Federal Register Vol. 82, No.190,

Federal Register Volume 82, Issue 190 (October 3, 2017)

Page Range45955-46121
FR Document

82_FR_190
Current View
Page and SubjectPDF
82 FR 46045 - Office of General Counsel; Agency Information Collection ExtensionPDF
82 FR 46043 - Sunshine Act Meeting NoticePDF
82 FR 46087 - Extension of Agency Information Collection Activity Under OMB Review: Critical Facility Information of the Top 100 Most Critical PipelinesPDF
82 FR 46091 - Proposed Extension of Information Collection; Training Plan Regulations and Certificate of Training [OMB Control No. 1219-0009]PDF
82 FR 46063 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 46052 - Notice of Receipt of Requests To Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations To Terminate Certain Uses-30-Day Comment PeriodPDF
82 FR 46050 - Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations to Terminate Certain Uses-180-Day Comment PeriodPDF
82 FR 46049 - Pesticide Product Registration; Receipt of Applications for New UsesPDF
82 FR 46057 - Sunshine Act Meetings; Deletion of Items From Sunshine Act MeetingPDF
82 FR 46056 - Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability CouncilPDF
82 FR 46011 - Petition for Reconsideration of Action in Rulemaking ProceedingPDF
82 FR 46056 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
82 FR 45990 - Significant New Use Rule on Certain Chemical SubstancesPDF
82 FR 46042 - Agency Information Collection Activities: Comment RequestPDF
82 FR 46119 - Data Collection Available for Public CommentsPDF
82 FR 46002 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Possession and Trip Limit Adjustment for the Common Pool FisheryPDF
82 FR 45962 - Negotiated Noncompetitive Agreements for the Use of Sand, Gravel, and/or Shell Resources on the Outer Continental ShelfPDF
82 FR 45984 - Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet; Brooklyn, NYPDF
82 FR 46004 - Special Anchorage Areas; Passagassawakeag River, Belfast Bay, Belfast, MainePDF
82 FR 46007 - Security Zones; Port Canaveral Harbor, Cape Canaveral Air Force Station, FLPDF
82 FR 46078 - M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation; Guidance for Industry; AvailabilityPDF
82 FR 46114 - American Century ETF Trust and American Century Investment Management, Inc.PDF
82 FR 46089 - Meeting of the NDCAC Executive Advisory BoardPDF
82 FR 46041 - Advisory Committee to the U.S. Section of the International Commission for the Conservation of Atlantic Tunas; Fall MeetingPDF
82 FR 46083 - Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for CommentsPDF
82 FR 46090 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Evaluation of the Youth CareerConnect (YCC) Grant Program, New CollectionPDF
82 FR 46036 - Foreign-Trade Zone 214-Lenoir County, North Carolina; Application for Expansion of Subzone 214A; Consolidated Diesel Company; Enfield, North CarolinaPDF
82 FR 46036 - Foreign-Trade Zone (FTZ) 57-Charlotte, North Carolina, Authorization of Limited Production Activity; DNP Imagingcomm America Corporation (Coatings and Lamination on Semi-Completed Coated Paper), Concord, North CarolinaPDF
82 FR 46039 - Proposed Information Collection; Comment Request; Cooperative Game Fish Tagging ReportPDF
82 FR 46041 - Proposed Information Collection; Comment Request; Pacific Islands Region Vessel and Gear Identification RequirementsPDF
82 FR 46074 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in ExportingPDF
82 FR 46036 - Certain Stainless Steel Sheet and Strip in Coils From Japan, the Republic of Korea, and Taiwan; Continuation of Antidumping Duty Orders and Countervailing Duty OrderPDF
82 FR 46000 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna FisheriesPDF
82 FR 46044 - Combined Notice of FilingsPDF
82 FR 46045 - Combined Notice of FilingsPDF
82 FR 46102 - Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Service Provider LicensesPDF
82 FR 46075 - Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; AvailabilityPDF
82 FR 46118 - Administrative Declaration of a Disaster for the State of CaliforniaPDF
82 FR 46119 - Interest RatesPDF
82 FR 46118 - Data Collection Available for Public CommentsPDF
82 FR 46120 - Notice of Rights and Protections Available Under the Federal Antidiscrimination and Whistleblower Protection LawsPDF
82 FR 45988 - Safety Zone, Blue Angels Air Show; St. Johns River, Jacksonville, FLPDF
82 FR 46011 - Migratory Bird Hunting; Supplemental Proposals for Migratory Game Bird Hunting Regulations for the 2018-19 Hunting Season; Notice of MeetingsPDF
82 FR 46042 - Cash Payment Method Will No Longer Be AcceptedPDF
82 FR 46115 - Proposed Collection; Comment RequestPDF
82 FR 46071 - Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; AvailabilityPDF
82 FR 46061 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
82 FR 46060 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
82 FR 46072 - Abbreviated New Drug Applications Submissions-Refuse-To-Receive Standards: Questions and Answers; Draft Guidance for Industry; AvailabilityPDF
82 FR 46065 - Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop; Request for CommentsPDF
82 FR 45955 - Importation of Fresh Persimmons From New Zealand Into the United StatesPDF
82 FR 46034 - Agenda and Notice of Public Meeting of the Delaware Advisory CommitteePDF
82 FR 46035 - Agenda and Notice of Public Meeting of the Delaware Advisory CommitteePDF
82 FR 45981 - Safety Zone; Patapsco River, Northwest and Inner Harbors; Baltimore, MDPDF
82 FR 46064 - Agency Information Collection Activities; Public Comment Request; Proposed Extension With Changes of a Currently Approved Collection; Evidence-Based Falls Prevention ProgramPDF
82 FR 46040 - Pacific Fishery Management Council; Public MeetingPDF
82 FR 46079 - Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug ApplicationsPDF
82 FR 46068 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
82 FR 46066 - Abbreviated New Drug Applications Submissions-Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; AvailabilityPDF
82 FR 46070 - Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
82 FR 46069 - Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory CommitteePDF
82 FR 46058 - Notice to All Interested Parties of the Termination of the Receivership of 10286-Horizon Bank; Bradenton, FloridaPDF
82 FR 46076 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
82 FR 46081 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
82 FR 45980 - Drawbridge Operation Regulation; Willamette River, Portland, ORPDF
82 FR 46035 - Submission for OMB Review; Comment RequestPDF
82 FR 46058 - FDIC Advisory Committee on Economic Inclusion (ComE-IN); Notice of MeetingPDF
82 FR 45979 - Special Local Regulation; Cumberland River, Nashville, TNPDF
82 FR 45977 - Special Local Regulation; Tennessee River, Chattanooga, TNPDF
82 FR 46034 - Submission for OMB Review; Comment RequestPDF
82 FR 46111 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Order Granting Approval of a Proposed Rule Change To Adopt Rules Relating to Trading in Index OptionsPDF
82 FR 46111 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Withdrawal of a Proposed Rule Change To Extend the Implementation Date for Certain Changes to the NYSE Arca Rule 5 and Rule 8 SeriesPDF
82 FR 46106 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of the GraniteShares Palladium Trust Under NYSE Arca Rule 8.201-EPDF
82 FR 46103 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Withdrawal of a Proposed Rule Change To Extend the Implementation Date For Certain Changes to Exchange Rules 14.11 and 14.12PDF
82 FR 46039 - Open Meeting of the Information Security and Privacy Advisory BoardPDF
82 FR 46088 - Certain Wi-Fi Enabled Electronic Devices and Components Thereof; Institution of InvestigationPDF
82 FR 46103 - PREDEX and PREDEX Capital Management, LLCPDF
82 FR 46120 - Advisory Board-Notice of Public MeetingsPDF
82 FR 46010 - Overweight ParcelsPDF
82 FR 46043 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Progress Reporting Form for the American Indian Vocational Rehabilitation Services (AIVRS) ProgramPDF
82 FR 46084 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingsPDF
82 FR 46085 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
82 FR 46087 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
82 FR 46085 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
82 FR 46085 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 46092 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978PDF
82 FR 46116 - Wells Fargo Exchange-Traded Funds Trust, et al.PDF
82 FR 46087 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed MeetingsPDF
82 FR 46093 - Astronomy and Astrophysics Advisory Committee; Notice of MeetingPDF
82 FR 46058 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
82 FR 45995 - Air Plan Approval; South Carolina; Interstate Transport (Prongs 1 and 2) for the 2010 1-Hour NO2PDF
82 FR 46010 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment AreaPDF
82 FR 45997 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment AreaPDF
82 FR 45986 - Safety Zone; Roanoke River, Plymouth, NCPDF
82 FR 45981 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CAPDF
82 FR 46089 - Hearings of the Judicial Conference Advisory Committee on the Federal Rules of Criminal ProcedurePDF
82 FR 45959 - Updated Statements of Legal Authority for the Export Administration RegulationsPDF
82 FR 45958 - Establishment of Class E Airspace; Hattiesburg, MSPDF
82 FR 45957 - Establishment of Class E Airspace; Picayune, MSPDF
82 FR 46016 - Fisheries of the Exclusive Economic Zone Off Alaska; Authorize Recreational Quota Entity To Participate in the Halibut IFQ ProgramPDF
82 FR 46094 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information and Safeguards InformationPDF

Issue

82 190 Tuesday, October 3, 2017 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46034 2017-21164
Animal Animal and Plant Health Inspection Service RULES Imports: Fresh Persimmons From New Zealand Into the United States, 45955-45957 2017-21185 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46042-46043 2017-21236 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46058-46062 2017-21122 2017-21188 2017-21189 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46063-46064 2017-21248 Civil Rights Civil Rights Commission NOTICES Meetings: Delaware Advisory Committee, 46034-46035 2017-21181 2017-21182 Coast Guard Coast Guard RULES Drawbridge Operations: Sacramento River, Sacramento, CA, 45981 2017-21099 Willamette River, Portland, OR; Cancellation, 45980-45981 2017-21169 Safety Zones: Belt Parkway Bridge Construction, Gerritsen Inlet; Brooklyn, NY, 45984-45986 2017-21232 Blue Angels Air Show, St. Johns River, Jacksonville, FL, 45988-45990 2017-21196 Patapsco River, Northwest and Inner Harbors; Baltimore, MD, 45981-45984 2017-21180 Roanoke River, Plymouth, NC, 45986-45988 2017-21100 Special Local Regulations: Cumberland River, Nashville, TN, 45979-45980 2017-21166 Stage 5 Airplane Noise Standards, 45977-45978 2017-21165 PROPOSED RULES Security Zones: Port Canaveral Harbor, Cape Canaveral Air Force Station, FL, 46007-46010 2017-21230 Special Anchorage Areas: Passagassawakeag River, Belfast Bay, Belfast, ME, 46004-46007 2017-21231 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Institute of Standards and Technology

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46035-46036 2017-21168
Community Living Administration Community Living Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evidence-Based Falls Prevention Program, 46064-46065 2017-21179 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 46043 2017-21318 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Annual Progress Reporting Form for the American Indian Vocational Rehabilitation Services Program, 46043-46044 2017-21142 Energy Department Energy Department See

Federal Energy Regulatory Commission

See

Western Area Power Administration

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment Area, 45997-46000 2017-21106 South Carolina; Interstate Transport (Prongs 1 and 2) for the 2010 1-Hour NO2 Standard, 45995-45997 2017-21121 Significant New Use Rule on Certain Chemical Substances, 45990-45995 2017-21237 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment Area, 46010-46011 2017-21109 NOTICES Pesticide Products: Applications for New Uses, 46049-46050 2017-21242 Requests To Voluntarily Cancel Pesticide Registrations and Amend Registrations To Terminate Certain Uses, 46050-46056 2017-21243 2017-21244 Federal Aviation Federal Aviation Administration RULES Class E Airspace; Establishments: Hattiesburg, MS, 45958-45959 2017-20967 Picayune, MS, 45957-45958 2017-20966 Federal Communications Federal Communications Commission PROPOSED RULES Petitions for Reconsideration of Action in Rulemaking Proceeding, 46011 2017-21239 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46056-46057 2017-21238 Meetings: Communications Security, Reliability, and Interoperability Council, 46056 2017-21240 Meetings; Sunshine Act, 46057-46058 2017-21241 Federal Deposit Federal Deposit Insurance Corporation NOTICES Meetings: Advisory Committee on Economic Inclusion, 46058 2017-21167 Terminations of Receivership: 10286—Horizon Bank, Bradenton, FL, 46058 2017-21172 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 46044-46045 2017-21206 2017-21207 2017-21208 Fish Fish and Wildlife Service PROPOSED RULES Migratory Bird Hunting: Supplemental Proposals for Migratory Game Bird Hunting Regulations for 2018-19 Hunting Season; Meetings, 46011-46015 2017-21195 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishing and Maintaining Lists of U.S. Milk Product, 46074-46075 2017-21212 Determination that SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 46070-46071 2017-21174 Guidance: Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin, 46075-46076 2017-21202 Abbreviated New Drug Applications Submissions—Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act, 46066-46068 2017-21175 Abbreviated New Drug Applications Submissions—Refuse-to-Receive Standards: Questions and Answers, 46072-46073 2017-21187 Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act, 46071-46072 2017-21190 M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation, 46078-46079 2017-21229 Meetings: Endocrinologic and Metabolic Drugs Advisory Committee, 46068-46069 2017-21176 Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, 46076-46078, 46081-46083 2017-21170 2017-21171 Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access, 46065-46066 2017-21186 Request for Comments: Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment, 46083-46084 2017-21218 Requests for Nominations: Tobacco Products Scientific Advisory Committee, 46069-46070 2017-21173 Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications: Johnson & Johnson Consumer Inc. et al., 46079-46081 2017-21177 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activites: DNP Imagingcomm America Corp., Foreign-Trade Zone 57, Charlotte, NC, 46036 2017-21215 Subzone Expansions; Applications: Consolidated Diesel Co., Foreign-Trade Zone 214, Lenoir County, NC, 46036 2017-21216 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Community Living Administration

See

Food and Drug Administration

See

National Institutes of Health

Homeland Homeland Security Department See

Coast Guard

See

Transportation Security Administration

Industry Industry and Security Bureau RULES Updated Statements of Legal Authority for the Export Administration Regulations, 45959-45962 2017-21003 Interior Interior Department See

Fish and Wildlife Service

See

Ocean Energy Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Stainless Steel Sheet and Strip in Coils From Japan, the Republic of Korea, and Taiwan, 46036-46039 2017-21210 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Wi-Fi Enabled Electronic Devices and Components Thereof, 46088-46089 2017-21157 Judicial Conference Judicial Conference of the United States NOTICES Hearings: Judicial Conference Advisory Committee on the Federal Rules of Criminal Procedure; Cancellation, 46089 2017-21030 Justice Department Justice Department NOTICES Meetings: National Domestic Communications Assistance Center Executive Advisory Board, 46089-46090 2017-21227 Labor Department Labor Department See

Mine Safety and Health Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evaluation of the Youth CareerConnect Grant Program, 46090-46091 2017-21217
Mine Mine Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Training Plan Regulations and Certificate of Training, 46091-46092 2017-21250 National Institute National Institute of Standards and Technology NOTICES Meetings: Information Security and Privacy Advisory Board, 46039 2017-21158 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 46085-46087 2017-21133 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 46084-46085 2017-21139 National Heart, Lung, and Blood Institute, 46085, 46087 2017-21136 2017-21137 National Institute of Allergy and Infectious Diseases, 46085 2017-21138 National Institute of Diabetes and Digestive and Kidney Diseases, 46087 2017-21130 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Atlantic Bluefin Tuna Fisheries, 46000-46002 2017-21209 Fisheries of the Northeastern United States: Northeast Multispecies Fishery; Georges Bank Cod Possession and Trip Limit Adjustment for the Common Pool Fishery, 46002-46003 2017-21234 PROPOSED RULES Fisheries of the Exclusive Economic Zone Off Alaska: Authorize Recreational Quota Entity to Participate in the Halibut IFQ Program, 46016-46033 2017-20894 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cooperative Game Fish Tagging Report, 46039-46040 2017-21214 Pacific Islands Region Vessel and Gear Identification Requirements, 46041-46042 2017-21213 Meetings: Advisory Committee to the U.S. Section of the International Commission for the Conservation of Atlantic Tunas, 46041 2017-21219 Pacific Fishery Management Council, 46040 2017-21178 National Science National Science Foundation NOTICES Antarctic Conservation Act Permits, 46092-46093 2017-21132 Meetings: Astronomy and Astrophysics Advisory Committee, 46093-46094 2017-21125 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Service Provider Licenses, 46102-46103 2017-21205 Facility Operating and Combined Licenses: Applications and Amendments Involving No Significant Hazard Considerations, etc., 46094-46102 2017-20084 Ocean Energy Management Ocean Energy Management Bureau RULES Negotiated Noncompetitive Agreements for the Use of Sand, Gravel, and/or Shell Resources on the Outer Continental Shelf, 45962-45977 2017-21233 Patent Patent and Trademark Office NOTICES Cash Payment Method Will No Longer Be Accepted, 46042 2017-21194 Postal Service Postal Service PROPOSED RULES Overweight Parcels, 46010 2017-21150 Saint Lawrence Saint Lawrence Seaway Development Corporation NOTICES Meetings: Advisory Board, 46120 2017-21155 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46115-46116 2017-21193 Applications: American Century ETF Trust and American Century Investment Management, Inc., 46114-46115 2017-21228 PREDEX and PREDEX Capital Management, LLC, 46103-46106 2017-21156 Wells Fargo Exchange-Traded Funds Trust, et al., 46116-46117 2017-21131 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 46103 2017-21160 Miami International Securities Exchange LLC, 46111-46114 2017-21163 NYSE Arca, Inc., 46106-46111 2017-21161 2017-21162 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46118-46119 2017-21198 2017-21203 2017-21235 Disaster Declarations: California, 46118 2017-21201 2017-21199 Interest Rates, 46119-46120 2017-21200 Transportation Department Transportation Department See

Federal Aviation Administration

See

Saint Lawrence Seaway Development Corporation

NOTICES Rights and Protections Available Under the Federal Antidiscrimination and Whistleblower Protection Laws, 46120-46121 2017-21197
Security Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Critical Facility Information of the Top 100 Most Critical Pipelines, 46087-46088 2017-21251 Western Western Area Power Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46045-46049 2017-21322 Reader Aids

Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.

82 190 Tuesday, October 3, 2017 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. APHIS-2015-0052] RIN 0579-AE26 Importation of Fresh Persimmons From New Zealand Into the United States AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

We are amending the regulations concerning the importation of fruits and vegetables to allow the importation of fresh persimmons from New Zealand into the United States. As a condition of entry, the persimmons must be produced in accordance with a systems approach that includes requirements for orchard certification, orchard pest control, post-harvest safeguards, fruit culling, traceback, sampling, and treatment with either hot water or modified atmosphere treatment. The persimmons will also have to be accompanied by a phytosanitary certificate with an additional declaration stating that they were produced under, and meet all the components of, the systems approach and were inspected and found to be free of quarantine pests in accordance with the requirements. This action allows the importation of fresh persimmons from New Zealand while continuing to protect against the introduction of plant pests into the United States.

DATES:

Effective November 2, 2017.

FOR FURTHER INFORMATION CONTACT:

Mr. David B. Lamb, Senior Regulatory Policy Specialist, IRM, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-1231; (301) 851-2103.

SUPPLEMENTARY INFORMATION: Background

The regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-79, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

On August 26, 2016, we published in the Federal Register (81 FR 58870-58873, Docket No. APHIS-2015-0052) a proposal 1 to amend the fruits and vegetables regulations to allow the importation of fresh persimmons (Diospyros kaki Thunb.) from New Zealand into the United States. As a condition of entry, the persimmons would have to be produced in accordance with a systems approach that includes requirements for orchard certification, orchard pest control, post-harvest safeguards, fruit culling, traceback, sampling, and treatment with either hot water or modified atmosphere treatment. The persimmons would also have to be accompanied by a phytosanitary certificate with an additional declaration stating that they were produced under, and meet all the components of, the systems approach and were inspected and found to be free of quarantine pests in accordance with the proposed requirements.

1 To view the proposed rule, supporting documents, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0052.

We solicited comments concerning our proposal for 60 days ending October 25, 2016. We received two comments by that date, from a private citizen and the national plant protection organization (NPPO) of New Zealand. One commenter generally objected to the importation of all fruits and vegetables into the United States, but did not otherwise address any issues germane to the proposal. The other comment is discussed in greater detail below.

In paragraph (d)(3) of the proposal, we proposed to require that diseased or insect-infested fruit and fruit with surface pests be culled either before or during packing and removed from the packinghouse. We also proposed to require that the culling include any damaged or deformed fruit. The NPPO of New Zealand stated that the removal of deformed fruit is a grading concern rather than a phytosanitary issue.

We disagree. As explained in the proposed rule, deformed fruit is more susceptible to infestation, as is damaged fruit.

In paragraph (d)(4), we proposed to require that shipping containers be marked to identify the place of production and packinghouse from which the consignment of fruit originated. The NPPO of New Zealand asked for clarification of the term “final shipping container,” which we used in the preamble of the proposed rule. The NPPO stated that each individual packed unit of New Zealand persimmons will be marked to identify the place of production and packinghouse from which the packed unit of fruit originated.

Our use of the term “final shipping container” was intended to refer to the individually packed units of the consignment and not the container in which the individually packed units are shipped. We have amended the text of paragraph (d)(4) to clarify that.

In paragraph (e), we proposed to require that inspectors from the NPPO of New Zealand visually inspect a sample of fruit from each consignment at a rate jointly agreed upon by the Animal and Plant Health Inspection Service (APHIS) and the NPPO of New Zealand, and cut fruit to inspect for quarantine pests that are internal feeders. The NPPO of New Zealand stated that, because there are no quarantine pests that are internal feeders on persimmons in New Zealand, cutting of fruit is not necessary.

As described in the pest risk assessment, there are seven Lepidoptera pests of quarantine significance present in New Zealand that could be introduced into the United States through the importation of fresh persimmons. The larvae of some or all of these pests, which are classified as leafroller moths, may bore into the fruit and feed internally. Evidence of infestation, including entrance holes and frass, would easily be detected during visual inspection except for the extensive calyx on persimmon fruit. Therefore, we proposed to require fruit cutting as an addition to visual inspection. We agree that fruit cutting is not necessary as long as the area of the fruit under the calyx is thoroughly examined for the presence of internally feeding pests. Therefore, we are amending the language in paragraph (e) to state that fruit cutting will be required only when visual evidence of internally feeding insects is discovered.

In paragraph (c)(2), we proposed to require that the NPPO of New Zealand or its approved designee visit and inspect the places of production monthly beginning at blossom drop and continuing until the end of the shipping season for quarantine pests. In paragraph (f), we also proposed that the persimmons be treated with hot water treatment or with modified atmosphere treatment by being packed in semi-permeable polymeric bags and stored at 0 °C for a minimum of 28 days. The NPPO of New Zealand stated that, because the persimmons will undergo a 28-day cold treatment prior to export, by the time persimmons are shipped, there will not be any persimmons in the place of production to inspect.

We agree with the commenter and are amending paragraph (c)(2) to state that inspection of places of production will continue until the end of the harvest season rather than the end of the shipping season.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

Executive Orders 12866 and 13771 and Regulatory Flexibility Act

This final 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. Further, because this rule is not significant, it is not a regulatory action under Executive Order 13771.

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 on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

APHIS is amending the regulations in 7 CFR 319.56, to allow the importation of fresh persimmon fruit (Diospyros kaki) into the entire United States from New Zealand subject to a systems approach. Most U.S. persimmon production takes place in California, where the 2011 value of production totaled about $13.6 million. The most recent data on U.S. persimmon imports show a total value of about $4.4 million in 2015.

The wholesale value of the persimmon fruit for which New Zealand has requested import access will be about $90,000 initially. The value of future imports is forecast to reach about $330,000, or about 2 percent of the U.S. persimmon market.

The Small Business Administration's (SBA) small-entity standard for entities involved in fruit farming is $750,000 or less in annual receipts (NAICS 111339). It is probable that most or all U.S. persimmon producers are small businesses by the SBA standard. We expect any impact of the rule for these entities will be minimal, given New Zealand's expected small share of the U.S. persimmon market.

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

Executive Order 12988

This final rule allows fresh persimmons to be imported into the United States from New Zealand. State and local laws and regulations regarding fresh persimmons imported under this rule will be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public, and 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. 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 final rule, which were filed under 0579-0456, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

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 final rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

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 are amending 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 319.56-80 is added to read as follows:
§ 319.56-80 Persimmons from New Zealand.

Fresh persimmons (Diospyros kaki Thunb.) may be imported into the United States only under the conditions described in this section. These conditions are designed to prevent the introduction of the quarantine pests Colletotrichum horii B. Weir & P.R. Johnst., Cnephasia jactatana (Walker), Cryptosporiopsis actinidiae P.R. Johnst., M.A. Manning & X. Meier, Ctenopseustis herana (Felder and Rogenhofer), Ctenopseustis obliquana (Walker), Epiphyas postvittana (Walker), Planotortrix excessana (Walker), Sperchia intractana (Walker), and Stathmopoda skelloni (Butler).

(a) Operational workplan. The national plant protection organization (NPPO) of New Zealand must provide an operational workplan to APHIS that details the activities that the NPPO of New Zealand will, subject to APHIS' approval of the workplan, carry out to meet the requirements of this section. The operational workplan must include and describe the quarantine pest survey intervals and other specific requirements as set forth in this section.

(b) Commercial consignments. Persimmons from New Zealand may be imported in commercial consignments only.

(c)(1) Place of production requirements. All places of production that participate in the export program must be approved by and registered with the New Zealand NPPO in accordance with the requirements of the operational workplan.

(2) The NPPO of New Zealand or its approved designee must visit and inspect the places of production monthly beginning at blossom drop and continuing until the end of the harvest season for quarantine pests. Appropriate pest controls must be applied in accordance with the operational workplan. If the NPPO of New Zealand finds that a place of production is not complying with the requirements of this section, no fruit from the place of production will be eligible for export to the United States until APHIS and the NPPO of New Zealand conduct an investigation and appropriate remedial actions have been implemented.

(d)(1) Packinghouse requirements. All packinghouses that participate in the export program must be approved by and registered with the New Zealand NPPO in accordance with the requirements of the operational workplan.

(2) During the time the packinghouse is in use for exporting persimmons to the United States, the packinghouse may only accept persimmons from registered approved places of production and the fruit must be segregated from fruit intended for other markets.

(3) All diseased or insect-infested fruit and fruit with surface pests must be culled either before or during packing and removed from the packinghouse. Culling must also include any damaged or deformed fruit.

(4) Boxes or other containers in which the fruit is shipped must be marked to identify the place of production where the fruit originated and the packinghouse where it was packed.

(5) The NPPO of New Zealand must monitor packinghouse operations to verify that the packinghouses are complying with the requirements of the systems approach. If the NPPO of New Zealand finds that a packinghouse is not complying with the requirements of this section, no fruit from the packinghouse will be eligible for export to the United States until APHIS and the NPPO of New Zealand conduct an investigation and appropriate remedial actions have been implemented.

(e) Sampling. Inspectors from the NPPO of New Zealand must inspect a biometric sample of the fruit from each consignment at a rate jointly agreed upon by APHIS and the NPPO of New Zealand. The inspectors must visually inspect for quarantine pests listed in the operational workplan required by paragraph (a) of this section and must cut fruit to inspect for the Lepidoptera pests of concern when visual signs of the internal feeders are present. If quarantine pests are detected in this inspection, the consignment will be prohibited entry into the United States.

(f) Treatment. Each consignment of persimmons must be subjected to a post-harvest treatment by either:

(1) Hot water treatment. The persimmons are held for 20 minutes in hot water at 50 °C (122 °F); or

(2) Modified atmosphere treatment. The persimmons are packed in semi-permeable polymeric bags and stored at 0 °C for a minimum of 28 days.

(g) Phytosanitary certificate. Each consignment of persimmons must be accompanied by a phytosanitary certificate of inspection issued by the New Zealand NPPO with an additional declaration stating that the fruit in the consignment were grown, packed, and inspected and found to be free of quarantine pests in accordance with the requirements of the systems approach. (Approved by the Office of Management and Budget under control number 0579-0456)

Done in Washington, DC, this 27th day of September 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-21185 Filed 10-2-17; 8:45 am] BILLING CODE 3410-34-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0320; Airspace Docket No. 17-ASO-12] Establishment of Class E Airspace; Picayune, MS AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action establishes Class E airspace extending upward from 700 feet above the surface at Picayune, MS, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving Highland Community Hospital Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the heliport.

DATES:

Effective 0901 UTC, December 7, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:

John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Highland Community Hospital Heliport, Picayune, MS, to support IFR operations under standard instrument approach procedures at the heliport.

History

The FAA published a notice of proposed rulemaking (NPRM in the Federal Register (82 FR 25991, June 6, 2017) Docket No. FAA-2017-0320 to establish Class E airspace extending upward from 700 feet above the surface at Highland Community Hospital Heliport, Picayune, MS, due to the new RNAV (GPS) standard instrument approach procedures developed for IFR operations at the heliport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This action amends title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Highland Community Hospital Heliport, Picayune, MS. This action provides the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at Highland Community Hospital Heliport.

Regulatory Notices and Analyses

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (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); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO MS E5 Highland Community, Picayune, MS [New] Highland Community Hospital Heliport, MS (Lat. 30°32′57″ N., long. 89°39′57″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the Highland Community Hospital Heliport.

Issued in College Park, Georgia, on September 22, 2017. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
[FR Doc. 2017-20966 Filed 10-2-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0321; Airspace Docket No. 17-ASO-11] Establishment of Class E Airspace; Hattiesburg, MS AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action establishes Class E airspace extending upward from 700 feet above the surface at Forrest General Hospital Heliport, Hattiesburg, MS, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving Forrest General Hospital Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the heliport.

DATES:

Effective 0901 UTC, December 7, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:

John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Forrest General Hospital Heliport, Hattiesburg, MS, to support IFR operations under standard instrument approach procedures at the heliport.

History

The FAA published a notice of proposed rulemaking (NPRM in the Federal Register (82 FR 27448, June 15, 2017) Docket No. FAA-2017-0321 to establish Class E airspace extending upward from 700 feet above the surface at Forrest General Hospital Heliport, Hattiesburg, MS, due to the new RNAV (GPS) standard instrument approach procedures for IFR operations at the heliport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6 mile radius of Forrest General Hospital Heliport, Hattiesburg, MS. This action provides the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at the Heliport.

Regulatory Notices and Analyses

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (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); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO MS E5 Forrest General, Hattiesburg, MS [New] Forrest General Hospital Heliport, MS (Lat. 31°19′08″ N., long. 89°19′44″ W.)

That airspace extending upward from 700 feet above the surface within a 6-mile radius of Forrest General Hospital Heliport.

Issued in College Park, Georgia, on September 22, 2017. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
[FR Doc. 2017-20967 Filed 10-2-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 746, 748, 750, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772, and 774 [Docket No. 170316279-7279-01] RIN 0694-AH38 Updated Statements of Legal Authority for the Export Administration Regulations AGENCY:

Bureau of Industry and Security, Commerce.

ACTION:

Final rule.

SUMMARY:

This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing a national emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural, non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.

DATES:

The rule is effective October 3, 2017.

FOR FURTHER INFORMATION CONTACT:

Nancy Kook, Regulatory Policy Division, Bureau of Industry and Security, Telephone: (202) 482-2440.

SUPPLEMENTARY INFORMATION: Background

The authority for all parts of the EAR (15 CFR parts 730-774) other than part 745 rests, in part, on Executive Order 13222 of August 17, 2001—National Emergency with Respect to Export Control Regulations, 66 FR 44025, 3 CFR, 2001 Comp., p. 783 and on annual presidential notices continuing the national emergency which was declared in that executive order pursuant to the International Emergency Economic Powers Act. This rule revises the authority paragraphs for the 23 affected parts of the EAR to remove references to the previous notice and add references to the most recent such notice, which the President signed on August 15, 2017.

This rule is purely procedural and makes no changes other than to revise CFR authority paragraphs for the purpose of making the authority citations current. It does not change the text of any section of the EAR, nor does it alter any right, obligation or prohibition that applies to any person under the EAR.

Rulemaking 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, distributive impacts, and equity). This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. This rule has been determined to be not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond 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 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 rule does not involve any collection of information.

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

4. The Department finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This rule only updates legal authority citations. It clarifies information and is non-discretionary. This rule does not alter any right, obligation or prohibition that applies to any person under the EAR. Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness otherwise required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. Because neither the Administrative Procedure Act nor any other law requires that notice of proposed rulemaking and an opportunity for public comment be given for this rule, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly, no Final Regulatory Flexibility Analysis is required and none has been prepared.

List of Subjects 15 CFR Part 730

Administrative practice and procedure, Advisory committees, Exports, Reporting and recordkeeping requirements, Strategic and critical materials.

15 CFR Parts 732, 740, 748, 750, and 758

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

15 CFR Part 734

Administrative practice and procedure, Exports, Inventions and patents, Research, Science and technology.

15 CFR Parts 736, 738, 770, and 772

Exports.

15 CFR Part 742

Exports, Terrorism.

15 CFR Part 743

Administrative practice and procedure, Reporting and recordkeeping requirements.

15 CFR Part 744

Exports, Reporting and recordkeeping requirements, Terrorism.

15 CFR Parts 746 and 774

Exports, Reporting and recordkeeping requirements.

15 CFR Part 754

Agricultural commodities, Exports, Forests and forest products, Horses, Petroleum, Reporting and recordkeeping requirements.

15 CFR Part 756

Administrative practice and procedure, Exports, Penalties.

15 CFR Part 760

Boycotts, Exports, Reporting and recordkeeping requirements.

15 CFR Part 762

Administrative practice and procedure, Business and industry, Confidential business information, Exports, Reporting and recordkeeping requirements.

15 CFR Part 764

Administrative practice and procedure, Exports, Law enforcement, Penalties.

15 CFR Part 766

Administrative practice and procedure, Confidential business information, Exports, Law enforcement, Penalties.

15 CFR Part 768

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

Accordingly, parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 746, 748, 750, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772 and 774 of the EAR (15 CFR parts 730-774) are amended as follows:

PART 730 [AMENDED] 1. The authority citation for 15 CFR part 730 is revised 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. 2151 note; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42 FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of September 15, 2016, 81 FR 64343 (September 19, 2016); Notice of November 8, 2016, 81 FR 79379 (November 10, 2016); Notice of January 13, 2017, 82 FR 6165 (January 18, 2017); Notice of May 9, 2017, 82 FR 21909 (May 10, 2017); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 732 [AMENDED] 2. The authority citation for 15 CFR part 732 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 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 15, 2017, 82 FR 39005 (August 16, 2017).

PART 734 [AMENDED] 3. The authority citation for 15 CFR part 734 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; 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, 2014 Comp., p. 223; Notice of November 8, 2016, 81 FR 79379 (November 10, 2016); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 736 [AMENDED] 4. The authority citation for 15 CFR part 736 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; 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. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 168; Notice of November 8, 2016, 81 FR 79379 (November 10, 2016); Notice of May 9, 2017, 82 FR 21909 (May 10, 2017); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 738 [AMENDED] 5. The authority citation for 15 CFR part 738 is revised 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; 42 U.S.C. 2139a; 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 15, 2017, 82 FR 39005 (August 16, 2017).

PART 740 [AMENDED] 6. The authority citation for 15 CFR part 740 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; 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 15, 2017, 82 FR 39005 (August 16, 2017).

PART 742 [AMENDED] 7. The authority citation for 15 CFR part 742 is revised 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 November 8, 2016, 81 FR 79379 (November 10, 2016); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 743 [AMENDED] 8. The authority citation for 15 CFR part 743 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; 78 FR 16129; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 744 [AMENDED] 9. The authority citation for 15 CFR part 744 is revised 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; 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. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of September 15, 2016, 81 FR 64343 (September 19, 2016); Notice of November 8, 2016, 81 FR 79379 (November 10, 2016); Notice of January 13, 2017, 82 FR 6165 (January 18, 2017); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 746 [AMENDED] 10. The authority citation for 15 CFR part 746 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 287c; Sec 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Presidential Determination 2007-7, 72 FR 1899, 3 CFR, 2006 Comp., p. 325; Notice of May 9, 2017, 82 FR 21909 (May 10, 2017); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 748 [AMENDED] 11. The authority citation for 15 CFR part 748 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 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 15, 2017, 82 FR 39005 (August 16, 2017).

PART 750 [AMENDED] 12. The authority citation for 15 CFR part 750 is revised 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 15, 2017, 82 FR 39005 (August 16, 2017).

PART 754 [AMENDED] 13. The authority citation for 15 CFR part 754 is revised 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); 15 U.S.C. 1824a; E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 756 [AMENDED] 14. The authority citation for 15 CFR part 756 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 758 [AMENDED] 15. The authority citation for 15 CFR part 758 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 760 [AMENDED] 16. The authority citation for 15 CFR part 760 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 762 [AMENDED] 17. The authority citation for 15 CFR part 762 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 764 [AMENDED] 18. The authority citation for 15 CFR part 764 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 766 [AMENDED] 19. The authority citation for 15 CFR part 766 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 768 [AMENDED] 20. The authority citation for 15 CFR part 768 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 770 [AMENDED] 21. The authority citation for 15 CFR part 770 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 772 [AMENDED] 22. The authority citation for 15 CFR part 772 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

PART 774 [AMENDED] 23. The authority citation for 15 CFR part 774 is revised 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; 42 U.S.C. 2139a; 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 15, 2017, 82 FR 39005 (August 16, 2017).

Dated: September 25, 2017. Richard E. Ashooh, Assistant Secretary for Export Administration.
[FR Doc. 2017-21003 Filed 10-2-17; 8:45 am] BILLING CODE 3510-33-P
DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management 30 CFR Part 583 [Docket ID: BOEM-2010-0041; MMAA104000] RIN 1010-AD90 Negotiated Noncompetitive Agreements for the Use of Sand, Gravel, and/or Shell Resources on the Outer Continental Shelf AGENCY:

Bureau of Ocean Energy Management, Interior.

ACTION:

Final rule.

SUMMARY:

This final rule establishes new regulations to address the use of Outer Continental Shelf (OCS) sand, gravel, and/or shell resources for shore protection, beach restoration, or coastal wetlands restoration projects by Federal, state, or local government agencies, and for use in construction projects authorized by or funded in whole or in part by the Federal Government. The final rule describes the negotiated noncompetitive agreement process for qualifying projects and codifies new and existing procedures.

DATES:

This rule is effective December 4, 2017.

FOR FURTHER INFORMATION CONTACT:

Deanna Meyer-Pietruszka, Chief, Office of Policy, Regulations, and Analysis, Bureau of Ocean Energy Management, at: [email protected] or 202-208-6352.

SUPPLEMENTARY INFORMATION:

On March 22, 2016, the Bureau of Ocean Energy Management (BOEM) published in the Federal Register (81 FR 15190) a proposed rule entitled “Negotiated Noncompetitive Leasing for the Use of Sand, Gravel, and Shell Resources on the Outer Continental Shelf.” BOEM received comments from 8 individuals and organizations. BOEM reviewed these comments, categorized and organized them by subject, and has provided responses to those substantive comments in Section III below. These comments are available for viewing in their original form on www.regulations.gov by searching for the term: “BOEM AD90.” BOEM also renumbered the sections contained in the proposed rule to facilitate any later amendments that may be necessary. Finally, BOEM altered the title of the proposed rule by replacing “Leasing” with “Agreements” to more accurately reflect the types of instruments BOEM uses to convey offshore sand, gravel, and/or shell resources (i.e. leases or memoranda of agreement, as described below).

Table of Contents I. Background A. Program Description B. Program History II. Section-by-Section Analysis of the Final Rule A. Subpart A—General B. Subpart B—Reserved C. Subpart C—Outer Continental Shelf Sand, Gravel, and/or Shell Resources Negotiated Agreements III. Summary of Comments Received on the Proposed Rule and BOEM Responses IV. Legal and Regulatory Analysis I. Background

Congress amended the Outer Continental Shelf Lands Act, 43 U.S.C. 1331-1356 (OCSLA), in 1994 to authorize the Secretary of the Interior to negotiate noncompetitive agreements with any person for the use of OCS sand, gravel, and/or shell resources in a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, state, or local government agency, or in a construction project either authorized by, or funded in whole or in part by the Federal Government. See 43 U.S.C. 1337(k)(2). In negotiating an agreement for use of the OCS sand, gravel, and/or shell resources, OCSLA provides that “the Secretary may assess a fee based on an assessment of the value of the resources and the public interest served by promoting development of the resources.” However, the same provision of OCSLA also states that no fee will be assessed directly or indirectly against a Federal, state, or local government agency. See 43 U.S.C. 1337(k)(2)(B).

A. Program Description

Generally, shore protection and beach and coastal wetlands restoration projects are initiated to rebuild eroding shoreline segments, such as beaches and dunes, barrier islands, and wetlands. In sensitive wetland areas, these projects are intended to forestall further erosion, restore habitat and/or to provide protection from hurricanes and storms. These projects are typically accomplished by placing sand, gravel, or shell resources directly on the beach, in open water areas that are the location of an eroded beach, and/or within breaches in the shoreline that compromise the integrity of the beach or barrier island system or its capacity to form, and subsequently maintain, a beach. Material may also be placed updrift from the beach, allowing longshore processes to redistribute the sand, gravel, and/or shell resources along the beach.

OCSLA authorizes BOEM to enter into a negotiated noncompetitive agreement when the use of OCS sand, gravel, and/or shell resources is authorized for qualifying projects. This negotiated agreement may take the form of a lease or a Memorandum of Agreement (MOA), depending upon the type of applicant(s) requesting use of OCS sand, gravel, and/or shell resources. If a non-Federal entity requests the use of OCS sand, gravel, and/or shell resources, the negotiated noncompetitive agreement required by OCSLA would generally take the form of a lease. If a Federal agency requests the use of OCS sand, gravel, and/or shell resources, BOEM and the Federal agency, as well as their Federal, state, or local government agency counterparts on the project, would enter into an MOA. For example, when a Federal agency partially or wholly funds a non-Federal entity to conduct a project that is otherwise eligible for OCS sand, gravel, and/or shell resources, the negotiated noncompetitive agreement may take the form of a three-party MOA. As warranted, the Federal applicant(s) and BOEM would designate a lead agency and enter into a cooperating agency agreement for the environmental analysis and review of the proposed project. Likewise, if another Federal agency is not involved, BOEM would ensure that appropriate environmental analysis and review is completed. The negotiated noncompetitive agreement in each of these situations would describe the project and procedures that would be followed, and identify environmental and administrative requirements that must be met. As described in Section III below in response to a comment received, the requirements and processes for entering into a negotiated noncompetitive agreement are the same whether the agreement takes the form of a lease or a MOA. The only distinction is that which Congress provides in OCSLA that, when these projects involve Federal agencies, the Federal agency “shall enter into a Memorandum of Agreement with the Secretary. . . .” See 43 U.S.C. 1337(k)(2)(D).

B. Program History

BOEM and its predecessor agencies—the Minerals Management Service and the Bureau of Ocean Energy Management, Regulation and Enforcement—through the Marine Minerals Program, have been exercising statutory authority regarding OCS sand, gravel, and/or shell resources under OCSLA pursuant to written guidelines, without the benefit of implementing regulations. BOEM has negotiated over 50 noncompetitive agreements, providing for the use of more than 100 million cubic yards of OCS sand, gravel, and/or shell resources for shore protection, beach restoration, or coastal wetlands restoration projects undertaken by a Federal, state, or local government agency, and for federally authorized or funded construction projects. BOEM believes that promulgation of regulations at this time is advisable to provide additional clarity and certainty and to help ensure continuity of the Marine Minerals Program.

II. Section-by-Section Analysis of the Final Rule Subpart A—General Section 583.100 What is BOEM's authority for information collection (IC)?

This section explains BOEM's authority for IC activities related to part 583. It explains the reasons the information is being collected and confirms the Office of Management and Budget (OMB) approval of the collection.

Section 583.105 What is the purpose of this rule and to whom does it apply?

This section explains that the purpose of this rule is to refine and formally adopt procedures for entering into negotiated noncompetitive agreements for the use of OCS sand, gravel, and/or shell resources for shore protection; beach or coastal wetlands restoration by a Federal, state, or local government agency; or for construction projects authorized or funded, in whole or in part, by the Federal Government. This section explains that the rule applies exclusively to the negotiated noncompetitive use of sand, gravel, and/or shell resources on the OCS and does not apply to competitive leasing of minerals, including oil, gas, sulphur, geopressured-geothermal and associated resources, and all other minerals that are authorized by an Act of Congress to be produced from “public lands” as defined in section 103 of the Federal Land Policy and Management Act of 1976, as amended (FLPMA). (43 U.S.C. 1701 et seq.)

Section 583.110 What is BOEM's authority for this rule?

This section explains that in adopting these regulations, BOEM is operating under authority granted to the Secretary of the Interior by OCSLA.

Section 583.115 What definitions do I need to know?

This section defines many of the terms commonly used in the Marine Minerals Program and now used in this part, including “borrow area,” “placement area,” and “project.” This section also defines other terms for purposes of this part, including “agreement,” “amendment,” “applicant,” “BOEM,” “Federal agency,” “local government,” “modification,” “program,” and “Secretary.” This section also makes the definitions applicable to Part 550 of Title 30 of the CFR applicable to this part.

Section 583.120 Who is qualified for a project?

This section explains who is qualified to enter into an agreement with BOEM for the use of OCS sand, gravel, and/or shell resources, and explains the requirements to comply with the relevant debarment regulations.

Section 583.125 What are my rights to seek reconsideration of an unfavorable decision by BOEM?

This section sets out the kinds of decisions that would be subject to reconsideration, and the process available to an unsuccessful applicant or adversely affected party for obtaining reconsideration.

Section 583.130 What are the minimum contents of an agreement to use OCS sand, gravel, and/or shell resources?

This section explains who is allowed to use OCS sand, gravel, and/or shell resources under these regulations, and explains that use authorizations are in the form of agreements that are negotiated on a case-by-case basis. It also explains that the agreements identify the location, type and volume of OCS sand, gravel, and/or shell resources allowed to be used under the agreement. In addition, it explains that an authorization to use OCS sand, gravel, and/or shell resources is not exclusive. BOEM has modified language in this section from the proposed rule by adding language stating that “terms and conditions and environmental stipulations” will be included in the list of the minimum contents of an agreement, and adding language to clarify the conditions under which more than one entity may use the same borrow area.

Subpart B—Reserved Subpart C—Outer Continental Shelf Sand, Gravel, and/or Shell Resources Negotiated Agreements Section 583.300 How do I submit a request for an agreement?

This section explains who may submit a request to BOEM to obtain an agreement for the use of OCS sand, gravel, and/or shell resources. It lists the information that the request must include, such as a detailed description of the proposed project and how it qualifies as a program or project eligible under OCSLA to receive OCS sand, gravel, and/or shell resources pursuant to a negotiated noncompetitive agreement; a description of borrow and placement areas; certain maps and data; other uses of the OCS and infrastructure in the borrow area that are known to the applicant; a description of the environmental evaluations that have been completed or are being prepared that cover the project, including both onshore and offshore components; a target date or date range when the resources will be needed; a description of the person or government entities that are undertaking the project and points of contact; a list of permits, licenses and authorization required for the project; a description of potential inconsistencies with state coastal zone management plans or other applicable state and local laws; and a statement explaining who authorized the project and how the project will be funded. Since issuance of the proposed rule, BOEM replaced the requirement that hard copy maps be provided with the request for a negotiated noncompetitive agreement in section 583.300(a)(2)(i); instead, the final rule requires digital (pdf) maps be provided. This modification in the final rule recognizes changes in technology and that most submissions are now made electronically.

Section 583.305 How will BOEM determine if a project qualifies?

This section lays out the factors that BOEM uses to determine whether a project qualifies for use of OCS sand, gravel, and/or shell resources under a negotiated noncompetitive agreement. The section enumerates the evaluation criteria, including: The project purpose; other uses of OCS sand, gravel, and/or shell resources that are currently or previously authorized from the same borrow area; the project funding source(s) and amounts; the proposed design and feasibility of the project; any potential environmental and safety risks associated with the project; other Federal interests located near or within the specified borrow area; comments received from potentially affected state or local governments, if any; the applicant's background and experience working on similar projects or activities; whether the project operations can be conducted in a manner that protects the environment and promotes orderly development of OCS mineral resources; whether activities can be conducted in a manner that does not pose a threat of serious harm or damage to, or waste of, any natural resources, any life, property, or the marine, coastal, or human environment; and whether the project is consistent with applicable statutes and their implementing regulations, which may include, but are not limited to, the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.), the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq.), the Marine Debris Research, Prevention, and Reduction Act (MDRPRA) (33 U.S.C. 1951 et seq.), the Marine Plastic Pollution Research and Control Act (MPPRCA) (33 U.S.C. 1901 et seq.), the Federal Water Pollution Control Act (FWPCA) (33 U.S.C. 1381 et seq.), and the International Convention for the Prevention of Pollution from Ships (MARPOL), MARPOL-Annex V Treaty.

Section 583.310 What process does BOEM use to technically and environmentally evaluate a qualified project?

This section explains the process that BOEM follows to evaluate a project that qualifies for the use of OCS sand, gravel, and/or shell resources to decide whether to enter into a negotiated noncompetitive agreement. It states that BOEM coordinates with relevant Federal agencies, states, and local governments, and any potentially affected federally recognized Indian tribes or Alaska Native corporations during this process. It also describes how BOEM evaluates the project and additional information provided under sections 583.300 and 583.305 to determine if the information is sufficient to conduct necessary technical and environmental reviews to comply with the requirements of applicable statutes and regulations, which may include, but are but not limited to: OCSLA (43 U.S.C. 1331 et seq.), the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.), the ESA (16 U.S.C. 1531 et seq.), the MMPA (16 U.S.C. 1361 et seq.), the Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA) (16 U.S.C. 1801 et seq.), the National Historic Preservation Act (NHPA) (54 U.S.C. 300101 et seq.), and the Coastal Zone Management Act (CZMA) (16 U.S.C. 1451 et seq.). Finally, this section provides that BOEM will not enter into a negotiated noncompetitive agreement until the information requested for the evaluation has been provided and BOEM has evaluated it.

Section 583.315 What is the process for negotiating and executing an agreement?

This section describes the steps BOEM takes once it has completed its technical, environmental and other evaluations. This section provides further that, once BOEM has completed its review of an application, BOEM will decide whether to enter into an agreement. This section provides that, if BOEM decides to enter into an agreement, BOEM will negotiate the terms of the agreement and prepare a draft agreement for the applicant's review and comment. The section also provides that, after BOEM considers the applicant's comments and suggestions, it may, at its discretion, finalize the agreement and send it to the applicant for signature. As provided in this section, once BOEM receives the agreement with the applicant's signature, BOEM will execute the agreement and distribute it to the parties to the agreement. Finally, this section describes the process BOEM would use when it decides not to approve an agreement.

Section 583.320 What kinds of information must be included in an agreement?

This section describes the minimum information that an agreement is required to include, such as an agreement number assigned by BOEM; the purpose of, and authorities for, the agreement; the designated and delineated borrow area(s); the project description, including the timeframe within which the project is to be started and completed; the terms and conditions of the agreement, including any reporting requirements; all obligations of the parties; and the signatures of appropriate individuals authorized to bind the applicants and BOEM. In this final rule, in section 583.320(e), BOEM added “environmental mitigations and operating parameters” to the examples of terms and conditions that might be included in an agreement, to make clear that, if there are any environmental mitigations or operating parameters, that information must be included in negotiated noncompetitive agreements.

Section 583.325 What is the effective date of an agreement?

This section describes what determines the effective date of the agreement.

Section 583.330 How will BOEM enforce the agreement?

This section describes how BOEM would enforce the terms of an agreement and the consequences, including termination, for failure to comply with any applicable law or with the agreement terms. This section also provides that the failure to comply in a timely and satisfactory manner with any provision, term or condition of the agreement may delay or prevent BOEM's approval of future requests for use of OCS sand, gravel, and/or shell resources on the part of the parties to the agreement.

Section 583.335 What is the term of the agreement?

This section explains when an agreement terminates: (1) By a date specified in the agreement; (2) pursuant to 30 CFR 583.350; or (3) when parties to the agreement notify BOEM in writing that sufficient resources, up to the amount authorized in the agreement, have been removed to complete the project. This section also explains that, absent extraordinary circumstances, no agreement will have a term that is longer than five years from its effective date. Examples of extraordinary circumstances where a term longer than five years may be appropriate include a program of multiple individual projects to be carried out over multiple seasons, or where the Congressional authorization for a project calls for multiple phases. It is within BOEM's sole discretion to determine when extraordinary circumstances warrant a term longer than five years. Prior to the end of the term in an agreement, the parties would have the option to request an extension or modification to the terms of the agreement, as set forth in section 583.345.

Section 583.340 What debarment or suspension obligations apply to transactions and contracts related to a project?

This section explains that the applicant has the obligation to ensure that all contracts and transactions related to an agreement issued under this part comply with the suspension and debarment regulations at 2 CFR part 180 and 2 CFR part 1400.

Section 583.345 What is the process for extending or modifying an agreement?

This section explains how an applicant may seek to extend or modify an agreement and spells out the timeframes when this might be accomplished. It provides that BOEM is under no obligation to extend or modify an agreement and cannot be held liable for the consequences of the expiration of an agreement. If BOEM approves a modification, BOEM will prepare an amendment to the agreement and provide it for review by the parties to the agreement prior to execution of the amendment. If BOEM disapproves the request, BOEM will notify the parties to the agreement of the reasons in writing. Parties to the agreement may ask the BOEM Director for reconsideration in accordance with section 583.125.

Section 583.350 When can an agreement be terminated?

This section explains the circumstances under which the Director will terminate an agreement after notice and an opportunity to be heard. The termination factors include fraud or misrepresentation. This section also explains the circumstances under which the Director may immediately suspend and subsequently terminate an agreement, including when there is noncompliance with the agreement; national security or defense reasons; or when the Director determines that: (1) There are situations in which continuing with the agreement would cause serious harm or damage to natural resources, life, property, the marine, coastal, or human environment, or significant historical or archaeological sites, structures or objects; (2) the threat of harm or damage will not disappear or decrease to an acceptable extent within a reasonable period of time; and (3) the advantages of termination outweigh the advantages of continuing the agreement. This section also explains the process for terminations and suspensions and explains that none of the parties to the agreement will be entitled to compensation as a result of expenses or lost revenues that may result from the termination.

III. Summary of Comments Received on the Proposed Rule and BOEM Responses General Comments on 30 CFR Part 583

Comment: Two commenters commended BOEM for its existing program to utilize OCS sand, gravel, and/or shell resources to repair damaged coastal areas and improve shore protection, beach restoration and coastal wetlands protection. They commented that BOEM's activities are beneficial, lawful, and properly within the jurisdiction of the United States Department of the Interior.

Response: BOEM and its predecessor agencies have been exercising statutory authority to successfully operate this popular program for many years. BOEM has negotiated over 50 agreements, providing for the use of more than 100 million cubic yards of OCS sand, gravel, and/or shell resources for shore protection, beach restoration, or coastal wetlands restoration. This final rule codifies the procedures BOEM has used to implement this program for many years and ensures consistency as the program continues to process requests for use of OCS sand, gravel, and/or shell resources and manage these resources into the future.

Comment: Another commenter suggested that BOEM needs to more clearly identify the basis that staff will use to weigh the stated criteria for approval of a negotiated noncompetitive agreement in the face of competing interests. The commenter also suggested that a timeline for approval of an agreement be stated in the rule.

Response: Currently, BOEM evaluates applications for the use of OCS sand, gravel, and/or shell resources on a case-by-case basis as they are submitted, taking into account relevant factors and criteria described in the rule and below. The criteria BOEM uses in evaluating an application are provided in Section 583.305. BOEM does not assign a weight to each criterion but considers each criterion in the context of the entire proposed project, as well as pending requests for other projects in the same or nearby borrow areas.

The timelines for processing applications and requests vary based upon a number of factors, including, but not limited to, completion of necessary environmental analyses (e.g., through the NEPA process) and consultation processes (e.g., Tribal consultations or ESA consultations). The environmental review process can range from six months to a year or more. The duration of the environmental review is variable and can be influenced by many factors that can drive different timeframes, including the scope and issues of a project, type of environmental review needed (e.g., Environmental Assessment (EA) or Environmental Impact Statement (EIS) under NEPA), applicability of reviews or consultations previously completed, additional information or studies that may be necessary, emergent stakeholder concerns, and whether or not another Federal partner is leading, or cooperating on, the environmental review and consultations. Once the environmental reviews and consultations are completed, it may take up to an additional six months to complete the process for issuing a final agreement, as project-specific stipulations in the agreement are negotiated between the applicant(s) and BOEM.

Because every project must be evaluated using a number of factors and project-specific information, BOEM determined that it is not possible to modify the rule as requested by the commenters. Providing specific weighting of criteria or providing an inflexible review deadline would be unnecessarily restrictive given the complexities of evaluating individual, site specific projects while complying with multiple statutes governing environmental review and consultation.

Comment: One commenter thought there should be public notice of every application and agreement to increase the transparency of the process. Another expressed that BOEM should consider a process to provide notice and solicit additional expressions of interest or proposals from the public when it receives an application for a particular area. Finally, one commenter stated that the procedures set out in the rule do not contain sufficient opportunities or avenues for public engagement.

Response: BOEM is endeavoring to increase transparency of the negotiated noncompetitive agreement process through efforts such as posting formal request letters on its Web page and coordinating with the states in advance of anticipated requests for OCS sand, gravel, and/or shell resources. BOEM will be unable, however, to formally solicit additional expressions of interest each time it receives an application because the applicable statutory provision governing agreements issued pursuant to these regulations specifically provides for a noncompetitive process where agreements are negotiated on a qualifying program or project basis. See 43 U.S.C. 1337(k)(2). Public notice of projects will be provided through the BOEM Web site and, as appropriate, during the public participation process of NEPA; the permitting process for authorized U.S. Army Corps of Engineers (USACE) civil works projects, through the USACE Section 404 permitting process, where applicable; and through BOEM engagement during stakeholder outreach and government-to-government consultations. In addition, to facilitate stakeholder awareness and engagement, BOEM holds annual regional Sand Management Working Group meetings in close consultation with the states to understand future projected OCS sand, gravel, and/or shell resource needs. BOEM seeks to make its process a collaborative effort that involves all interested stakeholders, where appropriate.

Comment: One commenter suggested that since sand resources are often identified by and valuable to local governments, they should be granted exclusive use for those OCS sand, gravel, and/or shell resources if they expend the resources to develop them as potential borrow areas. The commenter referenced local government funding of borrow area studies and questioned whether funding would be reimbursed if the area studied is authorized for use by another party. The commenter suggested that BOEM should decide which particular use of resources is in the national interest.

Response: An executed agreement grants the right to a party to extract and use OCS sand, gravel, and/or shell resources from a designated borrow area as further described below. The provision of OCSLA, which this final rule implements, does not provide for agreements that grant the exclusive use of OCS sand, gravel, and/or shell resources, but rather provides for the negotiation of agreements on a noncompetitive basis as qualifying projects and programs are proposed. See 43 U.S.C. 1337(k)(2). BOEM does not reimburse parties for independent studies conducted on the OCS. However, BOEM does often work with individual states through funded cooperative agreements to identify potential sand resources on the OCS. BOEM operates the program in the national interest and in keeping with the policies under OCSLA for providing access to OCS sand, gravel, and/or shell resources.

Comment: A commenter expressed concern that a proximal OCS borrow area specifically identified for a local project as containing appropriate material could be removed by another entity, thereby increasing the cost to the original local sponsor as they have to haul material from a greater distance. A commenter also suggested that BOEM needs a way to prioritize projects.

Response: BOEM encourages ongoing dialogue among stakeholders so that it can manage the interests of multiple parties in these critical resources going forward. BOEM facilitates such discussions through its annual regional Sand Management Working Group meetings. In addition, BOEM will undertake additional future coordination with interested stakeholders to identify and manage overlapping interest by state and local governments in using OCS borrow areas. As BOEM evaluates an individual project through the environmental analyses, it will consider potential cumulative impacts to borrow areas from other past, present and proposed uses.

Comment: A commenter suggested that the non-exclusive use of resources provision is not workable because the rule does not specify that concurrent negotiated noncompetitive agreements will be non-conflicting, and could provide an advantage to the first applicant granted access to use a resource.

Response: Nothing in OCSLA authorizes BOEM to grant an ownership interest in OCS borrow areas or the sand, gravel, and/or shell resources on the OCS, or the exclusive use of an OCS sand, gravel, or shell resource in a negotiated noncompetitive agreement (43 U.S.C. 1337(k)(2)). In BOEM negotiated agreements, BOEM expressly reserves the right to authorize other uses in the designated borrow area that will not unreasonably interfere with activities authorized under the agreement. BOEM allows parties to an agreement to review and comment on any proposed authorizations for use of OCS sand resources in the designated borrow area while their agreement is in effect. To the extent there are multiple projects in the same borrow area, the negotiated noncompetitive agreements may encourage coordination between the parties to reduce the potential for space/use conflicts.

This final rule modified language in the proposed rule at section 583.130 to state “BOEM may allow other entities to use OCS sand, gravel, and/or shell resources from the same borrow area if these uses are determined by BOEM to be non-conflicting and do not exceed the availability of the OCS resource.”

Comment: One commenter stated that the proposed rule does not address borrow area sediment use, quantity, and quality.

Response: Regarding borrow sediment use, section 583.120 (a) states that “BOEM may enter into an agreement with any person proposing to use OCS sand, gravel, or shell resources for a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration.” Section 583.300(a) requires that the applicant detail how the material will be used and how the proposed project qualifies as an eligible project. Regarding quantity, section 583.130 calls for any issued agreement to identify the volume and type of OCS sand, gravel, and/or shell resources that may be obtained from the authorized borrow site for the qualified project. gravel, and/or shell.

Aside from identifying the type of resources included in an agreement, the regulation does not address quality. BOEM will not make representations as to any aspects of quality, other than the type, of any particular material utilized for qualified projects. It is the applicant's responsibility to assess the quality of the type of OCS sand, gravel, and/or shell resources in a borrow area as it relates to the suitability of these resources for the applicant's proposed use.

Comment: A commenter suggested that BOEM prepare a programmatic environmental impact statement for this rule, as well as engage in consultation under the Endangered Species Act. The commenter felt that a project-by-project approach to NEPA and ESA consultations would fail to account for cumulative impacts from multiple projects.

Response: These final regulations are administrative and procedural in nature and therefore meet the criteria set forth in 43 CFR 46.210(i) for a Departmental “categorical exclusion” in that this rule is “. . . of an administrative, financial, legal, technical, or procedural nature. . . .” BOEM has also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215. Similarly, the rule does not itself result in any impacts to listed species under the ESA.

BOEM has determined, in its discretion under NEPA, it will either individually or programmatically evaluate the environmental impacts of projects as they are proposed, when there is sufficient information on the proposal to be evaluated, including but not limited to the timing, location, and resources that may be implicated. Without these types of project specific details, impacts could not be reasonably evaluated at a national programmatic level. NEPA requires, even in project specific analyses, that cumulative impacts from past, present, and reasonably foreseeable activities be considered. There is a similar requirement during ESA consultations to ensure cumulative impacts on listed species are considered.

Comments Related to Specific Sections of the Rule 583.120 Who is qualified for a project?

Comment: One commenter suggested that the rule seems to apply only to Federal projects and makes the application process to obtain an agreement easier when another Federal agency is one of the applicants. Another commenter noted that the proposed rule seems to apply only to projects funded in whole or in part by the Federal Government, and it questions how these regulations will affect local and state projects proposed without a Federal partner. A commenter asked how BOEM's negotiated noncompetitive agreement process addresses when non-Federal projects identify borrow areas that a Federal project also identifies.

Response: OCSLA, at 43 U.S.C. 1337(k), provides that BOEM may enter into agreements for use of OCS sand, gravel, and/or shell resources in: (i) A program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, state, or local government agency; or (ii) for use in a construction project, other than a project described in clause (i), that is funded in whole or in part by or authorized by the Federal Government (emphasis added). These new regulations at 30 CFR part 583 codify the process for BOEM to enter into negotiated noncompetitive agreements for any of these types of projects. Therefore, a state or local government agency may qualify for a negotiated noncompetitive agreement to use these OCS resources for a project they undertake for shore protection, beach restoration, or coastal wetlands restoration, whether or not they have a Federal partner for the project. Whether a project is undertaken by or funded by a Federal partner or by a non-Federal applicant, the requests are reviewed and processed similarly by BOEM, including, but not limited to, analyzing multiple interests in the same borrow areas at the time a negotiated noncompetitive agreement is processed.

Comment: A commenter stated that it appears the process for approval of a negotiated noncompetitive agreement will take more time and be more expensive than preparing a Memorandum of Agreement (MOA) for a Federal project.

Response: The timing and expense to obtain an MOA for federally funded, authorized, or constructed projects is the same as for a lease for a non-federal project. Similar required information must be submitted in an application for any negotiated noncompetitive agreement, whether it takes the form of a lease (for projects that do not have a Federal partner) or an MOA (for projects including a Federal agency). Both will undergo the same environmental scrutiny. The decision to call an agreement a MOA versus a lease is strictly a matter of whether another Federal agency is involved, as mandated by OCSLA at 43 U.S.C. 1337(k)(D) (“Any Federal agency which proposes to make use of sand, gravel, and/or shell resources subject to the provisions of this subchapter shall enter into a Memorandum of Agreement with the Secretary concerning the potential use of those resources.”). The application review process and all other requirements are the same.

Comment: A commenter asked whether a project might be approved to extract material and create a stockpile onshore, for use as needed over time. The commenter also inquired whether an entity would be allowed to sell any excess material deemed unnecessary for the original purpose to defray costs.

Response: Regarding borrow sediment use, section 583.120(a) states that “BOEM may enter into an agreement with any person proposing to use OCS sand, gravel, or shell resources for a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration . . . ” (emphasis added). Other uses are not authorized under this section of OCSLA. BOEM, with the support of its sister agency the Bureau of Safety and Environmental Enforcement (BSEE), will enforce the provisions of the lease and will take appropriate enforcement actions, if necessary. The new regulation section 583.300(a) specifically requires that the applicant detail how the material will be used and how it qualifies as an eligible project. Staging of the OCS sand, gravel, and/or shell resources onshore for ultimate use in a qualified project or program may be approved so long as the resources are ultimately used for the qualified project identified in the agreement, during the agreement term. However, the sale of excess material not needed for the project would not be a qualified use of the OCS sand, gravel, and/or shell resources and would therefore not be an authorized use.

583.125 What are my rights to seek reconsideration of an unfavorable decision by BOEM?

Comment: One commenter suggested that besides the right to request reconsideration of the Director provided by section 583.125, appellants should be allowed to appeal pursuant to 30 CFR part 590, like appeals from other DOI land management decisions. Another commenter thought the appeals process was too limited and provided too much authority to the BOEM Director to decide whether a project qualifies. One commenter requested clarification that this regulation would not affect actions brought under the Administrative Procedure Act.

Response: The reconsideration process for unsuccessful applicants in this rule is consistent with the process BOEM has provided to unsuccessful bidders in other leasing programs administered by the Bureau. See e.g., 30 CFR 556.517 and 585.118. Due to the similarities between this program and other mineral leasing programs administered by BOEM, the Bureau determined that using a similar process to allow applicants to request reconsideration of disapprovals of applications for leases or MOAs related to OCS sand, gravel, and/or shell resources would give applicants an appropriate review opportunity. Therefore, the final rule includes BOEM's standard process of allowing unsuccessful applicants, whose request was disapproved or disqualified by the Regional Director or equivalent, to seek reconsideration by the Director. This final rule provides for a reconsideration process for decisions on negotiated noncompetitive agreements under 43 U.S.C. 1337(k). Agreements typically include a dispute resolution process as part of the terms negotiated with the applicants; therefore, a separate appeals process is not necessary once the agreement is executed.

583.130 What are the minimum contents of an agreement to use OCS sand, gravel, and/or shell resources?

Comment: A commenter requested that BOEM specify that the minimum contents of an agreement should include terms and conditions, including recommended, as well as required environmental mitigation requirements. A commenter questioned whether more than one entity might use the same resource.

Response: Text has been added to this final rule in section 583.130, to provide that the negotiated noncompetitive agreement will include “terms and conditions and environmental stipulations.” As noted above, text was also added to respond to a comment on non-exclusive use of the resources in a borrow area to state, “BOEM may allow other entities to use OCS sand, gravel, and/or shell resources from the same borrow area if these uses are determined by BOEM to be non-conflicting and do not exceed the availability of the OCS resource.”

583.300  How do I submit a request for an agreement?

Comment: One commenter suggested that duplicative information is currently submitted in association with an application under this rule and a Clean Water Act application. It suggested instead that submission of the Clean Water Act application be allowed to fulfill the information request for any overlapping items.

Response: BOEM needs the information identified in the regulations to inform its own decision on whether to issue a negotiated noncompetitive agreement for OCS sand, gravel, and/or shell resources. There may be information requested by section 583.300 that is also collected under the Clean Water Act permit application. In cases where duplicative information is required by more than one agency, BOEM will allow applicants to submit that portion of the Clean Water Act permit application to BOEM as part of the negotiated noncompetitive agreement application to reduce reporting burdens.

Comment: Another commenter urged BOEM to modify its rule to include a requirement to identify the location of existing and planned submarine cables, called proximate critical infrastructure, and then for applicants to coordinate and consult about OCS sand, gravel, and/or shell resource extraction operations with the infrastructure owners as a condition to qualifying for a negotiated agreement with BOEM. The commenter encourages the establishment of default or minimum separation distances to protect submarine cables.

Response: Although submarine cables are not identified specifically in the rule, the careful evaluation of other uses of potential OCS borrow areas are considered throughout the review process. Minimum separation distances from known infrastructure are already incorporated into the language of negotiated noncompetitive agreements. In addition, survey requirements help ensure that activities avoid hazards or anthropogenic resources, including, but not limited to, potential shipwrecks and infrastructure. BOEM has added a reference to infrastructure to the final rule at section 583.300(a)(4), a term which would include submarine cables and other similar such hazards. BOEM, however, encourages submarine cable owners and operators to coordinate with and inform BOEM on the placement and location of such infrastructure to further reduce the potential for space/use conflicts. BOEM appreciates recent overtures from this industry about this concern and we look forward to ongoing coordination on these issues.

Comment: A commenter asked that BOEM specify that all requests for an agreement should include ecological information, including surveys of wildlife and habitat characterizations. A commenter requested that BOEM clarify that separate Marine Mammal Protection Act and Endangered Species Act permit authorizations may be required for geophysical data acquisition activities, such as sub-bottom profiling and seismic surveys.

Response: BOEM believes these issues are already addressed adequately under section 583.300(a)(5) and (a)(8). The minimum list of items that should accompany a request is provided in section 583.300(a). This list is not meant to be exhaustive of all steps/authorizations that may be required in order to provide the necessary information, such as permits for survey work that may be required to support the request. For example, the need for Marine Mammal Protection Act and Endangered Species Act authorizations is project and species specific and cannot be determined in advance of a request.

583.310 What process does BOEM use to technically and environmentally evaluate a qualified project?

Comment: One commenter suggested that an Environmental Impact Statement should be prepared about the effects of resource removal and placement.

Response: Once BOEM determines that a project qualifies for a negotiated noncompetitive agreement, a project-specific environmental evaluation process begins, consistent with the Bureau's obligations under NEPA and other applicable law. BOEM will evaluate the project and all relevant information provided to determine if the information is sufficient to conduct necessary technical and environmental reviews to assure the project complies with the requirements of relevant statutes or regulations. As required by law, BOEM complies with NEPA in undertaking agency action. BOEM will determine the level of environmental review (e.g., environmental assessment or environmental impact statement) appropriate to the NEPA process once it has enough site-specific and project information. During that NEPA process and any related ESA consultation, BOEM identifies and evaluates cumulative impacts.

583.320 What kinds of information must be included in an agreement?

Comment: A commenter suggested that BOEM should add language to its rule so that it may require environmental mitigation measures and a reservation for BOEM to modify the agreement and/or terms and conditions to further mitigate detrimental environmental effects.

Response: BOEM considers potential mitigation measures throughout the environmental review process for the application and during drafting of negotiated noncompetitive agreements. BOEM develops environmental protection or mitigation measures for an individual project when reviewing the application and while drafting the agreement or as a result of ESA consultation. BOEM includes these measures, as appropriate, as terms and conditions in the agreement. BOEM has modified the final rule language to explicitly reference environmental mitigations in section 583.320(e).

583.335 What is the term of the agreement?

Comment: One commenter objected to a term of only five years, especially since non-federal projects, and those with multiple phases, may have a planning horizon of more than thirty years. The commenter suggested that any negotiated noncompetitive agreement should have a term that coincides with the permitting timelines of the relevant state. Another commenter noted that by limiting the term to only five years, non-federal sponsors may lose the borrow area for subsequent project phases. In addition, the commenter concluded that only federally authorized projects were eligible for a negotiated noncompetitive agreement extension based on the example of “extraordinary circumstances” contained in the “Section-by-Section Analysis of the Proposed Rule” (81 FR 15190, 15193, March 22, 2016) that states that extensions may be obtained “where the Congressional authorization for a project called for multiple phases.”

Response: BOEM has determined that having a maximum term for negotiated noncompetitive agreements (see section 583.335(b)), absent an extraordinary circumstance, encourages timely and efficient use of the OCS sand, gravel, and/or shell resources, informs the environmental analyses necessary for BOEM to make a decision on the agreement, and enables BOEM to manage competing uses and requests for use of OCS sand, gravel, and/or shell resources from OCS borrow areas.

BOEM examined a number of options for maximum terms for agreements, absent extraordinary circumstances. A longer maximum agreement term could serve as an incentive for agencies or authorities to seek authorizations for highly speculative projects far into the future that may be unlikely to be funded or that would change significantly in scope and require additional environmental analysis in the future. Therefore, BOEM selected five years as the maximum term for negotiated noncompetitive agreements, which considers the lead times needed for a project applicant to obtain an agreement and enter into related construction contracts. There must be some reasonable time limit within which BOEM expects the resources to be used and the project completed to fulfill the Bureau's statutory obligations and manage the resources responsibly for multiple stakeholders.

Congressional authorization is not the only available condition for demonstrating an extraordinary circumstance justifying a term longer than five years under section 585.335, or for obtaining a negotiated noncompetitive agreement extension under section 585.345. When referring to section 583.307, the preamble to the proposed rule reads: “Examples of extraordinary circumstances where an initial term longer than five years may be appropriate would include a program of multiple individual projects to be carried out over multiple seasons or where the Congressional authorization for a project called for multiple phases.” (81 FR 15190, 15193, March 22, 2016) (emphasis added). These are examples of instances where an initial negotiated noncompetitive agreement term of greater than five years may be considered, and are not meant to be an exhaustive list. Extensions to agreements are addressed in section 583.345 concerning processes for modification and may be granted, in BOEM's discretion, after it re-evaluates the project and conducts any additional reviews that may be appropriate.

583.345 What is the process for extending or modifying an agreement?

Comment: A commenter expressed concern that BOEM would not be able to modify an agreement.

Response: Per section 583.345, an agreement may be extended or modified; the rule provides a process for requesting such an amendment.

IV. Legal and Regulatory Analysis Regulatory Planning and Review (Executive Order (E.O.) 12866)

E.O. 12866 provides that the Office of Information and Regulatory Affairs (OIRA), a part of the OMB, will review all significant rules. OIRA has determined that this rule is not significant.

(1) A regulatory impact analysis is not required. This rule formalizes existing policies and procedures that govern the use of OCS sand, gravel, and/or shell resources. The existing policies, procedures, consultations and monitoring requirements for the noncompetitive use of OCS sand, gravel, and/or shell resources are longstanding and have remained relatively consistent for two decades. This rule does not materially change the existing requirements for authorizing the use of OCS sand, gravel, and/or shell resources through leases or MOAs for shore protection, beach or wetlands restoration by a Federal, state or local government agency, or for construction projects authorized or funded, in whole or in part, by the Federal Government. The regulatory baseline is essentially the same as the rule. BOEM believes that any changes between the current BOEM process and this rule are immaterial and would not impose additional compliance obligations or costs upon the regulated entities.

Formalizing the existing conveyance process will provide certainty to the public entities requesting noncompetitive leases or MOAs for OCS sand, gravel, and/or shell resources. BOEM believes there is a benefit to the regulated entities in the form of regulatory certainty when Federal, state and local government agencies desire to use OCS sand, gravel, and/or shell resources for qualifying projects. Entities affected by this rulemaking had the opportunity to comment through the rulemaking process on the proposed provisions, which are consistent with current practices for the conveyance of sand, gravel, and/or shell resources.

(2) This rule does not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. It reflects the existing process developed over the life of the program in cooperation with other Federal agencies, including the U.S. Fish and Wildlife Service (FWS), National Marine Fisheries Service (NMFS) and U.S. Army Corps of Engineers, and state and local governments.

(3) This rule does not have an annual effect on the economy of $100 million or more and does not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities. This rule simply codifies BOEM's longstanding existing practice.

(4) This rule does not alter the budgetary effects of existing entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.

(5) This rule does not raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

Improving Regulation and Regulatory Review (E.O. 13563)

E.O. 13563 reaffirms the principles of E.O. 12866, while calling for improvements in the nation's regulatory system to promote predictability; reduce uncertainty; and use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. BOEM has developed this rule in a manner consistent with these requirements.

Reducing Regulation and Controlling Regulatory Costs (E.O. 13771)

This rule is not an E.O. 13771 regulatory action because it is not significant under E.O. 12866.

Regulatory Flexibility Act (RFA)

BOEM certifies this rule would not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq.). A Regulatory Flexibility Analysis is not required. Small public entities affected by this rulemaking may be cities, counties, towns, townships, villages or special districts, with a population of less than 50,000. Small entities are occasionally parties to an agreement for the use of OCS sand, gravel, and/or shell resources. Over the last two decades, BOEM has issued nearly 50 leases or MOAs with 22 parties, of which five were small public entities. Four out of the five small public entities received significant Federal cost-shares to conduct beach replenishment projects. The application and monitoring requirements are necessary to comply with Federal law and provide BOEM and the public with the best information on the topographic changes in the OCS borrow areas due to dredging. Since BOEM is not proposing any material changes to the longstanding requirements for the use of OCS sand, gravel, and/or shell resources, this rulemaking does not have a substantial effect on small entities.

Small Business Regulatory Enforcement Fairness Act (SBREFA)

The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small businesses about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of BOEM enforcement activities, you may call 1-888-734-3247. You may comment to the Small Business Administration without fear of retaliation. Allegations of discrimination/retaliation filed with the Small Business Administration will be investigated for appropriate action.

This rule is not a major rule under the SBREFA (5 U.S.C. 804 (2)). This rule:

(a) Will not have an annual effect on the economy of $100 million or more;

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and,

(c) Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Unfunded Mandates Reform Act

This rule would not impose an unfunded mandate on State, local, or tribal governments, or the private sector of more than $100 million per year. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.) is not required.

Takings Implication Assessment (E.O. 12630)

Under the criteria in E.O. 12630, this rule will not have significant takings implications. The rule is not a governmental action capable of interference with constitutionally protected property rights. A Takings Implication Assessment is not required.

Federalism (E.O. 13132)

Under the criteria in E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. This rule does not substantially and directly affect the relationship between the Federal and state and local governments. To the extent that State and local governments have a role in OCS activities, this rule would not affect that role. A Federalism Assessment is not required.

Civil Justice Reform (E.O. 12988)

This rule complies with the requirements of E.O. 12988. Specifically, this rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and,

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

Consultation With Indian Tribes (E.O. 13175)

The U.S. Department of the Interior (DOI) strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. BOEM's Tribal Liaison Officer has certified that this regulation does not have tribal implications as defined in section 1(a) of E.O. 13175 and has determined that the regulation does not have substantial and direct effects on federally recognized tribes or any Alaska Native Corporation established pursuant to the Alaska Native Claims Settlement Act (ANCSA) (43 U.S.C. 1601 et seq.)

As it relates to any federally recognized Indian tribe, this rule merely formalizes existing policies and procedures that govern the use of OCS sand, gravel, and/or shell resources. The existing policies, procedures, consultations and monitoring requirements for the noncompetitive use of OCS sand, gravel, and/or shell resources are longstanding and have remained relatively consistent for two decades. If BOEM determines an individual project authorized under this part may have effects on federally recognized tribes or any Alaska Native Corporation, BOEM will initiate consultation as soon as possible consistent with E.O. 13175 and DOI tribal consultation policies. A tribe or Alaska Native Corporation may also request BOEM to initiate consultation pursuant to E.O. 13175.

Paperwork Reduction Act (PRA) of 1995

This rule contains a collection of information request that was submitted to OMB for review and approval under 44 U.S.C. 3501 et seq. The Paperwork Reduction Act (44 U.S.C. 3501-3521) provides that an agency may not conduct or sponsor, and a person is not required to respond to, a “collection of information,” unless it has a currently valid OMB control number. Collections of information include requests and requirements that an individual, partnership, or corporation obtain information, and report it to a Federal Agency (44 U.S.C. 3502; 5 CFR 1320.2(c) and (k)).

BOEM included a request for approval of a collection of information in the proposed rule. OMB approved the collection for the final rule under control number 1010-0191 for a total of 243 burden hours. The final rule adds a new part 583 to address the use of OCS sand, gravel, and/or shell resources for shore protection or replenishment, wetland restoration, or qualified construction projects. This part describes the negotiated noncompetitive agreement process for qualifying projects and codifies procedures.

The title of the IC request is “30 CFR 583, Negotiated Noncompetitive Agreements for the Use of Sand, Gravel, and Shell Resources on the OCS.” Respondents are other Federal, state, and local government agencies; corporations; and individual entities. Responses will primarily be required to obtain or retain a benefit. The frequency of response will vary depending on the requirement. BOEM will protect proprietary information according to 30 CFR 550.197, “Data and information to be made available to the public or for limited inspection,” the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations at 43 CFR part 2. BOEM will collect the information under this part to evaluate applications for leases/agreements to access sand, gravel, or shell resources on the OCS; to balance multiple uses of the OCS; and to monitor activities for environmental protection and safety.

In response to the proposed rule, BOEM received two comments that addressed aspects of the information collection for this rulemaking and are summarized below. One commenter suggested that the required information submitted with their permit application is duplicative of the information submitted in a Clean Water Act application. In cases where the information is duplicative in nature, BOEM will allow submission of the information in the Clean Water Act permit application to BOEM to comply with the filing requirements of this rule. However, BOEM did not change the burden hours for this requirement, because we do not have sufficient data to estimate how many parties seeking agreements will be able to use this means of reducing the burdens of the application process. This comment is addressed in more detail in the preamble of this final rule.

Another commenter focused on consultation with the fishing industry regarding renewable energy projects, which is outside the scope of this rulemaking. This commenter stated that the information request does not include any provision requiring consultation with the fishing industry or reporting requirements that would ensure a project is compatible with consideration of fishing rights. However, such outreach and coordination does occur through the NEPA, MSFCMA and other consultation processes.

The information collection burdens were not changed from the proposed rule. The following table provides a breakdown of the IC requirements and burdens in this part.

Burden Table Citation 30 CFR 583 Reporting and recordkeeping requirement Hour burden Average
  • number of
  • annual
  • responses
  • Annual burden hours
    Subpart A—General—Federal, State, & local governments 125 Apply for reconsideration to the BOEM Director within 15 days of notification; include statement of reasons; 1 copy to program office 2 1 2 Subpart A—General—Corporations 125 Apply for reconsideration to the BOEM Director within 15 days of notification; include statement of reasons; 1 copy to program office 2 1 2 Subpart A—General—Individuals 125 Apply for reconsideration to the BOEM Director within 15 days of notification; include statement of reasons; 1 copy to program office 2 1 2 Total Subpart A 3 6 Subpart C—OCS Sand, Gravel, & Shell Resources Negotiated Agreements—State & local governments 300 Submit to BOEM a written request to obtain agreement; including, but not limited to: Detailed description of project; maps (geographic coordinates); G&G data; description/documentation of environmental evaluations; target dates; description of parties involved; required permits (status of/potential conflicts); points of contact info. for all parties involved; statement of funding 10 4 40 305; 310(d) Submit additional information as requested by BOEM 5 1 5 315(b) Request that the BOEM Director reconsider a disapproved agreement Burden covered under 30 CFR part 583, subpart A 2 315(c)-(e) Review and comment on draft agreement; sign and return copies for execution by BOEM 8 3 24 335(a) Submit written notification to BOEM once resources authorized are obtained 1 1 1 340 Assure all contractors comply with 2 CFR part 180 & 2 CFR part 1400 in contract/transaction 2 1 2 345 Submit written request to extend or modify agreement to BOEM within 180 days before expiration; submit any other documentation requested by BOEM; sign and return amendment; request that the BOEM Director reconsider a disapproved request to extend or modify 2 2 4 345(b) Submit written request for letter amendment 1 1 1 Subpart C—OCS Sand, Gravel, & Shell Resources Negotiated Agreements—Corporations 300 Submit to BOEM a written request to obtain agreement; including, but not limited to: Detailed description of project; maps (geographic coordinates); G&G data; description/documentation of environmental evaluations; target dates; description of parties involved; required permits (status of/potential conflicts); points of contact info. for all parties involved; statement of funding 10 4 40 305; 310(d) Submit additional information as requested by BOEM 5 1 5 315(b) Request that the BOEM Director reconsider a disapproved agreement Burden covered under 30 CFR part 583, subpart A 2 315(c)-(e) Review and comment on draft agreement; sign and return copies for execution by BOEM 8 3 24 335(a) Submit written notification to BOEM once resources authorized are obtained 1 1 1 340 Assure all contractors comply with 2 CFR part 180 & 2 CFR part 1400 in contract/transaction 2 1 2 345 Submit written request to extend or modify agreement to BOEM within 180 days before expiration; submit any other documentation requested by BOEM; sign and return amendment; request that the BOEM Director reconsider a disapproved request to extend or modify 2 2 4 345(b) Submit written request for letter amendment 1 1 1 Subpart C—OCS Sand, Gravel, & Shell Resources Negotiated Agreements—Individuals 300 Submit to BOEM a written request to obtain agreement; including, but not limited to: Detailed description of project; maps (geographic coordinates); G&G data; description/documentation of environmental evaluations; target dates; description of parties involved; required permits (status of/potential conflicts); points of contact info. for all parties involved; statement of funding 10 4 40 305; 310(d) Submit additional information as requested by BOEM 5 1 5 315(b) Request that the BOEM Director reconsider a disapproved agreement Burden covered under 30 CFR part 583, subpart A 2 315(c)-(e) Review and comment on draft agreement; sign and return copies for execution by BOEM 8 3 24 335(a) Submit written notification to BOEM once resources authorized are obtained 1 1 1 340 Assure all contractors comply with 2 CFR part 180 & 2 CFR part 1400 in contract/transaction 2 1 2 345 Submit written request to extend or modify agreement to BOEM within 180 days before expiration; submit any other documentation requested by BOEM; sign and return amendment; request that the BOEM Director reconsider a disapproved request to extend, modify, or change 2 2 4 345(b) Submit written request for letter amendment 1 1 1 Total Subpart C 39 237 Grand Total 42 243

    An agency may not conduct or sponsor, and you are not required to respond to, a collection of information unless it has a currently valid OMB control number. The public may comment, at any time, on the accuracy of the IC burden estimate in this rule and may submit any comments to the Information Collection Clearance Officer, Office of Policy, Regulation and Analysis; Bureau of Ocean Energy Management; VAM-BOEM DIR; 45600 Woodland Road, Sterling, Virginia 20166.

    National Environmental Policy Act

    This rule does not constitute a major Federal action significantly affecting the quality of the human environment. BOEM has analyzed this rule under the criteria of the NEPA and DOI's NEPA implementing regulations at 43 CFR part 46. This rule meets the criteria set forth in 43 CFR 46.210(i) for a Departmental “categorical exclusion” in that this rule is “. . . of an administrative, financial, legal, technical, or procedural nature . . . .” BOEM has also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215.

    Information Quality Act (IQA)

    In accordance with the IQA, DOI has issued guidance regarding the quality of information that it relies upon for regulatory decisions. This guidance is available at DOI's Web site at http://www.doi.gov.

    Send your comments to the U.S. Department of the Interior, Bureau of Ocean Energy Management, Office of Policy, Regulation and Analysis, Attn: IQA Comments, 45600 Woodland Road, VAM-BOEM DIR, Sterling, Virginia 20166.

    Effects on the Energy Supply (E.O. 13211)

    This rule is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.

    Clarity of This Regulation

    We are required by E.O. 12866, E.O. 12988, and the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

    (a) Be logically organized;

    (b) Use the active voice to address readers directly;

    (c) Use clear language rather than jargon;

    (d) Be divided into short sections and sentences; and

    (e) Use lists and tables wherever helpful.

    List of Subjects in 30 CFR Part 583

    Administrative practice and procedure, Beach restoration, Coastal wetlands restoration, Continental shelf, Federal lands, Gravel, Government contracts, Intergovernmental relations, Marine minerals, Marine minerals program, Noncompetitive agreements, Negotiated agreements, Outer Continental Shelf, Reporting and recordkeeping, Sand, Shell resources, and Shore protection.

    Dated: September 27, 2017. Katharine S. MacGregor, Acting Assistant Secretary—Land and Minerals Management.

    For the reasons stated in the preamble, BOEM amends 30 CFR chapter V by adding 30 CFR part 583 to subchapter B to read as follows:

    PART 583—NEGOTIATED NONCOMPETITIVE AGREEMENTS FOR THE USE OF OUTER CONTINENTAL SHELF SAND, GRAVEL, AND/OR SHELL RESOURCES Subpart A—General Sec. 583.100 What is BOEM's authority for information collection (IC)? 583.105 What is the purpose of this part and to whom does it apply? 583.110 What is BOEM's authority for this part? 583.115 What definitions do I need to know? 583.120 Who is qualified for a project? 583.125 What are my rights to seek reconsideration of an unfavorable decision by BOEM? 583.130 What are the minimum contents of an agreement to use OCS sand, gravel, and/or shell resources? Subpart B—[Reserved] Subpart C—Outer Continental Shelf Sand, Gravel, and/or Shell Resources Negotiated Agreements Sec. 583.300 How do I submit a request for an agreement? 583.305 How will BOEM determine if a project qualifies? 583.310 What process does BOEM use to technically and environmentally evaluate a qualified project? 583.315 What is the process for negotiating and executing an agreement? 583.320 What kinds of information must be included in an agreement? 583.325 What is the effective date of an agreement? 583.330 How will BOEM enforce the agreement? 583.335 What is the term of the agreement? 583.340 What debarment or suspension obligations apply to transactions and contracts related to a project? 583.345 What is the process for extending or modifying an agreement? 583.350 When can an agreement be terminated? Authority:

    43 U.S.C. 1334.

    Subpart A—General
    § 583.100 What is BOEM's authority for information collection (IC)?

    The IC requirements contained in part 583 have been approved by OMB under 44 U.S.C. 3501 and assigned control number 1010-0191. The information is being collected to determine if the applicant for a negotiated noncompetitive agreement (agreement) for the use of sand, gravel, and/or shell resources on the Outer Continental Shelf (OCS) is qualified to enter into such an agreement and to determine if the requested action is warranted. Applicants and parties to an agreement are required to respond to requests related to IC activities.

    § 583.105 What is the purpose of this part and to whom does it apply?

    The regulations in this part provide procedures for entering into negotiated noncompetitive agreements for the use of OCS sand, gravel, and/or shell resources. The rules of this part apply exclusively to negotiated noncompetitive use of OCS sand, gravel, and/or shell resources and do not apply to competitive leasing of minerals, including oil, gas, sulphur, geopressured-geothermal and associated resources, and all other minerals that are authorized by an Act of Congress to be produced from “public lands” as defined in section 103 of the Federal Land Policy and Management Act of 1976, as amended (43 U.S.C. 1701 et seq.).

    § 583.110 What is BOEM's authority for this part?

    (a) Pursuant to authority granted by section 8(k) of the Outer Continental Shelf Lands Act (OSCLA), as amended (43 U.S.C. 1337(k)), the Secretary has authority to negotiate a noncompetitive agreement for the use of OCS sand, gravel, and/or shell resources:

    (1) In a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, State, or local government agency; or

    (2) In a construction project, other than a project described in paragraph (a)(1) of this section, that is funded in whole or in part by or authorized by the Federal Government.

    (b) The Secretary has delegated authority to BOEM to administer the negotiated noncompetitive agreement provisions of OCSLA and prescribe the rules and regulations necessary to carry out those provisions.

    § 583.115 What definitions do I need to know?

    The definitions at 30 CFR 550.105 apply to this part. In addition, when used in this part, the following terms will have the meaning given below:

    Agreement means a negotiated noncompetitive agreement that authorizes a person to use OCS sand, gravel, and/or shell resources in a program of, or project for, shore protection, beach restoration or coastal wetlands restoration undertaken by one or more Federal, state or local government agencies, or in a construction project authorized by, or funded in whole or in part by, the Federal government. The form of the agreement will be a Memorandum of Agreement (if one or more of the parties to the agreement, other than BOEM, is a Federal agency) or a lease (if all of the parties to the agreement other than BOEM are non-Federal agencies or persons).

    Amendment means a modification to the agreement between BOEM and the parties to the agreement that extends or modifies the terms of the agreement.

    Applicant means any person proposing to use OCS sand, gravel, and/or shell resources for a shore protection, beach restoration or coastal wetlands restoration project undertaken by a Federal, state or local government agency, or a construction project authorized by, or funded in whole or in part by, the Federal Government. If multiple persons or Federal, state, or local governments, other than BOEM, partner on a project they will be considered joint applicants.

    BOEM means the Bureau of Ocean Energy Management of the U.S. Department of the Interior (DOI).

    Borrow area means the offshore geographic area(s) or region(s) where OCS sand, gravel, and/or shell resources have been identified for potential use in a specific project.

    Federal agency means any department, agency, or instrumentality of the United States.

    Local government means the governing authority at the county or city level with jurisdiction to administer a particular project(s).

    Modification means the process whereby parties to an agreement and BOEM mutually agree to change, alter or amend an existing agreement.

    Placement area means the geographic area in which OCS sand, gravel, and/or shell resources, used by agreement, will be placed pursuant to that agreement.

    Program means a group of related projects that may be the subject of a negotiated noncompetitive agreement for the use of OCS sand, gravel, and/or shell resources.

    Project means an undertaking that may be the subject of a negotiated noncompetitive agreement for the use of OCS sand, gravel, and/or shell resources.

    Secretary means the Secretary of the Interior.

    § 583.120 Who is qualified for a project?

    (a) BOEM may enter into an agreement with any person proposing to use OCS sand, gravel, and/or shell resources for a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, state, or local government agency or in a construction project that is funded in whole or in part by or authorized by the Federal Government.

    (b) To request an agreement under this part, the applicant must be:

    (1) A Federal, state, or local government agency;

    (2) A citizen or national of the United States;

    (3) An alien lawfully admitted for permanent residence in the United States, as defined in the Immigration and Nationality Act, as amended (8 U.S.C. 1101(a)(20));

    (4) A private or public corporation organized under the laws of the United States, or of any State or territory thereof; or

    (5) An association of such citizens, nationals, resident aliens, or private or public corporations.

    (c) When entering into an agreement under this part, all applicants are subject to the requirements of 2 CFR part 180 and 2 CFR part 1400.

    § 583.125 What are my rights to seek reconsideration of an unfavorable decision by BOEM?

    (a) After being notified of disqualification or disapproval of an agreement or modification, an unsuccessful applicant, or adversely affected party to an agreement, may apply for reconsideration by the Director.

    (1) All applications for reconsideration must be submitted to the Director within 15 days of being notified of disqualification or disapproval of an agreement or modification, and must be accompanied by a statement of reasons for the requested reconsideration, with one copy also submitted to the program office whose decision is the subject of the request for reconsideration.

    (2) The Director will respond in writing within 30 days.

    (b) No appeal rights are available under 30 CFR part 590 and 43 CFR part 4, subpart E.

    § 583.130 What are the minimum contents of an agreement to use OCS sand, gravel, and/or shell resources?

    Any use of OCS sand, gravel, and/or shell resources in an agreement will be negotiated on a case-by-case basis. The agreement will specify, at a minimum, who may use the OCS sand, gravel, and/or shell resources; the nature of the rights granted, including any terms and conditions and environmental stipulations; and the location, type, and volume of OCS sand, gravel, and/or shell resources. An authorization to use OCS sand, gravel, and/or shell resources identified in an agreement is not exclusive; BOEM may allow other entities to use OCS sand, gravel, and/or shell resources from the same borrow area if these uses are determined by BOEM to be non-conflicting and do not exceed the availability of the OCS resource.

    Subpart B—[Reserved] Subpart C—Outer Continental Shelf Sand, Gravel, and/or Shell Resources Negotiated Agreements
    § 583.300 How do I submit a request for an agreement?

    Any person may submit a written request to BOEM to obtain an agreement for the use of OCS sand, gravel, and/or shell resources for use in a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, state, or local government agency, or in a construction project that is funded in whole or in part by or authorized by the Federal Government.

    (a) The written request must include:

    (1) A detailed description of the proposed project for which the OCS sand, gravel, and/or shell resources will be used and how it qualifies as a program or project eligible under OCSLA to use OCS sand, gravel, or shell resources;

    (2) A description of the proposed borrow area(s) and placement area(s), along with maps with geographic coordinates depicting the location of the desired borrow area(s), the OCS block number(s), OCS Planning Area(s), OCS Protraction Diagram Designation(s), and the placement area(s). These should include:

    (i) A detailed set of digital (e.g., portable document format or pdf) maps with coordinates and navigation features of the desired OCS project area (including borrow area and other project features); and

    (ii) Digital geo-referenced spatial and tabular data depicting the borrow area with features, such as geological sampling locations and any hard or live-bottom benthic habitat present;

    (3) Any available geological and geophysical data used to select, design, and delineate the borrow area(s) and potential borrow areas considered but not selected for final design in digital format, geo-referenced where relevant. These may include:

    (i) Sediment sampling (sediment cores and grab samples) data such as physical description sheets, photographs, core locations, and grain size analysis; and

    (ii) Geophysical data such as subbottom profiler, marine magnetometer, and side-scan sonar data, and bathymetry including geo-referenced navigation survey tracklines, shotpoints, and/or timestamps;

    (4) Any other uses of the OCS or infrastructure in the borrow area that are known to the applicant at the time of application submittal;

    (5) A description of the environmental evaluations and corresponding documents that have been completed or are being prepared that cover all offshore and onshore components of the project, as applicable;

    (6) A target date or date range when the OCS sand, gravel, and/or shell resources will be needed;

    (7) A description of the person or government entities undertaking the project;

    (8) A list of any permits, licenses or authorizations required for the project and their current status;

    (9) A description of any potential inconsistencies with state coastal zone management plans and/or any other applicable state and local statutes, regulations or ordinances;

    (10) The name, title, telephone number, mailing address and email address of any points of contact for any Federal agencies, state, or local governments, and contractor(s) with whom the applicant has contracted or intends to contract;

    (11) A statement explaining who authorized the project and how the project is to be funded, indicating whether the project is federally funded, in whole or in part, and whether the project is authorized by the Federal Government; and

    (12) For any other Federal, state, or local government agency identified in the application, the name, title, mailing address, telephone number, and email address of both a primary and a secondary point of contact for the agency.

    (b) [Reserved]

    § 583.305 How will BOEM determine if a project qualifies?

    BOEM will make a determination as to whether the project, as described in § 583.300, qualifies for a negotiated noncompetitive agreement for the use of OCS sand, gravel, and/or shell resources. Within 15 business days of receipt of the application, BOEM will determine if the application is complete or will request additional information. After it has determined the application is complete, BOEM will review the application and notify the applicant in writing whether the project qualifies for an agreement. In determining whether a project qualifies for an agreement, BOEM will consider, among other criteria, the following:

    (a) The project purpose;

    (b) Other uses of OCS sand, gravel, and/or shell resources from the same borrow area that are currently or were previously authorized by BOEM for other projects or programs, including the location, type and volume of such resources;

    (c) The project funding source(s) and amounts;

    (d) The proposed design and feasibility of the project;

    (e) Any potential environmental and safety risks associated with the project;

    (f) Other federal interests located near or within the specified borrow area;

    (g) Comments received from potentially affected state or local governments, if any;

    (h) The applicant's background and experience working on similar projects or activities;

    (i) Whether the project operations can be conducted in a manner that protects the environment and promotes orderly development of OCS mineral resources;

    (j) Whether activities can be conducted in a manner that does not pose a threat of serious harm or damage to, or waste of, any natural resource, any life (including fish and other aquatic life), property, or the marine, coastal, or human environment; and

    (k) Whether the project is consistent with the requirements of applicable statutes and their implementing regulations, which may include, but are not limited to, the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.), the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq.), the Marine Debris Research, Prevention, and Reduction Act (MDRPRA) (33 U.S.C. 1951 et seq.), the Marine Plastic Pollution Research and Control Act (MPPRCA) (33 U.S.C. 1901 et seq.), the Federal Water Pollution Control Act (FWPCA) (33 U.S.C. 1381 et seq.), and the International Convention for the Prevention of Pollution from Ships (MARPOL), MARPOL-Annex V Treaty.

    § 583.310 What process does BOEM use to technically and environmentally evaluate a qualified project?

    (a) Once BOEM has determined a project qualifies for an agreement, BOEM will begin the project evaluation process to decide whether to enter into a negotiated noncompetitive agreement.

    (b) BOEM will coordinate with relevant Federal agencies, State, and local governments and any potentially affected federally recognized Indian tribes or Alaska Native Corporations in the project evaluation.

    (c) BOEM will evaluate the project and additional information provided pursuant to §§ 583.300 and 583.305, to determine if the information is sufficient to conduct necessary technical and environmental reviews to comply with the requirements of applicable statutes and regulations, which may include, but are not limited to: OCSLA (43 U.S.C. 1331 et seq.), the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.), the ESA (16 U.S.C. 1531 et seq.), the MMPA (16 U.S.C. 1361 et seq.), the Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA) (16 U.S.C. 1801 et seq.), the National Historic Preservation Act (NHPA) (54 U.S.C. 300101 et seq.), and the Coastal Zone Management Act (CZMA) (16 U.S.C. 1451 et seq.).

    (d) BOEM will not enter into a negotiated noncompetitive agreement with the applicant until the information requested for the evaluation has been provided and BOEM has evaluated it.

    § 583.315 What is the process for negotiating and executing an agreement?

    (a) Upon completion of the technical, environmental and other evaluations established in §§ 583.305 and 583.310, BOEM will decide whether to enter into a negotiated noncompetitive agreement with the applicant for use of OCS sand, gravel, or shell resources for its proposed project.

    (b) If BOEM decides not to enter into such an agreement, BOEM will inform the applicant of its reasons for not doing so. An applicant may ask the BOEM Director for reconsideration of this decision, in accordance with § 583.125(a).

    (c) If BOEM has decided to enter into a negotiated noncompetitive agreement with the applicant, BOEM will negotiate the terms and conditions of the agreement with the applicant and prepare a draft agreement for the applicant's review.

    (d) After considering comments and suggestions from the applicant, BOEM, at its discretion, may finalize the agreement and distribute it to the applicant for signature.

    (e) Upon receipt of the agreement with the applicant's signature, BOEM will execute the agreement. A copy of the executed agreement will be mailed to the parties.

    § 583.320 What kinds of information must be included in an agreement?

    Every agreement is negotiated on a case-by-case basis, but at a minimum, must include:

    (a) An agreement number, as assigned by BOEM;

    (b) The purpose of, and authorities for, the agreement;

    (c) Designated and delineated borrow area(s);

    (d) A project description, including the timeframe within which the project is to be started and completed;

    (e) The terms and conditions of the agreement, including any reporting requirements, environmental mitigations, and operating parameters;

    (f) All obligations of the parties; and

    (g) The signatures of appropriate individuals authorized to bind the applicant and BOEM.

    § 583.325 What is the effective date of an agreement?

    The agreement will become effective on the date when all parties to the agreement have signed it.

    § 583.330 How will BOEM enforce the agreement?

    (a) Failure to comply with any applicable law or any provision, term, or condition of the agreement may result in the termination of the agreement, a referral to an appropriate Federal or State agency for enforcement, or both. Termination of the agreement for noncompliance will be in the sole discretion of the Director.

    (b) The failure to comply in a timely and satisfactory manner with any provision, term or condition of the agreement may delay or prevent BOEM's approval of future requests for use of OCS sand, gravel, and/or shell resources on the part of the parties to the agreement.

    § 583.335 What is the term of the agreement?

    (a) An agreement will terminate upon one of the following, whichever occurs first:

    (1) The agreement expires by its own terms, unless the term is extended prior to expiration under § 583.345;

    (2) The project is terminated, as set forth in § 583.350; or

    (3) A party to the agreement notifies BOEM, in writing, that sufficient OCS sand, gravel, and/or shell resources, up to the amount authorized in the agreement, have been obtained to complete the project.

    (b) Absent extraordinary circumstances, no agreement will be for a term longer than five years from its effective date.

    § 583.340 What debarment or suspension obligations apply to transactions and contracts related to a project?

    The parties to an agreement must ensure that all contracts and transactions related to an agreement issued under this part comply with the suspension and debarment regulations in 2 CFR part 180 and 2 CFR part 1400.

    § 583.345 What is the process for extending or modifying an agreement?

    (a) Unless otherwise provided for in the agreement, the parties to the agreement may submit to BOEM a written request to extend or modify an agreement. BOEM is under no obligation to extend or modify an agreement and cannot be held liable for the consequences of the expiration of an agreement. With the exception of paragraph (b) of this section, any such requests must be made at least 180 days before the term of the agreement expires. BOEM will respond to the request for modification within 30 days of receipt and request any necessary information and evaluations to comply with § 583.305. BOEM may approve the request, disapprove it, or approve it with modifications subject to the requirements of § 583.305.

    (1) If BOEM approves a request to extend or modify an agreement, BOEM will draft an agreement modification for review by the parties to the agreement in the form of an amendment to the original agreement. The amendment will include:

    (i) The agreement number, as assigned by BOEM;

    (ii) The modification(s) agreed to;

    (iii) Any additional mitigation required; and

    (iv) The signatures of the parties to the agreement and BOEM.

    (2) If BOEM disapproves a request to extend or modify an agreement, BOEM will inform the parties to the agreement of the reasons in writing. Parties to the agreement may ask the BOEM Director for reconsideration in accordance with § 583.125.

    (b) By written request, for strictly minor modifications that do not change the substance of the project or the analyzed environmental effects of the project, including but not limited to, the change of a business address, the substitution of a different Federal, State or local government agency contact, or an extension of less than 30 days, parties to the agreement may memorialize the minor modification in a letter from BOEM to the parties indicating the request has been granted.

    § 583.350 When can an agreement be terminated?

    (a) The Director will terminate any agreement issued under this part upon proof that it was obtained by fraud or misrepresentation, after notice and an opportunity to be heard has been afforded to the parties of the agreement.

    (b) The Director may immediately suspend and subsequently terminate any agreement issued under this part when:

    (1) There is noncompliance with the agreement, pursuant to § 583.330 (a); or

    (2) It is necessary for reasons of national security or defense; or

    (3) The Director determines that:

    (i) Continued activity under the agreement would cause serious harm or damage to natural resources; life (including human and wildlife); property; the marine, coastal, or human environment; or sites, structures, or objects of historical or archaeological significance;

    (ii) The threat of harm or damage will not disappear or decrease to an acceptable extent within a reasonable period of time; and

    (iii) The advantages of termination outweigh the advantages of continuing the agreement.

    (c) The Director will immediately notify the parties to the agreement of the suspension or termination. The Director will also mail a letter to the parties to the agreement at their record post office address with notice of any suspension or termination and the cause for such action.

    (d) In the event that BOEM terminates an agreement under this section, none of the parties to the agreement will be entitled to compensation as a result of expenses or lost revenues that may result from the termination.

    [FR Doc. 2017-21233 Filed 10-2-17; 8:45 am] BILLING CODE -P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2017-0727] RIN 1625-AA08 Special Local Regulation; Tennessee River, Chattanooga, TN AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a special local regulation for all navigable waters of the Tennessee River from mile marker (MM) 453.0 to MM 453.6. This action is necessary to provide for the safety of life on these navigable waters near Chattanooga, TN during the Swim the Suck marine event. Entry into, transiting through, or anchoring within this regulated area is prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.

    DATES:

    This rule is effective from 9:15 a.m. through 9:45 a.m. on October 14, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0727 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 notice of enforcement, call Petty Officer Jonathan Braddy, Marine Safety Detachment Nashville, U.S. Coast Guard, telephone 615-736-5421, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Ohio Valley 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 it is impracticable.

    We must establish this special local regulation by October 14, 2017 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. The NPRM process would delay the establishment of the special local regulation until after the scheduled date of the marine event and jeopardize public safety.

    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. Delaying this rule would be impracticable and contrary to the public interest because immediate action is necessary to protect persons and property from the dangers associated with the marine event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the Swim the Suck marine event from 9:15 a.m. through 9:45 a.m. on October 14, 2017 will present a safety concern for all navigable waters on the Tennessee River extending from mile marker (MM) 453.0 to MM 453.6. The purpose of this rulemaking is to ensure the safety of life and vessels on the navigable waters before, during, and after the scheduled event.

    IV. Discussion of the Rule

    This rule establishes a special local regulation from 9:15 a.m. through 9:45 a.m. on October 14, 2017 for all navigable waters on the Tennessee River from MM 453.0 to MM 453.6. The duration of the special local regulation is intended to ensure the safety of life and vessels on these navigable waters before, during, and after the scheduled event. No vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative.

    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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, duration, and time-of-day of the regulated area. Vessel traffic will be able to safely navigate through the affected area before and after the scheduled event. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the regulated area and the rule allows vessels to seek permission to enter the area.

    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 regulated area 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.

    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 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 the establishment of a special local regulation lasting one half of an hour extending less than one mile that will prohibit entry on all navigable waters of the Tennessee River from MM 453.0 to MM 453.6. It is categorically excluded from further review under paragraph 35(a) of Figure 2-1 of the Commandant Instruction and a Record of Environmental Consideration was not necessary.

    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 temporary § 100.35T08-0727 to read as follows:
    § 100.35T08-0727 Special Local Regulation; Tennessee River, Chattanooga, TN.

    (a) Location. The following area is a temporary special local regulation: All navigable waters of the Tennessee River between mile marker (MM) 453.0 and MM 453.6, Chattanooga, TN.

    (b) Effective period. This section will be effective from 9:15 a.m. through 9:45 a.m. on October 14, 2017.

    (c) Special local regulations. (1) Entry into this area is prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.

    (2) Persons or vessels desiring entry into or passage through the area must request permission from the COTP or a designated representative. U.S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16 or by telephone at 1-800-253-7465.

    (d) Informational broadcasts. The COTP or a designated representative will inform the public through broadcast notices to mariners of the enforcement period for the special local regulation, as well as any changes in the dates and times of enforcement.

    Dated: September 18, 2017. M.B. Zamperini, Captain, U.S. Coast Guard, Captain of the Port, Sector Ohio Valley.
    [FR Doc. 2017-21165 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2017-0812] RIN 1625-AA08 Special Local Regulation; Cumberland River, Nashville, TN AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a special local regulation for all navigable waters of the Cumberland River from mile marker (MM) 190.0 to MM 195.0. This action is necessary to provide for the safety of life on these navigable waters near Nashville, TN during the Music City Head Race. Entry into, transiting through, or anchoring within this regulated area is prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.

    DATES:

    This rule is effective from 9 a.m. on October 6, 2017 through 7 p.m. on October 7, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0812 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 notice of enforcement, call Petty Officer Jonathan Braddy, Marine Safety Detachment Nashville, U.S. Coast Guard, telephone 615-736-5421, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Ohio Valley 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 it is impracticable. This event is among the annual recurring events listed in 33 CFR 100.801, Table 1, line no. 65, between mile marker (MM) 190.0 to MM 195.0, as occuring on the last weekend in September. This year, the dates of the event have been changed by the event organizer to the first weekend in October.

    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. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to protect the persons and property from the dangers associated with the race.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the Music City Head Race from 9 a.m. through 7 p.m. on October 6, 2017 and from 4 a.m. through 7 p.m. on October 7, 2017, will be a safety concern for all navigable waters on the Cumberland River extending from mile marker (MM) 190.0 to MM 195.0. The purpose of this rulemaking is to ensure the safety of life and vessels on these navigable waters before, during, and after the scheduled event.

    IV. Discussion of the Rule

    This rule establishes a special local regulation from 9 a.m. through 7 p.m. on October 6, 2017 and from 4 a.m. through 7 p.m. on October 7, 2017 for all navigable waters on the Cumberland River from MM 190.0 to MM 195.0. The duration of the regulated area is intended to ensure the safety of life and vessels on these navigable waters before, during, and after the scheduled event. No vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative.

    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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, duration, and time-of-day of the special local regulation. Vessel traffic will be able to safely navigate through the affected area before and after the scheduled event. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the regulated area and the rule allows vessels to seek permission to enter the area.

    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 regulated area 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.

    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 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 the establishment of a special local regulation lasting twenty-three hours over two days extending a limited distance of five miles that will prohibit entry on all navigable waters of the Cumberland River from MM 190.0 to MM 195.0. It is categorically excluded from further review under paragraph 35(a) of Figure 2-1 of the Commandant Instruction and a Record of Environmental Consideration was not necessary.

    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 § 100.35T08-0812 to read as follows:
    § 100.35T08-0812 Special Local Regulation; Cumberland River, Nashville, TN.

    (a) Location. All navigable waters of the Cumberland River between mile marker (MM) 190.0 and MM 195.0, Nashville, TN.

    (b) Effective period. This section will be enforced from 9 a.m. on October 6, 2017 through 7 p.m. on October 7, 2017.

    (c) Special local regulations. (1) Entry into this area is prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.

    (2) Persons or vessels desiring entry into or passage through the area must request permission from the COTP or a designated representative. U.S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16 or by telephone at 1-800-253-7465.

    (d) Informational broadcasts. The COTP or a designated representative will inform the public through broadcast notices to mariners of the enforcement period for the special local regulation, as well as any changes in the dates and times of enforcement.

    Dated: September 18, 2017. M.B. Zamperini, Captain, U.S. Coast Guard, Captain of the Port, Sector Ohio Valley.
    [FR Doc. 2017-21166 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0826] Drawbridge Operation Regulation; Willamette River, Portland, OR AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of temporary deviation from drawbridge regulation; cancellation.

    SUMMARY:

    The Coast Guard is canceling the temporary deviation concerning the Morrison Bridge across the Willamette River, mile 12.8, at Portland, Oregon. A temporary interim rule has been approved which grants the bridge owner, Multnomah County, an extension of time to replace the bridge decking. The temporary interim rule effectively replaces the temporary deviation.

    DATES:

    The temporary deviation published on September 1, 2017 (82 FR 41520), is cancelled as of October 3, 2017.

    ADDRESSES:

    The docket for this deviation, USCG-2017-0826, 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 Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected]

    SUPPLEMENTARY INFORMATION:

    On September 1, 2017, we published a temporary deviation entitled “Drawbridge Operation Regulation; Willamette River, Portland, OR” in the Federal Register (82 FR 41520). The temporary deviation provided Multnomah County with additional time to complete necessary bridge repairs. This deviation was authorized under 33 CFR 117.35.

    While replacing the bridge decking, the bridge owner's construction crew experienced delays with both material deliveries and machining bolt hole tolerances. Therefore, more time was needed to complete the necessary tests and inspections. The subject temporary deviation was approved by mistake in an attempt to give the bridge owner more time to finish construction. After approval of the temporary deviation it was discovered that 180 days would not be enough time to complete construction. After we approved this temporary deviation, we approved a temporary interim rule in order to provide more time to finish the bridge construction. The temporary interim rule effectively replaces the temporary deviation. Therefore, we are cancelling this temporary deviation; docket number USCG-2017-0826 concerning the Morrison Bridge.

    Dated: September 27, 2017. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2017-21169 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0918] 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 Sacramento Century Challenge bicycle race. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

    DATES:

    This deviation is effective from 7 a.m. through 10 a.m. on October 7, 2017.

    ADDRESSES:

    The docket for this deviation, USCG-2017-0918, 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 Carl T. Hausner, 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 Tower Drawbridge over the Sacramento River, mile 59.0, at Sacramento, CA. The drawbridge 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 7 a.m. through 10 a.m. on October 7, 2017, to allow the community to participate in the Sacramento Century Challenge bicycle race. 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. In the event of an emergency the draw can open on signal if at least one hour notice is given to the bridge operator. There are no immediate alternate routes for vessels to pass. The Coast Guard will also inform the users of the waterway 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: September 27, 2017. Carl T. Hausner, District Bridge Chief, Eleventh Coast Guard District.
    [FR Doc. 2017-21099 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0808] RIN 1625-AA00 Safety Zone; Patapsco River, Northwest and Inner Harbors; Baltimore, MD AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for certain waters of the Patapsco River, Northwest Harbor and Inner Harbor. This action is necessary to provide for the safety of life on the navigable waters at Baltimore, MD, during the movement of the historic sloop-of-war USS CONSTELLATION on October 26, 2017. If necessary, due to inclement weather, the event will be rescheduled for October 27, 2017. This action will prohibit persons and vessels from entering the safety zone unless authorized by the Captain of the Port Maryland—National Capital Region.

    DATES:

    This rule is effective from 8 a.m. on October 26, 2017, through 1 p.m. on October 27, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0808 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 Mr. Ronald L. Houck, at Sector Maryland—National Capital Region, Waterways Management Division, U.S. Coast Guard; telephone 410-576-2674, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port 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

    On September 15, 2017, Historic Ships in Baltimore of Baltimore, MD, notified the Coast Guard that from 9 a.m. to noon on October 26, 2017, it will be conducting a tow of the historic sloop-of-war USS CONSTELLATION in Baltimore, MD, from its berth at the Inner Harbor to a point on the Patapsco River near the Fort McHenry National Monument and Historic Shrine, and its return to its berth at the Inner Harbor.

    This rule involves the USS CONSTELLATION “turn-around” cruise, an event that takes place in Baltimore, MD. A permanent safety zone for this rule, with an enforcement period from 2 p.m. through 7 p.m. local time annually on the Thursday before Memorial Day (observed), has been published and is detailed at Title 33 Code of Federal Regulations, section 165.512. However, due to a change in scheduling, the event this year is planned for October 26, 2017. If necessary, due to inclement weather, the event will be rescheduled for October 27, 2017. The event is scheduled to start at 9 a.m. and the event location remains unchanged.

    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 due to the short time period between event planners notifying the Coast Guard of details concerning the event, on September 15, 2017, and publication of this safety zone. It is impracticable and contrary to the public interest to publish an NPRM to provide a notice and an opportunity for comment period because we must establish this safety zone by October 26, 2017 to ensure the safety of vessels and the navigable waters before, during, and after the scheduled event. Such hazards include vessels colliding, sinking or grounding, creating hazards to navigation, and threatening the marine environment.

    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. Delaying the effective date of this rule would be impracticable and contrary to public interest because immediate action is needed to respond to the potential safety hazards associated with a movement of a historic sloop-of war being towed in confined waters during the boating season in Baltimore, MD.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that potential hazards associated with the USS CONSTELLATION “turn-around” cruise will be a safety concern for anyone on the Patapsco River, Northwest Harbor and Inner Harbor. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.

    IV. Discussion of the Rule

    This rule establishes a safety zone from 8 a.m. through 1 p.m. on October 26, 2017, and, if necessary due to inclement weather, from 8 a.m. through 1 p.m. on October 27, 2017. The safety zone will include all navigable waters within 200 yards ahead of and 100 yards outboard or aft of the historic sloop-of-war USS CONSTELLATION while operating in the Inner Harbor, the Northwest Harbor or the Patapsco River. This location is entirely within the Area of Responsibility of the COTP Maryland-National Capital Region, as set forth at 33 CFR 3.25-15.

    This rule requires any unauthorized persons in the regulated area at the time this safety zone is in effect to immediately proceed out of the zone. Except for USS CONSTELLATION “turn-around” participants, and vessels at berth, mooring, or at anchor, this rule temporarily requires all vessels in the designated safety zone as defined by this rule to immediately depart the safety zone. Entry into this safety zone is prohibited, unless specifically authorized by the COTP Maryland—National Capital Region. Coast Guard personnel will be present to prevent the movement of unauthorized persons into the zone. Federal, state, and local agencies may assist the Coast Guard in the enforcement of this rule. The COTP Maryland—National Capital Region will issue Broadcast Notices to Mariners to further publicize the safety zone and notify the public of changes in the status of the zone. Such notices will continue until the event is complete. The regulatory text appears at the end of this document.

    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 13771 directs agencies to control regulatory costs through a budgeting process. 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 (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    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 Patapsco River, Northwest Harbor and Inner Harbor for five hours during the weekday when vessel traffic is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 22A about the zone. Such notifications will be updated as necessary, to keep the maritime community informed of the status of the safety 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 five hours that will prohibit entry within 200 yards ahead of and 100 yards outboard or aft of the historic sloop-of-war USS CONSTELLATION. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated under ADDRESSES.

    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.T05-0808 to read as follows:
    § 165.T05-0808 Safety Zone; Patapsco River, Northwest and Inner Harbors; Baltimore, MD.

    (a) Definitions. As used in this section:

    Captain of the Port Maryland—National Capital Region means the Commander, U.S. Coast Guard Sector Maryland—National Capital Region or any Coast Guard commissioned, warrant, or petty officer who has been authorized by the Captain of the Port, Maryland—National Capital Region to assist in enforcing the safety zone described in paragraph (b) of this section.

    USS CONSTELLATION “turn-around” participants means the USS CONSTELLATION, its support craft and the accompanying towing vessels.

    (b) Location. The following area is a moving safety zone: The navigable waters within 200 yards ahead of or 100 yards outboard or aft of the historic sloop-of-war USS CONSTELLATION, while operating in the Inner Harbor, the Northwest Harbor or the Patapsco River.

    (c) Regulations. (1) The general safety zone regulations found in 33 CFR 165.23 apply to the safety zone created by this temporary section, § 165.T05.0808.

    (2) With the exception of USS CONSTELLATION “turn-around” participants, and vessels at berth, mooring, or at anchor, entry into or remaining in this zone is prohibited, unless authorized by the Captain of the Port, Maryland—National Capital Region. All vessels underway within this safety zone at the time it is implemented shall depart the safety zone.

    (3) Persons or vessels requiring entry into or passage through the moving safety zone must first request authorization from the Captain of the Port, Maryland—National Capital Region to seek permission to transit the area. The Captain of the Port, Maryland—National Capital Region can be contacted at telephone number (410) 576-2693 and on Marine Band Radio VHF Channel 16 (156.8 MHz). The Coast Guard vessels enforcing this section can be contacted on Marine Band Radio VHF Channel 16 (156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light, or other means, the person or vessel shall proceed as directed. If permission is granted, all persons or vessels must comply with the instructions of the Captain of the Port, Maryland—National Capital Region, and proceed at the minimum speed necessary to maintain a safe course while within the zone.

    (4) The COTP Maryland—National Capital Region will notify the public of any changes in the status of this safety zone by Marine Safety Radio Broadcast on VHF-FM marine band radio channel 22A (157.1 MHZ).

    (d) Enforcement officials. The U.S. Coast Guard may be assisted by Federal, State and local agencies in the patrol and enforcement of the zone.

    (e) Enforcement period. This section will be enforced from 8 a.m. through 1 p.m. on October 26, 2017, and, if necessary due to inclement weather, from 8 p.m. through 1 p.m. on October 27, 2017.

    Dated: September 27, 2017. Lonnie P. Harrison, Jr., Captain, U.S. Coast Guard, Captain of the Port Maryland—National Capital Region.
    [FR Doc. 2017-21180 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0937] RIN 1625-AA00 Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet; Brooklyn, NY AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary interim rule and request for comments.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on the navigable waters of Gerritsen Inlet surrounding the Belt Parkway Bridge. This action is necessary to provide for the safety of life on these navigable waters in Brooklyn, NY, during bridge replacement operations, both planned and unforeseen, until the new bridge is built and the existing bridge is removed. This regulation prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port New York or a designated representative.

    DATES:

    This rule is effective without actual notice from October 3, 2017 through December 31, 2018. For the purposes of enforcement, actual notice will be used from 12:01 a.m. on October 1, 2017 through October 3, 2017.

    Comments and related material may be received by the Coast Guard during the effective period.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2017-0937 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Mr. Jeff Yunker, Coast Guard Sector New York, Waterways Management Division, telephone 718-354-4195, email [email protected] or Mr. Craig Lapiejko, Coast Guard First District Waterways Management Branch, telephone 617-223-8351, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port New York DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking NYC DOT New York City Department of Transportation § Section TIR Temporary Interim Rule U.S.C. United States Code II. Background Information and Regulatory History

    In a letter received by the Coast Guard on May 16, 2013 NYC DOT and their contractors outlined the first five phases of operations that require in-channel work in the construction and demolition of the Belt Parkway Bridge. On November 29, 2013, the Coast Guard published a NPRM titled “Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet, Brooklyn, NY” (78 FR 71546). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this bridge construction. During the comment period that ended December 20, 2013, we received no comments.

    On May 12, 2014, the Coast Guard published a TIR and request for comments titled “Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet, Brooklyn, NY” (79 FR 26848). During the comment period that ended June 2, 2014, we received no comments.

    On July 25, 2014 the Coast Guard published a correcting amendment titled “Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet, Brooklyn, NY” (79 FR 43255). There we corrected an inadvertent error included in one of the coordinates of the safety zone.

    The NYC DOT has requested the USCG safety zone and the USCG bridge permit be extended until June 30, 2018, to complete all remaining contract operations in and over the channel, including, but not limited to, substructure concrete placements, steel erection, concrete bridge deck placements, installation of navigation lighting, channel clean up and final fathometric surveying. The Coast Guard is issuing this TIR with an effective date through December 31, 2018 in case of additional project delays due to unforeseen circumstances.

    The Coast Guard is issuing this temporary interim 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), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking with respect to this rule because it is impracticable as it is necessary to protect the safety of both the construction crew and the waterway users operating in the vicinity of the bridge construction zone. A delay or cancellation of the currently ongoing bridge rehabilitation project in order to accommodate a full notice and comment period would delay necessary operations, result in increased costs, and delay the date when the bridge is expected to reopen for normal operations.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. It would be impracticable and contrary to the public interest to delay promulgating this rule, for the reasons stated above. The Coast Guard will enforce the safety zone described in this rule to all vessel traffic during circumstances that pose an imminent threat to waterway users operating in the area. The Coast Guard will provide as much advanced notice as possible prior to enforcement.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that potential hazards associated with the construction of the Belt Parkway replacement bridge over Gerritsen Inlet will be a safety concern for anyone within approximately 300 feet of the existing bridge. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during bridge construction.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published November 29, 2013 or on our TIR published May 12, 2014. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM or in the previous TIR except for the effective period.

    This rule establishes a safety zone from 12:01 a.m. on October 1, 2017 through December 31, 2018. The safety zone will cover all navigable waters within approximately 300 feet of the existing Belt Parkway Bridge over Gerritsen Inlet. The duration of the zone is intended to ensure the safety of vessels and these navigable waters during bridge construction. 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 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, and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the fact that vessel traffic will only be restricted from this safety zone for limited durations and the safety zone covers only a small portion of the navigable waterway. The Coast Guard will notify the public whenever the safety zone is being enforced and whenever enforcement is suspended through Broadcast Notice to Mariners via VHF-FM marine channel 16, First Coast Guard District Local Notice to Mariners at https://www.navcen.uscg.gov, Marine Safety Information Bulletins, or other appropriate means. The rule also allows people to seek permission to enter the zone. Additionally, NYC DOT has a Community Liaison for this project that also communicates with upstream mariners regarding the bridge project and channel status.

    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.

    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.

    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 usually enforced for less than 1 hour that will prohibit entry within approximately 300 feet of the existing Belt Parkway Bridge over Gerritsen Inlet. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    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.

    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 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, visit http://www.regulations.gov/privacyNotice.

    Documents mentioned in this TIR as being available in the docket, and all public comments, will be 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.

    List of Subjects in 33 CFR Part 165

    Marine safety, Navigation (water), Reporting and recordkeeping requirements, 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, 160.5; Department of Homeland Security Delegation No. 0170.1.

    2. Add § 165.T01-0937 to read as follows:
    § 165.T01-0937 Safety Zone; Belt Parkway Bridge Construction, Gerritsen Inlet, Brooklyn, NY.

    (a) Location. The following area is a safety zone: All navigable waters of Gerritsen Inlet: Southeast of a line from 40°35′09.46″ N., 073°54′53.92″ W. to 40°35′15.60″ N., 073°54′42.07″ W., and Northwest of a line from 40°35′04.88″ N., 073°54′45.43″ W. to 40°35′10.34″ N., 073°54′35.71″ W. (NAD 83).

    (b) Definitions. The following definitions apply to this section:

    (1) Designated Representative. A “designated representative” is any Coast Guard commissioned, warrant or petty officer of the U.S. Coast Guard who has been designated by the Captain of the Port Sector New York (COTP), to act on his or her behalf. The designated representative may be on an official patrol vessel or may be on shore and will communicate with vessels via VHF-FM radio or loudhailer. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation.

    (2) Official Patrol Vessels. Official patrol vessels may consist of any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP.

    (c) Enforcement Periods.

    (1) This regulation is enforceable 24 hours a day from 12:01 a.m. on October 1, 2017 through December 31, 2018.

    (2) Prior to commencing or suspending enforcement of this regulation, the COTP and designated on-scene patrol personnel will notify the public whenever the regulation is being enforced and whenever enforcement is lifted, to include dates and times. The means of notification will include, but are not limited to, Broadcast Notice to Mariners and Local Notice to Mariners, Marine Safety Information Bulletins, or other appropriate means.

    (d) Regulations. (1) The general regulations contained in 33 CFR 165.23, as well as the following regulations, apply.

    (2) During periods of enforcement, all persons and vessels must comply with all orders and directions from the COTP or the COTP's designated representative.

    (3) During periods of enforcement, upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light, or other means, the operator of the vessel must proceed as directed.

    Dated: September 14, 2017. M.H. Day, Captain, U.S. Coast Guard, Captain of the Port New York.
    [FR Doc. 2017-21232 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0886] RIN 1625-AA00 Safety Zone; Roanoke River, Plymouth, NC AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for one mile of navigable waters of the Roanoke River in Plymouth, North Carolina. This temporary safety zone is intended to restrict vessel traffic from a portion of the Roanoke River during the Virginia Outlaw Drag Boat Association End of the Year Showdown high speed boat race. This action is intended to restrict vessel traffic movement in the regulated area to protect participants, spectators, and property from the hazards posed by high speed boat races. Entry of vessels or persons into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP), North Carolina or a designated representative.

    DATES:

    This rule is effective from 11 a.m. on October 7, 2017, through 6 p.m. on October 8, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble, go to http://www.regulations.gov, type USCG-2017-0886 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, contact Petty Officer Matthew Tyson, Waterways Management Division, U.S. Coast Guard Sector North Carolina, Wilmington, NC; telephone: 910-772-2221, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port 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. The Coast Guard was not notified of the need for this rule until September 13, 2017. It is impracticable and contrary to the public interest to delay this action. Waiting for a comment period to run would inhibit the Coast Guards' ability to protect the public and participants from the dangers associated with the high speed boat race scheduled on October 7 and October 8, 2017.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. Immediate implementation is required to protect the public and participants from the dangers associated with these activities.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP North Carolina has determined that potential hazards associated with the Virginia Outlaw Drag Boat Association End of the Year Showdown scheduled on October 7 and October 8, 2017, is a safety concern for mariners during the high speed boat race on the Roanoke River in Plymouth, North Carolina. This rule is necessary to protect persons and vessels from the potential hazards associated with the high speed boat race.

    IV. Discussion of the Rule

    This rule establishes a safety zone which will be enforced for portions of the day on October 7 and October 8, 2017, on the navigable waters of the Roanoke River in Plymouth, North Carolina. The safety zone will include all navigable waters from approximate positions: Latitude 35°52′25″ N., longitude 076°44′33″ W., then northwest to latitude 35°52′29″ N., longitude 076°44′37″ W., then southwest along the shoreline to latitude 35°52′00″ N., longitude 076°45′31″ W., then south to latitude 35°51′56″ N., longitude 076°45′30″ W., then northeast along the shoreline to the point of origin, on the Roanoke River, Plymouth, North Carolina. This safety zone will be established for the safety of mariners and participants during the high speed boat race. For safety reasons, no public spectators will be allowed to view the event from the waterway. Vessel traffic will be able to pass through the safety zone between race sets with permission. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP North Carolina or a designated representative.

    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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, and duration of the safety zone. The regulation enforcement period, approximately seven hours per day for two consecutive days, should not overly burden vessel traffic given its short duration. This safety zone will impact a one mile segment of the Roanoke River, Plymouth, NC. Additionally, the rule allows for vessel operators to request permission from the COTP North Carolina or the designated representative to enter and transit through the safety zone. The Coast Guard will issue a Broadcast Notice to Mariners to notify vessels in the region of the establishment of this regulation.

    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 the precise number of small entities impacted is unknown, the Roanoke River has a low number of vessels transiting the area planned for the safety zone during the enforcement period. Although 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 7 hours per day on two consecutive days that prohibits entry into a portion of Roanoke River, Plymouth, NC. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    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.T05-0886 to read as follows:
    § 165.T05-0886 Safety Zone, Roanoke River Plymouth, NC.

    (a) Location. The following area is a safety zone: All navigable from approximate positions: Latitude 35°52′25″ N., longitude 076°44′33″ W., then northwest to latitude 35°52′29″ N., longitude 076°44′37″ W., then southwest along the shoreline to latitude 35°52′00″ N., longitude 076°45′31″ W., then south to latitude 35°51′56″ N., longitude 076°45′30″ W. (WGS 84), then northeast along the shoreline to the point of origin, on the Roanoke River, Plymouth, North Carolina.

    (b) Definitions. As used in this section, “designated representative” means a Coast Guard Patrol Commander, that includes a Coast Guard commissioned, warrant or petty officer designated by the Captain of the Port North Carolina (COTP) for the enforcement of the safety zone. “Captain of the Port” means the Commander, Coast Guard Sector North Carolina. “Participants” means persons and vessels involved in the high speed boat race.

    (c) Regulations. (1) The general regulations governing safety zones in § 165.23 apply to the area described in paragraph (a) of this section.

    (2) With the exception of participants, entry into or remaining in this safety zone is prohibited unless authorized by the COTP North Carolina or the COTP North Carolina's designated representative. All vessels within this safety zone when this section becomes effective must depart the zone immediately.

    (3) To request permission to remain in, enter, or transit through the safety zone, contact the COTP North Carolina or the COTP North Carolina's representative through the Coast Guard Sector North Carolina Command Duty Officer, Wilmington, North Carolina, at telephone number 910-343-3882 or on VHF-FM marine band radio channel 13 (165.65 MHz) or channel 16 (156.8 MHz).

    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol and enforcement of the safety zone by Federal, State, and local agencies.

    (e) Enforcement period. This section will be enforced from 11 a.m. through 6 p.m. daily on October 7 and October 8, 2017.

    Dated: September 27, 2017. Bion B. Stewart, Captain, U.S. Coast Guard, Captain of the Port, North Carolina.
    [FR Doc. 2017-21100 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0577] RIN 1625-AA11 Safety Zone, Blue Angels Air Show; St. Johns River, Jacksonville, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a safety zone on the waters of the St. Johns River in vicinity of Naval Air Station (NAS) Jacksonville, Florida during the Blue Angels Air Show. This rulemaking prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative.

    DATES:

    This rule is effective from 8 a.m. on November 3, 2017 through 5 p.m. on November 5, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0577 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 Lieutenant Allan Storm, Sector Jacksonville, Chief, Waterways Management Division, U.S. Coast Guard; telephone (904) 714-7616, 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

    On April 25, 2017, NAS Jacksonville submitted a marine event application to the Coast Guard for the Blue Angels Air Show that will take place from November 3, 2017 through November 5, 2017. The air show will consist of various flight demonstrations over the St. Johns River in vicinity of NAS Jacksonville. Over the years, there have been unfortunate instances of aircraft mishaps that involve crashing during performances at various air shows around the world. Occasionally, these incidents result in a wide area of scattered debris in the water that can damage property or cause significant injury or death to the public observing the air shows. The Captain of the Port (COTP) Jacksonville has determined that a safety zone is necessary to protect the general public from hazards associated with aerial flight demonstrations. In response, on August 1, 2017, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone, Blue Angels Air Show; St. Johns River, Jacksonville, FL (82 FR 35717). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this air show. During the comment period that ended August 31, 2017, we received no comments.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Jacksonville has determined that potential hazards associated with aerial flight demonstrations will be a safety concern for members of the public observing the event from the water. The purpose of the rule is to ensure the safety of vessels and persons on the navigable waters of the St. Johns River in vicinity of NAS Jacksonville, Florida.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published August 1, 2017. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

    This rule establishes a safety zone, from 8 a.m. to 5 p.m. on November 3, 2017 through November 5, 2017, on the waters of the St. Johns River in vicinity of NAS Jacksonville, Florida during the Blue Angels Air Show. The safety zone will encompass all waters within an area approximately three quarters of a mile parallel to the shoreline, and one mile out into the St. Johns River in Jacksonville, FL. The duration of the zone is intended to ensure the safety of the public and these navigable waters during the aerial flight demonstrations. No vessel or person is permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The Coast Guard will provide notice of the regulated area 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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which would impact a small designated area of the St. Johns River for nine hours on each of the three days the air show is occurring. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow 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 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.

    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.

    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 that would prohibit persons and vessels from transiting through a one square mile regulated area during a three day air show lasting nine hours daily. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    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.T07-0577 to read as follows:
    § 165.T07-0577 Safety Zone, Blue Angels Air Show; St. Johns River, Jacksonville, FL.

    (a) Regulated area. The following area is a safety zone located on the St. Johns River in Jacksonville, FL. All waters of the St. Johns River encompassed within an imaginary line connecting the following points: Starting at Point 1 in position 30°13′41″ N.; 081°39′45″ W. thence due east to Point 2 in position 30°13″41″ N.; 081°38′35″ W. thence south to Point 3 in position 30°14′27″ N.; 081°38′35″ W. thence west to Point 4 in position 30°14′27″ N.; 081°39′45″ W. thence following the shoreline north back to the point of origin. These coordinates are based on North American Datum 1983.

    (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 Jacksonville in the enforcement of the regulated area.

    (c) Regulations. (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Jacksonville or a designated representative.

    (2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Jacksonville by telephone at (904) 714-7557, or a designated representative via VHF-FM radio on channel 16, to request authorization. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or a designated representative.

    (3) The Coast Guard will provide notice of the regulated area through Broadcast Notice to Mariners via VHF-FM channel 16 or by on-scene designated representatives.

    (d) Enforcement period. This rule will be enforced daily from 8 a.m. until 5 p.m. from November 3, 2017 through November 5, 2017.

    Dated: September 28, 2017. Todd C. Wiemers, Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
    [FR Doc. 2017-21196 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2016-0207; FRL-9966-84] RIN 2070-AB27 Significant New Use Rule on Certain Chemical Substances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    EPA is finalizing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes, which was the subject of premanufacture notice (PMN) P-11-482. This action requires persons who intend to manufacture (defined by statute to include import) or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and take such actions as are required with that determination. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

    DATES:

    This final rule is effective November 2, 2017.

    ADDRESSES:

    EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2016-0207. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, process, or use the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482). The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include, but are not limited to:

    Manufacturers (including importers) or processors of the subject chemical substance (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

    This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127, and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a SNUR must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export the chemical substance that is the subject of a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

    II. Background A. What action is the Agency taking?

    EPA is finalizing a SNUR for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482). This final action requires persons who intend to manufacture or process the chemical substance for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. In the Federal Register of June 8, 2017 (79 FR 26644) (FRL-9959-37), EPA proposed a SNUR for this chemical substance that was the subject of P-11-482. EPA received no comments to the proposed SNUR and is finalizing the SNUR as proposed. See the proposed SNUR for details and the basis of the proposed SNUR.

    B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III of this document. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. Persons who must report are described in § 721.5.

    C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.

    III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

    • The projected volume of manufacturing and processing of a chemical substance.

    • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

    • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

    • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

    In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.

    To determine what would constitute a significant new use for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482), EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

    IV. Rationale and Objectives for the Rule A. Rationale

    During review of the PMN P-11-482, the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes, EPA concluded that one or more of the criteria of concern established at § 721.170 were met. For additional discussion on this chemical substance, see Unit II. of this rule.

    B. Objectives

    EPA is issuing this SNUR for a specific chemical substance which has undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

    • EPA will receive notice of any person's intent to manufacture or process a TSCA Chemical Substance Inventory (TSCA Inventory) listed chemical substance for the described significant new use before that activity begins.

    • EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

    • EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

    • EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

    Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

    V. Applicability of the Significant New Use Designation

    If uses begun after the proposed rule was published were considered ongoing rather than new, any person could defeat the SNUR by initiating the significant new use before the final rule was issued. Therefore, EPA designated the date of public release/web posting of the proposed rule, as the cutoff date for determining whether the new use is ongoing. Consult the Federal Register Notice of April 24, 1990 (55 FR 17376), (FRL-3658-5) for a more detailed discussion of the cutoff date for ongoing uses. Any person who began commercial manufacture or processing of the chemical substances identified in this rule for any of the significant new uses designated in the proposed SNUR after the date of publication of the proposed SNUR, must stop that activity before the effective date of the final rule. Persons who ceased those activities will have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires, before engaging in any activities designated as significant new uses. If a person were to meet the conditions of advance compliance under 40 CFR 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities.

    VI. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: Development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).

    In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

    In the TSCA section 5(e) consent orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

    Any request by EPA for the triggered and pended testing described in the Consent Order was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substance. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

    The recommended tests specified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

    SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

    • Human exposure and environmental release that may result from the significant new use of the chemical substances.

    VII. SNUN Submissions

    According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/how-submit-e-pmn.

    VIII. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substance during the development of the direct final rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2016-0207.

    IX. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the risk assessment documents included in the public docket. These information sources supply information relevant to whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2).

    The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Unit II and in the documents noted above. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitely. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.

    X. Statutory and Executive Order Reviews A. Executive Order 12866

    This action establishes a SNUR for the chemical substance that is the subject of a PMN and a TSCA section 5(e) consent order. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review (58 FR 51735, October 4, 1993).

    B. Paperwork Reduction Act (PRA)

    According to the PRA, (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

    EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.

    The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

    Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

    C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

    1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

    2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

    A copy of that certification is available in the docket for this action.

    This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

    • A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

    • Submission of the SNUN would not cost any small entity significantly more than $8,300.

    Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

    D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this final rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

    E. Executive Order 13132

    This action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

    F. Executive Order 13175

    This final rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This final rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this final rule.

    G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

    H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

    J. Executive Order 12898

    This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects 40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

    40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

    Dated: September 15, 2017. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

    PART 9—[AMENDED] 1. The authority citation for part 9 continues to read as follows: Authority:

    7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

    2. In §  9.1, add the following section in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
    §  9.1 OMB approvals under the Paperwork Reduction Act. 40 CFR citation OMB control No. *    *    *    *    * Significant New Uses of Chemical Substances *    *    *    *    * 721.10927 2070-0012 *    *    *    *    *
    PART 721—[AMENDED] 3. The authority citation for part 721 continues to read as follows: Authority:

    15 U.S.C. 2604, 2607, and 2625(c).

    4. Add § 721.10927 to subpart E to read as follows:
    § 721.10927 Bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (PMN P-11-482) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) (particulate), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. A National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 meets the requirements of § 721.63(a)(4).

    (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). A significant new use is any use involving an application method that generates a vapor, mist or aerosol.

    (iii) Disposal. Requirements as specified in § 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).

    (iv) Release to water. Requirements as specified in § 721.90(b)(1) and (c)(1). Any predictable or purposeful release of a manufacturing stream associated with any use of the substance from any site is a significant new use other than the water releases described in the manufacturing process of PMN P-11-482.

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), (j), and (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

    [FR Doc. 2017-21237 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0045; FRL-9968-73-Region 4] Air Plan Approval; South Carolina; Interstate Transport (Prongs 1 and 2) for the 2010 1-Hour NO2 Standard AGENCY:

    Environmental Protection Agency.

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve a revision to the South Carolina State Implementation Plan (SIP), submitted by the South Carolina Department of Health and Environmental Control (DHEC), on December 7, 2016, addressing the Clean Air Act (CAA) interstate transport (prongs 1 and 2) infrastructure SIP requirements for the 2010 1-hour Nitrogen Dioxide (NO2) 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, commonly referred to as an “infrastructure SIP.” Specifically, EPA is taking final action to approve South Carolina's December 7, 2016, SIP submission addressing prongs 1 and 2 to ensure that air emissions in the State do not significantly contribute to nonattainment or interfere with maintenance of the 2010 1-hour NO2 NAAQS in any other state.

    DATES:

    This rule will be effective November 2, 2017.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2017-0045. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information may not be publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the 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. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Andres Febres of the 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. Mr. Febres can be reached by telephone at (404) 562-8966 or via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    By statute, SIPs meeting the requirements of sections 110(a)(1) and (2) of the CAA are to be submitted by states within three years after promulgation of a new or revised NAAQS to provide for the implementation, maintenance, and enforcement of the new or revised NAAQS. EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Sections 110(a)(1) and (2) require 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 newly established or revised NAAQS. More specifically, section 110(a)(1) provides the procedural and timing requirements for infrastructure SIPs. Section 110(a)(2) lists specific elements that states must meet for the infrastructure SIP requirements related to a newly established or revised NAAQS. The contents of an infrastructure SIP submission may vary depending upon the data and analytical tools available to the state, as well as the provisions already contained in the state's implementation plan at the time in which the state develops and submits the submission for a new or revised NAAQS.

    Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and 110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes 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 from 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) and from interfering with measures to protect visibility in another state (prong 4). 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.

    On January 22, 2010, EPA established a new 1-hour primary NAAQS for NO2 at a level of 100 parts per billion, based on a 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. See 75 FR 6474 (February 9, 2010). This NAAQS is designed to protect against exposure to the entire group of nitrogen oxides (NOX). NO2 is the component of greatest concern and is used as the indicator for the larger group of NOX. Emissions that lead to the formation of NO2 generally also lead to the formation of other NOX. Therefore, control measures that reduce NO2 can generally be expected to reduce population exposures to all gaseous NOX which may have the co-benefit of reducing the formation of ozone and fine particles both of which pose significant public health threats.

    States were required to submit infrastructure SIP submissions for the 2010 1-hour NO2 NAAQS to EPA no later than January 22, 2013. For comprehensive information on 2010 1-hour NO2 NAAQS, please refer to the Federal Register notice cited immediately above.

    In a notice of proposed rulemaking published August 15, 2017 (82 FR 38646), EPA proposed to approve South Carolina's December 7, 2016, SIP submission concluding that its SIP adequately addresses prong 1 and prong 2 requirements for the 2010 1-hour NO2 NAAQS. South Carolina provided the following reasons for its determination: (1) The SIP contains state regulations that directly or indirectly control NOX emissions; (2) all areas in the United States are designated as unclassifiable/attainment for the 2010 1-hour NO2 NAAQS; (3) monitored 1-hour NO2 design values in South Carolina and surrounding states (Georgia, North Carolina, and Florida) are below the 2010 standard; and (4) point source emissions of NOX in the State have trended downward. All other applicable infrastructure SIP requirements for South Carolina for the 2010 1-hour NO2 NAAQS have been addressed in separate rulemakings. See 80 FR 14019 (March 18, 2015), 81 FR 56512 (August 22, 2016), and 81 FR 63704 (September 16, 2016).

    The details of South Carolina's submission and the rationale for EPA's action are explained in the August 15, 2017, notice of proposed rulemaking. Comments on the proposed rulemaking were due on or before September 14, 2017. EPA did not receive any adverse comments on the proposed action.

    II. Final Action

    As described above, EPA is taking final action to approve South Carolina's December 7, 2016, SIP revision addressing prongs 1 and 2 of CAA section 110(a)(2)(D)(i) for the 2010 1-hour NO2 NAAQS. EPA is taking final action to approve this portion South Carolina's infrastructure SIP submission because South Carolina's SIP includes adequate provisions to prevent emissions sources within the State from significantly contributing to nonattainment or interfering with maintenance of this standard in any other state.

    III. 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. This 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 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, this action for the state of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have substantial direct effects on an Indian Tribe. The Catawba Indian Nation Reservation is located within the State of South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, “all state and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” However, EPA has determined that this action does not have substantial direct effects on an Indian Tribe because it is not approving any specific rule, but rather determining that South Carolina's already approved SIP meets certain CAA requirements. EPA notes this action will not impose substantial direct costs on Tribal governments or preempt Tribal law.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 4, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    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.

    Dated: September 21, 2017. Onis “Trey” Glenn, III, Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

    PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart PP—South Carolina 2. In § 52.2120, the table in paragraph (e) is amended by adding the entry “110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour NO2 NAAQS” at the end of the table to read as follows:
    § 52.2120 Identification of plan.

    (e) * * *

    Provision State
  • effective
  • date
  • EPA approval date Explanation
    *         *         *         *         *         *         * 110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour NO2 NAAQS 12/7/2016 10/3/2017, [insert Federal Register citation] Addressing Prongs 1 and 2 of section 110(a)(2)(D)(i) only.
    [FR Doc. 2017-21121 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0396; FRL-9968-54-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking direct final action to approve the 2011 base year inventory for the Baltimore, Maryland moderate nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS). The State of Maryland submitted the emission inventory through the Maryland Department of the Environment (MDE) to meet the nonattainment requirements for moderate ozone nonattainment areas for the 2008 8-hour ozone NAAQS. EPA is approving the 2011 base year emissions inventory for the 2008 8-hour ozone NAAQS as a revision to the Maryland state implementation plan (SIP) in accordance with the requirements of the Clean Air Act (CAA).

    DATES:

    This rule is effective on December 4, 2017 without further notice, unless EPA receives adverse written comment by November 2, 2017. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the Federal Register and inform the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0396 at https://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, 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, please contact the person identified in the For Further Information Contact section. 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.

    FOR FURTHER INFORMATION CONTACT:

    Gavin Huang, (215) 814-2042, or by email at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Ground level ozone is formed when nitrogen oxides (NOX) and volatile organic compounds (VOC) react in the presence of sunlight. NOX and VOC are referred to as ozone precursors and are emitted by many types of pollution sources, including motor vehicles, power plants, industrial facilities, and area wide sources, such as consumer products and lawn and garden equipment. Scientific evidence indicates that adverse public health effects occur following exposure to ozone. These effects are more pronounced in children and adults with lung disease. Breathing air containing ozone can reduce lung function and inflame airways, which can increase respiratory symptoms and aggravate asthma or other lung diseases. In response to this scientific evidence, EPA promulgated in 1979 the first ozone NAAQS, the 0.12 part per million (ppm) 1-hour ozone NAAQS. See 44 FR 8202 (February 8, 1979). Before the first ozone NAAQS, EPA had previously promulgated a NAAQS for total photochemical oxidants. See 36 FR 8186 (April 30, 1971).

    On July 18, 1997, EPA promulgated a revised ozone NAAQS of 0.08 ppm, averaged over eight hours. 62 FR 38855. This 8-hour ozone NAAQS was determined to be more protective of public health than the previous 1979 1-hour ozone NAAQS. In 2008, EPA revised the 8-hour ozone NAAQS from 0.08 to 0.075 ppm. See 73 FR 16436 (March 27, 2008).1

    1 On October 1, 2015, EPA strengthened the 8-hour ozone NAAQS to 0.070 ppm. See 80 FR 65292 (October 16, 2015). This rulemaking addresses the 2008 8-hour ozone NAAQS and does not address the 2015 8-hour ozone NAAQS.

    On May 21, 2012, the Baltimore, Maryland area was designated as moderate nonattainment for the 2008 8-hour ozone NAAQS. 77 FR 30088. The designation of the Baltimore, Maryland area as moderate nonattainment was effective July 20, 2012. The Baltimore, Maryland nonattainment area is comprised of Anne Arundel County, Baltimore County, Baltimore City, Carroll County, Harford County, and Howard County. Under section 172(c)(3) of the CAA, Maryland is required to submit a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutants in its moderate nonattainment area.

    II. Summary of SIP Revision and EPA Analysis

    Under CAA section 172(c)(3), states are required to submit a comprehensive, accurate, and current account of actual emissions from all sources (point, nonpoint, nonroad, and onroad) in the nonattainment area. CAA section 182(a)(1) and (b) requires that areas designated as nonattainment and classified as moderate submit an inventory of all sources of ozone precursors no later than 2 years after the effective date of designation. EPA's guidance for emissions inventory development calls for actual emissions to be used in the base year inventory. The state must report annual emissions as well as “summer day emissions.” As defined in 40 CFR 51.900(v), “summer day emissions” means, “an average day's emissions for a typical summer work weekday. The state will select the particular month(s) in summer and the day(s) in the work week to be represented.”

    On December 30, 2016, MDE submitted a formal revision (SIP #16-16) to its SIP. The SIP revision consists of the 2011 base year inventory for the Baltimore, Maryland nonattainment area for the 2008 8-hour ozone NAAQS. In accordance with EPA's requirements for ozone SIP planning, “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements,” MDE selected 2011 for its base year emissions inventory. See 80 FR 12263 (March 6, 2015). MDE's 2011 base year inventory includes emissions estimates covering the general source categories of stationary point, area (nonpoint), quasi-point, nonroad mobile, onroad mobile, and Marine-Air-Rail (M-A-R). In its 2011 base year inventory, MDE reported actual annual emissions and typical summer day emissions for the months of May through September for VOC, NOX, and carbon monoxide (CO). Although MDE also reported annual emissions for fine particulate matter (PM2.5), sulfur dioxide (SO2), and ammonia (NH3) and typical summer day emissions for CO, in this approval of the 2011 base year emissions inventory for the 2008 ozone NAAQS, EPA is approving only relevant ozone precursors, which are VOC and NOX.

    Table 1 summarizes the 2011 VOC and NOX emission inventory by source sector for Maryland's moderate nonattainment area. Annual emissions are given in tons per year (tpy) and summer weekday emissions are given by tons per day (tpd).

    Table 1—Summary of 2011 Emissions for the Baltimore, Maryland Nonattainment Area Source category Ozone
  • season daily
  • (tpd)
  • VOC NOX Annual
  • (tpy)
  • VOC NOX
    Point 8.228 107.676 2,153.41 16,950.46 Quasi-Point 1.080 5.383 387.102 1,946.98 Area 68.093 8.502 21,827.01 5,441.14 Nonroad 38.618 28.628 9,678.69 8,799.27 Onroad 45.34 116.73 15,761.71 41,265.21 M-A-R 1.64 18.43 597.27 6,727.63 Anthropogenic BNAA * Subtotal 162.999 285.352 50,405.190 81,130.694 * Baltimore Nonattainment Area (BNAA).

    Point sources are large, stationary, and identifiable sources of emissions that release pollutants into the atmosphere. For the 2011 inventory, point sources are defined as stationary commercial or industrial operations that emit more than 10 tpy of VOC or 25 tpy of NOX. Maryland obtained its point source data from the MDE Air and Radiation Management Administration (ARMA) point source emissions inventory. ARMA identifies and inventories stationary sources for the point source emissions inventory through inspections, investigations, permitting, and equipment registrations.

    Quasi-point sources are sources that contain a wide variety of air emission sources, including traditional point sources, on-road mobile sources, off-road mobile sources, and area sources. For these sources, the emissions are totaled under a single point source and referred to as a “quasi-point source.” MDE identified three facilities that met these requirements which include the Aberdeen Proving Grounds, Baltimore Washington International Airport, and the Port of Baltimore.

    Nonpoint sources, also known as area sources, are sources of pollution that are small and numerous and have not been inventoried as specific point or mobile sources. For example, these sources include residential heating emissions and emissions from consumer solvents. To inventory these sources, they are grouped so that emissions can be estimated collectively using one methodology. MDE calculated nonpoint emissions for the Baltimore, Maryland nonattainment area by multiplying emissions factors specific for each source category with some known indicator of collective activity for each source category, such as population or employment data.

    Nonroad sources are mobile sources other than onroad vehicles, including aircraft, locomotives, construction and agricultural equipment, and marine vessels. Emissions from different source categories are calculated using various methodologies. The methodologies used for nonroad source emission estimates include EPA's National Mobile Inventory Model (NMIM—April 5, 2009) and EPA's emission factors.

    Onroad or highway sources are vehicles, such as cars, trucks, and buses, which are operated on public roadways. These onroad emissions were estimated using EPA's Motor Vehicle Emission Simulator (MOVES) model, version 2010a, using appropriate activity levels, such as vehicle miles traveled (VMT) estimates developed from vehicle count data maintained by the State Highway Administration (SHA) of the Maryland Department of Transportation (MDOT).

    M-A-R sources include marine vessels, airports, and railroad locomotives. M-A-R emissions were estimated using data from surveyed sources or state and federal reporting agencies.

    EPA reviewed Maryland's 2011 base year emission inventory's results, procedures, and methodologies for the Baltimore, Maryland moderate nonattainment area and found them to meet the applicable requirements for approval under sections 110, 172(c)(3) and 182(a)(1) and (b) of the CAA. EPA's review and analysis is detailed in a Technical Support Document (TSD) prepared for this rulemaking. The TSD is available online at http://www.regulations.gov, Docket Number EPA-R03-OAR-2017-0396.

    III. Final Action

    EPA is approving the Maryland SIP revision which includes the 2011 base year inventory for the 2008 8-hour ozone NAAQS for the Baltimore, Maryland moderate nonattainment area because the inventory was prepared in accordance with requirements in sections 110, 172(c)(3) and 182(a)(1) and (b) of the CAA and its implementing regulations including 40 CFR 51.915. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of this issue of the Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 4, 2017 without further notice unless EPA receives adverse comment by November 2, 2017. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

    IV. Statutory and Executive Order Reviews A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 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 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 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

    B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 4, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this issue of the Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action.

    This action approving Maryland's 2011 base year inventory for the 2008 8-hour ozone NAAQS for the Baltimore, Maryland moderate nonattainment area may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: September 7, 2017. Cecil Rodrigues, Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

    PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart V—Maryland 2. In § 52.1070, the table in paragraph (e) is amended by adding an entry for “2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard” at the end of the table to read as follows:
    § 52.1070 Identification of plan.

    (e) * * *

    EPA Approved Non-Regulatory and Quasi-Regulatory Material Name of non-regulatory SIP revision Applicable geographic area State
  • submittal date
  • EPA approval date Additional
  • explanation
  • *         *         *         *         *         *         * 2011 Base Year Emissions Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard Baltimore, Maryland 2008 Ozone Moderate Nonattainment Area 12/30/2016 10/3/2017 [Insert Federal Register citation] See § 52.1075(r).
    3. Section 52.1075 is amended by adding paragraph (r) to read as follows:
    § 52.1075 Base year emissions inventory.

    (r) EPA approves as a revision to the Maryland state implementation plan the 2011 base year emissions inventory for the Baltimore, Maryland moderate nonattainment area for the 2008 8-hour ozone national ambient air quality standards submitted by the Maryland Department of the Environment on December 30, 2016. The 2011 base year emissions inventory includes emissions estimates that cover the general source categories of stationary point, quasi-point, area (nonpoint), nonroad mobile, onroad mobile, and Marine-Air-Rail (M-A-R). The inventory includes actual annual emissions and typical summer day emissions for the months of May through September for the ozone precursors, VOC and NOX.

    [FR Doc. 2017-21106 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 150121066-5717-02] RIN 0648-XF724 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries AGENCY:

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

    ACTION:

    Temporary rule; inseason General category bluefin tuna quota transfer.

    SUMMARY:

    NMFS is transferring 156.4 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the General category for the remainder of the 2017 fishing year, to account for overharvests of the January, June through August, and September subquotas. This action is intended to preserve the opportunity for General category fishermen to participate in the October through November and December General category fisheries to the extent that transferrable quota is available and is based on consideration of the regulatory determination criteria regarding inseason adjustments and applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels when fishing commercially for BFT.

    DATES:

    The quota transfer is effective September 28, 2017 through December 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Sarah McLaughlin or Brad McHale, 978-281-9260.

    SUPPLEMENTARY INFORMATION:

    Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended by Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014). NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

    The base quota for the General category is 466.7 mt, as established in the 2015 BFT quota final rule (80 FR 52198, August 28, 2015). See § 635.27(a). Each of the General category time periods (January, June through August, September, October through November, and December) is allocated a “subquota” or portion of the annual General category quota. Although it is called the “January” subquota, the regulations allow the General category fishery under this quota to continue until the subquota is reached or March 31, whichever comes first. The subquotas for each time period are as follows: 24.7 mt for January; 233.3 mt for June through August; 123.7 mt for September; 60.7 mt for October through November; and 24.3 mt for December. Any unused General category quota rolls forward within the fishing year, which coincides with the calendar year, from one time period to the next, and is available for use in subsequent time periods. On December 19, 2016, NMFS published an inseason action transferring 16.3 mt of BFT quota from the December 2017 subquota to the January 2017 subquota period, resulting in a subquota of 41 mt for the January 2017 period and a subquota of 8 mt for the December 2017 period (81 FR 91873). For 2017, NMFS also transferred 40 mt from the Reserve to the General category effective March 2, resulting in an adjusted General category quota of 506.7 mt (82 FR 12747, March 7, 2017). The 2017 General category fishery is open until December 31, 2017, or until the General category quota is reached, whichever comes first. Prior to this action, the adjusted Reserve category quota was 156.4 mt, and was most recently adjusted in the action to augment the 2017 BFT Reserve category quota with available underharvest of the 2016 adjusted U.S. BFT quota (82 FR 43500, September 18, 2017).

    Quota Transfer

    Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria at § 635.27(a)(8). NMFS has considered all of the relevant determination criteria and their applicability to the General category fishery. These considerations include, but are not limited to, the following:

    NMFS considered the catches of the General category quota to date (including during the summer/fall and winter fisheries in the last several years), and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). Preliminary landings data as of September 22, 2017, indicate that the General category has landed 596 mt this year, which exceeds the overall General category quota of 506.7 mt. NMFS closed the General category fishery when the September subquota (123.7 mt) was met, effective September 17, 2017 (82 FR 43711, September 19, 2017). Without a quota transfer at this time, the October through November and December General category subquotas would not be available to General category participants because the entire General category quota of 506.7 mt has been reached and exceeded. Approximately 81 percent (717.3 mt) of the total of the BFT subquotas for all commercial categories (888.7 mt, as published in the 2015 BFT quota final rule) has been harvested as of September 22, 2017, however, and NMFS anticipates that some amount of quota may remain unused by the end of the year even with the transfer. Absent a transfer at this time, this segment of the fishery would have to remain closed if no adjustment is made, even though NMFS anticipates that commercial-sized BFT will be readily available to vessels fishing under the General category quota when the General category fishery is scheduled to reopen on October 1, 2017. Transferring 156.4 mt of BFT quota from the Reserve category would allow this segment of the fishery to continue fishing and would result in a total of 663.1 mt being available to the General category for the 2017 General category fishing season.

    Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT quota transferred before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered General category landings over the last several years and landings to date this year. Landings are highly variable and depend on access to commercial-sized BFT and fishing conditions, among other factors. A portion of the transferred quota covers overharvests in the category as prosecuted to date, and thus has already been harvested. For the remainder of the transferred quota, which make the remaining subquotas whole to the extent that transferrable quota is available, there is a high probability that the transferred quota will be harvested during the October through November and December time periods.

    NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2017 landings and dead discards. In the last several years, total U.S. BFT landings have been below the total available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2017 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and NMFS anticipates having sufficient quota to do that.

    Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen and provided by BFT dealers continue to provide NMFS with valuable data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT over the longest time-period allowable would support the collection of a broad range of data for these studies and for stock monitoring purposes.

    This transfer would be consistent with the current U.S. quota, which was established and analyzed in the 2015 BFT quota final rule, and with objectives of the 2006 Consolidated HMS FMP and amendments. (§ 635.27(a)(8)(v) and (vi)). Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and Amendment 7, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)).

    Based on the considerations above, NMFS is transferring all of the available 156.4 mt from the Reserve category to the General category with the objective of making the remaining subquotas whole. Therefore, NMFS adjusts the General category quota to 663.1 mt for the 2017 General category fishing season (i.e., through December 31, 2017, or until the General category quota is reached, whichever comes first), and adjusts the Reserve category quota to 0 mt. If necessary, NMFS will close the General category fishery for October through November and for December when the available subquotas for those time periods are reached.

    Monitoring and Reporting

    NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov or by using the HMS Catch Reporting App. Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional action (e.g., quota adjustment or closure) is necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register. In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

    NMFS reminds General category participants that when the fishery reopens October 1, 2017, the BFT General category daily retention limit will be one large medium or giant BFT (measuring 73″ or greater) per vessel per day/trip.

    Classification

    The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

    The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer for the remainder of 2017 is impracticable and contrary to the public interest as such a delay would result in continued closure of the General category fishery (because the available quota has been met) and the need to re-open the fishery later in the October through November time period, rather than the fishery automatically re-opening on October 1. The delay would preclude the fishery from harvesting BFT that are available on the fishing grounds and that might otherwise become unavailable during a delay. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

    This action is being taken under § 635.27(a)(9) (Inseason adjustments) and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 971 et seq. and 1801 et seq.

    Dated: September 28, 2017. Emily Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-21209 Filed 9-28-17; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 151211999-6343-02] RIN 0648-XF713 Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Possession and Trip Limit Adjustment for the Common Pool Fishery AGENCY:

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

    ACTION:

    Temporary rule; inseason adjustment.

    SUMMARY:

    This action decreases the possession and trip limits for Georges Bank cod for Northeast multispecies common pool vessels for the remainder of the 2017 fishing year, through April 30, 2018. Recent catch data reported through September 19, 2017, indicates that the common pool fishery has already caught 2.4 metric tons, or 65.7 percent, of the Trimester 2 Georges Bank cod Total Allowable Catch since the second trimester began on September 1, 2017. We project that, at its current trajectory, the common pool will catch its Trimester 2 TAC well before the end of the second trimester, and is also at risk of exceeding its annual 2017 quota. This possession and trip limit decrease is intended to prevent the common pool fishery from exceeding its allocation for this stock prior to the end of the fishing year.

    DATES:

    This possession and trip limit decrease is effective September 28, 2017, through April 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Claire Fitz-Gerald, Fishery Management Specialist, (978) 281-9255.

    SUPPLEMENTARY INFORMATION:

    The regulations at § 648.86(o) authorize the Regional Administrator to adjust the possession and trip limits for common pool vessels in order to help prevent the overharvest or underharvest of the common pool quotas.

    Recent catch data reported through September 19, 2017, indicates that the common pool fishery has already caught 2.4 metric tons, or 65.7 percent, of the Trimester 2 Georges Bank (GB) cod Total Allowable Catch (TAC) since the second trimester began on September 1, 2017. The current GB cod possession and trip limit for GB cod is 250 pounds per DAS, and up to 500 pounds per trip. Under these possession limits, the common pool fishery caught its Trimester 1 TAC and triggered an area closure for GB cod on July 27, 2017. We project that, at its current trajectory, the common pool will catch its Trimester 2 TAC well before the end of the second trimester, and is also at risk of exceeding its annual 2017 quota. In the event that the common pool exceeds its 2017 quota, regulations require that the overage must be deducted from the following year's quota, which would have a negative economic impact on common pool vessels. Therefore, a decrease to the possession and trip limits is being implemented to help prevent the common pool fishery from exceeding its quota for the 2017 fishing year.

    Effective September 28, 2017, the GB cod possession and trip limits are decreased to 25 lb (11.3 kg) per day and 50 lb (22.7 kg) per trip, as summarized in the table below. Common pool groundfish vessels that have declared their trip through the vessel monitoring system (VMS) or interactive voice response system, and crossed the VMS demarcation line prior to September 28, 2017, are not subject to the new possession and trip limits for that trip.

    Table 1—New Possession and Trip Limits for GB Cod Permit type Current possession/trip limits New possession/trip limits Days-At-Sea (A DAS) 250 lb (113.4 kg) per DAS, up to 500 lb (226.8 kg) per trip 25 lb (11.3 kg) per DAS, up to 50 lb (22.6 kg) per trip. Handgear A 250 lb (113.4 kg) per trip 25 lb (11.3 kg) per trip. Handgear B 25 lb (11.3 kg) per trip Unchanged. Small Vessel Category 25 lb (11.3 kg) per trip, within combined 300 lb (136.1 kg) trip limit for cod, haddock, and yellowtail flounder Unchanged.

    Weekly quota monitoring reports for the common pool fishery are on our Web site at: http://www.greateratlantic.fisheries.noaa.gov/ro/fso/MultiMonReports.htm. We will continue to monitor common pool catch through vessel trip reports, dealer-reported landings, VMS catch reports, and other available information and, if necessary, we will make additional adjustments to common pool management measures.

    Classification

    This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

    The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.

    The regulations at § 648.86(o) authorize the Regional Administrator to adjust the Northeast multispecies possession and trip limits for common pool vessels in order to help prevent the overharvest or underharvest of the pertinent common pool quotas. The catch data used as the basis for this action only recently became available. The available analysis indicates that the common pool fishery has already achieved 65.7 percent of its second trimester GB cod TAC within the first three weeks of the trimester and if the GB cod possession and trip limits are not reduced immediately, the common pool fishery may exceed its quota for this stock. This action reduces the probability of the common pool fishery exceeding its quota for GB cod. Any overages of the common pool quota for this stock would undermine conservation objectives and trigger the implementation of accountability measures that would have negative economic impacts on the common pool vessels. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, would prevent NMFS from implementing the necessary possession and trip limit adjustment in a timely manner, which could undermine conservation objectives of the Northeast Multispecies Fishery Management Plan, and cause negative economic impacts to the common pool fishery.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: September 28, 2017. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-21234 Filed 9-28-17; 4:15 pm] BILLING CODE 3510-22-P
    82 190 Tuesday, October 3, 2017 Proposed Rules DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 110 [Docket Number USCG-2016-0989] RIN 1625-AA01 Special Anchorage Areas; Passagassawakeag River, Belfast Bay, Belfast, Maine AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish two special anchorage areas in the Passagassawakeag River in the vicinity of Belfast, Maine. This proposed action is necessary to facilitate safe navigation in that area and provide safe and secure anchorages for vessels less than 20 meters in length. This action is intended to increase the safety of life and property in the Passagassawakeag River in the vicinity of Belfast, improve the safety of anchored vessels, and provide for the overall safe and efficient flow of vessel traffic and commerce. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before December 4, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0989 in the Federal eRulemaking Portal http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, contact Mr. Craig Lapiejko, Waterways Management at Coast Guard First District, telephone (617) 223-8351, email [email protected] or Chief Marine Science Technician Chris Bains, Waterways Management Division at Coast Guard Sector Northern New England, telephone (207) 347-5003, 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, Purpose, and Legal Basis

    Beginning in the fall of 2008, the Town of Belfast, Maine (ME) Harbor Committee began to discuss the possibility of designating a special anchorage area in the waters off Belfast in the Passagassawakeag River due to the rise of commercial and recreational vessel traffic. Over the next several years the Belfast harbormaster had several discussions with the First Coast Guard District, Waterways Management Division, to understand the processes involved with creating a special anchorage area. In March 2016, the harbormaster submitted a draft proposal to the Belfast City Council and subsequently the town began talks with Coast Guard Sector Northern New England regarding establishment of a special anchorage area in Belfast.

    The proposed special anchorage areas are intended to reduce the risk of vessel collisions and to promote safe and efficient travel in the navigable channel of the Passagassawakeag River to the mouth of Belfast Bay clearly defining the mooring fields historically used by the town. All proposed coordinates are North American Datum 1983 (NAD 83).

    The rule is intended to reduce the risk of vessel collisions by creating two special anchorage areas in the Passagassawakeag River in the vicinity of the northeastern portion of Belfast, ME. The Coast Guard proposes this rulemaking under the authority established in 33 U.S.C. 471, 1221 through 1236, and 2071.

    III. Discussion of Proposed Rule

    The proposed rule would create two special anchorage areas, referred to as special anchorage areas A and B in the Passagassawakeag River in the vicinity of Belfast, ME. Special anchorage area A is approximately 554,800 sq. yards and is on the north side of the river located between the mouth of the Goose River and Patterson Pt, downstream of the US RT 1 Bridge. Special anchorage area B is approximately 693,889 sq. yards and located along the southern shores of the river located between the Belfast Town docks to Belfast City Park.

    Vessels less than 20 meters in length, when at anchor in these special anchorage areas, will not be required to sound signals or display anchorage lights or shapes when at anchor. Additionally, mariners using these anchorage areas are encouraged to contact local and state authorities, such as the local harbormaster, to ensure compliance with any additional applicable state and local laws. Such laws may involve, for example, compliance with direction from the local harbormaster when placing or using moorings within the anchorage.

    BILLING CODE 9110-04-P EP03OC17.001 BILLING CODE 9110-04-C IV. Regulatory Analyses

    We developed this proposed 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.

    A. Regulatory Planning and Review

    Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

    The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See the OMB Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs'” (February 2, 2017).

    We anticipate the economic impact of the proposed rule to not be significant. This proposed determination is based on the historic and current use of the area as well as the minimal impact this proposed rule would have on surface navigation. The potential impact would be minimized for the following reasons: 1) normal surface navigation will not be affected as these two areas in the Passagassawakeag River in the vicinity of the northeastern portion of Belfast has been historically used as a mooring field by the Town of Belfast; and 2) this proposed rule would simply permit eligible vessels in existing mooring areas to not to sound signals or exhibit anchor lights or shapes when at anchor there.

    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 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 Passagassawakeag River in Belfast, ME may be small entities, for the reasons stated above in section IV.A, 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 section. 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.

    C. Collection of Information

    This proposed rule would 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 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.

    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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this proposed 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 made a preliminary determination 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 proposed rule involves the establishment of special anchorage areas. It appears that this action may be categorically excluded from further review under paragraph 34(f) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary Record of Environmental Consideration is 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 proposed 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.

    V. 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. Documents mentioned in this notice of proposed rulemaking as being available in the docket, 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.

    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 NPRM as being available in the docket, and all public comments, will be 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 110

    Anchorage grounds.

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 110 as follows:

    PART 110—ANCHORAGE REGULATIONS 1. The authority citation for part 110 continues to read as follows: Authority:

    33 U.S.C. 471; 1221 through 1236, 2071; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.

    2. Amend § 110.4 to by adding paragraph (d) to read as follows:
    § 110.4 Penobscott Bay, Maine.

    (d) Passagassawakeag River, Belfast Bay, Belfast, Maine.— (1) Special anchorage area A. All of the waters enclosed by a line beginning at latitude 44°25′23″ N., longitude 068°58′55″ W.; thence to latitude 44°25′30″ N., longitude 068°58′48″ W.; thence to latitude 44°25′33″ N., longitude 068°59′15″ W.; thence to latitude 44°25′39″ N., longitude 068°59′17″ W.; thence to latitude 44°25′48″ N., longitude 068°59′57″ W.; thence to latitude 44°25′46″ N., longitude 069°00′08″ W.; thence to the point of beginning.

    (2) Special anchorage area B. All of the waters enclosed by a line beginning at latitude 44°25′17″ N., longitude 068°59′00″ W.; thence to latitude 44°24′56″ N., longitude 068°59′23″ W.; thence to latitude 44°25′20″ N., longitude 068°59′38″ W.; thence to latitude 44°25′44″ N., longitude 069°00′09″ W.; thence to the point of beginning.

    Note to § 110.4(d):

    All coordinates referenced use datum: NAD 83. All anchoring in the areas is under the supervision of the town of Belfast harbormaster or other such authority as may be designated by the authorities of the Town of Belfast, Maine. Mariners using these special anchorage areas are encouraged to contact local and state authorities, such as the local harbormaster, to ensure compliance with any additional applicable state and local laws.

    Dated: September 7, 2017. S.D. Poulin, Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
    [FR Doc. 2017-21231 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0146] RIN 1625-AA87 Security Zones; Port Canaveral Harbor, Cape Canaveral Air Force Station, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to expand the geographical boundaries of a permanent security zone at Port Canaveral Harbor. This action is necessary to ensure the security of vessels, facilities, and the surrounding areas within this zone. This rule is intended to prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within the security zone unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before November 3, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2017-0146 using the Federal eRulemaking 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 proposed rulemaking, call or email Lieutenant Allan Storm, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone (904) 714-7616, 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 § Section U.S.C. United States Code COTP Captain of the Port II. Background, Purpose, and Legal Basis

    On October 3, 1988, the Coast Guard published a final rule creating a permanent security zone at Port Canaveral Harbor, Cape Canaveral, Florida (53 FR 38718) to safeguard the waterfront and military assets along the U.S. Navy's Poseidon Wharf inside the southeast portion of Port Canaveral Harbor's Middle Basin. This waterfront area is located on Cape Canaveral Air Force Station (CCAFS), a U.S. Air Force military installation. Additionally, the northern and northeast portion of the Middle Basin's waterfront is located almost entirely on CCAFS property, and within this area are piers utilized by the U.S. Air Force and U.S. Army. CCAFS routinely conducts operations critical to national security.

    The U.S. Navy requested to amend the current regulation in 33 CFR 165.705(b) to expand the geographical boundaries to include the northern and northeastern portion of the Middle Basin of Port Canaveral Harbor in order to ensure the safety and security of military assets and infrastructure along the entire CCAFS waterfront.

    The COTP Jacksonville has determined it is necessary to expand the security zone to ensure the security of military assets and waterfront facilities from destruction, loss, or injury from sabotage or other subversive acts, accidents or other causes of a similar nature, while still allowing for safe navigation within the Middle Basin of Port Canaveral Harbor. The proposed expanded geographical boundaries would encompass the entire CCAFS waterfront in the middle basin, with a perpendicular boundary distance from the shore varying from approximately 120 feet to 665 feet. The purpose of the proposed rule is to ensure the security of vessels, facilities, and the surrounding areas within the security zone. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.

    III. Discussion of Proposed Rule

    The Coast Guard proposes to expand the geographical boundaries of the current regulated area in 33 CFR 165.705(b) to include the navigable waters of the Port Canaveral Harbor's Middle Basin. The proposed amendment would redesignate § 165.705(b) to new § 165.705(a)(2) and would read as follows: “Security Zone B. Middle Basin, Port Canaveral Harbor, at Cape Canaveral Air Force Station, Brevard County, Florida. All waters within the following coordinates inside the Middle Basin: starting at Point 1 in position 28°24′54.49″ N., 80°36′39.13″ W.; thence south to Point 2 in position 28°24′53.27″ N., 80°36′39.15″ W.; thence east to Point 3 in position 28°24′53.25″ N., 80°36′30.41″ W.; thence south to Point 4 in position 28°24′50.51″ N., 80°36′30.41″ W.; thence southeast to Point 5 in position 28°24′38.15″ N., 80°36′17.18″ W.; thence east to Point 6 in position 28°24′38.16″ N., 80°36′ 14.92″ W.; thence northeast to Point 7 in position 28°24′39.36″ N., 80°36′13.37″ W.; thence following the land based perimeter boundary to the point of origin.”

    The proposed rule would also make the following amendments: (1) Change the title of the existing regulation in 33 CFR 165.705 from “Port Canaveral Harbor, Cape Canaveral, Florida” to “Security Zones: Port Canaveral Harbor, Cape Canaveral Air Force Station, FL”; (2) add a new paragraph (c) and change the title to “(c) Regulations”; (3) redesignate existing paragraph (d) as new paragraph (c)(1) with minor non-substantive changes; (4) redesignate existing paragraph (c) as new paragraph (c)(2) with minor non-substantive changes; (5) and add a new paragraph (c)(3), which states: “Persons desiring to enter, transit through, anchor in, or remain within the security zone may request permission from the COTP Jacksonville by telephone at 904-714-7557, or a designated representative via VHF-FM radio on channel 16. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or the designated representative.” Lastly, we propose to add a new paragraph (b), entitled “Definitions” and propose a new definition for the term “designated representative.”

    IV. Regulatory Analyses

    We developed this proposed 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 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

    The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See the OMB Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

    The economic impact of this proposed rule is not significant. Although persons and vessels may not enter, transit through, anchor it, or remain within the security zone without authorization from the COTP Jacksonville or a designated representative, they may operate in the navigable water adjacent to the proposed security zone and the Federal channel.

    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 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 security zone may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on a substantial number of small entities.

    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 section. 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.

    C. Collection of Information

    This proposed rule would 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 E.O. 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 E.O. 13132.

    Also, this proposed rule does not have tribal implications under E.O. 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.

    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 proposed rule would not result in such an expenditure, the Coast Guard discusses the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this proposed 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 made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. The proposed rule involves expanding the geographical boundaries of a permanent security zone that will prohibit entry within certain navigable waters of the Port Canaveral Harbor's Middle Basin.

    Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary Record of Environmental Consideration (REC) supporting this determination is 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 proposed 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.

    V. Public Participation and Request for Comments

    Public participation is essential to effective rulemaking, and the Coast Guard will consider all comments and related materials 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 NPRM as being available in the docket, and all public comments, will be 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 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 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. Revise § 165.705 to read as follows:
    § 165.705: Security Zones: Port Canaveral Harbor, Cape Canaveral Air Force Station, FL.

    (a) Regulated areas.

    (1) Security Zone A. East (Trident) Basin, Port Canaveral Harbor, at Cape Canaveral Air Force Station, Brevard County, Florida. All waters of the East Basin north of latitude 28°24′36″ N.

    (2) Security Zone B. Middle Basin, Port Canaveral Harbor, at Cape Canaveral Air Force Station, Brevard County, Florida. All waters within the following coordinates inside the Middle Basin: Starting at Point 1 in position 28°24′54.49″ N., 80°36′39.13″ W.; thence south to Point 2 in position 28°24′53.27″ N., 80°36′39.15″ W.; thence east to Point 3 in position 28°24′53.25″ N., 80°36′30.41″ W.; thence south to Point 4 in position 28°24′50.51″ N., 80°36′30.41″ W.; thence southeast to Point 5 in position 28°24′38.15″ N., 80°36′17.18″ W.; thence east to Point 6 in position 28°24′38.16″ N., 80°36′14.92″ W.; thence northeast to Point 7 in position 28°24′39.36″ N., 80°36′13.37″ W.; thence following the land based perimeter boundary to the point of origin. These coordinates are based on North American Datum 1983.

    (b) Definitions. The term “designated representative” means personnel designated by or assisting the Captain of the Port (COTP) Jacksonville in the enforcement of the security zone. This includes Coast Guard Patrol Commanders, Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels and federal, state, and local law officers designated by or assisting the COTP Jacksonville in the enforcement of regulated navigation areas and security zones.

    (c) Regulations.

    (1) The general regulations governing security zones found in 33 CFR 165.33 apply to the security zones described in paragraph (a) of this section.

    (2) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the security zone unless authorized by the COTP Jacksonville or a designated representative.

    (3) Persons desiring to enter, transit through, anchor in, or remain within the security zone may request permission from the COTP Jacksonville by telephone at 904-714-7557, or a designated representative via VHF-FM radio on channel 16. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or the designated representative.

    Dated: September 28, 2017. T.C. Wiemers, Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
    [FR Doc. 2017-21230 Filed 10-2-17; 8:45 am] BILLING CODE 9110-04-P
    POSTAL SERVICE 39 CFR Part 111 Overweight Parcels AGENCY:

    Postal ServiceTM.

    ACTION:

    Request for comments.

    SUMMARY:

    The Postal Service is contemplating amendment of the Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®), to address the challenges presented by overweight parcels that make their way into the postal network. To aid us in this effort, we are requesting comments from the postal community regarding a variety of suggested actions to resolve or ameliorate this problem. Overweight parcels for the purpose of this notice are defined as anything in excess of 70 pounds or the maximum weight allowed for HAZMAT.

    DATES:

    Submit comments on or before November 2, 2017.

    ADDRESSES:

    Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to [email protected], with a subject line of “Overweight Parcels.” Faxed comments are not accepted.

    You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.

    FOR FURTHER INFORMATION CONTACT:

    Direct questions or comments to Lizbeth J. Dobbins by email at [email protected] or phone (202) 268-3789.

    SUPPLEMENTARY INFORMATION: The Challenge of Overweight Parcels

    Overweight parcels should never be accepted for delivery into the postal network. On occasion an item, such as a returns parcel, gets into the Postal network and arrives at a destination plant or post office. It is unsafe to return the item back through the postal network so the receiving office contacts the customer and asks the customer to pick up the package. Sometimes the package is abandoned which creates another safety issue trying to dispose of the overweight item.

    Part of the challenge is that we do not want overweight items at any time since these items cause numerous safety issues and we strongly discourage mailers from entering them into the postal system. We do not accept them at postal retail counters either and yet, these items still get into the postal system.

    In order to discourage unsafe practices, the Postal Service is seeking input from the mailing community about how to prevent overweight packages from entering the postal system, and if they get into the postal system, the appropriate postage to be paid. The maximum weight for postage payment is 70 pounds.

    Suggested Remedies

    One partial remedy would be to assess additional postage on overweight parcels discovered in the postal network. Thus, if a package weight is 75 pounds, and it arrives at the destination office, with postage calculated at 70 pounds, an additional 5 pounds worth of postage could be collected (70 plus 5). Or if the item is 80 pounds, postage would be collected on the additional 10 pounds. This would appear to provide the Postal Service with at least some degree of reimbursement for the extra service provided.

    As a further deterrent, another possibility would be to charge not only additional postage, but an additional penalty fee (perhaps $20.00). Thus, for an 80 pound parcel the total amount due would include the postage payment for 70 pounds, a postage surcharge for the additional 10 pounds and a $20 penalty.

    Since HAZMAT parcels have lower maximum weight limits, and overweight HAZMAT parcels may pose additional safety challenges, it would seem appropriate to provide an additional element of deterrence with regard to the mailing of such items. Thus, for example, if a 65-pound HAZMAT package exceeded the maximum weight limit of 25 pounds, the amount due might include not only the postage on the actual weight of the package, but an additional surcharge of $20.00 for each 10 pounds (or fraction thereof) in excess of the applicable weight limit.

    We look forward to feedback on this important safety issue.

    Stanley F. Mires, Attorney, Federal Compliance.
    [FR Doc. 2017-21150 Filed 10-2-17; 8:45 am] BILLING CODE 7710-12-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0396; FRL-9968-53-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Baltimore, Maryland Nonattainment Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) proposes to approve, as a state implementation plan (SIP) revision, the 2011 base year inventory for the Baltimore, Maryland moderate nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS) submitted by the State of Maryland through the Maryland Department of the Environment (MDE). In the Final Rules section of this issue of the Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A more detailed description of the state submittal and EPA's evaluation is included in a technical support document (TSD) prepared in support of this rulemaking action. A copy of the TSD is available, upon request, from the EPA Regional Office listed in the ADDRESSES section of this document or is also available electronically within the Docket for this rulemaking action. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

    DATES:

    Comments must be received in writing by November 2, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0396 at https://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, 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. 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 the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Gavin Huang, (215) 814-2042, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    For further information, please see the information provided in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this issue of the Federal Register publication.

    Dated: September 7, 2017. Cecil Rodrigues, Acting Regional Administrator, Region III.
    [FR Doc. 2017-21109 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1 and 20 [MB Docket No 11-43; Report No. 3081] Petition for Reconsideration of Action in Rulemaking Proceeding AGENCY:

    Federal Communications Commission.

    ACTION:

    Petition for Reconsideration.

    SUMMARY:

    A Petition for Reconsideration (Petition) has been filed in the Commission's rulemaking proceeding by Rick Chessen, on behalf of NCTA-The Internet & Television Association.

    DATES:

    Oppositions to the Petition must be filed on or before October 18, 2017. Replies to an opposition must be filed on or before October 30, 2017.

    ADDRESSES:

    Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Lyle Elder, Media Bureau, at (202) 418-2365 or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's document, Report No. 3081, released September 21, 2017. The full text of the Petition is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554. It also may be accessed online via the Commission's Electronic Comment Filing System at: http://apps.fcc.gov/ecfs/. The Commission will not send a Congressional Review Act (CRA) submission to Congress or the Government Accountability Office pursuant to the CRA, 5.U.S.C. because no rules are being adopted by the Commission.

    Subject: Video Description: Implementation of the Twenty-First Century Communications and Video Accessibility Act of 2010, FCC 17-88, published at 82 FR 37345, August 10, 2017, in MB Docket No. 11-43. This document is being published pursuant to 47 CFR 1.429(e). See also 47 CFR 1.4(b)(1) and 1.429(f), (g).

    Number of Petitions Filed: 1.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2017-21239 Filed 10-2-17; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 20 [Docket No. FWS-HQ-MB-2017-0028; FF09M21200-178-FXMB1231099BPP0] RIN 1018-BB73 Migratory Bird Hunting; Supplemental Proposals for Migratory Game Bird Hunting Regulations for the 2018-19 Hunting Season; Notice of Meetings AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Proposed rule; supplemental.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), proposed in an earlier document this year to establish annual hunting regulations for certain migratory game birds for the 2018-19 hunting season. This supplement to that proposed rule provides the regulatory alternatives for the 2018-19 duck hunting seasons, announces the Service Migratory Bird Regulations Committee (SRC) and Flyway Council meetings, and provides Flyway Council recommendations resulting from their March meetings.

    DATES:

    Comments: We will accept comments on this proposed rule and any subsequent proposed rules resulting from upcoming SRC meetings until January 15, 2018.

    Meetings: The SRC will meet to consider and develop proposed regulations for the 2018-19 migratory game bird hunting seasons on October 17-18, 2017. Meetings on both days will commence at approximately 8:30 a.m.

    ADDRESSES:

    You may submit comments on the proposals by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments on Docket No. FWS-HQ-MB-2017-0028.

    U.S. mail or hand-delivery: Public Comments Processing, Attn: FWS-HQ-MB-2017-0028; Division of Policy, Performance, and Management Programs; U.S. Fish and Wildlife Service, MS: BPHC; 5275 Leesburg Pike, Falls Church, VA 22041.

    We will not accept emailed or faxed comments. We will post all comments on http://www.regulations.gov. This generally means that your entire submission—including any personal identifying information—will be posted on the Web site. See the Public Comments section, below, for more information.

    Meetings: The October 17-18, 2017, SRC meeting will be at the U.S. Fish and Wildlife Service Midwest Regional Office, 5600 American Boulevard, Bloomington, MN 55437.

    FOR FURTHER INFORMATION CONTACT:

    Ron W. Kokel at: Division of Migratory Bird Management, U.S. Fish and Wildlife Service, Department of the Interior, MS: MB, 5275 Leesburg Pike, Falls Church, VA 22041; (703) 358-1714.

    SUPPLEMENTARY INFORMATION:

    New Process for the Annual Migratory Game Bird Hunting Regulations

    As part of DOI's retrospective regulatory review, 2 years ago we developed a schedule for migratory game bird hunting regulations that is more efficient and provides hunting season dates much earlier than was possible under the old process. The new process makes planning easier for the States and all parties interested in migratory bird hunting. Beginning in the summer of 2015, with the development of the 2016-17 hunting seasons, we started promulgating our annual migratory game bird hunting regulations using a new schedule that combines the previously used early- and late-season regulatory processes into a single process. We make decisions for harvest management based on predictions derived from long-term biological information and established harvest strategies and, therefore, can establish migratory bird hunting seasons much earlier than the system we used for many years. Under the new process, we develop proposed hunting season frameworks for a given year in the fall of the prior year. We then finalize those frameworks a few months later, thereby enabling the State agencies to select and publish their season dates in early summer. We provided a detailed overview of the new process in the August 3, 2017, Federal Register (82 FR 36308). This proposed rule is the second in a series of proposed and final rules for the establishment of the 2018-19 hunting seasons.

    Service Migratory Bird Regulations Committee Meetings

    The SRC will meet October 17-18, 2017, to review information on the current status of migratory game birds, consider Flyway Council recommendations, and develop 2018-19 migratory game bird regulations recommendations for these species. In accordance with Departmental policy, these meetings are open to public observation. You may submit written comments to the Service on the matters discussed.

    Regulatory Schedule for 2017-18

    On August 3, 2017, we published a proposal to amend title 50 of the Code of Federal Regulations (CFR) at part 20 (82 FR 36308). The proposal provided a background and overview of the migratory bird hunting regulations process, and addressed the establishment of seasons, limits, and other regulations for hunting migratory game birds under §§ 20.101 through 20.107, 20.109, and 20.110 of subpart K. This document is the second in a series of proposed, supplemental, and final rules for migratory game bird hunting regulations. We will publish additional supplemental proposals for public comment in the Federal Register as population, habitat, harvest, and other information become available. Major steps in the 2018-19 regulatory cycle relating to open public meetings and Federal Register notifications were illustrated in the diagram at the end of the August 3, 2017, proposed rule (82 FR 36308).

    All sections of this and subsequent documents outlining hunting frameworks and guidelines are organized under the numbered headings set forth in the August 3, 2017, proposed rule (82 FR 36308). Later sections of this and subsequent documents will refer only to numbered items requiring attention. Therefore, it is important to note that we will omit those items requiring no attention, and remaining numbered items will be discontinuous, thereby making the list appear incomplete.

    The regulatory alternatives for the 2018-19 duck hunting seasons are shown at the end of this document. We plan to publish proposed season frameworks in mid-December 2017. We plan to publish final season frameworks in late February 2018.

    Review of Public Comments

    This proposed rulemaking describes recommended changes or specific preliminary proposals that vary from the 2017-18 regulations and issues requiring discussion, action, or the attention of the States or tribes. We will publish responses to all proposals and written comments when we develop final frameworks for the 2018-19 season. We seek additional information and comments on this supplemental proposed rule.

    New proposals and modifications to previously described proposals are discussed below. Wherever possible, they are discussed under headings corresponding to the numbered items identified in the August 3, 2017, proposed rule (82 FR 36308). Only those categories requiring attention or for which we received Flyway Council recommendations are discussed below.

    1. Ducks

    Duck harvest management categories are: (A) General Harvest Strategy; (B) Regulatory Alternatives, including specification of framework dates, season length, and bag limits; (C) Zones and Split Seasons; and (D) Special Seasons/Species Management.

    A. General Harvest Strategy

    Council Recommendations: The Mississippi Flyway Council recommended that regulation changes be restricted to one step per year, both when restricting as well as liberalizing hunting regulations.

    Service Response: As we stated in the August 3, 2017, proposed rule (82 FR 36308), we intend to continue use of Adaptive Harvest Management (AHM) to help determine appropriate duck-hunting regulations for the 2018-19 season. AHM is a tool that permits sound resource decisions in the face of uncertain regulatory impacts, as well as providing a mechanism for reducing that uncertainty over time. The current AHM protocol is used to evaluate four alternative regulatory levels based on the population status of mallards and their breeding habitat (i.e., abundance of ponds). Special hunting restrictions are enacted for certain species, such as canvasbacks, black ducks, scaup, and pintails.

    Regarding the Mississippi Flyway Council recommendation to limit regulatory changes to one step per year, we recognize the longstanding interest by the Council to impose a one-step constraint on regulatory changes. We note that the Central and Mississippi Flyways have worked with Service staff during the past 3 years to revisit the AHM protocol for managing harvest of mid-continent mallards. This effort has included a discussion of appropriate management objectives, regulatory packages, and management of non-mallard stocks. These discussions are the appropriate venue to discuss what role, if any, a one-step constraint might play in management of waterfowl in the Central and Mississippi Flyways. Such discussions should include the potential impact of a one-step constraint on the frequency of when the liberal, moderate, and restrictive packages would be recommended. On a final note, while we recognize the Council's concern about potentially communicating a large regulatory change to hunters, we have concerns about the appropriateness of a one-step constraint in situations when the status of the waterfowl resource may warrant such a measure. We look forward to continued work with the Flyway Councils on this issue.

    B. Regulatory Alternatives

    Council Recommendations: The Mississippi and Central Flyway Councils recommended that regulatory alternatives for duck hunting seasons remain the same as those used in 2017-18. The Mississippi Flyway Council further recommended changing the framework closing date to January 31 during “moderate” and “liberal” seasons.

    Service Response: As we stated in final rules published last year (81 FR 17302, March 28, 2016) and earlier this year (82 FR 24786, May 30, 2017), we do not support the Council's recommendation to extend the duck season framework closing date to January 31 at this time. We note that the current framework opening and closing dates were developed through a cooperative effort between all four Flyway Councils and that framework dates are only one of several components that comprise the regulatory packages utilized in AHM. Regulatory packages also consider season length, daily bag limits, and shooting hours. The current regulatory packages in the Mississippi Flyway should remain unchanged until revisions to the AHM protocols have been completed. Those efforts will include examination of duck harvest management objectives, model updates, and revisions to regulatory packages, including framework dates. We prefer that the issue of framework dates and any other component of the regulatory packages be addressed through this cooperative process and would prefer a comprehensive approach to revising regulatory packages rather than making incremental changes.

    Thus, the regulatory alternatives proposed in the August 3, 2017, Federal Register (82 FR 36308) will be used for the 2018-19 hunting season (see accompanying table at the end of this document for specific information). In 2005, the AHM regulatory alternatives were modified to consist only of the maximum season lengths, framework dates, and bag limits for total ducks and mallards. Restrictions for certain species within these frameworks that are not covered by existing harvest strategies will be addressed in the proposed frameworks rule in early December 2017. For those species with specific harvest strategies (pintails, black ducks, and scaup), those strategies will again be used for the 2018-19 hunting season.

    D. Special Seasons/Species Management i. September Teal Seasons

    Council Recommendations: The Mississippi Flyway Council recommended that early teal seasons in Iowa, Michigan, and Wisconsin be made operational beginning with the 2018 season and remain operational thereafter. The frameworks would follow the teal harvest strategy, except that Iowa would retain the option of selecting an early September duck season in lieu of an early teal season. Iowa would choose between an early September duck season or early teal season beginning with the 2018-19 hunting season, and this decision will remain in effect under current frameworks. The Council also recommended that Kentucky and Tennessee be granted operational 4-day teal only seasons when 16-day teal seasons are offered for the 2018-19 season and beyond. If a 9-day teal season is offered, the Council recommends that both States would revert to their original 5-day wood duck and teal seasons. The Kentucky and Tennessee seasons would follow the existing teal harvest strategy.

    16. Doves

    Council Recommendations: The Atlantic and Mississippi Flyway Councils recommended that the framework closing date for mourning doves in the Eastern Management Unit (EMU) be moved from January 15 to January 31 for the 2018-19 hunting season, and that the National Mourning Dove Harvest Strategy be revised accordingly. The Central and Mississippi Flyway Councils recommended that the National Mourning Dove Harvest Strategy be revised to allow a fixed opening framework date of September 14 for the Texas South Dove Zone.

    Service Response: We agree with the Atlantic and Mississippi Flyway Councils' recommendation to extend the EMU's framework closing date to January 31. A review of the available data on mourning dove nesting phenology in the EMU indicated that <1 percent of all mourning dove nest initiations detected occurred in January; thus, the impacts on mourning dove reproduction will be minimal. Furthermore, the maximum additional harvest expected as a result of this action is negligible in relation to the number of mourning doves in the EMU (<0.2 percent of the fall population). Therefore, we do not expect that this action will result in significant impacts to the EMU mourning dove population. However, we also note that nesting phenology may have changed in some areas since the studies cited in the EMU recommendation were conducted and may continue to change in the future. Thus, framework dates later than January 31 should not be considered without new studies that document contemporary nesting phenology throughout the EMU, which would allow assessment of the impact of a later closing date on mourning dove productivity.

    Regarding the Central and Mississippi Flyway Councils' recommendation, we supported a change in the opening date to September 14 for the Texas South Dove Zone (82 FR 24794, May 30, 2017). However, we noted that the National Dove Harvest Strategy used to guide dove harvest management had language that did not allow the earlier date, and would need to be revised. Therefore, we delayed implementation of the earlier opening date until the 2018-19 season. We support the recommendations and the change made to the Harvest Strategy, which will allow the earlier framework date in the Texas South Dove Zone for the 2018-19 season.

    Public Comments

    The Department of the Interior's policy is, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, we invite interested persons to submit written comments, suggestions, or recommendations regarding the proposed regulations. Before promulgation of final migratory game bird hunting regulations, we will take into consideration all comments we receive. Such comments, and any additional information we receive, may lead to final regulations that differ from these proposals.

    You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES. We will not accept comments sent by email or fax or to an address not listed in ADDRESSES. Finally, we will not consider hand-delivered comments that we do not receive, or mailed comments that are not postmarked, by the date specified in DATES. We will post all comments in their entirety—including your personal identifying information—on http://www.regulations.gov. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Division of Migratory Bird Management, 5275 Leesburg Pike, Falls Church, VA.

    We will consider, but possibly may not respond in detail to, each comment. As in the past, we will summarize all comments we receive during the comment period and respond to them after the closing date in any final rules.

    Required Determinations

    Based on our most current data, we are affirming our required determinations made in the August 3, 2017, proposed rule (82 FR 36308); see that document for descriptions of our actions to ensure compliance with the following statutes and Executive Orders:

    • National Environmental Policy Act;

    • Endangered Species Act;

    • Regulatory Flexibility Act;

    • Small Business Regulatory Enforcement Fairness Act;

    • Paperwork Reduction Act;

    • Unfunded Mandates Reform Act; and

    • Executive Orders 12630, 12866, 12988, 13132, 13175, 13211, 13563, and 13771.

    List of Subjects in 50 CFR Part 20

    Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.

    Authority

    The rules that eventually will be promulgated for the 2018-19 hunting season are authorized under 16 U.S.C. 703-711, 16 U.S.C. 712, and 16 U.S.C. 742 a-j.

    Dated: September 21, 2017. Todd D. Willens, Acting Assistant Secretary for Fish and Wildlife and Parks. BILLING CODE 4333-15-P EP03OC17.000
    [FR Doc. 2017-21195 Filed 10-2-17; 8:45 a.m.] BILLING CODE 4333-15-C
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Parts 300 and 679 [Docket No. 161222999-7884-01] RIN 0648-BG57 Fisheries of the Exclusive Economic Zone Off Alaska; Authorize Recreational Quota Entity To Participate in the Halibut IFQ Program AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS issues a proposed rule that would authorize formation of a recreational quota entity (RQE) that could participate in the Pacific Halibut and Sablefish Individual Fishing Quota Program in International Pacific Halibut Commission Regulatory Areas 2C and 3A in the Gulf of Alaska. The RQE would be authorized to purchase and hold a limited amount of commercial halibut quota share that would yield additional pounds of recreational fishing quota on an annual basis to augment the amount of halibut available for harvest in the charter halibut fishery. The RQE would provide a mechanism for a compensated reallocation of a portion of commercial halibut quota share to the charter halibut fishery. This proposed rule is necessary to promote social and economic flexibility in the charter halibut fishery, and is intended to promote the goals and objectives of the Northern Pacific Halibut Act of 1982, and other applicable laws.

    DATES:

    Submit comments on or before November 17, 2017.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2016-0158, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0158, 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).

    Electronic copies of the Environmental Assessment, Regulatory Impact Review (RIR), and the Initial Regulatory Flexibility Analysis (IRFA) (collectively, Analysis) prepared for this action are available from www.regulations.gov or from the NMFS Alaska Region Web site at alaskafisheries.noaa.gov.

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted by mail to NMFS at the above address; by email to [email protected]; or by fax to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    Kurt Iverson, 907-586-7228, [email protected]

    SUPPLEMENTARY INFORMATION:

    Authority for Action

    The International Pacific Halibut Commission (IPHC) and NMFS manage fishing for Pacific halibut (Hippoglossus stenolepis) through regulations established under authority of the Northern Pacific Halibut Act of 1982 (Halibut Act). The IPHC adopts regulations governing the Pacific halibut (halibut) fishery under the Convention between the United States and Canada for the Preservation of the Halibut Fishery of the North Pacific Ocean and Bering Sea (Convention), signed at Ottawa, Ontario, on March 2, 1953, as amended by a Protocol Amending the Convention (signed at Washington, DC, on March 29, 1979). For the United States, regulations developed by the IPHC are subject to acceptance by the Secretary of State with concurrence from the Secretary of Commerce. After acceptance by the Secretary of State and the Secretary of Commerce, NMFS publishes the IPHC regulations in the Federal Register as annual management measures pursuant to 50 CFR 300.62. The final rule implementing IPHC regulations for the 2017 fishing season was published March 7, 2017 (82 FR 12730). IPHC regulations affecting sport fishing for halibut and vessels in the charter fishery in IPHC Regulatory Areas 2C (Southeast Alaska) and Areas 3A (South Central Alaska) may be found in sections 3, 25, and 28 of that final rule (82 FR 12730, March 7, 2017).

    The Halibut Act, at sections 773c(a) and (b), provides the Secretary of Commerce with general responsibility to carry out the Convention and the Halibut Act. In adopting regulations that may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act, the Secretary of Commerce is directed to consult with the Secretary of the department in which the U.S. Coast Guard is operating, which is currently the Department of Homeland Security.

    The Halibut Act, at section 773c(c), also provides the North Pacific Fishery Management Council (Council) with authority to develop regulations, including limited access regulations, that are in addition to, and not in conflict with, approved IPHC regulations. Regulations developed by the Council may be implemented by NMFS only after approval by the Secretary of Commerce. The Council has exercised this authority in the development of halibut fishery management measures, codified at 50 CFR parts 300.65, 300.66, and 300.67. The Council also developed the Individual Fishing Quota (IFQ) Program for the commercial halibut and sablefish fisheries, codified at 50 CFR part 679. Management of halibut in the IFQ Program is authorized under section 773 of the Halibut Act.

    Management of the Halibut Fishery Description of the Action Area

    This proposed action would change halibut fishery management in IPHC Regulatory Areas 2C and 3A. These regulatory areas are referred to as “IFQ Regulatory Areas” throughout the IFQ Program regulations at 50 CFR part 679 and as “Commission Regulatory Areas” throughout the halibut management regulations at 50 CFR parts 300.65, 300.66, and 300.67. These terms are synonymous with “IPHC Regulatory Areas” and may be used interchangeably throughout this document. This preamble uses the term “Area 2C” and “Area 3A” to refer to IPHC Regulatory Areas 2C and 3A, respectively. Additional information on the action area is provided in Section 2.3 of the Analysis.

    Background on the Halibut Fishery

    The harvest of halibut in Alaska occurs in three fisheries—the commercial, sport, and subsistence fisheries. The commercial halibut fishery is managed under the IFQ Program. The sport fishery includes unguided and guided anglers. Guided anglers are commonly called “charter” anglers because they fish from chartered vessels. Throughout this preamble, the term “charter fishery” is used to refer to the fishery prosecuted by guided anglers. The subsistence fishery provides an opportunity for rural residents and members of an Alaska Native tribe to retain halibut for personal use or customary trade. The following sections of the preamble summarize charter fishery management and aspects of the commercial IFQ fishery that are relevant for the proposed RQE Program.

    Charter Halibut Fishery

    Sport fishing activities for halibut in Areas 2C and 3A are subject to different regulations, depending on whether those activities are guided or unguided. Guided sport fishing (charter fishing) for halibut is subject to charter restrictions under Federal regulations that are generally more restrictive than the regulations for unguided anglers. Charter fishery regulations apply if a charter vessel guide is providing assistance, for compensation, to a person who is sport fishing, to take or attempt to take fish during any part of a charter vessel fishing trip. Unguided anglers typically use their own vessels and equipment, or they may rent a vessel and fish with no assistance from a guide.

    Over the years, the Council and NMFS have developed specific management programs for the charter fishery to achieve allocation and conservation objectives. The Council and NMFS have developed these management programs with the intent of maintaining stability and economic viability in the charter fishery by establishing: (1) Limits on the number of charter vessel operators; (2) allocations of halibut to the charter fishery that vary with abundance; and (3) a process for determining annual charter angler harvest restrictions to limit charter fishery harvest to the established allocations.

    The charter fisheries in Areas 2C and 3A are currently managed under the Charter Halibut Limited Access Program (CHLAP) and the Catch Sharing Plan (CSP). The CHLAP limits the number of operators in the charter fishery, while the CSP establishes annual allocations to the charter and commercial fisheries and describes a process for determining annual management measures to limit charter harvest to the allocations in each management area. The CHLAP and the CSP are summarized below and described in more detail in Section 4.4 of the Analysis.

    Historic and Current Management Measures for the Charter Fishery

    The CHLAP and CSP were developed in response to increasing harvests in the charter fisheries in Areas 2C and 3A over the past 20 years. Until 2003, charter and unguided anglers were managed under the same two-halibut daily bag limit in all IPHC Regulatory Areas in Alaska. Since 2003, charter management measures have become more restrictive in Areas 2C and 3A, where most charter fishing occurs, as NMFS and the IPHC have sought to limit charter harvests to specific harvest limits. In 2003, NMFS implemented a final rule to establish a guideline harvest level (GHL) that identified target harvest limits for the charter fishery in Areas 2C and 3A (68 FR 47256, August 8, 2003). After the GHL was implemented, NMFS and the IPHC implemented a variety of additional management measures in Areas 2C and 3A in an effort to constrain charter fishery harvests to the harvest limits established by the GHL. Section 4.4.2.2 of the Analysis describes historical catch limits, regulations, and harvest in the charter fisheries in Areas 2C and 3A.

    In Area 2C, charter anglers have only been allowed to harvest a bag limit of one halibut per person, per day since 2009. Implementation of a one-halibut daily bag limit was intended to keep charter fishery harvests to approximately the Area 2C GHL. In the years following implementation of the one-fish bag limit, additional restrictions were required to maintain harvest near the Area 2C GHL, including a prohibition on halibut harvest by charter captains and crew, limits on the maximum number of lines that could be deployed, maximum size limits, and beginning in 2012, a reverse slot limit that allows charter vessel anglers to retain halibut that are either below or above a specific size range. With the implementation of the CSP in 2014, charter fishery management became more restrictive in Area 2C to maintain charter fishery harvests within the Area 2C CSP allocations. In 2017, the charter fishery in Area 2C has a catch limit of 915,000 pounds and is managed under a one-fish daily bag limit with a reverse slot limit that allows retention of a halibut of 44 inches or less, or 80 inches or more, and a prohibition on the harvest of halibut by skippers or crew. Charter management measures for Area 2C are summarized in Table 4-10 of the Analysis.

    In Area 3A, a two-fish daily bag limit with no size limits was maintained until the CSP went into effect in 2014. Since 2014, the Area 3A charter fishery has continued to be managed under a two-fish daily bag limit, but management measures have become increasingly restrictive each year to maintain charter fishery harvests within the CSP allocation. In 2017, the charter fishery in Area 3A has a catch limit of 1,890,000 pounds and is managed under a two-fish daily bag limit with a 28-inch maximum size limit on one fish; a 4-fish annual limit for each charter fishery angler; closures to charter fishing on Wednesdays throughout the year; closures to charter fishing during three specific Tuesdays in the summer; a limit of only one charter trip per day per vessel (and per charter halibut permit); and a prohibition on the harvest of halibut by skippers or crew. Charter management measures for Area 3A are summarized in Table 4-11 of the Analysis.

    Charter Halibut Limited Access Program (CHLAP)

    NMFS implemented the CHLAP in January 2010 (75 FR 554, January 5, 2010). The CHLAP established Federal charter halibut permits (CHPs) that are required for operators in the charter halibut fishery in Areas 2C and 3A. NMFS determined the eligibility of applicants and issued CHPs in 2010. CHPs were required for participation in the charter halibut fishery beginning in 2011. NMFS implemented the CHLAP, based on recommendations by the Council, to meet allocation objectives in the charter halibut fishery. Specifically, this program provides stability in the fishery by limiting the number of charter vessels that may participate in Areas 2C and 3A. The CHLAP also issues a limited number of permits to non-profit corporations representing specified rural communities and to U.S. military morale programs for service members.

    Since implementation of the CHLAP, all vessel operators in Areas 2C and 3A with charter anglers on board must have an original, valid permit on board during every charter vessel fishing trip on which halibut are caught and retained. CHPs are endorsed for the appropriate IPHC Regulatory Area (Area 2C or Area 3A) and the maximum number of anglers that may catch and retain halibut on a charter vessel fishing trip, ranging from 4 to 38 anglers.

    Complete regulations for the CHLAP are published at §§ 300.65, 300.66, and 300.67. Additional details on the development and rationale for the CHLAP can be found in the proposed rule for the CHLAP (74 FR 18178, April 21, 2009).

    Catch Sharing Plan for IPHC Regulatory Areas 2C and 3A

    The CSP was implemented by NMFS in January 2014 (78 FR 75844, December 12, 2013). The CSP replaced the GHL that was in place from 2004 through 2013 for managing the charter fisheries in Areas 2C and 3A. The CSP establishes commercial IFQ and charter fishery allocations that vary proportionally with changing levels of annual halibut abundance and that are intended to balance the differing needs of the commercial IFQ and charter fisheries over a wide range of halibut abundance in Areas 2C and 3A. Under the CSP, the IPHC divides a combined catch limit for Areas 2C and 3A into separate annual catch limits for the commercial IFQ and charter halibut fisheries pursuant to the CSP's allocation formulas.

    The CCLs for Areas 2C and 3A are specified by the IPHC during an iterative process that takes place each year. In late November of each year, the IPHC begins the process of assessing the halibut resource, and provides a preliminary estimate of exploitable biomass of halibut. The exploitable biomass is the amount of halibut that could be available for harvest by commercial, sport, and subsistence fisheries. The IPHC determines the exploitable biomass using a combination of harvest data from the commercial, sport, and subsistence fisheries, and information collected during scientific surveys and sampling of halibut bycatch in other fisheries. The IPHC calculates the Total Constant Exploitation Yield (CEY), or the target level for total removals (in net pounds) for each IPHC regulatory area, by multiplying the estimate of exploitable biomass by the harvest rate specified for that IPHC regulatory area. For Areas 2C and 3A, the IPHC subtracts estimates of other removals from the Total CEY. Other removals include unguided sport harvest, subsistence harvest, and bycatch of halibut in non-target commercial fisheries. In Areas 2C and 3A, the remaining CEY, after other removals are subtracted, is the Fishery CEY. For Areas 2C and 3A, the Fishery CEY is equal to the annual combined catch limit for the commercial IFQ fishery and the charter fishery. This process is depicted in Figure 4-1 of the Analysis.

    A fixed percentage of the annual CCLs for Area 2C and 3A is allocated to the commercial IFQ and charter fisheries (for additional detail see Figures 4-3 and 4-4 in the Analysis). The fixed percentage allocation to each fishery varies with halibut abundance and differs between Areas 2C and 3A. Overall, the charter fishery's relative share of the CCL is higher when the CCL is lower, but lower when the CCL is higher. At current levels of abundance, the charter fishery is allocated approximately 18 percent of the CCLs for both Areas 2C and 3A, and the commercial IFQ fishery is allocated approximately 82 percent. The IPHC multiplies the CSP allocation percentages for Area 2C and 3A by the annual CCL in that area to calculate the commercial and charter halibut allocations in net pounds. Fishery-specific catch limits are calculated by deducting separate estimates of wastage (i.e., the mortality of discarded fish) from the commercial IFQ and charter fishery allocations (see Figure 4-1 of the Analysis). NMFS publishes the CCLs and associated allocations in the Federal Register as part of the IPHC annual management measures pursuant to 50 CFR 300.62. The process for determining commercial IFQ and charter catch limits under the CSP is described in more detail in Section 4.4.1.2.1 of the Analysis.

    Additional detail on the development and rationale for the CSP can be found in preamble for the CSP proposed rule (78 FR 39122, June 28, 2013), and in the final rule implementing the CSP (78 FR 75844, December 12, 2013).

    Process for Setting Annual Management Measures

    The CSP also describes a public process by which the Council develops recommendations to the IPHC for charter angler harvest restrictions (annual management measures) that are intended to limit harvest to the annual charter fishery catch limit in Areas 2C and 3A. The process for setting annual management measures is described in more detail in Section 4.4.1.2.2 of the Analysis. Key elements of the process are summarized below.

    Each year in October, the Council's Charter Halibut Management Committee (Charter Committee) reviews charter harvest in Areas 2C and 3A during the current year in relation to the charter catch limit. Staff from the Alaska Department of Fish and Game, Council, and NMFS provide an analysis to predict harvest for the upcoming year under a range of alternative management measures. Some of these measures may directly restrict the number or size of fish that may be retained (e.g., daily bag limits, trip limits, annual limits, and size limits). Some of these measures may indirectly restrict the number of halibut that may be retained (e.g., day of week closures, or prohibition on harvest by skipper and crew). After reviewing this analysis, the Charter Committee makes recommendations on possible management measures for Areas 2C and 3A to be analyzed for the coming year.

    In December of each year, the Council considers the recommendations of the Charter Committee, the analysis on projected charter harvests under a range of management measures, and any additional information. After considering public input, the Council selects management measures to recommend to the IPHC that are intended to keep charter harvest within the charter fishery allocation in Area 2C and Area 3A under a range of different CCLs that may be established by the IPHC.

    At its annual meeting in January of each year, the IPHC allocates the CCL for Area 2C and Area 3A between the commercial IFQ fishery and the charter fishery for that year based on the CSP regulations at 50 CFR 300.65. The IPHC takes into account Council recommendations, any additional information available to the IPHC, and input from the public and IPHC staff. After considering this information and other information on the abundance of the halibut resource in Areas 2C and 3A, the IPHC adopts CCLs for Areas 2C and 3A and charter halibut management measures designed to keep charter harvest in Area 2C and Area 3A within the catch limits specified under the CSP for the adopted CCLs. Once accepted by the Secretary of State with the concurrence of the Secretary of Commerce, NMFS publishes in the Federal Register the charter halibut management measures for each area as part of the IPHC annual management measures.

    Guided Angler Fish Program

    In 2014, as part of the CSP, NMFS implemented the Guided Angler Fish (GAF) Program to authorize limited annual transfers of commercial halibut IFQ as GAF to qualified CHP holders. The GAF Program provides additional harvest opportunities for charter anglers. Using GAF, qualified CHP holders may offer charter anglers the opportunity to retain halibut up to the limit for unguided anglers when charter management measures limit charter anglers to a more restrictive harvest limit. For example, if charter management regulations in Area 2C restrict charter anglers to a one-halibut daily bag limit, a charter angler could retain one halibut and use one GAF to retain a second halibut, bringing the retained amount to two halibut—the same daily bag limit that applies to unguided anglers. The GAF Program is described in more detail in Section 4.4.1.2.4 of the Analysis and in the proposed rule for the CSP (78 FR 39122, June 28, 2013). Regulations implementing the GAF Program are at §§ 300.65, 679.5, 679.41, 679.42, and 679.45. A brief summary of the key elements of the GAF Program is provided below.

    In order to receive GAF, an IFQ holder and a CHP holder receiving GAF must submit an application to NMFS for review and approval. Guided Angler Fish transfers may be between separate IFQ and CHP holders, or a person holding both IFQ and a CHP can transfer their IFQ to himself or herself as GAF. Upon approval of the transfer application, NMFS issues a GAF permit to the holder of the CHP. Once the transfer is approved, the GAF permit holder may offer additional GAF harvest opportunities to anglers on board the vessel on which the operator's GAF permit and the assigned CHP are used.

    NMFS issues GAF in whole numbers of halibut based on a conversion factor from IFQ pounds. Conversion factors are based on the average net weights of GAF harvested in the applicable IPHC Regulatory Area (Area 2C or 3A) during the previous year. Average weights are determined from data that charter vessel guides report directly to NMFS. For 2017, 74 pounds of IFQ yields one GAF in Area 2C, and 42 pounds of IFQ yields one GAF in Area 3A. Based on self-reported data, CHP holders have paid more than $5 per pound of IFQ transferred as GAF in Area 2C and 3A, making GAF quite expensive, especially in Area 2C (see Section 4.4.2.3 in the Analysis for additional detail). In part due to the high costs of leasing GAF, annual participation has been low, averaging about 48,000 pounds per year from 2014 through 2016.

    Three restrictions on GAF transfers were implemented with the GAF Program. First, IFQ holders in Area 2C are limited to transferring up to 1,500 pounds or 10 percent, whichever is greater, of their initially-issued annual halibut IFQ for use as GAF. In Area 3A, IFQ holders may transfer up to 1,500 pounds or 15 percent, whichever is greater, of their initially-issued annual halibut IFQ for use as GAF. Second, no more than 400 GAF will be assigned during one year to a GAF permit assigned to a holder of a CHP that is endorsed for six or fewer anglers. Third, no more than a total of 600 GAF will be assigned during one year to a GAF permit assigned to a holder of a CHP endorsed for more than six anglers. The restrictions on transfers of GAF are intended to prevent a particular individual, corporation, or other entity from acquiring an excessive share of halibut fishing privileges as GAF.

    NMFS' costs associated with management, data collection, and enforcement of the GAF Program are recoverable through IFQ Program Cost Recovery fees. The IFQ permit holder is responsible for paying IFQ Program Cost Recovery fees on all pounds of IFQ landed as GAF. The fee calculation is based on the standard price calculated by NMFS, aggregated to IPHC Regulatory Area 2C or 3A.

    Commercial Individual Fishing Quota (IFQ) Fishery

    The commercial halibut and sablefish fisheries off Alaska are managed under the IFQ Program (November 9, 1993; 58 FR 59375). The IFQ Program was implemented in 1995. The commercial halibut fishery is also referred to as the “directed halibut fishery.” The IFQ Program limits access to the commercial directed halibut fishery to those persons holding halibut quota share (QS) in specific management areas. A more detailed description of QS allocation and management is provided in Section 4.5.1 of the Analysis and summarized here.

    The IFQ Program assigned QS by IPHC Regulatory Area based on certain thresholds of historical participation in the commercial halibut fishery. NMFS initially issued QS to qualified participants beginning in 1994. Once QS was issued, NMFS allows QS to be transferred from initial recipients to individuals meeting specific eligibility requirements. The GAF Program does not authorize the transfer of QS from the commercial IFQ fishery for use in the charter fishery. QS provides individual harvesting privileges that are allocated on an annual basis through the issuance of IFQ permits.

    An annual IFQ permit authorizes the holder to harvest a specified amount of halibut in a designated IPHC Regulatory Area. The specific amount of IFQ (in net pounds) is determined by the number of QS units held, the total number of QS units issued in a specific IPHC Regulatory Area, and the total amount of the halibut catch limit allocated by the IPHC in a particular year. If the abundance of halibut decreases over time, the catch limit will decrease and, subsequently, the number of pounds on a person's annual IFQ permit also will decrease. By providing an exclusive privilege to harvest a certain amount of the catch limit at the beginning of the season, and by extending the season over a longer period, the IFQ Program allows QS holders to determine where and when to fish, how much gear to deploy, and how much overall investment to make in harvesting.

    The Council and NMFS developed the IFQ Program with several goals in mind. Particularly applicable to this proposed action, the IFQ Program was designed to preserve an owner-operated fleet and to limit consolidation of QS ownership. To accomplish these goals, the IFQ Program was designed to control transferability of QS through: (1) Limits on the amount of QS that can be owned or controlled by individuals and companies (QS transfer and use caps); (2) vessel size categories that limit the size of vessels that can use the annual allocations resulting from the QS; (3) restrictions on who can purchase catcher vessel QS; and (4) limitations on leasing certain categories of QS.

    Halibut QS is designated as one of four QS categories (also called “vessel categories” or “size categories” of QS). The term “vessel class” is also sometimes used, but the term “category” will be used in this preamble to be consistent with the term used in regulation. These categories include A-category for freezer catcher-processor vessels; B-category for vessels greater than 60 ft length overall (LOA); C-category for vessels 36 ft to 60 ft LOA; and D-category for vessels 35 ft or less LOA. The term “catcher vessel QS” refers to QS that can be used to catch, but cannot be used to process, halibut at sea (i.e., B-, C-, and D-category QS). Halibut QS also has a designation of “blocked” or “unblocked.” Blocked QS must be sold as a unit, and cannot be separated. No person may hold more than three blocks of halibut QS in any IFQ regulatory area. The purpose of the QS block provision was to ensure that the smallest, most affordable QS would remain available to a part-time fleet of smaller operators in order to maintain some of the fleet diversity that existed prior to the IFQ Program's implementation, and to reduce potential disruption to isolated Alaska fishing communities. The preamble to the proposed rule for the IFQ Program, published on December 3, 1992 (57 FR 57130), describes the IFQ Program in more detail.

    Community Quota Entity Program

    After implementation of the IFQ Program, the total amount of QS held by residents of small, coastal communities and the number of IFQ holders substantially declined. To alleviate the social and economic impacts of this consolidation on rural communities, the Council revised the IFQ Program in 2004 to allow a distinct set of remote coastal communities with few economic alternatives to purchase and hold catcher vessel QS in Areas 2C, 3A, and 3B (69 FR 23681, April 30, 2004). This action was implemented in order to help ensure access to and sustain participation in the commercial halibut and sablefish fisheries. Eligible communities can form non-profit corporations called Community Quota Entities (CQEs) to purchase catcher vessel QS. The IFQ resulting from the QS must be leased (i.e., made available for fishing) to community residents annually.

    NMFS determined that CQE eligibility applied to 46 Alaskan communities, based on certain criteria for size, accessibility, and historical participation in the halibut or sablefish fisheries. Eligible communities must establish a non-profit corporation to become a CQE. The non-profit corporation must submit an application to NMFS detailing its organization, structure, and proposed procedures for leasing IFQ to community residents (among other requirements). If NMFS approves the application, a CQE may form to represent that community and the CQE may obtain QS by transfer. Currently, 28 communities have formed non-profit corporations and have applied for and been approved to obtain QS by transfer. Of those 28 CQEs, 4 have purchased QS. Community Quota Entities may also apply to NMFS to be able to participate in the CHLAP by purchasing CHPs, and are authorized to receive Community Charter Halibut Permits which is similar to a CHP, but available only to CQEs. To date, 20 CQEs have applied for and been issued Community Charter Halibut Permits. Although CQE's may also receive CHPs by purchasing (i.e., transferring) them from non-CQE permit holders, no CQE has received any CHPs by transfer to date.

    Although CQEs are subject to different constraints than individual QS holders in the IFQ Program, in some cases, the CQE is subject to the same limitations as individual permit holders in the IFQ Program. For example, each CQE is held to the same QS use caps (i.e., ownership caps) as an individual holder. In other cases, the CQE is subject to less restrictive measures to provide for the differing purpose and use of the QS when held by communities. For example, the vessel size categories do not apply to QS when held by CQEs. In yet other cases, the CQE is subject to more restrictive measures than individuals, in part to protect existing holders and preserve entry-level opportunities for fishermen residing in fishery-dependent communities that are not are not eligible to form a CQE. For example, CQEs cannot purchase D-category halibut QS in Area 2C. In addition, there are caps on the amount of QS that all CQEs combined can purchase, and CQEs cannot lease more than 50,000 pounds of halibut IFQ to an individual resident. A detailed list of provisions specifically applicable to CQEs is provided in Section 4.5.2 of the Analysis.

    Purpose and Need for Proposed Rule

    Currently, the charter fishery is limited to harvesting its percentage of the Area 2C or 3A combined catch limit it is allocated under the CSP. Charter catch limits increase or decrease as total halibut abundance increases or decreases. When halibut abundance is relatively low, as it has been in recent years compared to abundance trends in the 1990s and 2000s, the charter allocations under the CSP are lower, resulting in more restrictive annual management measures.

    The only way that charter operators can currently provide more opportunity to charter clients than the established management measures allow for in their area is through participation in the GAF Program by individual charter operators. Because of the current restrictions on charter harvests under the existing charter allocations under the CSP and the limited flexibility for charter operators to provide additional harvest opportunities to their clients, the charter fishery has expressed its desire to find a market-based mechanism to increase its overall allocation of the halibut resource.

    Based on these concerns, in 2015, the Council initiated the analytic process to develop a “market-based mechanism” to allow a non-profit entity (similar to a CQE) to purchase and hold a limited amount of commercial halibut QS on behalf of charter anglers. The intent of the Council was to provide additional harvest opportunity and less restrictive annual harvest measures for charter anglers in times of low halibut abundance, while complying with total halibut removals under the catch limits established by the IPHC under the CSP. In initiating this effort, the Council sought to balance the objectives of participants in the charter fishery without undermining the goals of the IFQ Program or creating significant adverse impacts to other halibut sectors. A complete history of the development of this proposed action is described in Section 2.2 of the Analysis.

    Proposed Recreational Quota Entity for Area 2C and Area 3A Overview

    In December 2016, the Council recommended the implementation of an RQE Program. This proposed RQE Program would provide a mechanism for the charter fishery to compensate the commercial IFQ fishery for halibut QS purchased from the commercial sector to increase the charter annual catch limits. The halibut RFQ that would result from that QS would provide potentially greater harvest opportunities to the clients of charter operators within Areas 2C and 3A.

    The Council and NMFS considered a no-action alternative to maintain the status quo (no RQE Program) and an alternative to authorize an RQE Program. The Council and NMFS also considered a broad range of elements and options to determine: The number of RQEs that could form; the amount and type of QS that could be purchased and held by the RQE; the process for setting annual management measures; how the RQE Program should interact with the GAF and CQE Programs; how the RQE could use funds, the organizational structure of the RQE; and the appropriate reporting requirements for the RQE. The specific elements and options recommended by the Council and proposed by NMFS are described below. The entire suite of elements and options considered, and the predicted effects of those elements and options (including the no-action alternative) are evaluated in detail in the Analysis.

    The Council stated that the principal objective of this proposed rule is to promote social and economic flexibility in the charter fishery by authorizing the development of an entity that would be eligible to purchase and hold commercial halibut QS in Areas 2C and 3A, thereby providing additional harvest opportunities to charter anglers. This proposed rule is intended to promote long-term efficiency in the use of the halibut resource by allowing transfers of QS between commercial QS holders and the charter fishery, through an RQE, under a “willing buyer and willing seller” approach.

    Description of Proposed Rule

    This proposed rule would allow an RQE to be established as an eligible entity to purchase halibut QS in Area 2C and Area 3A, with limitations, for use by the charter fishery as a whole. Using a structure similar to a CQE, the RQE would be an eligible participant in the IFQ Program and could purchase Area 2C and 3A halibut QS for use by all charter halibut anglers in the respective area. Any halibut QS purchased by the RQE would be held by this entity for the common use of charter halibut anglers. If approved, Federal regulations would be amended to allow the RQE to acquire QS.

    Halibut QS held by the RQE would generate annual pounds of recreational fishing quota (RFQ), a type of annual harvest privilege similar to IFQ that would have special requirements that pertain only to the RQE. RFQ would be calculated in the same manner as IFQ. Under this proposed rule, the specific amount of RFQ (in net pounds) would be determined by the number of QS units held by the RQE as of October 1 of the preceding calendar year, the total number of halibut QS units issued in Area 2C or 3A as of January 15 of the year the IFQ or RFQ is issued, and the total amount of halibut allocated to the commercial IFQ fisheries in Areas 2C and 3A for that year.

    Although the amount of RFQ would be calculated in the same way as IFQ, it would be subject to different requirements. The additional pounds of RFQ for each regulatory area would be combined with the charter catch limit determined under the CSP to calculate an adjusted charter catch limit for the year for Area 2C or 3A. Annual charter management measures for Areas 2C and 3A would be analyzed, recommended to the IPHC, and adopted for implementation based on the estimated adjusted charter catch limits. Recreational Fishing Quota held by the RQE would be available for harvest by all charter anglers aboard registered charter vessels of any size, regardless of the QS category from which that RFQ originated. Under this proposed rule, RFQ could not be transferred as GAF. Unless specified in this proposed rule, regulations that refer only to IFQ permit holders would not apply to the RQE. Likewise, unless specified in this proposed rule, regulations that refer only to IFQ would not apply to RFQ.

    This proposed rule would not change the underlying allocations to the commercial IFQ fishery and charter fishery specified in the CSP, and would not change the total QS pool. Therefore, the QS holders in the commercial IFQ fishery who do not transfer QS to the RQE would receive the same amount of IFQ pounds issued for their QS units regardless of the amount of QS transferred to, and held by, the RQE.

    Provisions of Proposed Rule RQE Organizational Structure

    The Council recommends and NMFS proposes to allow the establishment of an RQE as a qualified non‐profit entity registered under the laws of the State of Alaska and recognized as exempt from Federal income tax by the Internal Revenue Service (IRS) to purchase and hold halibut QS for use by the charter fishery. The QS held by an RQE could yield RFQ annually. This proposed rule would allow a single non-profit entity to form to represent and manage separate QS holdings for Areas 2C and 3A.

    The Council and NMFS considered an option to allow formation of two RQEs, one to represent Area 2C and another in Area 3A, but ultimately decided that one RQE would provide administrative efficiencies for purchasing and managing commercial QS. The Council and NMFS initially considered allowing multiple RQEs within Area 2C and 3A, but recommended against that structure to avoid potential competition against each other to purchase QS, and to reduce potential administrative costs.

    The structure of the RQE is proposed to be similar to non-profits established to hold QS under the CQE Program. The Council recommended and NMFS proposes that the RQE be a non-profit entity to help ensure it represents the interests of the charter operators, whereas a for-profit entity could result in increased costs. The Council has consistently recommended, and NMFS has consistently approved the use of non-profit entities for the purposes of holding QS in other limited access programs. The proposed RQE organizational structure is consistent with past practice. Also, a non-profit entity that is independent of the Federal or state governments could more quickly and more flexibly take advantage of favorable market conditions for purchasing QS than a program administered by the Federal or state governments. More information on the structure of the proposed RQE is provided in section 4.8.1.1 of the Analysis.

    NMFS proposes new definitions in § 679.2 for “Recreational fishing quota (RFQ)” and “Recreational quota entity (RQE).”

    Eligibility

    The Council recommended establishment of a single RQE that is a qualified non-profit entity registered with the IRS to purchase and hold commercial halibut QS for use by the guided halibut sector.” To implement this recommendation, NMFS proposes requirements specifying that the RQE must be a qualified non-profit entity registered under the laws of the State of Alaska and recognized as exempt from Federal income tax by the IRS. Non-profit status is a state law concept and does not directly apply to Federal tax law. A non-profit organization may be eligible for certain benefits, such as state sales, property and income tax exemptions. Although most Federal tax-exempt organizations are non-profit organizations, being recognized as a non-profit organization at the state level does not automatically grant the organization exemption from Federal income tax. To qualify as exempt from Federal income tax, an organization must seek recognition of exemption from Federal income tax under section 501(a) of the Internal Revenue Code.

    This proposed rule would establish specific requirements for an entity to be authorized as the RQE. To be approved as the entity eligible to purchase and hold halibut QS, the applicant wishing to become the RQE would be required to demonstrate it is a non-profit entity registered under the laws of the State of Alaska by submitting to NMFS the articles of incorporation and management organization information, including bylaws and a list of key personnel including, but not limited to, the board of directors, officers, representatives, and managers.

    Articles of incorporation are public documents that must be filed with the state agency where the corporation becomes incorporated (e.g., with Alaska's Division of Corporations, Business, and Professional Licensing). NMFS proposes that the RQE would need to be incorporated within the State of Alaska consistent with incorporation requirements applicable to CQEs. Bylaws are private documents describing the organization's operating procedures that are not filed with any government agency. The Council and NMFS chose to not specify how the board of directors of the RQE should be structured. The Council and NMFS considered options to require a certain number of board members representing different user groups, but ultimately decided that these decisions were best left to the RQE (see Section 4.8.1.6 of the Analysis). The Council intends that the RQE board should have the flexibility to tailor its composition in a way that best addresses the RQE's needs. The Council noted that a representative of the Alaska Department of Revenue may sit as an ex‐officio (non-voting) member of the RQE board, and the Commissioner of the Alaska Department of Fish and Game, or their designee, may sit as a voting member of the RQE board; however, the Council did not intend be prescriptive with respect to RQE board membership. The Council intended for the RQE to determine whether these officials would be a member of the RQE board. For example, if funding for the RQE is provided or administered by the State of Alaska, then a board member from the Alaska Department of Revenue might be beneficial; however, the Council intended for this determination to be at the discretion of the RQE. Because the Council intended for the RQE to have flexibility to select members of the RQE board, NMFS does not propose to specify the composition of the RQE board in regulation.

    In addition to demonstrating it is a non-profit corporation recognized by the State of Alaska, the applicant wishing to become the RQE would be required to demonstrate it has been granted an exemption from Federal income tax by the IRS by submitting to NMFS the IRS acknowledgement of the entity's Federal tax exemption.

    NMFS proposes to require the approved RQE to maintain its non-profit and tax-exempt status, as described above. If the approved RQE entity does not meet this requirement, NMFS would not issue the RFQ that would otherwise be issued to the RQE based on its QS holdings. In addition, NMFS would provide the approved RQE entity with an opportunity to reinstate its non-profit and/or tax-exempt status. If the approved RQE entity does not demonstrate to NMFS that it is a qualified non‐profit entity registered under the laws of the State of Alaska and recognized as exempt from federal income tax by the IRS by the established deadline, NMFS would issue an Initial Administrative Determination (IAD) to revoke the entity's status as the approved RQE and to require the entity to divest its QS holdings. The entity would have the opportunity to appeal the IAD through the National Appeals Office under the provisions established at 15 CFR part 906. The application and procedures for approving the application to become an RQE would be modeled after the application and process for CQEs. The applicant would complete the “Application for a Non-profit Corporation to be Designated as a Recreational Quota Entity (RQE)” and submit it to NMFS Alaska Region for review and approval. The application form would be available on the NMFS Alaska Region Web site at https://alaskafisheries.noaa.gov/ after the effective date of the final rule, assuming a final rule is published. NMFS would approve the first complete RQE application it receives. NMFS would notify the RQE when its application has been approved. Once approved, NMFS would establish an account for QS and RFQ holdings when the RQE acquires QS. If NMFS disapproves the application, that determination could be appealed to the NOAA Fisheries National Appeals Office under the provisions established at 15 CFR part 906.

    NMFS proposes adding a new paragraph § 679.41(n) to describe the application process and eligibility requirements for a prospective RQE.

    Restrictions on Transfers

    Under this proposed RQE Program, two-way transfers of QS would be allowed. Quota share acquired by the RQE could be transferred to an otherwise eligible participant in the commercial IFQ fishery. Because QS and the resulting IFQ used in the commercial IFQ fishery is subject to vessel categories and block designations on initially-issued QS—unlike the QS and resulting RFQ used by the RQE, which is exempt from such categories and designations—NMFS will track QS units, IFQ pounds, and vessel category and block designations that apply to ensure that original categories and designations for the commercial IFQ fishery are maintained during the transfer process.

    The Council recommended and NMFS proposes two-way transfers because it is expected that there would be variability from year to year in the amount of QS the RQE would be interested in using as RFQ. For example, if halibut biomass increases, the RQE may hold QS that is not needed to yield RFQ to provide additional opportunities for participants in the charter fishery, and may decide to sell a portion of its QS to an eligible buyers in the commercial fishery sector.

    NMFS proposes modifying § 679.42 to describe the QS transfer process for RQEs.

    Annual Limit on Transfers to an RQE

    This proposed rule would establish area-specific annual limits on the amount of halibut QS that can transfer to an RQE. The intended effect of these transfer limits is to limit the amount of halibut QS that could be transferred from the commercial IFQ fishery and used as RFQ in the charter fishery each year, and to minimize any abrupt negative impacts that may occur to participants in the commercial IFQ fishery or to CQEs due to additional competition in the QS market that could occur with the entry of an RQE. Annual transfer limits would allow users in the commercial IFQ and charter fisheries time to adapt business plans and personal strategies to changes in the composition of the fisheries.

    The Council recommended and NMFS proposes an annual transfer limit equivalent to 1 percent of the commercial QS units in Area 2C based on the 2015 pool of all QS categories (59,477,396 units). Based on the 2015 QS pool, the RQE would be limited to receiving by transfer a maximum of 594,774 units of Area 2C QS in a year. Even if the QS pool changes in future years, this proposed rule would fix the annual transfer limit in Area 2C at 594,774 QS units. This will clearly define the limit for fishery participants and prevent a change in the limit if there are future changes in the Area 2C or 3A QS pools. For example, in 2017, the QS:IFQ ratio is 14.1209 QS units per pound of IFQ, and the annual transfer limit would be 42,120 pounds of IFQ for Area 2C.

    The Council recommended and NMFS proposes an annual transfer limit equivalent to 1.2 percent of the commercial QS pool in Area 3A based on the 2015 pool of all QS categories (184,893,008 units). For example, based on the 2015 QS pool, the RQE would be limited to receiving by transfer a maximum of 2,218,716 units of Area 3A QS in a year. Even if the QS pool changes in future years, this proposed rule would fix the annual transfer limit in Area 3A at 2,218,716 QS units. For example, in 2017, the QS:IFQ ratio is 23.8911QS units per pound of IFQ, and the annual transfer limit would be 92,868 pounds of IFQ for Area 3A.

    For both Area 2C and 3A, the Council and NMFS considered annual transfer limits between 0.5 and 5 percent and determined that 1 percent for Area 2C and 1.2 percent for Area 3A were the appropriate annual transfer limits because they would allow the RQE to reach the cumulative use limits on QS holding (discussed in the next section) in 10 years if the RQE purchased the maximum amount of QS in each area in each year after the RQE Program is implemented. The Council indicated that limiting annual transfers at these proposed limits and allowing the RQE to reach its maximum QS holdings over as few as 10 years would balance the desire to provide adequate additional harvest opportunity to charter anglers, while at the same time mitigating the potentially disruptive impacts on the QS market with the entry of the RQE. Therefore, the proposed annual limits are equal to 1/10 of the cumulative holdings limits. Annual transfer limits are discussed in further detail in Section 4.8.1.2.2 of the Analysis.

    NMFS proposes adding a new paragraph at § 679.42(f)(8) to describe the annual transfer limits on QS for RQEs.

    Limit on Total QS Holdings by the RQE

    The Council recommended and NMFS proposes a limit on the total amount of halibut QS that can be held by the RQE. This rule proposes that for Area 2C, the RQE could hold up to 10 percent of the 2015 commercial QS pool. This proportion would be calculated based on the entire QS pool, including categories and blocks of QS units that the RQE would be prohibited from purchasing (discussed in the next sections of this preamble). Ten percent of the 2015 commercial QS pool equates to 5,947,740 units.

    This rule proposes a limit on QS holdings for Area 3A of 12 percent of the 2015 entire commercial QS pool, including categories and blocks of QS units that the RQE would be prohibited from purchasing. Twelve percent of the 2015 commercial QS pool equates to 22,187,161 units.

    As described in the previous section for annual transfer limits for the RQE, this proposed rule would fix the limits on total QS holdings by the RQE in regulations so that they are clearly defined for fishery participants and will not fluctuate if there are future changes in the Area 2C or 3A QS pools.

    The Council and NMFS considered limits that ranged from 5 to 20 percent of the 2015 QS pools in each area. The Council recommended and NMFS proposes 10 percent and 12 percent limits in Areas 2C and 3A, respectively, to provide a balance between providing ample opportunity for additional harvest opportunity for the charter fishery, while seeking to alleviate potential adverse impacts to commercial halibut participants from increased competition in the QS market and higher QS prices that could occur if the RQE were provided a higher limit on QS holdings by the RQE. The limits on RQE holdings of QS are discussed in further detail in Section 4.8.1.2.3 of the Analysis.

    NMFS proposes adding a new paragraph at § 679.42(f)(8) to describe the QS holding limits for the RQE.

    Limit on GAF Transfers as RQE Holdings Increase

    As part of the RQE Program, the Council recommends and NMFS proposes to limit the total amount of GAF that could be used annually by CHP holders by limiting the amount of GAF that could be transferred to the charter fishery as RQE QS holdings increase.

    Under existing regulations, a significant amount of GAF could be transferred to CHP holders each year. For example, based on 2015 data, if all QS holders transferred the maximum allowable amounts of IFQ as GAF to eligible CHP holders, 49.1 percent of the Area 2C IFQ and 35.5 percent of the Area 3A could potentially be transferred as GAF. However, actual participation in the GAF Program has been relatively low. From 2014 through 2016, less than 1.25 percent of Area 2C IFQ, and less than 0.2 percent of Area 3A IFQ have been transferred as GAF in any year. Based on the cost to transfer IFQ as GAF noted earlier in this preamble, NMFS considers it very unlikely that participation in the GAF Program will increase substantially and approach the maximum allowable transfer limits. Notwithstanding that unlikelihood, the Council determined and NMFS agrees that limiting the amount of GAF that could be transferred to the charter fishery as RQE QS holdings increase appropriately balances the objective of establishing an RQE to further increase harvest opportunity in the charter fishery while minimizing the negative impacts that may result in the commercial IFQ fishery from transfers of QS.

    The Council recommended and NMFS proposes restricting GAF transfers so that in any year, the combined amount of RFQ and GAF transferred to CHP holders could not exceed a poundage equal to the maximum amount of pounds that could be issued as RFQ in Area 2C or 3A.

    The following two examples describe how NMFS would administer this provision in Area 2C. Under this proposed rule, in Area 2C the RQE may hold a maximum of 10 percent of the 2015 Area 2C QS pool (5,947,740 units). These two examples use the 2017 QS:IFQ ratio for Area 2C (14.1209 QS units per pound of IFQ), and the 2017 conversion factor for IFQ to GAF for Area 2C (74 pounds of IFQ to yield one GAF). The first example assumes the RQE held the maximum amount of QS units (5,947,740 units) in Area 2C. Under this example, the RQE would be issued 421,201 pounds of RFQ (5,947,740 QS units/14.1209 QS:IFQ = 421,201 pounds), and NMFS would not approve any transfers of GAF to CHP holders in Area 2C during that calendar year because the combined amount of RFQ and GAF transferred by CHP holders would exceed the cumulative limit for RFQ and GAF in Area 2C (421,201 pounds). The second example assumes the RQE held 50 percent of the RQE's Area 2C cumulative QS limit (i.e., 2,973,870 units). Under this example, the RQE would be issued 210,601 pounds of RFQ (2,973,870 QS units/14.1209 QS:IFQ = 210,601 pounds), and NMFS could approve GAF transfers to CHP holders equivalent to 210,601 pounds of IFQ, or 2,845 GAF (210,600 pounds/74 pounds of IFQ per GAF = 2,845 GAF) during that calendar year before the combined amount of RFQ and GAF transferred to CHP holders would exceed as the cumulative limit for RFQ and GAF in Area 2C (421,201 pounds). Under this second example, NMFS would approve GAF transfers for CHP holders until 2,845 GAF had been transferred to CHP holders in Area 2C. Once 2,845 GAF had been transferred to CHP holders in Area 2C, NMFS would disapprove all subsequent transfers of GAF in Area 2C for the remainder of the calendar year.

    The Council and NMFS considered options that would not have restricted transfers of GAF even if the RQE reached its cumulative use limit of QS. The Council recommended and NMFS proposes limiting the total amount of annual poundage that could be reallocated to the charter fishery as RFQ and GAF to the cumulative use limit on RQE holdings. This limit was chosen, as described in the previous section of the preamble, to balance the concerns of commercial fishery participants about the increased potential for reallocation to the charter fishery with the interests of charter operators to increase harvest opportunities. The limit on GAF transfers as RQE QS holdings increase is discussed in further detail in Section 4.8.1.2.4 of the Analysis.

    NMFS proposes adding a new paragraph at § 300.65(c)(5)(ii)(D)(1)(iv) to limit the transfer of IFQ to GAF as the RQE increases its holdings of QS.

    Vessel Category Restrictions

    The Council recommended and NMFS proposes limits on the amounts of QS the RQE could hold by vessel category in Areas 2C and 3A. The RQE would be limited to holding an amount equal to 10 percent of D-category QS and an amount equal to 10 percent of B-category QS, based on the 2015 QS pools, in Area 2C. Translated to QS units, this proposed rule would prohibit the RQE from holding more than 889,548 units of D-category QS, and more than 265,524 units of B-category QS in Area 2C (see Table 4-40 of the Analysis).

    Under this proposed rule, the RQE would be prohibited from purchasing or holding D-category QS in Area 3A. The RQE could purchase any amount, up to the annual transfer and cumulative use limits of A-, B-, and C-category QS in Area 3A.

    The Council and NMFS considered the current composition of the QS pools in Areas 2C and 3A, and the potential impact on specific QS categories when proposing these regulations. D-category QS cannot be fished on vessels greater than 35 ft LOA in Area 3A or 2C. Thus, the proposed limits on the RQE acquiring D-category shares is intended to maintain vessel size diversity in the commercial fleet. Additionally, the Council and NMFS noted that D-category QS tends to sell for a lower price and could therefore make it a desirable and accessible category of QS for the RQE to purchase (see Section 4.5 of the Analysis). Therefore, the limits are being proposed to reduce the potential for the RQE to obtain so much D-category QS as to impact the size diversity of the commercial IFQ fishery fleet by substantially reducing the amount of QS available for small vessels in the commercial fleet. The proposed limits on D-category QS purchases are also intended to protect the opportunity for new entrants in the commercial fishery because these participants often use vessels that are 35 ft LOA or less.

    In Area 2C, B- and C-category QS also provide entry-level opportunities. A total prohibition on acquisition of D-category QS in Area 2C could put market pressure on other parts of the Area 2C QS market that are important for entry and diversity. While C-category QS makes up about 79 percent of the total Area 2C QS pool, B-category QS represents a relatively small percentage (4.5 percent, as shown in Table 4-19 of the Analysis). Therefore, the Council recommended and NMFS proposes limiting RQE QS purchases in Area 2C to 10 percent of the B-category QS pool (based on the 2015 QS pool). Because restrictions on B-category QS transfers would limit the QS market opportunity for the RQE in Area 2C, the Council recommended and NMFS proposes some limited opportunity in the D-category market to relieve some of the potential market pressure on the remaining C-category QS (10 percent of the D-category QS pool in Area 2C). These provisions would ensure that most of the B- and D-category QS are used in the commercial IFQ fishery and are intended to balance entry-level opportunities and fleet diversity in the commercial IFQ fishery, with potential benefits to the charter fishery from transfers of QS to the RQE. The proposed vessel category restrictions are discussed in more detail in Section 4.8.1.2.5 of the Analysis.

    NMFS proposes adding a new paragraph at § 679.42(f)(8) describing RQE use limits for specific vessel categories of QS.

    Block Restrictions

    In addition to vessel category restrictions for the RQE, the Council recommended and NMFS proposes limits on the size of QS blocks that the RQE could purchase. The RQE would be prohibited from purchasing blocks of QS by category that equate to 1,500 pounds or less (based on 2015 pounds). For Area 2C, this means that the RQE could not purchase blocked QS of 24,250 units or less. For Area 3A, the RQE would be prohibited from purchasing blocked QS of 35,620 units or less. The Council recommended and NMFS proposes these prohibitions to ensure that small and more affordable blocks of QS remain available for purchase by new entrants and small businesses in the commercial IFQ fishery. The prohibition on the transfer of small blocks of QS will have limited impact on the total available market of QS that the RQE could purchase. Block restrictions are discussed in more detail in Section 4.8.1.3 of the Analysis.

    NMFS proposes to add a new paragraph at § 679.42(g)(1)(iii) to establish restrictions on the type and amount of blocked QS that the RQE can hold.

    Revisions for the Calculation of the Charter Catch Limit and Establishment of Annual Management Measures

    This proposed rule would also modify several regulations to facilitate the proper accounting of RFQ. This section describes the process that would be used annually to calculate the amount of RFQ and establish annual management measures.

    On October 1 of each year, the RQE's QS holdings would be used as the basis for estimating the number of RFQ pounds to add to the charter allocation under the CSP for the following calendar year. This estimated combined allocation would be used to recommend the charter fishery management measures for the following year. The process and timeline for setting annual management measures would remain unchanged. Once the IPHC annual management measures are approved, typically in late February or early March, NMFS would issue pounds of RFQ to the RQE based on the number of QS units held by the RQE on October 1 of the previous year to augment the charter catch limit established under the CSP. The Council recommended and NMFS proposes establishing October 1 as the date for determining how many QS units would yield RFQ so that the Council's Charter Committee and the Council would be able to estimate the pounds of RFQ that the RQE would receive in the following year and be able to factor that amount into its recommendations for charter management measures in the following year.

    The RFQ would not be issued to the RQE in the upcoming fishing year for any QS that the RQE received by transfer after October 1. If the RQE transfers QS that it holds on October 1 to a recipient in the commercial IFQ fishery after that date, NMFS would not issue IFQ to the commercial recipient for that QS in the following calendar year. This approach is similar to the method used in the commercial fishery to allow the transfer of QS but not the IFQ once that IFQ has been used. In this case, NMFS would consider that RFQ is effectively “used” if it is assigned to the charter allocation for the following calendar year. If the RQE receives QS by transfer after October 1, that QS would not result in the issuance of RFQ for the following calendar year. However, if the RQE subsequently transferred any QS received by transfer after October 1 that did not result in RFQ back to the commercial IFQ fishery, NMFS would issue IFQ to the commercial recipient for that QS.

    In late November of each year, NMFS would estimate the pounds of RFQ that the QS units held by the RQE on October 1 would yield in the upcoming year based on the current year's QS:IFQ ratio and the IPHC's preliminary estimate of the possible combined catch limits in Areas 2C and 3A.

    In December of each year, the Council would recommend a range of potential charter management measures for Areas 2C and 3A that would be expected to limit charter harvests in an area to the estimated charter catch limit plus the estimated supplemental pounds provided by the RFQ.

    NMFS proposes revising § 679.40(c)(2) to clarify that NMFS would use the QS pool for the IFQ regulatory area, including Areas 2C and 3A, on record with the Alaska Region, NMFS, on January 15 of that year for purposes of calculating the amount of IFQ and RFQ for that regulatory area for that year. This proposed revision to move the date of record from January 31 to January 15 of each year would ensure that the IPHC would be able to determine the amount of IFQ and RFQ and the total allocations that would be assigned to the commercial IFQ and charter fisheries, respectively, when it adopts annual management measures at its annual meeting in late January.

    NMFS also proposes revising § 300.65(c) to authorize the use of RFQ in the charter fishery, and to describe how and when QS holdings by the RQE would be calculated and added to the charter catch limit under the CSP.

    Redistribution of Excess RFQ

    The Council recommended and NMFS proposes a temporary redistribution of RFQ from the RQE to the commercial IFQ fishery if the RQE holdings of QS provide a charter harvest opportunity greater than the unguided recreational management measures in either Area 2C or 3A. The current management measure for unguided recreational anglers in both areas is a daily bag limit of two halibut of any size. Under this proposed rule, NMFS would not issue annual RFQ in excess of the adjusted charter catch limit (the sum of the annual guided sport catch limit under the CSP and RFQ from the RQE's QS holdings on October 1 of the previous year) needed for charter anglers to obtain the unguided recreational management measures for that area.

    The Council and the Analysis use the term “reallocate” to describe the temporary (1-year) redistribution of excess RFQ to the commercial IFQ fishery. NMFS notes that the term reallocate is often used in other regulations to describe a permanent transfer of harvest privileges from one group of participants to another. NMFS uses the term redistribute in this proposed rule to clarify for fishery participants and the public that the distribution of excess RFQ to commercial IFQ fishery participants is in effect for one year, and is not a permanent reallocation.

    The Council recommended and NMFS proposes the following process for the temporary redistribution of RFQ (as IFQ) to the commercial IFQ fishery, in the event that the RQE has QS holdings in excess of the amount needed to provide charter anglers with harvest opportunities equal to those for unguided recreational anglers. Each January, the IPHC will recommend charter fishery management measures for Areas 2C and 3A that are expected to limit charter harvest to the adjusted charter catch limit for each area (the sum of the annual guided sport catch limit under the CSP and the estimated amount of RFQ from the RQE's QS holdings on October 1 of the previous year).

    After the IPHC recommends charter fishery management measures, NMFS will determine if a redistribution of excess RFQ is necessary. If the IPHC has adopted charter fishery management measures that are equivalent to the unguided recreational management measures in either Area 2C or 3A (e.g., a daily bag limit of two halibut of any size), NMFS would determine the amount of RFQ that would be needed to account for charter harvest in Area 2C and Area 3A under the recommended management measures and issue that amount as RFQ to supplement the charter fishery allocation under the CSP. The difference between the total amount of available RFQ and the amount needed for the charter fishery would be excess RFQ. NMFS would redistribute the amount of excess RFQ using the process recommended by the Council.

    Under this proposed rule, 50 percent of any RFQ in excess of the amount needed to achieve the unguided recreational management measures in either Area 2C or 3A would be redistributed as IFQ to all catcher vessel QS holders in the applicable area (Area 2C or Area 3A) who held not more than 32,333 QS units in Area 2C, and 47,469 QS units in Area 3A (i.e., the amount of QS that yielded 2,000 pounds of IFQ in 2015) in the year prior to the redistribution, and who also held that QS eligible for redistribution during the year that the redistribution occurs. This 50 percent would be redistributed among qualified QS holders in proportion to their QS holdings.

    The Council's recommendation stated that 50 percent of excess RFQ should be redistributed “equally” to all qualified QS holders. During Council deliberations, NMFS staff and the Council clarified how NMFS would implement the Council's recommendation. NMFS proposes to implement this provision by dividing the amount of IFQ available for redistribution to qualified QS holders by the total amount of QS units held by all qualified QS holders. For example, if there were 50,000 pounds of excess RFQ to be redistributed as IFQ in Area 3A in calendar year 2025 among QS holders who held not more than 47,469 QS units in the year prior to the redistribution (2024), and in the year during which the redistribution occurs (2025), and the total sum of all QS held by those qualified QS holders was 500,000 units, then each of these qualified QS holders would receive an additional 1/10 of a pound of IFQ in 2025 for each QS unit held. NMFS does not issue IFQ in less than one pound increments, therefore NMFS would round the amount of redistributed IFQ to the nearest pound for each qualified QS holder. Section 4.8.1.3 of the Analysis provides additional information on the method NMFS would use to redistribute excess RFQ.

    This proposed rule would require the QS holder to hold the QS in the year prior to the redistribution to meet the clear intent of the Council, as well as in the year that the redistribution occurs in order to ensure the proper administration of this provision. NMFS proposes this requirement to ensure that IFQ is issued to persons who hold the underlying QS eligible to receive the redistribution. If NMFS were to redistribute RFQ as IFQ only to QS holders that held QS in the year prior to the redistribution, it is possible that a person could hold QS in the year prior to the redistribution, subsequently transfer that QS before NMFS issues IFQ for the following year, and receive IFQ from the redistribution even though that person does not hold QS. Issuing IFQ to persons who do not currently hold QS would be contrary to the current functioning of the IFQ Program (i.e., IFQ is issued to persons who hold QS).

    Under this proposed rule, the remaining 50 percent of RFQ in excess of the amount needed to achieve the unguided sport management measures in either Area 2C or 3A would be redistributed equally among all CQEs that held halibut QS in the applicable area (Area 2C or Area 3A) in the year prior to the redistribution as well as in the year that the redistribution occurs. If no CQE held QS in the applicable area (Area 2C or Area 3A) in the preceding year and in the year that the redistribution occurs, this 50 percent of the excess RFQ would not be redistributed in that area. In other words, the excess RFQ would be unfished or “left in the water” for conservation. The rationale for requiring the CQE to hold QS in the year prior to the redistribution, and in the year the redistribution occurs is the same as the rationale for the redistribution to catcher vessel QS holders described above. NMFS solicits comments from the public on whether excess RFQ should be redistributed to eligible catcher vessel QS holders and CQEs based on this proposed methodology.

    The Council and NMFS considered options that would not have required a redistribution of RFQ as only IFQ, and alternative methods to redistribute RFQ as IFQ. The Council recommended and NMFS proposes the reallocation procedures in this rule to provide additional harvest opportunity among holders of small amounts of QS as well as to CQEs who hold QS on behalf of coastal community residents. Section 4.8.1.4 of the Analysis describes the options considered by the Council and NMFS and notes that based on the current levels of halibut abundance and the cumulative use limits in Area 2C and 3A, it is unlikely that the RQE could hold an amount of QS that would result in the need for redistribution of excess RFQ.

    NMFS proposes to add regulations under § 679.40(c) to describe how excess RFQ would be redistributed.

    Cost Recovery Fees

    The Magnuson-Stevens Act at section 304(d)(2)(A) requires that cost recovery fees be collected for the costs directly related to the management, data collection, and enforcement of any limited access privilege programs. This includes programs such as the commercial halibut IFQ Program, under which a dedicated allocation is provided to IFQ permit holders. Fees owed are a percentage, not to exceed 3 percent, of the ex-vessel value of fish landed and debited from IFQ permits. Each year, NMFS sends fee statements to IFQ holders whose annual IFQ was landed; those holders must remit fees by January 31 of the following year. Under this proposed rule, the RQE would be responsible for all cost recovery fees on their annual RFQ.

    NMFS calculates IFQ cost recovery fee assessments in November each year. To determine cost recovery fees for IFQ holders, NMFS uses data reported by Registered Buyers to compute annual standard ex-vessel IFQ prices by month and port (or, if confidential, by port group). NMFS publishes these standard prices in the Federal Register each year. For example, NMFS published the 2016 standard ex-vessel IFQ prices in the Federal Register on December 13, 2016 (81 FR 89990). NMFS uses the standard prices to compute the total annual fishery value of the IFQ fisheries. NMFS determines the fee percentage by dividing management, data collection, and enforcement costs for the IFQ Program by total IFQ fishery value. In recent years, IFQ costs have exceeded 3 percent; therefore, the cost recovery fee percentage has been set at the maximum of 3 percent. Unlike commercial IFQ, which is only subject to cost recovery fees when landed, the RFQ held by the RQE would be considered “used” when issued, because management measures will be based on the combined amount of the RFQ and charter fishery catch limit in each regulatory area.

    In years when the RQE holds QS and the RFQ is issued to augment the charter fishery's catch limit, the charter fishery would be effectively using all of this RFQ; therefore, the RQE would pay cost recovery fees on all of its RFQ. Since all annual RFQ issued to the RQE would be considered “used,” NMFS would levy the fee calculated for the RQE's annual RFQ pounds that are issued, rather than estimating RFQ harvest at each point of charter landings. The fee would be calculated using the standard price calculated for Area 2C or 3A and the RFQ held by the RQE. This is similar to the method used to apply an ex-vessel value for GAF. The IFQ cost recovery fee could be levied on the RQE each year the RQE holds QS, and the resulting RFQ is issued to augment the catch limit in the charter fishery. All holdings acquired by the RQE on October 1 of the prior year would be subject to the IFQ cost recovery fee.

    For purposes of cost recovery, the RQE would pay fees on all resulting pounds of RFQ, even if the charter fishery's harvest was under its catch limit in Area 2C or 3A for that year. In December of each year, NMFS would (1) determine the standard prices and the cost recovery fee percentage; (2) announce the standard prices and the cost recovery fee percentage in the Federal Register; and (3) issue the RQE a fee assessment. The RFQ fee assessment would be based on the number of RFQ pounds added to either the Area 2C or 3A charter catch limit based on QS holdings as of October 1 of the prior year multiplied by the standard price for Area 2C or Area 3A, and multiplied by the cost recovery fee percentage (around 3 percent in recent years). The cost recovery fee payment from the RQE to NMFS would be due by January 31 of each year.

    Based on NMFS policy, only “incremental” costs, i.e., those incurred as a result of IFQ management, are assessable as cost recovery fees. The costs to develop the regulations, accounting, and reporting systems for the RQE Program would be considered incremental and extensions of the IFQ Program and would be recoverable under cost recovery. Agency costs related to development of the RQE Program will be included in the IFQ cost recovery fee assessment. Recently, the costs to administer the IFQ Program has been at or above the 3 percent cost recovery fee limit; therefore, additional costs due to the development of the RQE Program would likely not increase the cost recovery fee percentage for IFQ permit holders. Additional information about assessing cost recovery fees for an RQE is provided in Section 4.8.1.5.1 of the Analysis.

    NMFS proposes revising regulations throughout § 679.45 to incorporate the RQE into the IFQ Program cost recovery fee estimation and collection process.

    General Reporting

    Because all RFQ would be considered landed or used by the RQE in the year for which it is issued and the standard prices would be applied to pounds of RFQ, the RQE would not be required to complete the recordkeeping and reporting requirements described for the IFQ Program at § 679.5(1). The RQE would be exempt from submitting the IFQ Prior Notice of Landing, Product Transfer, IFQ Landing, IFQ Transshipment Authorization, and IFQ Departure reports.

    Annual Report

    The Council recommended and NMFS proposes that the RQE file an annual report with the Council by January 31 of each year that details the administrative activities and business operations of the RQE during the prior year for each year that it holds commercial QS. Although not specifically requested by the Council, NMFS proposes that the annual report also be submitted to NMFS for reasons described below.

    The RQE would be required to include the following general information in its annual report: (1) Any changes to the bylaws, board of directors, or other key management personnel of the RQE during the preceding year; (2) amounts and descriptions of annual administrative expenses; (3) amounts and descriptions of funds spent on conservation, research, and promotion of the halibut resource and a summary of the results; and (4) amounts and descriptions of all other expenses. Additionally, the RQE would be required to submit the following information by regulatory area: (1) The total amount of halibut QS by vessel category and block held by the RQE at the start of the calendar year, on October 1, and at the end of the calendar year; (2) a list of all transfers (purchases, sales, and any other transfers) of halibut QS, including transaction prices if applicable; and (3) the number of CHPs and associated angler endorsements purchased and held by the RQE.

    The Council did not specify what would happen if the RQE did not submit a timely and complete annual report. Section 679.41(c)(10)(ii) requires a CQE to submit a timely and complete annual report to NMFS before a transfer of QS will be approved or IFQ will be issued. NMFS proposes a similar requirement for the RQE at new paragraph § 679.41(c)(11)(i). If the RQE held QS in the previous year and has not submitted a timely and complete annual report by the January 31 deadline, NMFS would not approve a transfer of QS or issue RFQ until the report is submitted. To confirm receipt of the report, NMFS is proposing that the RQE submit the annual report to both the Council and NMFS. NMFS seeks public comment on whether these requirements, similar to those for CQEs, should apply to the RQE.

    NMFS proposes adding § 679.5(v) to include the RQE annual report requirements.

    Other Regulatory Changes

    NMFS proposes revisions throughout the IFQ regulations at 50 CFR part 679 that refer to “an IFQ permit holder” to also include the term “RQE” where applicable.

    NMFS proposes revisions throughout 50 CFR part 679 that refer to the IFQ permit that also pertain to the RQE to include the term “RFQ permit account.” NMFS proposes these revisions because the RQE would not be issued an IFQ fishing permit. Instead, NMFS proposes establishing an RFQ permit account for the RQE that would be used to administer RFQ as described in this proposed rule.

    NMFS also proposes revisions throughout 50 CFR part 679 that refer to IFQ to include the term “RFQ” when the regulations refer to IFQ and RFQ.

    These minor changes are shown in the proposed regulatory text.

    Appeals

    This proposed rule would change several references within §§ 679.41 and 679.45 that describe the former procedure for appealing an IAD to the NOAA Fisheries' Alaska Office of Administrative Appeals. Those procedures were described at to § 679.43. NOAA Fisheries has centralized the appeals process in the National Appeals Office, which operates out of NOAA Fisheries' headquarters in Silver Spring, MD. The National Appeals Office is now charged with processing appeals that were filed with the Office of Administrative Appeals, Alaska Region. The procedure for appealing an IAD through the National Appeals Office is at 15 CFR part 906 (79 FR 7056, February 6, 2014). This proposed rule would update the regulations referring to appeals procedures for the IFQ Program to refer to 15 CFR part 906 instead of to § 679.43.

    Council Intent Regarding the Functioning of the RQE

    During the development of the RQE Program, the Council and NMFS considered, but did not propose regulations that would address RQE funding, limits on the use of RQE funds, and the purchase of CHPs by the RQE. This section of the preamble provides the public with a description of the overall intent of the Council regarding RQE funding and limits on the use of RQE funds, and notes that NMFS would regulate the purchase of CHPs by the RQE consistent with existing regulations.

    RQE Funding

    The Council did not recommend and NMFS does not propose regulations that would define the specific type of incorporation (e.g., a 501(c)(3) non-profit corporation) for the RQE. Likewise, the Council did not recommend and NMFS does not propose regulations regarding the acquisition of funds the RQE may use to purchase QS. Section 4.8.1.1 of the Analysis describes the different types of non-profit structures that an RQE could use, and how those non-profits may use and receive funds.

    Limit on Use of RQE Funds

    The Council did not recommend and NMFS does not propose regulations regarding the use of funds obtained by the RQE. However, the Council did indicate how funds obtained by the RQE could be used to meet the objectives of the RQE Program. The Council indicated that it intended for the RQE to use funds primarily for the acquisition of commercial halibut QS; halibut conservation and research; promotion of the halibut resource; and administrative costs. NMFS notes that this proposed rule would require the RQE to submit an annual report describing its annual expenditures (described in a previous section of this preamble) to NMFS and the Council. Based on information received in this annual report, the Council could choose to initiate a subsequent action that would limit the use of funds held by the RQE in the future if the RQE's annual reports indicate that RQE funds are being used in a manner that is contrary to the Council's intent described above.

    Purchase of Charter Halibut Permits by an RQE (§ 300.67)

    The Council did not specify limits on the acquisition of CHPs by the RQE; therefore, the RQE would be subject to regulations that apply to any other person, as defined at § 300.61, for purposes of purchasing and holding CHPs. Section 300.67(j) states that a person may not own, hold, or control more than five CHPs, with limited exceptions. The RQE would be authorized to purchase and hold up to five transferable CHPs in both regulatory areas combined. Any purchases or sales of CHPs by the RQE would be required to be reported in the RQE's annual report to the Council and NMFS.

    Classification

    Regulations governing the U.S. fisheries for Pacific halibut are developed by the IPHC, the Pacific Fishery Management Council, the North Pacific Fishery Management Council, and the Secretary of Commerce. Section 5 of the Halibut Act (16 U.S.C. 773c) allows the Regional Council having authority for a particular geographical area to develop regulations governing fishing for halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The Halibut Act, at sections 773c(a) and (b), provides the Secretary of Commerce with the general responsibility to carry out the Convention with the authority to, in consultation with the Secretary of the department in which the U.S. Coast Guard is operating, adopt such regulations as may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act. This proposed rule is consistent with the Halibut Act and other applicable laws.

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

    Regulatory Impact Review (RIR)

    An RIR was prepared to assess all costs and benefits of available regulatory alternatives. The RIR considers all quantitative and qualitative measures. A copy of this analysis is available from NMFS (see ADDRESSES). The Council recommended and NMFS proposes this rule based on those measures that maximized net benefits to the Nation. Specific aspects of the economic analysis are discussed below in the Initial Regulatory Flexibility Analysis section.

    Initial Regulatory Flexibility Analysis

    An Initial Regulatory Flexibility Analysis (IRFA) was prepared for this action, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. The IRFA describes the action; the reasons why this action is proposed; the objectives and legal basis for this proposed rule; the number and description of directly regulated small entities to which this proposed rule would apply; the recordkeeping, reporting, and other compliance requirements of this proposed rule; and the relevant Federal rules that may duplicate, overlap, or conflict with this proposed rule. The IRFA also describes significant alternatives to this proposed rule that would accomplish the stated objectives of the Magnuson-Stevens Act, and any other applicable statutes, and that would minimize any significant economic impact of this proposed rule on small entities. The description of the proposed action, its purpose, and the legal basis are explained in the preamble and are not repeated here. A summary of the IRFA follows. A copy of the IRFA is available from NMFS (see ADDRESSES).

    The Small Business Administration (SBA) criteria for determining whether an entity is “small” for purposes of the RFA are discussed in more detail in Section 5.3 of the Analysis. The SBA has established a small business size standard for businesses, including their affiliates, whose primary industry is “finfish fishing” (see 50 CFR 200.2). Commercial halibut QS holders are considered finfish fishers under the RFA. A business primarily involved in finfish fishing (North American Industry Classification Systems code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual gross receipts not in excess of the applicable size standard for all its affiliated operations worldwide. On December 29, 2015, NMFS issued a final rule establishing the small business size standard of $11 million in annual gross receipts for all businesses in the commercial fishing industry (80 FR 81194). This new size standard applies to all businesses included under the North American Industry Classification Systems code 11411 for purposes of RFA compliance only. The new size standard became effective July 1, 2016, and was used to estimate the number of directly regulated small entities in this IRFA.

    For this proposed action, the pool of small, directly regulated entities would be limited to those entities that would be engaging in QS transfer (i.e., QS holders, including CQEs, and a future RQE). CQEs and the proposed RQE would be considered a small entity, or more specifically, a small organization as defined by the RFA. A small organization is “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” In addition, no CQE has more than $11 million in annual gross receipts. The RQE that is proposed under this action would not be expected to have $11 million in annual gross receipts because it does not currently hold halibut QS that would yield $11 million in annual gross receipts. Commercial halibut QS holders would also be considered directly regulated. Most of the QS holders in the halibut IFQ Program are small entities.

    Number and Description of Small Entities Regulated by This Proposed Rule

    NMFS considers commercial halibut fishing vessels as proxies for small entities because IFQ from more than one QS holder is often fished from the same vessel. NMFS estimates that 812 vessels across all IPHC regulatory areas landed halibut in 2014, the most recent year of complete data on the value of halibut landings by vessel. Of those, 11 vessels would be considered large entities because they showed revenues that exceeded the $11 million threshold. The remaining 801 vessels would be considered directly regulated small entities for this proposed rule. See Section 5.6 of the Analysis for more information.

    Description of Significant Alternatives That Minimize Adverse Impacts on Small Entities

    This proposed action is expected to have distributional impacts to the identified directly regulated small entities. Transfers of QS would be voluntary among all the small, directly regulated entities identified in the IRFA. The preferred alternative is the only alternative considered that would give current halibut QS holders an additional opportunity to transfer their QS and the RQE an opportunity to form and obtain QS. As noted earlier in this preamble, the Council and NMFS considered the status quo and the preferred alternative. However, under the preferred alternative, the Council and NMFS considered a wide range of potential limitations on the amount and type of QS that could be held by the RQE. The wide variation in the options considered under the preferred alternative provided the Council and NMFS with a broad range of potential policy choices to minimize the adverse impacts.

    Under the preferred alternative, the RQE representing the charter fishery would not be expected to participate in the IFQ Program (and purchase halibut QS) if it did not benefit the charter fishery as a whole. QS holders, including CQEs, would not be expected to engage in a QS transaction with the RQE if it did not benefit from that transfer. However, there is a potential for the RQE to affect the QS market by increasing competition in the market. This increased competition could limit the ability for persons in the commercial IFQ fishery to expand their QS holdings by increasing the market price of QS or limiting the amount of QS available to commercial QS holders and CQEs. This potential negative impact is considered in the Regulatory Impact Review (Section 4.8.2 of the Analysis). To mitigate the expected effects on the QS market, the Council recommended and NMFS proposes provisions to limit the amount and types of QS that could be acquired by the RQE, annually and cumulatively.

    Specifically, the Council's preferred alternative (and this proposed rule) would create an annual transfer limitation of 1 percent of the QS in Area 2C and an annual transfer limitation of 1.2 percent of the QS in Area 3A. Cumulative use limits for the charter fishery are proposed to limit the combined amount of commercial QS held by RQE and transferred under GAF (10 percent in Area 2C and 12 percent in Area 3A). Proposed transfer limits include prohibiting the RQE from purchasing D-category QS in Area 3A and limiting it to holding 10 percent of D-category QS in Area 2C, and restricting purchase of B-category QS to no more than 10 percent in Area 2C and 10 percent of B-category QS in Area 2C. Block restrictions would prohibit the RQE from purchasing small blocks of QS. This proposed rule would seek to derive the greatest net benefit for small regulated entities by increasing market opportunities in the charter fishery while ameliorating adverse impacts that could occur for QS holders and CQEs in the commercial IFQ fishery if QS holdings by the RQE were not limited. Overall, the net benefits to directly regulated small entities are expected to be positive.

    Duplicate, Overlapping, or Conflicting Federal Rules

    NMFS has not identified any duplication, overlap, or conflict between this proposed action and existing Federal rules.

    Recordkeeping, Reporting, and Other Compliance Requirements

    The RFA requires a description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record. This proposed rule would require new information collections from an RQE. Under this proposed rule, a non-profit entity that wants to become an RQE would need to complete an application and submit it to NMFS for approval. This application would require submission of the entity's articles of incorporation, the corporate by-laws, a list of key personnel, including the Board of Directors, officers, representatives, and managers. NMFS would approve the first complete RQE application it receives.

    If the RQE wants to receive or transfer halibut QS, it would need to use the “Application for Transfer QS To or From an RQE” available on the NMFS Alaska Region Web site at https://alaskafisheries.noaa.gov/. Additionally, the RQE would be required to submit an annual report detailing its activities to NMFS and the Council. The RQE would also be subject to cost recovery fees so it would need to comply with the existing cost recovery fee payment requirements for IFQ permit holders. These recordkeeping and reporting requirements are expected to be administrative in nature.

    Collection-of-Information Requirements

    This proposed rule contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). NMFS has submitted these requirements to OMB for approval under a temporary new information collection, to be merged after approval with OMB Control Number 0648-0272. Public reporting burden is estimated to average per response: 200 hours for Application for a Non-Profit Corporation to be Designated as a Recreational Quota Entity; 2 hours for Application for Transfer of QS To or From an RQE; 40 hours for RQE Annual Report; 1 minute for electronic submission of cost recovery fee; and 30 minutes for non-electronic fee submission for IFQ Permit Holder Fee Submission Form. Public comment is sought regarding: Whether these proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden statement; ways to enhance quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information, to NMFS (see ADDRESSES), and by email to [email protected] or fax to 202- 395-5806.

    Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to penalty for failure to comply with, a collection of information subject to the requirement 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.

    List of Subjects 50 CFR Part 300

    Administrative practice and procedure, Antarctica, Canada, Exports, Fish, Fisheries, Fishing, Imports, Indians, Labeling, Marine resources, Reporting and recordkeeping requirements, Russian Federation, Transportation, Treaties, Wildlife.

    50 CFR Part 679

    Alaska, Fisheries, Reporting and recordkeeping requirements.

    Dated: September 25, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR parts 300 and 679 are proposed to be amended as follows:

    PART 300—INTERNATIONAL FISHERIES REGULATIONS Subpart E—Pacific Halibut Fisheries 1. The authority citation for part 300, subpart E, continues to read as follows: Authority:

    16 U.S.C. 773-773k.

    2. In § 300.65: a. Add paragraph (c)(1)(iii); b. Revise paragraph (c)(4)(i); and c. Add paragraphs (c)(4)(iii) and (c)(5)(ii)(D)(1)(iv) to read as follows:
    § 300.65 Catch sharing plan and domestic management measures in waters in and off Alaska.

    (c) * * *

    (1) * * *

    (iii) Authorizes the use of Commission regulatory areas 2C and 3A RFQ resulting from halibut QS held by the RQE as authorized in part 679 to this title to supplement the annual guided sport catch limit in the corresponding area, pursuant to paragraph (c)(4) of this section.

    (4) * * *

    (i) The Commission regulatory areas 2C and 3A annual guided sport catch limits are determined by subtracting wastage from, and adding any pounds of RFQ held by an RQE for that area to, the allocations in Tables 3 and 4 of this subpart E, adopted by the Commission as annual management measures, and published in the Federal Register as required in § 300.62.

    (iii) The amount of QS held by the RQE for Commission regulatory area 2C and 3A as of October 1 each year will be the basis for determining the amount of RFQ pounds that will be added to the annual guided sport catch limit for the corresponding area in the upcoming year.

    (5) * * *

    (ii) * * *

    (D) * * *

    (1) * * *

    (iv) In the applicable Commission regulatory area, either Area 2C or Area 3A, the sum of IFQ halibut equivalent pounds, as defined in § 679.2 of this title, from the transfer of IFQ to GAF and the pounds of RFQ issued to the RQE during a calendar year does not exceed an amount that is greater than the amount derived from:

    (A) 5,947,740 units of Area 2C QS; or

    (B) 22,187,161 units of Area 3A QS.

    PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 3. The authority citation for part 679 continues to read as follows: Authority:

    16 U.S.C. 773 et seq.; 1801 et seq.; 3631 et seq.; Pub. L. 108-447; Pub. L. 111-281.

    4. In § 679.2, add definitions for “Recreational Fishing Quota (RFQ)” and “Recreational Quota Entity (RQE)” in alphabetical order to read as follows:
    § 679.2 Definitions.

    Recreational Fishing Quota (RFQ) means the pounds of halibut issued annually to a Recreational Quota Entity to supplement the annual guided sport catch limit under the catch sharing plan for IFQ regulatory areas 2C and 3A pursuant to § 300.65(c) of this title.

    Recreational Quota Entity (RQE) means a non-profit entity incorporated under the laws of the State of Alaska, recognized as exempt from federal income tax by the Internal Revenue Service, and authorized by NMFS to participate in the Halibut IFQ Program to hold commercial halibut quota share to supplement the annual guided sport catch limit in IFQ regulatory areas 2C and 3A under the catch sharing plan pursuant to § 300.65(c) of this title. NMFS will authorize only one RQE at a time.

    5. In § 679.4, add paragraph (d)(1)(iv) to read as follows:
    § 679.4 Permits.

    (d) * * *

    (1) * * *

    (iv) RFQ permit account. An RFQ permit account identifies the amount of RFQ authorized for use by charter vessel anglers in Area 2C or Area 3A. The number of pounds of RFQ allocated to the RFQ permit account will be added to the annual guided sport catch limit under the catch sharing plan (described at 50 CFR 300.65(c)) for the appropriate IFQ regulatory area, Area 2C or Area 3A.

    6. In § 679.5: a. Revise paragraphs (l)(7)(ii)(A) and (l)(7)(ii)(C) and (D); and b. Add paragraphs (l)(9) and (v) to read as follows:
    § 679.5 Recordkeeping and reporting (R&R).

    (l) * * *

    (7) * * *

    (ii) * * *

    (A) Applicability. An IFQ permit holder who holds an IFQ permit against which a landing was made or an RQE that holds RFQ must submit to NMFS a complete IFQ Permit Holder Fee Submission Form provided by NMFS.

    (C) Completed application. NMFS will process an IFQ Permit Holder Fee Submission Form provided that a paper or electronic form is completed by the IFQ permit holder or an RQE that holds RFQ, with all applicable fields accurately filled in, and all required additional documentation is attached.

    (D) IFQ landing summary and estimated fee liability. NMFS will provide to an IFQ permit holder and an RQE that holds RFQ an IFQ Landing and Estimated Fee Liability page as required by § 679.45(a)(2). The IFQ permit holder must either accept the accuracy of the NMFS estimated fee liability associated with his or her IFQ landings for each IFQ permit, or calculate a revised IFQ fee liability in accordance with paragraph (l)(7)(ii)(E) of this section. The IFQ permit holder may calculate a revised fee liability for all or part of his or her IFQ landings.

    (9) An annual report on RQE activities must be submitted to NMFS by the RQE as required at § 679.5(v).

    (v) Recreational Quota Entity Program Annual Report—(1) Applicability. The RQE must submit a timely and complete annual report on the RQE's administrative activities and business operation for each calendar year that it holds halibut recreational fishing quota (RFQ) and quota shares (QS). The RQE may combine annual reports on its holdings of halibut QS and RFQ for IFQ regulatory areas 2C and 3A into one report. The RQE must submit annual report data for the halibut QS and RFQ it held during the calendar year. The RQE is not required to submit an annual report for any calendar year in which it did not hold any halibut QS or RFQ.

    (2) Time limits and submittal. By January 31, the RQE must submit a complete annual report for the prior calendar year to the North Pacific Fishery Management Council, 605 West 4th Ave., Suite 306, Anchorage, AK 99501-2252, and to NMFS-Alaska Regional Administrator, P.O. Box 21668, Juneau, AK 99802-1668.

    (3) Complete annual report. A complete annual report contains all general report requirements described in paragraphs (v)(4)(i) through (v)(4)(iv) of this section, and all information specific to IFQ regulatory areas 2C and 3A described in paragraphs (v)(5)(i) through (v)(5)(iii) of this section.

    (4) General report requirements. The RQE must annually report the following information:

    (i) Any changes to the bylaws, board of directors, or other key management personnel of the RQE from the preceding year;

    (ii) Amount and description of annual administrative expenses;

    (iii) Amount and description of funds spent on conservation and research, including a summary of the results of those expenditures; and

    (iv) Amount and description of all other expenses incurred by the RQE.

    (5) Information by IFQ regulatory area. For each IFQ regulatory area represented by the RQE, the RQE must annually report the following information:

    (i) The total amount of halibut QS by category and blocks held by the RQE at the start of the calendar year, on October 1, and at the end of the calendar year;

    (ii) A list of all transfers (purchases or sales) of halibut QS, including the transaction price; and

    (iii) A description of the number of charter halibut permits and number of angler endorsements purchased and held by the RQE.

    7. In § 679.7, add paragraph (f)(3)(i)(C) to read as follows:
    § 679.7 Prohibitions.

    (f) * * *

    (3) * * *

    (i) * * *

    (C) Use fixed gear as defined in § 679.2 to retain halibut RFQ.

    8. In § 679.40: a. Revise paragraph (b); b. Revise paragraph (c) heading and paragraph (c)(2); c. Add paragraphs (c)(4) and (g)(2)(iii); d. Revise paragraph (h)(3) introductory text; and e. Add paragraph (h)(3)(iii) to read as follows:
    § 679.40 Sablefish and halibut QS.

    (b) Annual allocation of IFQ and RFQ. The Regional Administrator shall assign halibut or sablefish IFQs to each person, except the RQE, holding unrestricted QS halibut or sablefish, respectively, up to the limits prescribed in § 679.42(e) and (f). Each assigned IFQ will be specific to an IFQ regulatory area and vessel category, and will represent the maximum amount of halibut or sablefish that may be harvested from the specified IFQ regulatory area and by the person to whom it is assigned during the specified fishing year, unless the IFQ assignment is changed by the Regional Administrator within the fishing year because of an approved transfer or because all or part of the IFQ is sanctioned for violating rules of this part. The Regional Administrator shall assign RFQ to the RQE pursuant to paragraph (c)(4) of this section.

    (c) Calculation of annual IFQ and RFQ allocations.

    (2) QS amounts. For purposes of calculating IFQs and RFQ for any fishing year, the amount of a person's QS and the amount of the QS pool for any IFQ regulatory area will be the amounts on record with the Alaska Region, NMFS, on January 15 of that year.

    (4) RFQ allocation to RQE—(i) RQE QS amounts. For purposes of calculating RFQ for any fishing year, the amount of halibut QS held by the RQE for either IFQ regulatory area 2C or 3A for the corresponding IFQ regulatory area will be the amounts on record with the Alaska Region, NMFS on October 1 of the year prior.

    (ii) Calculation of RFQ. The annual allocation of RFQ halibut to an RQE (person r) in IFQ regulatory area 2C or 3A (area a) will be equal to the product of the annual commercial catch limit as defined in § 300.61 of this title, and the QS held by the RQE (specified in paragraph (c)(4)(i) of this section) divided by the QS pool for that area (specified in paragraph (c)(2) of this section). No overage or underage adjustments will be applied to the RQE's annual RFQ. Expressed algebraically, the annual RFQ halibut allocation formula is as follows:

    RFQra = [fixed gear TACa × (QSra/QS poola)]

    (iii) Excess RFQ. NMFS will not issue the RQE any excess RFQ. Excess RFQ is the difference between the amount of RFQ based on the QS held by the RQE and the amount of RFQ needed to provide charter fishery management measures that are equivalent to unguided recreational fishery management measures. If the annual management measures published pursuant to § 300.62 of this title specify charter fishery management measures that are equivalent to the unguided recreational management measures, NMFS will:

    (A) Calculate the annual allocation of halibut RFQ to the RQE as specified in paragraph (c)(4)(ii) of this section;

    (B) Determine the amount of RFQ needed to supplement the annual guided sport catch limit from the CSP in Area 2C and Area 3A (described in § 300.65(c)) to account for charter fishery harvests under the charter fishery management measures specified in the annual management measures and issue that amount of RFQ to the RFQ permit account.

    (C) Calculate the amount of excess RFQ by subtracting the amount of RFQ issued as determined in paragraph (c)(4)(iii)(B) of this section from the annual calculation of RFQ halibut to the RQE as calculated in paragraph (c)(4)(iii)(A) of this section.

    (iv) Redistribution of excess RFQ. Excess pounds of RFQ will be redistributed as IFQ as follows:

    (A) 50 percent to all catcher vessel QS holders in the applicable area who held not more than 32,333 QS units in Area 2C, and 47,469 QS units in Area 3A in the current calendar year and in the calendar year prior to the redistribution, in proportion to their QS holdings; and

    (B) 50 percent divided equally among all CQEs that held halibut QS in the applicable IFQ regulatory area (Area 2C or Area 3A) in the current calendar year and in the calendar year prior to the redistribution. If no CQE held QS in the applicable IFQ regulatory area (Area 2C and Area 3A) in the current calendar year and in the calendar year prior to the redistribution, that RFQ will not be redistributed as IFQ and will not be available for use by any CQE, IFQ permit holder, or RQE in that calendar year.

    (g) * * *

    (2) * * *

    (iii) The fish will not be calculated as part of the recreational harvest of halibut and will not be debited against the RFQ permit account or the annual guided sport catch limit as defined in § 300.61 of this title.

    (h) * * *

    (3) Source of debit. NMFS will use the following sources (see paragraphs (h)(3)(i), (ii) and (iii) of this section) of information to debit a CDQ halibut, IFQ halibut, IFQ sablefish, or RFQ permit account:

    (iii) All annual RFQ halibut issued to an RQE will be considered landed in the year for which it is issued.

    9. In § 679.41: a. Redesignate paragraph (c)(11) as (c)(12); b. Add new paragraph (c)(11); c. Revise paragraphs (d)(1) and (g)(1); and d. Add paragraphs (g)(9) through (11), and (n) to read as follows:
    § 679.41 Transfer of quota shares and IFQ.

    (c) * * *

    (11) If the person applying to receive or transfer QS is an RQE, the following determinations are required:

    (i) The RQE applying to receive or transfer QS, has submitted the timely and complete annual report required by § 679.5(v);

    (ii) The RQE applying to receive QS is eligible to hold QS on behalf of the charter halibut sector in IFQ regulatory area 2C or 3A; and

    (iii) The RQE applying to receive QS has received notification of approval of eligibility to receive QS on behalf of the charter halibut sector in IFQ regulatory area 2C or 3A as described in paragraph (d)(1) of this section.

    (d) * * *

    (1) Application for Eligibility. All persons applying to receive QS or IFQ must submit an Application for Eligibility to Receive QS/IFQ (Application for Eligibility) containing accurate information to the Regional Administrator. An Application for Eligibility to Receive QS/IFQ (Application for Eligibility) is not required for a CQE if a complete application to become a CQE, as described in paragraph (l)(3) of this section, has been approved by the Regional Administrator on behalf of an eligible community. An Application for Eligibility to Receive QS/IFQ (Application for Eligibility) is not required for the RQE if a complete application to become an RQE, as described in paragraph (n)(2) of this section, has been approved by the Regional Administrator. The Regional Administrator will not approve a transfer of IFQ or QS to a person until the Application for Eligibility for that person is approved by the Regional Administrator. The Regional Administrator will provide an Application for Eligibility form to any person on request.

    (g) * * *

    (1) Except as provided in paragraph (f), paragraph (g)(2), paragraph (l), or paragraph (n) of this section, only persons who are IFQ crew members, or who were initially issued QS assigned to vessel categories B, C, or D, and meet the eligibility requirements in this section, may receive by transfer QS assigned to vessel categories B, C, or D, or the IFQ resulting from it.

    (9) For transfers of QS to an RQE, the RQE may only receive halibut QS that is assigned to IFQ regulatory area 2C or 3A.

    (10) For transfers of QS from an RQE:

    (i) Quota category and block designations at time of purchase by an RQE are retained if QS is transferred to an eligible QS holder for use in the IFQ program.

    (ii) NMFS will not issue any IFQ from any QS transferred from an RQE to a QS holder for use in the IFQ program for a calendar year if that QS resulted in the issuance of RFQ to an RQE during that calendar year.

    (11) RQE eligibility. (i) To maintain eligibility as the RQE authorized by NMFS, the RQE must be a non-profit entity incorporated under the laws of the State of Alaska and recognized as exempt from federal income tax by the Internal Revenue Service as required by paragraph (n)(1)(i) of this section.

    (ii) If the Regional Administrator determines the RQE approved by NMFS does not meet the requirement specified in in paragraph (n)(1)(i) of this section, NMFS will notify the RQE of the Regional Administrator's determination and specify that the RQE has 60 days to meet the requirement in paragraphs (n)(1)(i) of this section to maintain eligibility as the RQE authorized by NMFS.

    (iii) If the RQE demonstrates to NMFS within 60 days of notification that it meets the requirement in paragraphs (n)(1)(i) of this section, NMFS will notify the RQE that it remains the authorized RQE.

    (iv) If the RQE does not demonstrate to NMFS within 60 days of notification that it meets the requirement in paragraphs (n)(1)(i) of this section, NMFS will issue an initial administrative determination (IAD):

    (A) Revoking authorization of the RQE;

    (B) Disallowing the RQE from receiving any QS by transfer;

    (C) Requiring the CQE to divest of any QS that it holds; and

    (D) Withholding the issuance of RFQ based on any QS that the RQE holds.

    (v) The RQE would have the opportunity to appeal the IAD through the National Appeals Office under the provisions established at 15 CFR part 906.

    (n) Transfer of halibut QS to an RQE—(1) RQE Organizational Structure. (i) The RQE will be a single entity representing IFQ regulatory Areas 2C and 3A.

    (ii) The RQE will be a non-profit entity incorporated under the laws of the State of Alaska and recognized as exempt from federal income tax by the Internal Revenue Service; and

    (iii) The RQE will submit an annual report to NMFS and the Council detailing RQE activities during the prior year according to § 679.5(v).

    (2) Application for Eligibility. Prior to initially receiving QS by transfer, a non-profit entity that intends to participate in the Halibut IFQ Program and purchase and hold halibut QS in Area 2C and Area 3A as the RQE must have approval from the Regional Administrator. To receive that approval, the non-profit entity seeking to become an RQE must submit a complete “Application for a Non-Profit Entity to be Designated as a Recreational Quota Entity (RQE)” (available on the NMFS Alaska Region Web site at https://alaskafisheries.noaa.gov/). NMFS will approve only one entity as the RQE. A complete application to become an RQE must include:

    (i) The articles of incorporation under the laws of the State of Alaska for that non-profit entity;

    (ii) Acknowledgement from the Internal Revenue Service that the non-profit entity is exempt from federal income tax under section 501(a) of the Internal Revenue Code;

    (iii) Management organization information, including:

    (A) The bylaws of the non-profit entity;

    (B) A list of key personnel of the managing organization including, but not limited to, the RQE board of directors, officers, representatives, and any managers;

    (C) A description of how the non-profit entity is qualified to manage QS on behalf of charter fishery participants and a demonstration that the non-profit entity has the management, technical expertise, and ability to manage QS and RFQ;

    (D) The name of the non-profit organization, taxpayer ID number, NMFS person number, permanent business mailing addresses, name of contact persons and additional contact information of the managing personnel for the non-profit entity, resumes of management personnel, name and notarized signature of applicant, and Notary Public signature and date when commission expires;

    (iv) A statement describing the procedures that will be used to determine the acquisition of funds to purchase QS.

    (3) Address for submittal of application: Regional Administrator, NMFS, P.O. Box 21668, Juneau, AK 99802.

    (4) Approval. NMFS will approve the first complete application received. If an application is approved, NMFS will notify the RQE by mail, unless another mode of communication is requested on the application.

    (5) Disapproval. If an application is disapproved, that determination may be appealed under the provisions established at 15 CFR part 906.

    10. In § 679.42: a. Add paragraph (a)(2)(v); b. Revise paragraph (f)(1) introductory text; and c. Add paragraphs (f)(8) and (g)(1)(iii) to read as follows:
    § 679.42 Limitations on use of QS and IFQ.

    (a) * * *

    (2) * * *

    (v) In IFQ regulatory areas 2C and 3A, RFQ held by an RQE may be harvested aboard charter vessels as defined at 50 CFR 300.61 of any size, regardless of the QS category from which that RFQ originated.

    (f) * * *

    (1) Unless the amount in excess of the following limits was received in the initial allocation of halibut QS, no person other than a CQE representing the community of Adak, AK, individually or collectively, or an RQE, may use more than:

    (8) RQE use limits—(i) Annual transfer limits. The RQE may not receive by transfer more than 594,774 units of Area 2C halibut QS and more than 2,218,716 units of Area 3A halibut QS in a year.

    (ii) Cumulative use limits. The RQE may not hold more than 5,947,740 units of Area 2C halibut QS and more than 22,187,161 units of Area 3A halibut QS.

    (iii) Vessel category restrictions. (A) The RQE may not hold more than 889,548 units of halibut QS in IFQ regulatory area 2C that is assigned to vessel category D.

    (B) The RQE may not hold halibut QS in IFQ regulatory area 3A that is assigned to vessel category D.

    (C) The RQE may not hold more than 265,524 units of halibut QS that is assigned to vessel category B in IFQ regulatory area 2C.

    (g) * * *

    (1) * * *

    (iii) The RQE is limited to receiving:

    (A) Transfers of halibut QS blocks of less than or equal to 24,250 quota share units in IFQ regulatory area 2C.

    (B) Transfers of halibut QS blocks of less than or equal to 35,620 quota share units in IFQ regulatory area 3A.

    11. In § 679.45: a. Revise paragraphs (a)(1), (a)(2)(i) introductory text, and (a)(2)(i)(A); b. Add paragraphs (a)(2)(i)(B)(3) and (a)(2)(i)(D); and c. Revise paragraphs (a)(3), (a)(4)(i), (b)(1), and (f)(2) to read as follows:
    § 679.45 IFQ cost recovery program.

    (a) * * *

    (1) Responsibility. An IFQ permit holder is responsible for cost recovery fees for landings of his or her IFQ halibut and sablefish, including any halibut landed as guided angler fish (GAF), as defined in § 300.61 of this title, derived from his or her IFQ accounts. An RQE is responsible for cost recovery fees for all RFQ issued to the RQE. An IFQ permit holder or RQE must comply with the requirements of this section.

    (2) * * *

    (i) General. IFQ fee liability means a cost recovery liability based on either the value of all landed IFQ and GAF derived from the permit holder's IFQ permit(s), or the value of all RFQ issued to an RQE.

    (A) Each year, the Regional Administrator will issue each IFQ permit holder a summary of his or her IFQ equivalent pounds landed as IFQ and GAF and will issue an RQE a summary of its RFQ pounds issued as part of the IFQ Landing and Estimated Fee Liability page described at § 679.5(l)(7)(ii)(D).

    (B) * * *

    (3) All RFQ issued to an RQE in IFQ regulatory area 2C or 3A will be assessed at the IFQ regulatory area 2C or 3A IFQ standard ex-vessel value.

    (D) An RQE may not challenge the standard ex-vessel value used to determine the fee liability for all RFQ issued to the RQE.

    (3) Fee Collection. (i) An IFQ permit holder with IFQ and/or GAF landings is responsible for collecting his or her own fee during the calendar year in which the IFQ fish and/or GAF are landed.

    (ii) An RQE is responsible for collecting its own fees during the calendar year in which the RFQ is issued to the RQE.

    (4) * * *

    (i) Payment due date. An IFQ permit holder or RQE must submit its IFQ fee liability payment(s) to NMFS at the address provided at paragraph (a)(4)(iii) of this section not later than January 31 of the year following the calendar year in which the IFQ or GAF landings were made or the RFQ was issued to the RQE.

    (b) * * *

    (1) General. (i) An IFQ permit holder must use either the IFQ actual ex-vessel value or the IFQ standard ex-vessel value when determining the IFQ fee liability based on ex-vessel value, except that landed GAF are assessed at the standard ex-vessel values derived by NMFS. An IFQ permit holder must base all fee liability calculations on the ex-vessel value that correlates to landed IFQ in IFQ equivalent pounds.

    (ii) An RQE must use the IFQ standard ex-vessel value derived by NMFS for all RFQ issued to the RQE.

    (f) * * *

    (2) After the expiration of the 30-day period, the Regional Administrator will evaluate any additional documentation submitted by an IFQ permit holder or RQE in support of its payment. If the Regional Administrator determines that the additional documentation does not meet the burden of proving the payment is correct, the Regional Administrator will send the IFQ permit holder or RQE an IAD indicating that the IFQ permit holder or RQE did not meet the burden of proof to change the IFQ fee liability as calculated by the Regional Administrator based upon the IFQ standard ex-vessel value. The IAD will set out the facts and indicate the deficiencies in the documentation submitted by the IFQ permit holder or RQE. An IFQ permit holder or RQE who receives an IAD may appeal the IAD, as described in paragraph (h) of this section.

    §§ 679.41 and 679.45 [Amended]
    12. In the table below, for each section indicated in the “Location” column, remove the title indicated in the “Remove” column from wherever it appears in the section, and add the title indicated in the “Add” column: Location Remove Add § 679.41(l)(3) introductory text, and (l)(3)(v)(E)(3) 50 CFR 679.43 15 CFR part 906 § 679.41(m)(5)(ii) § 679.43 15 CFR part 906 § 679.45(b)(2) landed as GAF. landed as GAF or issued as RFQ. § 679.45(b)(3)(ii) landed GAF landed GAF and RFQ issued to an RQE. § 679.45(b)(3)(v) introductory text aggregated IFQ regulatory area 2C or 3A, to GAF landings. aggregated by IFQ regulatory area 2C or 3A, to GAF landings and RFQ issued to an RQE. § 679.45(d)(2)(i)(A) and (B) IFQ and GAF IFQ, RFQ, and GAF § 679.45(d)(2)(i)(C) include GAF costs. include RQE and GAF costs. § 679.45(d)(2)(ii) as commercial catch or as GAF as commercial catch, RFQ, or GAF § 679.45(d)(4) IFQ and GAF IFQ, RFQ, and GAF § 679.45(d)(4), (e)(1) introductory text, (e)(1)(ii), and (f)(1)(i) IFQ permit holder IFQ permit holder or RQE § 679.45(e)(1)(i), and (e)(1)(ii) IFQ permit holder IFQ permit holder or RQE § 679.45(e)(1)(i) the IFQ permit holder's estimated fee liability the estimated fee liability § 679.45(e)(2) IFQ fishing permit held IFQ fishing permit or RFQ permit account held § 679.45(e)(2), (f)(1)(ii), and (f)(5) IFQ permit holder IFQ permit holder or RQE § 679.45(f)(1) introductory text IFQ permit holder has IFQ permit holder or RQE has § 679.45(f)(3) § 679.43 15 CFR part 906 § 679.45(f)(4) the IFQ permit holder must pay the IFQ permit holder or RQE must pay § 679.45(g) IFQ permit holder unless the permit holder requests IFQ permit holder or RQE unless the IFQ permit holder or RQE requests § 679.45(g) IFQ permit holder's IFQ permit holder's or RQE's § 679.45(h) § 679.43 15 CFR part 906
    [FR Doc. 2017-20894 Filed 10-2-17; 8:45 am] BILLING CODE 3510-22-P
    82 190 Tuesday, October 3, 2017 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request September 28, 2017.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden 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 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 regarding this information collection received by November 2, 2017 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW., Washington, DC 20503. Commentors are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8681.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Grain Inspection, Packers & Stockyards Administration

    Title: Regulations and Statement of General Policy Issued under the Packers and Stockyards Act, and Related Reporting and Recordkeeping Requirements—Packers and Stockyards Programs.

    OMB Control Number: 0580-0015.

    Summary of Collection: The Grain Inspection, Packers and Stockyards Administration (GIPSA) administers the provisions of the Packers and Stockyards Act of 1921 (Act), as amended and supplemented (7 U.S.C. 181-229c). The Act is designed to protect the financial interests of livestock and poultry producers engaged in commerce of livestock and live poultry sold for slaughter. It also protects members of the livestock and poultry marketing, processing, and merchandising industries from unfair, unjustly discriminatory, deceptive, or anti-competitive practices in the livestock, meat, and poultry industries. GIPSA will collect information using several forms.

    Need and Use of the Information: GIPSA requires regulated entities in the livestock, meat packing, and poultry industries to keep records, submit information to GIPSA, and provide information to third parties. GIPSA will collect information to monitor and examine financial, competitive and trade practices in the livestock, meatpacking, and poultry industries. Also, the information will help assure that the regulated entities do not engage in unfair, unjustly discriminatory, or deceptive trade practices or anti-competitive behavior.

    Description of Respondents: Business or other for-profit.

    Number of Respondents: 16,205.

    Frequency of Responses: Recordkeeping; Third party disclosure; Reporting: On occasion; Semi-annually; Annually.

    Total Burden Hours: 348,328.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2017-21164 Filed 10-2-17; 8:45 am] BILLING CODE 3410-KD-P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the Delaware Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of briefing meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a briefing meeting of the Delaware Advisory Committee to the Commission will convene at 9:00 a.m. (EDT) on Wednesday, November 1, 2017 at Widener University Delaware Law School, 4601 Concord Pike, Wilmington DE 19803-0406. The purpose of the briefing is to hear from government officials, advocates, and others on Policing in Communities of Color and Implicit Bias in Delaware.

    DATES:

    Wednesday, November 1, 2017 (EDT).

    Time: 9:00 a.m.-6:00 a.m. Briefing Meeting and Public Session.

    ADDRESSES:

    Widener University Delaware Law School, 4601 Concord Pike, Wilmington DE 19803-0406.

    FOR FURTHER INFORMATION CONTACT:

    Ivy Delaviez at [email protected], or 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at [email protected] at the Eastern Regional Office at least ten (10) working days before the scheduled date of the meeting.

    Time will be set aside at the end of the briefing so that members of the public may address the Committee after the formal presentations have been completed. Persons interested in the issue are also invited to December 1, 2017. Written comments may be mailed to the Eastern Regional Office, U.S. Commissionon Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://www.facadatabase.gov/committee/meetings.aspx?cid=240 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

    Tentative Agenda Wednesday, November 1, 2017 I. Welcome and Introductions 9:00AM II. Briefing 9:15AM to 6:00PM Panels III. Open Session—at the conclusion of panels IV. Planning Meeting V. Adjournment Dated: September 28, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-21182 Filed 10-2-17; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the Delaware Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of monthly planning meetings.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Delaware State Advisory Committee to the Commission will convene by conference call, on Monday, October 16 at 10:00 a.m. (EDT). The purpose of the meeting is to make preparations for a briefing meeting on Policing in Communities of Color and Implicit Bias in Delaware, including refining the agenda and list of the invited expert presenters. The briefing meeting is planned for November 1, 2017 at Widener University Delaware Law School, 4601 Concord Pike, Ruby R. Vale Moot Courtroom, Wilmington, DE 19803-0406. A public session will convene directly following the briefing in November.

    DATES:

    Monday, October 16, 2017, at 10:00 a.m. (EDT) and Wednesday, November 1, 2017.

    ADDRESSES:

    Public Call-In Information on Monday, October 16, 2017: Conference call number: 1-800-210-9006 and conference call ID: 4124362.

    FOR FURTHER INFORMATION CONTACT:

    Ivy L. Davis, at [email protected] or by phone at 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362. Please be advised that before placing them into the conference call, the conference call operator may ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number herein.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362.

    Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at http://facadatabase.gov/committee/meetings.aspx?cid=240; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

    Agenda I. Welcome and Introductions Rollcall II. Planning Meeting —Discuss Project Planning III. Other Business IV. Adjournment Dated: September 28, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-21181 Filed 10-2-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: National Institute of Standards and Technology (NIST).

    Title: NIST Summer Institute for Middle School Science Teachers (NIST Summer Institute) and the NIST Research Experience for Teachers (NIST RET) Programs Application Requirements.

    OMB Control Number: 0693-0059.

    Form Number(s): NIST-1103.

    Type of Request: Regular submission (Revision of a currently approved information collection).

    Number of Respondents: 100.

    Average Hours per Response: 1.

    Burden Hours: 100.

    Needs and Uses: The NIST Summer Institute and the NIST RET are two competitive financial assistance (Cooperative agreement) programs that offer middle school (Grades 6-8) science teachers an opportunity to participate in hands-on activities, lectures, tours, visits, or in scientific research with scientists and engineers in NIST laboratories. The aim is to encourage them to inspire students to pursue careers in science, technology, engineering, and mathematics 9STME) fields. This request is for the information collection for form NIST-1003 that must be completed by nominated teachers. The information is used in making cooperative agreement decisions.

    Revisions: The former question 18 on the form has been removed, as this was found not to be pertinent for the program. An additional sentence has been added for question 23 (formerly question 24), ”Please discuss some scientific ideas you would like to learn more about and what information you would like to bring home to your students, as this will assist in planning the modules for the Summer Institute.” Finally, a new question has been added, new question 24, which relates to the RET program, and will help in the evaluation of the applicants to that sub-program.

    Affected Public: U.S. public school districts, U.S. accredited private educational institutions, and U.S. middle school (Grades 6-8) science teachers.

    Frequency: Annually.

    Respondent's Obligation: Required to obtain benefits.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2017-21168 Filed 10-2-17; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-40-2017] Foreign-Trade Zone (FTZ) 57—Charlotte, North Carolina, Authorization of Limited Production Activity; DNP Imagingcomm America Corporation (Coatings and Lamination on Semi-Completed Coated Paper), Concord, North Carolina

    On May 30, 2017, the Charlotte Regional Partnership, Inc., grantee of FTZ 57, submitted a notification of proposed production activity to the FTZ Board on behalf of DNP Imagingcomm America Corporation (DNP), within Subzone 57C, in Concord, North Carolina.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (82 FR 28627-28628, June 23, 2017). On September 27, 2017, the applicant was notified of the FTZ Board's conditional decision that no further review of the activity is warranted at this time. The production activity described in the notification was authorized, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14, and further subject to a five-year time limit (ending September 27, 2022) on admission of foreign status chemical binders (classifiable under HTSUS 3824.90, according to the notification).

    Dated: September 27, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-21215 Filed 10-2-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-152-2017] Foreign-Trade Zone 214—Lenoir County, North Carolina; Application for Expansion of Subzone 214A; Consolidated Diesel Company; Enfield, North Carolina

    An application has been submitted to the Foreign-Trade Zones Board (the Board) by the North Carolina Department of Transportation, grantee of FTZ 214, requesting an expansion of Subzone 214A on behalf of Consolidated Diesel Company (CDC). The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on September 26, 2017.

    Subzone 214A was approved on May 8, 2000 (Board Order 1093, 65 FR 33294, May 23, 2000) and consists of the following sites: Site 1 (239 acres) CDC manufacturing plant, 9377 U.S. Highway 301 North, Whitakers; Site 2 (10 acres) CDC training center and warehouse, located directly across U.S. Highway 301 from Site 1, Whitakers; and, Site 3 (26 acres) E.B. Grain Company warehouse, 7301 U.S. Highway 301 North, Rocky Mount, North Carolina. The applicant is requesting authority to expand the subzone to include an additional site as follows: Proposed Site 4 (17.98 acres)—18388 U.S. Highway 301, Enfield, North Carolina. The applicant is also requesting to remove existing Site 3 of the subzone. No additional authorization for production activity has been requested at this time. The existing subzone and the proposed site would be subject to the existing activation limit of FTZ 214.

    In accordance with the Board's regulations, Kathleen Boyce of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is November 13, 2017. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to November 27, 2017.

    A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Kathleen Boyce at [email protected] or (202) 482-1346.

    Dated: September 27, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-21216 Filed 10-2-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-588-845, A-580-834, A-583-831, C-580-835] Certain Stainless Steel Sheet and Strip in Coils From Japan, the Republic of Korea, and Taiwan; Continuation of Antidumping Duty Orders and Countervailing Duty Order AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    As a result of determinations by the Department of Commerce (the Department) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) orders on certain stainless steel sheet and strip (SSSS) in coils from Japan, the Republic of Korea (Korea), and Taiwan, and the countervailing duty (CVD) order on SSSS in coils from Korea would likely lead to continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, the Department is publishing notice of the continuation of the AD orders and the CVD order.

    DATES:

    Applicable October 3, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Terre Keaton Stefanova, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1280.

    SUPPLEMENTARY INFORMATION: Background

    On July 27, 1999, the Department published the AD orders on SSSS in coils from Japan, Korea, and Taiwan.1 On August 6, 1999, the Department published the CVD order on SSSS in coils from Korea.2 On July 1, 2016, the Department published the notice of initiation of its third sunset reviews of the AD Orders on SSSS in coils from Japan, Korea, and Taiwan, and its third sunset review of the CVD Order on SSSS in coils from Korea, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).3 On July 1, 2016, the ITC instituted its review of the Orders. 4

    1See Notice of Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order; Stainless Steel Sheet and Strip in Coils from Japan, 64 FR 40565 (July 27, 1999); and Notice of Antidumping Duty Order; Stainless Steel Sheet and Strip in Coils from United Kingdom, Taiwan and South Korea, 64 FR 40555 (July 27, 1999) (collectively, AD Orders).

    2See Amended Final Determination: Stainless Steel Sheet and Strip in Coils from the Republic of Korea; and Notice of Countervailing Duty Orders: Stainless Steel Sheet and Strip in Coils from France, Italy, and the Republic of Korea, 64 FR 42923 (August 6, 1999) (CVD Order).

    3See Initiation of Five-Year (“Sunset”) Review, 81 FR 43185 (July 1, 2016).

    4See Stainless Steel Sheet and Strip in Coils from Japan, Korea, and Taiwan; Institution of a Five-Year Reviews, 81 FR 43238 (July 1, 2016).

    As a result of these sunset reviews, the Department found that revocation of the AD orders on SSSS in coils from Japan, Korea, and Taiwan would likely lead to continuation or recurrence of dumping, and that revocation of the CVD order would likely lead to continuation or recurrence of countervailable subsidies.5 The Department, therefore, notified the ITC of the magnitude of the dumping margins and net countervailable subsidy rates likely to prevail should the AD orders and CVD order be revoked.

    5See Stainless Steel Sheet and Strip in Coils from Japan, the Republic of Korea, and Taiwan: Final Results of the Expedited Sunset Reviews of the Antidumping Duty Orders, 81 FR 78114 (November 7, 2016); see also Stainless Steel Sheet and Strip in Coils from the Republic of Korea: Final Results of Expedited Sunset Review of the Countervailing Duty Order, 81 FR 78111 (November 7, 2016).

    On September 26, 2017, pursuant to sections 751(c) and 752(a) of the Act, the ITC published its determination that revocation of the AD orders on SSSS in coils from Japan, Korea, and Taiwan and revocation of the CVD order on SSSS in coils from Korea would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.6

    6See Stainless Steel Sheet and Strip in Coils from Japan, the Republic of Korea, and Taiwan; Determinations, 82 FR 44841 (September 26, 2017).

    Scope of the Orders

    The merchandise covered by these Orders is stainless steel sheet and strip in coils. Stainless steel is an alloy steel containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. The subject sheet and strip is a flat-rolled product in coils that is greater than 9.5 mm in width and less than 4.75 mm in thickness, and that is annealed or otherwise heat treated and pickled or otherwise descaled. The subject sheet and strip may also be further processed (i.e., cold-rolled, polished, aluminized, coated, etc.), provided that it maintains the specific dimensions of sheet and strip following such processing.

    The merchandise subject to these Orders is classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheadings: 7219.13.00.31, 7219.13.00.51, 7219.13.00.71, 7219.13.00.81, 7219.14.00.30, 7219.14.00.65, 7219.14.00.90, 7219.32.00.05, 7219.32.00.20, 7219.32.00.25, 7219.32.00.35, 7219.32.00.36, 7219.32.00.38, 7219.32.00.42, 7219.32.00.44, 7219.33.00.05, 7219.33.00.20, 7219.33.00.25, 7219.33.00.35, 7219.33.00.36, 7219.33.00.38, 7219.33.00.42, 7219.33.00.44, 7219.34.00.05, 7219.34.00.20, 7219.34.00.25, 7219.34.00.30, 7219.34.00.35, 7219.35.00.05, 7219.35.00.15, 7219.35.00.30, 7219.35.00.35, 7219.90.00.10, 7219.90.00.20, 7219.90.00.25, 7219.90.00.60, 7219.90.00.80, 7220.12.10.00, 7220.12.50.00, 7220.20.10.1 0, 7220.20.10.15, 7220.20.10.60, 7220.20.10.80, 7220.20.60.05, 7220.20.60.10, 7220.20.60.15, 7220.20.60.60, 7220.20.60.80, 7220.20.70.05, 7220.20.70.1 0, 7220.20.70.15, 7220.20.70.60, 7220.20.70.80, 7220.20.80.00, 7220.20.90.30, 7220.20.90.60, 7220.90.00.10, 7220.90.00.15, 7220.90.00.60, and 7220.90.00.80. (Prior to 2001, U.S. imports under HTSUS statistical reporting numbers 7219.13.00.31, 7219.13.00.51, 7219.13.00.71, 7219.13.00.81 were entered under HTSUS statistical reporting numbers 7219.13.00.30, 7219.13.00.50, 7219.13.00.70, 7219.13.00.80.) Although the HTSUS subheadings are provided for convenience and customs purposes, the Department's written description of the merchandise subject to these Orders is dispositive.

    Excluded from the scope of these Orders are the following: (1) Sheet and strip that is not annealed or otherwise heat treated and pickled or otherwise descaled, (2) sheet and strip that is cut to length, (3) plate (i.e., flat-rolled stainless steel products of a thickness of 4.75 mm or more), (4) flat wire (i.e., cold-rolled sections, with a prepared edge, rectangular in shape, of a width of not more than 9.5 mm), and (5) razor blade steel, (6) flapper valve steel, (7) suspension foil, (8) certain stainless steel foil for automotive catalytic converters, (9) permanent magnet iron-chromium-cobalt alloy stainless strip, (10) certain electrical resistance ally steel, (11) certain martensitic precipitation-hardenable stainless steel, and (12) three specialty stainless steels typically used in certain industrial blades and surgical and medication instruments. Items 5 through 12 are further described below.

    Razor blade steel is a flat-rolled product of stainless steel, not further worked than cold-rolled (cold-reduced), in coils, of a width of not more than 23 mm and a thickness of 0.266 mm or less, containing, by weight, 12.5 to 14.5 percent chromium, and certified at the time of entry to be used in the manufacture of razor blades. See Chapter 72 of the HTSUS, “Additional U.S. Note” 1(d).

    Flapper valve steel is also excluded from the scope: This product is defined as stainless steel strip in coils containing, by weight, between 0.37 and 0.43 percent carbon, between 1.15 and 1.35 percent molybdenum, and between 0.20 and 0.80 percent manganese. This steel also contains, by weight, phosphorus of 0.025 percent or less, silicon of between 0.20 and 0.50 percent, and sulfur of 0.020 percent or less. The product is manufactured by means of vacuum arc re-melting, with inclusion controls for sulphide of no more than 0.04 percent and for oxide of no more than 0.05 percent. Flapper valve steel has a tensile strength of between 210 and 300 ksi, yield strength of between 170 and 270 ksi, plus or minus 8 ksi, and a hardness CRv) of between 460 and 590. Flapper valve steel is most commonly used to produce specialty flapper valves in compressors.

    Suspension foil excluded from the scope is a specialty steel product used in the manufacture of suspension assemblies for computer disk drives. Suspension foil is described as 302/304 grade or 202 grade stainless steel of a thickness between 14 and 127 microns, with a thickness tolerance of plus-or-minus 2.01 microns, and surface glossiness of 200 to 700 percent Gs. Suspension foil must be supplied in coil widths of not more than 407 mm, and with a mass of 225 kg or less. Roll marks may only be visible on one side, with no scratches of measurable depth. The material must exhibit residual stresses of 2 mm maximum deflection, and flatness of 1.6 mm over 685 mm length.

    Certain stainless steel foil for automotive catalytic converters is also excluded from the scope. This stainless steel strip in coils is a specialty foil with a thickness of between 20 and 110 microns used to produce a metallic substrate with a honeycomb structure for use in automotive catalytic converters. The steel contains, by weight, carbon of no more than 0.030 percent, silicon of no more than 1.0 percent, manganese of no more than 1.0 percent, chromium of between 19 and 22 percent, aluminum of no less than 5.0 percent, phosphorus of no more than 0.045 percent, sulfur of no more than 0.03 percent, lanthanum of less than 0.002 or greater than 0.05 percent, and total rare earth elements of more than 0.06 percent, with the balance iron.

    Permanent magnet iron-chromium-cobalt alloy stainless strip is also excluded from the scope. This ductile stainless steel strip contains, by weight, 26 to 30 percent chromium, and 7 to 10 percent cobalt, with the remainder of iron, in widths 228.6 mm or less, and a thickness between 0.127 and 1.270 mm. It exhibits magnetic remanence between 9,000 and 12,000 gauss, and a coercivity of between 50 and 300 oersteds. This product is most commonly used in electronic sensors and is currently available under proprietary trade names such as “Arnokrome III.” 7

    7 “Arnokrome III” is a trademark of the Arnold Engineering Company.

    Certain electrical resistance alloy steel is also excluded from the scope. This product is defined as a non-magnetic stainless steel manufactured to American Society of Testing and Materials (ASTM) specification B344 and containing, by weight, 36 percent nickel, 18 percent chromium, and 46 percent iron, and is most notable for its resistance to high temperature corrosion. It has a melting point of 1390 degrees Celsius and displays a creep rupture limit of 4 kilograms per square millimeter at 1000 degrees Celsius. This steel is most commonly used in the production of heating ribbons for circuit breakers and industrial furnaces, and in rheostats for railway locomotives. The product is currently available under proprietary trade names such as “Gilphy 36.” 8

    8 “Gilphy 36” is a trademark of Imphy, SA.

    Certain martensitic precipitation-hardenable stainless steel is also excluded from the scope. This high-strength, ductile stainless steel product is designated under the Unified Numbering System (UNS) as S45500-grade steel, and contains, by weight, 11 to 13 percent chromium, and 7 to 10 percent nickel. Carbon, manganese, silicon and molybdenum each comprise, by weight, 0.05 percent or less, with phosphorus and sulfur each comprising, by weight, 0.03 percent or less. This steel has copper, niobium, and titanium added to achieve aging, and will exhibit yield strengths as high as 1700 Mpa and ultimate tensile strengths as high as 1750 Mpa after aging, with elongation percentages of 3 percent or less in 50 mm. It is generally provided in thicknesses between 0.635 and 0.787 mm, and in widths of 25.4 mm. This product is most commonly used in the manufacture of television tubes and is currently available under proprietary trade names such as “Durphynox 17.” 9

    9 “Durphynox 17” is a trademark of Imphy, S.A.

    Three specialty stainless steels typically used in certain industrial blades and surgical and medical instruments are also excluded from the scope. These include stainless steel strip in coils used in the production of textile cutting tools (e.g., carpet knives).10 This steel is similar to AISI grade 420 but containing, by weight, 0.5 to 0.7 percent of molybdenum. The steel also contains, by weight, carbon of between 1.0 and 1.1 percent, sulfur of 0.020 percent or less, and includes between 0.20 and 0.30 percent copper and between 0.20 and 0.50 percent cobalt. This steel is sold under proprietary names such as “GIN4 Mo.” The second excluded stainless steel strip in coils is similar to AISI 420-J2 and contains, by weight, carbon of between 0.62 and 0.70 percent, silicon of between 0.20 and 0.50 percent, manganese of between 0.45 and 0.80 percent, phosphorus of no more than 0.025 percent and sulfur of no more than 0.020 percent. This steel has a carbide density on average of 100 carbide particles per 100 square microns. An example of this product is “GIN5” steel. The third specialty steel has a chemical composition similar to AISI 420 F, with carbon of between 0.37 and 0.43 percent, molybdenum of between 1.15 and 1.35 percent, but lower manganese of between 0.20 and 0.80 percent, phosphorus of no more than 0.025 percent, silicon of between 0.20 and 0:50 percent, and sulfur of no more than 0.020 percent. This product is supplied with a hardness of more than Bv 500 guaranteed after customer processing, and is supplied as, for example, “GIN6.” 11

    10 This list of uses is illustrative and provided for descriptive purposes only.

    11 “GIN4 Mo”, “GIN5”, and “GIN6” are the proprietary grades of Hitachi Metals America, Ltd.

    In addition, as a result of changed circumstances reviews,12 the Department revoked, in part, the Japanese AD order with respect to imports of the following products:

    12See Stainless Steel Sheet and Strip in Coils from Japan: Final Results of Changed Circumstance Antidumping Duty Review, and Determination To Revoke Order in Part, 65 FR 17856 (April 5, 2000) (SSSS in Coils from Japan I); Stainless Steel Sheet and Strip in Coils from Japan: Final Results of Changed Circumstance Antidumping Duty Review, and Determination To Revoke Order in Part, 65 FR 54841 (September 11, 2000) (SSSS in Coils from Japan II); Stainless Steel Sheet and Strip in Coils from Japan: Final Results of Changed Circumstance Antidumping Duty Review and Determination To Revoke Order in Part, 65 FR 64423 (October 27, 2000) (SSSS in Coils from Japan III); Stainless Steel Sheet and Strip in Coils from Japan: Final Results of Changed Circumstance Antidumping Duty Review, and Determination To Revoke Order in Part, 65 FR 77578 (December 12, 2000) (SSSS in Coils from Japan IV).

    • Stainless steel welding electrode strips that are manufactured in accordance with American Welding Society (AWS) specifications ANSIIAWS A5.9-93.13

    13See SSSS in Coils from Japan I, 65 FR 17856.

    • Certain stainless steel used for razor blades, medical surgical blades, and industrial blades that are sold under proprietary names such as DSRIK7, DSRIKA, and DSRIK9.14

    14See SSSS in Coils from Japan II, 65 FR 54841.

    • Certain stainless steel lithographic sheet that is made of 304-grade stainless steel.15

    15See SSSS in Coils from Japan III, 65 FR 64423.

    • Certain nickel clad stainless steel sheet.16

    16See SSSS in Coils from Japan IV, 65 FR 77578.

    Continuation of the Orders

    As a result of the determinations by the Department and the ITC that revocation of the AD orders and the CVD order would likely lead to continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD orders on SSSS in coils from Japan, Korea, and Taiwan and the CVD order on SSSS in coils from Korea.

    U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of continuation of these orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, the Department intends to initiate the next five-year reviews of these orders not later than 30 days prior to the fifth anniversary of the effective date of continuation.

    These five-year (sunset) reviews and this notice are in accordance with sections 751(c) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).

    Dated: September 27, 2017. Carole Showers, Executive Director, Office of Policy performing the duties of the Deputy Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2017-21210 Filed 10-2-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Institute of Standards and Technology Open Meeting of the Information Security and Privacy Advisory Board AGENCY:

    National Institute of Standards and Technology, Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Information Security and Privacy Advisory Board (ISPAB) will meet Wednesday, October 25, 2017 from 9:00 a.m. until 4:30 p.m., Eastern Time, Thursday, October 26, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, and Friday, October 27, 2017 from 9:00 a.m. until 12:00 p.m. Eastern Time. All sessions will be open to the public.

    DATES:

    The meeting will be held on Wednesday, October 25, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, Thursday, October 26, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, and Friday, October 27, 2017 from 9:00 a.m. until 12:00 p.m. Eastern Time.

    ADDRESSES:

    The meeting will be held at the Constitution Hall, American University, 4400 Massachusetts Ave. NW., Washington, DC 20016.

    FOR FURTHER INFORMATION CONTACT:

    Matthew Scholl, Information Technology Laboratory, NIST, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899-8930, Telephone: (301) 975-2941, Email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the Information Security and Privacy Advisory Board (ISPAB or Board) will meet Wednesday, October 25, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, Thursday, October 26, 2017, from 9:00 a.m. until 4:30 p.m., Eastern Time, and Friday, October 27, 2017 from 9:00 a.m. until 12:00 p.m. Eastern Time. All sessions will be open to the public. The ISPAB is authorized by 15 U.S.C. 278g-4, as amended, and advises the National Institute of Standards and Technology (NIST), the Secretary of Homeland Security, and the Director of the Office of Management and Budget (OMB) on information security and privacy issues pertaining to Federal government information systems, including thorough review of proposed standards and guidelines developed by NIST. Details regarding the ISPAB's activities are available at http://csrc.nist.gov/groups/SMA/ispab/index.html.

    The agenda is expected to include the following items:

    —Deliberations and recommendations by the Board on security and privacy issues, —Presentation and discussion on next generation identity management technologies, —Discussion on plans for IT modernization in the U.S. Government IT infrastructure, —Presentation by Congressional Staff on potential cybersecurity proposals, —OMB presentation on current and planned policy for cybersecurity and discussion, —Presentation and discussion on U.S. Department of Homeland Security Binding Operational Directives, —Presentation and discussion on agency Inspectors General cybersecurity audit and metrics usage, —Panel discussion/presentation on NIST Internet of Things Cybersecurity Program, and —Updates on NIST Information Technology Laboratory cybersecurity and privacy work.

    Note that agenda items may change without notice. The final agenda will be posted on the Web site indicated above. Seating will be available for the public and media. Pre-registration is not required to attend this meeting.

    Public Participation: The ISPAB agenda will include a period, not to exceed thirty minutes, for oral comments from the public (Wednesday, October 25, 2017, between 4:00 p.m. and 4:30 p.m.). Speakers will be selected on a first-come, first served basis. Each speaker will be limited to five minutes. Questions from the public will not be considered during this period. Members of the public who are interested in speaking are requested to contact Matthew Scholl at the contact information indicated in the FOR FURTHER INFORMATION CONTACT section of this notice.

    Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to attend in person are invited to submit written statements. In addition, written statements are invited and may be submitted to the ISPAB at any time. All written statements should be directed to the ISPAB Secretariat, Information Technology Laboratory, 100 Bureau Drive, Stop 8930, National Institute of Standards and Technology, Gaithersburg, MD 20899-8930.

    Kevin Kimball, Chief of Staff.
    [FR Doc. 2017-21158 Filed 10-2-17; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Cooperative Game Fish Tagging Report AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before December 4, 2017.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Eric Orbesen, Southeast Fisheries Science Center, 75 Virginia Beach Dr., Miami, FL 33149, (305) 361-4253 or [email protected]

    SUPPLEMENTARY INFORMATION: I. Abstract

    This request is for extension of a current information collection.

    The Cooperative Game Fish Tagging Program was initiated in 1971 as part of a comprehensive research program resulting from passage of Public Law 86-359, Study of Migratory Game Fish, and other legislative acts under which the National Marine Fisheries Service (NMFS) operates. The Cooperative Tagging Center attempts to determine the migration patterns of, and other biological information for, billfish, tunas, and swordfish. The fish tagging report is provided to the angler with the tags, and he/she fills out the card with the information when a fish is tagged and mails it to NMFS. Information on each species is used by NMFS to determine migratory patterns, distance traveled, stock boundaries, age, and growth. These data are necessary input for developing management criteria by regional fishery management councils, states, and NMFS.

    II. Method of Collection

    Information is submitted by mail, and occasionally, international anglers scan the report cards and submit them via email to [email protected]

    III. Data

    OMB Control Number: 0648-0247.

    Form Number(s): NOAA Form 88-162.

    Type of Review: Regular submission (extension of a current information collection).

    Affected Public: Individuals or households.

    Estimated Number of Respondents: 12,000.

    Estimated Time per Response: 2 minutes.

    Estimated Total Annual Burden Hours: 400 hours.

    Estimated Total Annual Cost to Public: $0 in recordkeeping/recording costs.

    IV. Request for Comments

    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 shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (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 respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: September 28, 2017. Sarah Brabson, NOAA PRA Clearance-Officer.
    [FR Doc. 2017-21214 Filed 10-2-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF718 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting (webinar).

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) and Science and Statistical salmon subcommittee (SSC-Salmon) will hold a joint one-day methodology review meeting via webinar, which is open to the public.

    DATES:

    The webinar meeting will be held on Tuesday, October 17, 2017, from 10 a.m. until 5 p.m. or until business for the day has been completed.

    ADDRESSES:

    The meeting will be held via webinar. To attend the webinar (1) join the meeting by visiting this link https://www.gotomeeting.com/webinar, (2) enter the Webinar ID: 900-513-115, and (3) enter your name and email address (required). After logging in to the webinar, please (1) dial this TOLL number 1-562-247-8321 (not a toll-free number), (2) enter the attendee phone audio access code 396-645-679, and (3) then enter your audio phone pin (shown after joining the webinar). NOTE: We have disabled Mic/Speakers as an option and require all participants to use a telephone or cell phone to participate. Technical Information and system requirements: PC-based attendees are required to use Windows® 7, Vista, or XP; Mac®-based attendees are required to use Mac OS® X 10.5 or newer; Mobile attendees are required to use iPhone®, iPad®, AndroidTM phone or Android tablet (See the GoToMehyeting WebinarApps). You may send an email to Mr. Kris Kleinschmidt at [email protected] or contact him at 503-820-2280, extension 411 for technical assistance. A public listening station is available at the Pacific Council office (address below).

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Robin Ehlke, Pacific Council; telephone: (503) 820-2410.

    SUPPLEMENTARY INFORMATION:

    The purpose of the methodology review meeting is to discuss and review proposed changes to analytical methods used in salmon management. Results and recommendations from this methodology review meeting will be presented at the November 14-20, 2017, Council meeting in Costa Mesa, CA where the Council is scheduled to take final action on the proposals. At the September 2017 meeting, the Council adopted one topic for consideration at the methodology review meeting. The topic under review is: Technical Revision to the Marine Survival Index of the Oregon Coastal Natural Coho Work Group Harvest Matrix. Public comments during the webinar will be received from attendees at the discretion of the chairs of the STT and SSC-Salmon.

    Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the 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 Mr. Kris Kleinschmidt (503) 820-2411 at least 10 business days prior to the meeting date.

    Dated: September 28, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-21178 Filed 10-2-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF709 Advisory Committee to the U.S. Section of the International Commission for the Conservation of Atlantic Tunas; Fall Meeting AGENCY:

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

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In preparation for the 2017 International Commission for the Conservation of Atlantic Tunas (ICCAT) meeting, the Advisory Committee to the U.S. Section to ICCAT is announcing the convening of its fall meeting.

    DATES:

    The meeting will be held on October 17-18, 2017. There will be an open session on Tuesday, October 17, 2017, from 9 a.m. through approximately 12:30 p.m. The remainder of the meeting will be closed to the public and is expected to end by 1 p.m. on October 18. Interested members of the public may present their views during the public comment session on October 17, 2017.

    ADDRESSES:

    The meeting will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Written comments should be sent via email to [email protected] Comments may also be sent via mail to Terra Lederhouse at NMFS, Office of International Affairs and Seafood Inspection, Room 10643, 1315 East-West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Terra Lederhouse, Office of International Affairs and Seafood Inspection, 301-427-8360.

    SUPPLEMENTARY INFORMATION:

    The Advisory Committee to the U.S. Section to ICCAT will meet October 17-18, 2017, first in an open session to consider management- and research-related information on stock status of Atlantic highly migratory species and then in a closed session to discuss sensitive matters. The open session will be from 9 a.m. through 12:30 p.m. on October 17, 2017, including an opportunity for public comment beginning at approximately 12 p.m. Comments may also be submitted in writing for the Advisory Committee's consideration. Interested members of the public can submit comments by mail or email; use of email is encouraged. All written comments must be received by October 13, 2017 (see ADDRESSES).

    NMFS expects members of the public to conduct themselves appropriately at the open session of the Advisory Committee meeting. At the beginning of the public comment session, an explanation of the ground rules will be provided (e.g., alcohol in the meeting room is prohibited, speakers will be called to give their comments in the order in which they registered to speak, each speaker will have an equal amount of time to speak and speakers should not interrupt one another). The session will be structured so that all attending members of the public are able to comment, if they so choose, regardless of the degree of controversy of the subject(s). Those not respecting the ground rules will be asked to leave the meeting.

    After the open session, the Advisory Committee will meet in closed session to discuss sensitive information relating to upcoming international negotiations regarding Atlantic highly migratory species conservation and management.

    Special Accommodations

    The meeting location is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Terra Lederhouse at (301) 427-8360 or [email protected] at least 5 days prior to the meeting date.

    Dated: September 28, 2017. Steven Wilson, Acting Director, Office of International Affairs and Seafood Inspection, National Marine Fisheries Service.
    [FR Doc. 2017-21219 Filed 10-2-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Pacific Islands Region Vessel and Gear Identification Requirements AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before December 4, 2017.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Walter Ikehara, (808) 725-5175 or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This request is for extension of a currently approved information collection.

    Regulations at 50 CFR 665.16 require that all U.S. vessels with Federal permits fishing for Western Pacific fishery management unit species display identification markings on the vessel and gear, as specified in 50 CFR 665 and 50 CFR 300. Vessels registered for use with a permit issued under Subparts B through E and Subparts G through I of 50 CFR 665, must display the vessel's official number on both sides of the deckhouse or hull, and on an appropriate weather deck. Vessels fishing for highly migratory species in the Western and Central Pacific Fisheries Commission (WCPFC) Convention Area must comply with the regulations at 50 CFR 300.217. These regulations require that vessels must display their international radio call sign on both sides of the deckhouse or hull, and on an appropriate weather deck, unless specifically exempted. Regulations at 50 CFR 300.35 require that vessels fishing under the South Pacific Tuna Treaty must display their international radio call sign on the hull, the deck, and on the sides of auxiliary equipment such as skiffs and helicopters. The numbers must be a specific size at specified locations. The display of the identifying numbers aids in fishery law enforcement.

    Western Pacific fisheries regulations at 50 CFR 665.128, 665.228, 665.428, 665.628 and 665.804 require that certain fishing gear must be marked. In the pelagic longline fisheries, the vessel operator must ensure that the official number of the vessel is affixed to every longline buoy and float. In the coral reef ecosystem fisheries, the vessel number must be affixed to all fish and crab traps. The marking of gear links fishing or other activity to the vessel, aids law enforcement, and is valuable in actions concerning the damage, loss of gear, and civil proceedings.

    II. Method of Collection

    Third party disclosure

    III. Data

    OMB Control Number: 0648-0360.

    Form Number: None.

    Type of Review: Regular submission (extension of a currently approved collection).

    Affected Public: Business or other for-profit organizations, individuals, or households.

    Estimated Number of Respondents: 339.

    Estimated Time per Response: 45 minutes per Pacific Islands fishing vessel; one hour and 15 minutes per South Pacific purse seine vessel; 5 minutes per gear marking.

    Estimated Total Annual Burden Hours: 2,348.

    Estimated Total Annual Cost to Public: $50,850 in recordkeeping/reporting costs.

    IV. Request for Comments

    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 shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (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 respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: September 28, 2017. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2017-21213 Filed 10-2-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office [Docket No. PTO-P-2017-0039] Cash Payment Method Will No Longer Be Accepted AGENCY:

    United States Patent and Trademark Office, Department of Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO) will no longer accept cash, including coins, as payment for products and services for which fees are required.

    DATES:

    Applicable Date: November 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Matthew Lee, Director, Receipts Accounting Division, Office of Finance, by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Effective November 1, 2017, the USPTO will no longer accept cash, including coins, as payment for products and services for which fees are required. This change is being made to streamline the administrative fee collection process and is in accordance with the Department of the Treasury's policy on agencies adopting a no-cash policy. See https://tfm.fiscal.treasury.gov/v1/bull/17-12.pdf. There is no requirement that the USPTO accept cash payments. See, e.g., 37 CFR 1.23.

    The USPTO's total net revenue for the last three fiscal years exceeded $3.0 billion each year, and the cash payment method collections averaged less than $14,000 each year. In fiscal year (FY) 2016, the cash payment method comprised less than $11,000, which represented less than 0.0004 percent of total net revenue collections. Furthermore, the USPTO processed over 4.95 million total fee transactions in FY 2016, and only 55 patent fees totaling under $5,000, and eleven trademark fees totally under $4,000, were paid by cash.

    The only other fees collected by cash in FY 2016 were about $1,500 in copying fees. The current self-service copiers are to be discontinued as part of Office plans to enter a “No Cost” contract with a vendor who will keep all payments collected in exchange for providing this service. See Setting and Adjusting Patent Fees During Fiscal Year 2017, 81 FR 68150, 68168 (Oct. 3, 2016) (proposed rule).

    For the past three years, the overwhelming majority of fees have been paid to the USPTO using a payment method other than cash, and the costs of handling, safeguarding, auditing, transporting, and depositing of cash payments greatly outweigh the benefits of continuing to accept the cash payment method.

    While the USPTO will no longer accept the cash payment method on or after November 1, 2017, payments will continue to be accepted in-person and by mail when made by check or money order, credit/debit card, or deposit account. Payment of fees attempted with cash will be refused and returned. More information about all accepted payment methods is available at https://www.uspto.gov/learning-and-resources/fees-and-payment/accepted-payment-methods.

    Dated: September 25, 2017. Joseph D. Matal, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2017-21194 Filed 10-2-17; 8:45 am] BILLING CODE 3510-16-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No. CFPB-2017-0033] Agency Information Collection Activities: Comment Request AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection, titled, “Generic Information Collection Plan for Studies of Consumers using Controlled Trials in Field and Economic Laboratory Settings.”

    DATES:

    Written comments are encouraged and must be received on or before December 4, 2017 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:

    Electronic: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Consumer Financial Protection Bureau (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552.

    Hand Delivery/Courier: Consumer Financial Protection Bureau (Attention: PRA Office), 1275 First Street NE., Washington, DC 20002.

    Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or Social Security numbers, should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Documentation prepared in support of this information collection request is available at www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435-9575, or email: [email protected] Please do not submit comments to this mailbox.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Generic Information Collection Plan for Studies of Consumers using Controlled Trials in Field and Economic Laboratory Settings.

    OMB Control Number: 3170-0048.

    Type of Review: Extension without change of a currently approved information collection.

    Affected Public: Individuals and Households.

    Estimated Number of Respondents: 42,600.

    Estimated Total Burden Hours: 38,400.

    Abstract: Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Bureau is tasked with researching, analyzing, and reporting on topics relating to the Bureau's mission, including developments in markets for consumer financial products and services, consumer awareness, and consumer behavior. The Bureau seeks to renew the OMB approval for a generic information collection plan to collect data from purposive samples through controlled trials in field and economic laboratory settings. This research will be used for developmental and informative purposes in order to increase the Bureau's understanding of consumer credit markets and household financial decision-making. Basic research projects will be submitted under this clearance. This is a routine request for OMB to renew its approval of the collections of information currently approved under this OMB control number. The Bureau is not proposing any new or revised collections of information pursuant to this request.

    Request For Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the 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 respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.

    Dated: September 27, 2017. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2017-21236 Filed 10-2-17; 8:45 am] BILLING CODE 4810-AM-P
    CONSUMER PRODUCT SAFETY COMMISSION Sunshine Act Meeting Notice TIME AND DATE:

    Wednesday, October 11, 2017, 10:00 a.m.-12:00 p.m.

    PLACE:

    Hearing Room 420, Bethesda Towers, 4330 East-West Highway, Bethesda, MD.

    STATUS:

    Commission Meeting—Open to the Public

    Matter To Be Considered:

    Briefing Matters: (1) Revision to the Notice of Requirements (NOR) for Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates—Notice of Proposed Rulemaking; (2) Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates—Final Rule

    A live webcast of the Meeting can be viewed at https://www.cpsc.gov/live.

    CONTACT PERSON FOR MORE INFORMATION:

    Rockelle Hammond, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814, (301) 504-7923.

    Dated: September 29, 2017. Alberta E. Mills, Acting Secretary.
    [FR Doc. 2017-21318 Filed 9-29-17; 4:15 pm] BILLING CODE 6355-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0105] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Progress Reporting Form for the American Indian Vocational Rehabilitation Services (AIVRS) Program AGENCY:

    Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 2, 2017.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0105. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 216-44, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact August Martin, 202-245-7410.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Annual Progress Reporting Form for the American Indian Vocational Rehabilitation Services (AIVRS) Program.

    OMB Control Number: 1820-0655.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments

    Total Estimated Number of Annual Responses: 88.

    Total Estimated Number of Annual Burden Hours: 968.

    Abstract: The Rehabilitation Services Administration (RSA) of the U.S. Department of Education's (ED) Office of Special Education and Rehabilitative Services (OSERS) will use this data collection form to capture the performance data from grantees funded under the American Indian Vocational Rehabilitation Services (AIVRS) program (CFDA # 84.250). RSA and ED will use the information gathered annually to: (a) Comply with reporting requirements under the Education Department General Administration Regulations (EDGAR) 34 CFR part 75.118, (b) provide information annually to Congress on activities conducted under this program, and (c) measure performance on the program in accordance with the program indicators identified in the Government Performance Result Act (GPRA). The proposed changes to the existing form will improve user friendliness, clarity of data questions, and accuracy of data reported. Since the ED no longer collects data regarding common measures, the entire section of the report that collects this data is deleted, further reducing burden. These revisions are not significantly different from the original collection, but are proposed to provide clarity, consistency, and usability. In many areas, the data element language has been modified with direct language instead of passive terminology.

    Dated: September 27, 2017. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2017-21142 Filed 10-2-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP17-1086-000.

    Applicants: Alliance Pipeline L.P.

    Description: § 4(d) Rate Filing: Negotiated Rate Filing November 2017 to be effective 11/1/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5046.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1087-000.

    Applicants: Iroquois Gas Transmission System, L.P.

    Description: § 4(d) Rate Filing: 092717 Negotiated Rates—Spark Energy Gas, LLC R-3045-22 to be effective 11/1/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5058.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1088-000.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.

    Description: § 4(d) Rate Filing: Volume No. 2—Orion Project to be effective 11/1/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5076.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1089-000.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.

    Description: § 4(d) Rate Filing: Orion Project—Recourse Rate Filing to be effective 11/1/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5079.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1090-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Amendments to Neg Rate Agmts (ExGen 43197-7 and 43198-8) to be effective 9/28/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5093.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1091-000.

    Applicants: Northern Natural Gas Company.

    Description: § 4(d) Rate Filing: 20170927 IDD Enhancement to be effective 11/1/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5106.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1092-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: W Roxbury Lateral—Revised NRA eff 11-1-2017 to be effective 11/1/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5116.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1093-000.

    Applicants: El Paso Natural Gas Company, L.L.C.

    Description: § 4(d) Rate Filing: Non-Conforming Agreement Filing (Atmos) to be effective 11/1/2017.

    Filed Date: 9/27/17.

    Accession Number: 20170927-5117.

    Comments Due: 5 p.m. ET 10/10/17.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 28, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-21208 Filed 10-2-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP15-1100-001.

    Applicants: National Fuel Gas Supply Corporation.

    Description: Compliance filing Decoupled Releases Compliance Filing to be effective N/A.

    Filed Date: 9/25/17.

    Accession Number: 20170925-5092.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP16-1299-003.

    Applicants: Kinetica Energy Express, LLC.

    Description: Compliance filing Compliance Filing to be effective 11/1/2016.

    Filed Date: 9/25/17.

    Accession Number: 20170925-5016.

    Comments Due: 5 p.m. ET 10/10/17.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 27, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-21207 Filed 10-2-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP17-1083-000.

    Applicants: MarkWest Pioneer, L.L.C.

    Description: MarkWest Pioneer, L.L.C. submits tariff filing per 154.204: Nonconforming Negotiated Rate Service Agreement to be effective 11/1/2017.

    Filed Date: 9/25/17.

    Accession Number: 20170925-5055.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1084-000.

    Applicants: Alliance Pipeline L.P.

    Description: Alliance Pipeline L.P. submits tariff filing per 154.204: Cargill sale to Macquarie to be effective 10/1/2017.

    Filed Date: 9/25/17.

    Accession Number: 20170925-5100.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Numbers: RP17-1085-000.

    Applicants: El Paso Natural Gas Company, L.L.C.

    Description: El Paso Natural Gas Company, L.L.C. submits tariff filing per 154.601: Negotiated Rate Agreement Update (Pioneer Oct-Dec 2017) to be effective 10/1/2017.

    Filed Date: 9/25/17.

    Accession Number: 20170925-5115.

    Comments Due: 5 p.m. ET 10/10/17.

    Docket Number: PR17-61-000.

    Applicants: ONEOK WesTex Transmission, L.L.C.

    Description: Tariff filing per 284.123(b), (e)+(g): Revised Statement of Operating Conditions—to be effective 9/1/2017.

    Filed Date: 9/22/17.

    Accession Number: 201709225130.

    Comments Due: 5 p.m. ET 10/13/17.

    284.123(g) Protests Due: 5 p.m. ET 11/21/17.

    Docket Number: PR17-62-000.

    Applicants: Trans-Pecos Pipeline, LLC.

    Description: Tariff filing per 284.123(b), (e)/: Trans-Pecos Pipeline, LLC Baseline SOC, to be effective 8/23/2017.

    Filed Date: 9/22/17.

    Accession Number: 201709225155.

    Comments/Protests Due: 5 p.m. ET 10/13/17.

    Docket Number: PR17-63-000.

    Applicants: Comanche Trail Pipeline, LLC.

    Description: Tariff filing per 284.123(b), (e)/: Comanche Trail Pipeline, LLC Baseline SOC, to be effective 8/24/2017.

    Filed Date: 9/22/17.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 29, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-21206 Filed 10-2-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Western Area Power Administration Office of General Counsel; Agency Information Collection Extension AGENCY:

    Western Area Power Administration, Department of Energy.

    ACTION:

    Submission for Office of Management and Budget review; request for comments.

    SUMMARY:

    Western Area Power Administration (WAPA), an agency within the Department of Energy (DOE), submitted an extension to an existing Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review, comment, and approval, as required under the Paperwork Reduction Act of 1995. The ICR seeks a 3-year extension for WAPA's Applicant Profile Data form (APD), OMB Control No. 1910-5136. The ICR described below identifies the request, including the anticipated public burden. The ICR is necessary for the proper performance of WAPA's functions. WAPA markets a limited amount of Federal hydropower. Due to the high demand for WAPA's power, WAPA needs the ability to collect information under the ICR in order to evaluate who may receive an allocation of Federal power pursuant to specific marketing plans. This APD public process only determines the information WAPA will collect in its ICR. The actual allocation of Federal power will be conducted through a separate marketing plan process outside the scope of this APD process.

    DATES:

    To ensure consideration, comments regarding this collection must be received on or before November 2, 2017. The Paperwork Reduction Act requires OMB to make a decision on the extension of the ICR within 60 days after this publication or receipt of the proposed collection of information, whichever is later. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. You may phone the Desk at 202-395-4718.

    ADDRESSES:

    Written comments should be sent to: The DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW., Washington, DC 20503.

    A copy of the comments should be sent to WAPA, attention Mr. Brent Osiek, Vice President of Power Marketing, Western Area Power Administration, 150 East Social Hall Avenue, Suite 300, Salt Lake City, UT 84111 or by email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the APD should be directed to Mr. Brent Osiek at the above address or by telephone at 801-524-5495. The APD is available on WAPA's Web page at www.wapa.gov/PowerMarketing/Pages/applicant-profile-data.aspx and www.wapa.gov/PowerMarketing/Documents/Applicant-Profile-Data-form.pdf.

    SUPPLEMENTARY INFORMATION: I. Statutory Authority

    Reclamation Laws are a series of laws arising from the Desert Land Act of 1877 and include, but are not limited to: The Desert Land Act of 1877, Reclamation Act of 1902, Reclamation Project Act of 1939, and the Acts authorizing each individual project such as the Central Valley Project Authorizing Act of 1937.1 The Reclamation Act of 1902 established the Federal reclamation program.2 The basic principle of the Reclamation Act of 1902 was that the United States, through the Secretary of the Interior, would build and operate irrigation works from the proceeds of public land sales in the sixteen arid Western states (a seventeenth was later added). The Reclamation Project Act of 1939 expanded the purposes of the reclamation program and specified certain terms for contracts that the Secretary of the Interior enters into to furnish water and power.3 In 1977, the Department of Energy Organization Act transferred the power marketing functions of the Department of the Interior to the Secretary of Energy, acting by and through a separate Administrator for WAPA.4 Section 5 of the Flood Control Act of 1944 is read in pari materia with Reclamation Laws with respect to WAPA.5

    1See Ch. 107, 19 stat. 377 (1877), Ch. 1093, 32 Stat. 388 (1902), Ch. 418, 53 Stat. 1187 (1939), Ch. 832, 50 Stat. 844, 850 (1937), all as amended and supplemented.

    2See Ch. 1093, 32 Stat. 388 (1902), as amended and supplemented.

    3See Ch. 418, 53 Stat. 1187 (1939), as amended and supplemented.

    4See 42 U.S.C. 7152(a)(1)(D).

    5See Act of December 22, 1944, Ch. 665, 58 Stat. 887, as amended and supplemented.

    II. Purpose of Proposed Collection

    WAPA is collecting—and will continue to collect—the data under its APD to properly perform its function of marketing a limited amount of Federal hydropower. The information WAPA collects is voluntary. Due to the high demand for WAPA's power and limited amount of available power, WAPA will use the information collected in the APD—and has used the information collected under the current OMB-approved control number—pursuant to its marketing plans, to determine an applicant's eligibility for an allocation of Federal power. As a result, the information WAPA collects under its APD is both necessary and useful.

    WAPA notes the Paperwork Reduction Act 6 is the process whereby WAPA obtains approval from OMB to collect information from the public. It is a legal requirement that WAPA must comply with before requesting an interested party submit an application for power. The Paperwork Reduction Act process is not the process in which interested parties apply for a new allocation of Federal power. The allocation of power from WAPA is outside the scope of this process and is completed in a separate marketing plan process by each WAPA region, when required.

    6See 44 U.S.C. 3501, et seq.

    III. Background to This Process and Responses to Comments A. Background

    On May 18, 2017, in compliance with the Paperwork Reduction Act, WAPA published a notice in the Federal Register inviting comments on extending WAPA's APD, OMB Control No. 1910-5136.7 WAPA provided a 60-day comment period. As part of that notice, WAPA invited comments on: (1) Whether the proposed continued collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden, 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 the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    7See 82 FR 22825 (2017).

    In May 2017, concurrent with the publication of the Federal Register notice, WAPA posted an Invitation for Comments on its Web page at www.wapa.gov/PowerMarketing/Pages/applicant-profile-data.aspx. WAPA emailed over 1,000 stakeholders (customers, interested parties, and customer associations) informing them of the publication of the Federal Register notice and Invitation for Comments. The email went to stakeholders in WAPA's service territory, which includes, but is not limited to, Arizona, California, Colorado, Iowa, Kansas, Minnesota, Montana, Nebraska, Nevada, New Mexico, North Dakota, South Dakota, Texas, Utah, and Wyoming.

    B. Response to Comments

    WAPA received no comments.

    IV. Information Collection Request: Applicant Profile Data, OMB Control No. 1910-5136

    WAPA submitted to OMB the request to extend WAPA's APD. The APD and responses to the APD will not be part of a system of records covered by the Privacy Act 8 and will be available under the Freedom of Information Act.9

    8See 5 U.S.C. 552(a).

    9See 5 U.S.C. 552. WAPA reserves the right to redact information to protect confidential or sensitive information, as provided under FOIA.

    A copy of the APD is available on WAPA's Web page at: www.wapa.gov/PowerMarketing/Pages/applicant-profile-data.aspx and www.wapa.gov/PowerMarketing/Documents/Applicant-Profile-Data-form.pdf. As discussed, WAPA is not making any significant changes in the content and format of the APD. The APD and the administrative record for the proposal justifying APD's continued use are available for inspection and copying at WAPA's Headquarters in Lakewood, Colorado.

    As part of this process, WAPA has identified the minimum amount of information WAPA needs for its regional offices to properly perform the power marketing functions of the agency. Due to the variations that may develop in each region, the regional office, through its marketing plan, may determine that it does not need to collect all of the information contained in the APD. As a result, WAPA will allow each region to use subsets of the form, where one region's APD may request less information than another region's APD. Also, to ensure equitable treatment of applications when issuing a call for applications, WAPA may provide additional directions to clarify certain sections of the APD, e.g., identify the year or years to use in preparing the APD. Rather than collect unnecessary information, WAPA seeks to collect only the minimal amount of information it needs. To be considered for an allocation of Federal power from WAPA under a marketing plan, the applicant must provide the information requested in the APD. If the requested information is not applicable or is not available, the applicant will note it on the APD. WAPA will request, in writing, additional information from any applicant whose application is deficient. WAPA will notify the applicant when the application is due. In the event an applicant fails to provide sufficient information to allow WAPA to make a determination regarding eligibility by the due date, the application will not be considered.

    V. Paperwork Reduction Requirements A. Introduction

    1. OMB Number: WAPA's existing OMB Number is 1910-5136. This number is displayed on the front page of the APD. It expires on September 30, 2017.

    2. Title: Applicant Profile Data.

    3. Type of Review: WAPA is seeking to extend its APD for 3 years.

    4. Purpose: The APD is necessary for the proper performance of WAPA's functions. WAPA markets a limited amount of Federal power. Due to the high demand for WAPA's power and limited amount of available power under established marketing plans, WAPA needs to be able to collect information to evaluate who may receive an allocation under a marketing plan. As a result, the information WAPA collects is both necessary and useful. This public process only determines the information WAPA will collect in its application. The actual allocation of Federal power under a specific marketing plan is outside the scope of this APD process.

    5. Respondent: The response is voluntary. However, if an entity seeks an allocation of Federal power, the respondent must submit an APD to the specified WAPA regional office. WAPA has identified the following class of respondents as the most likely to apply: Municipalities, cooperatives, public utilities, irrigation districts, Native American tribes, and Federal and State agencies. The respondents will be located in Arizona, California, Colorado, Iowa, Kansas, Minnesota, Montana, Nebraska, Nevada, New Mexico, North Dakota, South Dakota, Texas, Utah, and Wyoming. The information submitted on the APD will not be part of a system of records covered by the Privacy Act 10 and will be available under the Freedom of Information Act.11

    10See 5 U.S.C. 552(a).

    11See 5 U.S.C. 552. WAPA reserves the right to redact information to protect confidential or sensitive information, as provided under FOIA.

    6. Annual Estimated Number of Respondents: The responses will be periodic and occur when WAPA has power available under a specific marketing plan process. Based on historical data, WAPA anticipates approximately 100 requests for power during the 3-year period when the OMB Clearance Number is in effect. This results in an estimated annual average of 33.33 respondents.

    7. Number of Burden Hours and Estimated Reporting and Recordkeeping Costs:

    a. Initial Application: WAPA anticipates that it will take less than 8 hours to complete the APD. Once the respondent completes the APD, it will submit the APD to WAPA for review. After submitting the APD, provided the APD is complete and no clarification is required, WAPA does not anticipate requiring any further information for the APD from the applicant, unless the applicant is successful in obtaining a power allocation. The applicant submits only one APD. It does not submit an APD every year. If the applicant receives a power allocation, the applicant will need to complete a regional contract with WAPA to receive a Federal power allocation. WAPA's standard contract terms are outside the scope of this process.

    Table 1—Annual Hour Burden Estimates Total number of unduplicated respondents 33.333 Reports filed per person 1 Total annual responses 33.333 Total annual burden hours 266.664 Average Burden: Per Collection: 8 Per Applicants: 8

    b. Recordkeeping: There is no mandatory recordkeeping requirement for the applicant if it does not receive an allocation of Federal power. In such case, any recordkeeping of the APD by a respondent is voluntary. For those entities that receive a Federal power allocation, WAPA requires the successful applicant to keep the information for 3 years after WAPA grants the power allocation and the applicant signs its regional contract with WAPA. The 3-year record retention policy will allow WAPA sufficient time to administer the regional contract and to ensure the applicant provided factual information in its application. A 3-year record retention policy will have little impact on most businesses in the electric utility industry. WAPA anticipates that it would take less than 1 hour per successful applicant, per year, for recordkeeping purposes. Within a 3-year period, WAPA anticipates having approximately 30 successful applicants.

    c. Methodology: Based on the total number of burden hours and the total number of applications described above, WAPA expects that over a 3-year period, the total burden hours to complete the APD is 800 hours (100 applicants over 3 years × 8 hours per applicant). This converts to an annual hourly burden of 266.7 hours. An entity will only complete the APD once; it is not required each year. WAPA anticipates that there will be additional cost burdens for recordkeeping of 1 hour per year for each applicant who receives a Federal power allocation. Over the course of 3 years, WAPA anticipates there will be 30 successful applicants. The power may be allocated in year 1, year 2, or year 3. For the purposes of determining the cost burden, WAPA will presume all 30 applicants received an allocation in year 1. As a result, the annual hourly burden for recordkeeping is 30 hours. For the purposes of this cost burden analysis, WAPA is assuming that a utility staff specialist will complete the APD. WAPA estimates a utility staff specialist rate, including administrative overhead, to be approximately $121/hour. For recordkeeping, WAPA estimates an administrative support rate of $60/hour.

    d. Summary of Burdens: Based on the above, WAPA estimates the total annual cost as [(8 × $121) × 33.33) + ((1 × $60) × 30)] = $34,063.44 per year. Using these estimates, the applicant's cost to complete the APD is a one-time cost per response of $968. In addition to the one-time cost, the applicant will incur an additional expense of 1 hour for recordkeeping per year at the administrative support rate of $60/hour if it successfully receives a power allocation under a marketing plan. The procedure and process for the allocation of power shall be the subject matter of a separate notice and is outside the scope of this process.

    Table 2—Annual Cost Burden Estimate Instrument Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Average
  • annual burden
  • hour
  • Cost per
  • burden hour
  • Cost per
  • response
  • Sub-total
  • cost
  • Prepare APD 33.33 1 8 $121 $968 $32,263.44 Recordkeeping 30 1 1 60 60 1,800.00 Total Cost 34,063.44
    B. Does the collection of data avoid unnecessary duplication?

    To avoid unnecessary duplication, only entities that desire a new WAPA allocation are required to submit an APD. As it relates to each component of the APD, there is no duplication. Section 1 is information WAPA needs to identify the applicant; whether the applicant is a statutorily-defined preference entity; 12 and whether the applicant is ready, willing, and able to receive and/or distribute Federal power. Section 2 identifies the amount of Federal power that the applicant requests. Section 3 identifies the applicant's loads. Section 4 identifies the applicant's power supply resources. Section 5 identifies the applicant's transmission delivery arrangements to receive Federal power. Section 6 is voluntary and provides the applicant with the ability to provide any additional information. Section 7 is an attestation that the information provided is true and accurate to the best of the applicant's knowledge.

    12See e.g., 43 U.S.C. 485h(c).

    C. Does the collection reduce the burden on the respondent, including small entities, to the extent practicable and appropriate?

    The information requested is the minimum amount of information needed to determine whether the applicant qualifies as a statutorily-defined preference entity and is ready, willing, and able to receive an allocation of Federal power under a marketing plan.13

    13See e.g., 43 U.S.C. 485h(c).

    D. Does the collection use plain, coherent, and unambiguous language that is understandable to the respondent?

    The collection uses plain, coherent, and unambiguous language that is understandable to the target audience. The terms in the collection are those used in the electric utility industry. WAPA does not market power to individual members of the public such as homeowners or shopkeepers. Preference entities are statutorily-designated potential customers who generally are involved in the power business. As a result, the language used in the application is understandable to the target audience.

    E. Is the collection consistent with and compatible with the respondent's current reporting and recordkeeping practices to the maximum extent practicable?

    The information collection is voluntary. WAPA will use the information to determine an allocation of Federal power under a marketing plan. As discussed above, there is no mandatory recordkeeping requirement on the applicant if it does not receive an allocation of Federal power. For those entities that receive a Federal power allocation, WAPA requires that they keep the information for 3 years after WAPA grants the power allocation and the applicant signs a Federal power contract. The 3-year record retention policy for such applicants allows WAPA sufficient time to administer the regional contract and to ensure the applicant provided factual information in its application. WAPA anticipates that a 3-year record retention policy will have little impact on most businesses in the power industry who will keep the APD as part of their normal business records. The procedure and process for the allocation of power shall be the subject matter of a separate marketing plan notice and is outside the scope of this process.

    F. Does the collection indicate the retention period for any recordkeeping requirements for the respondent?

    The APD identifies that there is no recordkeeping requirement for the respondent if it does not receive an allocation of Federal power. It also identifies that applicants who receive an allocation of Federal power must retain the records for 3 years.

    G. Does the collection inform the public of the information the public needs to exercise scrutiny concerning the agency need to collect information (the reasons the information is collected, the way it is used, an estimate of the burden, whether the response is voluntary, required to obtain a benefit, or mandatory and a statement that no person is required to respond unless a valid OMB control number is displayed)?

    WAPA has a limited amount of power available and WAPA's Administrator has discretion in allocating power under a marketing plan. WAPA will (a) use the information collected on the application, (b) not accept incomplete applications, and (c) work with respondents that require assistance in completing the application. No respondent is required to submit any information unless a valid OMB control number is displayed. No respondent is required to submit any information unless they desire a Federal power allocation under a marketing plan.

    H. Is the collection developed by an office that has planned and allocated resources for the efficient and effective management and use of the information collected?

    WAPA's regional power marketing offices will administer and evaluate the applications. Use and management of the collected information were factored into each office's functions and resource requirements. Historically, WAPA has requested the same relative information from applicants and effectively used WAPA resources to utilize and manage the information in its determinations. Each office will make a recommendation to WAPA's Administrator on which applicant(s) should be awarded a Federal power allocation based upon marketing plan requirements and the information contained in the APD. WAPA's Administrator has discretion in the final award of power allocations. The procedure and process for the allocation of power shall be the subject matter of a separate marketing plan notice and is outside the scope of this process.

    I. Does the collection use effective and efficient statistical survey methods?

    Since the information collected is used to help determine whether an applicant may receive an allocation of Federal power, this section is not applicable.

    J. Does the collection use information technology to the maximum extent practicable to reduce the burden and to improve data quality, agency efficiency, and responsiveness to the public?

    The APD will be accessible for downloading via WAPA's Web page at www.wapa.gov/PowerMarketing/Documents/Applicant-Profile-Data-form.pdf. WAPA will accept email and mail submission of the APD.

    VII. Invitation for Comments

    WAPA invites public comment on its request to extend its APD that WAPA submitted to OMB pursuant to the Paperwork Reduction Act of 1995. The Paperwork Reduction Act requires OMB to make a decision on the ICR within 60 days after this publication or receipt of the proposed collection of information, whichever is later.14 Comments should be sent directly to the addresses listed in the ADDRESSES section.

    14See 5 CFR 1320.10(b).

    Dated: August 25, 2017. Mark A. Gabriel, Administrator.
    [FR Doc. 2017-21322 Filed 9-29-17; 4:15 pm] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2017-0008; FRL-9967-34] Pesticide Product Registration; Receipt of Applications for New Uses AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.

    DATES:

    Comments must be received on or before November 2, 2017.

    ADDRESSES:

    Submit your comments, identified by the Docket Identification (ID) Number and the File Symbol of interest as show in the body of this document, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. Registration Applications

    EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.

    III. New Uses

    1. EPA Registration Number: 352-591. Docket ID number: EPA-HQ-OPP-2017-0397. Applicant: E. I. DuPont de Nemours and Company, Inc. (S300/419), Chestnut Run Plaza, 974 Centre Road, Wilmington, DE 19805. Active ingredient: Cymoxanil. Product type: Fungicide. Proposed uses: Arugula; bean, succulent; brassica, leafy greens, subgroup 4-16B; carrot, roots; celtuce; florence fennel; garden cress; ginseng; leaf petiole vegetable subgroup 22B; leafy greens subgroup 4-16A, except spinach; mango; upland cress; vegetable, fruiting, group 8-10, except tomato; and vegetable, tuberous and corm, subgroup 1C. Contact: RD.

    2. EPA Registration Number: 352-604. Docket ID number: EPA-HQ-OPP-2017-0397. Applicant: E. I. DuPont de Nemours and Company, Inc. (S300/419), Chestnut Run Plaza, 974 Centre Road, Wilmington, DE 19805. Active ingredients: Famoxadone and cymoxanil. Product type: Fungicide. Proposed use: Arugula; bean, succulent; brassica, leafy greens, subgroup 4-16B; carrot, roots; celtuce; florence fennel; garden cress; ginseng; leaf petiole vegetable subgroup 22B; leafy greens subgroup 4-16A, except spinach; mango; upland cress; vegetable, fruiting, group 8-10, except tomato; and vegetable, tuberous and corm, subgroup 1C. Contact: RD.

    3. EPA Registration Number: 352-605. Docket ID number: EPA-HQ-OPP-2017-0397. Applicant: E. I. DuPont de Nemours and Company, Inc. (S300/419), Chestnut Run Plaza, 974 Centre Road, Wilmington, DE 19805. Active ingredient: Famoxadone. Product type: Fungicide. Proposed use: Arugula; bean, succulent; brassica, leafy greens, subgroup 4-16B; carrot, roots; celtuce; florence fennel; garden cress; ginseng; leaf petiole vegetable subgroup 22B; leafy greens subgroup 4-16A, except spinach; mango; upland cress; vegetable, fruiting, group 8-10, except tomato; and vegetable, tuberous and corm, subgroup 1C. Contact: RD.

    4. EPA Registration Number: 71512-7. Docket ID number: EPA-HQ-OPP-2017-0224. Applicant: ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077. Active ingredient: Flonicamid. Product type: Insecticide. Proposed uses: New use on Clover & crop group expansions/conversions to the brassica, leafy greens subgroup 4-16B; cottonseed subgroup 20C; celtuce; florence fennel; kohlrabi; leaf, petiole vegetable subgroup 22B; leafy greens subgroup 4-16A, except spinach; and vegetable, brassica, head and stem, group 5-16. Contact: RD.

    5. EPA Registration Number: 71512-9. Docket ID number: EPA-HQ-OPP-2017-0224. Applicant: ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077. Active ingredient: Flonicamid. Product type: Insecticide. Proposed uses: New use on clover & crop group expansions/conversions to the brassica, leafy greens subgroup 4-16B; cottonseed subgroup 20C; celtuce; florence fennel; kohlrabi; leaf, petiole vegetable subgroup 22B; leafy greens subgroup 4-16A, except spinach; and vegetable, brassica, head and stem, group 5-16. Contact: RD.

    6. EPA Registration Number: 71512-10. Docket ID number: EPA-HQ-OPP-2017-0224. Applicant: ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077. Active ingredient: Flonicamid. Product type: Insecticide. Proposed uses: New use on Clover & crop group expansions/conversions to the brassica, leafy greens subgroup 4-16B; cottonseed subgroup 20C; celtuce; florence fennel; kohlrabi; leaf, petiole vegetable subgroup 22B; leafy greens subgroup 4-16A, except spinach; and vegetable, brassica, head and stem, group 5-16. Contact: RD.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: September 11, 2017. Delores Barber, Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
    [FR Doc. 2017-21242 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2017-0467; FRL-9966-87] Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations to Terminate Certain Uses—180-Day Comment Period AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel their registrations and to amend their product registrations to terminate uses. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled and uses terminated only if such sale, distribution, or use is consistent with the terms as described in the final order.

    DATES:

    Comments must be received on or before April 2, 2018.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0467, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Green, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0367; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me?

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. What action is the Agency taking?

    This notice announces receipt by EPA of requests from registrants to cancel certain pesticide products and amend product registrations to terminate certain uses. The affected products and the registrants making the requests are identified in Tables 1-3 of this unit.

    Unless a request is withdrawn by the registrant or if the Agency determines that there are substantive comments that warrant further review of this request, EPA intends to issue an order in the Federal Register canceling and amending the affected registrations.

    Table 1—Product Registrations With Pending Requests for Cancellation Registration No. Company
  • No.
  • Product name Active ingredient
    53883-370 53883 Quali-Pro Oxadiazon 50 WSB Oxadiazon. CA-130009 91606 Aspergillus Flavus AF36 Aspergillus flavus strain AF36. WY-080010 8033 Assail 70WP Insecticide Acetamiprid.
    Table 2—Product Registrations With Pending Requests for Amendment Registration No. Company
  • No.
  • Product name Active ingredient Uses to be terminated
    2724-404 2724 Zoecon RF-322 Ovicidal Pump Spray MGK 264; Piperonyl butoxide; Pyrethrins; & S-Methoprene Use on horses. 49620-2 49620 EKA SC-R Sodium chlorate Defoliants/desiccants applied to: Agricultural drainage systems, beans (dried type), corn, cotton, fallow land, flax, guar, peas (Southern), peppers (chili type), potatoes, rice, safflower, sorghum, soybeans, sunflowers, wheat; and as an herbicide applied to nonagricultural settings (commercial, industrial, and residential). 49620-6 49620 EKA SC-R Aqueous Sodium chlorate Defoliants/desiccants applied to: Agricultural drainage systems, beans (dried type), corn, cotton, fallow land, flax, guar, peas (Southern), peppers (chili type), potatoes, rice, safflower, sorghum, soybeans, sunflowers, wheat; and as an herbicide applied to nonagricultural settings (commercial, industrial, and residential).

    Table 3 of this unit includes the names and addresses of record for the registrants of the products listed in Table 1 and Table 2 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1 and Table 2 of this unit.

    Table 3—Registrants Requesting Voluntary Cancellation and/or Amendments EPA company No. Company name and address 2724 Wellmark International, 1501 E. Woodfield Road, Suite 200 West, Schaumburg, IL 60173. 8033 Nippon Soda Co., Ltd., Agent Name: Nisso America, Inc., 88 Pine Street, 14th Floor, New York, NY 10005. 49620 Akzo Nobel Pulp and Performance Chemicals, Inc., Agent Name: Keller and Heckman, LLP, 1001 G Street NW., Suite 500 West, Washington, DC 20001. 53883 Control Solutions, Inc., 5903 Genoa Red Bluff Road, Pasadena, TX 77507. 91606 California Cattlemen's Association Feeder Council, 1221 H Street, Sacramento, CA 95814. III. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register.

    Section 6(f)(1)(B) of FIFRA (7 U.S.C. 136d(f)(1)(B)) requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) (7 U.S.C. 136d(f)(1)(C)) requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless:

    1. The registrants request a waiver of the comment period, or

    2. The EPA Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.

    The registrants listed in Table 3 of Unit II have not requested that EPA waive the 180-day comment period. Accordingly, EPA will provide a 180-day comment period on the proposed requests.

    IV. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product cancellation or use termination should submit the withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT. If the products have been subject to a previous cancellation or use termination action, the effective date of cancellation or use termination and all other provisions of any earlier cancellation or use termination action are controlling.

    V. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the action. If the requests for voluntary cancellation and amendment to terminate uses are granted, the Agency intends to publish the cancellation order in the Federal Register.

    In any order issued in response to these requests for cancellation of product registrations and for an amendment to terminate uses, EPA proposes to include the following provisions for the treatment of any existing stocks of the products listed in Tables 1 and 2 of Unit II.

    A. For Product 53883-370.

    The registrant has requested to the Agency via letter to distribute existing stocks for an 18-month period for products 53883-370.

    For all other voluntary product cancellations identified in Table 1 of Unit II, registrants will be permitted to sell and distribute existing stocks of voluntarily canceled products for 1 year after the effective date of the cancellation, which will be the date of publication of the cancellation order in the Federal Register. Thereafter, registrants will be prohibited from selling or distributing the products identified in Table 1 of Unit II, except for export consistent with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal.

    Once EPA has approved product labels reflecting the requested amendment to terminate the use identified in Table 2 of Unit II, registrants will be permitted to sell or distribute products under the previously approved labeling for a period of 18 months after the date of Federal Register publication of the cancellation order, unless other restrictions have been imposed. Thereafter, registrants will be prohibited from selling or distributing the products whose labels include the terminated use identified in Table 2 of Unit II, except for export consistent with FIFRA section 17 or for proper disposal.

    Persons other than the registrant may sell, distribute, or use existing stocks of canceled products and products whose labels include the terminated use until supplies are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products and terminated use.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: September 8, 2017. Delores Barber, Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
    [FR Doc. 2017-21243 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2017-0466; FRL-9966-85] Notice of Receipt of Requests To Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations To Terminate Certain Uses—30-Day Comment Period AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by pesticide registrants to voluntarily cancel certain pesticide product registrations and to amend certain product registrations to terminate uses. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled and uses terminated only if such sale, distribution, or use is consistent with the terms as described in the final order.

    DATES:

    Comments must be received on or before November 2, 2017.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0466, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
    FOR FURTHER INFORMATION CONTACT:

    Christopher Green, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0367; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. What action is the Agency taking?

    This notice announces receipt by EPA of requests from pesticide registrants to cancel certain pesticide products and amend product registrations to terminate certain uses. The affected products and the registrants making the requests are identified in Tables 1A-3 of this unit.

    Unless a request is withdrawn by the registrant or if the Agency determines that there are substantive comments that warrant further review of this request, EPA intends to issue an order in the Federal Register canceling and amending the affected registrations. The cancellations of products listed in Table 1B will be effective December 31, 2020. The requests to cancel these products would terminate the last Spirodiclofen products registered for use in the United States.

    Table 1A—Product Registrations With Pending Requests for Cancellation Registration No. Company No. Product name Active ingredient 211-25 211 Pheno Cen Germicidal Detergent Potassium 2-benzyl-4-chlorophenate; o-Phenylphenol, potassium salt; & p-tert-Amylphenol, potassium salt. 211-32 211 Pheno-Cen Spray Disinfectant/Deodorant Ethanol; & o-Phenylphenol (NO INERT USE). 211-36 211 Tri-Cen Sodium 2-benzyl-4-chlorophenate; o-Phenylphenol, sodium salt; & p-tert-Amylphenol, sodium salt. 211-62 211 Low PH Phenolic 256 2-Benzyl-4-chlorophenol; & o-Phenylphenol (NO INERT USE). 769-989 769 AllPro Mosquito Barrier Spray Permethrin. 875-183 875 Divosan MH Iodine. 1677-22 1677 Mikroklene Oxirane, methyl-, polymer with oxirane, monobutyl ether, compound with iodine; & Phosphoric acid. 1677-58 1677 Mikroklene DF Oxirane, methyl-, polymer with oxirane, monobutyl ether, compound with iodine; & Phosphoric acid. 1677-89 1677 Bac-Flush Iodine; & Phosphoric acid. 2217-617 2217 Garden Weeder DCPA (or chlorthal-dimethyl?). 3862-18 3862 Germ-I-San Nonylphenoxypolyethoxyethanol-iodine complex; & Phosphoric acid. 4787-40 4787 Chlorpyrifos Technical Chlorpyrifos. 4787-41 4787 Nufos Technical Chlorpyrifos. 4787-51 4787 Cheminova Abamectin Technical Abamectin. 4787-62 4787 Chlorpyrifos Technical II Chlorpyrifos. 5383-114 5383 Polyphase HS32 Propiconazole; & Carbamic acid, butyl-, 3-iodo-2-propynyl ester. 5383-120 5383 Polyphase Micro HS30 Propiconazole; & Carbamic acid, butyl-, 3-iodo-2-propynyl ester. 7616-81 7616 Kem Tek Spa Kem Floating Brominator Bromochloro-5-ethyl-5-methyl-2,4-imidazolidinedione. 9480-7 9480 Sani-Wipe Isopropyl alcohol; & Alkyl* dimethyl benzyl ammonium chloride *(67%C12, 25%C14, 7%C16, 1%C8, C10, and C18). 9688-127 9688 Chemsico Total Release Fogger K MGK 264; Pyrethrins; & Piperonyl butoxide. 10088-23 10088 Spa Concentrated Swimming Pool Algaecide-Pool Side Surface Germicide Alkyl* dimethyl benzyl ammonium chloride *(60%C14, 30%C16, 5%C18, 5%C12); & Alkyl* dimethyl ethylbenzyl ammonium chloride *(68%C12, 32%C14). 10088-29 10088 CD Cleaner Disinfectant Deodorizer Fungicide Alkyl* dimethyl benzyl ammonium chloride *(60%C14, 30%C16, 5%C18, 5%C12); & Alkyl* dimethyl ethylbenzyl ammonium chloride *(68%C12, 32%C14). 10088-42 10088 10% Liquid Sanitizer Disinfectant Alkyl* dimethyl benzyl ammonium chloride *(60%C14, 30%C16, 5%C18, 5%C12); & Alkyl* dimethyl ethylbenzyl ammonium chloride *(68%C12, 32%C14). 10088-52 10088 Lemon Scented Disinfectant Cleaner Alkyl* dimethyl benzyl ammonium chloride *(60%C14, 30%C16, 5%C18, 5%C12); & Alkyl* dimethyl ethylbenzyl ammonium chloride *(68%C12, 32%C14). 10088-103 10088 A-Plus Germicidal Spray & Wipe Cleaner Alkyl* dimethyl benzyl ammonium chloride *(60%C14, 30%C16, 5%C18, 5%C12); & Alkyl* dimethyl ethylbenzyl ammonium chloride *(68%C12, 32%C14). 10088-104 10088 Mis-Tery Household Disinfectant and Deodorizer Spray Ethanol; 4-tert-Amylphenol; & o-Phenylphenol (NO INERT USE). 10088-105 10088 C-Spray Disinfectant Deodorant Ethanol; 4-tert-Amylphenol; & o-Phenylphenol (NO INERT USE). 10163-185 10163 Prokil Cryolite WDG Cryolite. 10324-130 10324 Maquat MC1416-10% CTP Alkyl* dimethyl benzyl ammonium chloride *(60%C14, 30%C16, 5%C18, 5%C12). 33955-474 33955 Acme Garden Weed Preventer Granules DCPA (or chlorthal-dimethyl?). 33955-509 33955 Acme Garden Weed Preventer Spray DCPA (or chlorthal-dimethyl?). 34810-8 34810 Wex-Cide Concentrated Germicidal Detergent 2-Benzyl-4-chlorophenol; & o-Phenylphenol (NO INERT USE). 39039-15 39039 Y-Tex Co-Ral Livestock Dust Coumaphos. 39444-9 39444 Micropur MP Silver. 39444-12 39444 Virustat Microbial Water Purification Cartridge Iodine. 47000-91 47000 TR-1 Total Release Fogger MGK 264; Pyrethrins; & Permethrin. 47000-95 47000 Fly Bomb 5-1-1 MGK 264; Pyrethrins; & Piperonyl butoxide. 47000-144 47000 Co-Ral Coumaphos 25% Dust Base Coumaphos. 51147-5 51147 Benzyl Benzoate Benylate. 53345-3 53345 Ercocide C Sodium chlorate. 53345-4 53345 Ercocide S Sodium chlorate. 59820-5 59820 Benzyl Benzoate Miticide Technical Benylate. 70385-7 70385 Clean Carpet Sanitizer 2-Benzyl-4-chlorophenol; 4-tert-Amylphenol; & o-Phenylphenol (NO INERT USE). CA-120002 100 Heritage Fungicide Azoxystrobin. NJ-980001 70506 Ziram 76DF Fungicide Ziram. WA-090014 71297 AFxRD-038 1-Methylcyclopropene. Table 1B—Product Registrations With Pending Requests for Cancellation Registration No. Company No. Product name Active ingredient 264-830 264 Spirodiclofen Technical Spirodiclofen. 264-831 264 Envidor 2 SC Spirodiclofen. Table 2—Product Registrations With Pending Requests for Amendment Registration No. Company No. Product name Active
  • ingredient
  • Uses to be terminated
    264-718 264 Spiromesifen Technical Spiromesifen Succulent shelled, edible-podded & dry shelled beans; & bulb vegetables (crop group 3-07). 400-577 400 Belmont 2.7 FS Metalaxyl Seed Treatment Uses: Canola, mustard seed, rapeseed cucurbit vegetables: chayote (fruit), Chinese waxgourd, citron melon, gherkin, edible gourd (includes hyotan, cucuzza, Chinese okra, and hechima), momordica spp. (includes balsam apple, balsam pear, bitter melon, Chinese cucumber), muskmelon (includes true cantaloupe, cantaloupe, casaba, crenshaw melon, golden pershaw melon, honeydew melon, honey balls, mango melon, Persian melon, pineapple melon, Santa Claus melon, and snake melon), pumpkin, summer squash (includes crookneck squash, scallop squash, straightneck squash, vegetable marrow, zucchini), winter squash (includes butternut squash, calabaza, hubbard squash), cucumis mixtar, cucumis pepo (includes acorn squash, spaghetti squash), watermelon (includes hybrids and/or varieties of citrullus lanatus). Leafy Vegetables: Amaranth (leafy, Chinese spinach**, tampala), cardoon, celery (including Chinese), celtuce, chervil, chrysanthemum (edible-leaved and garland), corn salad, cress (garden and upland), dandelion, dock, endive, fennel (finochio), lettuce (head and leaf), orach, parsley, purslane (garden and winter), radicchio, rhubarb, and Swiss chard, brassica (cole) head, stem and leafy vegetables broccoli (including Chinese and raab), Brussels sprouts, cabbage (including Chinese bok choy, Chinese napa and mustard), cauliflower, cavalo broccoli, collards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, and rape greens. Fruiting Vegetables: Eggplant, groundcherry, pepino, pepper (including bell pepper, chili pepper, cooking pepper, pimento, sweet pepper), tomatillo, and tomato. Onions (dry bulb and green): Root and Tuber Vegetables: Arracacha, arrowroot, artichoke (Chinese and Jerusalem), burdock (edible), canna (edible), cassava (bitter and sweet), celery root, chayote, chervil, chicory, chufa, dasheen, ginger, ginseng, horseradish, leren, parsley (turnip-rooted), parsnip, radish (includes oriental dalkon), rutabaga, salsify (includes black and Spanish), skirret, sweet potato, tanier, turmeric, turnip, yam bean (jicama, manioc pea), yam. 5383-104 5383 Troy Mergal K14 5-Chloro-2-methyl-3(2H)-isothiazolone; & 2-Methyl-3(2H)-isothiazolone Metal working fluids. 10807-199 10807 Misty Dualcide P3 RTU Permethrin Adult mosquito control section. 19713-156 19713 Drexel Captan 4L Fungicide Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-235 19713 Drexel Captan 50W Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-258 19713 Drexel Captan Technical Captan Turf (golf courses), sod farms, soil seedbeds and greenhouse bench treatments. 19713-268 19713 Drexel Kaptan 50W Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-362 19713 Drexel 80% Captan Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-385 19713 Drexel 80% Kaptan Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-405 19713 Drexel Captan 80 EDF Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-500 19713 Drexel Captan Technical Two Captan Seedbeds and greenhouse bench treatments. 19713-631 19713 Drexel Captan Technical 97% Captan Turf (golf courses), sod farms, soil seedbeds and greenhouse bench treatments. 19713-644 19713 DCC Captan 4L (Alternate name: Captan 4L) Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-646 19713 Drexel Captan 50W Fungicide Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 19713-652 19713 Drexel Captan 80 WDG Captan Turf, sod farm, golf course, lawn seedbed, soil and greenhouse bench treatment. 33658-33 33658 Reality Termiticide/Insecticide Permethrin Agricultural crop use directions section. 34704-427 34704 Captan 50-W Captan Soil and greenhouse bench treatment. 34704-1075 34704 Captan 80 WDG Captan Grasses (ornamental in non-pastured areas)/turf (golf course), (lawn seedbeds)/turf (sod farms), soil and greenhouse bench treatment. 34704-1076 34704 Captan 4L Captan Grasses (ornamentals in non-pastured areas and lawn seedbeds), soil, and greenhouse bench treatment. 42750-145 42750 Imazethapyr TGAI Imazethapyr Clearfield rice. 42750-146 42750 Imazeth 2SC Imazethapyr, ammonium salt Clearfield rice. 64321-1 64321 Bio Kill Brand Insecticide Permethrin Food crops. 66675-3 66675 CS 2005—(Magna-Bon Bahama Klear)-Alternate Copper sulfate pentahydrate Swimming pool, outdoor hot tub and spa usages, and post-harvest fruit and vegetable wash. 91232-3 91232 FD Tebuconazole 3.6F Tebuconazole Seed treatment use on corn.

    Table 3 of this unit includes the names and addresses of record for the registrants of the products listed in Table 1A, Table 1B and Table 2 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1A, Table 1B and Table 2 of this unit.

    Table 3—Registrants Requesting Voluntary Cancellation and/or Amendments EPA Company
  • No.
  • Company name and address
    100 Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-8300. 211 Central Solutions, Inc., 401 Funston Road, Kansas City, KS 66115. 264 Bayer CropScience, LP, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. 400 MacDermid Agricultural Solutions, Inc., C/O Arysta LifeScience North America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. 769 Value Gardens Supply, LLC, D/B/A Value Garden Supply, Agent Name: JM Specialty Consulting, LLC, 44 Pine Lane Ranch Road, Laurel, MS 39443. 875 Diversey, Inc., 1410 Newman Road, Racine, WI 53406. 1677 Ecolab, Inc., 1 Ecolab Place, St. Paul, MN 55102. 2217 PBI/Gordon Corp., 1217 West 12th Street, P.O. Box 014090, Kansas City, MO 64101-0090. 3862 ABC Compounding Co., Inc., P.O. Box 80729, Conyers, GA 30013. 4787 Cheminova A/S, Agent Name: FMC Corporation, 1735 Market Street, Room 1971, Philadelphia, PA 19103. 5383 Troy Chemical Corporation, Agent Name: Troy Corporation, 8 Vreeland Road, Florham Park, NJ 07932. 7616 Kik Pool Additives, Inc., Agent Name: Delta Analytical Corporation, 12510 Prosperity Drive, Suite 160, Silver Spring, MD 20904. 9480 Professional Disposables International, Inc., Agent Name: Delta Analytical Corp., 12510 Prosperity Drive, Suite 160, Silver Spring, MD 20904. 9688 Chemsico, A Division of United Industries Corp., P.O. Box 142642, St. Louis, MO 63114-0642. 10088 Athea Laboratories, Inc., P.O. Box 240014, Milwaukee, WI 53224. 10163 Gowan Company, P.O. Box 5569, Yuma, AZ 85366. 10324 Mason Chemical Company, 723 W. Algonquin Rd., Suite B, Arlington Heights, IL 60005. 10807 Amrep, Inc., Agent Name: Zep, Inc. C/O Compliance Services, 1259 Seabord Industrial Blvd. NW., Atlanta, GA 30318. 19713 Drexel Chemical Company, P.O. Box 13327, Memphis, TN 38113-0327. 33658 Gharda Chemicals Limited, Agent Name: IPM Resources, LLC, 4032 Crockers Lake Blvd., Ste. 818, Sarasota, FL 34238. 33955 PBI/Gordon Corp., 1217 West 12th Street, P.O. Box 014090, Kansas City, MO 64101-0090. 34704 Loveland Products, Inc., P.O. Box 1286, Greeley, CO 80632-1286. 34810 Wexford Labs, Inc., 325 Leffingwell Ave., Kirkwood, MI 63122. 39039 Y-Tex Corporation, 1825 Big Horn Avenue, Cody, WY 82414. 39444 Katadyn Produkte, D/B/A Katadyn Products, Inc., Agent Name: Regwest Company, LLC, 8203 West 20th Street, Suite A, Greeley, CO 80634-4696. 42750 Albaugh, LLC, P.O. Box 2127, Valdosta, GA 31604-2127. 47000 Chem-Tech, Ltd., 110 Hopkins Drive, Randolph, WI 53956. 51147 Vertellus, LLC, 201 N. Illinois Street, Suite 1800, Indianapolis, IN 46204. 53345 Erco Worldwide, Agent Name: Lewis & Harrison, LLC, 122 C Street NW., Suite 505, Washington, DC 20001. 59820 Allergopharma Joachim, Agent Name: Brazos Associates, Inc., 621 West 4th Street, Cordell, OK 73632. 64321 Jesmond Holding AG, Agent Name: Registrations by Design, Inc., P.O. Box 1019, Salem, VA 24153-3805. 66675 Magna-Bon II, LLC, 1531 NW 25th Drive, Okeechobee, FL 34972. 70385 ProRestore Products, Agent Name: Lewis & Harrison, LLC, 122 C Street NW., Suite 505, Washington, DC 20001. 70506 United Phosphorus, Inc., 630 Freedom Business Center, Suite 402, King of Prussia, PA 19406. 71297 AgroFresh, Inc., 400 Arcola Road, P.O. Box 7000, Collegeville, PA 19426. 91232 Fengdeng USA, Inc., 123 Cornell Road, Bala Cynwyd, PA 19004.
    III. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register.

    Section 6(f)(1)(B) of FIFRA (7 U.S.C. 136d(f)(1)(B)) requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) (7 U.S.C. 136d(f)(1)(C)) requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless:

    1. The registrants request a waiver of the comment period, or

    2. The EPA Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.

    The registrants listed in Table 3 of Unit II have requested that EPA waive the 180-day comment period. Accordingly, EPA will provide a 30-day comment period on the proposed requests.

    IV. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product cancellation or use deletion should submit the withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT. If the products have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling.

    V. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the action. If the requests for voluntary cancellation and amendments to terminate uses are granted, the Agency intends to publish the cancellation order in the Federal Register.

    In any order issued in response to these requests for cancellation of product registrations and for amendments to terminate uses, EPA proposes to include the following provisions for the treatment of any existing stocks of the products listed in Tables 1A, 1B and 2 of Unit II.

    A. For Products 211-25, 211-32, 211-36, 211-62 and 34810-8

    The registrant has requested to the Agency via letter to sell existing stocks for an 18-month period for products 211-25, 211-32, 211-36, 211-62 and 34810-8.

    B. For the Products Listed in Table 1b, 264-830 and 264-831

    As there are no risk concerns for these products, after December 31, 2020, the registrant will be prohibited from producing, selling, or distributing existing stocks of products containing Spirodiclofen.

    C. For Products 47000-91, 47000-95 and 47000-144

    The registrant has requested to the Agency via letter to manufacture and/or distribute existing stocks for a 24-month period starting the date of the request which was April 25, 2017 for products 47000-91 and 47000-95, and June 28, 2017 for product 47000-144.

    For all other voluntary product cancellations identified in Table 1A of Unit II, registrants will be permitted to sell and distribute existing stocks of voluntarily canceled products for 1 year after the effective date of the cancellation, which will be the date of publication of the cancellation order in the Federal Register. Thereafter, registrants will be prohibited from selling or distributing the products identified in Table 1A of Unit II, except for export consistent with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal.

    Once EPA has approved product labels reflecting the requested amendments to terminate uses identified in Table 2 of Unit II, registrants will be permitted to sell or distribute products under the previously approved labeling for a period of 18 months after the date of Federal Register publication of the cancellation order, unless other restrictions have been imposed. Thereafter, registrants will be prohibited from selling or distributing the products whose labels include the terminated uses identified in Table 2 of Unit II, except for export consistent with FIFRA section 17 or for proper disposal.

    Persons other than the registrant may sell, distribute, or use existing stocks of canceled products and products whose labels include the terminated uses until supplies are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products and terminated uses.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: September 8, 2017. Delores Barber, Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
    [FR Doc. 2017-21244 Filed 10-2-17; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC or Commission) Communications Security, Reliability, and Interoperability Council (CSRIC) VI will hold its second meeting.

    DATES:

    October 26, 2017.

    ADDRESSES:

    Federal Communications Commission, Room TW-C305 (Commission Meeting Room), 445 12th Street SW., Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Jeffery Goldthorp, Designated Federal Officer, (202) 418-1096 (voice) or [email protected] (email); or Suzon Cameron, Deputy Designated Federal Officer, (202) 418-1916 (voice) or [email protected] (email).

    SUPPLEMENTARY INFORMATION:

    The meeting will be held on October 26, 2017, from 1:00 p.m. to 5:00 p.m. in the Commission Meeting Room of the Federal Communications Commission, Room TW-C305, 445 12th Street SW., Washington, DC 20554.

    The CSRIC is a Federal Advisory Committee that will provide recommendations to the FCC to improve the security, reliability, and interoperability of communications systems. On March 19, 2017, the FCC, pursuant to the Federal Advisory Committee Act, renewed the charter for the CSRIC for a period of two years through March 18, 2019. The meeting on October 26, 2017, will be the second meeting of the CSRIC under the current charter. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will provide audio and/or video coverage of the meeting over the Internet from the FCC's Web page at http://www.fcc.gov/live. The public may submit written comments before the meeting to Jeffery Goldthorp, CSRIC Designated Federal Officer, by email to [email protected] or U.S. Postal Service Mail to Jeffery Goldthorp, Associate Bureau Chief, Public Safety and Homeland Security Bureau, Federal Communications Commission, 445 12th Street SW., Room 7-A325, Washington, DC 20554.

    Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to [email protected] or by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (tty). Such requests should include a detailed description of the accommodation needed. In addition, please include a way the FCC can contact you if it needs more information. Please allow at least five days' advance notice; last-minute requests will be accepted, but may be impossible to fill.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2017-21240 Filed 10-2-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1116] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before December 4, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-1116.

    Title: Submarine Cable Reporting.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit, not-for-profit institutions.

    Number of Respondents and Responses: 63 respondents; 63 responses.

    Estimated Time per Response: 190 hours.

    Frequency of Response: On occasion and annual reporting requirements.

    Obligation to Respond: Voluntary. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 303(r) and 403.

    Total Annual Burden: 11,970 hours.

    Total Annual Cost: No Cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: Information provided pursuant to this request will be viewed as presumptively confidential upon submission because the information would reflect reports on weaknesses in or damage to national communications infrastructure, and the release of this sensitive information to the public could potentially facilitate terrorist targeting of critical infrastructure and key resources. The submissions also may contain internal confidential information that constitutes trade secrets and commercial/financial information that the respondent does not routinely make public and public release of the submitted information could cause competitive harm by revealing information about the types and deployment of cable equipment and the traffic that flows across the system. For these reasons, the information requested in (b) (Terrestrial Route Map) and (c) (Undersea Location Spreadsheet) above is presumptively exempt from public disclosure under Freedom of Information Act (FOIA) Exemption 3, 5 U.S.C. 552(b)(3), and section 4(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(j), as implemented in 47 CFR 0.457(c)(1)(i) (exempting disclosure of “maps showing the exact location of submarine cables”). The information requested in (a) (System Status and Restoration Messages) and (d) (Restoration Capability) described above will be considered exempt under Exemption 4 of the Freedom of Information Act (FOIA), 5 U.S.C. 552(b)(4). If a FOIA request is filed for information submitted in response to this request, the respondent whose records are the subject of the request will be notified of the FOIA request and given the opportunity to oppose release of the records. See 47 CFR 0.461(d)(3). We note that the information provided in response to this request will be shared with the Department of Homeland Security's National Communications System (NCS) and relevant Executive Branch agencies on a confidential basis. See 44 U.S.C. 3510.

    Needs and Uses: This information is needed in order to support Federal government national security and emergency preparedness communications programs, for the purposes of providing situational awareness of submarine cable system performance as well as a greater understanding of potential physical threats to the submarine cable systems. This information will provide situational awareness regarding the operational status of submarine cable systems to the Federal government, and allow the Executive Branch to assess potential risks and threats to these critical communications systems in the context of other available information.

    Federal Communications Commission. Marlene H. Dortch, Secretary. Office of the Secretary.
    [FR Doc. 2017-21238 Filed 10-2-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION Sunshine Act Meetings; Deletion of Items From Sunshine Act Meeting September 22, 2017.

    The following items have been deleted from the list of items scheduled for consideration at the Tuesday, September 26, 2017, Open Meeting and previously listed in the Commission's Notice of September 19, 2017.

    2 MEDIA TITLE: Cable Television Technical and Operational Standards (MB Docket No. 12-217)
  • SUMMARY: The Commission will consider a Report and Order that modernizes its cable television technical rules to reflect the cable industry's use of digital transmission systems.
  • 3 MEDIA TITLE: Revitalization of the AM Radio Service (MB Docket No. 13-249)
  • SUMMARY: The Commission will consider a Third Report and Order that will relax or eliminate certain rules pertaining to AM broadcasters employing and maintaining directional antenna arrays.
  • Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2017-21241 Filed 9-29-17; 11:15 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION FDIC Advisory Committee on Economic Inclusion (ComE-IN); Notice of Meeting AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice of open meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, notice is hereby given of a meeting of the FDIC Advisory Committee on Economic Inclusion, which will be held in Washington, DC. The Advisory Committee will provide advice and recommendations on initiatives to expand access to banking services by underserved populations.

    DATES:

    Wednesday, October 18, 2017, from 9:00 a.m. to 3:45 p.m.

    ADDRESSES:

    The meeting will be held in the FDIC Board Room on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Committee Management Officer of the FDIC, at (202) 898-7043.

    SUPPLEMENTARY INFORMATION:

    Agenda: The agenda will be focused on Safe Accounts, 2016 FDIC Bank Survey Results, Financial Inclusion for Persons with Disabilities, and an update on Neighborhood Access to Bank Branches. The agenda may be subject to change. Any changes to the agenda will be announced at the beginning of the meeting.

    Type of Meeting: The meeting will be open to the public, limited only by the space available on a first-come, first-served basis. For security reasons, members of the public will be subject to security screening procedures and must present a valid photo identification to enter the building. The FDIC will provide attendees with auxiliary aids (e.g., sign language interpretation) required for this meeting. Those attendees needing such assistance should call (703) 562-6067 (Voice or TTY) at least two days before the meeting to make necessary arrangements. Written statements may be filed with the committee before or after the meeting. This ComE-IN meeting will be Webcast live via the Internet at: http://fdic.windrosemedia.com. Questions or troubleshooting help can be found at the same link. For optimal viewing, a high-speed internet connection is recommended. The ComE-IN meeting videos are made available on-demand approximately two weeks after the event.

    Dated: September 28, 2017. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary, Federal Deposit Insurance Corporation.
    [FR Doc. 2017-21167 Filed 10-2-17; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10286—Horizon Bank; Bradenton, Florida

    Notice is hereby given that the Federal Deposit Insurance Corporation (FDIC) as Receiver for Horizon Bank, Bradenton, Florida (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed Receiver of Horizon Bank on September 10, 2010. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: September 28, 2017. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2017-21172 Filed 10-2-17; 8:45 am] BILLING CODE 6714-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-17-1083] Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Notifiable Diseases Surveillance System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on December 22, 2016 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

    CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

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

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

    (d) 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, e.g., permitting electronic submission of responses; and

    (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

    Proposed Project

    Evaluation of the National Tobacco Prevention and Control Public Education Campaign (OMB Control Number 0920-1083, Expiration 09/30/2017)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    In 2012, HHS/CDC launched Phase 1 of the National Tobacco Prevention and Control Public Education Campaign (The Campaign). The primary objectives of The Campaign are to encourage smokers to quit smoking and to encourage nonsmokers to communicate with smokers about the dangers of smoking. To evaluate “The Campaign,” CDC obtained OMB approval for information collections beginning in 2012 (OMB Control Number 0920-0923). CDC conducted baseline and follow-up surveys with both smokers and nonsmokers.

    In 2013, CDC launched Phase 2 of “The Campaign” and conducted an additional survey with smokers and one additional survey with nonsmokers under OMB Control Number 0920-0923.

    CDC recently completed collecting the information needed to evaluate Phase 3 of “The Campaign,” which launched in early 2014. The evaluation of The Campaign in 2014 consisted of a longitudinal cohort using four waves of online surveys involving smokers and three waves involving nonsmokers to assess their awareness of and reactions to the 2014 advertisements as related to The Campaign's objectives (see previously-approved information collection with OMB Control Number 0920-0923, expired 3/31/2017).

    The final wave of this data collection effort also served as a pre-campaign baseline for Phase 4 of the campaign in 2015. The CDC subsequently aired Phase 5 of the campaign in 2016. To evaluate Phases 4 and 5, CDC fielded four additional waves of survey data collection. CDC fielded these data collections from September to November in 2015 and March to June, June to August, and November to December of 2016 (see previously approved information collection under OMB Control Number 0920-1083, expires 9/30/2017).

    CDC has scheduled to launch new media activities for Phases 6 and 7 of “The Campaign” in early 2017 and early 2018, respectively. To support evaluation of “The Campaign” through Phases 6 and 7, CDC plans to field five new waves of information collection. CDC will field the surveys in English and Spanish and will occur during 2017 and 2018. Once enrolled in the first wave of data collection, researchers will re-contact all participants for follow-up at subsequent survey waves.

    The sample for the data collection will originate from two sources: (1) An online longitudinal cohort of smokers and nonsmokers, sampled randomly from postal mailing addresses in the United States (address-based sample, or ABS); and (2) the existing GfK KnowledgePanel, an established long-term online panel of U.S. adults. The ABS-sourced longitudinal cohort will consist of smokers and nonsmokers who have not previously participated in any established online panels to reduce potential panel conditioning bias from previous participation. GfK will recruit the new cohort, utilizing similar recruitment methods that are used in the recruitment of KnowledgePanel. To support larger sample sizes that will allow for more in-depth subgroup analysis, which is a key objective for CDC, researchers will use the GfK KnowledgePanel in combination with the new ABS-sourced cohort. Researchers will conduct all online surveys, regardless of sample source, via the GfK KnowledgePanel Web portal for self-administered surveys.

    Researchers will collect information through Web surveys (self-administered on computers in the respondent's home or in another convenient location). Researchers will collect information about smokers' and nonsmokers' awareness of and exposure to specific campaign advertisements; knowledge, attitudes, beliefs related to smoking and secondhand smoke; and other marketing exposure. The surveys will also measure behaviors related to smoking cessation (among the smokers in the sample) and behaviors related to nonsmokers' encouragement of smokers to quit smoking, recommendations of cessation services, and attitudes about other tobacco and nicotine products.

    It is important to evaluate “The Campaign” in a context that assesses the dynamic nature of tobacco product marketing and uptake of various tobacco products, particularly since these may affect successful cessation rates. Survey instruments may be updated to include new or revised items on relevant topics, including cigars, noncombustible tobacco products, and other emerging trends in tobacco use.

    Participation is voluntary and there are no costs to respondents other than their time. CDC estimates the total response burden at 37,170 hours over two years between August 2017 and February 2019. Thus, CDC estimates the total annualized burden hours at 18,585 for the combined English and Spanish versions of each survey.

    Estimated Annualized Burden Hours (Type of)
  • respondents
  • Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • General Population Screening & Consent Questionnaire (English) 23,750 1 5/60 Screening & Consent Questionnaire (Spanish) 1,250 1 5/60 Adults Smokers and Nonsmokers, ages 18-54, in the United States Smoker Survey (Wave A) (English) 6,175 1 30/60 Smoker Survey (Wave A) (Spanish) 325 1 30/60 Smoker Survey (Wave B) (English) 3,800 1 30/60 Smoker Survey (Wave B) (Spanish) 200 1 30/60 Smoker Survey (Wave C) (English) 3,800 1 30/60 Smoker Survey (Wave C) (Spanish) 200 1 30/60 Smoker Survey (Wave D) (English) 3,800 1 30/60 Smoker Survey (Wave D) (Spanish) 200 1 30/60 Smoker Survey (Wave E) (English) 3,800 1 30/60 Smoker Survey (Wave E) (Spanish) 200 1 30/60 Nonsmoker Survey (Wave A) (English) 2,375 1 30/60 Nonsmoker Survey (Wave A) (Spanish) 125 1 30/60 Nonsmoker Survey (Wave B) (English) 1,900 1 30/60 Nonsmoker Survey (Wave B) (Spanish) 100 1 30/60 Nonsmoker Survey (Wave C) (English) 1,900 1 30/60 Nonsmoker Survey (Wave C) (Spanish) 100 1 30/60 Nonsmoker Survey (Wave D) (English) 1,900 1 30/60 Nonsmoker Survey (Wave D) (Spanish) 100 1 30/60 Nonsmoker Survey (Wave E) (English) 1,900 1 30/60 Nonsmoker Survey (Wave E) (Spanish) 100 1 30/60
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2017-21122 Filed 10-2-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-17KB] Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Notifiable Diseases Surveillance System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on January 17, 2017 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

    CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

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

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

    (d) 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, e.g., permitting electronic submission of responses; and

    (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

    Proposed Project

    Assessment of the Market for Electronic Technology for Underground Coal Mining Safety and Health Applications—New—Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health, Office of Mine Safety and Health Research.

    Background and Brief Description

    Underground coal mining in the U.S. is a relatively small industry (about 46,000 employees) that operates in a unique and hazardous work environment. The common presence of explosive gasses and other hazards creates special safety requirements for equipment, including safety and health protection technologies, used in underground coal mines.

    The MINER Act of 2006 assigned the National Institute for Occupational Safety and Health (NIOSH) the responsibility to enhance development of new mine safety and health protection technology and technological applications and to expedite the commercial availability and implementation of such technology. As part of this study, NIOSH seeks to identify the barriers to commercial availability and implementation of such technology in U.S. mines.

    Experience to date has shown that there are many issues that the U.S. mining industry faces that create barriers to the availability and implementation of safety technologies, and we believe there are other more subtle reasons that we do not fully understand as a Government research agency. The data will help provide insight into what the most important barriers are from the perspective of the organizations that must purchase, use, approve, and manufacture these safety technologies.

    NIOSH has an understanding of some of these barriers, however, NIOSH is not an end user of these products. Thus, the goal of the study is to provide a complete perspective of the barriers from the point of view of the mine operators and technology innovators, in order to improve the efficacy of the contract and grant awards that NIOSH administers under the authority of the MINER Act.

    The Federal Mine Safety & Health Act of 1977, Section 501 authorizes the collection of this data. A CDC contractor will collect the required data.

    NIOSH will identify 200 stakeholder organizations for structured interviews and a workshop. Stakeholder organizations include those parties involved in the development, supply, use, and regulation of safety and health protection technologies relevant to underground coal mining. Because there is no nationally representative database of these stakeholder organizations, NIOSH will use web searches of supplier and mining company Web sites, online mining publications, trade association member directories, federal and state regulator Web sites, and university mining research and development programs to compile a list of 200 organizations. Representatives of NIOSH Office of Mining Safety and Health Research will also augment the search with their input.

    From the 200 stakeholder organizations, 150 representatives will participate in structured interviews. CDC expects that a pre-call to each organization will require 15 minutes to complete and the structured interview will require 60 minutes to complete, including the time it may take respondents to look-up and retrieve needed information.

    In addition, 30 stakeholder representatives will participate in the workshop. The burden table below reflects 15 hours of burden for each workshop group. This includes the in-person participation of 9 hours and 6 hours of travel time. A total of 10 respondents per year will participate in the workshop. The estimated annualized burden hours for the respondents' time to participate in this information collection are 217 hours.

    CDC seeks a three-year OMB approval to collect information.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (hours)
  • Receptionists Pre-call 67 1 15/60 General and Operations Managers Structured Interview 25 1 1 Industrial Production Managers Structured Interview 13 1 1 Architecture and Engineering Occupations Structured Interview 12 1 1 General and Operations Managers Workshop 5 1 15 Industrial Production Managers Workshop 3 1 15 Architecture and Engineering Occupations Workshop 2 1 15
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2017-21188 Filed 10-2-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-1035] Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Notifiable Diseases Surveillance System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 13, 2017 to obtain comments from the public and affected agencies. CDC received seven comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

    CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

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

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

    (d) 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, e.g., permitting electronic submission of responses; and

    (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

    Proposed Project

    Assessing School-centered HIV/STD Prevention Efforts in a Local Education Agency (OMB Control #0920-1035, expiration 11/30/2017)—Revision—Division of Adolescent and School Health (DASH), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    HIV infections remain high among young men who have sex with men. The estimated number of new HIV infections increased between 2008 and 2010 both overall and among MSM ages 13 to 24. Sexual risk behaviors associated with HIV, other sexually transmitted disease (STD), and pregnancy often emerge in adolescence. The 2015 Youth Risk Behavior Surveillance System (YRBSS) data revealed 41.2% of U.S. high school students reported having had sex, and among those who had sex in the previous three months, only 56.9% reported having used a condom during last sexual intercourse. The data revealed high school students identifying as gay, lesbian, and bisexual and those reporting sexual contact with both males and females were more likely to engage in sexual risk-taking behaviors than heterosexual students.

    Given the disproportionate risk for HIV among YMSM ages 13-24, it is important to find ways to reach the younger youth (i.e., ages 13-19) in this range to decrease sexual risk behaviors and increase health-promoting behaviors such as routine HIV testing. Schools provide one opportunity for this. Because schools enroll more than 22 million teens (ages 14-19) and often have existing health and social services infrastructure, schools and their staff members are well-positioned to connect youth to a wide range of needed services, including housing assistance, support groups, and sexual health services such as HIV testing. As a result, CDC's DASH has focused a number of HIV and STD prevention efforts on strategies that can be implemented in or centered around schools.

    For this revised information collection project, CDC requests a one-year OMB approval. This CDC-funded information collection project is the third data collection to assess HIV and STD prevention efforts in one local education agency (LEA). CDC's cooperative agreement, under funding opportunity announcement PS13-1308: Promoting Adolescent Health through School-Based HIV/STD Prevention and School-Based Surveillance, funds agencies and organizations to implement the following four key strategies. Strategy 1: School-Based Surveillance; Strategy 2: School-Based HIV/STD Prevention; Strategy 3: Capacity Building Assistance for School-Based HIV/STD Prevention; and Strategy 4: School-Centered HIV/STD Prevention for Young Men Who Have Sex with Men. This project aligns with Strategy 4 implementation.

    This collection will provide data and reports for the LEA, and will allow the LEA to identify program areas that are working well and other areas that need improvement. The findings will allow CDC to determine the potential impact of currently recommended strategies and make changes to those recommendations if necessary.

    The questionnaire covers demographics, HIV/STD risk behaviors, use of HIV/health services, experiences at school, including school connectedness, harassment and bullying, homophobia, support of LGBTQ students, sexual orientation, receipt of referral for HIV and STD prevention health services, and health education.

    This data collection system involves administration of a paper-and-pencil questionnaire to seven high schools that are participating in the HIV/STD prevention project. This is the third and final data collection of a 4-year project that includes three data collections; previous data collections occurred in December 2014 and December 2016. Data collection points coincide with the approximate beginning, mid-way, and end points of the cooperative agreement.

    We anticipate the final data collection will yield data from up to 16,500 high school students in grades 9 through 12 at the selected schools. Although some students may have completed the questionnaire in one or more of the previous years, this is not a longitudinal design and researchers will not track individual student responses across the years. Researchers will not collect personally identifiable information.

    All students' parents will receive parental consent forms to provide them with an opportunity to opt their children out of the study. Each student will read verbal assent language that explains that he or she may choose not to complete the questionnaire or may skip any questions without penalty. Participation is voluntary.

    The estimated burden per response ranges from 35-45 minutes due to the variability in skip patterns that may occur. Students will complete the questionnaire only once under this approval. Annualizing the collection over a one-year period results in an estimated annualized burden of 11,000 hours for respondents. There are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per respondent
  • Avg. burden per response
  • (in hours)
  • Students in grades 9-12 Youth Health and School Climate Questionnaire 16,500 1 40/60
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2017-21189 Filed 10-2-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10529] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by December 4, 2017.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10529 Quarterly Medicaid and CHIP Budget and Expenditure Reporting for the Medical Assistance Program, Administration and CHIP

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Quarterly Medicaid and CHIP Budget and Expenditure Reporting for the Medical Assistance Program, Administration and CHIP; Use: MBES/CBES is a financial reporting system that produces Budget and expenditures for Medical Assistance and Children's Health Insurance Program. All forms are to be filed on a quarterly basis and need to be certified by the States to the CMS. The forms consist of CMS-21 and -21B, CMS-37, and CMS-64.

    Forms CMS-21 and -21B provide CMS with the information necessary to issue quarterly grant awards, monitor current year expenditure levels, determine the allowability of state claims for reimbursement, develop Children's Health Insurance Program (CHIP) financial management information, provide for state reporting of waiver expenditures, and ensure that the federally established allotment is not exceeded. They are also necessary in the redistribution and reallocation of unspent funds over the federally mandated timeframes.

    Form CMS-37 due dates are November 15, February 15, May 15 and August 15 of each fiscal year. While all submissions represent equally important components of the grant award cycle, the May and November submissions are particularly significant for budget formulation. The November submission introduces a new fiscal year to the budget cycle and serves as the basis for the formulation of the Medicaid portion of the President's Budget, which is presented to Congress in January. The February and August submissions are used primarily for budget execution in providing interim updates to our Office of Financial Management, the Department of Health and Human Services, the Office of Management and Budget, and Congress depending on the scheduling of the national budget review process in a given fiscal year. The submissions provide us with base information necessary to track current year obligations and expenditures in relation to the current year appropriation and to notify senior managers of any impending surpluses or deficits.

    Form CMS-64 is used to issue quarterly grant awards, monitor current year expenditure levels, determine allowed state claims for reimbursement, develop Medicaid financial management information provide for state reporting of waiver expenditures, ensure that the federally-established limit is not exceeded for HCBS waivers, and to allow for the implementation of the Assignment of Rights and Part A and Part B Premium (i.e., accounting for overdue Part A and Part B Premiums under state buy-in agreements)—Billing Offsets. Form Number: CMS-10529 (OMB control number: 0938-1265); Frequency: Quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 672; Total Annual Hours: 17,920. (For policy questions regarding this collection contact Chris Kessler at 410-786-7168).

    Dated: September 28, 2017. William N. Parham, III Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2017-21248 Filed 10-2-17; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Public Comment Request; Proposed Extension With Changes of a Currently Approved Collection; Evidence-Based Falls Prevention Program AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to ACL's Evidence-Based Falls Prevention Program. This notice solicits comments on a proposed extension with minor changes of a currently approved collection.

    DATES:

    Submit written or electronic comments on the collection of information by December 4, 2017.

    ADDRESSES:

    Submit electronic comments on the collection of information to [email protected] Submit written comments on the collection of information to: Shannon Skowronski, U.S. Department of Health and Human Services: Administration for Community Living, Washington, DC 20201.

    FOR FURTHER INFORMATION CONTACT:

    Shannon Skowronski at [email protected] or 202-795-7438.

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or update of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, ACL invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility; (2) the accuracy of ACL'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.

    The Evidence-Based Falls Prevention Programs is a cooperative agreement financed through the Prevention and Public Health Fund (PPHF), most recently with FY 2017 PPHF funds. The statutory authority for cooperative agreements under the current program announcement is contained in the Public Health Service Act, 42 U.S.C. 300u-2 (Community Programs) and 300u-3 (Information Programs); and Consolidated and Further Continuing Appropriations Act, 2015, Pub. L. 113-235, Div. G., Title II, § 219(a); and the Patient Protection and Affordable Care Act, 42 U.S.C. 300u-11 (Prevention and Public Health Fund).

    The Evidence-Based Falls Prevention Programs support a national resource center and award competitive grants to implement evidence-based community programs that have been proven to reduce the incidence of falls for older adults and adults with disabilities (including Tribal elders). The programs also identify sustainable funding mechanisms for these programs via the resource center, promote the importance of falls prevention strategies, and provide public education about the risks of falls and ways to prevent them.

    OMB approval of the existing set of Falls Prevention data collection tools (OMB Control Number, 0985-0039) expires on 01/31/2018. This data collection continues to be necessary for monitoring program operations and outcomes. ACL/AoA proposes to use the following tools: (1) Semi-annual performance reports to monitor grantee progress; (2) a Host Organization Data form to record location of agencies that sponsor programs that will allow mapping of the delivery infrastructure; and (3) a set of tools used to collect information at each program completed by the program leaders (Program Information Cover Sheet and Attendance Log), a Participant Information Form completed by each participant, and a Post Program Survey to be completed by a random sample of participants. ACL/AoA intends to continue using an online data entry system for the program and participant survey data. In addition to non-substantive formatting edits, minor changes are being proposed to 2 of the 5 currently approved tools, as indicated below. All changes proposed are based on feedback from a focus group that included a sub-set of current grantees and consultation with subject-matter experts.

    • On the Participant Information Form:

    1. Additional chronic conditions have been added to the list of options

    2. Question #11 (assessing the frequency and impact of falls) has been enhanced to include the location of the fall(s) and further assess impact

    3. Two questions have been added (#15 and #16) to examine modifications made to home and activity level

    • On the Post-Program Survey:

    1. Question #2 (assessing the frequency and impact of falls) has been enhanced to include the location of the fall(s) and further assess impact

    2. Questions #6 and #7 have been modified slightly—removing references to home modifications and activity level. Home modifications and activity level are now addressed in questions #8 and #9 instead.

    Estimated Annualized Burden Hours

    The proposed Falls Prevention Data Collection Tools can be found at ACL's Web site at: https://www.acl.gov/about-acl/public-input.

    The total estimated burden is 4,345 hours per year. ACL/AoA estimates the burden of this collection of information as 288 hours for project staff, 1,435 hours for local agency staff, and 2,622 hours for individuals.

    Type of
  • respondent
  • Form name Estimated number of respondents Number of responses
  • per respondent
  • Average
  • time per
  • response
  • (in hours)
  • Total
  • burden hours
  • (annual)
  • Project staff Semi-annual Performance Report 18 Twice a year 8 288 Local agency leaders Program Information Cover Sheet/Participant Information Form/Attendance Log/Post Program Survey 700 leaders Twice a year (one set per program) .50 700 Local data entry staff 46 data entry staff Once per program x 1400 programs .50 700 Local organization staff and local database entry staff Host Organization Data Form 700 staff 1 .05 35 Program participants Participant Information Form 16,390 1 .10 1,639 Program participants Post Program Survey 983 1 .10 983 Total Burden Hours 4,345
    Dated: September 20, 2017. Mary Lazare, Principal Deputy Administrator.
    [FR Doc. 2017-21179 Filed 10-2-17; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5437] Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access.” The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.

    DATES:

    The public workshop will be held on October 20, 2017, from 8:30 a.m. to 4:30 p.m., Eastern Standard Time. Submit either electronic or written comments on this public workshop by November 20, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 20, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-N-5437 for “Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Sam Raney, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967, email: [email protected]; or Markham Luke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4712, Silver Spring, MD 20993, 301-796-5556, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The conventional approach to establish bioequivalence (BE) for most topical dermatological generic drug products relies upon clinical endpoint BE studies. The risk of failing to demonstrate BE due to the relative insensitivity of these clinical endpoint studies, combined with their burden and length, may represent a barrier to generic drug development and may adversely impact patient access to some topical dermatological generic drug products. FDA is evaluating alternative BE approaches for topical dermatological generic drug products, using methods that are more efficient, and also more sensitive and reproducible. FDA believes that these BE approaches would benefit from public discussion.

    II. Topics for Discussion at the Public Workshop

    This public workshop will focus on a discussion of current regulatory science initiatives intended to foster the development of topical dermatological generic drug products, examining alternative BE approaches that may be more efficient and less risky than traditional approaches. FDA is also interested in receiving public input about any barriers that may limit the use of such alternative BE approaches in the development of topical dermatological generic drug products. Public input is also sought about strategies to overcome these barriers.

    III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop must register online at https://survey.co1.qualtrics.com/jfe/form/SV_9YQDLZJRjXtYiXz. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

    Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by October 13, 2017, midnight, Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization.

    If you need special accommodations due to a disability, please contact Sam Raney (see FOR FURTHER INFORMATION CONTACT) no later than October 13, 2017.

    Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation, or to submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by October 16, 2017. All requests to make oral presentations must be received by the close of registration on October 9, 2017. If selected for presentation, any presentation materials must be emailed to [email protected] no later than October 13, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

    Streaming webcast of the public workshop: This public workshop will also be webcast. A live webcast of this workshop will be viewable at https://collaboration.fda.gov/ogddermaldrug/ on the day of the workshop.

    If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm557252.htm.

    Dated: September 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21186 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5670] Abbreviated New Drug Applications Submissions—Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA.” This draft guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The draft guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals.

    DATES:

    Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-5670 for “ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA.” This guidance is intended to assist applicants preparing to submit amendments to ANDAs or PASs to FDA under section 505(j) of the FD&C Act (21 U.S.C. 355(j)) by explaining how the review goals established as part of GDUFA II apply to these submissions. In accordance with the “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022” (GDUFA II Commitment Letter, available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf), FDA agreed to certain review goals and procedures for the review of amendments pending as of or received on or after the GDUFA II effective date.

    The GDUFA II Commitment Letter reflects significant changes in the classification of and review goals for amendments to ANDAs and PASs under the Generic Drug User Fee Amendments of 2012 (GDUFA I). Under GDUFA I, amendments were classified into a complex tier system based on the following factors:

    • Whether the amendment was solicited (submitted in response to a complete response letter) or unsolicited (submitted on the applicant's own initiative).

    • Whether the amendment was major or minor.

    • The number of amendments submitted to the ANDA or PAS.

    • Whether an inspection was necessary to support the information contained in the amendment.

    GDUFA II simplified the amendment review goals and no longer subjects them to a tier system; however, review goals are still dependent on several factors. In general, under GDUFA II, amendments will be designated as either standard or priority, will be classified as major or minor, and will receive a goal date based on the factors discussed in the draft guidance, including whether a preapproval inspection is needed. When finalized, this draft guidance will replace the December 2001 guidance for industry “Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications.” This draft guidance supersedes the July 2014 draft guidance for industry “ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA.”

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 314.96 have been approved under OMB control number 0910-0001.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21175 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5891] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The public meeting will be held on October 18, 2017, from 8 a.m. to 5 p.m.

    ADDRESSES:

    Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the Tommy Douglas Conference Center can be accessed at: http://www.tommydouglascenter.com/.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-5891. The docket will close on October 17, 2017. Submit either electronic or written comments on this public meeting by October 17, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 17, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Comments received on or before October 11, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-N-5891for “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before October 11, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 3, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 4, 2017.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact LaToya Bonner at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: September 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21176 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory Committee AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products.

    FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

    DATES:

    Nominations received on or before December 4, 2017 will be given first consideration for membership on the Tobacco Products Scientific Advisory Committee. Nominations received after December 4, 2017 will be considered for nomination to the committee as later vacancies occur.

    ADDRESSES:

    All nominations for membership should be sent electronically by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002.

    FOR FURTHER INFORMATION CONTACT:

    Regarding all nomination questions for membership: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373 (choose Option 5), [email protected]

    Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site by using the following link: https://www.fda.gov/AdvisoryCommittees/default.htm.

    SUPPLEMENTARY INFORMATION:

    FDA is requesting nomination for voting members on the Tobacco Products Scientific Advisory Committee.

    I. General Description of the Committee Duties

    The Tobacco Products Scientific Advisory Committee (the Committee) advises the Commissioner of Food and Drugs (the Commissioner) or designee in discharging responsibilities related to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations to the Commissioner.

    II. Criteria for Voting Members

    The Committee consists of 12 members including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. Almost all non-Federal members of this committee serve as Special Government Employees. The Committee includes nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members include seven members who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. The nine voting members also include one member who is an officer or employee of a State or local government or of the Federal Government, and one member who is a representative of the general public. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years.

    III. Nomination Procedures

    Any interested person may nominate one or more qualified individuals for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest.

    This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21173 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-2530] Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has determined that SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

    FOR FURTHER INFORMATION CONTACT:

    Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455.

    SUPPLEMENTARY INFORMATION:

    In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the listed drug, which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

    The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is known generally as the Orange Book. Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

    A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

    SPECTAZOLE (econazole nitrate) topical cream, 1%, is the subject of NDA 018751, held by Alvogen Malta Operations Ltd., and initially approved on December 23, 1982. SPECTAZOLE is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum; in the treatment of cutaneous candidiasis; and in the treatment of tinea versicolor.

    SPECTAZOLE (econazole nitrate) topical cream, 1%, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

    Lachman Consultant Services, Inc. submitted a citizen petition dated April 21, 2017 (Docket No. FDA-2017-P-2530), under 21 CFR 10.30, requesting that the Agency determine whether SPECTAZOLE (econazole nitrate) topical cream, 1%, was withdrawn from sale for reasons of safety or effectiveness.

    After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that SPECTAZOLE (econazole nitrate) topical cream, 1%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of SPECTAZOLE (econazole nitrate) topical cream, 1%, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.

    Accordingly, the Agency will continue to list SPECTAZOLE (econazole nitrate) topical cream, 1%, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

    Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21174 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5739] Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II).

    DATES:

    Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to Dockets Management Staff, 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-2017-D-5739 for “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA; Draft Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” This draft guidance describes an enhanced pathway for discussions between FDA and an applicant (or prospective applicant) preparing to submit an ANDA for a complex product to FDA. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.

    This draft guidance reflects a unified approach to all formal meetings between FDA and ANDA applicants or prospective ANDA applicants for complex products. This draft guidance is intended to assist ANDA applicants and prospective ANDA applicants in generating and submitting to FDA a meeting request and the associated meeting package for these complex products, as defined in this guidance, to be submitted under section 505(j) of the FD&C Act (21 U.S.C 355(j)) and as contemplated in GDUFA II.

    As part of the commitments FDA made in connection with GDUFA II, FDA agreed to develop a program to assist ANDA applicants and prospective ANDA applicants of complex products before the submission of an ANDA to FDA. As stated in the “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022” (GDUFA II Goals or Commitment Letter), this pre-ANDA program is intended to:

    . . . clarify regulatory expectations for prospective applicants early in product development, assist applicants to develop more complete submissions, promote a more efficient and effective ANDA review process, and reduce the number of review cycles required to obtain ANDA approval, particularly for [complex products](GDUFA II Commitment Letter at 14).

    To facilitate development of complex products that may be submitted in an ANDA, FDA and industry agreed to a series of meetings between ANDA applicants and prospective ANDA applicants and FDA to discuss the proposed complex product and support submission of a high-quality, approvable ANDA.

    In addition to developing a robust pre-ANDA program, FDA agreed to respond to requests for and conduct meetings related to the development of complex products submitted on or after October 1, 2017, within specific timeframes.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information has been approved under OMB control number 0910-0797.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21190 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5846] Abbreviated New Drug Applications Submissions—Refuse-To-Receive Standards: Questions and Answers; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Refuse-to-Receive Standards: Questions and Answers.” This draft guidance is intended to assist applicants preparing to submit abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs. This guidance provides answers to questions we have received from applicants regarding the guidance for industry, “ANDA Submissions—Refuse-to-Receive Standards” (RTR Standards guidance). The questions and answers address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to Drug Master Files (DMFs), product quality, and bioequivalence (BE) and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an ANDA.

    DATES:

    Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-5846 for “ANDA Submissions—Refuse-to-Receive Standards: Questions and Answers.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://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 https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Refuse-to-Receive Standards: Questions and Answers.” This draft guidance is intended to assist applicants preparing to submit ANDAs and certain prior approval supplements (PASs) to ANDAs. This guidance provides answers to questions we have received from applicants regarding the guidance for industry, “ANDA Submissions—Refuse-to-Receive Standards” and the filing process, in general. The questions and answers address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to DMFs, product quality, and BE and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to RTR an ANDA. FDA evaluates each submitted ANDA individually to determine whether the Agency can receive it for review. When FDA decides to receive an ANDA, it means the Agency has made a threshold determination that the ANDA is a substantially complete application (i.e., an ANDA that, on its face, is sufficiently complete to permit a substantive review). FDA's regulations at 21 CFR 314.101 provide the regulatory authority by which FDA may in certain cases, and will in others, RTR an ANDA.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “ANDA Submissions—Refuse-to-Receive Standards.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21187 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0192] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by November 2, 2017.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0509. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting—21 U.S.C. 371 OMB Control Number 0910-0509—Extension

    The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food that the processor of the food is in compliance with applicable country of origin regulatory requirements. With regard to U.S. milk products, FDA is the competent U.S. food safety authority to provide this information to foreign governments. FDA provides the requested information about processors in the form of lists, which are provided to the foreign governments and posted online at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.

    Currently, FDA provides Chile, China, and the European Union (EU) with a list of U.S. milk product manufacturers/processors that: (1) Have expressed interest in exporting their products to these countries; (2) are subject to FDA's jurisdiction; and (3) are not the subject of a pending enforcement action (i.e., an injunction or seizure or a pending warning letter).

    FDA has published guidance documents for these countries under the authority of section 701(h) of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)), which authorizes the Secretary of Health and Human Services (the Secretary) to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of FDA.

    The guidance documents explain what information manufacturers/processors should submit to FDA to be considered for inclusion on the lists and what criteria FDA intends to use to determine eligibility for placement on the lists. The guidance documents also explain how FDA intends to update the list and communicate any new information to the government that requested the list. Finally, the guidance documents note that the information is provided voluntarily by manufacturers/processors with the understanding that it will be posted on FDA's external Web site and communicated to, and possibly further disseminated by, the government that requested the list; thus, FDA considers the information on the lists to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4).

    Application for inclusion on each list is voluntary. However, some foreign governments may require inclusion on the list for acceptance of imported food. FDA recommends that U.S. manufacturers/processors that want to be placed on the export lists send FDA the following information: (1) Country to which the milk manufacturer/processor wants to export product; (2) type of milk product facility; (3) the Food Facility Registration Module number (the information collected by this module is approved under OMB control number 0910-0502); (4) name and address of the firm and the manufacturing plant; (5) name, telephone number, and email address of the contact person; (6) list of products divided into three categories: Presently shipped, ready to ship, and available for shipment in the next 3 years; (7) identities of Agencies that inspected the plant; (8) date of last inspection, plant number, and copy of last inspection notice; and (9) if other than an FDA inspection, copy of last inspection report.

    We request that this information be updated every 2 years.

    We use the information submitted by firms to determine their eligibility for placement on the export lists, which are published on our Web site. The purpose of the lists is to help foreign governments in their determinations of which U.S. milk product manufacturers and processors are eligible to export to their respective countries.

    FDA has recently developed an electronic registry system (Form FDA 3972) that allows milk product manufacturers and processors to electronically send a request to FDA to be included on the export lists. Manufacturers and processors that prefer to submit a paper request in a format of their own choosing will still have the option to do so. Electronic Form FDA 3972 collects the same information as is currently collected via the existing paper-based process. Draft screenshots of Form FDA 3972 and instructions are available at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm496929.htm and is entitled “Dairy Listing Module.”

    Description of Respondents: Respondents to this collection of information include U.S. milk product manufacturers/processors subject to FDA jurisdiction that wish to export to certain foreign countries that require inclusion on export lists.

    In the Federal Register of June 15, 2017 (82 FR 27485), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received three comments, however, they were not responsive to the four collection of information topics solicited and therefore will not be discussed in this document.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average burden
  • per response
  • Total hours
    New requests to be placed on the lists 2,000 1 2,000 1 2,000 Biennial update 2,000 1 2,000 0.5 (30 minutes) 1,000 Occasional updates 200 1 200 0.5 (30 minutes) 100 Total 3,100 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate on the number of manufacturers/processors that have submitted new written requests, biennial updates, and occasional updates over the past 10 years. The estimate of the number of burden hours it will take a manufacturer/processor to gather the information needed to be placed on the list or update its information is based on FDA's experience with manufacturers/processors submitting similar requests. FDA believes that the information to be submitted will be readily available to manufacturers/processors. This collection is also incorporating information collected to maintain lists of eligible exporters of dairy products who wish to export to the EU from OMB control number 0910-0320, “Request for Information from U.S. Processors that Export to the European Community.”

    FDA estimates that 2,000 firms will average 60 minutes (1 hour) to submit new requests for inclusion on the list, 2,000 firms will average 30 minutes (0.5 hour) to update their information every 2 years, and 200 firms will average 30 minutes (0.5 hour) to occasionally update their information in this system. We also believe that submission via the electronic registry system will not affect the burden estimates. An electronic registry will enhance the ability of firms to more efficiently request inclusion on export lists. FDA calculates, therefore, that the total burden for this collection is 3,100 hours ((2,000 × 1) plus (2,000 × 0.5) plus (200 × 0.5)).

    Dated: September 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21212 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5767] Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) permits any person to submit to the FDA an abbreviated new drug application (ANDA) to seek approval to market a generic version of a previously approved drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, and teduglutide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin should be submitted as an ANDA rather than as new drug application (NDA).

    DATES:

    Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-5767 for “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Gail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1672, Silver Spring, MD 20993-0002, 301-796-9291.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.” In general, for FDA to approve an ANDA submitted under section 505(j) of the FD&C Act, an ANDA applicant must demonstrate, among other things, that the proposed generic drug has the “same” active ingredient(s) as and is bioequivalent to its reference listed drug, and that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the proposed generic drug are adequate to assure and preserve its identity, strength, quality, and purity (sections 505(j)(2)(A) and (4) (21 U.S.C. 355(j)(2)(A) and (4)) of the FD&C Act). If a person is seeking approval of a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, or teduglutide) and intends to submit an application that refers to a previously approved peptide drug product of rDNA origin, if the active ingredient in the proposed synthetic peptide drug product can be shown to be the same as the active ingredient in the peptide drug product of rDNA origin, whether the application should be submitted as an ANDA under section 505(j) of the FD&C Act or as a new drug application under section 505(b) of the FD&C Act will depend largely on the impurity profile for the synthetic peptide drug product as compared to the impurity profile for the peptide drug product of rDNA origin. Differences in impurities, particularly peptide-related impurities, may affect the safety or effectiveness of a peptide drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of rDNA origin should be submitted as an ANDA rather than an NDA.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the submission of ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.

    II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information required under 21 CFR part 314 for the submission of NDAs and ANDAs is approved under OMB control number 0910-0001, and the submission of controlled correspondence pertaining to ANDAs is approved under OMB control number 0910-0797.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21202 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4918] Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The public meeting will be held on November 1, 2017, from 8 a.m. to 5 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4918. The docket will close on October 27, 2017. Submit either electronic or written comments on this public meeting by October 27, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 27, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Comments received on or before October 17, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-N-4918 for “Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the docket (see the ADDRESSES section) on or before October 17, 2017, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 6, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 10, 2017.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21171 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5139] M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GIF) entitled “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. The guidance is intended to provide recommendations on the organization of the common technical document (CTD)/eCTD and replaces the August 2001 FDA guidance for industry “M4: Organization of the CTD” and the October 2005 FDA guidance for industry “Granularity Document Annex to M4: Organization of the CTD.”

    DATES:

    The announcement of the guidance is published in the Federal Register on October 3, 2017.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-5139 for “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation; Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration (CDER), 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Regarding the guidance: Norman R. Schmuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 2526, Silver Spring, MD 20993-0002, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548.

    SUPPLEMENTARY INFORMATION: I. Background

    In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically-based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

    ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the members of the ICH Association.

    The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers.

    The M4 guidance provides guidance on the organization of the CTD and eCTD for Modules 2 through 5 providing direction on the location and hierarchy of headings within modules, document pagination and segregation, section numbering within documents, and the formatting of the table of contents. The guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. The guidance provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions, and includes “Appendices for eCTD v4 Submissions” to facilitate the implementation of the next major version of the eCTD. This guidance replaces both the August 2001 FDA GIF “M4: Organization of the CTD” and the October 2005 FDA GIF “Granularity Document Annex to M4: Organization of the CTD.” This merger reflects the 2002 addition of the Annex: Granularity Document into the “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use.”

    There have been no updates or changes relative to Module 4 or Module 5.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the organization of the CTD for the registration of pharmaceuticals for human use. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Electronic Access

    Persons with access to the internet may obtain the document at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: September 28, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-21229 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4563] Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is withdrawing approval of 7 new drug applications (NDAs) and 71 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

    DATES:

    Withdrawal of approval is effective November 2, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

    SUPPLEMENTARY INFORMATION:

    The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications pursuant to the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

    Application No. Drug Applicant NDA 014349 Delfen (nonoxynol-9) Contraceptive Foam, 12.5% Johnson & Johnson Consumer Inc., 199 Grandview Rd., Skillman, NJ 08558. ANDA 019346 Dextrose 60% Injection USP in Plastic Container Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. H2-2, Lake Forest, IL 60045. NDA 019810 Prilosec (omeprazole) Delayed-Release Capsules, 10 milligrams (mg), 20 mg, and 40 mg AstraZeneca Pharmaceuticals LP, One MedImmune Way, Gaithersburg, MD 20878. NDA 020184 Aceon (perindopril erbumine) Tablets, 2 mg, 4 mg, and 8 mg Symplmed Pharmaceuticals, LLC, 5375 Medspace Way, Cincinnati, OH 45227. NDA 022345 Potiga (ezogabine) Tablets, 50 mg, 200 mg, 300 mg, and 400 mg GlaxoSmithKline Intellectual Property Management LTD England, c/o GlaxoSmithKline, 1250 South Collegeville Road, P.O. Box 5089, Collegeville, PA 19426. NDA 021712 Fluxid (famotidine) Orally Disintegrating Tablets, 20 mg and 40 mg UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080. ANDA 040108 Acetazolamide for Injection USP, Equivalent to (EQ) 500 mg base/vial Hospira, Inc. ANDA 040206 Digoxin Injection USP, 0.25 mg/milliliter (mL)   Do. ANDA 040527 Phentermine Hydrochloride (HCl) Capsules USP, 37.5 mg Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512. ANDA 040899 Hydroxyzine HCl Tablets USP, 10 mg, 25 mg, and 50 mg   Do. ANDA 060099 Penicillin G Procaine for Injection, 300,000 units/vial and 1,500,000 units/vial Pfizer Inc., 235 East 42nd St., New York, NY 10017. ANDA 063161 Tobramycin Injection USP, EQ 40 mg base/mL Hospira, Inc. ANDA 070171 Naloxone HCl Injection USP, 0.02 mg/mL   Do. ANDA 070186 Disopyramide Phosphate Capsules USP, EQ 100 mg base Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 070233 Propranolol HCl Tablets USP, 20 mg Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 070255 Naloxone HCl Injection, 0.4 mg/mL Hospira, Inc. ANDA 070698 Methyldopate HCl Injection USP, 50 mg/mL, ADD-Vantage Vial   Do. ANDA 070699 Methyldopate HCl Injection USP, 50 mg/mL, Fliptop Vial   Do. ANDA 070739 Verapamil HCl Injection, 2.5 mg/mL, 2 mL Abbojet-PA Syringe   Do. ANDA 070740 Verapamil HCl Injection, 2.5 mg/mL, 4 mL Abbojet Syringe Vial   Do. ANDA 070803 Enflurane USP, 99.9% Abbott Laboratories, Hospital Products Division, 200 Abbott Park Rd., D389, Bldg. J45-2, Abbott Park, IL 60064. ANDA 070888 Aminocaproic Acid Injection USP, 250 mg/mL Hospira, Inc. ANDA 071357 Tolazamide Tablets USP, 100 mg Sun Pharmaceutical Industries, Inc. ANDA 071438 Ritodrine HCl in Dextrose 5% Injection, 30 mg/100 mL Hospira, Inc. ANDA 071618 Ritodrine HCl Injection USP, 10 mg/mL   Do. ANDA 071619 Ritodrine HCl Injection USP, 15 mg/mL   Do. ANDA 071982 Droperidol and Fentanyl Citrate Injection, 2.5 mg/mL and EQ 0.05 mg base/mL   Do. ANDA 072321 Pancuronium Bromide Injection, 2 mg/mL   Do. ANDA 073199 Sulfamethoxazole and Trimethoprim Injection USP, 80 mg/mL and 16 mg/mL   Do. ANDA 073310 Tolmetin Sodium Tablets USP, EQ 200 mg base Sun Pharmaceutical Industries, Inc. ANDA 073428 CO-LAV (polyethylene glycol 3350 and electrolytes) for Oral Suspension Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811. ANDA 073433 GO-EVAC (polyethylene glycol 3350 and electrolytes) for Oral Suspension   Do. ANDA 073677 Carbastat (carbachol) Intraocular Solution, 0.01% Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936. ANDA 074168 Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074280 Lorazepam Injection USP, 2 mg/mL and 4 mg/mL Hospira, Inc. ANDA 074296 Cimetidine HCl Injection, EQ 300 mg base/2 mL (Carpuject)   Do. ANDA 074412 Cimetidine HCl Injection, EQ 300 mg base/2 mL   Do. ANDA 074422 Cimetidine HCl Injection, EQ 300 mg base/2 mL, ADD-Vantage Vial   Do. ANDA 074468 Cimetidine HCl in Sodium Chloride 0.9% Injection in Plastic Container, EQ 90 mg base/100 mL, EQ 120 mg base/100 mL, EQ 180 mg base/100 mL, EQ 240 mg base/100 mL, EQ 360 mg/100 mL, and EQ 480 mg base/100 mL   Do. ANDA 074620 Butorphanol Tartrate Injection USP, 1 mg/mL and 2 mg/mL   Do. ANDA 074758 Acyclovir for Injection USP, EQ 500 mg base/vial and EQ 1 gram (g) base/vial   Do. ANDA 074801 Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL   Do. ANDA 075385 Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075453 Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base   Do. ANDA 076883 Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg Teva Pharmaceuticals USA, Inc. ANDA 077052 Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ 20 mg base, and EQ 40 mg base Sun Pharmaceutical Industries, Inc. ANDA 077937 Meloxicam Tablets, 7.5 mg and 15 mg   Do. ANDA 078081 Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg base, and EQ 10 mg base   Do. ANDA 078158 Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL Hospira, Inc. ANDA 078483 Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg and 12.5 mg Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC 27703. ANDA 080136 Isoniazid Tablets, 100 mg Sun Pharmaceutical Industries, Inc. ANDA 080209 Prednisone Tablets USP, 5 mg Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 Summercrest Dr., Columbia, MD 21045. ANDA 080224 Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540 mg/100 mL Hospira, Inc. ANDA 083345 Potassium Chloride for Injection Concentrate USP, 1 milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL   Do. ANDA 083808 Quinidine Sulfate Tablets USP, 200 mg Contract Pharmacal Corp., c/o SciRegs International Inc. ANDA 084623 Chlordiazepoxide HCl Capsules USP, 10 mg Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 55369. ANDA 084644 Chlordiazepoxide HCl Capsules USP, 5 mg   Do. ANDA 084710 Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g Pfizer Inc. ANDA 085061 Folic Acid Tablets USP, 1 mg Contract Pharmacal Corp., c/o SciRegs International Inc. ANDA 085933 Phentermine HCl Tablets USP Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960. ANDA 086494 Chlordiazepoxide HCl Capsules, 25 mg Teva Pharmaceuticals USA, Inc. ANDA 086821 Hydroxyzine HCl Injection USP, 50 mg/mL Hospira, Inc. ANDA 087416 Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject   Do. ANDA 087546 Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject   Do. ANDA 087862 Hydroxyzine HCl Tablets USP, 100 mg Sun Pharmaceutical Industries, Inc. ANDA 088147 Aminophylline in Sodium Chloride 0.45% Injection, 100 mg/100 mL and 200 mg/100 mL Hospira, Inc. ANDA 088367 Lidocaine HCl Injection USP, 10%   Do. ANDA 088542 Lidocaine HCl Injection USP, 4%   Do. ANDA 089162 Cyclopentolate HCl Ophthalmic Solution, 1% Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC-45, Fort Worth, TX 76134. ANDA 089347 Diatrizoate Meglumine and Diatrizoate Sodium Injection USP, 66%; 10% Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe Township, NJ 08831. ANDA 089393 Glycopyrrolate Injection USP, 0.2 mg/mL Hospira, Inc. ANDA 089488 Diphenhydramine HCl Capsules, 25 mg Sun Pharmaceutical Industries, Inc. ANDA 089521 Phenytoin Sodium Injection USP, 50 mg/mL, Ampule Hospira, Inc. ANDA 089537 Procainamide HCl Injection USP, 500 mg/mL, Carpuject   Do. ANDA 089744 Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject   Do. ANDA 089915 Leucovorin Calcium for Injection, EQ 100 mg base/vial Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618. NDA 202258 Victrelis (boceprevir) Capsules, 200 mg Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. NDA 203093 Vitekta (elvitegravir) Tablets, 85 mg and 150 mg Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.

    Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective November 2, 2017. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on the date that this notice becomes effective (see DATES) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

    Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21177 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4977] Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The public meeting will be held on October 31, 2017, from 8 a.m. to 5 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4977. The docket will close on October 27, 2017. Submit either electronic or written comments on this public meeting by October 27, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 27, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Comments received on or before October 17, 2017, will be provided to the committees. Comments received after that date will be taken into consideration by the Agency.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-N-4977 for “Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committees will discuss new drug application (NDA) 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 17, 2017, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 6, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 10, 2017.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-21170 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0502] Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is seeking public input on the design of the REMS Platform Standards Initiative, as well as methods and best practices for its construction. To facilitate this, FDA is making available the “REMS Platform Standards Initiative: Needs Assessment” (needs assessment), which summarizes a range of risk evaluation and mitigation strategies (REMS) activities that could be standardized and integrated into the health care system through the use of electronic data standards.

    DATES:

    The comment period will be open indefinitely.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2013-N-0502 for “REMS Platform Standards Initiative: Needs Assessment; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Adam Kroetsch, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301-796-3842, [email protected]; or Aaron Sherman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 240-402-0493, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    On October 5, 2015, FDA launched the REMS Platform Standards Initiative (previously referred to as the “Common REMS Platform Initiative”), with the goal of developing and leveraging electronic health data standards, referred to as “REMS platform standards,” to further standardize certain activities associated with REMS with elements to assure safe use (ETASU), and integrate them into existing health care systems. (Information about the initiative can be found at: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM507451.pdf). Since then, FDA has been working to determine the most effective methods for carrying out this initiative, including how best to engage the public on the project and advance the development of REMS platform standards. To achieve these ends, FDA is publishing the “REMS Platform Standards Initiative: Needs Assessment,” which seeks to provide REMS stakeholders, standards developers, and health information technology (IT) systems developers with specific, detailed information on the areas in which standards development is needed and the information that the data standards would need to communicate to effectively carry out REMS activities. FDA seeks comment on the document as a whole, as well as on the specific questions that follow.

    (1) Does this needs assessment cover all of the REMS activities for which standards development would be beneficial?

    (2) Which REMS activities should be given highest priority for standards development?

    (3) What standards already exist that could be used to address the needs and facilitate the REMS activities described in the needs assessment?

    (4) Where (if at all) do new standards need to be developed?

    (5) What other opportunities exist to leverage health IT to facilitate the completion of REMS activities?

    FDA hopes that the needs assessment will help identify areas where standards development projects to support REMS are already underway, as well as areas that are ripe for standards development, enabling interested stakeholders to engage further in this project.

    What is the REMS Platform Standards Initiative?

    The goal of the REMS Platform Standards Initiative is to leverage electronic health data standards to standardize certain activities in REMS with ETASU and integrate them into health IT systems. Under the initiative, FDA seeks to work with third-party standards development organizations to encourage the development of electronic data standards that may be used to facilitate communication between REMS and their participants. Once the standards are developed, FDA would maintain a list of REMS platform standards, encourage their use in REMS with ETASU, and encourage the development of tools that use these standards to integrate REMS into health care providers' existing systems.

    Why is FDA launching the REMS Platform Standards Initiative?

    This initiative was launched for a number of reasons. Stakeholders have requested a centralized method to enroll in and interact with REMS with ETASU and more fundamental standardization of REMS architecture. There is also a need for a comprehensive set of standards for REMS to help minimize REMS burden on the health care delivery system and integrate REMS into health IT systems.

    The goal of the REMS Platform Standards Initiative is to give all stakeholders—including sponsors, data vendors, clinical decision support system developers (such as those for hospitals, private practices, etc.)—a “fixed target” for standardization and integration. If successful, this will clarify how sponsors can develop standardized REMS that are more easily integrated into the health care system and what health care providers must do to comply with those REMS. Ultimately, REMS that are more effectively standardized and integrated into the health care system should facilitate enhanced compliance and safer use of drugs that have REMS.

    II. Electronic Access

    Persons with access to the Internet may obtain the needs assessment at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM565594.pdf.

    Dated: September 19, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-21218 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel NICHD Education Grants.

    Date: November 6, 2017.

    Time: 3:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6710 B Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Joanna Kubler-Kielb, Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5B01, Bethesda, MD 20892-7510, 301-435-6916, [email protected].

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel, SPROUTS: Development of eating behaviors in early childhood.

    Date: November 13, 2017.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, 6710 B Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review Administrator Division of Scientific Review National Institute of Child Health and Human D, 6100 Executive Boulevard, Room 5B01, Bethesda, MD 20892-9304, (301) 435-6680, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)
    Dated: September 27, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-21139 Filed 10-2-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following NHLBI Mentored Clinical and Basic Science Review Committee meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Clinical and Basic Science Review Committee.

    Date: October 26-27, 2017.

    Time: 10:30 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Crowne Plaza National Airport, 1480 Crystal Drive, Arlington, VA 22202.

    Contact Person: Keith A. Mintzer, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7186, Bethesda, MD 20892-7924, 301-827-7949, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: September 27, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-21136 Filed 10-2-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Peer Review Meeting.

    Date: October 26-27, 2017.

    Time: 12:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call).

    Contact Person: Susana Mendez, DVM, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G53B, National Institutes of Health, NIAID, 5601 Fishers Lane Dr., MSC 9823, Bethesda, MD 20892-9823, (240) 669-5077, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: September 27, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-21138 Filed 10-2-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Diseases and Pathophysiology of the Visual System Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Nataliya Gordiyenko, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, MSC 7846, Bethesda, MD 20892, 301-435-1265, [email protected].

    Name of Committee: Oncology 1—Basic Translational Integrated Review Group; Cancer Etiology Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco, CA 94102.

    Contact Person: Ola Mae Zack Howard, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Room 4192, MSC 7806, Bethesda, MD 20892, 301-451-4467, [email protected].

    Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neurotoxicology and Alcohol Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Washington, DC Downtown, 1199 Vermont Avenue NW., Washington, DC 20005.

    Contact Person: Jana Drgonova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5213, Bethesda, MD 20892, 301-827-2549, [email protected]

    Name of Committee: Oncology 1—Basic Translational Integrated Review Group; Cancer Molecular Pathobiology Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Ritz-Carlton at Tysons Corner, 1700 Tysons Blvd., McLean, VA 22102.

    Contact Person: Manzoor Zarger, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6208, MSC 7804, Bethesda, MD 20892, (301) 435-2477, [email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Molecular and Cellular Endocrinology Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Alexandria Old Town, 1900 Diagonal Road, Alexandria, VA 22314.

    Contact Person: Liliana Norma Berti-Mattera, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, RM 4215, Bethesda, MD 20892, [email protected].

    Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Systemic Injury by Environmental Exposure.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: DoubleTree by Hilton Hotel Los Angeles—Westside, 6161 West Centinela Avenue, Culver City, CA 90230.

    Contact Person: Meenakshisundar Ananthanarayanan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4200, Bethesda, MD 20817, 301-435-1234, [email protected].

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Chemo/Dietary Prevention Study Section.

    Date: October 26, 2017,

    Time: 8:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015.

    Contact Person: Svetlana Kotliarova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health. 6701 Rockledge Drive, Room 6214, Bethesda, MD 20892, 301-594-7945, [email protected].

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Therapeutic Approaches to Genetic Diseases Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: JW Marriott New Orleans, 614 Canal Street, New Orleans, LA 70130.

    Contact Person: Methode Bacanamwo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2200, Bethesda, MD 20892, 301-827-7088, [email protected].

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Virology—A Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202.

    Contact Person: Kenneth M. Izumi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3204, MSC 7808, Bethesda, MD 20892, 301-496-6980, [email protected].

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Drug Discovery for the Nervous System Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Pier 5 Hotel, 711 Eastern Avenue, Baltimore, MD 21202.

    Contact Person: Mary Custer, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4148, MSC 7850, Bethesda, MD 20892, (301) 435-1164, [email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Integrative and Clinical Endocrinology and Reproduction Study Section.

    Date: October 26, 2017.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Alexandria Old Town/Duke Street, 1456 Duke Street, Alexandria, VA 22314.

    Contact Person: Dianne Hardy, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6175, MSC 7892, Bethesda, MD 20892, 301-435-1154, [email protected].

    Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Biomaterials and Biointerfaces Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Courtyard Seattle Downtown, 612 2nd Avenue, Seattle, WA 98104.

    Contact Person: Joseph D. Mosca, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158, MSC 7808, Bethesda, MD 20892, (301) 408-9465, [email protected].

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Cancer Immunopathology and Immunotherapy Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Warwick Allerton Hotel, 701 North Michigan Avenue, Chicago, IL 60611.

    Contact Person: Denise R. Shaw, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, 301-435-0198, [email protected].

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroplasticity and Neurotransmitters Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Fairmont Hotel, 2401 M Street, Washington, DC 20037.

    Contact Person: Suzan Nadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301-435-1259, [email protected].

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Biobehavioral Mechanisms of Emotion, Stress and Health Study Section.

    Date: October 26-27, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Melrose Hotel, 2430 Pennsylvania Avenue NW., Washington, DC 20037.

    Contact Person: Samantha Smith, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, Bethesda, MD 20892, 301-827-5491, [email protected].

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Cellular and Molecular Biology of Neurodegeneration Study Section.

    Date: October 26-27, 2017.

    Time: 8:30 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Darcy, Curio Collection by Hilton, 1515 Rhode Island Avenue NW., Washington, DC 20005.

    Contact Person: Laurent Taupenot, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4183, MSC 7850, Bethesda, MD 20892, 301-435-1203, [email protected].

    Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Cancer, Heart, and Sleep Epidemiology—A Study Section.

    Date: October 26-27, 2017.

    Time: 8:30 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue NW., Washington, DC 20037.

    Contact Person: Denise Wiesch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3138, MSC 7770, Bethesda, MD 20892, (301) 437-3478, [email protected].

    Name of Committee:Vascular and Hematology Integrated Review Group; Vascular Cell and Molecular Biology Study Section.

    Date: October 26-27, 2017.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Larry Pinkus, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4132, MSC 7802, Bethesda, MD 20892, (301) 435-1214, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 27, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-21133 Filed 10-2-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK Ancillary Studies.

    Date: November 1, 2017.

    Time: 3:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 594-8898, [email protected]

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Computational and Experimental Resources for Virome Analysis in Inflammatory Bowel Disease (CERVAID).

    Date: November 14, 2017.

    Time: 12:30 p.m. to 1:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Paul A. Rushing, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7345, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-8895, [email protected]

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR-16-034: Artificial Pancreas Ancillary Studies (R01).

    Date: November 15, 2017.

    Time: 1:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7119, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, 301-594-2242, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)
    Dated: September 27, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-21130 Filed 10-2-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the NHLBI Mentored Patient-Oriented Research Review Committee meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Heart, Lung, and Blood Initial Review Group NHLBI Mentored Patient-Oriented Research Review Committee.

    Date: October 26-27, 2017.

    Time: 8:30 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Cambria Hotels & Suites—Rockville, 1 Helen Heneghan Way, Rockville, MD 20850.

    Contact Person: Stephanie Johnson Webb, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892, 301-827-7992, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: September 27, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-21137 Filed 10-2-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Critical Facility Information of the Top 100 Most Critical Pipelines AGENCY:

    Transportation Security Administration, DHS.

    ACTION:

    30-day Notice.

    SUMMARY:

    This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0050, abstracted below to OMB for an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on July 6, 2017, 82 FR 31341. TSA developed and implemented a plan to review the security plans and inspect critical pipeline systems to comply with a requirement in the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act).

    DATES:

    Send your comments by November 2, 2017. A comment to OMB is most effective if OMB receives it within 30 days of publication.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Christina A. Walsh, TSA PRA Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), 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 OMB control number. The ICR documentation will be made available at http://www.reginfo.gov upon its submission to OMB. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—

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

    (2) Evaluate the accuracy of the agency's estimate of the burden;

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

    (4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Consistent with the requirements of Executive Order (EO) 13771, Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.

    Information Collection Requirement

    Title: Critical Facility Information of the Top 100 Most Critical Pipelines.

    Type of Request: Extension of a currently approved collection.

    OMB Control Number: 1652-0050.

    Forms(s): Critical Facility Security Review.

    Affected Public: Pipeline companies.

    Abstract: The 9/11 Act specifically tasked TSA to develop and implement a plan for reviewing the pipeline security plans and inspecting critical facilities of the 100 most critical pipeline systems. See sec. 1557 of the 9/11 Act (Pub. L. 110-53; 121 Stat. 266, 475, Aug. 3, 2007; codified at 6 U.S.C. 1207(b)). TSA visits critical pipeline facilities and collects site-specific information from pipeline operators on facility security policies, procedures, and physical security measures. TSA uses the information to determine strengths and weaknesses at the nation's critical pipeline facilities, areas to target for risk reduction strategies, pipeline industry implementation of the TSA Pipeline Security Guidelines, and operator implementation of recommendations made during TSA critical facility visits.

    Number of Respondents: 160.

    Estimated Annual Burden Hours: An estimated 720 hours annually.

    Dated: September 28, 2017. Christina A. Walsh, TSA Paperwork Reduction Act Officer, Office of Information Technology.
    [FR Doc. 2017-21251 Filed 10-2-17; 8:45 am] BILLING CODE 9110-05-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1072] Certain Wi-Fi Enabled Electronic Devices and Components Thereof; Institution of Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 29, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Sharp Corporation of Japan and Sharp Electronics Corporation of Montvale, New Jersey. Supplements to the complaint were filed on August 30, 2017 and September 21, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain Wi-Fi enabled electronic devices and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,325,838 (“the '838 patent”) and U.S. Patent No. 8,279,809 (“the '809 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute.

    The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

    ADDRESSES:

    The complaint except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Co