110(a)(2)(D)(ii) Interstate and International Transport Provisions: Section 110(a)(2)(D)(ii) requires SIPs to include provisions ensuring compliance with sections 115 and 126 of the Act, relating to interstate and international pollution abatement. Regulation 401 KAR 51:010. Attainment Status Designations designates the status of all areas of the Commonwealth of Kentucky with regard to attainment of the NAAQS. Regulation 401 KAR 51:017. Prevention of significant deterioration of air quality and Regulation 401 KAR 51:052. Review of new sources in or impacting upon nonattainment areas, Section 1, require Kentucky to provide notice to nearby states that may be affected by proposed major source modifications. These regulations cite to Federal notification requirements under 40 CFR Sections 51.166 and 52.21, and to 401 KAR 52:100. Public, affected state, and US. EPA review, Section 6, which requires that public notice for permit actions be provided to affected states. Additionally, Kentucky does not have any pending obligation under sections 115 and 126 of the CAA. EPA has made the preliminary determination that Kentucky's SIP is adequate for ensuring compliance with the applicable requirements relating to interstate and international pollution abatement for the 2010 1-hour SO2 NAAQS.

    6. 110(a)(2)(E) Adequate Resources and Authority, Conflict of Interest, and Oversight of Local Governments and Regional Agencies: Section 110(a)(2)(E) requires that each implementation plan provide (i) necessary assurances that the state will have adequate personnel, funding, and authority under state law to carry out its implementation plan, (ii) that the state comply with the requirements respecting state boards pursuant to section 128 of the Act, and (iii) necessary assurances that, where the state has relied on a local or regional government, agency, or instrumentality for the implementation of any plan provision, the state has responsibility for ensuring adequate implementation of such plan provisions. EPA is proposing to approve Kentucky's SIP submission as meeting the requirements of sub-elements 110(a)(2)(E)(i), (ii), and (iii).

    In support of EPA's proposal to approve elements 110(a)(2)(E)(i) and (iii), KDAQ's infrastructure submission demonstrates that it is responsible for promulgating rules and regulations for the NAAQS, emissions standards, general policies, a system of permits, fee schedules for the review of plans, and other planning needs. With respect to having the necessary funding and authority to implement the Kentucky SIP, Kentucky regulation, 401 KAR 50:038. Air Emissions Fee, and the following State statutes support sub-elements (i) and (iii): KRS 224.10-100. Powers and Duties of the Cabinet and KRS 224.10-020. Departments within the cabinet—Offices and divisions within the departments—Appointments. As evidence of the adequacy of KDAQ's resources with respect to sub-elements (i) and (iii), EPA submitted a letter to KDAQ on March 12, 2015, outlining 105 grant commitments and current status of these commitments for fiscal year 2014. The letter EPA submitted to KDAQ can be accessed at www.regulations.gov using Docket ID No. EPA-R04-OAR-2014-0426. Annually, states update these grant commitments based on current SIP requirements, air quality planning, and applicable requirements related to the NAAQS. There were no outstanding issues in relation to the SIP for fiscal year 2014, therefore, KDAQ's grants were finalized and closed out. In addition, the requirements of 110(a)(2)(E)(i) and (iii) are met when EPA performs a completeness determination for each SIP submittal. This determination ensures that each submittal provides evidence that adequate personnel, funding, and legal authority under state law has been used to carry out the state's implementation plan and related issues. KDAQ's authority is included in all prehearings and final SIP submittal packages for approval by EPA. EPA has made the preliminary determination that Kentucky has adequate resources for implementation of the 2010 1-hour SO2 NAAQS. Accordingly, EPA is proposing to approve Kentucky's infrastructure SIP submission with respect to section 110(a)(2)(E)(i) and (iii).

    Section 110(a)(2)(E)(ii) requires that Kentucky comply with section 128 of the CAA. Section 128 requires at 128(a)(1) the majority of members of the state board or body which approves permits or enforcement orders represent the public interest and do not derive any significant portion of their income from persons subject to permitting or enforcement orders under the CAA; and 128(a)(2) any potential conflicts of interest by such board or body, or the head of an executive agency with similar, powers be adequately disclosed. For purposes of section 128(a)(1), Kentucky has no boards or bodies with authority over air pollution permits or enforcement actions. Such matters are instead handled by the Director of the KDAQ. As such, a “board or body” is not responsible for approving permits or enforcement orders in Kentucky, and the requirements of section 128(a)(1) are not applicable. For purposes of section 128(a)(2), KDAQ's SIP has been updated. On October 3, 2012, EPA took final action to approve incorporation of KRS Chapters 11A.020, 11A.030, 11A.040 and Chapters 224.10-020 and 224.10-100 into the SIP to address the conflict of interest requirements of section 128. See 77 FR 60307. These SIP-approved state statutes establish the powers and duties of the cabinet, departments within the cabinet, and offices and divisions within such departments (Chapters 224.10-020 and 224.10-100), and support sub-element (ii) by requiring adequate disclosures of potential conflicts (KRS 11A.020. Public servant prohibited from certain conduct—Exception—Disclosure of personal or private interest) and otherwise ensuring that public officers and servants do not engage in activities that may present a conflict of interest (KRS 11A.030 Considerations in determination to abstain from action on official decision—Advisory opinion; and KRS 11A.040 Acts prohibited for public servant or officer—Exception). With the incorporation of these regulations and statutes into the Kentucky SIP, EPA has made the preliminary determination that the Commonwealth has adequately addressed the requirements of section 128(a)(2), and accordingly has met the requirements of section 110(a)(2)(E)(ii) with respect to infrastructure SIP requirements. Thus, EPA is proposing approval of KDAQ's infrastructure SIP submission for the 2010 1-hour SO2 NAAQS with respect to section 110(a)(2)(E)(ii).

    7. 110(a)(2)(F) Stationary Source Monitoring and Reporting: Section 110(a)(2)(F) requires SIPs to meet applicable requirements addressing (i) the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources, (ii) periodic reports on the nature and amounts of emissions and emissions related data from such sources, and (iii) correlation of such reports by the state agency with any emission limitations or standards established pursuant to this section, which reports shall be available at reasonable times for public inspection. The Kentucky infrastructure submission describes how the major source and minor source emission inventory programs collect emission data throughout the Commonwealth and ensure the quality of such data. Kentucky meets these requirements through Chapter 50 General Administrative Procedures, specifically 401 KAR 50:050 Monitoring. 401 KAR 50:050, Section 1, Monitoring Records and Reporting, states that the cabinet may require a facility to install, use, and maintain stack gas and ambient air monitoring equipment and to establish and maintain records, and make periodic emission reports at intervals prescribed by the cabinet. 401 KAR 50:050 Monitoring, Section 1, Monitoring, Records, and Reporting, establishes the requirements for the installation, use, and maintenance of stack gas and ambient air monitoring equipment, and authorizes the cabinet to require the owner or operator of any affected facility to establish and maintain records for this equipment and make periodic emission reports at intervals prescribed by the cabinet. Also, KRS 224.10-100 (23) requires that any person engaged in any operation regulated pursuant to this chapter file with the cabinet reports containing information as to location, size, height, rate of emission or discharge, and composition of any substance discharged or emitted into the ambient air or into the waters or onto the land of the Commonwealth, and such other information the cabinet may require. In addition, EPA is unaware of any provision preventing the use of credible evidence in the Kentucky SIP.22

    22 “Credible Evidence,” makes allowances for owners and/or operators to utilize “any credible evidence or information relevant” to demonstrate compliance with applicable requirements if the appropriate performance or compliance test had been performed, for the purpose of submitting compliance certification and can be used to establish whether or not an owner or operator has violated or is in violation of any rule or standard.

    Additionally, Kentucky is required to submit emissions data to EPA for purposes of the National Emissions Inventory (NEI). The NEI is EPA's central repository for air emissions data. EPA published the Air Emissions Reporting Rule (AERR) on December 5, 2008, which modified the requirements for collecting and reporting air emissions data (73 FR 76539). The AERR shortened the time states had to report emissions data from 17 to 12 months, giving states one calendar year to submit emissions data. All states are required to submit a comprehensive emissions inventory every three years and report emissions for certain larger sources annually through EPA's online Emissions Inventory System. States report emissions data for the six criteria pollutants and the precursors that form them—nitrogen oxides, SO2, ammonia, lead, carbon monoxide, particulate matter, and volatile organic compounds. Many states also voluntarily report emissions of hazardous air pollutants. Kentucky made its latest update to the NEI on November 6, 2014. EPA compiles the emissions data, supplementing it where necessary, and releases it to the general public through the Web site http://www.epa.gov/ttn/chief/eiinformation.html. EPA has made the preliminary determination that Kentucky's SIP and practices are adequate for the stationary source monitoring systems related to the 2010 1-hour SO2 NAAQS. Accordingly, EPA is proposing to approve Kentucky's infrastructure SIP submission with respect to section 110(a)(2)(F).

    8. 110(a)(2)(G) Emergency Powers: This section requires that states demonstrate authority comparable with section 303 of the CAA and adequate contingency plans to implement such authority. Kentucky's infrastructure SIP submission identifies air pollution emergency episodes and preplanned abatement strategies as outlined in the following Kentucky regulations in Chapter 55 Emergency Episodes, specifically: 401 KAR 55:005. Significant harm criteria, 401 KAR 55:010. Episode Criteria, and 401 KAR 55:015. Episode Declaration. 401 KAR 55:005. Significant Harm Criteria, Section 1, Purpose, defines those levels of pollutant concentration which must be prevented in order to avoid significant harm to the health of persons. 401 KAR 55:010. Episodic Criteria, defines those levels of pollutant concentrations which justify the proclamation of an air pollution alert, air pollution warning, an air pollution emergency. 401 KAR 55:015. Episode Declaration, provides for the curtailment or reduction of processes or operations which emit an air contaminant or an air contaminant precursor whose criteria has been reached and are located in the affected areas for which an episode level has been declared.

    In addition, KRS 224.10-100 Powers and duties of cabinet and KRS 224.10-410 Order for discontinuance, abatement, or alleviation of condition or activity without hearing—Subsequent hearing, establish the authority for Kentucky's secretary to issue orders to person(s) for discontinuance, abatement, or alleviation of any condition or activity without hearing because the condition or activity presents a danger to the health or welfare of the people of the state, and for the cabinet to require adoption of any remedial measures deemed necessary. EPA has made the preliminary determination that Kentucky's SIP, and state laws are adequate for emergency powers related to the 2010 1-hour SO2 NAAQS. Accordingly, EPA is proposing to approve Kentucky's infrastructure SIP submission with respect to section 110(a)(2)(G).

    9. 110(a)(2)(H) SIP Revisions: Section 110(a)(2)(H), in summary, requires each SIP to provide for revisions of such plan (i) as may be necessary to take account of revisions of such national primary or secondary ambient air quality standard or the availability of improved or more expeditious methods of attaining such standard, and (ii) whenever the Administrator finds that the plan is substantially inadequate to attain the NAAQS or to otherwise comply with any additional applicable requirements. As previously discussed, KDAQ is responsible for adopting air quality rules and revising SIPs as needed to attain or maintain the NAAQS. Kentucky has the ability and authority to respond to calls for SIP revisions, and has provided a number of SIP revisions over the years for implementation of the NAAQS.

    KDAQ is responsible for adopting air quality rules and revising SIPs as needed to attain or maintain the NAAQS in Kentucky. 401 KAR Chapter 53 Ambient Air Quality and Chapter 51 Attainment and Maintenance of the National Ambient Air Quality Standards grant KDAQ the broad authority to implement the CAA, and as such, provides KDAQ the authority to prepare and develop, after proper study, a comprehensive plan for the prevention of air pollution. These statutes also provide KDAQ the ability and authority to respond to calls for SIP revisions, and KDAQ has provided a number of SIP revisions over the years for implementation of the NAAQS. Additionally, 401 KAR 53:010 outlines the ambient air quality standards necessary for the protection of the public health, the general welfare, and the property and people in the Commonwealth and states that within 60 days of promulgation or revision of any NAAQS by EPA, the cabinet will initiate a process to promulgate or review this administrative regulation. 401 KAR 51:010. Attainment Status Designations provides provisions for the Cabinet to review applicable data and submit to EPA proposed revisions to the list of attainment-nonattainment areas. EPA has made the preliminary determination that Kentucky adequately demonstrates a commitment to provide future SIP revisions related to the 2010 1-hour SO2 NAAQS when necessary. Accordingly, EPA is proposing to approve Kentucky's infrastructure SIP submission for the 2010 1-hour SO2 NAAQS with respect to section 110(a)(2)(H).

    10. 110(a)(2)(J) Consultation with Government Officials, Public Notification, and PSD and Visibility Protection: EPA is proposing to approve Kentucky's infrastructure SIP submission for the 2010 1-hour SO2 NAAQS with respect to the general requirement in section 110(a)(2)(J) to include a program in the SIP that provides for meeting the applicable consultation requirements of section 121, the public notification requirements of section 127, PSD, and visibility. EPA's rationale for each sub-element is described below.

    Consultation with government officials (121 consultation): Section 110(a)(2)(J) of the CAA requires states to provide a process for consultation with local governments, designated organizations and Federal Land Managers carrying out NAAQS implementation requirements pursuant to section 121 relative to consultation. This requirement is met through provisions in separate implementation plans, such as the Regional Haze SIP, which provide for continued consultation with government officials, including the Federal Land Managers (FLMs). Kentucky adopted consultation procedures in coordination with the transportation partners in the Commonwealth, for the implementation of transportation conformity, which includes the development of mobile inventories for SIP development. Required partners covered by Kentucky's consultation procedures include Federal, state and local transportation and air quality agency officials. Implementation of transportation conformity as outlined in the consultation procedures requires KDAQ to consult with Federal, state and local transportation and air quality agency officials on the development of motor vehicle emissions budgets. Also, KDAQ notes in its April 26, 2013, SIP submission that the following Kentucky regulations provide the Commonwealth the authority to meet this requirement: 401 KAR 50:055. General compliance requirements; 401 KAR 50:060. Enforcement; 401 KAR 50:065. Conformity of general federal actions; 401 KAR 50:066. Conformity of Transportation Plans, Programs, and Projects; 401 KAR 51:017. Prevention of Significant Deterioration of Air Quality; and 401 KAR 51:052. Review of new sources in or impacting upon nonattainment areas. EPA has made the preliminary determination that Kentucky's SIP and practices adequately demonstrate consultation with government officials related to the 2010 1-hour SO2 NAAQS when necessary for the consultation with government officials element of section 110(a)(2)(J).

    Public notification (127 public notification): These requirements are met through the following Kentucky regulations: 401 KAR 51:001. Definitions for 401 KAR Chapter 51; 401 KAR 51:005. Purpose and General Provisions; 401 KAR 51:010. Attainment Status Designations; 401 KAR 51:017. Prevention of significant deterioration of air quality; 401 KAR 51:052. Review of new sources in or impacting upon nonattainment areas; and 401 KAR 52:100. Public, Affected State, and US. EPA Review. Additionally, Kentucky provides air quality information to the public via its Web site at: http://eppcapp.ky.gov/daq/. EPA has made the preliminary determination that Kentucky's SIP and practices adequately demonstrate the Commonwealth's ability to provide public notification related to the 2010 1-hour SO2 NAAQS when necessary for the public notification element of section 110(a)(2)(J).

    PSD: With regard to the PSD element of section 110(a)(2)(J), this requirement may be met by a state's confirmation in an infrastructure SIP submission that new major sources and major modifications in the state are subject to a PSD program meeting all the current structural requirements of part C of title I of the CAA. As discussed in more detail above under section 110(a)(2)(C), Kentucky's SIP contains the relevant SIP revisions necessary to satisfy the structural PSD requirements of this element of section 110(a)(2)(J). EPA has made the preliminary determination that Kentucky's SIP is adequate for the PSD element of section 110(a)(2)(J).

    Visibility protection: EPA's 2013 Guidance notes that it does not treat the visibility protection aspects of section 110(a)(2)(J) as applicable for purposes of the infrastructure SIP approval process. EPA recognizes that states are subject to visibility protection and regional haze program requirements under Part C of the Act (which includes sections 169A and 169B). However, there are no newly applicable visibility protection obligations after the promulgation of a new or revised NAAQS. Thus, EPA has determined that states do not need to address the visibility component of 110(a)(2)(J) in infrastructure SIP submittals. As such, EPA has made the determination that it does not need to address the visibility protection element of section 110(a)(2)(J) in Kentucky's infrastructure SIP submission related to the 2010 1-hour SO2 NAAQS.

    11. 110(a)(2)(K) Air Quality Modeling and Submission of Modeling Data: Section 110(a)(2)(K) of the CAA requires that SIPs provide for performing air quality modeling so that effects on air quality of emissions from NAAQS pollutants can be predicted and submission of such data to the EPA can be made. This requirement is met through Kentucky regulations 401 KAR 50:040. Air Quality Models and 401 KAR 50:050. Monitoring. Additionally, Kentucky participates in a regional effort to coordinate the development of emissions inventories and conduct regional modeling for several NAAQS, including the 2010 1-hour SO2 NAAQS, for the Southeastern states. Taken as a whole, Kentucky's air quality regulations and practices demonstrate that KDAQ has the authority to provide relevant data for the purpose of predicting the effect on ambient air quality of the 2010 1-hour SO2 NAAQS. EPA has made the preliminary determination that Kentucky's SIP and practices adequately demonstrate the Commonwealth's ability to provide for air quality modeling, along with analysis of the associated data, related to the 2010 1-hour SO2 NAAQS. Accordingly, EPA is proposing to approve Kentucky's infrastructure SIP submission with respect to section 110(a)(2)(K).

    12. 110(a)(2)(L) Permitting Fees: This section requires the SIP to direct the owner or operator of each major stationary source to pay to the permitting authority, as a condition of any permit required under the CAA, a fee sufficient to cover (i) the reasonable costs of reviewing and acting upon any application for such a permit, and (ii) if the owner or operator receives a permit for such source, the reasonable costs of implementing and enforcing the terms and conditions of any such permit (not including any court costs or other costs associated with any enforcement action), until such fee requirement is superseded with respect to such sources by the Administrator's approval of a fee program under title V.

    Kentucky regulation, 401 KAR 50:038 Air Emissions Fee, 23 provides for the assessment of fees necessary to fund the state permit program. KDAQ ensures this is sufficient for the reasonable cost of reviewing and acting upon PSD and NNSR permits. Additionally, Kentucky has a fully approved title V operating permit program at 401 KAR 52:020 Title V permits 24 that covers the cost of implementation and enforcement of PSD and NNSR permits after they have been issued. EPA has made the preliminary determination that Kentucky's SIP and practices adequately provide for permitting fees related to the 2010 1-hour SO2 NAAQS, when necessary. Accordingly, EPA is proposing to approve Kentucky's infrastructure SIP submission with respect to section 110(a)(2)(L).

    23 This rule is not approved into the federally approved SIP.

    24 This rule is not approved into the federally approved SIP.

    13. 110(a)(2)(M) Consultation and Participation by Affected Local Entities: Section 110(a)(2)(M) of the Act requires states to provide for consultation and participation in SIP development by local political subdivisions affected by the SIP. This requirement is met through provisions in separate implementation plans, such as the regional haze SIP, which provide for continued consultation with government officials, including the FLMs. Kentucky regulation, 401 KAR 50:066. Conformity of transportation plans, programs, and projects, and the interagency consultation process as directed by Kentucky's approved Conformity SIP and 40 CFR 93.112 provide for consultation with local groups. More specifically, Kentucky adopted state-wide consultation procedures for the implementation of transportation conformity which includes the development of mobile inventories for SIP development and the requirements that link transportation planning and air quality planning in nonattainment and maintenance areas. Required partners covered by Kentucky's consultation procedures include Federal, state and local transportation and air quality agency officials. The state and local transportation agency officials are most directly impacted by transportation conformity requirements and are required to provide public involvement for their activities including the analysis demonstrating how they meet transportation conformity requirements. Further, Kentucky's SO2 infrastructure SIP submission notes that the following State regulations and State statutes provide the Commonwealth the authority to meet the requirements of this element: 401 KAR 50:066. Conformity of transportation plans, programs, and projects; 401 KAR 52:100. Public, Affected State, and US EPA Review; and KRS Chapter 77. Air Pollution Control. EPA has made the preliminary determination that Kentucky's SIP and practices adequately demonstrate consultation with affected local entities related to the 2010 1-hour SO2 NAAQS when necessary.

    V. Proposed Action

    With the exception of interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states and visibility protection requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4) and the minor source program requirements of section 110(a)(2)(C), EPA is proposing to approve Kentucky's April 26, 2013, infrastructure SIP submission for the 2010 1-hour SO2 NAAQS for the above described infrastructure SIP requirements. EPA is proposing to approve these portions of Kentucky's infrastructure SIP submission for the 2010 1-hour SO2 NAAQS because these aspects of the submission are consistent with section 110 of the CAA.

    VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

    • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

    • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

    • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

    • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

    • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

    • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

    • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

    • does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: March 25, 2016. Heather McTeer Toney, Regional Administrator, Region 4.
    [FR Doc. 2016-07644 Filed 4-1-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 88 [NIOSH Docket 094] World Trade Center Health Program; Petition 010—Peripheral Neuropathy; Finding of Insufficient Evidence AGENCY:

    Centers for Disease Control and Prevention, HHS.

    ACTION:

    Denial of petition for addition of a health condition.

    SUMMARY:

    On January 5, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 010) to add peripheral neuropathy to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add peripheral neuropathy to the List. The Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

    DATES:

    The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of April 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Rachel Weiss, Program Analyst, 1090 Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 (this is a toll-free number); email [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Approval to Submit Document to the Office of the Federal Register C. Petition 010 D. Administrator's Determination on Petition 010 A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act) Public Law 111-347, as amended by Public Law 114-113, added Title XXXIII to the Public Health Service Act (PHS Act) 1 establishing the WTC Health Program within the Department of Health and Human Services (HHS). The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001 or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors).

    1 Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm to 300mm-61. Those portions of the Zadroga Act found in Titles II and III of Public Law 111-347 do not pertain to the WTC Health Program and are codified elsewhere.

    All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his or her designee.

    Pursuant to section 3312(a)(6)(B) of the PHS Act, interested parties may petition the Administrator to add a health condition to the List in 42 CFR 88.1. After receipt of a petition to add a condition to the List, the Administrator must take one of the following four actions described in PHS Act, section 3312(a)(6)(B) and 42 CFR 88.17: (i) Request a recommendation of the STAC; (ii) publish a proposed rule in the Federal Register to add such health condition; (iii) publish in the Federal Register the Administrator's determination not to publish such a proposed rule and the basis for such determination; or (iv) publish in the Federal Register a determination that insufficient evidence exists to take action under (i) through (iii) above.

    B. Approval To Submit Document to the Office of the Federal Register

    The Secretary, HHS, or her designee, the Director, Centers for Disease Control and Prevention (CDC) and Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), authorized the undersigned, the Administrator of the WTC Health Program, to sign and submit the document to the Office of the Federal Register for publication as an official document of the WTC Health Program. Thomas R. Frieden, M.D., M.P.H., Director, CDC, and Administrator, ATSDR, approved this document on March 24, 2016, for publication.

    C. Petition 010

    On January 5, 2016, the Administrator received a petition to add “peripheral neuropathy” to the List (Petition 010).2 The petition was submitted by a Fire Department of New York member who responded to the September 11, 2001, terrorist attacks in New York City. The petitioner indicated that he was diagnosed with peripheral neuropathy shortly after the incident. The petitioner described two studies as the medical basis for his petition: A study of the short-term effects of WTC dust on the sciatic nerve of laboratory rats, and another concerning neuropathic symptoms in WTC responders and survivors. Both studies, as well as an initial literature search conducted by the WTC Health Program, are described below.

    2See Petition 010, WTC Health Program: Petitions Received. http://www.cdc.gov/wtc/received.html.

    D. Administrator's Determination on Petition 010

    The Administrator has established a policy for evaluating whether to add non-cancer health conditions to the List of WTC-Related Health Conditions, published online in the Policies and Procedures section of the WTC Health Program Web site.3 In accordance with the policy, the Administrator directs the WTC Health Program to conduct a review of the scientific literature to determine if the available scientific information has the potential to provide a basis for a decision on whether to add the condition to the List. The literature review includes published, peer-reviewed epidemiologic studies (including direct observational studies in the case of health conditions such as injuries) about the health condition among 9/11-exposed populations. The studies are reviewed for their relevance, quantity, and quality to provide a basis for deciding whether to propose adding the health condition to the List. Where the available evidence has the potential to provide a basis for a decision, the scientific and medical evidence is further assessed to determine whether a causal relationship between 9/11 exposures and the health condition is supported. A health condition may be added to the List if published, peer-reviewed, direct observational or epidemiologic studies, as appropriate, provide substantial support 4 for a causal relationship between 9/11 exposures and the health condition in 9/11-exposed populations. If the evidence assessment provides only modest support 5 for a causal relationship between 9/11 exposures and the health condition, the Administrator may then evaluate additional published, peer-reviewed, epidemiologic studies, conducted among non-9/11-exposed populations, evaluating associations between the health condition of interest and 9/11 agents.6 If that additional assessment establishes substantial support for a causal relationship between a 9/11 agent or agents and the health condition, the health condition may be added to the List.

    3 John Howard MD, Administrator of the WTC Health Program, Policy and Procedures for Adding Non-Cancer Conditions to the List of WTC-Related Health Conditions, October 21, 2014. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.

    4 The substantial evidence standard is met when the Program assesses all of the available, relevant information and determines with high confidence that the evidence supports its findings regarding a causal association between the 9/11 exposure(s) and the health condition.

    5 The modest evidence standard is met when the Program assesses all of the available, relevant information and determines with moderate confidence that the evidence supports its findings regarding a causal association between the 9/11 exposure(s) and the health condition.

    6 9/11 agents are chemical, physical, biological, or other agents or hazards reported in a published, peer-reviewed exposure assessment study of responders or survivors who were present in the New York City disaster area, at the Pentagon site, or at the Shanksville, Pennsylvania site, as those locations are defined in 42 CFR 88.1.

    In accordance with section 3312(a)(6)(B) of the PHS Act, 42 CFR 88.17, and the policy for the addition of non-cancer health conditions to the List, the Administrator reviewed the evidence presented in Petition 010. The WTC Health Program conducted a systematic literature search of the published scientific and medical literature 7 for evidence of a causal relationship between 9/11 exposures and peripheral neuropathy and reviewed both studies submitted in the petition.

    7 Databases searched include: PubMed, Health & Safety Science Abstracts, Toxicology Abstracts, Toxline, Scopus, Embase, and NIOSHTIC-2.

    The first study cited by the petitioner, “Analysis of Short-Term Effects of World Trade Center Dust on Rat Sciatic Nerve,” by Stecker et al. 8 investigated the short-term effects of WTC dust on the sciatic nerve in laboratory rats. This study was not identified in the literature search. Because this study does not meet the policy's requirement that the decision to add a health condition to the List must be based on epidemiologic studies of 9/11-exposed populations, it was not further considered.

    8 Mark Stecker, Jacqueline Segelnick, Marc Wilkenfeld, Analysis of Short-Term Effects of World Trade Center Dust on Rat Sciatic Nerve, JOEM 56(10):1024-1028, October 2014.

    The systematic literature search identified only one epidemiologic study regarding peripheral neuropathy in 9/11-exposed populations, which was the second study cited by the petitioner, “Neuropathic Symptoms in World Trade Center Disaster Survivors and Responders,” by Wilkenfeld et al. 9 Upon review of the study's relevance, quantity, and quality, the paper was found to have numerous limitations, including a small sample size; exclusive use of subjective self-reported outcome and exposure data; lack of information about comparability among the groups; lack of objective measurements to confirm the presence of peripheral neuropathy; and absence of control for key confounders other than the comorbidities studied. Each of these limitations affect the strength of the study results, and thus the Wilkenfeld et al. study is not sufficient to provide the Administrator with a potential basis for deciding whether to propose adding peripheral neuropathy to the List.

    9 Marc Wilkenfeld, Melissa Fazzari, Jacqueline Segelnick, and Mark Stecker, Neuropathic Symptoms in World Trade Center Disaster Survivors and Responders, JOEM 58(1):83-86, January 2016.

    Due to the substantial limitations inherent in the only available study, the Administrator has concluded that the available evidence does not have the potential to provide a basis for a decision on whether to add peripheral neuropathy to the List.

    The findings described above led the Administrator to determine that insufficient evidence exists to take further action, including either proposing the addition of peripheral neuropathy to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 88.17(a)(2)(ii)) or publishing a determination not to publish a proposed rule in the Federal Register (pursuant to PHS Act, sec. 3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)). The Administrator has also determined that requesting a recommendation from the STAC (pursuant to PHS Act, sec. 3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)) is unwarranted.

    For the reasons discussed above, the request made in Petition 010 to add peripheral neuropathy to the List of WTC-Related Health Conditions is denied.

    Dated: March 28, 2016. John Howard, Administrator, World Trade Center Health Program and Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services.
    [FR Doc. 2016-07567 Filed 4-1-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management 43 CFR Parts 3100, 3160, and 3170 [15X.LLWO300000.L13100000.NB0000] RIN 1004-AE14 Waste Prevention, Production Subject to Royalties, and Resource Conservation AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Proposed rule; extension of public comment period.

    SUMMARY:

    On February 8, 2016, the Bureau of Land Management (BLM) published in the Federal Register a proposed rule that would reduce waste of natural gas from venting, flaring, and leaks during oil and natural gas production activities on onshore Federal and Indian leases. The proposed rule would also clarify when produced gas lost through venting, flaring, or leaks is subject to royalties, and when oil and gas production used on site would be royalty-free. The proposed rule would replace existing provisions related to venting, flaring, and royalty-free use of gas contained in the 1980 Notice to Lessees and Operators of Onshore Federal and Indian Oil and Gas Leases, Royalty or Compensation for Oil and Gas Lost (NTL-4A), which is over 3 decades old. Today's Federal Register Notice extends the public comment period for 14 days beyond the initial comment period deadline.

    DATES:

    The comment period for the proposed rule published on February 8, 2016 (81 FR 6616) is extended. Send your comments on this proposed rule to the BLM on or before April 22, 2016. The BLM need not consider, or include in the administrative record for the final rule, comments that the BLM receives after the close of the comment period or comments delivered to an address other than those listed below (see ADDRESSES).

    ADDRESSES:

    Mail: U.S. Department of the Interior, Director (630), Bureau of Land Management, Mail Stop 2134 LM, 1849 C St. NW., Washington, DC 20240, Attention: 1004-AE14. Personal or messenger delivery: Bureau of Land Management, 20 M Street SE., Room 2134 LM, Attention: Regulatory Affairs, Washington, DC 20003. Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions at this Web site.

    FOR FURTHER INFORMATION CONTACT:

    Eric Jones at the BLM Moab Field Office, 82 East Dogwood Ave., Moab, UT 84532, or by telephone at 435-259-2117; or Timothy Spisak at the BLM Washington Office, 20 M Street SE., Room 2134LM, Washington, DC 20003, or by telephone at 202-912-7311. For questions relating to regulatory process issues, please contact Faith Bremner, BLM Washington Office, at 202-912-7441. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individuals during normal business hours. FIRS is available 24 hours a day, 7 days a week to leave a message or question with the above individuals. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION: Public Comment Procedures

    If you wish to comment, you may submit your comments by any one of the methods listed in the ADDRESSES section above. Please make your comments as specific as possible by confining them to issues directly related to the content of the proposed rule, and explain the basis for your comments. The comments and recommendations that will be most useful and likely to influence agency decisions are:

    1. Those supported by quantitative information or studies; and

    2. Those that include citations to, and analyses of, the applicable laws and regulations.

    The BLM is not obligated to consider or include in the Administrative Record for the rule comments received after the close of the comment period (see DATES) or comments delivered to an address other than those listed above (see ADDRESSES).

    Comments, including names and street addresses of respondents, will be available for public review at the address listed under ADDRESSES during regular hours (7:45 a.m. to 4:15 p.m.), Monday through Friday, except holidays.

    Before including your address, telephone number, email address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask in your comment to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so.

    Background

    The proposed rule was published on February 8, 2016 (81 FR 6616), with a 60-day comment period closing on April 8, 2016. Since publication, the BLM has received requests to extend the comment period on the proposed rule, as well as requests not to extend the comment period. Commenters requesting an extension cited the technical nature and complexity of the proposed rule; its potential interaction with the BLM's proposals to update and replace oil and gas production measurement rules currently found in Onshore Orders 3, 4, and 5; and the Environmental Protection Agency's proposed rule to establish standards for control of emissions of methane and volatile organic compounds (VOCs) from certain oil and gas production activities, which would be codified as 40 CFR part 60 subpart OOOOa. Comments opposing an extension cited extensive pre-proposal activities to gather public input; the length of time already provided for public comments; what the commenters characterize as an urgent need to finalize updated rules to address ongoing losses of natural gas and royalty revenues; and the environmental impacts of venting and flaring of methane from oil and gas operations on Federal and Indian lands.

    After considering these requests, the BLM has determined that it is appropriate to grant the requests to extend the comment period for a limited time. The BLM is hereby extending the comment period on the proposed rule for 14 days. The closing date of the extended comment period is April 22, 2016.

    Janice M. Schneider, Assistant Secretary, Land and Minerals Management.
    [FR Doc. 2016-07646 Filed 4-1-16; 8:45 am] BILLING CODE 4310-84-P
    81 64 Monday, April 4, 2016 Notices DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-NOP-15-0086; NOP-15-17] National Organic Standards Board (NOSB): Notice of Intent To Renew Charter and Call for Nominations AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Notice: Intent to renew Charter and call for nominations.

    SUMMARY:

    The National Organic Standards Board (NOSB) was established to assist in the development of standards for substances to be used in organic production and to advise the Secretary on the implementation of the Organic Foods Production Act of 1990 (OFPA). Through this Notice, USDA is announcing the following: its intent to renew the Charter of the NOSB, which expires on May 8, 2016; its call for nominations to fill five (5) upcoming vacancies for appointments in 2017, and its call for nominations for a pool of candidates to fill future unexpected vacancies in any of the position categories should that occur.

    DATES:

    The current NOSB Charter expires on May 8, 2016. Written nominations must be postmarked on or before June 3, 2016.

    ADDRESSES:

    Nomination applications can be sent via email to Michelle Arsenault at [email protected], or mailed to: USDA-AMS-NOP, 1400 Independence Avenue SW., Room 2642-S., Ag Stop 0268, Washington, DC 20250-0268. Electronic submittals are preferred.

    FOR FURTHER INFORMATION CONTACT:

    Michelle Arsenault, (202) 720-0081; Email: [email protected];

    SUPPLEMENTARY INFORMATION:

    The OFPA of 1990, as amended (7 U.S.C. Section 6501 et seq.), requires the Secretary to establish an organic certification program for producers and handlers of agricultural products that have been produced using organic methods. The OFPA includes the requirement that the Secretary establish a NOSB in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2 et seq.). The purpose of the NOSB is to assist in the development of a proposed National List of Allowed and Prohibited Substances and to advise the Secretary on the implementation of the OFPA.

    Pursuant to the FACA, notice is hereby given that the Secretary of Agriculture intends to renew the NOSB Charter for two years. The NOSB is of a continuing nature due to the changes in organic production and marketing brought about through advancements in science and technology.

    The NOSB is composed of 15 members including; four individuals who own or operate an organic farming operation, two individuals who own or operate an organic handling operation; one individual who owns or operates a retail establishment with significant trade in organic products; three individuals with expertise in areas of environmental protection and resource conservation; three individuals who represent public interest or consumer interest groups; one scientist with expertise in the fields of toxicology, ecology, or biochemistry; and one individual who is a certifying agent. Through this Notice, the USDA seeks to fulfill two goals: Firstly, it is seeking nominations to fill five (5) upcoming vacancies for the following positions: One (1) organic producer; one (1) individual with expertise in areas of environmental protection and resource conservation; one (1) representative of a public or consumer interest group; one (1) organic handler or processor; and one (1) scientist (toxicology, ecology or biochemistry). The Secretary of Agriculture will appoint one person to each of these five positions to serve a 5-year term of office beginning January 24, 2017, and ending January 23, 2022. Secondly, the USDA is seeking nominations to fill future unexpected vacancies in any of the position categories. These nominations will be held as a pool of candidates that the Secretary of Agriculture can draw upon as replacement appointees if unexpected vacancies occur. A person appointed to fill a vacancy will serve for the remainder of the 5-year term of the vacant position.

    As per the OFPA, individuals seeking appointment to the NOSB must meet the definition of the position that they seek as identified under section 6518 of this title, as well as satisfy the selection criteria for an NOSB member.

    Selection criteria include the following: An understanding of organic principles and practical experience in the organic community; demonstrated experience and interest in organic production and organic certification; demonstrated experience with respect to agricultural products produced and handled on certified organic farms; a commitment to the integrity of the organic food and fiber industry; demonstrated experience in the development of public policy such as participation on public or private advisory boards, boards of directors or other comparable organizations; support of consumer and public interest organizations; participation in standards development or involvement in educational outreach activities; the ability to evaluate technical information and to fully participate in Board deliberation and recommendations; the willingness to commit the time and energy necessary to assume Board duties; and other such factors as may be appropriate for specific positions.

    To nominate yourself or someone else, please submit the following: a resume (required), Form AD-755 (required), which can be accessed at: http://www.usda.gov/documents/OCIO_AD_755_Master_2012.pdf, a cover letter, and a list of endorsements or letters of recommendation (optional). Resumes must be no longer than 5 pages, and should include a summary of the following information: Current and past organization affiliations; areas of expertise; education; career positions held; any other notable positions held.

    If USDA receives a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552), for records relating to NOSB nominations, your application materials may be released to the requester. Prior to the release of the information, personally identifiable information protected by the FOIA Privacy Act will be redacted.

    Nominations are open to all individuals without regard to race, color, religion, gender, national origin, age, mental or physical disability, marital status, or sexual orientation. To ensure that the recommendations of the NOSB take into account the needs of the diverse groups that are served by the Department, membership on the NOSB shall include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities.

    The information collection requirements concerning the nomination process have been previously cleared by the Office of Management and Budget (OMB) under OMB Control No. 0505-0001.

    Dated: March 30, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
    [FR Doc. 2016-07616 Filed 4-1-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Notice of Funds Availability: Inviting Applications for the Foreign Market Development Cooperator Program

    Announcement Type: New.

    Catalog of Federal Domestic Assistance (CFDA) Number: 10.600.

    SUMMARY:

    The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Foreign Market Development Cooperator (Cooperator) program. The intended effect of this notice is to solicit applications from eligible applicants for fiscal year 2017 and to set out criteria for the award of funds under the program in October 2016. The Cooperator program is administered by personnel of the Foreign Agricultural Service (FAS).

    DATES:

    All applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Applications received after this date will not be considered.

    FOR FURTHER INFORMATION CONTACT:

    Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by e-mail: [email protected] Information is also available on the FAS Web site at the following URL address: http://www.fas.usda.gov/programs/foreign-market-development-program-fmd.

    SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description

    Authority: The Cooperator program is authorized by Title VII of the Agricultural Trade Act of 1978, as amended. Cooperator program regulations appear at 7 CFR part 1484.

    Purpose: The Cooperator program is designed to create, expand, and maintain foreign markets for U.S. agricultural commodities and products through cost-share assistance. Financial assistance under the Cooperator program will be made available on a competitive basis and applications will be reviewed against the evaluation criteria contained herein and in the Cooperator program regulations. All U.S. agricultural commodities, except tobacco, are eligible for consideration.

    FAS allocates funds in a manner that effectively supports the strategic decision-making initiatives of the Government Performance and Results Act (GPRA) of 1993. In deciding whether a proposed project will contribute to the effective creation, expansion, or maintenance of foreign markets, FAS considers whether the applicant provides a clear, long-term agricultural trade strategy and a program effectiveness time line against which results can be measured at specific intervals using quantifiable product or country goals. FAS also considers the extent to which a proposed project targets markets with the greatest growth potential. These factors are part of the FAS resource allocation strategy to fund applicants who can demonstrate performance and address the objectives of the GPRA.

    II. Award Information

    Under the Cooperator program, FAS enters into agreements with eligible nonprofit U.S. trade organizations to share the cost of certain overseas marketing and promotion activities. Funding priority is given to organizations that have the broadest possible producer representation of the commodity being promoted and that are nationwide in membership and scope. Cooperators may receive assistance only for generic activities that do not involve promotions targeted directly to consumers. The program generally operates on a reimbursement basis.

    III. Eligibility Information

    1. Eligible Applicants: To participate in the Cooperator program, an applicant must be a nonprofit U.S. agricultural trade organization.

    2. Cost Sharing: To participate in the Cooperator program, an applicant must agree to contribute resources to its proposed promotional activities. The Cooperator program is intended to supplement, not supplant, the efforts of the U.S. private sector. The contribution must be at least 50 percent of the value of resources provided by CCC for activities conducted under the project agreement.

    The degree of commitment of an applicant to the promotional strategies contained in its application, as represented by the cost-share contributions specified therein, is considered by FAS when determining which applications will be approved for funding. Cost-share may be actual cash invested or in-kind contributions, such as professional staff time spent on design and execution of activities. The Cooperator program regulations, including sections 1484.50 and 1484.51, provide detailed discussion of eligible and ineligible cost-share contributions.

    3. Other: Applications should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without federal funding assistance and why participating organization(s) are unlikely to carry out the project without such assistance.

    IV. Application and Submission Information

    1. Address to Request Application Package: Organizations are encouraged to submit their Foreign Market Development (FMD) applications to the FAS through the web-based Unified Export Strategy (UES) application. The UES allows applicants to submit a single consolidated and strategically coordinated proposal that incorporates requests for funding for virtually all of the FAS marketing programs, financial assistance programs, and market access programs. The suggested UES format encourages applicants to examine the constraints or barriers to trade faced, identify activities that would help overcome such impediments, consider the entire pool of complementary marketing tools and program resources, and establish realistic export goals.

    Applicants planning to use the web-based application must contact FAS' Program Operations Division to obtain site access information. The web-based application may be found at the following URL address: https://www.fas.usda.gov/ues/webapp/.

    FAS highly recommends applying via the web-based application as this format virtually eliminates paperwork and expedites the FAS processing and review cycle. However, applicants also have the option of submitting an electronic version of their application to FAS at [email protected]

    2. Content and Form of Application Submission: To be considered for the Cooperator program, an applicant must submit to FAS information required by section 1484.20 of the Cooperator program regulations. In addition, in accordance with the Office of Management and Budget's policy (68 FR 38402 (June 27, 2003)) regarding the need to identify entities that are receiving government awards, all applicants must submit a Dun and Bradstreet Data Universal Numbering System (DUNS) number. An applicant may request a DUNS number at no cost by calling the dedicated toll-free DUNS number request line at 1-866-705-5711.

    In addition, in accordance with 2 CFR part 25, each entity that applies to the Cooperator program and does not qualify for an exemption under 2 CFR 25.110 must:

    (i) Provide a valid DUNS number in each application or plan it submits to CCC;

    (ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and

    (iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.

    Similarly, in accordance with 2 CFR part 170, each entity that applies to the Cooperator program and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive funding under the Cooperator program. Incomplete applications and applications that do not otherwise conform to this announcement or the Cooperator program regulations will not be accepted for review.

    FAS administers various other agricultural export assistance programs, including the Market Access Program (MAP), the Emerging Markets Program, the Quality Samples Program, and the Technical Assistance for Specialty Crops program. Any organization that is not interested in applying for the Cooperator program, but would like to request assistance through one of the other programs mentioned, should contact the Program Operations Division.

    3. Submission Dates and Times: All applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. By the application deadline, all Cooperator program applicants, regardless of the method of submitting an application, must also submit a signed certification statement as specified in 7 CFR 1484.20(a)(14) to the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture, Room 6512, 1400 Independence Ave. SW., Washington, DC 20250. Applications or certifications received after this date will not be considered.

    4. Funding Restrictions: Certain types of expenses are not eligible for reimbursement by the program, and there are limits on other categories of expenses. CCC also will not reimburse unreasonable expenditures or expenditures made prior to approval. Full details are available in sections 1484.54 and 1484.55 of the Cooperator program regulations.

    V. Application Review Information

    1. Criteria and Review Process: Following is a description of the FAS process for reviewing applications and the criteria for allocating available Cooperator program funds.

    (1) Phase 1—Sufficiency Review and FAS Divisional Review

    Applications received by the closing date will be reviewed by FAS to determine the eligibility of the applicants and the completeness of the applications. These requirements appear in sections 1484.14 and 1484.20 of the Cooperator program regulations as well as in this Notice. Applications that meet the requirements then will be further evaluated by the appropriate Commodity Branch office of FAS' Cooperator Programs Division. The Commodity Branch will review each application against the criteria listed in section 1484.21 of the Cooperator program regulations. The purpose of this review is to identify meritorious proposals. The Commodity Branch then recommends an appropriate funding level for each application for consideration by the Office of the Deputy Administrator, Office of Trade Programs.

    (2) Phase 2—Competitive Review

    Meritorious applications are passed on to the Office of the Deputy Administrator, Office of Trade Programs, for the purpose of allocating available funds among those applicants. Applicants will compete for funds on the basis of the following allocation criteria as appropriate (the number in parentheses represents a percentage weight factor):

    (a) Contribution Level (40)

    • The applicant's 6-year average share (2012-2017) of all contributions under the Cooperator program (contributions may include cash and goods and services provided by U.S. entities in support of foreign market development activities) compared to the applicant's 6-year average share (2012-2017) of the funding level for all Cooperator program participants.

    (b) Past Export Performance (20)

    • The 6-year average share (2011-2016) of the value of exports promoted by the applicant compared to the applicant's 6-year average share (2011-2016) of the funding level for all Cooperator participants plus, for those groups participating in the MAP program, a 6-year average share (2011-2016) of all MAP budgets.

    (c) Past Demand Expansion Performance (20)

    • The 6-year average share (2011-2016) of the total value of world trade of the commodities promoted by the applicant compared to the applicant's 6-year average share (2011-2016) of all Cooperator program expenditures plus, for those groups participating in the MAP program, a 6-year average share (2011-2016) of all MAP expenditures.

    (d) Future Demand Expansion Goals (10)

    • The projected total dollar value of world trade of the commodities being promoted by the applicant for the year 2022 compared to the applicant's requested funding level.

    (e) Accuracy of Past Demand Expansion Projections (10)

    • The actual dollar value share of world trade of the commodities being promoted by the applicant for the year 2015 compared to the applicant's past projected share of world trade of the commodities being promoted by the applicant for the year 2015, as specified in the applicant's 2012 Cooperator program application.

    The Commodity Branches' recommended funding levels for each applicant are converted to percentages of the total Cooperator program funds available and then multiplied by each weight factor to determine the amount of funds allocated to each applicant.

    2. Anticipated Announcement Date: Announcements of funding decisions for the Cooperator program are anticipated during October 2016.

    VI. Award Administration Information

    1. Award Notices: FAS will notify each applicant in writing of the final disposition of its application. FAS will send an approval letter and project agreement to each approved applicant. The approval letter and project agreement will specify the terms and conditions applicable to the project, including the levels of Cooperator program funding and cost-share contribution requirements.

    2. Administrative and National Policy Requirements: Interested parties should review the Cooperator program regulations, which are available at the following URL address: http://www.fas.usda.gov/programs/foreign-market-development-program-fmd. Hard copies may be obtained by contacting the Program Operations Division.

    3. Reporting: FAS requires various reports and evaluations from Cooperators. Reporting requirements are detailed in the Cooperator program regulations in sections 1484.53, 1484.70, and 1484.72.

    VII. Agency Contact(s)

    For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by e-mail: [email protected]

    Signed at Washington, DC on the 25th of March, 2016. Bryce Quick, Acting Administrator, Foreign Agricultural Service, and Vice President, Commodity Credit Corporation.
    [FR Doc. 2016-07637 Filed 4-1-16; 8:45 am] BILLING CODE 3410-10-P
    DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Notice of Funds Availability: Inviting Applications for the Market Access Program

    Announcement Type: New.

    Catalog of Federal Domestic Assistance (CFDA) Number: 10.601.

    SUMMARY:

    The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Market Access Program (MAP). The intended effect of this notice is to solicit applications from eligible applicants for fiscal year 2017 and to set out criteria for the award of funds under the program in October 2016. The MAP is administered by personnel of the Foreign Agricultural Service (FAS).

    DATES:

    All applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Applications received after this date will not be considered.

    FOR FURTHER INFORMATION CONTACT:

    Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by email: [email protected] Information is also available on the FAS Web site at the following URL address: http://www.fas.usda.gov/programs/market-access-program-map.

    SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description

    Authority: The MAP is authorized under Section 203 of the Agricultural Trade Act of 1978, as amended. MAP regulations appear at 7 CFR part 1485.

    Purpose: The MAP is designed to create, expand, and maintain foreign markets for U.S. agricultural commodities and products through cost-share assistance. Financial assistance under the MAP will be made available on a competitive basis, and applications will be reviewed against the evaluation criteria contained herein and in the MAP regulations. All U.S. agricultural commodities, except tobacco, are eligible for consideration.

    FAS allocates funds in a manner that effectively supports the strategic decision-making initiatives of the Government Performance and Results Act (GPRA) of 1993. In deciding whether a proposed project will contribute to the effective creation, expansion, or maintenance of foreign markets, FAS considers whether the applicant provides a clear, long-term agricultural trade strategy and a program effectiveness time line against which results can be measured at specific intervals using quantifiable product or country goals. FAS also considers the extent to which a proposed project targets markets with the greatest growth potential. These factors are part of the FAS resource allocation strategy to fund applicants who can demonstrate performance and address the objectives of the GPRA.

    II. Award Information

    Under the MAP, the CCC enters into agreements with eligible Participants to share the cost of certain overseas marketing and promotion activities. MAP Participants may receive assistance for generic or brand promotion activities. For generic activities, funding priority is given to organizations that have the broadest possible producer representation of the commodity being promoted and that are nationwide in membership and scope. For branded activities, only nonprofit U.S. agricultural trade organizations, nonprofit state regional trade groups (SRTGs), U.S. agricultural cooperatives, and state government agencies can participate directly in the brand program. The MAP generally operates on a reimbursement basis.

    III. Eligibility Information

    1. Eligible Applicants: To participate in the MAP, an applicant must be a nonprofit U.S. agricultural trade organization, a nonprofit state regional trade group, a U.S. agricultural cooperative, or a state government agency. A small-sized U.S. commercial entity may participate through a MAP Participant.

    2. Cost Sharing: To participate in the MAP, an applicant must agree to contribute resources to its proposed promotional activities. The MAP is intended to supplement, not supplant, the efforts of the U.S. private sector. In the case of generic promotion, the contribution must be at least 10 percent of the value of resources provided by CCC for such generic promotion. In the case of brand promotion, the contribution must be at least 50 percent of the total cost of such brand promotion.

    The degree of commitment of an applicant to the promotional strategies contained in its application, as represented by the cost-share contributions specified therein, is considered by FAS when determining which applications will be approved for funding. Cost-share may be actual cash invested or in-kind contributions, such as professional staff time spent on design and execution of activities. The MAP regulations, in section 1485.16, provide a detailed discussion of eligible and ineligible cost-share contributions.

    3. Other: Applications should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without federal funding assistance and why participating organization(s) are unlikely to carry out the project without such assistance.

    IV. Application and Submission Information

    1. Address To Request Application Package: Organizations are encouraged to submit their MAP applications to FAS through the web-based Unified Export Strategy (UES) application. The UES allows interested applicants to submit a single consolidated and strategically coordinated proposal that incorporates requests for funding for virtually all of the FAS marketing programs, financial assistance programs, and market access programs. The suggested UES format encourages applicants to examine the constraints or barriers to trade that they face, identify activities that would help overcome such impediments, consider the entire pool of complementary marketing tools and program resources, and establish realistic export goals. Applicants planning to use the web-based system must contact FAS' Program Operations Division to obtain site access information. The web-based application may be found at the following URL address: https://www.fas.usda.gov/ues/webapp/.

    FAS highly recommends applying via the web-based application, as this format virtually eliminates paperwork and expedites the FAS processing and review cycle. However, applicants also have the option of submitting an electronic version of their application to FAS at [email protected]

    2. Content and Form of Application Submission: To be considered for the MAP, an applicant must submit to FAS information required by section 1485.13 of the MAP regulations. In addition, in accordance with the Office of Management and Budget's policy (68 FR 38402 (June 27, 2003)) regarding the need to identify entities that are receiving government awards, all applicants must submit a Dun and Bradstreet Data Universal Numbering System (DUNS) number. An applicant may request a DUNS number at no cost by calling the dedicated toll-free DUNS number request line at (866) 705-5711.

    In addition, in accordance with 2 CFR part 25, each entity that applies to the MAP and does not qualify for an exemption under 2 CFR 25.110 must:

    (i) Provide a valid DUNS number in each application or plan it submits to CCC;

    (ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and

    (iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.

    Similarly, in accordance with 2 CFR part 170, each entity that applies to MAP and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive MAP funding.

    Incomplete applications and applications that do not otherwise conform to this announcement and the MAP regulations will not be accepted for review.

    FAS administers various other agricultural export assistance programs including the Foreign Market Development Cooperator (Cooperator) program, the Emerging Markets Program, the Quality Samples Program, and the Technical Assistance for Specialty Crops program. Any organization that is not interested in applying for the MAP, but would like to request assistance through one of the other programs mentioned, should contact the Program Operations Division.

    3. Submission Dates and Times: All applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. By the application deadline, all MAP applicants, regardless of the method of submitting an application, must also submit a signed certification statement as specified in 7 CFR 1485.13(a)(2)(i)(E) to the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture, Room 6512, 1400 Independence Ave. SW., Washington, DC 20250. Applications or certifications received after this date will not be considered.

    4. Funding Restrictions: Certain types of expenses are not eligible for reimbursement by the program, and there are limits on other categories of expenses. CCC also will not reimburse unreasonable expenditures or expenditures made prior to approval. Full details are available in the MAP regulations in section 1485.17.

    V. Application Review Information

    1. Criteria and Review Process: Following is a description of the FAS process for reviewing applications and the criteria for allocating available MAP funds.

    (1) Phase 1—Sufficiency Review and FAS Divisional Review:

    Applications received by the closing date will be reviewed by FAS to determine the eligibility of the applicants and the completeness of the applications. These requirements appear in sections 1485.12 and 1485.13 of the MAP regulations. Applications that meet the requirements then will be further evaluated by the appropriate Commodity Branch office of FAS' Cooperator Programs Division. The Commodity Branch will review each application against the criteria listed in section 1485.14(b) and (c) of the MAP regulations as well as in this Notice. The purpose of this review is to identify meritorious proposals and to recommend an appropriate funding level for each application based upon these criteria.

    (2) Phase 2—Competitive Review:

    Meritorious applications then will be passed on to the Office of the Deputy Administrator, Office of Trade Programs, for the purpose of allocating available funds among the applicants. Applicants will compete for funds on the basis of the following allocation criteria as applicable (the number in parentheses represents a percentage weight factor):

    (a) Applicant's Contribution Level (40)

    • The applicant's 4-year average share (2014-2017) of all contributions under the MAP (cash and goods and services provided by U.S. entities in support of overseas marketing and promotion activities) compared to the applicant's 4-year average share (2014-2017) of the funding level for all MAP Participants.

    (b) Past Performance (30)

    • The 3-year average share (2013-2015) of the value of exports promoted by the applicant compared to the applicant's 2-year average share (2015-2016) of the funding level for all MAP Participants plus, for those groups participating in the Cooperator program, the 2-year average share (2015-2016) of all Cooperator program budgets.

    (c) Projected Export Goals (15)

    • The total dollar value of projected exports promoted by the applicant for 2017 compared to the applicant's requested funding level.

    (d) Accuracy of Past Projections (15)

    • Actual exports for 2015 as reported in the 2017 MAP application compared to past projections of exports for 2015 as specified in the 2015 MAP application.

    The Commodity Branches' recommended funding levels for each applicant are converted to percentages of the total MAP funds available and then multiplied by each weight factor as described above to determine the amount of funds allocated to each applicant.

    2. Anticipated Announcement Date: Announcements of funding decisions for the MAP are anticipated during October 2016.

    VI. Award Administration Information

    1. Award Notices: FAS will notify each applicant in writing of the final disposition of its application. The FAS will send an approval letter and program agreement to each approved applicant. The approval letter and program agreement will specify the terms and conditions applicable to the project, including the levels of MAP funding and cost-share contribution requirements.

    2. Administrative and National Policy Requirements: Interested parties should review the MAP regulations, which are available at the following URL address: http://www.fas.usda.gov/programs/market-access-program-map. Hard copies may be obtained by contacting the Program Operations Division.

    3. Reporting: FAS requires various reports and evaluations from MAP Participants. Reporting requirements are detailed in sections 1485.22 and 1485.23 of the MAP regulations.

    VII. Agency Contact(s)

    For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by email: [email protected]

    Signed at Washington, DC, on the 25th of March, 2016. Bryce Quick, Acting Administrator, Foreign Agricultural Service, and Vice President, Commodity Credit Corporation.
    [FR Doc. 2016-07636 Filed 4-1-16; 8:45 am] BILLING CODE 3410-10-P
    DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Notice of Funds Availability: Inviting Applications for the Emerging Markets Program SUMMARY:

    The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Emerging Markets Program (EMP). The intended effect of this notice is to solicit applications from the private sector and from government agencies for fiscal year 2017 and to set out criteria for the award of funds under the program in October 2016. The EMP is administered by personnel of the Foreign Agricultural Service (FAS).

    DATES:

    To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Any applications received after this time will be considered only if funds are still available.

    FOR FURTHER INFORMATION CONTACT:

    Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by email: [email protected] Information is also available on the Foreign Agricultural Service Web site at http://www.fas.usda.gov/programs/emerging-markets-program-emp.

    SUPPLEMENTARY INFORMATION: A. Funding Opportunity Description

    Announcement Type: New.

    Catalog of Federal Domestic Assistance (CFDA) Number: 10.603.

    Authority: The EMP is authorized by section 1542(d)(1) of the Food, Agriculture, Conservation and Trade Act of 1990 (The Act), as amended. The EMP regulations appear at 7 CFR part 1486.

    1. Purpose. The EMP assists U.S. entities in developing, maintaining, or expanding exports of U.S. agricultural commodities and products by funding activities that improve emerging markets' food and rural business systems, including reducing potential trade barriers in such markets. The EMP is intended primarily to support export market development efforts of the private sector, but EMP resources may also be used to assist public organizations.

    All U.S. agricultural commodities, except tobacco, are eligible for consideration. Agricultural product(s) should be comprised of at least 50 percent U.S. origin content by weight, exclusive of added water, to be eligible for funding. Proposals that seek support for multiple commodities are also eligible. EMP funding may only be used to develop, maintain, or expand emerging markets for U.S. agricultural commodities and products through generic activities. EMP funding may not be used to support the export of another country's products to the United States, or to promote the development of a foreign economy as a primary objective.

    2. Appropriate Activities. All EMP projects must fall into at least one of the following four categories:

    (a) Assistance to teams consisting primarily of U.S. individuals expert in assessing the food and rural business systems of other countries. This type of EMP project must include all three of the following:

    • Conduct an assessment of the food and rural business system needs of an emerging market;

    • Make recommendations on measures necessary to enhance the effectiveness of these systems; and

    • Identify opportunities and projects to enhance the effectiveness of the emerging market's food and rural business systems.

    To be eligible, such proposals must clearly demonstrate that experts are primarily agricultural consultants, farmers, and other persons from the private sector and government officials, and that they have expertise in assessing the food and rural business systems of other countries.

    (b) Assistance to enable individuals from emerging markets to travel to the United States so that these individuals can, for the purpose of enhancing the food and rural business systems in their countries, become familiar with U.S. technology and agribusiness and rural enterprise operations by consulting with food and rural business system experts in the United States.

    (c) Assistance to enable U.S. agricultural producers and other individuals knowledgeable in agricultural and agribusiness matters to travel to emerging markets to assist in transferring their knowledge and expertise to entities in emerging markets. Such travel must be to emerging markets. Travel to developed markets is not eligible under the program even if the traveler's targeted market is an emerging market.

    (d) Technical assistance to implement the recommendations, projects, and/or opportunities identified under 2(a) above. Technical assistance that does not implement the recommendations, projects, and/or opportunities identified by assistance under 2(a) above is not eligible under the EMP.

    Proposals that do not fall into one or more of the four categories above, regardless of previous guidance provided regarding the EMP, are not eligible for consideration under the program.

    EMP funds may not be used to support normal operating costs of individual organizations, nor as a source to recover pre-award costs or prior expenses from previous or ongoing projects. Proposals that counter national strategies or duplicate activities planned or already underway by U.S. non-profit agricultural commodity or trade associations (“cooperators”) will not be considered. Other ineligible expenditures include: branded product promotions (e.g., in-store, restaurant advertising, labeling, etc.); advertising; administrative and operational expenses for trade shows; Web site development; equipment purchases; and the preparation and printing of brochures, flyers, and posters (except in connection with specific technical assistance activities such as training seminars). For a more complete description of ineligible expenditures, please refer to the EMP regulations.

    3. Eligible Markets. The Act defines an emerging market as any country that the Secretary of Agriculture determines:

    (a) Is taking steps toward developing a market-oriented economy through the food, agriculture, or rural business sectors of the economy of the country; and

    (b) Has the potential to provide a viable and significant market for U.S. agricultural commodities or products of U.S. agricultural commodities.

    Because EMP funds are limited and the range of potential emerging market countries is worldwide, consideration will be given only to proposals that target countries or regional groups with per capita income of less than $12,736 (the current ceiling on upper middle income economies as determined by the World Bank [World Development Indicators; July 2015, http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS]) and populations of greater than 1 million.

    Income limits and their calculation can change from year to year with the result that a given country may qualify under the legislative and administrative criteria one year, but not the next. Therefore, CCC has not established a fixed list of emerging market countries.

    A few countries technically qualify as emerging markets but may require a separate determination before funding can be considered because of political sensitivities.

    B. Award Information

    In general, all qualified proposals received before the application deadline will compete for EMP funding. The applicant's willingness to contribute resources, including cash, goods, and services, will be a critical factor in determining which proposals are funded under the EMP. Each proposal will also be judged on the potential benefits to the industry represented by the applicant and the degree to which the proposal demonstrates industry support.

    The limited funds and the range of eligible emerging markets worldwide generally preclude CCC from approving large budgets for individual projects. While there is no minimum or maximum amount set for EMP-funded projects, most projects are funded at a level of less than $500,000 and for a duration of approximately one year. Private entities may submit multi-year proposals requesting higher levels of funding that may be considered in the context of a detailed strategic implementation plan. Funding in such cases is generally limited to three years and provided one year at a time with commitments beyond the first year subject to interim evaluations and funding availability. Proposals from government entities are not eligible for multi-year funding.

    Funding for successful proposals will be provided through specific agreements. The CCC, through FAS, will be kept informed of the implementation of approved projects through the requirement to provide interim progress reports and final performance reports. Changes in the original project timelines and adjustments within project budgets must be approved in advance by FAS.

    Note:

    EMP funds awarded to government agencies must be expended or otherwise obligated by close of business, September 30, 2017.

    C. Eligibility and Qualification Information

    1. Eligible Applicants: Any U.S. private or government entity (e.g., universities, trade associations, agricultural cooperatives, state regional trade groups (SRTGs), state departments of agriculture, federal agencies, for-profit entities, and consulting businesses) with a demonstrated role or interest in exports of U.S. agricultural commodities or products may apply to the program. Proposals from research and consulting organizations will be considered if they provide evidence of substantial participation by and financial support from the U.S. industry. For-profit entities may not use program funds to conduct private business, promote private self-interests, supplement the costs of normal sales activities, or promote their own products or services beyond specific uses approved by CCC in a given project. Foreign organizations, whether government or private, may participate as third parties in activities carried out by U.S. organizations but are not eligible for direct funding assistance from the program.

    U.S. export market development cooperators and SRTGs may seek funding to address priority, market specific issues and to undertake technical assistance activities supported by an approved EMP assessment.

    2. Cost Sharing: No private sector proposal will be considered without the element of cost-share from the applicant and/or U.S. partners. The EMP is intended to complement, not supplant, the efforts of the U.S. private sector. There is no minimum or maximum amount of cost-share, though the degree of commitment to a proposed project, represented by the amount and type of private funding, is one factor used in determining which proposals will be approved for funding. Cost-share may be actual cash invested or professional time of staff assigned to the project. Proposals for which private industry is willing to commit cash, rather than in-kind contributions, such as staff resources, will be given priority consideration.

    Cost-sharing is not required for proposals from government agencies, but is mandatory for all other eligible entities, even when they may be party to a joint proposal with a government agency. Contributions from USDA or other government agencies or programs may not be counted toward the stated cost-share requirement of other applicants. Similarly, contributions from foreign (non-U.S.) organizations may not be counted toward the cost-share requirement, but may be counted in the total cost of the project.

    3. Other: Proposals should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance. Applicants may submit more than one proposal.

    D. Application and Submission Information

    1. Address To Request Application Package: EMP applicants have the opportunity to utilize the Unified Export Strategy (UES) application process, an online system that provides a means for interested applicants to submit a consolidated and strategically coordinated single proposal that incorporates funding requests for any or all of the market development programs administered by FAS.

    Applicants are strongly encouraged to submit their applications to FAS through the web-based UES application. The Internet-based format reduces paperwork and expedites FAS' processing and review cycle. Applicants planning to use the on-line UES system must contact the Program Operations Division to obtain site access information. The Internet-based application is located at the following URL address: https://www.fas.usda.gov/ues/webapp/.

    Although FAS highly recommends applying via the UES, applicants also have the option of submitting an electronic application to FAS at [email protected]

    2. Content and Form of Application Submission: To be considered for the EMP, an applicant must submit to FAS information required by this Notice of Funds Availability and the EMP regulations at 7 CFR part 1486. EMP regulations and additional information are available at the following URL address: http://www.fas.usda.gov/programs/emerging-markets-program-emp.

    In addition, in accordance with the Office of Management and Budget's issuance of a final policy (68 FR 38402 (June 27, 2003)) regarding the need to identify entities that are receiving government awards, all applicants must submit a Dun and Bradstreet Data Universal Numbering System (DUNS) number. An applicant may request a DUNS number at no cost by calling the dedicated toll-free DUNS number request line at (866) 705-5711.

    In addition, in accordance with 2 CFR part 25, each entity that applies to the EMP and does not qualify for an exemption under 2 CFR 25.110 must:

    (i) Provide a valid DUNS number in each application or plan it submits to CCC;

    (ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and

    (iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.

    Similarly, in accordance with 2 CFR part 170, each entity that applies to the EMP and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive EMP funding.

    Applications should be no longer than ten (10) pages and include the following information:

    (a) Date of proposal;

    (b) Name of organization submitting proposal;

    (c) Organization address, telephone, and fax;

    (d) Tax ID number;

    (e) DUNS number;

    (f) Primary contact person;

    (g) Full title of proposal;

    (h) Target market(s);

    (i) Specific description of activity/activities to be undertaken;

    (j) Clear demonstration that successful implementation will benefit an emerging market's food and rural business system and/or reduce potential trade barriers, and will benefit a particular industry as a whole, not just the applicant(s);

    (k) Current conditions in the target market(s) affecting the intended commodity or product;

    (l) Description of the need to assess the food and rural business systems of the emerging market, or of the recommendations, projects, and/or opportunities previously identified by an approved EMP assessment that are to be addressed by the project;

    (m) Project objectives;

    (n) Performance measures: Benchmarks for quantifying progress in meeting the objectives;

    (o) Rationale: Explanation of the underlying reasons for the project proposal and its approach, the anticipated benefits, and any additional pertinent analysis;

    (p) Explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance;

    (q) Timeline(s) for implementation of activity, including start and end dates;

    (r) Information on whether similar activities are or have previously been funded with USDA resources in the target country or countries (e.g., under the MAP and/or Cooperator programs);

    (s) Detailed line item activity budgets:

    • Cost items should be allocated separately to each participating organization;

    • Individual expense items constituting a proposed activity's overall budget (e.g., salaries, travel expenses, consultant fees, administrative costs, etc.) should be listed on separate line items, each clearly indicating:

    (1) Which items are to be covered by EMP funding;

    (2) Which are to be covered by the participating U.S. organization(s); and

    (3) Which are to be covered by foreign third parties (if applicable);

    • Cost line items for consultant fees should show the calculation of the daily rate and the number of days;

    • Cost line items for travel expenses should show the number of trips and the destination, cost, and objective for each trip; and

    (t) Qualifications of applicant(s) should be included as an attachment.

    3. Funding Restrictions: Certain types of expenses are not eligible for reimbursement by the program, and there are limits on other categories of expenses, such as indirect overhead charges, travel expenses, and consulting fees. CCC will also not reimburse unreasonable expenditures or expenditures made prior to approval of a proposal. Full details of the funding restrictions are available in the EMP regulations.

    4. Submission Dates and Times: EMP proposals are reviewed on a rolling basis during the fiscal year as long as EMP funding is available as set forth below:

    • Proposals received by 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered for funding with other proposals received by that date;

    • Proposals not approved for funding during the review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;

    • Proposals received after 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered in the order received for funding only if funding remains available.

    5. Other Submission Requirements: All Internet-based applications must be properly submitted by 5 p.m., Eastern Daylight Time, June 3, 2016, in order to be considered for funding; late submissions received after the deadline will be considered only if funding remains available. All applications submitted by email must be received by 5 p.m. Eastern Daylight Time, June 3, 2016, at [email protected] in order to receive the same consideration.

    E. Application Review Information

    1. Criteria: Key criteria used in judging proposals include:

    Evaluation criteria. FAS will consider a number of factors when reviewing proposals, including:

    • Appropriateness of the Activity, including the ability of the applicant to provide an experienced U.S.-based staff with knowledge and expertise to ensure adequate development, supervision, and execution of the proposed project; the entity's willingness to contribute resources, including cash and goods and services of the U.S. industry, with greater weight given to cash contributions (for private sector proposals only); and the conditions or constraints affecting the level of U.S. exports and market share for the agricultural commodity/product (30%);

    • Market Impact, including the degree to which the proposed project is likely to contribute to the development, maintenance, or expansion of U.S. agricultural exports to emerging markets; demonstration of how a proposed project will benefit a particular industry as a whole; and the quality of the project's proposed performance measures (50%); and

    • Completeness and Viability of the proposal along with past program results and evaluations, if applicable (20%).

    Please see 7 CFR part 1486 for additional evaluation criteria.

    2. Review and Selection Process: All applications undergo a multi-phase review within FAS, by appropriate FAS field offices, and, as needed, by the private sector Advisory Committee on Emerging Markets to determine the qualifications, quality, and appropriateness of projects and the reasonableness of project budgets.

    F. Federal Award Administration Information

    1. Award Notices: FAS will notify each applicant in writing of the final disposition of the submitted application. FAS will send an approval letter and project agreement to each approved applicant. The approval letter and agreement will specify the terms and conditions applicable to the project, including the levels of EMP funding and cost-share contribution requirements.

    2. Administrative and National Policy Requirements: Interested parties should review the EMP regulations, which are available at the following URL address: http://www.fas.usda.gov/programs/emerging-markets-program-emp.

    3. Reporting. Quarterly progress reports for all programs one year or longer in duration are required. Projects of less than one year generally require a mid-term progress report. Final performance reports are due 90 days after completion of each project. Content requirements for both types of reports are contained in the Project Agreement. Final financial reports are also due 90 days after completion of each project as attachments to the final reports. Please see 7 CFR part 1486 for additional reporting requirements.

    G. Federal Awarding Agency Contact(s)

    For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by email: [email protected]

    Signed at Washington, DC, on 25th day of March, 2016. Bryce Quick, Acting Administrator, Foreign Agricultural Service and Vice President, Commodity Credit Corporation.
    [FR Doc. 2016-07638 Filed 4-1-16; 8:45 am] BILLING CODE 3410-10-P
    DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Notice of Funds Availability: Inviting Applications for the Technical Assistance for Specialty Crops Program

    Announcement Type: New.

    Catalog of Federal Domestic Assistance (CFDA) Number: 10.604.

    SUMMARY:

    The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Technical Assistance for Specialty Crops (TASC) program. The intended effect of this notice is to solicit applications from the private sector and from government agencies for fiscal year 2017 and to set out criteria for the award of funds in October 2016. The TASC program is administered by personnel of the Foreign Agricultural Service (FAS).

    DATES:

    To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Any applications received after this time will be considered only if funds are still available.

    FOR FURTHER INFORMATION CONTACT:

    Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by email: [email protected] Information is also available on the FAS Web site at http://www.fas.usda.gov/programs/technical-assistance-specialty-crops-tasc.

    SUPPLEMENTARY INFORMATION: A. Funding Opportunity Description

    Authority: The TASC program is authorized by section 3205 of Pub. L. 107-171. TASC regulations appear at 7 CFR part 1487.

    Purpose: The TASC program is designed to assist U.S. organizations by providing funding for projects that address sanitary, phytosanitary, or technical barriers that prohibit or threaten the export of U.S. specialty crops. U.S. specialty crops, for the purpose of the TASC program, are defined to include all cultivated plants, or the products thereof, produced in the United States except wheat, feed grains, oilseeds, cotton, rice, peanuts, sugar, and tobacco.

    Prior to the enactment of the Agricultural Act of 2014 (Act) on February 7, 2014, the TASC program was not available to address technical barriers to trade except for those that were related to sanitary or phytosanitary issues. The Act amended the statute authorizing the TASC program to allow the program to be used to address technical barriers to trade regardless of whether the barriers are related to a sanitary or phytosanitary barrier. The TASC regulations have been amended to reflect the recent statutory change.

    As a general matter, TASC program projects should be designed to address the following criteria:

    • Projects should identify and address a sanitary, phytosanitary, or technical barrier that prohibits or threatens the export of U.S. specialty crops;

    • Projects should demonstrably benefit the represented industry rather than a specific company or brand;

    • Projects must address barriers to exports of commercially-available U.S. specialty crops for which barrier removal would predominantly benefit U.S. exports; and

    • Projects should include an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance.

    Examples of expenses that CCC may agree to reimburse under the TASC program include, but are not limited to: Initial pre-clearance programs, export protocol and work plan support, seminars and workshops, study tours, field surveys, development of pest lists, pest and disease research, reasonable logistical and administrative support, and travel and per diem expenses.

    B. Award Information

    In general, all qualified proposals received before the specified application deadline will compete for funding. The limited funds and the range of barriers affecting the exports of U.S. specialty crops worldwide preclude CCC from approving large budgets for individual projects. Proposals requesting more than $500,000 in any given year will not be considered. Additionally, private entities may submit multi-year proposals that may be considered in the context of a detailed strategic implementation plan. The maximum duration of an activity is five years. Funding in such cases may, at FAS' discretion, be provided one year at a time with commitments beyond the first year subject to interim evaluations and funding availability. In order to validate funding eligibility, proposals must specify previous years of TASC funding for each proposed activity/title/market/constraint combination. Government entities are not eligible for multi-year funding.

    Applicants may submit multiple proposals, and applicants with previously approved TASC proposals may apply for additional funding. The number of approved projects that a TASC participant can have underway at any given time is five. Please see 7 CFR part 1487 for additional restrictions.

    FAS will consider providing either grant funds as direct assistance to U.S. organizations or technical assistance on behalf of U.S. organizations, provided that the organization submits timely and qualified proposals. FAS will review all proposals against the evaluation criteria contained in the program regulations.

    Funding for successful proposals will be provided through specific agreements. These agreements will incorporate the proposal as approved by FAS. FAS must approve in advance any subsequent changes to the project. FAS or another Federal agency may be involved in the implementation of approved projects.

    C. Eligibility Information

    1. Eligible Applicants: Any U.S. organization, private or government, with a demonstrated role or interest in exporting U.S. agricultural commodities may apply to the program. Government organizations consist of Federal, State, and local agencies. Private organizations include non-profit trade associations, universities, agricultural cooperatives, state regional trade groups, and private companies.

    Foreign organizations, whether government or private, may participate as third parties in activities carried out by U.S. organizations, but are not eligible for direct funding assistance from the program.

    2. Cost Sharing or Matching: FAS considers the applicant's willingness to contribute resources, including cash, goods, and services of the U.S. industry and foreign third parties, when determining which proposals are approved for funding.

    3. Funding Justification: Proposals should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance.

    D. Application and Submission Information

    1. Application through the Unified Export Strategy (UES): Organizations are strongly encouraged to submit their applications to FAS through the web-based UES application. Using the UES application process reduces paperwork and expedites FAS's processing and review cycle. Applicants planning to use the UES system must contact FAS' Program Operations Division to obtain site access information, including a user ID and password. The UES Internet-based application may be found at the following URL address: https://www.fas.usda.gov/ues/webapp/.

    Although FAS highly recommends applying via the web-based UES application, applicants have the option of submitting an electronic version to FAS at [email protected]

    2. Content and Form of Application Submission: All TASC proposals must contain complete information about the proposed projects as described in § 1487.5(b) of the TASC program regulations. In addition, in accordance with the Office of Management and Budget's policy directive (68 FR 38402 (June 27, 2003)) regarding the need to identify entities that are receiving government awards, all applicants must submit a Dun and Bradstreet Data Universal Numbering System (DUNS) number. An applicant may request a DUNS number at no cost by calling the dedicated toll-free DUNS number request line at (866) 705-5711.

    In addition, in accordance with 2 CFR part 25, each entity that applies to the TASC and does not qualify for an exemption under 2 CFR 25.110 must:

    (i) Provide a valid DUNS number in each application or plan it submits to CCC;

    (ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and

    (iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.

    Similarly, in accordance with 2 CFR part 170, each entity that applies to the TASC program and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive TASC funding.

    Incomplete applications and applications that do not otherwise conform to this announcement will not be accepted for review.

    3. Submission Dates and Times: TASC proposals are reviewed on a rolling basis during the fiscal year as long as TASC funding is available as set forth below:

    • Proposals received by 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered for funding with other proposals received by that date;

    • Proposals not approved for funding during the review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;

    • Proposals received after 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered in the order received for funding only if funding remains available.

    Notwithstanding the foregoing, a proposal may be submitted for expedited consideration under the TASC Quick Response process if, in addition to meeting all requirements of the TASC program, a proposal clearly identifies a time-sensitive activity. In these cases, a proposal may be submitted at any time for an expedited evaluation. Such a proposal must include a specific request for expedited evaluation.

    FAS will track the time and date of receipt of all proposals.

    4. Funding Restrictions: Although funded projects may take place in the United States or abroad, all eligible projects must specifically address sanitary, phytosanitary, or technical barriers to the export of U.S. specialty crops.

    Certain types of expenses are not eligible for reimbursement by the program, such as the costs of market research, advertising, or other promotional expenses, and will be set forth in the written program agreement between CCC and the participant. CCC will also not reimburse unreasonable expenditures or any expenditure made prior to approval of a proposal.

    5. Other Submission Requirements: All applications must be properly submitted through the UES by 5 p.m., Eastern Daylight Time, June 3, 2016, in order to be considered for funding; late submissions received after the deadline will be considered only if funding remains available. All applications submitted by email must be received by 5 p.m. Eastern Daylight Time, June 3, 2016, at [email protected] in order to receive the same consideration.

    E. Application Review Information

    1. Criteria: FAS follows the evaluation criteria set forth in § 1487.6 of the TASC regulations. Reviewers will evaluate according to the following criteria:

    (1) The nature of the specific export barrier and the extent to which the proposal is likely to successfully remove, resolve, or mitigate that barrier (12.5%);

    (2) The potential trade impact of the proposed project on market retention, market access, and market expansion, including the potential for expanding commercial sales in the targeted market (12.5%);

    (3) The completeness and viability of the proposal. Among other things, this can include the cost of the project and the amount of other resources dedicated to the project, including cash, goods, and services of the U.S. industry and foreign third parties (15%);

    (4) The ability of the organization to provide an experienced staff with the requisite technical and trade experience to execute the proposal (15%);

    (5) The extent to which the proposal is targeted to a market in which the United States is generally competitive (17.5%);

    (6) The degree to which time is essential to addressing specific export barriers (5%);

    (7) The ability of the applicant to provide a broad base of producer representation (12.5%);

    (8) The effectiveness and potential of the performance measures (10%);

    2. Review and Selection Process: FAS will review proposals for eligibility and will evaluate each proposal against the criteria referred to above. The purpose of this review is to identify meritorious proposals, recommend an appropriate funding level for each proposal based upon these factors, and submit the proposals and funding recommendations to the Deputy Administrator, Office of Trade Programs. FAS may, when appropriate, request the assistance of other U.S. government subject area experts in evaluating the merits of a proposal.

    F. Award Administration Information

    1. Federal Award Notices: FAS will notify each applicant in writing of the final disposition of the submitted application. FAS will send an approval letter and agreement to each approved applicant. The approval letter and agreement will specify the terms and conditions applicable to the project, including levels of funding, timelines for implementation, and written evaluation requirements.

    2. Administrative and National Policy Requirements: The agreements will incorporate the details of each project as approved by FAS. Each agreement will identify terms and conditions pursuant to which CCC will reimburse certain costs of each project. Agreements will also outline the responsibilities of the participant. Interested parties should review the TASC program regulations found at 7 CFR part 1487 in addition to this announcement. TASC program regulations are available at the following URL address: http://www.fas.usda.gov/programs/technical-assistance-specialty-crops-tasc. Hard copies may be obtained by contacting the Program Operations Division at (202) 720-4327.

    3. Reporting: TASC participants will be required to submit regular interim reports and a final performance report, each of which evaluate the TASC project using the performance measures presented in the approved proposal, as set forth in the written program agreement.

    G. Federal Awarding Agency Contact

    For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by e-mail: [email protected]

    Signed at Washington, DC on the 25th of March, 2016. Bryce Quick, Acting Administrator, Foreign Agricultural Service, and Vice President, Commodity Credit Corporation.
    [FR Doc. 2016-07633 Filed 4-1-16; 8:45 am] BILLING CODE 3410-10-P
    DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Notice of Funds Availability: Inviting Applications for the Quality Samples Program

    Announcement Type: New.

    Catalog of Federal Domestic Assistance (CFDA) Number: 10.605.

    SUMMARY:

    The Commodity Credit Corporation (CCC) announces it is inviting proposals for the 2017 Quality Samples Program (QSP). The intended effect of this notice is to solicit applications from eligible applicants for fiscal year 2017 and to set out the criteria for the award of funds under the program in October 2016. QSP is administered by personnel of the Foreign Agricultural Service (FAS).

    DATES:

    To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Any applications received after this time will be considered only if funds are still available.

    FOR FURTHER INFORMATION CONTACT:

    Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by email: [email protected] Information is also available on the FAS Web site at http://www.fas.usda.gov/programs/quality-samples-program-qsp.

    SUPPLEMENTARY INFORMATION: A. Funding Opportunity Description

    Authority: QSP is authorized under Section 5(f) of the CCC Charter Act, 15 U.S.C. 714c(f).

    Purpose: QSP is designed to encourage the development and expansion of export markets for U.S. agricultural commodities by assisting U.S. entities in providing commodity samples to potential foreign importers to promote a better understanding and appreciation for the high quality of U.S. agricultural commodities.

    QSP participants will be responsible for procuring (or arranging for the procurement of) commodity samples, exporting the samples, and providing the on-site technical assistance necessary to facilitate successful use of the samples by importers. Participants that are funded under this announcement may seek reimbursement from QSP for the sample purchase price and for the cost of transporting the samples domestically to the port of export and then to the foreign port or point of entry. Transportation costs from the foreign port or point of entry to the final destination are not eligible for reimbursement. CCC will not reimburse the costs incidental to purchasing and transporting samples, such as: Inspection or documentation fees, certificates of any kind, tariffs, etc. Although providing technical assistance is required for all projects, QSP will not reimburse the costs of providing technical assistance. A QSP participant will be reimbursed after CCC reviews its reimbursement claim and determines that the claim is complete.

    General Scope of QSP Projects: QSP projects are the activities undertaken by a QSP participant to provide an appropriate sample of a U.S. agricultural commodity to a foreign importer, or a group of foreign importers, in a given market. The purpose of the project is to provide information to an appropriate target audience regarding the attributes, characteristics, and proper use of the U.S. commodity. A QSP project addresses a single market/commodity combination.

    As a general matter, QSP projects should conform to the following guidelines:

    • Projects should benefit the represented U.S. industry and not a specific company or brand;

    • Projects should develop a new market for a U.S. product, promote a new U.S. product, or promote a new use for a U.S. product rather than promote the substitution of one established U.S. product for another;

    • Commodities provided under a QSP project must be available on a commercial basis and in sufficient supply;

    • The QSP project must either subject the commodity sample to further processing or substantial transformation in the importing country, or the sample must be used in technical seminars in the importing country designed to demonstrate to an appropriate target audience the proper preparation or use of the sample in the creation of an end product;

    • Samples provided in a QSP project shall not be directly used as part of a retail promotion or supplied directly to consumers. However, the end product (that is, the product resulting from further processing, substantial transformation, or a technical preparation seminar) may be provided to end-use consumers to demonstrate to importers consumer preference for that end product;

    • Samples shall be in quantities less than a typical commercial sale and limited to the amount sufficient to achieve the project goal (e.g., not more than a full commercial mill run in the destination country); and

    • Projects should be completed within one year of CCC approval.

    QSP projects shall target foreign importers and audiences who:

    • Have not previously purchased the U.S. commodity that will be transported under QSP;

    • Are unfamiliar with the variety, quality attributes, or end-use characteristics of the U.S. commodity;

    • Have been unsuccessful in previous attempts to import, process, and market the U.S. commodity (e.g., because of improper specification, blending, formulation, sanitary, or phytosanitary issues);

    • Are interested in testing or demonstrating the benefits of the U.S. commodity; or

    • Need technical assistance in processing or using the U.S. commodity.

    B. Award Information

    Under this announcement, the number of projects per participant will not be limited. However, individual projects will be limited to $75,000 of QSP reimbursement. Projects comprised only of technical preparation seminars (that is, projects that do not include further processing or substantial transformation of the sample) will be limited to $15,000 of QSP reimbursement due to the need for smaller samples. Financial assistance will be made available on a reimbursement basis only; cash advances will not be made available to any QSP participant.

    All proposals will be reviewed against the evaluation criteria contained herein and funds will be awarded on a competitive basis. Funding for successful proposals will be provided through specific agreements between the applicant and CCC. These agreements will incorporate the proposal as approved by FAS. FAS must approve in advance any subsequent changes to the project.

    C. Eligibility Information

    1. Eligible Applicants: Any United States private or government entity with a demonstrated role or interest in exporting U.S. agricultural commodities may apply to the program. Government organizations consist of Federal, State, and local agencies. Private organizations include non-profit trade associations, universities, agricultural cooperatives, state regional trade groups, and profit-making entities.

    2. Cost Sharing: FAS considers the applicant's willingness to contribute resources, including cash, goods, and services of the U.S. industry and foreign third parties, when determining which proposals to approve for funding.

    3. Proposals should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance. Applicants may submit more than one proposal.

    D. Application and Submission Information

    1. Address to Request Application Package: Organizations shall submit their QSP applications to FAS through the web-based Uniform Export Strategy (UES) application. The UES allows applicants to submit a single consolidated and strategically coordinated proposal that incorporates requests for funding for virtually all of the FAS marketing programs, financial assistance programs, and market access programs. The suggested UES format encourages applicants to examine the constraints or barriers to trade that they face, identify activities that would help overcome such impediments, consider the entire pool of complementary marketing tools and program resources, and establish realistic export goals.

    Applicants must contact FAS' Program Operations Division to obtain UES Web site access information. The Internet-based application may be found at the following URL address: https://www.fas.usda.gov/ues/webapp/.

    2. Content and Form of Application Submission: To be considered for QSP, an applicant must submit to FAS, via the UES, information detailed in this notice. Additionally, in accordance with the Office of Management and Budget's policy directive (68 FR 38402 (June 27, 2003)) regarding the need to identify entities that are receiving government awards, all applicants must submit a Dun and Bradstreet Data Universal Numbering System (DUNS) number. An applicant may request a DUNS number at no cost by calling the dedicated toll-free DUNS number request line at (866) 705-5711.

    In addition, in accordance with 2 CFR part 25, each entity that applies to the QSP and does not qualify for an exemption under 2 CFR 25.110 must:

    (i) Provide a valid DUNS number in each application or plan it submits to CCC;

    (ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and

    (iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.

    Similarly, in accordance with 2 CFR part 170, each entity that applies to the QSP and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive QSP funding.

    Incomplete applications and applications that do not otherwise conform to this announcement will not be accepted for review.

    Proposals should contain, at a minimum, the following:

    (a) Organizational information, including:

    • Organization's name, address, Chief Executive Officer (or designee), Federal Tax Identification Number (TIN), and DUNS number;

    • Type of organization;

    • Name, telephone number, fax number, and email address of the primary contact person;

    • A description of the organization and its membership;

    • A description of the organization's prior export promotion experience; and

    • A description of the organization's experience in implementing an appropriate trade/technical assistance component.

    (b) Market information, including:

    • An assessment of the market;

    • A long-term strategy in the market; and

    • U.S. export value/volume and market share (historic and goals) for 2010-2016.

    (c) Project information, including:

    • A brief project title;

    • The amount of funding requested;

    • The beginning and end dates for the proposed project;

    • A brief description of the specific market development trade constraint or opportunity to be addressed by the project;

    • A description of the activities planned to address the constraint or opportunity, including how the sample will be used in the end-use performance trial, the attributes of the sample to be demonstrated and its end-use benefit, and details of the trade/technical servicing component (including who will provide and fund this component);

    • The performance measures that will be used to benchmark performance and measure the effectiveness of the project, the long-term sales to the market, and the benefits to the represented industry;

    • A description of the sample to be provided (i.e., commodity, quantity, quality, type, and grade), including a justification for why a sample with such characteristics is needed (this justification should explain why the project could not be effective with a smaller sample);

    • An itemized list of all estimated costs associated with the project for which reimbursement will be sought;

    • The importer's role in the project regarding handling and processing the commodity sample; and

    • An explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance;

    (d) Information indicating all funding sources and amounts to be contributed by each entity that will supplement implementation of the proposed project. This may include the organization that submitted the proposal, private industry entities, host governments, foreign third parties, CCC, FAS, or other Federal agencies. Contributed resources may include cash, goods, or services.

    3. Submission Dates and Times: QSP applications are reviewed on a rolling basis during the fiscal year as long as QSP funding is available as set forth below:

    • Proposals received by 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered for funding with other proposals received by that date;

    • Proposals not approved for funding during this review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;

    • Proposals received after 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered in the order received for funding only if funding remains available.

    4. Other Submission Requirements: All applications must be properly submitted through the UES by 5 p.m., Eastern Daylight Time, June 3, 2016, in order to be considered for funding; submissions received after this deadline will be considered only if funding remains available.

    5. Funding Restrictions: Proposals that request more than $75,000 of CCC funding for individual projects will not be considered. Projects comprised only of technical preparation seminars will be limited to $15,000 in QSP funding. CCC will not reimburse unreasonable expenditures or expenditures made prior to approval of a proposal.

    E. Application Review Information

    1. Criteria and Review Process: FAS will use the following criteria in evaluating QSP proposals, each weighted at 10%:

    • The income, population, or market share growth potential in the proposed market;

    • Benefits of project would accrue to entire industry, not a single company;

    • The proposed sample size is appropriate to the project;

    • The ability of the organization to provide an experienced staff with the requisite technical and trade experience to execute the proposal;

    • The extent to which the proposal is targeted to a market in which the United States is generally competitive;

    • The potential for expanding commercial sales in the proposed market;

    • The nature of the specific market constraint or opportunity identified and how well it is addressed by the proposal;

    • The extent to which the importer's contribution in terms of handling and processing enhances the potential outcome of the project;

    • The amount of reimbursement requested and the organization's willingness to contribute resources, including cash, goods, and services of the U.S. industry and foreign third parties; and

    • How well the proposed technical assistance component assures that performance trials will effectively demonstrate the intended end-use benefit.

    FAS will also review and evaluate how well the following unweighted criteria are addressed in the proposal:

    • The quality of the performance measures and how effective they will be in demonstrating the impact of the project;

    • The assessment of the market;

    • The long-term strategy in the market; and

    • Export goals in each country.

    Proposals will be evaluated by the appropriate Commodity Branch in FAS' Cooperator Programs Division. The Commodity Branches will review each proposal against the factors described above. The purpose of this review is to identify meritorious proposals, recommend an appropriate funding level for each proposal based upon these factors, and submit proposals and funding recommendations to the Deputy Administrator, Office of Trade Programs.

    2. Anticipated Announcement Date: Announcements of funding decisions for QSP are anticipated during October 2016.

    F. Award Administration Information

    1. Award Notices: FAS will notify each applicant in writing of the final disposition of the submitted application. FAS will send an approval letter and agreement to each approved applicant. The approval letter and agreement will specify the terms and conditions applicable to the project, including the levels of QSP funding and any cost-share contribution requirements.

    2. Administrative and National Policy Requirements: The agreements will incorporate the details of each project as approved by FAS. Each agreement will identify terms and conditions pursuant to which CCC will reimburse certain costs of each project. Agreements will also outline the responsibilities of the participant, including, but not limited to, procurement (or arranging for procurement) of the commodity sample at a fair market price, arranging for transportation of the commodity sample within the time limit specified in the agreement (organizations should endeavor to ship commodities within 6 months of the effective date of the agreement), compliance with cargo preference requirements (shipment on United States flag vessels, as required), compliance with the Fly America Act requirements (shipment on United States air carriers, as required), timely and effective implementation of technical assistance, and submission of a written evaluation report within 90 days of expiration or termination of the agreement.

    QSP projects are subject to review and verification by FAS' Compliance, Security and Emergency Planning Division. Upon request, a QSP participant shall provide to CCC the original documents that support the participant's reimbursement claims. CCC may deny a claim for reimbursement if the claim is not supported by adequate documentation.

    3. Reporting: A written evaluation report must be submitted via the UES within 90 days of the expiration or termination of each participant's QSP agreement. Evaluation reports should address all performance measures that were presented in the proposal.

    G. Agency Contact(s)

    For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture by courier: Room 6512, 1400 Independence Ave. SW., Washington, DC 20250, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by email: [email protected]

    Signed at Washington, DC, on the 25th of March, 2016. Bryce Quick, Acting Administrator, Foreign Agricultural Service, and Vice President, Commodity Credit Corporation.
    [FR Doc. 2016-07635 Filed 4-1-16; 8:45 am] BILLING CODE 3410-10-P
    DEPARTMENT OF AGRICULTURE Forest Service Ashley Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Ashley Resource Advisory Committee (RAC) will meet in Vernal, Utah. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: http://cloudapps-usda-gov.force.com/FSSRS/RAC_Page?id=001t0000002JcvKAAS.

    DATES:

    Meeting will be held from 6:00 p.m. to 8:00 p.m. on April 20, 2016.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at Ashley National Forest (NF) Supervisor's Office, 355 North Vernal Avenue, Vernal, Utah.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Ashley NF Supervisor's Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Louis Haynes, RAC Coordinator, by phone at 435-781-5105 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Conduct a final evaluation and roll call;

    2. Vote on each submitted project; and

    3. Finalize recommendations for funding of project long forms for the Designated Federal Officer's approval.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by April 6, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Attention: Louis Haynes, RAC Coordinator, Ashley NF Supervisor's Office, 355 North Vernal Avenue, Vernal, Utah 84078; by email to [email protected], or via facsimile to 435-781-5142.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: March 25, 2016. Dustin Bambrough, Acting Forest Supervisor.
    [FR Doc. 2016-07568 Filed 4-1-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Rural Utilities Service Information Collection Activity; Comment Request AGENCY:

    Rural Utilities Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested.

    DATES:

    Comments on this notice must be received by June 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, Rural Development, United States Department of Agriculture, 1400 Independence Avenue SW., STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-4492. FAX: (202) 720-8435. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for extension.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., STOP 1522, Washington, DC 20250-1522. FAX: (202) 720-8435. Email: [email protected]

    Title: Wholesale Contracts for the Purchase and Sale of Electric Power.

    OMB Control Number: 0572-0089.

    Type of Request: Extension of a currently approved information collection.

    Abstract: Most RUS financed electric systems are cooperatives and are organized in a two-tiered structure. Retail customers are members of the distribution system that provides electricity to their homes and business. Distribution cooperatives, in turn, are members of power supply cooperatives, also known as generation and transmission cooperatives (G&T's) that generate or purchase power and transmit the power to the distribution systems.

    For a distribution system, a lien on the borrower's assets generally represents adequate security. However, since most G&T revenues flow from its distribution members, RUS requires, as a condition of a loan or loan guarantee to a G&T the long-term requirements wholesale power contract to purchase their power from the G&T at rates that cover all the G&T's expenses, including debt service and margins. RUS Form 444 is the standard form of the wholesale power contract. The Form is used by RUS G&T borrowers to enter into agreement with their distribution members for purchase of power from the G&T. Most borrowers adapt this form to meet their specific needs. The contract is prepared and executed by the G&T and each member and by RUS and the information allows RUS to determine credit quality and credit worthiness to determine repayment ability for loans and loan guarantees.

    Estimate of Burden: Public reporting burden for this collection of information is estimated to average 6 hours per response.

    Respondents: Small business or other for-profit; not-for-profit organizations.

    Estimated Number of Respondents: 20.

    Estimated Number of Responses per Respondent: 1.

    Estimated Total Annual Burden on Respondents: 120 hours.

    Copies of this information collection can be obtained from Rebecca Hunt, RUS Program Development and Regulatory Analysis, at (202) 205-3660; Facsimile: (202) 720-8435 or Email: [email protected]

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Dated: March 28, 2016. Brandon McBride, Administrator, Rural Utilities Service.
    [FR Doc. 2016-07506 Filed 4-1-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160316249-6249-01] XRIN 0691-XC051 BE-15: Annual Survey of Foreign Direct Investment in the United States AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Annual Survey of Foreign Direct Investment in the United States (BE-15). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-15. A completed report covering a reporting company's fiscal year ending during the previous calendar year is due by May 31 (or by June 30 for reporting companies that use BEA's eFile system). This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-15 survey forms and instructions are available on the BEA Web site at www.bea.gov/fdi.

    Definitions

    (a) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (b) Foreign, when used in a geographic sense, means that which is situated outside the United States or which belongs to or is characteristic of a country other than the United States.

    (c) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (d) Business enterprise means any organization, association, branch, or venture that exists for profit-making purposes or to otherwise secure economic advantage, and any ownership of any real estate.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from each U.S. business enterprise in which a foreign person has a direct and/or indirect ownership interest of at least 10 percent of the voting stock in an incorporated business enterprise, or an equivalent interest in an unincorporated business enterprise, and that meets the additional conditions detailed in Form BE-15.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on the operations of U.S. affiliates of foreign companies.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-15 inquiries can be made by phone to (202) 606-5615 or by sending an email to be12/[email protected]

    When To Report: A completed report covering a reporting company's fiscal year ending during the previous calendar year is due by May 31 (or by June 30 for reporting companies that use BEA's eFile system).

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0034.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 18.2 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0034, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07460 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160303194-6194-01] XRIN: 0691-XC043 BE-37: Quarterly Survey of U.S. Airline Operators' Foreign Revenues and Expenses AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of U.S. Airline Operators' Foreign Revenues and Expenses (BE-37). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-37. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-37 survey form and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from each U.S. person whose total covered revenues or total covered expenses were $500,000 or more during the previous year, or are expected to be $500,000 or more during the current year.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on U.S. airline operators' foreign revenues and expenses.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-37 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 45 days after the end of each calendar quarter.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0011. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 4 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0011, Washington DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07468 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160304201-6201-01] XRIN 0691-XC049 BE-577: Quarterly Survey of U.S. Direct Investment Abroad—Transactions of U.S. Reporter With Foreign Affiliate AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of U.S. Direct Investment Abroad—Transactions of U.S. Reporter with Foreign Affiliate (BE-577). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-577. Reports are due 30 days after the close of each calendar or fiscal quarter; 45 days if the report is for the final quarter of the financial reporting year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-577 survey forms and instructions are available on the BEA Web site at www.bea.gov/dia.

    Definitions

    (a) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (b) Foreign, when used in a geographic sense, means that which is situated outside the United States or which belongs to or is characteristic of a country other than the United States.

    (c) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (d) Business enterprise means any organization, association, branch, or venture that exists for profit-making purposes or to otherwise secure economic advantage, and any ownership of any real estate.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from each U.S. person that has a direct and/or indirect ownership interest of at least 10 percent of the voting stock in an incorporated foreign business enterprise, or an equivalent interest in an unincorporated foreign business enterprise, and that meets the additional conditions detailed in Form BE-577.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on transactions between parent companies and their affiliates and on direct investment positions (stocks).

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey form and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-577 inquiries can be made by phone to (202) 606-5557 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 30 days after the close of each calendar or fiscal quarter; 45 days if the report is for the final quarter of the financial reporting year.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0004. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 1 hour per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0004, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07472 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160304199-6199-01] XRIN 0691-XC047 BE-125: Quarterly Survey of Transactions in Selected Services and Intellectual Property With Foreign Persons AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of Reporting Requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons (BE-125). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-125. Reports are due 45 days after the end of each fiscal quarter except for the final quarter. After the end of fiscal year of the U.S. person, reports must be filed within 90 days. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-125 survey form and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from each U.S. person who had sales of covered services or intellectual property to foreign persons that exceeded $6 million during the previous fiscal year, or are expected to exceed that amount during the current fiscal year; or had purchases of covered services or intellectual property from foreign persons that exceeded $4 million during the previous fiscal year, or are expected to exceed that amount during the current fiscal year. Because the thresholds are applied separately to sales and purchases, the reporting requirements may apply only to sales, only to purchases, or to both sales and purchases.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on U.S. international trade in selected services and intellectual property.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-125 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 45 days after the end of each fiscal quarter, except for the final quarter of the reporter's fiscal year when reports must be filed within 90 days.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0067. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 18 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0067, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07470 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160304202-6202-01] XRIN: 0691-XC050 BE-605: Quarterly Survey of Foreign Direct Investment in the United States—Transactions of U.S. Affiliate With Foreign Parent AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Foreign Direct Investment in the United States—Transactions of U.S. Affiliate with Foreign Parent (BE-605). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-605. Reports are due 30 days after the close of each calendar or fiscal quarter; 45 days if the report is for the final quarter of the financial reporting year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-605 survey forms and instructions are available on the BEA Web site at www.bea.gov/fdi.

    Definitions

    (a) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (b) Foreign, when used in a geographic sense, means that which is situated outside the United States or which belongs to or is characteristic of a country other than the United States.

    (c) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (d) Business enterprise means any organization, association, branch, or venture that exists for profit-making purposes or to otherwise secure economic advantage, and any ownership of any real estate.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from each U.S. business enterprise in which a foreign person has a direct and/or indirect ownership interest of at least 10 percent of the voting stock in an incorporated business enterprise, or an equivalent interest in an unincorporated business enterprise, and that meets the additional conditions detailed in Form BE-605.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on transactions between parent companies and their affiliates and on direct investment positions (stocks).

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey form and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-605 inquiries can be made by phone to (202) 606-5577 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 30 days after the close of each calendar or fiscal quarter; 45 days if the report is for the final quarter of the financial reporting year.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0009. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 1 hour per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0009, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07471 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160304195-6195-01] RIN 0691-XC044 BE-30: Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of U.S. Carriers AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of U.S. Carriers (BE-30). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-30. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-30 survey form and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from each U.S. person whose total covered revenues or total covered expenses were $500,000 or more during the previous year, or are expected to be $500,000 or more during the current year.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on U.S. ocean freight carriers' foreign revenues and expenses.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-30 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 45 days after the end of each calendar quarter.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0011. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 4 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0011, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07465 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160304197-6197-01] RIN 0691-XC045 BE-150: Quarterly Survey of Payment Card and Bank Card Transactions Related to International Travel AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Payment Card and Bank Card Transactions Related to International Travel (BE-150). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-150. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-150 survey forms and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) U.S. credit card companies and personal identification number (PIN)-based debit network companies that process payment and bank card transactions between U.S. cardholders and foreign businesses and between foreign cardholders and U.S. businesses.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on the credit, debit, charge, automated teller machine (ATM), and point of sale transactions of U.S. persons traveling abroad and foreign persons traveling in the United States.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-150 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 45 days after the end of each calendar quarter.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0072. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 16 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0072, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07474 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160304198-6198-01] XRIN 0691-XC046 BE-45: Quarterly Survey of Insurance Transactions by U.S. Insurance Companies With Foreign Persons AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons (BE-45). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-45. Reports are due 60 days after the end of each calendar quarter, or 90 days after the close of the calendar year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-45 survey form and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from U.S. persons whose covered transactions exceeded $8 million (positive or negative) during the prior calendar year, or are expected to exceed that amount during the current calendar year.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on cross-border insurance transactions between U.S. insurance companies and foreign persons.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-45 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 60 days after the end of each calendar quarter, or 90 days after the close of the calendar year.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0066. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 8 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0066, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07469 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160303193-6193-01] XRIN: 0691-XC042 BE-29: Annual Survey of Foreign Ocean Carriers' Expenses in the United States AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Annual Survey of Foreign Ocean Carriers' Expenses in the United States (BE-29). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-29. Reports are due 90 days after the end of each calendar year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-29 survey form and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    (e) Carriers means owners or operators of dry cargo, passenger (including cruise and combination) and tanker vessels, including very large crude carriers (VLCCs), calling at U.S. ports.

    (f) Foreign Carriers means those carriers whose residence is outside the United States, including those who own or operate their own chartered (U.S.-flag or foreign-flag) vessels. They also include foreign subsidiaries of U.S. companies operating their own or chartered vessels as carriers for their own accounts.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from U.S. agents of foreign carriers who handle 40 or more port calls in the reporting period by foreign ocean vessels, or have total annual covered expenses for all foreign ocean vessels handled by the U.S. agent of $250,000 or more.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What to Report: This survey collects information on foreign ocean carriers' expenses in the United States.

    How to Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-29 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 90 days after the end of each calendar year.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0012. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 3 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0012, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07462 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160303190-6190-01] XRIN 0691-XC040 BE-9: Quarterly Survey of Foreign Airline Operators' Revenues and Expenses in the United States AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Foreign Airline Operators' Revenues and Expenses in the United States (BE-9). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-9. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-9 survey form and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from U.S. offices, agents, or other representatives of foreign airline operators that transport freight, express, and passengers to or from the United States and whose total covered revenues or total covered expenses were $5,000,000 or more during the previous year, or are expected to be $5,000,000 or more during the current year.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on foreign airline operators' revenues and expenses in the United States.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-9 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 45 days after the end of each calendar quarter.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0068. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 6 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0068, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07464 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160303191-6191-01] XRIN 0691-XC041 BE-11: Annual Survey of U.S. Direct Investment Abroad AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Annual Survey of U.S. Direct Investment Abroad (BE-11). This survey is authorized by the International Investment and Trade in Services Survey Act.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-11. A completed report covering a reporting company's fiscal year ending during the previous calendar year is due by May 31. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-11 survey forms and instructions are available on the BEA Web site at www.bea.gov/dia.

    Definitions

    (a) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (b) Foreign, when used in a geographic sense, means that which is situated outside the United States or which belongs to or is characteristic of a country other than the United States.

    (c) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (d) Business enterprise means any organization, association, branch, or venture that exists for profit-making purposes or to otherwise secure economic advantage, and any ownership of any real estate.

    Reporting

    Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.

    Who Must Report: (a) Reports are required from each U.S. person that has a direct and/or indirect ownership interest of at least 10 percent of the voting stock in an incorporated foreign business enterprise, or an equivalent interest in an unincorporated foreign business enterprise, and that meets the additional conditions detailed in Form BE-11.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on the operations of U.S. parent companies and their foreign affiliates.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-11 inquiries can be made by phone to (202) 606-5566 or by sending an email to be10/[email protected]

    When To Report: A completed report covering a reporting company's fiscal year ending during the previous calendar year is due by May 31.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0053. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 138 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0053, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108.

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07463 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Bureau of Economic Analysis [Docket No. 160304200-6200-01] XRIN: 0691-XC048 BE-185: Quarterly Survey of Financial Services Transactions Between U.S. Financial Services Providers and Foreign Persons AGENCY:

    Bureau of Economic Analysis, Commerce.

    ACTION:

    Notice of reporting requirements.

    SUMMARY:

    By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons (BE-185). This survey is authorized by the International Investment and Trade in Services Survey Act and by Section 5408 of the Omnibus Trade and Competitiveness Act of 1988.

    SUPPLEMENTARY INFORMATION:

    This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-185. Reports are due 45 days after the end of each fiscal quarter, except for the final quarter of the U.S. person's fiscal year when reports must be filed within 90 days. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 et seq.), and 15 CFR part 801. Survey data on international trade in services and direct investment that are not collected pursuant to the 2012 rule are described separately in 15 CFR part 801. The BE-185 survey form and instructions are available on the BEA Web site at www.bea.gov/ssb.

    Definitions

    (a) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the U.S. Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency).

    (b) U.S. person means any person resident in the United States or subject to the jurisdiction of the United States.

    (c) United States, when used in a geographic sense, means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.

    (d) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States.

    Reporting

    Who Must Report: (a) Reports are required from each U.S. person who had sales of covered financial services to foreign persons that exceeded $20 million during the previous fiscal year, or are expected to exceed that amount during the current fiscal year; or had purchases of covered financial services from foreign persons that exceeded $15 million during the previous fiscal year, or are expected to exceed that amount during the current fiscal year. Because the thresholds are applied separately to sales and purchases, the reporting requirements may apply only to sales, only to purchases, or to both sales and purchases.

    (b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

    What To Report: The survey collects information on transactions in the covered financial services between U.S. financial services providers and foreign persons.

    How To Report: Reports can be filed using BEA's electronic reporting system at www.bea.gov/efile. Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, can be downloaded from the BEA Web site given above. Form BE-185 inquiries can be made by phone to BEA at (202) 606-5588 or by sending an email to [email protected]

    When To Report: Reports are due to BEA 45 days after the end of each fiscal quarter, except for the final quarter of the reporter's fiscal year when reports must be filed within 90 days.

    Paperwork Reduction Act Notice

    This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0065. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 10 hours per response. Additional information regarding this burden estimate may be viewed at www.reginfo.gov; under the Information Collection Review tab, click on “Search” and use the above OMB control number to search for the current survey instrument. Send comments regarding this burden estimate to Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and to the Office of Management and Budget, Paperwork Reduction Project 0608-0065, Washington, DC 20503.

    Authority:

    22 U.S.C. 3101-3108 and 15 U.S.C. 4908(b).

    Brian C. Moyer, Director, Bureau of Economic Analysis.
    [FR Doc. 2016-07473 Filed 4-1-16; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-909] Certain Steel Nails From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2013-2014 Correction

    In notice document 2016-05994 beginning on page 14092 in the issue of Wednesday, March 16, 2016, make the following correction:

    Due to numerous errors, the table on page 14094 is being reprinted in its entirety to read as follows:

    Exporter Weighted-
  • average
  • margin
  • (percent)
  • Stanley 11.95 Chiieh Yung Metal Ind. Corp. 11.95 Dezhou Hualude Hardware Products Co., Ltd. 11.95 Hebei Cangzhou New Century Foreign Trade Co., Ltd. 11.95 Nanjing Caiqing Hardware Co., Ltd. 11.95 Qingdao D&L Group Ltd. 11.95 SDC International Aust. PTY. Ltd. 11.95 Shandong Dinglong Import & Export Co., Ltd 11.95 Shanghai Curvet Hardware Products Co., Ltd. 11.95 Shanghai Yueda Nails Industry Co., Ltd 11.95 Shanxi Hairui Trade Co., Ltd. 11.95 Shanxi Pioneer Hardware Industrial Co., Ltd. 11.95 Shanxi Tianli Industries Co., Ltd. 11.95 S-Mart (Tianjin) Technology Development Co., Ltd. 11.95 Suntec Industries Co., Ltd. 11.95 Tianjin Jinchi Metal Products Co., Ltd. 11.95 Tianjin Jinghai County Hongli Industry & Business Co., Ltd. 11.95 Tianjin Lianda Group Co., Ltd. 11.95 Tianjin Universal Machinery Imp. & Exp. Corporation 11.95 Tianjin Zhonglian Metals Ware Co., Ltd. 11.95 Xi'an Metals & Minerals Import & Export Co., Ltd. 11.95
    [FR Doc. C1-2016-05994 Filed 4-1-16; 8:45 am] BILLING CODE 1505-01-D
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE548 New England Fishery Management Council; Public Meeting AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

    DATES:

    The meeting will be held on Tuesday, Wednesday and Thursday, April 19, 20, and 21, 2016. It will start at 9 a.m. on April 19, and at 8:30 a.m. on both April 20 and 21.

    ADDRESSES:

    The meeting will be held at the Mystic Hilton Hotel, 20 Coogan Boulevard, Mystic, CT 06355; telephone: (860) 572-0731, or online at http://hiltonmystic.com/.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950; telephone: (978) 465-0492.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492, ext. 113.

    SUPPLEMENTARY INFORMATION: Agenda Tuesday, April 19, 2016

    After introductions and any announcements, the Council meeting will open with brief reports from the NEFMC Chairman and Executive Director, the NOAA Regional Administrator for the Greater Atlantic Region (GAR), Northeast Fisheries Science Center and Mid-Atlantic Fishery Management Council liaisons, NOAA General Counsel and Office of Law Enforcement representatives, and staff from the Atlantic States Marine Fisheries Commission and the U.S Coast Guard. Following these reports, the Council will receive two others from representatives of the Northeast Fisheries Science Center; the first is on the status of the Northeast continental shelf ecosystem; and a second will cover scientific efforts to assess the vulnerability of fish stocks to climate change. Next, the NEFMC's Ecosystem-Based Fisheries Management Committee will provide an update on its progress to develop a working example of a fisheries ecosystem plan. After a lunch break, the Council will discuss and prepare comments on NOAA Fisheries draft National Bycatch Strategy and the agency's proposed draft Standardized Bycatch Reporting Methodology.

    Wednesday, April 20, 2016

    The second day of the meeting will begin with an overview of progress to develop Amendment 22 to the Northeast Multispecies Fishery Management Plan. The Council is considering a limited access program for the whiting/hake fishery via this action. A public comment period is then scheduled during which any member of the public may bring issues forward that relate to Council business but are not included on the published agenda for this meeting. During this morning session, the Atlantic Herring Committee will provide a briefing on progress on Amendment 8 to the Herring FMP, an action that would address: (1) Localized depletion; and (2) long-term harvest strategies for Atlantic herring, including an acceptable biological catch (ABC) control rule that explicitly accounts for herring's role in the ecosystem. The Committee report will also include discussion of plans for a workshop on a management strategy evaluation of the herring ABC control rule and a request that the Council initiate a framework adjustment to revise the Georges Bank haddock catch cap accountability measures. After a lunch break and during a discussion about NOAA's Omnibus Industry-Funded Monitoring Amendment, the Council also will, in cooperation with NOAA, discuss and refine existing alternatives and possibly select preferred alternatives for target levels of monitoring coverage in the Atlantic herring fishery. Approval of the associated draft Environmental Assessment will occur at the NEFMC's June Council meeting. Under the Sea Scallop Committee's agenda item, discussions are planned in which NEFMC members will review results of the Council‐sponsored workshop to address concerns about scallop fishing pressure in nearshore areas. They will also review a draft outline and work plan for the five-year performance review of the limited access general category IFQ program and hear information about increased fishing activity in the Northern Gulf of Maine management area. If warranted, the NEFMC may initiate an action at this meeting to address this last topic.

    Thursday, April 21, 2016

    The final meeting day will begin with a report from the Council's Habitat Committee Chair. After a review of work to date, the committee will ask for Council approval of the Omnibus Deep-Sea Coral Amendment management alternatives for the purpose of further development and analyses. A presentation is then scheduled on the draft Northeast Regional Ocean Plan. The next report will address plans for a peer review (fall 2016) of the in-season discard methodology to be used by NOAA Fisheries. The report will include a discussion of the terms of reference approved by the Northeast Regional Coordinating Committee. Following a mid-day lunch break, and under the auspices of the Groundfish Committee, there will be: a progress report on work to evaluate the groundfish monitoring program, and an update on other groundfish priorities for 2016, including windowpane flounder management measures and improving the process to develop recreational fishery management measures. The Council will adjourn after it addresses any other outstanding business during the afternoon of April 21st.

    Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies (see ADDRESSES) at least 5 days prior to the meeting date.

    Dated: March 29, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-07557 Filed 4-1-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE460 Takes of Marine Mammals Incidental to Specified Activities; Sand Quality Study Activities at the Children's Pool Beach, La Jolla, California AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice; proposed Incidental Harassment Authorization (IHA); request for comments.

    SUMMARY:

    NMFS has received an application from the City of San Diego for an IHA to take small numbers of marine mammals, by Level B harassment, incidental to the conduct of sand quality study activities at the Children's Pool Beach in La Jolla, California. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to the City of San Diego to take, by Level B harassment only, three species of marine mammals during the specified activities.

    DATES:

    Comments and information must be received no later than May 4, 2016.

    ADDRESSES:

    Comments on the IHA application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is [email protected] NMFS is not responsible for email comments sent to addresses other than the one provided here. Comments sent via email, including all attachments, must not exceed a 25-megabyte size.

    All comments received are a part of the public record and will generally be posted to http://www.nmfs.noaa.gov/pr/permits/incidental/ without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

    An electronic copy of the IHA application containing a list of the references used in this document may be obtained by visiting the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental/. In case of problems accessing these documents, please call the contact listed below. Documents cited in this notice, including the IHA application, may also be viewed, by appointment, during regular business hours, at the aforementioned address.

    FOR FURTHER INFORMATION CONTACT:

    Dale Youngkin, Office of Protected Resources, NMFS, 301-427-8401.

    SUPPLEMENTARY INFORMATION: Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.), direct the Secretary of Commerce (Secretary) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals, by United States citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    Authorization for the incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

    Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) of the MMPA establishes a 45-day time limit for NMFS's review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of small numbers of marine mammals. Within 45 days of the close of the public comment period, NMFS must either issue or deny the authorization.

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Summary of Request

    On December 14, 2015, NMFS received an application from the City of San Diego, Transportation & Storm Water Department, Storm Water Division, requesting an IHA for the taking of marine mammals incidental to the conduct of sand quality study activities. NMFS determined that the IHA application was adequate and complete on February 25, 2016.

    The City of San Diego would undertake the proposed sand quality sampling activities between June 1, 2016 and December 14, 2016 at the Children's Pool Beach in La Jolla, California. Visual stimuli due to the presence of technicians on the beach and their sand sample collection activities during the study has the potential to result in the take of marine mammals through behavioral disturbance. The requested IHA would authorize the take, by Level B (behavioral) harassment, of small numbers of Pacific harbor seals (Phoca vitulina richardii), California sea lions (Zalophus californianus), and northern elephant seals (Mirounga angustirostris) incidental to sand quality sampling activities of the Children's Pool Beach at La Jolla, CA. Additional information on the sand quality sampling activities at the Children's Pool Beach is contained in the IHA application, which is available electronically (see ADDRESSES).

    Description of the Proposed Specified Activity Overview

    The City of San Diego plans to conduct a sand quality study at the Children's Pool Beach in La Jolla, CA in order to fulfill a special condition that was part of a permit issued by the California Coastal Commission (Commission). The special provision required a feasibility study to analyze the sand quality, and methods for improving sand quality, at Children's Pool Beach. Children's Pool Beach is currently listed on the Clean Water Act Section 303(d) list as impaired for Fecal Indicator Bacteria (FIB). Additionally, researchers have identified pinniped molting and excrement as a potential source of mercury to the environment (McHuron, Harvey et al. 2014, Cossaboon, Ganguli et al. 2015). The sand quality study will analyze the current extent and magnitude of FIB and mercury contamination in the beach sand at Children's Pool Beach, and will assess several possible variable effects including tidal cycles, wave regimes, sand depth, and seasonal variability during the effective dates of the IHA.

    The California Coastal Commission's permit certified the City's request to amend its Land Use Plan. Specifically, the City's amendment included revisions to allow seasonal closure at Children's Pool Beach during the Pacific harbor seal pupping season, generally from December 15 to May 15 of every year. The amendment applies only to Children's Pool Beach, and is intended to allow special protection of the harbor seals at Children's Pool Beach during the vulnerable months of their pupping season.

    The sand quality sampling activities would involve teams of two to three people collecting sand samples for approximately four hours along transects parallel to the shoreline between the water line and the seawall/bluff railing. Sixteen sampling events are proposed for the sand quality study period between June 1 and December 14, 2016. Sand sample collection would involve grab samples of surface layer sand (surface up to 20 cm of sand to be collected with a sterilized spoon). A small subset of samples per event would be collected from the subsurface via narrow plastic cores (approximately 5 centimeters [cm] by 60 cm) driven into the sand by hand to the extent possible, and then sunk to the desired depth with a small rubber mallet. Approximately 21 samples would be collected per event. Visual stimuli due to the presence of researchers on the beach collecting sand samples would potentially result in behavioral disturbance of pinnipeds hauled out on the beach, which would equate to a take under the MMPA.

    Proposed Dates and Duration

    The City of San Diego is planning to begin the project at the Children's Pool in La Jolla, CA after the beach is opened to the public in May, with completion of the sand sampling activities to be completed prior to closure of the beach to the public in December, 2016. The City of San Diego and NMFS are requiring a moratorium on all sand sampling activities during harbor seal pupping and weaning (i.e., December 15th to May 15th). A moratorium on sampling activities would also be required for an additional two weeks prior to initiating the sand collection activities in order to accommodate late-weaning pups. Therefore, work on this project would only be performed between June 1st and December 14th of 2016.

    Proposed sand sampling activities would occur during daylight hours only, as stipulated in the IHA application. In addition, prior to sand sampling events, the beach would be surveyed for the presence of northern fur seals and/or Guadalupe fur seals. If either of these species are observed hauled out or in the water at Children's Pool Beach, sand sampling would not commence. This precaution is included due to the unusually high number of strandings of fur seals along the entire California coast beginning in January, 2015, which has resulted in the declaration of an Unusual Mortality Event (UME) for Guadalupe fur seal (http://www.nmfs.noaa.gov/pr/health/mmume/guadalupefurseals2015.html). In addition, an UME has been declared, and has been ongoing since 2013, for California sea lion pups and yearling due to elevated strandings of pups in Southern California (http://www.nmfs.noaa.gov/pr/health/mmume/

    californiasealions2013.htm). While there have been relatively high numbers of strandings of Guadalupe fur seals coast-wide in California, the presence of this species in California, and at Children's Pool Beach in particular, would be considered extremely rare due to the fact that they prefer isolated rocky haul out sites (Riedman, 1990). As the presence of fur seals at this location would be such a rare event, it is likely that the animal would be sick or injured if it were to be present. Therefore, sand sampling activities would not be conducted and coordination with the stranding network and/or a period of observation would commence, as described in further detail below. Take of fur seals would not be authorized under this IHA. Proposed Specific Geographic Region

    The La Jolla Children's Pool Beach is located at 850 Coast Boulevard, La Jolla, CA 92037 (32°50′51.18″ North, 117°16′41.94″ West). All sand quality sampling events will take place at Children's Pool Beach. The locations of the beach and the study area can be found in the City of San Diego's IHA application.

    Detailed Description of the Proposed Specified Activities

    The Children's Pool was created in 1931 by building a breakwater wall which created a protected pool for swimming. Although partially filled with sand, the Children's Pool still has open water for swimming and a beach for sunbathing and beachcombing. The Children's Pool and nearby shore areas (i.e., shoreline, beaches, and reefs of La Jolla) are used by swimmers, sunbathers, SCUBA divers and snorkelers, shore/surf fishermen, school classes, tide pool explorers, kayakers, surfers, boogie and skim boarders, seal, sea lion, bird and nature watchers, and for other activities by the general public. As such, Children's Pool Beach is a highly disturbed urban environment, and seals have been documented to respond less sensitively to stimuli compared to seals at other sites (Hanan, 2004, Hanan & Associates 2011; Hanan and Hanan 2014; Hahn 2010). Per Dr. Doyle Hanan, who has a long history of work with seals at this location, harbor seals hauled out at Children's Pool Beach generally are habituated to the environment, and allow approaches of up to two to three meters before showing signs of disturbance.

    All sand sampling activities will take place on the sandy beach area. Samples will be collected along transects parallel to the shoreline between the water's edge and the bluff/railing, while ensuring a distance of at least three meters (m) from any pinnipeds on the beach. Samples would consist of grab samples from the surface, with a subset of samples collected approximately 25 to 50 cm below the sand surface by using a hollow tube (approximately 5 cm by 60 cm) driven into the sand by hand and/or with a small rubber mallet with minimal digging.

    All sand sampling events will be conducted during daylight hours, and each sampling event would be approximately four hours in duration. Sampling events will be scheduled to the maximum extent practicable to occur during the daily period of lowest haul out occurrence (generally 8:30 a.m.-3:30 p.m.). Because the City of San Diego already closes the Children's Pool Beach during harbor seal pupping season (December 15 through May 15), work on this project will be performed between June 1 and December 14, 2016, and up to 16 sampling events would be conducted during this timeframe. The first six sand sampling events are planned to occur soon after June 1, 2016. The first three sampling events (Phase 1a) are designed to maximize sampling area and to capture critical conditions when FIB may be at their highest concentrations. During each Phase 1a event, three transects parallel to the shoreline at the swash zone, the high-tide line, and the supralittoral zone will be established relative to the seawall railing and three surface sand (SS) FIB samples (top 2 centimeters) will be collected across each of the transects at approximately left, middle, and right beach. In addition, subsurface sand (SbS) FIB samples will also be collected at three of the nine SS sampling location during each event at approximately 25-50 centimeters below the surface. A maximum of 21 FIB samples, including field replicates, will be collected for each Phase 1a monitoring event, for an approximate maximum Phase 1a total of 63 FIB samples. The remaining three sampling events (Phase 1b) will consist of biased sampling based on Phase 1a preliminary findings. The study design for Phase 1b will be finalized in consultation with the City. A maximum of 21 FIB samples, including field replicates, will be collected for each Phase 1b monitoring event, for an approximate maximum Phase 1b total of 63 FIB samples. These early test results can then be compared with additional test results from up to 10 additional sampling events that could be collected during the warmer, high-public-use summer and fall months.

    Description of Marine Mammals in the Specified Geographic Area of the Proposed Specified Activity

    Information on marine mammal species for which take would be authorized is included below. Further information on the biology and local distribution of these marine mammal species and others in the region can be found in the NMFS Marine Mammal Stock Assessment Reports, which are available online at: http://www.nmfs.noaa.gov/pr/sars/.

    Three species of pinnipeds are known to occur in the Children's Pool proposed action area and off the Pacific coastline (see Table 1 below). Pacific harbor seals are the most common species likely to be found within the immediate vicinity of the activity area. California sea lions and northern elephant seals may also be found within the immediate vicinity of the activity area, but are more rare occurrences than harbor seals. Northern fur seals and Guadalupe fur seals are even more rarely observed at this location (Northern and Guadalupe fur seals have been seen observed at nearby beaches on rare occasions, and a northern fur seal was observed hauled out at La Jolla Cove, which is less than a mile from Children's Pool, per a personal communication with Dr. Hanan [February 4, 2016], a scientist with extensive knowledge of the area and the species occurring there). Fur seals are not known to haul out in such urban mainland beaches, and their presence would likely be attributed to sickness or injury if they were observed in this location. Therefore, only three species are considered to be potentially exposed to effects of the proposed sand sampling activities, as sand sampling activities would not be conducted if fur seals were present and coordination with the stranding network would commence. A variety of other marine mammal species have on occasion been reported in the coastal waters off southern California. However, none of these species have been reported to occur in the immediate proposed action area of the Children's Pool Beach. Therefore, NMFS does not expect, and does not propose to authorize, incidental take of marine mammal species other than Pacific harbor seals, California sea lions, and northern elephant seals from the proposed specified activities. Table 1 below provides information on these marine mammal species, their habitat, and conservation status in the nearshore area of the general region of the proposed project area.

    Table 1—The Habitat, Abundance, and Conservation Status of Pacific Harbor Seals, California Sea Lions, and Northern Elephant Seals Species Habitat Occurrence Range Best population
  • estimate
  • (minimum) 1
  • ESA 2 MMPA 3
    Pacific harbor seal (Phoca vitulina richardii) Coastal Common Coastal temperate to polar regions in Northern Hemisphere 30,968 (27,348)—California stock NL NC. Northern elephant seal (Mirounga angustirostris) Coastal, pelagic when not migrating Common Eastern and Central North Pacific—Alaska to Mexico 179,000 (81,368)—California breeding stock NL NC. California sea lion (Zalophus californianus) Coastal, shelf Common Eastern North Pacific Ocean—Alaska to Mexico 296,750 (153,337)—U.S. stock NL NC. NA = Not available or not assessed. 1 NMFS Marine Mammal Stock Assessment Reports. 2 U.S. Endangered Species Act: EN = Endangered, T = Threatened, DL = Delisted, and NL = Not listed. 3 U.S. Marine Mammal Protection Act: D = Depleted, S = Strategic, and NC = Not classified.
    Pacific Harbor Seal

    Harbor seals are widely distributed in the North Atlantic and North Pacific. Two subspecies exist in the Pacific Ocean: P. v. stejnegeri in the western North Pacific near Japan, and P. v. richardii in the eastern North Pacific. The subspecies in the eastern North Pacific Ocean inhabits near-shore coastal and estuarine areas from Baja California, Mexico, to the Pribilof Islands in Alaska. These seals do not make extensive pelagic migrations, but do travel 300 to 500 kilometers (km) (162 to 270 nautical miles [nmi]) on occasion to find food or suitable breeding areas; (Herder 1986, Harvey and Goley 2011). Previous assessments of the status of harbor seals have recognized three stocks along the west coast of the continental U.S.: (1) California, (2) Oregon and Washington outer coast waters, and (3) inland waters of Washington. An unknown number of harbor seals also occur along the west coast of Baja California, at least as far south as Isla Asuncion, which is about 100 miles south of Punta Eugenia. Animals along Baja California are not considered to be a part of the California stock because it is not known if there is any demographically significant movement of harbor seals between California and Mexico and there is no international agreement for joint management of harbor seals. Harbor seal presence at haul-out sites is seasonal with peaks in abundance during their pupping and molting periods. Pupping and molting periods are first observed to the south and progress northward up the coast with time (e.g., January to May near San Diego, April to June in Oregon and Washington) (Jeffries 1984, Huber, Jeffries et al. 2001); Hanan, 2004; Hanan & Associates, 2011).

    In California, approximately 400 to 600 harbor seal haul-out sites are distributed along the mainland coast and on offshore islands, including intertidal sandbars and ledges, rocky shores and islets, and beaches (Harvey et al., 1995; Hanan, 1996; Lowry et al., 2008). Preferred haul-out sites are those that are protected from the wind and waves, and allow access to deep water for foraging (Perrin, Würsig et al. 2008). Of the known haul-out sites, 14 locations are rookeries (2 locations have multiple sites, for a total of 17 sites) on or near the mainland of California. The population of harbor seals has grown off the U.S. west coast and has led to new haul-out sites being used in California (Hanan, 1996). Harbor seals are one of the most common and frequently observed marine mammals along the coastal environment.

    The Children's Pool area is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA (321.9 km [200 miles]). The number of harbor seals in this area has increased since 1979, and they have been documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). Pacific harbor seals haul-out year-round on beaches and rocks (i.e., breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area) below the lifeguard tower at Children's Pool. According to Yochem (2005), the Children's Pool beach site is used by harbor seals at all hours of the day and at all tides with the exception of occasional high tide/high swell events in which the entire beach is awash. Harbor seals are documented to give birth on these beaches during December through May (Hanan, 2004; Hanan & Associates, 2011). The official start to pupping season is December 15 at Children's Pool Beach. Females in an advanced stage of pregnancy begin to show up on the Children's Pool beach by late October to early November. Several studies have identified harbor seal behavior and estimated harbor seal numbers including patterns of daily and seasonal area use (Yochem and Stewart, 1998; Hanan & Associates, 2011; Linder, 2011). Males, females, and pups (in season) of all ages and stages of development are observed at the Children's Pool and adjacent areas.

    Children's Pool is one of the three known haul-out sites for this species in San Diego County. These animals have been observed in this area moving to/from the Children's Pool, exchanging with the rocky reef directly west of and adjacent to the breakwater and with Seal Rock, which is about 150 m (492 ft) west of the Children's Pool. Harbor seals have also been reported on the sandy beach just southwest of the Children's Pool. At low tide, additional space for hauling-out is available on the rocky reef areas outside the retaining wall and on beaches immediately southward. Haul-out times vary by time of year, from less than an hour to many hours. There have been no foraging studies at this site, but harbor seals have been observed in nearshore waters and kelp beds nearby, including La Jolla Cove.

    In southern California, a considerable amount of information is known about the movements and ecology of harbor seals, but population structure in the region is not as well known (Stewart and Yochem, 1994, 2000; Keper et al., 2005; Hanan & Associates, 2011). Linder (2011) suggests that this population moves along the California coast and the beach at Children's Pool is part of a “regional network of interconnected” haul-out and pupping sites. Harbor seals often haul-out in protected bays, inlets, and beaches (Reeves et al., 1992). At and near the Children's Pool, harbor seals haul-out on the sand, rocks, and breakwater base in numbers of 0 to 15 harbor seals to a maximum of about 150 to 250 harbor seals depending on the time of day, season, and weather conditions (Hanan, 2004, Hanan & Associates, 2011; Linder, 2011). Because space is limited behind the breakwater at the Children's Pool, Linder (2011) predicted that it is unlikely that numbers will exceed 250 harbor seals. Based on monitoring from a camera, Western Alliance for Nature (WAN) reported that during the month of May 2013 up to 302 harbor seals were documented resting on the Children's Pool beach at any given time, with additional harbor seals on the rocks and in the water (Wan, personal communication). Almost every day, except for weekends, over 250 individual harbor seals were present on the beach. During the months of September 2012 to January 2013, the average number of harbor seals on the beach varied from 83 to 120 animals before people entered the beach or when people were behind the rope. During this same period, when people were on the beach and/or across the rope, the average number of harbor seals varied from 7 to 27. The City of San Diego observed 12 counts totaling more than 200 and a maximum of 238 animals during the 2014 to 2015 construction window. The weather (i.e., wind and/or rain) and the proximity of humans to the beach likely affect the presence of harbor seals on the beach.

    Radio-tagging and photographic studies have revealed that only a portion of seals utilizing a hauling-out site are present at any specific moment or day (Hanan, 1996, 2005; Gilbert et al., 2005; Harvey and Goley, 2011; and Linder, 2011). These radio-tagging studies indicate that harbor seals in Santa Barbara County haul-out about 70 to 90% of the days annually (Hanan, 1996). The City of San Diego expects harbor seals to behave similarly at the Children's Pool. Tagged and branded harbor seals from other haul-out sites have been observed by Dr. Hanan at the Children's Pool. For example, harbor seals with red-stained heads and coats, which are typical of some harbor seals in San Francisco Bay have been observed at Children's Pool, indicating that seals tagged at other locations and haul-out sites visit the site. A few seals have been tagged at the Children's Pool and there are no reports of these tagged animals at other sites (probably because of very low re-sighting efforts and a small sample size [10 individuals radio-tagged]), which may indicate a degree of site-fidelity (Yochem and Stewart, 1998). These studies further indicate that seals are constantly moving along the coast including to/from the offshore islands and that there may be as many as 600 individual harbor seals using Children's Pool during a year, but certainly not all at one time.

    The City of San Diego has fitted a polynomial curve to the number of expected harbor seals hauling-out at the Children's Pool by month (see Figure 2 of the IHA application and Figure 1 below) based on counts at the Children's Pool by Hanan (2004), Hanan & Associates (2011), Yochem and Stewart (1998), and the Children's Pool docents (Hanan, 2004).

    EN04AP16.001

    A complete count of all harbor seals in California is impossible because some are always away from the haul-out sites. A complete pup count (as is done for other pinnipeds in California) is also not possible because harbor seals are precocial, with pups entering the water almost immediately after birth. Population size is estimated by counting the number of seals ashore during the peak haul-out period (May to July) and by multiplying this count by a correction factor equal to the inverse of the estimated fraction of seals on land. Based on the most recent harbor seal counts (2009) and including a revised correction factor, the estimated population of harbor seals in California is 30,196 individuals (NMFS, 2011), with an estimated minimum population of 26,667 for the California stock of harbor seals. Counts of harbor seals in California increased from 1981 to 2004. The harbor seal is not listed under the ESA and the California stock is not considered depleted or strategic under the MMPA (Carretta et al., 2010).

    California Sea Lion

    The California sea lion is a separate species from the Galapagos sea lion (Zalophus wollebaeki) and the extinct Japanese sea lion (Zalophus japonicus) (Brunner, 2003; Wolf et al., 2007; Schramm et al., 2009), and is found from southern Mexico to southwestern Canada. The breeding areas of the California sea lion are on islands located in southern California, western Baja California, and the Gulf of California. A genetic analysis of California sea lions identified five genetically distinct geographic populations: (1) Pacific Temperate, (2) Pacific Subtropical, (3) Southern Gulf of California, (4) Central Gulf of California, and (5) Northern Gulf of California (Schramm et al., 2009). In that study, the Pacific Temperate population included rookeries within U.S. waters and the Coronados Islands just south of U.S./Mexico border. Animals from the Pacific Temperate population range north into Canadian waters, and movement of animals between U.S. waters and Baja California waters has been documented, though the distance between the major U.S. and Baja California rookeries is at least 740.8 km (400 nmi). Males from western Baja California rookeries may spend most of the year in the United States.

    The entire California sea lion population cannot be counted because all age and sex classes are never ashore at the same time. In lieu of counting all sea lions, pups are counted during the breeding season (because this is the only age class that is ashore in its entirety), and the numbers of births is estimated from the pup count. The size of the population is then estimated from the number of births and the proportion of pups in the population. Censuses are conducted in July after all pups have been born. There are no rookeries at or near the Children's Pool, although in the past two years births have been reported at La Jolla Cove (about 0.75 km [0.47 miles] east of Children's Pool). Population estimates for the U.S. stock of California sea lions range from a minimum of 153,337 to an average estimate of 296,750 animals. The California sea lion is not listed under the ESA and the U.S. stock is not considered depleted or strategic under the MMPA.

    The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. On infrequent occasions, one or two California sea lions have been observed on the sand or rocks at or near the Children's Pool (i.e., breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area). These sites are not usual haul-out locations for California sea lions. The City of San Diego commissioned two studies of harbor seal abundance trends at the Children's Pool. Both studies reported that appearances of California sea lions are infrequent, but not rare at Children's Pool (Yochem and Stewart 1998); Hanan, 2004; Hanan & Associates, 2011). During 2013, the City of San Diego observed one juvenile and three adult California sea lions at the Children's Pool. During 2014, the City of San Diego observed 22 California sea lions (during 19 days) at the Children's Pool. Adult sea lions were also observed hauling out on rocks and cliffs near the Children's Pool. A report from 2015 monitoring is still in process at this time.

    Northern Elephant Seal

    Northern elephant seals breed and give birth in California (U.S.) and Baja California (Mexico), primarily on offshore islands (Stewart et al., 1994) from December to March (Stewart and Huber, 1993). Spatial segregation in foraging areas between males and females is evident from satellite tag data (Le Beouf et al., 2000). Males migrate to the Gulf of Alaska and western Aleutian Islands along the continental shelf to feed on benthic prey, while females migrate to pelagic areas in the Gulf of Alaska and the central North Pacific to feed on pelagic prey (Le Beouf et al., 2000). Adults return to land between March and August to molt, with males returning later than females. Adults return to their feeding areas again between their spring/summer molting and their winter breeding seasons.

    Populations of northern elephant seals in the U.S. and Mexico have recovered after being nearly hunted to extinction (Stewart et al., 1994). Northern elephant seals underwent a severe population bottleneck and loss of genetic diversity when the population was reduced to an estimated 10 to 30 individuals (Hoelzel et al., 2002). However, movement and genetic exchange continues between rookeries when they start breeding (Huber et al., 1991). The California breeding population is now demographically isolated from the Baja California population. The California breeding population is considered in NMFS's stock assessment report to be a separate stock.

    A complete population count of elephant seals is not possible because all age classes are not ashore simultaneously. Elephant seal population size is typically estimated by counting the number of pups produced and multiplying by the inverse of the expected ratio of pups to total animals (McCann, 1985). Based on counts of elephant seals at U.S. rookeries in 2010, Lowry et al. (2014) reported that 40,684 pups were born. Lowry et al. (2014) applied a multiplier of 4.4 to extrapolate from total pup counts to a population estimate of approximately 179,000 elephant seals. This multiplier is derived from life tables based on published elephant seal fecundity and survival rates, and reflects a population with approximately 23% pups (Cooper and Stewart, 1983; Le Boeuf and Reiter, 1988; Hindell 1991; Huber et al., 1991; Reiter and Le Boeuf, 1991; Clinton and Le Boeuf, 1993; Le Boeuf et al., 1994; Pistorius and Bester, 2002; McMahon et al., 2003; Pistorius et al., 2004; Condit et al., 2014). The minimum population size for northern elephant seals in 2010 can be estimated very conservatively as 81,368, which is equal to twice the observed pup count (to account for the pups and their mothers). The population is reported to have grown at 3.8% annually since 1988 (Lowry et al., 2014). Northern elephant seals are not listed under the ESA and are not considered as depleted or a strategic stock under the MMPA.

    The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. On infrequent occasions, juvenile northern elephant seal have been observed on the sand or rocks at or near the Children's Pool (i.e., breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area). These sites are not usual haul-out locations for northern elephant seals. The City of San Diego commissioned two studies of harbor seal abundance trends at the Children's Pool. Both studies reported that appearances of northern elephant seals are infrequent, but not rare at Children's Pool (Yochem and Stewart 1998); Hanan, 2004; Hanan & Associates, 2011). During 2013, the City of San Diego observed two juvenile northern elephant seals at the Children's Pool. During 2014, the City of San Diego observed 30 juvenile elephant seals (during 29 days) at the Children's Pool. A report from 2015 monitoring is still in process at this time.

    Potential Effects of the Proposed Specified Activity on Marine Mammals

    A significant body of monitoring data exists for pinnipeds at Children's Pool. In addition, pinnipeds have co-existed with heavy public use at this location, and are likely habituated to human presence and activity. Nevertheless, the City of San Diego's sand sampling activities have the potential to disturb pinnipeds present on the beach. Past monitoring at this location has revealed that some or all of the seals present may move or flush from the beach in response to the presence of humans or their pets as well as crew and equipment associated with construction, though some may remain hauled-out. No stampeding of seals—a potentially dangerous occurrence in which large numbers of animals succumb to mass panic and rush away from a stimulus—has been documented. While it is likely impossible to conduct the proposed sand sampling activities without provoking some response in hauled-out animals, precautionary mitigation measures, described later in this document, help ensure that this type of disturbance would be minimized. Under these conditions, it is anticipated that seals would exhibit a continuum of responses, beginning with alert movements (e.g., raising the head), which may then escalate to movement away from the stimulus and possible flushing into the water. Flushed seals typically re-occupy the haul-out within minutes to hours of the stimulus.

    In the absence of appropriate mitigation measures, it is possible that pinnipeds could be subject to injury, serious injury, or mortality, likely through abandonment of pups. However, based on a significant body of site-specific data, harbor seals are unlikely to sustain any harassment that may be considered biologically significant. Individual animals would, at most, flush into the water in response to the sand sampling activities, but may also simply become alert or move across the beach away from the sand sampling crew.

    California sea lions and northern elephant seals have been observed as less sensitive to stimulus than harbor seals during monitoring at numerous other sites. For example, monitoring of pinniped disturbance as a result of abalone research in the Channel Islands showed that while harbor seals flushed at a rate of 69 percent, California sea lions flushed at a rate of only 21 percent. The rate for elephant seals declined to 0.1 percent (VanBlaricom, 2010). In the event that either of these species is present during management activities, they would be expected to display a minimal reaction to maintenance activities, and it is expected that reaction would be less than that expected of harbor seals.

    Children's Pool is a rookery for harbor seals, so we have evaluated the potential for injury, serious injury, or mortality to pups. Pup injury or mortality would be most likely to occur in the event of extended separation of a mother and pup, or trampling in a stampede. As discussed previously, no stampedes have been recorded at Children's Pool. Any California sea lions or northern elephant seals present would be independent juveniles or adults; therefore, analysis of impacts on pups is not relevant for those species.

    The period of mother-pup bonding, a critical time needed to ensure pup survival and maximize pup health, is not expected to be impacted by the sand sampling activities. Harbor seal pups are extremely precocious, swimming and diving immediately after birth and throughout the lactation period, unlike most other phocids which normally enter the sea only after weaning (Lawson and Renouf, 1985; Cottrell et al., 2002; Burns et al., 2005). Lawson and Renouf (1987) investigated harbor seal mother-pup bonding in response to natural and anthropogenic disturbance. In summary, they found that the most critical bonding time is within minutes after birth. As described previously, the peak of pupping season is typically concluded by mid-May, and the beach is closed to the public until that time. An additional two week period was added to that time before sand sampling activities could begin (to begin June 1) in order to account for any potentially late-weaning pups. As such, it is expected that mother-pup bonding would likely be concluded as well. In addition, mitigation measures described later in this document further reduce the likelihood of any impacts to pups, whether through injury or mortality or interruption of mother-pup bonding (which may lead to abandonment).

    In summary, and based on extensive monitoring data, we believe that impacts to hauled-out pinnipeds during estuary management activities would be behavioral harassment of limited duration (i.e., less than one day) and limited intensity (i.e., temporary flushing at most). Stampeding, and therefore injury or mortality associated with stampeding, is not expected. Further, the continued use of the haul-out despite decades of public use at this site indicates that abandonment of the haul-out is unlikely.

    Anticipated Effects on Marine Mammal Habitat

    Harbor seals have been observed hauling-out and documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). It is one of the three known haul-out sites for this species in San Diego County and is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA. In addition to Pacific harbor seals, California sea lions and northern elephant seals have also been observed at Children's Pool Beach occasionally (Yochem and Stewart 1998; Hanan 2004; Hanan & Associates 2014). More information on this population of Pacific harbor seals can be found in the “Description of Marine Mammals in the Specified Geographic Area of the Proposed Specified Activity.”

    The primary anticipated adverse impact upon habitat consists of the removal of sand from the beach. This change is minor, temporary, and limited in duration to the period of the sand sampling activities. All sand sampling activities will take place on the sand beach area normally occupied by hauled out seals. Although sand will be collected from the beach, the total volume removed over the course of the study is estimated to be less than one cubic foot. Additionally, a subset of samples will be collected approximately 25 to 50 centimeters (cm) below the sand surface. Because of the mechanism of collection (use of a hollow plastic tube and rubber mallet with minimal digging), only transient sand displacement is anticipated. Therefore, we do not anticipate impacts to habitat.

    The area of habitat affected is small and the effects are localized and temporary; thus there is no reason to expect any significant reduction in habitat available for other habitat uses. No aspect of the project is anticipated to have any permanent effect on the location or use of pinniped haul-outs or related habitat features in the area. Further, the site is already very disturbed by members of the public who come to the area during the day and night to view the pinnipeds. The City of San Diego and NMFS do not project any loss or modification of physical habitat for these species. Any potential temporary loss or modification of habitat due to the presence of the sand sampling technicians and their activities during the proposed sand quality study is expected by the City of San Diego and NMFS to be quickly restored after the sand sampling activities end.

    For these reasons, NMFS anticipates that the proposed action would result in no impacts to marine mammal habitat beyond rendering the areas of Children's Pool Beach immediately around the sand sampling activities less desirable. These sampling activities would be temporary and would occur relatively infrequently, as they are anticipated to occur up to 16 times over the months of May to December for approximately four hours at a time. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.

    Proposed Mitigation

    In order to issue an Incidental Take Authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must prescribe, where applicable, the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

    The City of San Diego has established the Children's Pool as a shared beach for pinnipeds and people except during pupping season, when the beach has been closed to the public in order to protect the seals. In the past, during the pupping season, a rope was placed along the upper part of the beach with signage to inform and designate how close people can come to the haul-out area and the pinnipeds. The timeframe for the rope has been extended so that it is now present year-round.

    The activities proposed by the applicant include a variety of measures to minimize potential impacts on marine mammals, including:

    Prohibition of Sand Sampling During Pupping Season

    Sand sampling activities shall be prohibited during the Pacific harbor seal pupping season (December 15th to May 15th), and for an additional two weeks thereafter to accommodate lactation and weaning of late season pups. Thus, sand quality study activities shall be prohibited until June 1, 2016 and would be required to end before December 15, 2016.

    Limiting Activity to Daylight Hours

    Sand sampling activities shall be conducted during daylight hours only. As Protected Species Observers (PSOs) will be required to monitor the sand sampling activities (see discussion below), conducting the sampling events during daylight hours with adequate visibility will allow observers to adequately observe and record activities.

    Daily Sand Sampling Timing

    Sand sampling activities shall be scheduled, to the maximum extent practicable, during the daily period of lowest haul-out occurrence, from approximately 8:30 a.m. to 3:30 p.m., as harbor seals typically have the highest daily or hourly haul-out period during the afternoon from 3 p.m. to 6 p.m. However, sand sampling activities may be extended from 7 a.m. to 7 p.m. to help assure that the project can be completed at a time with low numbers of seals hauled out.

    Avoidance/Minimization of Interaction with Pinnipeds

    As stated above, per Dr. Doyle Hanan, ongoing observations of harbor seals at Children's Pool have indicated a habituation to the presence of people and therefore, generally show signs of disturbance when people are very close to them on the beach (generally less than two to three meters). Sand sampling activities will be conducted such that humans remain at least three meters from hauled out pinnipeds at all times. While the study calls for taking samples along transects, there is enough flexibility to allow for variation from the transect line to collect samples and still allow for minimizing approach to pinnipeds on the beach. Therefore, hauled out pinnipeds will be minimized or avoided, and efforts will be made to avoid disturbing/alerting/flushing them.

    Protected Species Observers

    Trained PSOs would be used to detect, document, and minimize impacts to marine mammals. More information about this measure is contained in the “Proposed Monitoring” section (below).

    Proposed Mitigation Conclusions

    NMFS has carefully evaluated the applicant's mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. NMFS's evaluation of potential measures included consideration of the following factors in relation to one another:

    • The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;

    • The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

    • The practicability of the measure for applicant implementation, including consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the activity.

    Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

    (1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    (2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to visual or auditory stimuli associated with the proposed sand quality study, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    (3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to visual or auditory stimuli associated with the proposed sand quality study, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    (4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to visual or auditory stimuli associated with the proposed sand quality study, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).

    (5) Avoidance of minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

    (6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on NMFS's evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Proposed Monitoring and Reporting

    In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must, where applicable, set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) require that requests for ITAs include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

    Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

    (1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;

    (2) An increase in our understanding of how many marine mammals are likely to be exposed to visual or auditory stimuli associated with the proposed sand quality study that we associate with specific adverse effects, such as behavioral harassment;

    (3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

    • Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict distance from source, and other pertinent information);

    • Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict distance from the source, and other pertinent information);

    • Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

    (4) An increased knowledge of the affected species;

    (5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures; and

    (6) An increase in our level of knowledge regarding the overall health of the monitored species, particularly in light of recent local UMEs and observations of malnutrition increases in the area.

    Proposed Monitoring

    The City of San Diego has developed a monitoring plan based on discussions between the City of San Diego and NMFS, as well as review of past IHAs granted to the City of San Diego. The plan is also included as an Appendix to our draft Environmental Assessment (EA) for issuance of the IHA for the sand quality study activities (see National Environmental Policy Act section below), which is available for public review along with the draft EA.

    The monitoring plan involves PSOs surveying and conducting hourly visual counts beginning prior to sand sampling activities (beginning at least 30 minutes prior to sampling activities), monitoring during sampling activities, and post-sand sampling monitoring (continuing for at least 30 minutes after sand sampling activities have ended). During each sample collection event, the PSO will conduct continuous monitoring from a vantage point along the seawall (weather permitting) or along the bluff above the beach, such that the full study area is in view. During the proposed sand sampling activities, monitoring shall assess behavior and potential behavioral responses to noise and visual stimuli due to the proposed activities. As noted above, if northern fur seals or Guadalupe fur seals are observed prior to commencement of activities, the activities will not occur and coordination with the stranding network will be initiated.

    Counts will be performed by species for three zones: Pinnipeds hauled out on the sandy beach area, pinnipeds observed in the water within approximately 30 meters of the beach, and pinnipeds hauled out on the reef/rocks just off the beach (including Seal Rock). Total counts, counts of juveniles (yearlings and pups), and counts of males/females (when possible) will be recorded. In addition to counts, continuous behavioral monitoring will be conducted for the duration of the sampling event to document any behavioral responses to visual (or other) stimuli, as noted in Table 2 below. When responses are observed, the type of take (i.e., alert and flush, movement of more than one meter, or change in direction of movement) and the assumed cause (whether related to sample collection activities or not) will be noted by species. Photographs and/or video will be taken to document these responses.

    Table 2—Seal Response to Disturbance Level Type of response Definition 1 Alert Seal head orientation or brief movement in response to disturbance, which may include turning head towards the disturbance, craning head and neck while holding the body rigid in a u-shaped position, changing from a lying to a sitting position, or brief movement of less than twice the animal's body length. Alerts would be recorded, but not counted as a `take'. 2 Movement Movements away from the source of disturbance, ranging from short withdrawals at least twice the animal's body length to longer retreats over the beach including changing direction of travel, or movement along the beach from a resting position. These movements would be recorded and counted as a `take'. 3 Flush All retreats (flushes) to the water. Flushing into the water would be recorded and counted as a `take'.

    Additional parameters will be recorded during the first and last count of each sampling event including Beaufort sea state; atmospheric conditions; cloud cover; visibility conditions; air and water temperature; tide height; and number of public visitors present by location at Children's Pool.

    Field observations will be documented on Field Monitoring Forms, and all observations and associated data, including daily monitoring reports, would be maintained on City of San Diego computers. A report summarizing mitigation and monitoring for the duration of the Children's Pool B