Federal Register Vol. 81, No.172,

Federal Register Volume 81, Issue 172 (September 6, 2016)

Page Range61099-61582
FR Document

81_FR_172
Current View
Page and SubjectPDF
81 FR 61255 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Authorization Request Forms/Certification/Letter of Medical NecessityPDF
81 FR 61215 - Sunshine Act Meeting NoticePDF
81 FR 61102 - Airworthiness Directives; All Hot Air BalloonsPDF
81 FR 61290 - Seventh Meeting of SC-233 Addressing Human Factors/Pilot Interface Issues for AvionicsPDF
81 FR 61216 - SES Performance Review BoardPDF
81 FR 61231 - Oklahoma; Amendment No. 2 to Notice of a Major Disaster DeclarationPDF
81 FR 61228 - Kentucky; Major Disaster and Related DeterminationsPDF
81 FR 61145 - Nondiscrimination on the Basis of Disability in Air Travel: Negotiated Rulemaking Committee Fifth MeetingPDF
81 FR 61196 - USPTO Cancer Moonshot ChallengePDF
81 FR 61290 - Agreement on Social Security Between the United States and Hungary; Entry into ForcePDF
81 FR 61186 - Truck and Bus Tires From the People's Republic of China: Preliminary Affirmative Determinations of Sales at Less Than Fair Value and Critical Circumstances, and Postponement of Final DeterminationPDF
81 FR 61130 - Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA into Schedule IPDF
81 FR 61184 - Foreign-Trade Zone (FTZ) 125-South Bend, Indiana; Authorization of Proposed Production Activity; LionsHead Specialty Tire & Wheel, LLC (Wheel Assemblies for Specialty Applications); Goshen, IndianaPDF
81 FR 61243 - Notice of Mailing/Street Address Change for the BLM-Cottonwood Field OfficePDF
81 FR 61243 - Notice of Individual Special Recreation Permit Requirement in the King Range National Conservation Area, CaliforniaPDF
81 FR 61185 - Foreign-Trade Zone (FTZ) 281-Miami, Florida; Authorization of Production Activity; Alpha Marketing Network, Inc. d/b/a AMN Distributors (Kitting-Wine Gift Sets); Miami, FloridaPDF
81 FR 61136 - Air Quality Designations for the 2012 Primary Annual Fine Particle (PM2.5PDF
81 FR 61106 - Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human UsePDF
81 FR 61239 - Proposed Information Collection; Federal Fish and Wildlife Permit Applications and Reports-Law EnforcementPDF
81 FR 61290 - Review of the Designation as a Foreign Terrorist Organization of Kata'ib Hizballah (and Other Aliases)PDF
81 FR 61104 - Amendments to Existing Validated End-User Authorization in the People's Republic of China: Boeing Tianjin Composites Co. Ltd.PDF
81 FR 61185 - Solid Fertilizer Grade Ammonium Nitrate From the Russian Federation: Rescission of Antidumping Duty Administrative Review; 2015-2016PDF
81 FR 61185 - 1-Hydroxyethylidene-1, 1-Diphosphonic Acid From People's Republic of China: Postponement of Preliminary Determination of Antidumping Duty InvestigationPDF
81 FR 61226 - Submission for OMB Review; 30-Day Comment Request; NIDDK Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases)PDF
81 FR 61198 - Information Collection; Submission for OMB Review, Comment RequestPDF
81 FR 61216 - Notice to All Interested Parties of the Termination of the Receivership of 10487-Sunrise Bank of Arizona, Phoenix, ArizonaPDF
81 FR 61259 - New Postal ProductsPDF
81 FR 61224 - Request for Public Comment on Draft Health Center Program Compliance ManualPDF
81 FR 61223 - Senior Executive Service Performance Review BoardPDF
81 FR 61254 - Agency Information Collection Activities; Comments Request for the Benefits Timeliness and Quality (BTQ) Review SystemPDF
81 FR 61253 - Agency Information Collection Activities; Comment Request for Nonmonetary Determination Activity ReportPDF
81 FR 61193 - Proposed Information Collection; Comment Request; Analysis and Review of Ocean Exploration Video ProductsPDF
81 FR 61142 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher/Processors Using Trawl Gear in the Central Regulatory Area of the Gulf of AlaskaPDF
81 FR 61143 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management AreaPDF
81 FR 61193 - Western Pacific Fishery Management Council; Public MeetingsPDF
81 FR 61215 - Environmental Management Site-Specific Advisory Board, Northern New MexicoPDF
81 FR 61257 - Lost Creek In SituPDF
81 FR 61216 - Notice of Re-Opening Request for Information (RFI): Stakeholder Input on Out-Year Marine and Hydrokinetic Program StrategyPDF
81 FR 61195 - Request for Comments on the Extended Missing Parts Pilot ProgramPDF
81 FR 61256 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Report on Occupational Employment and WagesPDF
81 FR 61182 - Eastern Washington Cascades Provincial Advisory CommitteePDF
81 FR 61252 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of Currently Approved Collection: 2017 School Crime Supplement (SCS) to the National Crime Victimization Survey (NCVS)PDF
81 FR 61251 - Agency Information Collection Activities; Proposed eCollection; eComments Requested; Approval of a New Collection; Assessing Potential Benefits of Accessible Web Content for Individuals Who Are BlindPDF
81 FR 61251 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection U.S. Official Order Forms for Schedules I and II Controlled Substances DEA Form 222PDF
81 FR 61217 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 61200 - National Environmental Policy Act Implementing ProceduresPDF
81 FR 61099 - Interpretation, Exemptions and Waiver Guidance Concerning the Federal Criminal Conflict of Interest Statute Prohibiting Acts Affecting a Personal Financial Interest; Amendment to Definition of “Employee”PDF
81 FR 61214 - Agency Information Collection Activities; Comment Request; Student Assistance General Provisions-Subpart K-Cash ManagementPDF
81 FR 61242 - Trinity River Adaptive Management Working Group; Public Meeting, Teleconference, and Web-Based MeetingPDF
81 FR 61244 - United States of America v. Iron Mountain Inc., et al.; Public Comment and Response on Proposed Final JudgmentPDF
81 FR 61241 - Low-Effect Habitat Conservation Plan for the Mount Hermon June Beetle, Santa Cruz County, CaliforniaPDF
81 FR 61183 - Proposed Information Collection; Comment Request; 2016-2018 Business R&D and Innovation SurveysPDF
81 FR 61181 - Re-Establishment of and Notice for Solicitation for the Council for Native American Farming and RanchingPDF
81 FR 61194 - Proposed Information Collection; Comment Request; Limited Access Death Master File Accredited Conformity Assessment Body Application for Firewalled StatusPDF
81 FR 61160 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Rehabilitation of the Jetty System at the Mouth of the Columbia River: Jetty A, North Jetty, and South Jetty, in Washington and Oregon; CorrectionPDF
81 FR 61199 - Notice of Intent To Prepare an Environmental Impact Statement (EIS) for the Housing Program at Wright-Patterson Air Force Base (AFB), OHPDF
81 FR 61218 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 61133 - Safety Zone; Swim Around Charleston; Charleston, SCPDF
81 FR 61257 - NASA Advisory Council; Science Committee; Ad Hoc Task Force on Big Data; MeetingPDF
81 FR 61100 - Revision of Fee Schedules; Fee Recovery for Fiscal Year 2016; CorrectionPDF
81 FR 61263 - Securities Investor Protection Corporation: Order Approving a Proposed Bylaw Change Relating to SIPC Fund Assessments on SIPC MembersPDF
81 FR 61283 - Order Making Fiscal Year 2017 Annual Adjustments to Registration Fee RatesPDF
81 FR 61259 - Product Change-Priority Mail Express and Priority Mail Negotiated Service AgreementPDF
81 FR 61260 - Product Change-Priority Mail Express and Priority Mail Negotiated Service AgreementPDF
81 FR 61229 - Louisiana; Major Disaster and Related DeterminationsPDF
81 FR 61230 - Louisiana; Amendment No. 2 to Notice of a Major Disaster DeclarationPDF
81 FR 61228 - Louisiana; Amendment No. 1 to Notice of a Major Disaster DeclarationPDF
81 FR 61230 - Louisiana; Amendment No. 3 to Notice of a Major Disaster DeclarationPDF
81 FR 61231 - Oklahoma; Amendment No. 1 to Notice of a Major Disaster DeclarationPDF
81 FR 61229 - Wisconsin; Major Disaster and Related DeterminationsPDF
81 FR 61159 - Revisions to the Requirements for Authority To Manufacture and Distribute Postage Evidencing SystemsPDF
81 FR 61269 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Withdrawal of a Proposed Rule Change Related to the Adoption of an Options Exchange Risk Control Standards PolicyPDF
81 FR 61266 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 9217 To Add a Provision and Related Fines Addressing Trade-Through ViolationsPDF
81 FR 61271 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change to Describe the Blackout Period Exposure Charge That May Be Imposed on GCF Repo ParticipantsPDF
81 FR 61288 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Amending Rule 12400 of the Code of Arbitration Procedure for Customer Disputes and Rule 13400 of the Code of Arbitration Procedure for Industry Disputes Relating to Broadening Chairperson Eligibility in ArbitrationPDF
81 FR 61260 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change Relating to the Listing and Trading of Shares of BlackRock Government Collateral Pledge Unit Under NYSE Arca Equities Rule 8.600PDF
81 FR 61268 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Amend NYSE Arca Equities Rule 8.700 and To List and Trade Shares of the Managed Emerging Markets Trust Under Proposed Amended NYSE Arca Equities Rule 8.700PDF
81 FR 61219 - Submission for OMB Review; Comment RequestPDF
81 FR 61260 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Withdrawal of an Advance Notice Related to the Adoption of an Options Exchange Risk Control Standards PolicyPDF
81 FR 61265 - Voya ETF Trust, et al., Notice of ApplicationPDF
81 FR 61269 - Rational Advisors, Inc. and Strategy Shares; Notice of ApplicationPDF
81 FR 61271 - Euroclear Bank SA/NV; Notice of Filing of Application To Modify an Existing Exemption From Clearing Agency RegistrationPDF
81 FR 61227 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 61250 - Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.PDF
81 FR 61249 - Bulk Manufacturer of Controlled Substances Application: IsosciencesPDF
81 FR 61248 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.PDF
81 FR 61250 - Importer of Controlled Substances Application: Unither Manufacturing, LLCPDF
81 FR 61249 - Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.PDF
81 FR 61182 - Medicine Bow-Routt National Forest and Thunder Basin National Grassland; Routt County, Colorado; Steamboat Ski Resort, Steamboat EISPDF
81 FR 61227 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
81 FR 61225 - National Institute on Aging; Notice of Closed MeetingPDF
81 FR 61225 - National Heart, Lung, and Blood Institute Notice of Closed MeetingsPDF
81 FR 61225 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 61231 - Announcement of Funding Awards: Housing Counseling Grants Fiscal Year 2016PDF
81 FR 61221 - Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship ProgramPDF
81 FR 61223 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket ApplicationsPDF
81 FR 61220 - Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
81 FR 61148 - Special Local Regulation; Little Annemessex River and Somers Cove, Crisfield, MDPDF
81 FR 61147 - Commodity Pool Operator Annual ReportPDF
81 FR 61161 - Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Electronic Monitoring ProgramPDF
81 FR 61199 - Notice Is Given of the Names of Members of the Performance Review Board for the Department of the Air ForcePDF
81 FR 61146 - Statement of Policy on the Commission's Interpretation of Intent To Produce Audible Effects Within the Meaning of the Commission's Fireworks Regulations Under the Federal Hazardous Substances ActPDF
81 FR 61148 - Title I-Improving the Academic Achievement of the Disadvantaged-Supplement Not SupplantPDF
81 FR 61456 - Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018PDF
81 FR 61294 - Head Start Performance StandardsPDF
81 FR 61538 - Adjustment of Civil Monetary Penalties for InflationPDF

Issue

81 172 Tuesday, September 6, 2016 Contents Agriculture Agriculture Department See

Forest Service

NOTICES Requests for Nominations: Council for Native American Farming and Ranching, 61181 2016-21280
AIRFORCE Air Force Department NOTICES Environmental Impact Statements; Availability, etc.: Housing Program at Wright-Patterson Air Force Base, OH, 61199-61200 2016-21274 Performance Review Board Membership, 61199 2016-21056 Antitrust Division Antitrust Division NOTICES Proposed Final Judgments and Competitive Impact Statements: United States of America v. Iron Mountain Inc., et al., 61244-61248 2016-21287 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2016-2018 Business R and D and Innovation Surveys, 61183-61184 2016-21281 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61217-61219 2016-21273 2016-21296 Centers Medicare Centers for Medicare & Medicaid Services RULES Civil Monetary Penalties, 61538-61582 2016-18680 Children Children and Families Administration RULES Civil Monetary Penalties, 61538-61582 2016-18680 Head Start Performance Standards, 61294-61453 2016-19748 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Ethnic Community Self-Help Program Data Indicators, 61219-61220 2016-21250 Coast Guard Coast Guard RULES Safety Zones: Swim Around Charleston, Charleston, SC, 61133-61136 2016-21272 PROPOSED RULES Special Local Regulations: Little Annemessex River and Somers Cove, Crisfield, MD; Withdrawal, 61148 2016-21173 Commerce Commerce Department See

Census Bureau

See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Technical Information Service

See

Patent and Trademark Office

Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Commodity Pool Operator Annual Report, 61147-61148 2016-21153 Consumer Product Consumer Product Safety Commission PROPOSED RULES Production of Audible Effects Within the Meaning of the Commission's Fireworks Regulations Under the Federal Hazardous Substances Act, 61146-61147 2016-21014 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Senior Corps Progress Report, 61198 2016-21327 Defense Department Defense Department See

Air Force Department

NOTICES National Environmental Policy Act Implementing Procedures, 61200-61214 2016-21294
Drug Drug Enforcement Administration RULES Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA Into Schedule I, 61130-61133 2016-21345 NOTICES Importers of Controlled Substances; Applications: Fisher Clinical Services, Inc., 61248-61249 2016-21240 Unither Manufacturing, LLC, 61250 2016-21239 Manufacturers of Controlled Substances; Applications: AMRI Rensselaer, Inc., 61250-61251 2016-21242 Cody Laboratories, Inc., 61249 2016-21238 Isosciences, 61249-61250 2016-21241 Education Department Education Department PROPOSED RULES Title I—Improving the Academic Achievement of the Disadvantaged—Supplement Not Supplant, 61148-61159 2016-20989 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Student Assistance General Provisions—Subpart K—Cash Management, 61214-61215 2016-21291 Election Election Assistance Commission NOTICES Meetings; Sunshine Act, 61215 2016-21441 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Benefits Timeliness and Quality (BTQ) Review System, 61254-61255 2016-21319 Nonmonetary Determination Activity Report, 61253-61254 2016-21318 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

NOTICES Meetings: Environmental Management Site-Specific Advisory Board, Northern New Mexico, 61215-61216 2016-21311
Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Requests for Information: Stakeholder Input on Out-Year Marine and Hydrokinetic Program Strategy, 61216 2016-21307 Environmental Protection Environmental Protection Agency RULES Air Quality Designations: Georgia and Florida 2012 Primary Annual Fine Particle (PM2.5) National Ambient Air Quality Standard, 61136-61142 2016-21338 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: All Hot Air Balloons, 61102-61104 2016-21409 NOTICES Meetings: Addressing Human Factors and Pilot Interface Issues for Avionics, 61290-61291 2016-21403 Federal Deposit Federal Deposit Insurance Corporation NOTICES Receiverships; Terminations: Sunrise Bank of Arizona, Phoenix, AZ, 61216 2016-21324 Federal Emergency Federal Emergency Management Agency NOTICES Major Disaster Declarations: Kentucky, 61228-61229 2016-21374 Louisiana; Amendment No. 1, 61228 2016-21262 Louisiana; Amendment No. 2, 61230 2016-21263 Louisiana; Amendment No. 3, 61230 2016-21261 Oklahoma; Amendment No. 1, 61231 2016-21260 Oklahoma; Amendment No. 2, 61231 2016-21375 Major Disasters and Related Determinations: Louisiana, 61229 2016-21264 Wisconsin, 61229-61230 2016-21259 Federal Trade Federal Trade Commission NOTICES Senior Executive Service Performance Review Board Members, 61216-61217 2016-21402 Fish Fish and Wildlife Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Fish and Wildlife Permit Applications and Reports; Law Enforcement, 61239-61241 2016-21336 Incidental Take Permits: Low-Effect Habitat Conservation Plan for Mount Hermon June Beetle, Santa Cruz County, CA, 61241-61242 2016-21286 Meetings: Trinity River Adaptive Management Working Group; Teleconference and Web-Based Meeting, 61242-61243 2016-21289 Food and Drug Food and Drug Administration RULES Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use, 61106-61130 2016-21337 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Participation in Medical Device Fellowship Program, 61221-61222 2016-21229 Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications, 61223 2016-21228 Determinations That Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness: AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products, 61220-61221 2016-21227 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Alpha Marketing Network, Inc. d.b.a. AMN Distributors, Foreign-Trade Zone 281, Miami, FL, 61185 2016-21339 LionsHead Specialty Tire and Wheel, LLC, Foreign-Trade Zone 125, South Bend, IN, 61184-61185 2016-21342 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Steamboat Ski Resort, Medicine Bow—Routt National Forest and Thunder Basin National Grassland, Routt Count, CO, 61182-61183 2016-21236 Meetings: Eastern Washington Cascades Provincial Advisory Committee, 61182 2016-21302 Government Ethics Government Ethics Office RULES Interpretation, Exemptions and Waiver Guidance Concerning the Federal Criminal Conflict of Interest Statute Prohibiting Acts Affecting a Personal Financial Interest, 61099-61100 2016-21293 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

Inspector General Office, Health and Human Services Department

See

National Institutes of Health

RULES Civil Monetary Penalties, 61538-61582 2016-18680 PROPOSED RULES Patient Protection and Affordable Care Act: Benefit and Payment Parameters for 2018, 61456-61536 2016-20896
Health Resources Health Resources and Services Administration NOTICES Health Center Program Compliance Manual; Draft, 61224-61225 2016-21321 Senior Executive Service Performance Review Board: Prospective Members, 61223-61224 2016-21320 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Housing Housing and Urban Development Department NOTICES Funding Awards: Housing Counseling Grants Fiscal Year 2016, 61231-61239 2016-21230 Industry Industry and Security Bureau RULES Validated End-User Authorization: Boeing Tianjin Composites Co., Ltd.; Amendments, 61104-61106 2016-21333 Inspector General Health Inspector General Office, Health and Human Services Department RULES Civil Monetary Penalties, 61538-61582 2016-18680 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: 1-Hydroxyethylidene-1, 1-Diphosphonic Acid From People's Republic of China, 61185 2016-21331 Solid Fertilizer Grade Ammonium Nitrate From Russian Federation, 61185-61186 2016-21332 Determinations of Sales at Less Than Fair Value: Truck and Bus Tires From People's Republic of China, 61186-61192 2016-21346 Justice Department Justice Department See

Antitrust Division

See

Drug Enforcement Administration

See

Justice Programs Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Assessing Potential Benefits of Accessible Web Content for Individuals Who Are Blind, 61251-61252 2016-21298 U.S. Official Order Forms for Schedules I and II Controlled Substances, 61251 2016-21297
Justice Programs Justice Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: School Crime Supplement to National Crime Victimization Survey, 61252-61253 2016-21299 Labor Department Labor Department See

Employment and Training Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61255-61256 2016-21451 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report on Occupational Employment and Wages, 61256 2016-21303
Land Land Management Bureau NOTICES Individual Special Recreation Permit Requirements: King Range National Conservation Area, CA, 61243-61244 2016-21340 Mailing and Street Address Changes: Cottonwood Field Office, 61243 2016-21341 NASA National Aeronautics and Space Administration NOTICES Meetings: National Aeronautics and Space Administration Advisory Council; Science Committee; Ad Hoc Task Force on Big Data, 61257 2016-21271 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: NIDDK Office of Minority Health Research Coordination Research Training and Mentor Programs Applications, 61226-61227 2016-21329 Meetings: Center for Scientific Review, 61225, 61227-61228 2016-21232 2016-21243 National Heart, Lung, and Blood Institute, 61225 2016-21233 National Institute on Aging, 61225-61226 2016-21234 National Institute on Alcohol Abuse and Alcoholism, 61227 2016-21235 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Cod by Catcher/Processors Using Trawl Gear in the Central Regulatory Area of the Gulf of Alaska, 61142-61143 2016-21316 Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area, 61143-61144 2016-21315 PROPOSED RULES Fisheries Off West Coast States: Pacific Coast Groundfish Fishery; Electronic Monitoring Program, 61161-61180 2016-21058 Takes of Marine Mammals Incidental to Specified Activities: Rehabilitation of Jetty System at Mouth of Columbia River: Jetty A, North Jetty, and South Jetty, in Washington and Oregon; Correction, 61160-61161 2016-21275 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Analysis and Review of Ocean Exploration Video Products, 61193 2016-21317 Meetings: Western Pacific Fishery Management Council, 61193-61194 2016-21314 National Technical National Technical Information Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61194-61195 2016-21279 Nuclear Regulatory Nuclear Regulatory Commission RULES Revision of Fee Schedules: Fee Recovery for Fiscal Year 2016; Correction, 61100-61102 2016-21270 NOTICES Environmental Assessments; Availability, etc.: Lost Creek In Situ Uranium Recovery Project; Underground Injection Control Class V Wells, 61257-61258 2016-21308 Patent Patent and Trademark Office NOTICES Cancer Moonshot Challenge, 61196-61198 2016-21349 Extended Missing Parts Pilot Program, 61195-61196 2016-21306 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 61259 2016-21322 Postal Service Postal Service PROPOSED RULES Requirements for Authority to Manufacture and Distribute Postage Evidencing Systems, 61159-61160 2016-21258 NOTICES Product Changes: Priority Mail Express and Priority Mail Negotiated Service Agreement, 61259-61260 2016-21265 2016-21266 2016-21267 Securities Securities and Exchange Commission NOTICES Applications: Euroclear Bank SA and NV, 61271-61283 2016-21245 Rational Advisors, Inc. and Strategy Shares, 61269-61271 2016-21246 Voya ETF Trust, et al., 61265-61266 2016-21247 Fiscal Year 2017 Annual Adjustments to Registration Fee Rates, 61283-61287 2016-21268 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 61288-61290 2016-21253 Fixed Income Clearing Corp., 61271 2016-21255 NYSE Arca, Inc., 61260-61263, 61268-61269 2016-21251 2016-21252 NYSE MKT, LLC, 61266-61268 2016-21256 Options Clearing Corp., 61260, 61269 2016-21249 2016-21257 Securities Investor Protection Corp., 61263-61265 2016-21269 Social Social Security Administration NOTICES Agreement on Social Security Between United States and Hungary, 61290 2016-21348 State Department State Department NOTICES Designations as Foreign Terrorist Organizations: Kata'ib Hizballah (and Other Aliases); Review, 61290 2016-21335 Transportation Department Transportation Department See

Federal Aviation Administration

PROPOSED RULES Nondiscrimination on Basis of Disability in Air Travel: Negotiated Rulemaking Committee Meeting, 61145-61146 2016-21357
Separate Parts In This Issue Part II Health and Human Services Department, Children and Families Administration, 61294-61453 2016-19748 Part III Health and Human Services Department, 61456-61536 2016-20896 Part IV Health and Human Services Department, Centers for Medicare & Medicaid Services, 61538-61582 2016-18680 Health and Human Services Department, Children and Families Administration, 61538-61582 2016-18680 Health and Human Services Department, Inspector General Office, Health and Human Services Department, 61538-61582 2016-18680 Health and Human Services Department, 61538-61582 2016-18680 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.

81 172 Tuesday, September 6, 2016 Rules and Regulations OFFICE OF GOVERNMENT ETHICS 5 CFR Part 2640 RIN 3209-AA09 Interpretation, Exemptions and Waiver Guidance Concerning the Federal Criminal Conflict of Interest Statute Prohibiting Acts Affecting a Personal Financial Interest; Amendment to Definition of “Employee” AGENCY:

Office of Government Ethics (OGE).

ACTION:

Interim final rule with request for comments.

SUMMARY:

The U.S. Office of Government Ethics is issuing this interim final rule to make a technical modification to the definition of “employee” in its regulations implementing the federal criminal conflict of interest statute concerning acts affecting a personal financial interest, in order to ensure their continued applicability to all individuals subject to requirements of the statute.

DATES:

This interim regulation is effective September 6, 2016. Comments are invited and are due in writing by November 7, 2016.

ADDRESSES:

You may submit comments, in writing, to OGE on this interim final rule, identified by RIN 3209-AA09, by any of the following methods:

E-Mail: [email protected] Include the reference “Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts Affecting A Personal Financial Interest); Amendment to Definition of `Employee' ” in the subject line of the message.

Fax: (202) 482-9237.

Mail/Hand Delivery/Courier: Office of Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917, Attention: “Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts Affecting A Personal Financial Interest); Amendment to Definition of `Employee.' ”

Instructions: All submissions must include OGE's agency name and the Regulation Identifier Number (RIN), 3209-AA09, for this rulemaking. All comments, including attachments and other supporting materials, will become part of the public record and be subject to public disclosure. Comments may be posted on OGE's Web site, www.oge.gov. Sensitive personal information, such as account numbers or Social Security numbers, should not be included. Comments generally will not be edited to remove any identifying or contact information.

FOR FURTHER INFORMATION CONTACT:

Christopher J. Swartz, Assistant Counsel, Office of Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917; Telephone: 202-482-9300; TTY: 800-877-8339; Fax: 202-482-9237.

SUPPLEMENTARY INFORMATION: I. Background

The U.S. Office of Government Ethics (OGE) is issuing this interim final rule making a technical modification to the definition of “employee” in its regulations implementing 18 U.S.C. 208. Section 208(a) prohibits participation in particular matters affecting a covered individual's personal and imputed financial interests. Section 208(b)(2) authorizes OGE to promulgate regulatory exemptions describing financial interests that are “too remote or too inconsequential” to warrant disqualification pursuant to section 208(a). Pursuant to 5 U.S.C. app. 402(b)(1) and Executive Order 12674 of April 12, 1989 (as modified by Executive Order 12731), OGE is responsible for providing uniform regulations interpreting section 208. In addition, section 208(d)(2) specifically directs OGE to adopt “uniform regulations for . . . exemptions” from the applicability of section 208(a). Consistent with these authorities, in 1996 OGE issued uniform regulations at 5 CFR part 2640 interpreting 18 U.S.C. 208 and establishing exemptions for all individuals subject to section 208(a). 61 FR 66830 (Dec. 18, 1996).

OGE established this uniform coverage by defining “employee” to mean “an officer or employee of the executive branch of the United States, or of any independent agency of the United States, a Federal Reserve bank director, officer, or employee, or an officer or employee of the District of Columbia,” including “a special Government employee as defined in 18 U.S.C. 202.” 5 CFR 2640.102(b). The language of this definition in 5 CFR part 2640 carefully covered all individuals then subject to the statute, including certain individuals who were not executive branch employees. Compare id. with 18 U.S.C. 208(a) (covering “an officer or employee of the executive branch of the United States Government, or of any independent agency of the United States, a Federal Reserve bank director, officer, or employee, or an officer or employee of the District of Columbia, including a special Government employee”). The applicability of 5 CFR part 2640 was, thus, coextensive with the applicability of section 208.

Recently, however, a cross-reference in the organic statute of a newly created board has expanded the coverage of the requirements of section 208 to include the board's members and staff, who would not otherwise be subject to section 208. Public Law 114-187, section 109(a) (2016). In order to ensure the continued applicability of 5 CFR part 2640 to all individuals subject to section 208, this interim regulation adds the phrase “. . . , or any other individual subject to requirements of 18 U.S.C. 208” at the end of the first sentence of the definition of “employee.” This technical amendment will guard against uncertainty as to the applicability of 5 CFR part 2640 to the members and staff of this board, as well as to others who may in the future become subject to section 208. Prior to issuing this regulation, OGE consulted with the Office of Personnel Management and the Department of Justice, and pursuant to section 201(c) of Executive Order 12674, as modified by Executive Order 12731, has obtained the concurrence of the Department of Justice.

II. Matters of Regulatory Procedure Administrative Procedure Act

Pursuant to sections 553(b) and 553(d)(3) of title 5 of the United States Code, the Director of the Office of Government Ethics has found good cause for dispensing with the usual requirements of notice and comment and a 30-day delay in the rule's effective date. Because this minor amendment is strictly technical in nature, providing notice and comment and delaying the effective date are unnecessary. Moreover, in clarifying the meaning of “employee,” this rule is an interpretative rule and thus exempt from notice and comment and a delay in effective date pursuant to 5 U.S.C. 553(b) and 553(d)(2), respectively. Finally, this rule recognizes exemptions, which exempts the rule from the 30-day delayed effective date pursuant to 5 U.S.C. 553(d)(1). Nonetheless, this interim final rule provides a 60-day comment period for agencies and the public. The Office of Government Ethics will review any comments received during the comment period and consider any modifications to this rule that appear warranted.

Regulatory Flexibility Act

As Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this interim final rule would not have a significant economic impact on a substantial number of small entities because it primarily affects covered employees.

Paperwork Reduction Act

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this regulation does not contain information collection requirements that require approval of the Office of Management and Budget.

Unfunded Mandates Reform Act

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), this interim final rule would not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.

Congressional Review Act

The Office of Government Ethics has determined that this rulemaking involves a nonmajor rule under the Congressional Review Act (5 U.S.C. chapter 8) and will, before the interim final rule takes effect, submit a report thereon to the U.S. Senate, House of Representatives and General Accounting Office in accordance with that law.

Executive Order 12866

In promulgating this rule amendment, the Office of Government Ethics has adhered to the regulatory philosophy and the applicable principles of regulation set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. The Office of Management and Budget has determined that this technical rule amendment is not “significant” under Executive Order 12866.

Executive Order 12988

As Director of the Office of Government Ethics, I have reviewed this interim final rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

List of Subjects in 5 CFR Part 2640

Conflict of interests, Government employees.

Approved: August 30, 2016. Walter M. Shaub, Jr., Director, Office of Government Ethics.

Accordingly, for the reasons set forth in the preamble, the Office of Government Ethics amends 5 CFR part 2640 as follows:

PART 2640—INTERPRETATION, EXEMPTIONS AND WAIVER GUIDANCE CONCERNING 18 U.S.C. 208 (ACTS AFFECTING A PERSONAL FINANCIAL INTEREST) 1. The authority citation for part 2640 continues to read as follows: Authority:

5 U.S.C. App. (Ethics in Government Act of 1978); 18 U.S.C. 208; E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306.

2. Revise the first sentence of § 2640.102(b) to read as follows:
§ 2640.102 Definitions.

(b) Employee means an officer or employee of the executive branch of the United States, or of any independent agency of the United States, a Federal Reserve bank director, officer, or employee, an officer or employee of the District of Columbia, or any other individual subject to requirements of 18 U.S.C. 208. * * *

[FR Doc. 2016-21293 Filed 9-2-16; 8:45 am] BILLING CODE 6345-03-P
NUCLEAR REGULATORY COMMISSION 10 CFR Part 171 [NRC-2015-0223] RIN 3150-AJ66 Revision of Fee Schedules; Fee Recovery for Fiscal Year 2016; Correction AGENCY:

Nuclear Regulatory Commission.

ACTION:

Final rule; correcting amendment.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) published a final rule amending regulations that became effective August 23, 2016. The fiscal year (FY) 2016 final fee rule, published June 24, 2016, amended the licensing, inspection, special project, and annual fees charged to NRC applicants and licensees. This document corrects the annual fee for materials licensees in the category “Nuclear laundries” from the FY 2016 rate of $0 to the FY 2015 rate of $40,100. This correction allows Agreement States to continue to collect fees in this fee category.

DATES:

Effective Date: September 6, 2016.

ADDRESSES:

Please refer to Docket ID NRC-2015-0223 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0223. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

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

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

FOR FURTHER INFORMATION CONTACT:

Michele Kaplan, Office of the Chief Financial Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-5256, email: [email protected]

SUPPLEMENTARY INFORMATION:

The NRC published a final rule amending regulations that became effective August 23, 2016. The FY 2016 final fee rule, published June 24, 2016 (81 FR 41171), amended the licensing, inspection, special project, and annual fees charged to NRC applicants and licensees.

Fee category 6.A. under § 171.16(d) includes fees for licenses for the commercial collection and laundry of items contaminated with byproduct material, source material, or special nuclear material [Program Code(s): 03218]. Because the NRC has no licensees in this category, the final rule inadvertently set the fee amount at $0. However, there are several Agreement States with licensees in this category. Agreement States that regulate nuclear laundries incorporate by reference the NRC fee schedule into their own regulations to establish their fees. To establish a fee for nuclear laundries in the absence of an NRC fee amount, the Agreement States would need to initiate a rulemaking, a timely and costly solution to fix the NRC's administrative oversight. Therefore, the NRC is correcting this oversight and changing the annual fee for fee category 6.A. for materials licensees from the FY 2016 rate of $0 to the FY 2015 rate of $40,100. This correction will have no material impact on the fees paid by NRC licensees for services; it will, however, allow Agreement States to continue to set and collect fees for regulated services in the equivalent fee category.

Rulemaking Procedure

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(3)(B), the NRC finds good cause to waive notice and opportunity for comment on this amendment. This amendment is needed to correct an inadvertent error by the NRC, which removed the fee amount for nuclear laundries. The NRC incorrectly believed that there would be no consequences to removing the fee amount because there are no NRC-regulated nuclear laundries for which the NRC must collect fees. However, the NRC did not realize that many Agreement States regulating nuclear laundries base their fees upon the NRC-prescribed amount. Removal of the NRC fee would have the unforeseen and unintended adverse consequence of preventing those Agreement States from collecting fees from nuclear laundries regulated by those Agreement States. This rulemaking merely restores the previously prescribed fee for NRC-regulated nuclear laundries. The sole purpose of this rulemaking is to allow those Agreement States that base their fees on the NRC-prescribed amount to collect fees from nuclear laundries regulated by those Agreement States. As set forth earlier, this action has no effect on NRC-regulated entities because there are no NRC-regulated nuclear laundries. For these reasons, the NRC finds, pursuant to 5 U.S.C. 553(d)(3), that good cause exists to make this rule effective upon publication of this notice.

List of Subjects in 10 CFR Part 171

Annual charges, Approvals, Byproduct material, Holders of certificates, Intergovernmental relations, Nonpayment penalties, Nuclear materials, Nuclear power plants and reactors, Registrations, Source material, Special nuclear material.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 171:

PART 171—ANNUAL FEES FOR REACTOR LICENSES AND FUEL CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY THE NRC 1. The authority citation for part 171 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 11, 161(w), 223, 234 (42 U.S.C. 2014, 2201(w), 2273, 2282); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 42 U.S.C. 2214; 44 U.S.C. 3504 note.

2. In § 171.16, paragraph (d), revise fee category 6.A. of the table to read as follows:
§ 171.16 Annual fees: Materials licensees, holders of certificates of compliance, holders of sealed source and device registrations, holders of quality assurance program approvals, and government agencies licensed by the NRC.

(d) * * *

Schedule of Materials Annual Fees and Fees for Government Agencies Licensed by NRC [See footnotes at end of table] Category of materials licenses Annual fees 123 *         *         *         *         *         *         * 6. Nuclear laundries: A. Licenses for commercial collection and laundry of items contaminated with byproduct material, source material, or special nuclear material [Program Code(s): 03218] $40,100 *         *         *         *         *         *         * 1 Annual fees will be assessed based on whether a licensee held a valid license with the NRC authorizing possession and use of radioactive material during the current FY. The annual fee is waived for those materials licenses and holders of certificates, registrations, and approvals who either filed for termination of their licenses or approvals or filed for possession only/storage licenses before October 1, 2015, and permanently ceased licensed activities entirely before this date. Annual fees for licensees who filed for termination of a license, downgrade of a license, or for a possession-only license during the FY and for new licenses issued during the FY will be prorated in accordance with the provisions of § 171.17. If a person holds more than one license, certificate, registration, or approval, the annual fee(s) will be assessed for each license, certificate, registration, or approval held by that person. For licenses that authorize more than one activity on a single license (e.g., human use and irradiator activities), annual fees will be assessed for each category applicable to the license. 2 Payment of the prescribed annual fee does not automatically renew the license, certificate, registration, or approval for which the fee is paid. Renewal applications must be filed in accordance with the requirements of parts 30, 40, 70, 71, 72, or 76 of this chapter. 3 Each FY, fees for these materials licenses will be calculated and assessed in accordance with § 171.13 and will be published in the Federal Register for notice and comment.
Dated at Rockville, Maryland, this 30th day of August, 2016.

For the Nuclear Regulatory Commission.

Cindy Bladey, Chief, Rules, Announcements and Directives Branch, Division of Administrative Services, Office of Administration.
[FR Doc. 2016-21270 Filed 9-2-16; 8:45 am] BILLING CODE 7590-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-8989; Directorate Identifier 2016-CE-025-AD; Amendment 39-18641; AD 2016-17-04 R1] RIN 2120-AA64 Airworthiness Directives; All Hot Air Balloons AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are revising Airworthiness Directive (AD) 2016-17-04, which applies to all hot air balloons equipped with BALÓNY KUBÍČEK spol. s r.o. Model Kubíček burners. Both the original and revised AD result from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. This AD action revises AD 2016-17-04 to eliminate certain unnecessary documentation requirements.

DATES:

This AD is effective on September 6, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 29, 2016 (81 FR 57449, August 23, 2016).

We must receive comments on this AD by October 21, 2016.

ADDRESSES:

You may send comments by any of the following methods:

Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

Fax: (202) 493-2251.

Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

For service information identified in this AD, contact BALÓNY KUBÍČEK spol. s r. o., Jarní 2a, 614 00 Brno, Czech Republic, telephone: +420 545 422 620; fax: +420 545 422 621; email: [email protected]; Internet: http://www.kubicekballoons.eu. You may view this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for locating Docket No. FAA-2016-8989.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8989; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4123; fax: (816) 329-4090; email: [email protected]

SUPPLEMENTARY INFORMATION: Discussion

On August 16, 2016, we issued AD 2016-17-04, Amendment 39-18617 (81 FR 57449, August 23, 2016). That AD required actions intended to address an unsafe condition on all hot air balloons equipped with a Kubíček burner and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. That MCAI states:

Three propane leaks were reported in the recent past on a burner manufactured by Balóny Kubíček spol. s.r.o., equipped with the fuel hoses made of hose material “EGEFLEX”.

This condition, if not detected and corrected, could result in a fire, damaging the balloon and its envelope, ultimately leading to an emergency landing, with consequent injury to balloon occupants and persons on the ground.

To address this potential unsafe condition, Balóny Kubíček spol. s.r.o. (the hose assemblies' manufacturer) published Service Bulletin (SB) N° BB/50, BB-S/11, AB24 rev. 1, which provides instructions for replacement of the affected fuel hoses with an improved part. As the affected burner and related fuel hoses can easily be installed on other hot air balloons, this AD applies to all possibly affected type designs.

For the reasons described above, this AD required identification and replacement of the affected fuel hoses.

You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8989.

Since we issued AD 2016-17-04, Amendment 39-18617 (81 FR 57449, August 23, 2016), we have determined that the AD should be revised to eliminate the unnecessary need to document the AD by logbook entry when the hot air balloon does not have fuel hoses made of “EGEFLEX” material. Therefore, the FAA determined that the inspection required should be eliminated and the applicability should be narrowed to only include those balloons that have both the Kubíček burner and fuel hoses made of “EGEFLEX” material installed.

Related Service Information Under 1 CFR Part 51

BALÓNY KUBÍČEK spol. s r.o. has issued Service Bulletin No. BB/50, BB-S/11, AB24 rev.1, dated May 12, 2016. The service information describes procedures for replacing all fuel hoses on burners that are made of “EGEFLEX” material. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

FAA's Determination and Requirements of This AD

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on type certificated products that incorporate the affected burners.

FAA's Determination of the Effective Date

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because this condition could result in a fire, damaging the balloon and its envelope, ultimately leading to an emergency landing, with consequent injury to the occupants and persons on the ground. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-8989; Directorate Identifier 2016-CE-025-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

Costs of Compliance

We estimate that this AD will affect 60 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the replacement requirement of this AD. The average labor rate is $85 per work-hour. Parts cost is about $200 per product.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $22,200, or $ 370 per product.

Authority for This Rulemaking

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

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

Regulatory Findings

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

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by removing AD 2016-17-04, Amendment 39-18617 (81 FR 57449, August 23, 2016), and adding the following new AD: 2016-17-04 R1 ALL HOT AIR BALLOONS: Amendment 39-18641; Docket No. FAA-2016-8989; Directorate Identifier 2016-CE-025-AD. (a) Effective Date

This airworthiness directive (AD) becomes effective on September 6, 2016.

(b) Affected ADs

This AD replaces AD 2016-17-04, Amendment 39-18617 (81 FR 57449, August 23, 2016) (“AD 2016-17-04”).

(c) Applicability

This AD applies to all hot air balloons, certificated in any category, that are equipped with all of the following:

(1) a BALÓNY KUBÍČEK spol. s r.o. Model Kubíček burner; and

(2) fuel hose(s) made of “EGEFLEX” material.

(d) Subject

Air Transport Association of America (ATA) Code 28: Fuel.

(e) Reason

This AD was prompted by mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as propane leaks on burners equipped with fuel hoses made of “EGEFLEX” material. We are issuing this AD to prevent propane leaks in the fuel hoses, which could result in a fire, damaging the balloon and its envelope, ultimately leading to an emergency landing, with consequent injury to the occupants and persons on the ground. This AD action revises AD 2016-17-04 to eliminate the unnecessary need to document the AD by logbook entry when the hot air balloon does not have fuel hoses made of “EGEFLEX” material. This is done by eliminating the inspection required and narrowing the applicability to only include those balloons that have both the Kubíček burner and fuel hoses made of “EGEFLEX” material.

(f) Actions and Compliance

Unless already done, no later than September 12, 2016 (this date is 14 days after August 29, 2016, which was the effective date of AD 2016-17-04), replace any fuel hose made of “EGEFLEX” material following BALÓNY KUBÍČEK spol. s r.o. Service Bulletin No. BB/50, BB-S/11, AB24 rev.1, dated May 12, 2016.

(g) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4123; fax: (816) 329-4090; email: [email protected] Before using any approved AMOC on any balloon to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

(3) Reporting Requirements: For any reporting requirement in this AD, a federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.

(h) Special Flight Permit

Special flight permits are prohibited.

(i) Related Information

Refer to MCAI European Aviation Safety Agency (EASA) AD No. 2016-0151, dated July 26, 2016, for related information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8989.

(j) Material Incorporated by Reference

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

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

(3) The following service information was approved for IBR on August 29, 2016 (81 FR 57449, August 23, 2016).

(i) BALÓNY KUBÍČEK spol. s r.o. Service Bulletin No. BB/50, BB-S/11, AB24 rev.1, dated May 12, 2016.

(ii) Reserved.

(4) For BALÓNY KUBÍČEK spol. s r.o. service information identified in this AD, contact BALÓNY KUBÍČEK spol. s r. o., Jarní 2a, 614 00 Brno, Czech Republic, telephone: +420 545 422 620; fax: +420 545 422 621; email: [email protected] Internet: http://www.kubicekballoons.eu.

(5) You may view this service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for locating Docket No. FAA-2016-8989.

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

Issued in Kansas City, Missouri, on August 30, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-21409 Filed 9-2-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 748 [Docket No. 160810722-6722-01] RIN 0694-AH05 Amendments to Existing Validated End-User Authorization in the People's Republic of China: Boeing Tianjin Composites Co. Ltd. AGENCY:

Bureau of Industry and Security, Commerce.

ACTION:

Final rule.

SUMMARY:

In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to revise the existing Validated End-User (VEU) list for the People's Republic of China (PRC) by updating the list of eligible destinations (facilities) for VEU Boeing Tianjin Composites Co. Ltd. (BTC). Specifically, BIS amends supplement No. 7 to part 748 of the EAR to change the written address of BTC's existing facility. The physical location of the facility has not changed. BIS updated the facility address after receiving notification of the change from BTC. The End-User Review Committee reviewed and authorized the amendment in accordance with established procedures. The updated address contributes to maintaining accurate location information for BTC's VEU.

DATES:

This rule is effective September 6, 2016.

FOR FURTHER INFORMATION CONTACT:

Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, U.S. Department of Commerce, Phone: 202-482-5991; Email: [email protected]

SUPPLEMENTARY INFORMATION:

Background Authorization Validated End-User

Validated End-Users (VEUs) are designated entities located in eligible destinations to which eligible items may be exported, reexported, or transferred (in-country) under a general authorization instead of a license. The names of the VEUs, as well as the dates they were so designated, and their respective eligible destinations (facilities) and items are identified in supplement No. 7 to part 748 of the EAR. Under the terms described in that supplement, VEUs may obtain eligible items without an export license from BIS, in conformity with § 748.15 of the EAR. Eligible items vary between VEUs and may include commodities, software, and technology, except those controlled for missile technology or crime control reasons on the Commerce Control List (CCL) (part 774 of the EAR).

VEUs are reviewed and approved by the U.S. Government in accordance with the provisions of § 748.15 and supplement Nos. 8 and 9 to part 748 of the EAR. The End-User Review Committee (ERC), composed of representatives from the Departments of State, Defense, Energy, Commerce, and other agencies as appropriate, is responsible for administering the VEU program. BIS amended the EAR in a final rule published on June 19, 2007 (72 FR 33646), to create Authorization VEU.

Amendment to Existing VEU Authorization for Boeing Tianjin Composites Co. Ltd. (BTC) in the People's Republic of China Revision to the List of “Eligible Destinations” for BTC

In this rule, BIS amends supplement No. 7 to part 748 to revise BTC's VEU authorization. Specifically, in this rule, BIS updates the written address of BTC's facility in the People's Republic of China to which the company's eligible items may be exported, reexported or transferred (in-country). The physical location of the facility has not changed.

The amendment to the address of BTC's facility is in response to a request from BTC. This amendment was approved by the ERC. The revision is as follows:

Revision to Address of BTC's Eligible Destination (Facility)

Current address: Boeing Tianjin Composites Co. Ltd., No. 4-388 Hebei Road, Tanggu Tianjin, China.

New address: Boeing Tianjin Composites Co. Ltd., 4566 Hebei Road, Marine Hi-Tech Development Area, Tanggu District, Tianjin, China 300451.

Export Administration Act

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.

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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. This rule involves collections previously approved by the Office of Management and Budget (OMB) under Control Number 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 43.8 minutes to prepare and submit form BIS-748; and for recordkeeping, reporting and review requirements in connection with Authorization VEU, which carries an estimated burden of 30 minutes per submission. This rule is expected to result in a decrease in license applications submitted to BIS. Total burden hours associated with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA) and OMB Control Number 0694-0088 are not expected to increase significantly as a result of this rule. Notwithstanding any other provisions of law, no person is required to respond to, nor be subject to a penalty for failure to comply with a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

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

4. Pursuant to the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), BIS finds good cause to waive the otherwise applicable requirement that this rule be subject to notice and the opportunity for public comment because it is unnecessary. In determining whether to grant VEU designations, a committee of U.S. Government agencies evaluates information about and commitments made by candidate companies, the nature and terms of which are set forth in 15 CFR part 748, supplement No. 8. The criteria for evaluation by the committee are set forth in 15 CFR 748.15(a)(2). The information, commitments, and criteria for this extensive review were all established through the notice of proposed rulemaking and public comment process (71 FR 38313 (July 6, 2006) (proposed rule), and 72 FR 33646 (June 19, 2007) (final rule)). Given the similarities between the authorizations provided under the VEU program and export licenses (as discussed further below), the publication of this information does not establish new policy. In publishing this final rule, BIS amends the authorization for an existing eligible VEU to update the address of the eligible destination (facility). This change has been made within the established regulatory framework of the VEU program. Further, this rule does not abridge the rights of the public or eliminate the public's option to export under any of the forms of authorization set forth in the EAR.

Publication of this rule in other than final form is unnecessary because the authorizations granted in the rule are consistent with the authorizations granted to exporters for individual licenses (and amendments or revisions thereof), which do not undergo public review. In addition, as with license applications, VEU authorization applications contain confidential business information, which is necessary for the extensive review conducted by the U.S. Government in assessing such applications. This information is extensively reviewed according to the criteria for VEU authorizations, as set out in 15 CFR 748.15(a)(2). Additionally, just as license applications are reviewed through an interagency review process, the authorizations granted under the VEU program involve interagency deliberation and result from review of public and non-public sources, including licensing data, and the measurement of such information against the VEU authorization criteria. Given the nature of the review, and in light of the parallels between the VEU application review process and the review of license applications, public comment on this authorization and subsequent amendments prior to publication is unnecessary. Moreover, because, as noted above, the criteria and process for authorizing and administering VEUs were developed with public comments, allowing additional public comment on this amendment to individual VEU authorizations, which was determined according to those criteria, is unnecessary.

Section 553(d) of the APA generally provides that rules may not take effect earlier than thirty (30) days after they are published in the Federal Register. However, BIS finds good cause to waive the 30-day delay in effectiveness for this rule pursuant to 5 U.S.C. 553(d)(3) because the delay would be contrary to the public interest. BIS is simply amending the authorization of an existing VEU to update the address of the eligible destination (facility). BIS amends the EAR in this rule consistent with established objectives and parameters administered and enforced by the responsible designated departmental representatives to the End-User Review Committee. Delaying this action's effectiveness would likely cause confusion regarding which items are authorized by the U.S. Government to be shipped to which eligible destination (facility), which would stifle the purpose of the VEU Program. Accordingly, it is contrary to the public interest to delay this rule's effectiveness.

No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required under the APA or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. As a result, no final regulatory flexibility analysis is required and none has been prepared.

List of Subjects in 15 CFR Part 748

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

Accordingly, part 748 of the EAR (15 CFR parts 730-774) is amended as follows:

PART 748—[AMENDED] 1. The authority citation for part 748 continues 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 4, 2016, 81 FR 52587 (August 8, 2016).

2. Amend supplement No. 7 to part 748 by revising the entry for “Boeing Tianjin Composites Co. Ltd.” in “China (People's Republic of)” to read as follows: Supplement No. 7 to Part 748—Authorization Validated End-User (VEU): List of Validated End-Users, Respective Items Eligible for Export, Reexport and Transfer, and Eligible Destinations Country Validated
  • end-user
  • Eligible items
  • (by ECCN)
  • Eligible destination Federal Register
  • citation
  • Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited to § 748.15(c). *         *         *         *         *         *         * Boeing Tianjin Composites Co. Ltd 1B001.f, 1D001 (limited to “software” specially designed or modified for the “use” of equipment controlled by 1B001.f), 2B001.b.2 (limited to machine tools with accuracies no better than (i.e., not less than) 13 microns), 2D001 (limited to “software,” other than that controlled by 2D002, specially designed or modified for the “use” of equipment controlled by 2B001.b.2), and 2D002 (limited to “software” for electronic devices, even when residing in an electronic device or system, enabling such devices or systems to function as a “numerical control” unit, capable of coordinating simultaneously more than 4 axes for “contouring control” controlled by 2B001.b.2) Boeing Tianjin Composites Co. Ltd., 4566 Hebei Road, Marine Hi-Tech Development Area, Tanggu District, Tianjin, China 300451 72 FR 59164, 10/19/07.
  • 74 FR 19382, 4/29/09.
  • 77 FR 10953, 2/24/12.
  • 77 FR 40258, 7/9/12.
  • 81 FR [INSERT PAGE NUMBER],
  • September 6, 2016.
  • *         *         *         *         *         *         *
    Dated: August 30, 2016. Kevin J. Wolf, Assistant Secretary for Export Administration.
    [FR Doc. 2016-21333 Filed 9-2-16; 8:45 am] BILLING CODE 3510-33-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 310 [Docket No. FDA-1975-N-0012; Formerly Part of Docket No. 1975N-0183H] RIN 0910-AF69 Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.

    DATES:

    This rule is effective September 6, 2017.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

    Pranvera Ikonomi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240-402-0272.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction A. Terminology Used in the OTC Drug Review Regulations B. Topical Antiseptics C. This Final Rule Covers Only Consumer Antiseptic Washes II. Background A. Significant Rulemakings Relevant to This Final Rule B. Public Meetings Relevant to This Final Rule C. Scope of This Final Rule D. Eligibility for the OTC Drug Review III. Comments on the Proposed Rule and FDA Response A. Introduction B. Description of General Comments and FDA Response C. Comments on Effectiveness and FDA Response D. Comments on Safety and FDA Response E. Comments on Individual Active Ingredients and FDA Response F. Comments on the Preliminary Regulatory Impact Analysis and FDA Response IV. Ingredients Not Generally Recognized as Safe and Effective V. Effective Date VI. Summary of Regulatory Impact Analysis A. Introduction B. Summary of Costs and Benefits VII. Paperwork Reduction Act of 1995 VIII. Environmental Impact IX. Federalism X. References Executive Summary Purpose of the Final Rule

    This final rule finalizes the consumer antiseptic wash proposed rule published in the Federal Register of December 17, 2013 (78 FR 76444) (2013 Consumer Wash Proposed Rule (PR)) and amends the 1994 TFM for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (59 FR 31402). The amendment is part of FDA's ongoing rulemaking to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972 (OTC Drug Review). This final rule applies to consumer antiseptic wash products that are intended for use with water and are rinsed off after use, including hand washes and body washes.

    In response to several comments submitted to the 2013 Consumer Wash PR, FDA has deferred further rulemaking on three specific active ingredients used in OTC consumer antiseptic wash products to allow for the development and submission of new safety and effectiveness data to the record for these ingredients. The deferred active ingredients are benzalkonium chloride, benzethonium chloride, and chloroxylenol. Accordingly, FDA does not make a determination of general recognition of safety and effectiveness for these three active ingredients in this final rule. The monograph or new drug status of these three ingredients will be addressed either after completion and analysis of ongoing studies to address the safety and efficacy data gaps of these ingredients or at a later date if these studies are not completed.

    With the exception of the three deferred consumer antiseptic wash active ingredients, this rulemaking finalizes the nonmonograph status of the remaining 19 active ingredients intended for use in consumer antiseptic washes identified in the 2013 Consumer Wash PR. As explained, either no additional data were submitted or the data and information that were submitted were not sufficient to support monograph conditions for these 19 consumer antiseptic wash ingredients. Therefore, with the exception of the three deferred consumer antiseptic wash active ingredients, this rule finalizes the 2013 Consumer Wash PR, which proposed amending the 1994 TFM, with the remaining 19 consumer antiseptic wash active ingredients found to be not GRAS/GRAE. Accordingly, these 19 consumer antiseptic wash drug products are misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352) and are new drugs under section 201(p) of the FD&C Act (21 U.S.C. 321(p)) for which approved applications under section 505 of the FD&C Act (21 U.S.C. 355) and part 314 (21 CFR part 314) of the regulations are required for marketing.

    In separate rulemakings, we are proposing conditions under which OTC consumer antiseptic rubs (products that are not rinsed off after use, including hand rubs and antibacterial wipes) (81 FR 42912, June 30, 2016) and OTC antiseptics intended for use by health care professionals in a hospital setting or other health care situation outside the hospital (80 FR 25166, May 1, 2015) are GRAS/GRAE. Accordingly, this final rule covers only OTC consumer antiseptic washes that are intended for use as either a hand wash or a body wash, and does not cover health care antiseptics (80 FR 25166), consumer antiseptic rubs (81 FR 42912), antiseptics identified as “first aid antiseptics” in the 1991 First Aid TFM (56 FR 33644), or antiseptics used by the food industry. Those antiseptic products are not addressed in this final rule.

    Summary of the Major Provisions of the Final Rule A. Effectiveness

    As explained in the 2013 Consumer Wash PR, a determination that an active ingredient is GRAS/GRAE for a particular intended use requires a benefit-to-risk assessment for that particular use of the ingredient. If the active ingredient in a drug product carries the potential risk associated with the drug (e.g., reproductive toxicity or carcinogenicity), but does not provide a clinical benefit, then the benefit-to-risk calculation shifts towards a not GRAS/GRAE status for that drug. New information on potential risks posed by the use of certain consumer antiseptic washes prompted us to reevaluate the data needed for classifying consumer antiseptic wash active ingredients as generally recognized as effective (GRAE). As a result, we proposed that the risk from the use of a consumer antiseptic wash drug product must be balanced by a demonstration—through studies that demonstrate a direct clinical benefit (i.e., a reduction of infection)—that the product is superior to washing with nonantibacterial soap and water in reducing infection (78 FR 76444 at 76450).

    We have considered the recommendations from the public meetings held by the Agency on antiseptics (see section II.B, table 2) and evaluated the available literature, as well as the data, the comments, and other information that were submitted to the rulemaking on the effectiveness of the consumer antiseptic wash active ingredients addressed in this final rule. The data and information submitted for these active ingredients are insufficient to demonstrate that there is any additional benefit from the use of these active ingredients in consumer antiseptic wash products compared to nonantibacterial soap and water. Consequently, the available data do not support a GRAE determination for these consumer antiseptic wash active ingredients.

    B. Safety

    As explained in the 2013 Consumer Wash PR, several important scientific developments that affect the safety evaluation of consumer antiseptic wash active ingredients have occurred since FDA's 1994 evaluation of the safety of consumer antiseptic active ingredients under the OTC Drug Review. New data suggests that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure is now available. New safety information also suggests that widespread antiseptic use could have an impact on the development of bacterial resistance. To support a classification of generally recognized as safe (GRAS) for consumer antiseptic wash active ingredients, we proposed that additional data was needed to demonstrate that those ingredients meet current safety standards (78 FR 76444 at 76453 to 76458).

    The minimum data needed to demonstrate safety for all consumer antiseptic wash active ingredients falls into three broad categories: (1) Safety data studies described in current FDA guidance (e.g., nonclinical and human pharmacokinetic studies, developmental and reproductive toxicity studies, and carcinogenicity studies); (2) data to characterize potential hormonal effects; and (3) data to evaluate the development of bacterial resistance.

    We have considered the recommendations from the public meetings held by the Agency on antiseptics (see section II.B, table 2) and evaluated the available literature, as well as the data, the comments, and other information that were submitted to the rulemaking on the safety of consumer antiseptic wash active ingredients addressed in this final rule. The available information and published data for the 19 active ingredients considered in this final rule are insufficient to establish the safety of long-term, daily repeated exposure to these active ingredients used in consumer wash products. Consequently, the available data do not support a GRAS determination for the consumer antiseptic wash active ingredients included in this rule.

    C. Costs and Benefits

    This final rule establishes that 19 active ingredients, including triclosan and triclocarban, are not GRAS/GRAE and consumer antiseptic wash products containing these ingredients are misbranded for use in consumer antiseptic washes. Regulatory action is being deferred on three active ingredients that were included in the proposed rule: Benzalkonium chloride, benzethonium chloride, and chloroxylenol. The primary estimated benefits come from reduced exposure to antiseptic active ingredients by 2.2 million pounds per year. Limitations in the available data characterizing the health effects resulting from widespread long-term exposure to these ingredients prevent us from translating the estimated reduced exposure into monetary equivalents of health effects. The primary estimate of costs annualized over 10 years is approximately $23.6 million at a 3 percent discount rate and $27.6 million at a 7 percent discount rate. These costs consist of total one-time costs of relabeling and reformulation ranging from $106.3 to $402.8 million. Under the final rule, we estimate that each pound of reduced exposure to antiseptic active ingredients will cost $12.97 to $14.28 at a 3 percent discount rate and $16.36 to $18.02 at a 7 percent discount rate.

    Summary of the costs and benefits of the final rule Total benefits Total costs annualized over 10 years
  • (in millions)
  • Total one-time costs
  • (in millions)
  • Total Reduced exposure to antiseptic ingredients by 2.2 million pounds annually $23.6 (at 3%)
  • $27.6 (at 7%)
  • $106.3 to $402.8.
    I. Introduction

    In the following sections, we provide a brief description of terminology used in the OTC Drug Review regulations, an overview of OTC topical antiseptic drug products, and a more detailed description of the OTC consumer antiseptic wash active ingredients that are the subject of this final rule.

    A. Terminology Used in the OTC Drug Review Regulations 1. Proposed, Tentative Final, and Final Monographs

    To conform to terminology used in the OTC Drug Review regulations (§ 330.10 (21 CFR 330.10)), the advance notice of proposed rulemaking that was published in the Federal Register of September 13, 1974 (39 FR 33103) (1974 ANPR), was designated as a “proposed monograph.” Similarly, the notices of proposed rulemaking, which were published in the Federal Register of January 6, 1978 (43 FR 1210) (1978 TFM), the Federal Register of June 17, 1994 (59 FR 31402) (1994 TFM), and the Federal Register of December 17, 2013 (78 FR 76444) (2013 Consumer Wash PR) were each designated as a TFM (see table 1 in section II.A).

    2. Category I, II, and III Classifications

    The OTC drug procedural regulations in § 330.10 use the terms “Category I” (generally recognized as safe and effective and not misbranded), “Category II” (not generally recognized as safe and effective or misbranded), and “Category III” (available data are insufficient to classify as safe and effective, and further testing is required). Section 330.10 provides that any testing necessary to resolve the safety or effectiveness issues that resulted in an initial Category III classification, and submission to FDA of the results of that testing or any other data, must be done during the OTC drug rulemaking process before the establishment of a final monograph (i.e., a final rule or regulation). Therefore, the proposed rules (at the tentative final monograph stage) used the concepts of Categories I, II, and III.

    At this final monograph stage, FDA does not use the terms “Category I,” “Category II,” and “Category III.” In place of Category I, the term “monograph conditions” is used; in place of Categories II and III, the term “nonmonograph conditions” is used.

    B. Topical Antiseptics

    The OTC topical antimicrobial rulemaking has had a broad scope, encompassing drug products that may contain the same active ingredients, but that are labeled and marketed for different intended uses. The 1974 ANPR for topical antimicrobial products encompassed products for both health care and consumer use (39 FR 33103). The ANPR covered seven different intended uses for these products: (1) Antimicrobial soap; (2) healthcare personnel hand wash; (3) patient preoperative skin preparation; (4) skin antiseptic; (5) skin wound cleanser; (6) skin wound protectant; and (7) surgical hand scrub (39 FR 33103 at 33140). FDA subsequently identified skin antiseptics, skin wound cleansers, and skin wound protectants as antiseptics used primarily by consumers for first aid use and referred to them collectively as “first aid antiseptics.” We published a separate TFM covering first aid antiseptics in the Federal Register of July 22, 1991 (56 FR 33644). In section III.E, we address comments filed in this rulemaking related to first aid antiseptics, but we do not otherwise discuss first aid antiseptics further in this document. This final rule does not have an impact on the monograph status of first aid antiseptics.

    The four remaining categories of topical antimicrobials were addressed in the 1994 TFM (59 FR 31402). The 1994 TFM covered: (1) Antiseptic hand wash (i.e., consumer hand wash); (2) health care personnel hand wash; (3) patient preoperative skin preparation; and (4) surgical hand scrub (59 FR 31402 at 31442). This final rule does not have an impact on the monograph status of health care personnel hand washes, patient preoperative skin preparations, or surgical hand scrubs. In the 1994 TFM, FDA also identified a new category of antiseptics for use by the food industry and requested relevant data and information (59 FR 31402 at 31440). In section III.B.4, we address comments filed in this rulemaking on antiseptics for use by the food industry, but we do not otherwise further discuss these antiseptics in this document. This final rule does not have an impact on the monograph status of antiseptics for food industry use.

    In the 2013 Consumer Wash PR, we proposed that our evaluation of OTC antiseptic drug products be further subdivided into health care antiseptics and consumer antiseptics (78 FR 76444 at 76446). These categories are distinct based on the proposed use setting, target population, and the fact that each setting presents a different risk for infection. In the 2013 Consumer Wash PR (78 FR 76444 at 76446 to 76447) and the consumer antiseptic rub proposed rule published in the Federal Register of June 30, 2016 (81 FR 42912) (2016 Consumer Rub PR), we proposed that our evaluation of OTC consumer antiseptic drug products be further subdivided into consumer washes (products that are rinsed off with water, including hand washes and body washes) and consumer rubs (products that are not rinsed off after use, including hand rubs and antibacterial wipes) (78 FR 764444 at 76447). Consumer antiseptic wash products are intended to be used when soap and water are available, whereas, consumer antiseptic rub products are intended to be used when soap and water are unavailable, and thus, are left on and not rinsed off. To account for the differences between consumer washes and consumer rubs, the safety and effectiveness of the active ingredients are being evaluated for each intended use separately. This final rule does not have an impact on the monograph status of consumer antiseptic rub products.

    C. This Final Rule Only Covers Consumer Antiseptic Washes

    We refer to the group of products covered by this final rule as “consumer antiseptic washes.” Consumer antiseptic washes include a variety of personal care products intended to be used with water, such as antibacterial soaps, hand washes, and antibacterial body washes. As discussed further in section III.B.3, these products may be used by consumers for personal use in the home and public settings on a frequent, daily basis. In the United States consumer setting, where the target population is composed of generally healthy individuals, the risk of infection and the scope of the spread of infection is relatively low compared to the health care setting, where patients are generally more susceptible to infection and the potential for spread of infection is high.

    This final rule covers only OTC consumer antiseptic washes that are intended for use as either a hand wash or a body wash, but that are not identified as “first aid antiseptics” in the 1991 First Aid TFM (56 FR 33644), health care antiseptics (80 FR 25166), consumer antiseptic rubs (81 FR 42912), or antiseptics used by the food industry. The distinctions between consumer washes and rubs, and between consumer hand washes and body washes are discussed in detail in the 2013 Consumer Wash PR (78 FR at 76446 to 76447) and the 2016 Consumer Rub PR (81 FR 42912). Completion of the monograph for Consumer Antiseptic Wash Products and certain other monographs for the active ingredient triclosan is subject to a Consent Decree entered by the U.S. District Court for the Southern District of New York on November 21, 2013, in Natural Resources Defense Council, Inc. v. United States Food and Drug Administration, et al., 10 Civ. 5690 (S.D.N.Y.).

    II. Background

    In this section, we describe the significant rulemakings and public meetings relevant to this rulemaking and discuss our response to comments received on the 2013 Consumer Wash PR.

    A. Significant Rulemakings Relevant to This Final Rule

    A summary of the significant Federal Register publications relevant to this final rule is provided in table 1. Other publications relevant to this final rule are available at http://www.regulations.gov in FDA Docket No. 1975-N-0012.

    Table 1—Significant Rulemaking Publications Related To Consumer Antiseptic Drug Products 1 Federal Register notice Information in notice 1974 ANPR (September 13, 1974, 39 FR 33103) We published an advance notice of proposed rulemaking to establish a monograph for OTC topical antimicrobial drug products, together with the recommendations of the advisory review panel (the Panel) responsible for evaluating data on the active ingredients in this drug class. 1978 Antimicrobial TFM (January 6, 1978, 43 FR 1210) We published our tentative conclusions and proposed effectiveness testing for the drug product categories evaluated by the Panel, reflecting our evaluation of the Panel's recommendations and comments and data submitted in response to the Panel's recommendations. 1991 First Aid TFM (July 22, 1991, 56 FR 33644) We amended the 1978 TFM to establish a separate monograph for OTC first aid antiseptic products. In the 1991 TFM, we proposed that first aid antiseptic drug products be indicated for the prevention of skin infections in minor cuts, scrapes, and burns. 1994 Healthcare Antiseptic TFM (June 17, 1994, 59 FR 31402) We amended the 1978 TFM to establish a separate monograph for the group of products referred to as OTC topical health care antiseptic drug products. These antiseptics are generally intended for use by health care professionals. In the 1994 TFM we also recognized the need for antibacterial personal cleansing products for consumers to help prevent cross- contamination from one person to another and proposed a new antiseptic category for consumer use: Antiseptic hand wash. 2013 Consumer Antiseptic Wash TFM (December 17, 2013, 78 FR 76444) We issued a proposed rule to amend the 1994 TFM and to establish data standards for determining whether OTC consumer antiseptic washes are GRAS/GRAE. In the 2013 Consumer Antiseptic Wash TFM, we proposed that additional safety and effectiveness data are necessary to support the safety and effectiveness of consumer antiseptic wash active ingredients. 2015 Health Care Antiseptic TFM (May 15, 2015, 80 FR 25166) We issued a proposed rule to amend the 1994 TFM and establish data standards for determining whether OTC health care antiseptics are GRAS/GRAE. In the 2015 Health Care Antiseptic TFM, we proposed that additional data are necessary to support the safety and effectiveness of health care antiseptic active ingredients. 2016 Consumer Antiseptic Rub TFM (June 30, 2016, 81 FR 42912) We issued a proposed rule to amend the 1994 TFM and to establish data standards for determining whether OTC consumer antiseptic rubs are GRAS/GRAE. In the 2016 Consumer Antiseptic Rub TFM, we proposed that additional safety and effectiveness data are necessary to support the safety and effectiveness of consumer antiseptic rub active ingredients. 1 The publications listed in table 1 can be found at FDA's “Status of OTC Rulemakings” Web site available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm070821.htm. The publications dated after 1993 can also be found in the Federal Register at https://www.federalregister.gov. B. Public Meetings Relevant to This Final Rule

    In addition to the Federal Register publications listed in table 1, there have been four meetings of the NDAC and one public feedback meeting that are relevant to the discussion of consumer antiseptic wash safety and effectiveness. These meetings are summarized in table 2.

    Table 2—Public Meetings Relevant to Consumer Antiseptics Date and type of meeting Topic of discussion January 1997 NDAC Meeting (Joint meeting with the Anti-Infective Drugs Advisory Committee) (January 6, 1997, 62 FR 764) Antiseptic and antibiotic resistance in relation to an industry proposal for consumer and health care antiseptic effectiveness testing (Health Care Continuum Model) (Refs. 1 and 2). March 2005 NDAC Meeting (February 18, 2005, 70 FR 8376) The use of surrogate endpoints and study design issues for the in vivo testing of health care antiseptics (Ref. 3). October 2005 NDAC Meeting (September 15, 2005, 70 FR 54560) Benefits and risks of consumer antiseptics. NDAC expressed concern about the pervasive use of consumer antiseptic washes where there are potential risks and no demonstrable benefit. To demonstrate a clinical benefit, NDAC recommended clinical outcome studies to show that antiseptic washes are superior to nonantibacterial soap and water (Ref. 4). November 2008 Public Feedback Meeting Demonstration of the effectiveness of consumer antiseptics (Ref. 5). September 2014 NDAC Meeting (July 29, 2014, 79 FR 44042) Safety testing framework for health care antiseptic active ingredients (Ref. 6). C. Scope of This Final Rule

    This rulemaking finalizes the nonmonograph status for the 19 listed consumer antiseptic wash active ingredients (see section II.D). Requests were made that benzalkonium chloride, benzethonium chloride, and chloroxylenol be deferred from inclusion in this consumer antiseptic wash final rulemaking to allow more time for interested parties to complete the studies necessary to fill the safety and efficacy data gaps identified in the 2013 Consumer Wash PR for these ingredients. In March 2016, we agreed to defer rulemaking on these three ingredients (see Docket No. 1975-N-0012 at http://www.regulations.gov). Accordingly, in this final rulemaking we do not discuss whether benzalkonium chloride, benzethonium chloride, and chloroxylenol are GRAS/GRAE for use as active ingredients in consumer antiseptic washes. The monograph or new drug status of these three ingredients will be finalized either after completion and analysis of ongoing studies to address the safety and efficacy data gaps of these ingredients or at a later date if these studies are not completed.

    For the 19 active ingredients included in this final rule, either no additional data were submitted since the 2013 Consumer Antiseptic Wash PR, or the data and information that were submitted were insufficient to support GRAS/GRAE findings. Therefore, these ingredients are not included in a monograph at this time. These active ingredients are not GRAS/GRAE for use in consumer antiseptic wash drug products and products containing these ingredients are new drugs for which approved new drug applications are required. Accordingly, FDA is amending part 310 (21 CFR part 310) to add the active ingredients covered by this final rule to the list in § 310.545 (21 CFR 310.545) of OTC drug products that are not GRAS/GRAE and are misbranded in the absence of an approved new drug application.

    D. Eligibility for the OTC Drug Review

    An OTC drug is covered by the OTC Drug Review if its conditions of use existed in the OTC drug marketplace on or before May 11, 1972 (37 FR 9464) (Ref. 7).1 Conditions of use include, among other things, active ingredient, dosage form and strength, route of administration, and specific OTC use or indication of the product (see § 330.14(a)). To determine eligibility for the OTC Drug Review, FDA typically must have actual product labeling or a facsimile of labeling that documents the conditions of marketing of a product before May 1972 (see § 330.10(a)(2)). FDA considers a drug that is ineligible for inclusion in the OTC monograph system to be a new drug that will require FDA approval through the new drug application (NDA) process. Ineligibility for use as a consumer antiseptic rub does not affect eligibility under any other OTC drug monograph.

    1 Also, note that drugs initially marketed in the United States after the OTC Drug Review began in 1972 and drugs without any U.S. marketing experience can be considered in the OTC monograph system based on submission of a time and extent application. (See § 330.14).

    1. Eligible Active Ingredients

    There are 19 of the antiseptic active ingredients eligible for the OTC Drug Review for use as a consumer antiseptic wash that are addressed in this final rule. These ingredients are:

    • Cloflucarban • Fluorosalan • Hexachlorophene • Hexylresorcinol • Iodophors (Iodine-containing ingredients) ○ Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) ○ Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) ○ Nonylphenoxypoly (ethyleneoxy) ethanoliodine ○ Poloxamer—iodine complex ○ Povidone-iodine 5 to 10 percent ○ Undecoylium chloride iodine complex • Methylbenzethonium chloride • Phenol (greater than 1.5 percent) • Phenol (less than 1.5 percent) • Secondary amyltricresols • Sodium oxychlorosene • Tribromsalan • Triclocarban • Triclosan • Triple dye

    In the 2013 Consumer Wash PR, we describe the lack of adequate data needed for a GRAS/GRAE determination for consumer antiseptic wash active ingredients (78 FR 76444). As discussed in section II.C, rulemaking has been deferred for three of the consumer antiseptic wash active ingredients—benzalkonium chloride, benzethonium chloride, and chloroxylenol. Accordingly, any references to consumer antiseptic wash active ingredients refer only to the 19 consumer antiseptic wash active ingredients listed in this section, unless otherwise stated.

    2. Ineligible Active Ingredients

    In the 2013 Consumer Wash PR, we also identified certain active ingredients that were considered ineligible for evaluation under the OTC Drug Review as a consumer antiseptic wash; but, we noted that if the requested documentation for eligibility was submitted, these active ingredients could be determined to be eligible for evaluation (78 FR 76444 at 76448). The active ingredients proposed to be ineligible in the 2013 Consumer Wash PR were:

    • Alcohol (ethyl alcohol) • Benzalkonium cetyl phosphate • Cetylpyridinium chloride • Chlorhexidine gluconate • Isopropyl alcohol • Polyhexamethylene biguanide • Salicylic acid • Sodium hypochlorite • Tea tree oil • Combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine

    We have not received any new information since the 2013 Consumer Wash PR demonstrating that these active ingredients are eligible for evaluation under the OTC Drug Review for use as a consumer antiseptic wash. Consequently, drug products containing these active ingredients are new drugs that will require FDA approval.

    III. Comments on the Proposed Rule and FDA Response A. Introduction

    In the 2013 Consumer Wash PR, interested parties were invited to submit comments on the proposed rule by June 16, 2014. In addition, interested parties had until December 16, 2014, to submit new data or information to the docket, with 2 additional months provided to submit comments on any new data or information submitted (78 FR 76444 at 76447).

    In response to the 2013 Consumer Wash PR, FDA received approximately 40 comments from drug manufacturers, trade associations, academia, testing laboratories, consumer groups, and health professionals, as well as over 1,800 comments filed by individuals. FDA also received additional data and information for certain consumer antiseptic wash active ingredients.

    We describe and respond to the comments in section III.B through III.F. We have numbered each comment to help distinguish between the different comments. We have grouped similar comments together under the same number, and in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.

    B. Description of General Comments and FDA Response 1. Advance Notice of Proposed Rulemaking

    (Comment 1) Several comments asserted that the new efficacy testing requirements proposed in the 2013 Consumer Wash PR were unprecedented. They stated that given the significance of the proposed change to the efficacy testing requirements for consumer antiseptics and the lack of precedent for this action, FDA should withdraw the proposed rule and reissue it as an ANPR to give industry and other stakeholders an opportunity to engage with FDA on the GRAE testing requirements for the active ingredients and surrogate endpoint testing of final formulations.

    (Response 1) The purpose of an ANPR is to allow the public a period of time to comment on regulations that the FDA may pursue as part of a future rulemaking. As explained in section II.A, we issued an ANPR for a monograph for OTC topical antimicrobial drug products in 1974, and a proposed rulemaking in the form of a TFM in 1978. We have amended the TFM for OTC topical antimicrobial drug products to address, for example, different categories of topical antimicrobial drug products and indications of use, as well as the need for new safety and effectiveness data based on evolving scientific developments and new information on risks associated with use of these drug products (59 FR 31402; 56 FR 33644; 78 FR 764444; 80 FR 25166; 81 FR 42912). For each amendment, we have allowed interested parties to submit comments on the proposals.

    In the 2013 Consumer Wash PR, we proposed that data from clinical outcome studies (demonstrating a reduction in infections) are necessary to support a GRAE determination for consumer antiseptic wash active ingredients (78 FR 76444). We explained that, if the active ingredient in a drug product does not provide clinical benefit but potentially increases the risk associated with the drug (e.g., from reproductive toxicity or carcinogenicity), then the benefit-to-risk calculation shifts, and the drug is not GRAS/GRAE. For the consumer antiseptic wash ingredients at issue here, because of new concerns about the potential risks (e.g., resistance and hormonal effects), the log reduction standard (a clinical simulation standard) proposed in the 1994 TFM, which was based on an invalidated surrogate endpoint (i.e., number of bacteria removed from the skin), is insufficient for establishing effectiveness of consumer antiseptic washes. Therefore, we proposed that clinical outcome studies were needed to demonstrate a direct clinical benefit.

    This proposed effectiveness requirement is consistent with the NDAC's recommendations from the October 2005 NDAC meeting regarding consumer antiseptics (Ref. 4). The October 2005 NDAC concluded that the existing test methods are based on the premise that bacterial reductions translate to a reduced potential for infection, and, although bacterial reduction can be demonstrated using tests that simulate conditions of actual use, there are no corresponding clinical data to demonstrate that bacterial reductions of the required magnitude produce a corresponding reduction in infection. Accordingly, the October 2005 NDAC recommended clinical outcome studies to demonstrate the clinical benefit of consumer antiseptic wash active ingredients and their superiority compared to a nonantibacterial wash, such as soap and water. In October 2008, we also held a public feedback meeting to discuss the demonstration of effectiveness of consumer antiseptic active ingredients.

    At each stage of this process, interested parties have had an opportunity to participate in these proceedings. It is not necessary now to withdraw the 2013 Consumer Wash PR and reissue it as an ANPR.

    (Comment 2) Several comments argued that the 2013 Consumer Wash PR should be reissued as an ANPR because the proposed rule only requests testing on the active ingredients to demonstrate effectiveness and fails to confirm whether the Agency will impose additional surrogate efficacy requirements for a final formulation. The comments contended that the Agency's approach is inconsistent with the approach taken in the 1994 TFM and other OTC monographs.

    (Response 2) The issue of whether the 2013 Consumer Wash PR should be reissued as an ANPR to include final product formulation testing does not need to be addressed in this final rule because we have determined that none of the active ingredients subject to this final rule are GRAE for use as a consumer antiseptic wash. Final formulation testing would be required for testing formulations containing active ingredients that have been determined as GRAS/GRAE.

    2. Effective Date

    (Comment 3) Several comments stated that FDA's timeline under the 2013 Consumer Wash PR for new data submission is unreasonable and that completing clinical outcome studies within the timeframe proposed by the Agency is unrealistic.

    (Response 3) We understand that, in certain circumstances, planning, implementing, and analyzing the data generated from a clinical outcome study can be a time-consuming process that may not be completed within the period granted for submission of additional data in response to the 2013 Consumer Wash PR. Accordingly, in the 2013 Consumer Wash PR, we provided a process for seeking an extension of time to submit the required safety and/or effectiveness data if needed (78 FR 76444 at 76447). As explained in the proposed rule, we stated that we would consider all the data and information submitted to the record in conjunction with all timely and completed requests to extend the timeline to finalize the monograph status for a given ingredient (78 FR 76444 at 76447). Consideration for deferral for an ingredient was given to requests with clear statements of intent to conduct the necessary studies required to fill all the data gaps identified in the proposed rule for that ingredient. After analyzing the data and information submitted related to the requests for extensions, we determined that deferral is warranted for three consumer antiseptic wash active ingredients—benzalkonium chloride, benzethonium chloride, and chloroxylenol—to allow more time for interested parties to complete the studies necessary to fill the safety and efficacy data gaps identified for these ingredients as indicated in the 2013 Consumer Wash PR. These three ingredients are not included in this final rule and will be addressed either after completion and analysis of ongoing studies to address the safety and efficacy data gaps of these ingredients or at a later date if these studies are not completed. We decline to defer final action on the proposed rule for the 19 remaining consumer antiseptic wash active ingredients.

    (Comment 4) One comment requested that the Agency finalize the monograph finding that triclosan and other antimicrobial chemicals are not GRAS/GRAE, and, in so finding, require that all consumer antiseptic wash active ingredients that are not GRAS/GRAE be removed from the market either immediately or within 6 months of the publication of the final rule.

    (Response 4) As discussed in section IV of this document, the data submitted to the Agency for the non-deferred consumer antiseptic wash active ingredients is insufficient to fill all the safety and effectiveness data gaps identified in the 2013 Consumer Wash PR. Thus, we find that these consumer antiseptic wash active ingredients, including tricoslan, are not GRAS/GRAE for use in OTC consumer antiseptic wash drug products. Products containing those ingredients are therefore not eligible for inclusion in a monograph and must be removed from the market or must be approved through an NDA or an abbreviated new drug application (ANDA).

    This final rule involves over 700 consumer antiseptic wash drug products, which are formulated with one or more of the 19 active ingredients discussed in this final rule. In the 2013 Consumer Wash PR, we recognized, based on the scope of products subject to this final rule, that manufacturers would need time to comply with the rule (78 FR 76444 at 76470). We therefore proposed that the final rule be effective 1 year after the publication in the Federal Register, finding that a period later than 1 year after publication of the final rule would neither be appropriate nor necessary (78 FR 76444 at 76470). We also believe that making the final rule effective immediately upon publication or effective 6 months after publication does not afford manufacturers the time necessary to remove from the market, or reformulate their products containing these active ingredients, given the broad scope of products that are the subject of this final rule. Thus, we decline to adopt an immediate or 6-month effective date for this rule and, instead, as discussed in section V, adopt our proposal that this final rule be effective 1 year after publication in the Federal Register.

    3. Definition of Consumer Antiseptic Washes

    (Comment 5) Several comments requested that the Agency clarify the definition of consumer antiseptic washes, stating that the definition of consumer antiseptics in the 2013 Consumer Wash PR does not include antiseptic products used in institutional settings. The commenters stated that by not including such products in the definition of consumer antiseptic washes, we put the general population at risk for increased levels of bacteria on skin, which may lead to increased infection and diseases for the general population.

    (Response 5) In the 2013 Consumer Wash PR, we explained that consumer antiseptic wash drug products addressed by this rulemaking include a variety of personal care products intended to be used with water, such as antibacterial soaps, hand washes, and body washes, which may be used by consumers for personal use in the home and in certain public settings on a frequent, even daily, basis (78 FR 76444 at 76446). We also indicate that “consumer antiseptic” is a broad term and meant to include all the types of antiseptic products used on a frequent or daily basis by consumers. This is consistent with the October 2005 NDAC meeting, at which consumer antiseptics were categorized as products used by the general public, including the use of those products in institutional and public settings (Ref. 4). Therefore, we clarify that consumer antiseptic wash products are products intended for use with water by the general population in the home or public settings on a frequent or daily basis. As such, antiseptic wash products used by health care professionals or commercial food handlers or as first aid antiseptic products are not considered consumer antiseptic wash products.

    4. Food Handler Antiseptics

    (Comment 6) Several comments requested that FDA make a distinction between hand wash products for use by consumers and hand wash products for use by commercial food handlers. The comments explained that the food industry includes commercial enterprises involved in food processing, preparation, or handling, but does not include home preparation. In addition, they explained that the food industry provides a different environment for hand washing compared to consumer use, and as a result, a separate monograph category should be created to define standards for food handlers. An opposing comment, however, objected to FDA creating another category of antiseptics for the food industry, arguing that these antiseptics raise the same safety concerns as consumer antiseptic wash products.

    The comments that advocated for a separate category for antiseptics used by the food industry stated that FDA recognized the distinction between consumer hand washes and hand washes in the food industry in the 2013 Consumer Wash PR by stating that “antiseptics for use by the food industry are not discussed further in this document” (78 FR at 76446). The comments said that, despite this statement, the absence of further language specifically addressing hand wash products for use in the food industry creates the potential that antiseptic hand wash products used in the food industry may, by default, be subject to the requirements of the 2013 Consumer Wash PR. They also requested that FDA clarify that hand wash products for use by the food industry can continue to be marketed under the current regulatory framework.

    (Response 6) As stated in the 2013 Consumer Wash PR and the 2015 Health Care Antiseptic PR, we continue to classify the food handler antiseptic washes as a separate and distinct monograph category, and we clarify that such products are not part of these rulemakings on the consumer antiseptic monograph (78 FR 76444 at 76446; 80 FR 25166 at 25168). A separate category is warranted because of additional issues raised by the public health consequences of foodborne illness, differences in frequency and type of use, and contamination of the hands by grease and other oils. We plan to address OTC antiseptic products for use by the food handler industry in a separate rulemaking.2 We plan to do a thorough evaluation of the safety and effectiveness of antiseptic active ingredients intended for this category of use. We also confirm that this final rule is not intended to affect antiseptic products indicated for use by the food industry.

    2 The Personal Care Products Council and American Cleaning Institute submitted a citizen petition in this rulemaking requesting FDA action on issues related to food handler antiseptic wash products. This citizen petition and other issues related to food handler products will be addressed in future documents.

    C. Comments on Effectiveness and FDA Response 1. Clinical Outcome Studies

    (Comment 7) Several comments challenged FDA's proposal that clinical outcome studies be conducted to demonstrate the effectiveness of the active ingredients for consumer antiseptic wash products, for the following reasons: (1) Clinical outcome studies are unjustified and not feasible; (2) the potential for antimicrobial resistance is unfounded because there has been no demonstration of a scientifically confirmed risk associated with the usage of consumer antiseptic products; (3) FDA has not properly considered the potential risks caused by lack of access to antibacterial products in consumers where specific populations of consumers may be at increased risk of infection; (4) the requirement for clinical outcome studies is far more extensive than antiseptic requirements for consumer, food, or health care antiseptics in other countries; and (5) simulation studies are a valid and feasible way to determine efficacy because they have been used since the publication of 1978 TFM, can be modified to include additional controls and surrogate endpoints that would satisfy the Agency's standards, and have been used to support approval of several NDAs.

    (Response 7) In the 2013 Consumer Wash PR, we proposed that data from clinical outcome studies (demonstrating a reduction in infections) are necessary to support a GRAE determination for consumer antiseptic wash active ingredients (78 FR 76444 at 76450). We explained that new concerns about the potential risks (e.g., resistance and hormonal effects) shifted the benefit-risk calculation. Therefore, the log reduction standard (a clinical simulation standard) proposed in the 1994 TFM, which was based on an invalidated surrogate endpoint (i.e., number of bacteria removed from the skin), was insufficient for establishing effectiveness of consumer antiseptic washes. The requirement for clinical outcome studies is based on the fact that sufficient data to clearly demonstrate the benefit from the use of consumer antiseptic washes compared to nonantibacterial soap and water are not available. Additionally, existing data cannot demonstrate a correlation between log reductions of bacteria achieved by antiseptic hand washing in surrogate testing and reduction of infection and, as the October 2005 NDAC also concluded, the ability of consumer antiseptic wash products to decrease bacteria on the skin is insufficient for a GRAE finding if it is not supported by a direct clinical benefit (Ref. 4). Hence, in general consumer settings where soap and water are readily available the benefit of using an antiseptic wash product must be supported by clinical outcome studies. The efficacy requirements for consumer antiseptic washes differ from the efficacy requirements proposed for consumer antiseptic rub products because the wash products are intended to be used when soap and water are not available (81 FR 42912) (2016 Consumer Rub PR). In addition, the consumer antiseptic wash efficacy requirements differ from the efficacy requirements for health care antiseptics used in a hospital setting, where study design limitations and ethical concerns prevent the use of clinical outcome studies (80 FR 25166 at 25175 to 25176).

    Moreover, as explained in the 2013 Consumer Wash PR, FDA's OTC regulations (§ 330.10(a)(4)(ii)) define the standards for establishing an OTC active ingredient as GRAE. These regulations require the efficacy of active ingredients for OTC drug products be demonstrated by controlled clinical trials (§§ 330.10(a)(4)(ii) and 314.126(b) (21 CFR 314.126(b)), unless this requirement is waived as provided in § 330.10(a)(4)(ii). These studies must be well controlled and able to distinguish the effect of a drug from other influences, such as a spontaneous change in the course of the disease, placebo effect, or biased observation (§ 314.126(a)).

    The requirement for controlled clinical trials also is consistent with the recommendations of the October 2005 NDAC that clinical outcome studies be used to demonstrate the clinical benefit of consumer antiseptic wash products and their superiority compared to a nonantibacterial wash, such as soap and water (Ref. 4). Although two clinical outcome studies we identified in the 2013 Consumer Wash PR did not demonstrate a benefit from the use of the tested antiseptic active ingredient, these studies were randomized, blinded, and placebo-controlled, and demonstrate that such clinical outcome studies are feasible. For these reasons, FDA's requirement that clinical outcome studies be conducted to demonstrate the effectiveness of the active ingredients for consumer antiseptic wash products is warranted and reasonable.

    (Comment 8) One comment also argued that FDA's requirement for clinical outcome studies based on its concern about the potential for increased antimicrobial resistance and endocrine disruption because of use of consumer antiseptic wash active ingredients is unfounded. The comment asserted that the requirement of clinical outcome studies is not supported by any demonstration of a confirmed risk associated with the use of consumer antiseptic products.

    (Response 8) We agree that the development of resistant mechanisms in natural settings is not sufficiently studied. However, as discussed in more detail in section III.D.2, the concerns regarding the extended use of antiseptics, its potential consequences on the systemic exposure, and its potential consequences on the development of bacterial resistance, must be assessed. A GRAS/GRAE determination for an active ingredient for a particular intended use requires a benefit-to-risk assessment—in this case, the risk posed by use of a consumer antiseptic wash drug product must be balanced by a demonstration that the product is statistically significant (p-value <0.05) in reducing infections compared to washing with nonantibacterial soap and water, which refers to a soap formulation, solid or liquid, that does not contain any antimicrobial ingredient.

    (Comment 9) Commenters also contend the Agency has not considered the potential risks of an increase in infections among consumers by their not having access to antibacterial product formulations and commenters included publications in support of their position.

    (Response 9) Although the submitted publications demonstrate some increase of infection in consumer settings, they do not address the effectiveness of consumer antiseptic wash products in the prevention or reduction of infections. The cited studies underscore the urgency of scientifically demonstrating the contribution of consumer antiseptics in lowering the infection rates in consumer settings. Although we acknowledge that there may be populations with increased vulnerability to bacterial infection, such as the elderly and persons with suppressed immune systems, the data to support the benefit of the use of consumer antiseptic wash products over that of nonantibacterial soap and water in these populations is still lacking.

    (Comment 10) Several comments stated that the clinical outcome requirements proposed in the 2013 Consumer Wash PR are more extensive and demanding than requirements for establishing GRAE for active ingredients in other OTC monographs, and more demanding than what is required for antiseptics that are approved for use in other countries.

    (Response 10) Although the requirement for clinical outcome studies for consumer antiseptic wash active ingredients may be a more stringent requirement than is used by some other countries, FDA's proposed effectiveness requirement is supported by FDA's regulations, the recommendations of the October 2005 NDAC, as well as by available data and publications studying the clinical outcome of antiseptics, all of which support the requirement of clinical outcome studies (Refs. 8 and 9). Moreover, the existence of published studies demonstrates that clinical outcome studies are feasible. For the reasons explained in this section, clinical outcome studies are necessary to assure that the potential risk from use of consumer antiseptic wash products is balanced by a demonstrated clinical benefit.

    (Comment 11) Several comments argued that clinical simulation studies are a valid way to demonstrate efficacy and that the log reduction of bacteria on skin proposed to demonstrate efficacy since the 1978 TFM, has been used to support the approval of several NDAs. The comments also proposed that clinical simulation studies can be modified to include additional controls and neutralizers to satisfy the Agency's requirements. The comments stated that neutralization solutions are already included in the American Society for Testing and Materials (ASTM) 3 E1174 “Standard Test method for Evaluation of the Effectiveness of Health Care Personnel Hand Wash Formulations,” and a vehicle control and an active control such as Hibiclens 4 percent could also be included in clinical simulation studies.

    3 General information about ASTM can be found at https://www.astm.org/.

    (Response 11) We agree that clinical simulation studies and surrogate endpoints have been used since the publication of the 1978 TFM (43 FR 1210) and continued to be a requirement for demonstrating effectiveness in the 1994 TFM (59 FR 31402). As addressed in the 2015 Health Care Antiseptic PR (80 FR 25166), we will continue to evaluate the effectiveness of health care antiseptic products based on both in vitro testing and clinical simulation studies. However, the ethical concerns and challenges of designing clinical trials in the hospital setting do not apply to the consumer antiseptic wash setting, where washing with soap and water is a readily available alternative for consumers, and clinical trials to demonstrate clinical superiority are ethical and feasible.

    With respect to approved marketing applications, we note that the Agency has not approved any applications for consumer antiseptic wash products since the publication of the 1994 TFM. The approved NDA products for which evaluation of efficacy is based on in vitro testing results and clinical simulation studies have been for antiseptic products used in the health care setting.

    Moreover, although the addition of vehicle and active controls, as well as the inclusion of neutralization solutions in the test method, may increase the accuracy of the testing itself, it does not meet the requirement of establishing a direct connection between the use of consumer antiseptic wash active ingredients and infection reduction in a general consumer setting. A surrogate study, with or without additional controls, is founded on the premise that reduction of bacteria on skin because of use of a consumer antiseptic active ingredient (or product) will result in reduction of infections, but it is not a direct proof of reduced infections. While we continue to propose the use of surrogate endpoints as a demonstration of effectiveness for health care antiseptics and consumer antiseptic rubs, the reasons for those different requirements, such as the challenges of conducting such studies in the health care setting, and the fact that consumer rubs, which are intended for use when soap and water is unavailable, do not apply to consumer antiseptic wash products used in general consumer settings. In addition, the infection risk in healthcare settings is greater than in consumer settings, and as such, a clinical outcome study for healthcare antiseptics raises ethical questions regarding the use of non-antimicrobial vehicle in patients. Studying the effectiveness of consumer wash antiseptics via clinical outcome studies in consumer settings is not unethical and, as previously shown, it is feasible (Refs. 8 and 9).

    As stated in the 2013 Consumer Wash PR, we have evaluated all clinical simulation studies that were submitted to the OTC Drug Review for evidence of antiseptic consumer wash active ingredient effectiveness demonstrated under the log reduction criteria (78 FR 76444 at 76451). We also evaluated the publications referenced in the comments submitted in response to the 2013 Consumer Wash PR. The studies described in the referenced publications lack the appropriate controls of a clinical outcome study, so we cannot, without additional evidence, attribute the reduction of infection rates to the use of antiseptic consumer wash active ingredients (Refs. 10 and 11). In sum, the studies we have evaluated are not adequately controlled to support an accurate assessment of the effectiveness of consumer antiseptic wash active ingredients.

    A demonstration of the effectiveness of the active ingredients used in consumer antiseptic wash products should result from robust, properly designed, randomized studies with adequate numbers of subjects and clearly defined endpoints and analysis, using reduction in infection rates rather than reduction in pathogen counts. For the reasons discussed in this section and in the 2013 Consumer Wash PR, adequate clinical outcome studies that identify the conditions of use on which an antiseptic active ingredient can demonstrate a reduction in the number of infections, are required to demonstrate the GRAE status of consumer antiseptic wash active ingredients.

    2. Testing of the Active Ingredient

    (Comment 12) Several comments argued that the testing of the active ingredients rather than testing of final formulation products is unnecessary and not feasible because the delivery of the active ingredient is heavily dependent on its vehicle and testing of the active ingredient alone is not possible. One comment stated that although several consumer antiseptic wash products may contain the same active ingredient, they can also contain different product formulations that account for the effective delivery of the active ingredient, and, thus, test results of one specific wash product may not represent the effectiveness of a variety of consumer antiseptic wash products formulated with the same active ingredient.

    (Response 12) The controlled clinical trials required by FDA's regulations are intended to demonstrate that the pharmacological effect of the drug when used under adequate directions for use will provide clinically significant relief of the type claimed (§§ 330.10(a)(4)(ii) and 314.126(b); 78 FR 76444 at 76450)), i.e. efficacy for the stated indication. GRAE determinations are made based on the active ingredient, not the product. We understand that testing the effectiveness of only the active ingredient using clinical outcome studies may not be feasible because the consumer uses the product in its final formulation form and not necessarily in the form of the isolated active ingredient. We agree that a variety of aspects of a final product formulation such as its pH, surfactancy, solubility, as well as the product's stability, depend on the formulation of the vehicle and can have an impact on the delivery of the active ingredient, as well as its antibacterial activity. We agree that test results of one specific wash product may not represent the effectiveness of a variety of consumer antiseptic wash products formulated with the same active ingredient. However, the proposal for conducting adequate and well-controlled clinical outcome studies to demonstrate that the active ingredient of a consumer antiseptic wash product is GRAE was not intended to be a study conducted only on the active ingredient, but rather a study designed to determine the contribution of the active ingredient to the effectiveness of the product. To determine that the active ingredient is GRAE, the clinical outcome studies should include at least two arms: The final formulation of the product and the vehicle. The effectiveness of the active ingredient, and hence its contribution in the reduction of infections, will be determined by comparing the infection rate of the active ingredient plus its vehicle to the infection rate of the vehicle in a consumer population. In the 2013 Consumer Wash PR, the referenced clinical outcome studies (Refs. 8 and 9) are two-arm studies where the effect of the antiseptic product in reduction of infections in a population is compared to a non-antibacterial product. It is in the presence of these controls (i.e., the vehicle or a non-antibacterial product) that the contribution of the active ingredient contained in a consumer wash antiseptic product can be determined. We note that if an ingredient is so highly formulation dependent that the results of the efficacy testing cannot be extrapolated to demonstrate the active ingredient's effectiveness, products containing such an ingredient may require an NDA.

    3. In Vitro Testing/Time-Kill Assays

    (Comment 13) Several comments urged FDA to revise its proposed in vitro test methods for consumer wash antiseptic active ingredients. They stated that for demonstrating antibacterial activity of active ingredients, it is more relevant to perform a minimal inhibitory concentration and minimal lethal concentration (MIC/MLC) test to determine the potency and spectrum of the antibacterial activity of the proposed active ingredient before it is included in an antibacterial product formulation. Several comments also recommended that FDA not establish specific performance criteria for MIC/MLC testing of the active ingredients because the ingredients have not yet been formulated.

    (Response 13) In addition to the clinical outcome studies FDA proposed in the 2013 Consumer Wash PR, FDA proposed an in vitro study consisting of a modified time-kill assay conducted on selected reference organisms and their respective clinical isolates, which are representative of bacterial strains most commonly encountered in general consumer settings (78 FR 76444 at 76452 to 76453). The purpose of the in vitro study is to characterize the antimicrobial activity of the active ingredients used in consumer antiseptic wash products.

    As explained in the 2013 Consumer Wash PR, the requirement for clinical outcome studies lessens the need for extensive in vitro studies, given that the primary support for a GRAE determination is the clinical outcome study. MIC/MLC tests assess the minimal concentration of the active ingredient needed to cause inhibition of growth and/or lethality to bacteria after a 24-hour exposure to the active ingredient. However, the exposure time of consumer wash active ingredients, based on the indications of use for antiseptic wash products, is much shorter—several minutes maximum. Thus, information on the ability of the antiseptic wash active ingredient to inhibit or eliminate bacterial growth after the prolonged exposure times used in the MIC/MLC testing is not relevant to the actual use of the consumer antiseptic wash product.

    The time-kill assay, on the other hand, is designed to test shorter exposure times against the microorganisms selected for testing with the test material, and as such, it provides more relevant information on how quickly the tested active ingredient eliminates the tested microorganisms. The time-kill assay also includes strains and clinical isolates of organisms most commonly found in consumer settings and provides relevant information on the kinetics of the antimicrobial activity of active ingredients with regard to the bactericidal activity of active ingredients used in consumer antiseptic wash products.

    Given that we are not requiring MIC/MLC tests to be performed, we do not address whether specific performance criteria should or should not be established for MIC/MLC testing of the active ingredients.

    (Comment 14) Several comments also contended that the time-kill assay should be used for characterization of final product formulation, rather than for evaluation of the effectiveness of the active ingredient, given that many characteristics of the formulation, such as its stability, solubility, and pH, have a significant influence on the performance outcome of the antiseptic product. They urged FDA to adopt ASTM E2783, “Standard Test Method for Assessment of Antimicrobial Activity for Water Miscible Compounds Using a Time-Kill Procedure,” as the standard for conducting the time-kill assay. They also argued that the performance criteria for the time-kill assay proposed in the 2013 Consumer Wash PR are more demanding than the performance abilities of approved health care antiseptic products.

    (Response 14) Testing requirements for the final product formulations are not addressed in this final rule because none of the active ingredients that are the subject of this final rule are considered GRAE for use in consumer antiseptic wash products, given the lack of sufficient effectiveness data for these ingredients. The testing requirements for final formulations of products containing the three deferred active ingredients will be addressed after a decision is made regarding the monograph status of those ingredients.

    In addition, for purposes of the three deferred active ingredients, we have reviewed the ASTM E2783-11 and do not disagree with the use of this method for the deferred active ingredients to help establish GRAE status for a consumer antiseptic wash product with a bacterial indication, as long as all the bacterial strains and the respective clinical isolates proposed in the 2013 Consumer Wash PR are included in the test.

    With regard to the comment that the performance criteria of the time-kill assay are more demanding than the performance abilities of approved health care antiseptic products, the proposed 99.9 percent elimination of bacteria describes the concentration and the time of contact at which the active ingredient would be considered bactericidal. This criterion is based on the performance of alcohol formulations (61 percent to 85 percent) and on the expectation that an effective consumer antiseptic product will demonstrate a comparable bactericidal activity. The 2013 Consumer Wash PR did not propose that a 99.9 percent performance criterion would have to be achieved on all the proposed reference strains and clinical isolates to make a GRAE determination for the active ingredient.

    In summary, the clinical results necessary to support a GRAE finding for any of the consumer antiseptic wash active ingredients addressed in this final rule have not been demonstrated. The effectiveness of each of the three consumer wash active ingredients deferred from this rulemaking will be evaluated on a case-by-case basis in the future.

    4. Melon Ball Model To Support a GRAE Determination

    In the 2013 Consumer Wash PR, we evaluated a study submitted to the OTC Drug Review involving a testing protocol referred to as the Melon Ball Disease Transmission (MBDT) model (78 FR 76444 at 76451 to 76452). The MBDT model attempts to link the efficacy of washing with antibacterial consumer wash to infection reduction by correlating the reduction of bacterial transfer to a food item following the use of a consumer antiseptic hand wash to a reduction of infection. In the 2013 Consumer Wash PR, FDA raised several concerns regarding the validity of the MBDT model. We found the MBDT model deficient and inadequate to link reduction of bacteria to a reduction in infection incidences (78 FR 76444 at 76451). Therefore, we concluded, the results of the MBDT study did not demonstrate the effectiveness of the consumer antiseptic hand wash used in the study.

    (Comment 15) Several comments disagreed with the Agency's concerns and supported the use of the MBDT model for establishing a GRAE classification for relevant active ingredients, as well as supported optional final formulation testing that is intended to correlate clinical simulation study results with clinical outcome. Published data and recent studies were included in the comments submitted in response to the 2013 Consumer Wash PR to address the validity of the MBDT model and two other models used along with the MBDT model: (1) The Palmar hand-contamination method—the model of bacterial hand contamination and (2) a computational simulation model known as the Quantitative Microbial Risk Assessment (QMRA) model.

    (Response 15) We reviewed and evaluated the submitted materials, including the studies previously addressed in the 2013 Consumer Wash PR. The studies show a reduction of bacteria on skin, as well as reduced bacterial transfer from hands to objects or food items because of use of consumer antiseptic wash products. In the Schaffner et al. study, statistical analysis and the QMRA model were used, in addition to the previously reported MBDT model, in an effort to establish a quantitative link between the effectiveness of antiseptic products and the reduced potential for disease such as Shigellosis and other low-dose enteric pathogens (Ref. 12).

    After evaluation, however, we find that the submitted data, which include the Palmar method and QMRA model, do not address the deficiencies of the MBDT model previously analyzed in the 2013 Consumer Wash PR for the following reasons:

    • The Palmar method is not reflective of the intended use of consumer antiseptic wash products and does not take into consideration the bacteria residing under the fingernails, which is an important reservoir for bacteria. Sufficient data to compare the Palmar method to the full-hand contamination method currently used are not provided.

    • The limitations of the dose-response model generated from S. flexneri dose-response studies, including the small number of subjects, variability in the dose-response data, and lack of uniformity on criteria used for the definition of illness, remains the same as previously addressed in the 2013 Consumer Wash PR (78 FR 76444 at 76451).

    • Although melon is a readily found food item, it cannot be used as a standardized tool for bacterial transfer. There are other factors besides the size of the melon balls, such as the melon's ripeness and surface texture, which may introduce variability to bacterial transfer. Also, bacterial transfer may be affected by the amount of fat/grease contained in a food item. These issues cannot be addressed by using the melon ball as a standardized object to study bacterial transfer (Ref. 13). The comments provided no useful data to assess the effects of these variables on the absolute counts of bacteria transferred from hands to food items and the overall study outcome.

    Overall, the MBDT model, including the QMRA analysis, cannot be used as a standardized method to validate the effectiveness of consumer antiseptic wash active ingredients. Such a model assesses bacterial transfer as a surrogate for disease and is not capable of showing the direct clinical benefit of an antiseptic active ingredient or an antiseptic product for the general consumer population. Instead, it measures the transfer of bacteria from contaminated hands to melon balls, a measurement that is then used in a risk assessment model to provide a hypothetical infection reduction estimate based on infection data generated from S. flexneri dose-response studies with limited data. The proposed MBDT model reflects only one facet of the multiple uses of consumer antiseptic wash products. Consumers can be exposed to pathogenic organisms not only through food preparation activities, but also through contact with a variety of fomites in the domestic setting. Furthermore, the MBDT model does not address the scenario where a consumer would transfer the disease from their contaminated hands to other parts of their bodies (self-inoculate).

    Although the QMRA analysis may be useful for exploratory analysis for risk assessment and management, it is not used for demonstrating the efficacy of drugs for approval. The comment provided references to show that QMRA analyses have been adopted by many agencies, including FDA. Our literature search confirms that QMRA analyses are used to estimate the impact of food safety policies (Ref. 14), or to predict the probability of adverse effects in vaccination (Ref. 15). However, we did not find any evidence of QMRA analysis employed as direct proof in determining the efficacy of a drug product or an active ingredient.

    The MBDT model fails to prove that reduction of the pathogen counts on hands will translate into a clinically meaningful benefit, and as such, the MBDT model cannot be a substitute for adequate clinical outcome studies that identify conditions of use under which an antiseptic wash active ingredient is capable of reducing the number of infections. The data demonstrating the effectiveness of the active ingredients used in consumer antiseptic wash products should result from robust, properly designed, randomized studies with adequate numbers of subjects and clearly defined endpoints and analysis, assessing reduction in infection rates rather than reduction in pathogen counts.

    5. American Society for Testing and Materials Standard Methods

    (Comment 16) Several comments addressed the test methods for demonstration of effectiveness for final product formulations and proposed that the Agency recognize several ASTM test methods for determination of effectiveness for final product formulations, including the ASTM E1174 “Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Hand Wash Formulations,” the ASTM E2784 “Standard Test Method for Evaluation of the Effectiveness of Hand Wash Formulations Using the Paper Towel (Palmar) Method of Hand Contamination,” the ASTM E1874 “Standard Test Methods for Recovery of Microorganisms From Skin Using the Cup Scrub Technique,” and the ASTM E2783 method “Standard Test Method for Assessment of Antimicrobial Activity for Water Miscible Compounds Using a Time-Kill Procedure.”

    (Response 16) As discussed in section IV, none of the active ingredients subject to this final rule have been found to be GRAE for use in a consumer antiseptic wash product. We will evaluate the GRAS/GRAE status of the three deferred active ingredients either upon completion and analysis of all safety and effectiveness studies required for these ingredients or at a later date if these studies are not completed (78 FR 76444 at 76458). For these reasons, it is premature to discuss final product formulation testing requirements before a decision is made on the adequacy of data to provide to support monograph status of the three deferred active ingredients.

    We note, however, that the suggestion to accept the ASTM test methods used in clinical simulation studies for final product formulation testing is based on the assumption that for the consumer antiseptic wash active ingredients for which clinical outcome studies will demonstrate effectiveness, only antibacterial claims would be supported. The guidelines for clinical outcome study design provided by the Agency with regard to the three deferred consumer antiseptic wash active ingredients allow for demonstration of reduction of infections of either bacterial or viral origin. If the clinical outcome studies demonstrate that these active ingredients can reduce infections of origin other than bacterial (i.e. viruses), additional testing to further characterize the activity of these ingredients must be determined. Therefore, testing requirements for final product formulation cannot be finalized before we have made a determination that a deferred active ingredient is GRAE. Depending on the indication(s) supported by clinical outcome studies for an active ingredient, additional final product formulation testing, other than the ASTM methods suggested, may be required.

    D. Comments on Safety and FDA Response 1. Additional Safety Testing Requirements

    (Comment 17) One comment stated that before proposing new safety testing, FDA must consider the actual risks. The comment argued that if current product exposures do not present risk based on the existing data, new data should not be required. The comment further recommended that existing data should be reviewed in relation to increased risk rather than increased analytic sensitivity and that if FDA finds that there is no demonstration of risk, FDA should conclude that the active ingredients and formulations are safe.

    (Response 17) We decline to withdraw our requirement in the 2013 Consumer Wash PR for the additional safety data that we determined is necessary to support a GRAS classification for the consumer antiseptic wash active ingredients. As explained in the 2013 Consumer Wash PR, several important scientific developments that affect the safety evaluation of the consumer antiseptic wash active ingredients have occurred since FDA's 1994 evaluation. New data and information on the antiseptic wash active ingredients raise concerns regarding potential risks from systemic absorption and long-term exposure, as well as development of bacterial resistance related to use of consumer antiseptic washes (78 FR 76444 at 76445). The data required by the 2013 Consumer Wash PR is necessary for FDA to conduct an adequate safety evaluation. The comments do not provide sufficient data to support a determination that these consumers antiseptic wash active ingredients can be classified as GRAS.

    2. Resistance

    (Comment 18) Numerous comments relating to the issue of bacterial resistance were submitted in response to the 2013 Consumer Wash PR. Some comments argued that the pervasive use of consumer antiseptics poses an unacceptable risk for the development of resistance and that these products should be removed from the market. Other comments disagreed and criticized the data on which they believe FDA has based its concerns.

    Specifically, several comments dismissed the in vitro data cited by FDA in the 2013 Consumer Wash PR as not reflecting real-life conditions. The comments recommended that the most useful assessment of the risk of biocide resistance and cross-resistance to antibiotics are in-situ studies, studies of clinical and environmental strains, or biomonitoring studies. Some comments asserted that studies of this type have reinforced the evidence that resistance and cross-resistance associated with antiseptics is a laboratory phenomenon observed only when tests are conducted under unrealistic conditions. Another comment cited the conclusions of an International Conference on Antimicrobial Research held in 2012 on a possible connection between biocide (antiseptic or disinfectant) resistance and antibiotic resistance to support the point that there is no correlation between antiseptic use and antibiotic resistance (Ref. 16).

    (Response 18) Laboratory studies have identified and characterized bacterial resistance mechanisms that confer a reduced susceptibility to antiseptics and, in some cases, clinically relevant antibiotics (Refs. 17 through 27). Bacteria expressing these resistance mechanisms with a decreased susceptibility to antiseptics have been isolated from a variety of natural settings (Refs. 28 through 30). These studies found that the prevalence of antiseptic tolerant subpopulations in the natural microbial populations studied is currently low. Morrissey et al. concluded, however, that their study findings could not rule out the existence of other resistant isolates that could be found if more isolates were analyzed.

    In general, studies have not clearly demonstrated an impact of antiseptic bacterial resistance mechanisms in the natural setting. However, the available studies have limitations. As FDA noted in the 2013 Consumer Wash PR, studies in a natural setting that it evaluated were limited by the small numbers and types of organisms, the brief time periods, and the locations examined; and more importantly, none of these studies address the level of exposure to the antiseptic active ingredient (Refs. 30 through 33) (78 FR 76444 at 76454). These limitations were also found in the studies cited by the comments (Refs. 35 through 37). There was, however, one study that found a difference in the antiseptic and antibiotic susceptibilities of some of the bacteria evaluated (Ref. 38).

    Carson et al. assessed the effect of antibacterial product use (cleaning products containing quaternary ammonium compounds including benzalkonium chloride and hand soap containing 0.2 percent triclosan) in the home environment on susceptibility to benzalkonium chloride, triclosan, and antibiotics. Data were collected as part of a longitudinal double-blind, randomized clinical trial that compared the susceptibilities of bacteria isolated from antibacterial user and nonuser households at baseline and after 1 year. The MICs of 645 isolates were evaluated. The study found that after 1 year of assigned product usage, bacterial isolates with high benzalkonium chloride MICs were more likely to have high triclosan MICs and be resistant to one or more antibiotics.

    Other data on a possible correlation between antiseptic and antibiotic resistance are conflicting. Copitch et al. found that the majority of isolates with decreased resistance to triclosan were also resistant to multiple antibiotics in their series of 428 isolates screened for decreased susceptibility to triclosan and a panel of antibiotics (Ref. 29). Conversely, Skovgaard et al. found no significant association between antibiotic resistance and triclosan tolerance when they compared the susceptibilities of current isolates of Staphylococcus epidermidis with isolates collected in the 1960s before introduction of triclosan to the market in Denmark (Ref. 30). An analysis of 1,600 isolates of Staphlococcus aureus has shown a moderate correlation between susceptibility to benzalkonium chloride and some classes of antibiotics (e.g., quinolones, beta-lactams, and macrolides), but not for triclosan (Ref. 39).

    In conclusion, bacteria expressing resistance mechanisms with a decreased susceptibility to antiseptics and some antibiotics have been isolated from a variety of natural settings (Refs. 28 and 29). Although the prevalence of antiseptic tolerant subpopulations in natural microbial populations is currently low, continued overuse of antiseptic active ingredients has the potential to select for resistant microorganisms.

    Adequate data do not currently exist to determine whether the development of bacterial antiseptic resistance could also select for antibiotic resistant bacteria or how significant this selective pressure would be relative to the overuse of antibiotics, an important driver for antibiotic resistance. Moreover, the possible correlation between antiseptic and antibiotic resistance is not the only concern. Reduced antiseptic susceptibility may allow the persistence of organisms in the presence of low-level residues and contribute to the survival of antibiotic resistant organisms. Data are not currently available to assess the magnitude of this risk.

    (Comment 19) Other comments disagreed that the development of resistance to a particular ingredient has been demonstrated. The comments also disagreed on the type of data needed to assess the risk of the development of resistance. One comment disagreed with the proposed testing described in the 2013 Consumer Wash PR, arguing that there are no standard laboratory methods for evaluating the development of antimicrobial resistance. With regard to the recommendation for mechanism studies, some comments asserted that it is unlikely that this kind of information can be developed for all active ingredients, particularly given that the mechanism(s) of action may be concentration dependent and combination/formulation effects may be highly relevant. The comments also believed that data characterizing the potential for transferring a resistance determinant to other bacteria is an unrealistic requirement for a GRAS determination.

    Conversely, one comment recommended that antimicrobial resistance be addressed first through in vitro MIC determinations. If an organism is shown to develop resistance rapidly, then the comment recommended that FDA should consider this negative information in its evaluation. The comment believed that this test of the potential for the development of resistance is important because consumer compliance with recommended use of consumer antiseptic wash products is variable and products that result in rapid antimicrobial resistance would pose a public health risk.

    (Response 19) In the 2013 Consumer Wash PR, we proposed a tiered approach as an efficient means of developing data to address this issue. Laboratory studies were proposed as a feasible first step in evaluating the impact of exposure to nonlethal amounts of antiseptic active ingredients on antiseptic and antibiotic bacterial susceptibilities. We noted that only limited data exist on the effects of antiseptic exposure on the bacteria that are predominant in the oral cavity, gut, skin flora, and the environment, and that these organisms represent pools of resistance determinants that are potentially transferable to human pathogens (78 FR 76444 at 76457). Thus, we proposed broader laboratory testing of consumer antiseptic active ingredients that would more clearly define the scope of the impact of antiseptic active ingredients on the development of antibiotic resistance and may enable identification of those antiseptic active ingredients for which the development of resistance is not a concern. We are aware that there are no standard protocols for these studies. However, there are numerous publications in the literature of studies of this type that could provide guidance on the study design (Refs. 40 through 44).

    For antiseptic active ingredients for which an effect on antiseptic and antibiotic susceptibilities is demonstrated, we proposed that additional data would be necessary to help assess the likelihood that changes in susceptibility observed in the preliminary studies would occur in the consumer setting. Several different types of data were recommended to assess whether or not ingredients with positive laboratory findings pose a public health risk, and the type of data needed would depend on what is already known about the antiseptic active ingredient's mechanism of action and persistence in the environment. We stated that we did not anticipate that it would be necessary to obtain data from multiple types of studies for each active ingredient to adequately assess its potential to affect resistance. Thus, the types of studies that would be acceptable to help address this issue are not limited to those described in the 2013 Consumer Wash PR (78 FR 76444 at 76457).

    (Comment 20) One comment noted that the recommendations in the proposed rule pertaining to the type of data that could be used did not consider the safety of usage of antiseptics for another sensitive population: The immunocompromised. The comment stated that this growing population may be at greater risk of developing bacterial resistance from repeated usage of antiseptics, and the comment noted the dangers that result from associated infections that are unresponsive to traditional antibiotics. The comment submitted no data to support its assertion, but asserted that there is a need for research to clarify whether the bacterial composition of immunocompromised individuals is adequately represented by the bacteria identified for testing in the proposed rule. The comment also suggested that there may be an additional need to perform surveillance of the effects seen in the immunocompromised after the use of consumer antiseptics for increased risk of bacterial resistance, because this has been demonstrated in clinical settings. Another comment recommended that FDA require that manufacturers establish and maintain active surveillance of this issue and require that this information be submitted to FDA every year.

    (Response 20) We acknowledge that there are segments of the general population that may be more at risk from antiseptic/antibiotic cross-resistance and that further research is needed to address this facet of this issue. However, because no monograph is being established for the consumer antiseptic wash active ingredients in this final rule, the requests for an FDA requirement for active surveillance of this issue do not apply for purposes of this final rule.

    3. Alternatives to Animal Studies

    (Comment 21) One comment requested that FDA provide guidance on how to reduce the use of animals in testing done to assess the safety of consumer antiseptic washes. The comment recommended that FDA require manufacturers to conduct efficacy testing in humans before safety testing in animals and to share the data resulting from any animal testing they conduct. The comment also recommended that FDA accept data from non-animal safety tests.

    In addition, the comment recommended that FDA reduce the number of rodent cancer bioassays required, by allowing for the extrapolation of data from the dermal route of administration to the oral route, and from the oral route to the dermal route. The comment requested that FDA consider whether physiologically based toxicokinetic modeling (PBTK), along with certain non-animal in vivo and in vitro absorption, distribution, metabolism, and excretion (ADME) data, could support route-to-route extrapolation. The comment further recommended that FDA adopt in vitro testing strategies to replace testing using animal models. Lastly, the comment stated that FDA should require manufacturers to share the data resulting from any animal testing they conduct.

    (Response 21) The required number of rodent cancer bioassay studies have in some cases been reduced for drug products; for instance, a waiver of dermal carcinogenicity may be considered for a substance used previously by another route if a chronic dermal study in an appropriate non-rodent species shows no potential neoplastic effects and there are no other causes for concern, such as absence of a positive genotoxicity signal and absence of association of exposure to the drug with a positive tumor signal in systemic carcinogenicity data (Refs. 45 and 46). However, at this point, the Agency has not adopted a policy regarding the use of route to route extrapolation method using alternatives to animal testing such as in vitro data, ADME and PBTK tools.

    We understand that animal use in tests for the efficacy and safety of human and animal products has been and continues to be a concern. We encourage sponsors to consult with us on non-animal testing methods they believe may be suitable, adequate, validated, and feasible. We are willing to consider if alternative methods could be assessed for equivalency to an animal test method.

    However, there are still many areas where animal testing is considered necessary and non-animal testing is not yet a fully available option. FDA continues to support efforts to reduce animal testing, particularly whenever new alternative methods for safety evaluation have been validated and accepted by International Council on Harmonization (ICH) regulatory authorities, but these efforts have not yet resulted in the development of alternative testing that eliminate animal testing altogether. We will not be discussing further in this final rule the specific issues raised in the comments on animal testing because these issues are outside the scope of this rulemaking.

    With respect to the recommendation that FDA require manufacturers to share the data resulting from any animal testing they conduct, FDA regulations require that data and information relevant to the monograph and a GRAS/GRAE determination be submitted to the docket for that monograph and made publicly available (§ 330.10(a)(2)). Accordingly, any such animal testing data should be publicly available and can be obtained from the docket for this rulemaking. We also note that although there is a process for submitting confidential information, the OTC drug monograph process is generally a public process. The Agency considers either non-confidential material that is submitted to the docket or information that is publicly available when making its evaluation of whether a given ingredient is GRAS/GRAE.

    E. Comments on Active Ingredients and FDA Response 1. Ethanol

    (Comment 22) A comment was submitted to this docket regarding the GRAS status of ethanol.

    (Response 22) This active ingredient is not marketed as a consumer antiseptic wash product, and, therefore is not addressed. We will address this comment, and any other comments regarding the GRAS status of ethanol, to the extent that it applies to indications reviewed in the 2015 Health Care Antiseptic PR and the 2016 Consumer Rub PR.

    2. Cetylpyridinium Chloride

    (Comment 23) As noted in the 2013 Consumer Wash PR, subsequent to the 1994 TFM we received requests that certain active ingredients be added to the antibacterial monograph (78 FR 764444 at 76448). One of these submissions included a citizen petition that requested that we allow the use of cetylpyridinium chloride as an antibacterial active ingredient for household liquid soap (Ref. 47).

    (Response 23) In the 2013 Consumer Wash PR, we identified certain active ingredients, including cetylpyridinium chloride that we considered ineligible for evaluation under the OTC Drug Review as a consumer antiseptic wash. We noted that if the requested documentation for eligibility was submitted, these active ingredients, including cetylpyridinium chloride, could be determined to be eligible for evaluation (78 FR 76444 at 76448). Neither the citizen petition, nor other submissions we have received in this rulemaking, include documentation demonstrating the eligibility of cetylpryridinium chloride for evaluation under the OTC Drug Review for use as a consumer antiseptic wash. Consequently, this citizen petition is denied and as indicated in section II.D, we consider consumer antiseptic wash products containing cetylpyridinium chloride to be new drugs that require FDA approval through the NDA process.

    3. Hexylrescorinol

    In the 2013 Consumer Wash PR, FDA proposed to classify hexylresorcinol as Category III for both safety and efficacy (78 FR 76444 at 76458). FDA determined that the administrative record for the safety of hexylresorcinol was incomplete with respect to the following:

    • Human pharmacokinetic studies under the maximal use conditions when applied topically, including documentation of validation of the methods used to measure hexylresorcinol and its metabolites • Animal pharmacokinetic studies on ADME • Data to help define the effect of formulation on dermal absorption • Dermal carcinogenicity • Developmental and reproductive toxicity (DART) data • Potential hormonal effects • Data from laboratory studies that assess the potential for the development of resistance to hexylresorcinol and cross-resistance to antibiotics in the types of organisms listed in section VII.C.3 of the 2013 Consumer Wash PR (78 FR 76444 at 76457)

    (Comment 24) One comment referenced a 13-week oral toxicology study from the National Toxicology Program (NTP) conducted in rats, in which there were reports of reduction in the size of seminal vesicles and hypospermatogenesis (abnormally low sperm production). The comment asserted that FDA should evaluate these effects on the male rat reproductive organs to fill the DART data gap for hexylresorcinol.

    (Response 24) Although this technical report was cited in the 2013 Consumer Wash PR (78 FR 76444 at 76475, Ref. 120) for hexylresorcinol, the data in this 13-week study is not sufficient to conduct an adequate DART assessment for hexylresorcinol (Ref. 48). Specifically, the NTP report described toxicity and carcinogenicity studies of hexylresorcinol. The report consisted of three sets of studies, 16-day studies, 13-week studies, and 2-year studies, all conducted in mice and rats of both sexes. Although the findings in the 13-week studies appear to show an effect of hexylresorcinol on the reproductive system in high-dose male rats, according to the NTP report, there was no difference in the reproductive findings between controls and high-dose-treated males. No adverse findings were noted for the reproductive organs examined in males and females treated with high doses of hexylresorcinol in the 2-year carcinogenicity studies in rats and mice. However, the findings from the general toxicity studies (13-week and 2-year carcinogenicity studies) do not address all relevant reproductive and developmental endpoints for hexylresorcinol. Accordingly, we find that the safety data gap for DART for hexylresorcinol has not been adequately addressed. No new data were submitted to the docket to fill other safety data gaps identified in the 2013 Consumer Wash PR. In addition, as discussed in section IV of this document, no new data were submitted to the docket to demonstrate the effectiveness of the active ingredients subject to this final rule, including hexylresorcinol, for use as a consumer antiseptic wash product. Therefore, hexylresorcinol is not GRAS/GRAE for use in consumer antiseptic wash products.

    4. Iodophors/Povidone-Iodine

    In the 2013 Consumer Wash PR, we proposed to classify iodophor complexes, including povidone-iodine, 5-10 percent, as Category III, determining that the available safety and effectiveness data were insufficient and further testing was required (78 FR 76444 at 76459). FDA determined that the administrative record for the safety of iodophors was incomplete with respect to the following:

    • Human studies of the absorption of iodine following maximal dermal exposure to the complexes • Human absorption studies of the carrier molecule for small molecular weight povidone molecules and the other carriers listed in the 2013 Consumer Wash PR • Dermal carcinogenicity studies for each of the iodophor complexes • Data from laboratory studies that assess the potential for the development of resistance to iodine and cross-resistance to antibiotics in the types of organisms listed in the 2013 Consumer Wash PR (78 FR 76444 at 76453)

    (Comment 25) One comment requested that the Agency clarify that multiuse consumer antiseptic products containing the active ingredient povidone-iodine intended for first aid use and general purpose antiseptic cleansing and labeled for only short-term use over limited areas of the skin are outside the scope of the 2013 Consumer Antiseptic PR. The comment explained that the skin cleanser's primary use is as a first aid antiseptic and it is sold in the first aid aisle of retail stores. They also explained that although the labeling provides for uses as a wash, it recommends only short term use over limited areas of the skin, consistent with the 1991 First Aid TFM; and thus, the safety studies proposed in the 2013 Consumer Wash PR should not be required for such multiuse skin cleansing products. The comments also requested that if FDA determines that multiuse antiseptic products are within the scope of the 2013 Consumer Wash PR, that a category I classification be maintained for povidone-iodine, 5-10 percent, with a molecular weight at or above 35,000 Daltons.

    (Response 25) The testing requirements for a GRAS/GRAE finding as proposed in the 2013 Consumer Wash PR, apply to all consumer antiseptic wash products containing the active ingredients that are the subject of this final rule and that are intended to be used with water, such as antibacterial soaps and antibacterial hand washes (76 FR 76444 at 76446). If the labeling for these products contains an indication for use as a consumer antiseptic wash, then the product is subject to the testing requirements of the 2013 Consumer Wash PR, even if the labeling also contains an indication for other uses, such as for a first aid antiseptic.

    Moreover, because consumer antiseptic washes may be used on multiple occasions throughout a person's lifetime, this use pattern is considered to be chronic. According to the International Council for Harmonization guideline, a use is considered chronic if a certain drug is used for a period of at least 6 months over the user's lifetime, including repeated, intermittent use. Thus, chronic exposure testing is necessary for a GRAS/GRAE determination for the active ingredients used in these consumer antiseptic wash products even if a particular ingredient's labeling recommends that the product's use should be limited in duration.

    In addition, we decline to classify povidone-iodine 5-10 percent with a molecular weight at or above 35,000 Daltons as Category I (GRAS/GRAE) for use in consumer washes. Although we stated in the 2013 Consumer Wash PR that the larger molecular weight-size povidone molecules pose no risk of absorption, and we only requested human absorption studies of the carrier molecule for small molecular weight povidone molecules, there are still remaining safety data gaps for the iodophors, including large molecule povidone-iodine (76 FR 76444 at 76459 to 76461). For example, we determined that the administrative record for the safety of iodophors was incomplete for dermal carcinogenicity studies. Accordingly, because the safety data gaps have not been addressed, we cannot make a GRAS determination on the iodophors, including the large molecule povidone-iodine.

    (Comment 26) Another comment stated that human absorption data required for the iodophors should take precedence over the requirement for dermal carcinogenicity studies to fill the safety data gaps for the iodophors. The comment argued that data from the human absorption studies may reduce the number of carcinogenicity studies needed to fill the safety data gaps for iodophors.

    (Response 26) Antiseptic products, such as povidone-iodine, are applied topically and require toxicological evaluation in dermal studies to assess the potential safety signals following the exposure. The reason for requiring dermal assessment is because the skin dose resulting from a topically applied drug product can be much higher than the dose detected in the skin as a result of systemic exposure. In addition, systemic exposure to the parent drug and metabolites can differ significantly in topically applied products compared to orally administered products because the skin has its own metabolic capability, and the first-pass metabolism, which is available following oral exposure, is bypassed in the topical route of administration. In some cases, a waiver of dermal carcinogenicity may be considered for a substance used previously by another route if a chronic dermal study in an appropriate non-rodent species shows no potential neoplastic effects and there are no other causes for concern, such as absence of a positive genotoxicity signal and absence of association of exposure to the drug with a positive tumor signal in systemic carcinogenicity data (Refs. 45 and 46). Furthermore, the absence of significant systemic absorption is not a qualifying reason to waive the requirement for the dermal carcinogenicity study.

    (Comment 27) A comment submitted on behalf of a marketer of an OTC antiseptic product containing povidone-iodine asserted that povidone-iodine does not pose a risk for the development of resistance (see section III.D.2 for a more general discussion on resistance). The comment noted that none of the studies cited in the 2013 Consumer Wash PR concerning the development of antiseptic/antibiotic resistance involve povidone-iodine. The comment stated that historically, povidone-iodine has not been associated with the development of resistance, and that it has been found to be a useful tool against several multidrug resistant bacteria. In support of its position, the comment submitted data on the chemistry and antimicrobial effects of povidone-iodine and studies of povidone-iodine's in vitro and in vivo effectiveness (Refs. 49 through 54).

    (Response 27) Elemental iodine, which is the active antimicrobial component of iodine containing antiseptics like povidone-iodine, is generally believed to be nonspecific in its antimicrobial action (Ref. 55). The antimicrobial activity of iodine is caused by its oxidizing effects on amino (NH-), thiol (SH-), phenolic hydroxyl (OH-) groups of amino acids and nucleotides. These reactions lead to a loss in protein structure and function and an inhibition of protein synthesis. Iodine also reacts with the double bonds of unsaturated fatty acid components of cell wall and organelle membranes, compromising the integrity of these structures. The effects of povidone-iodine on cell ultrastructure have been observed at concentrations as low as 0.025 percent povidone-iodine in Staphylococcus aureus, Esherichia coli, and Candida albicans (Ref. 49). A decrease in enzyme (β-galactosidase) activity and nucleotide efflux was also apparent at 0.42 and 0.83 percent povidone-iodine (Ref. 49). These concentrations are well below the concentrations of povidone-iodine found in currently marketed products.

    A search of the published literature revealed two studies that attempted to select for resistant bacterial strains after repeated exposure to sublethal concentrations of povidone-iodine (Refs. 56 and 57). Houang et al. studied the potential for the development of resistance to povidone-iodine by serial passage of two strains of each of the following organisms: Escherichia coli, Klebsiella aerogenes, and one strain of Serratia marcescens in sub-inhibitory concentrations (Ref. 56). The authors reported no significant differences in MIC, minimum bactericidal concentration, or killing time after 20 passages. Similarly, Prince et al. reported that they had failed to detect any changes in the MIC of six Gram-negative bacteria (Proteus mirabilis, Serratia marcescens, Serratia rubidaea, Pseudomonas cepacia (now known as Burkholderia cepacia), Pseudomonas aeruginosa, and Salmonella enteritidis) after 20 serial passages in povidone-iodine (Ref. 57).

    The search also revealed some reports of Burkholderia cepacia contamination of povidone-iodine products (Refs. 58 through 62). However, the antiseptic susceptibilities of the organisms isolated were never established, making it hard to determine whether the contamination was the result of an existing intrinsic antiseptic resistance that has been associated with Burkholderia cepacia or the development of an increased tolerance. In addition, the literature search revealed no reports of the development of resistance to povidone-iodine. Consequently, given iodine's multiple nonspecific toxic effects on bacteria at low concentrations and the lack of reports of the development of resistance to iodine, there currently are insufficient data on which to base a concern about the development of resistance to povidone-iodine. Consequently, additional data on the development of antimicrobial resistance to povidone-iodine are not needed to make a GRAS determination.

    5. Triclocarban

    In the 2013 Consumer Wash PR, FDA proposed to classify triclocarban as Category III for safety and efficacy (78 FR 76444 at 76449). FDA determined that the administrative record for the safety of triclocarban was incomplete with respect to the following:

    • Human pharmacokinetic studies under the maximal use conditions when applied topically, including documentation of validation of the methods used to measure triclocarban and its metabolites • Animal pharmacokinetic studies on ADME • Data to help define the effect of formulation on dermal absorption • Dermal carcinogenicity • Developmental and reproductive toxicity data • Potential hormonal effects • Data from laboratory studies that assess the potential for the development of resistance to triclocarban and cross-resistance to antibiotics in the types of organisms listed in section VII.C.3 of the 2013 Consumer Wash PR (78 FR 76444 at 76456 to 76462)

    (Comment 28) One comment referenced a DART study conducted by Monsanto in 1979. The study was summarized in a triclocarban data set compiled in 2002 by the Triclocarban (TCC) Consortium and the Soap and Detergent Association. The comment requested that FDA evaluate the results of the study to fill the DART safety gap for triclocarban.

    (Response 28) The TCC Consortium Report was retrieved from the Environmental Protection Agency (EPA) High Production Volume Information System Web site. We were unable to locate the 1979 Monsanto study in the docket and it does not appear to be available in the public domain. Thus, we cannot review this study for purposes of this final rule. The data cited in the TCC Consortium data set are proprietary and are publicly available only in the form of a summary (Ref. 63). In addition, the submitted safety assessments with the study summaries do not constitute an adequate record on which to base a GRAS classification (§ 330.10(a)(4)(i)). For FDA to evaluate the safety of triclocarban for this rulemaking, there must be published studies or publicly available data with sufficient details that enable an independent review of such data.

    (Comment 29) One comment also stated that triclocarban was nominated to the NTP for toxicological evaluation in 2014, and based on this nomination, a Research Concept has been adopted by NTP (Ref. 64). The comment asserted that the author of the Triclocarban Research Concept only discussed FDA's proposal in regard to human absorption studies even though it identified several data gaps that were identified by FDA, including ADME and DART studies. The comment concluded that FDA should coordinate its efforts with those of the NTP to ensure that experiments on the toxicological testing of triclocarban are not being duplicated.

    (Response 29) We concur with the comment that FDA should coordinate efforts with NTP. NTP through collaboration with FDA regularly meets with FDA scientists to coordinate research efforts and eliminate duplicative work whenever possible. Although this ongoing study may provide important information on triclocarban, there are still other missing data gaps for triclocarban for which information has not been submitted and no interested parties have committed to filling these data gaps. Accordingly, deferring consideration of this active ingredient until the study is completed is unwarranted.

    In conclusion, we find that the safety data gap for DART for triclocarban has not been adequately addressed. No new data for triclocarban were submitted to the docket to fill other safety data gaps identified in the 2013 Consumer Wash PR. In addition, as discussed in section IV, no new data were submitted to the docket to demonstrate the effectiveness of the active ingredients subject to this final rule, including triclocarban, for use as a consumer antiseptic wash product. Therefore, triclocarban is not considered GRAS/GRAE for use in consumer antiseptic wash products.

    6. Triclosan

    In the 2013 Consumer Wash PR, the Agency found that the administrative record for triclosan was incomplete with respect to several safety data and requested that additional information be submitted for the following safety gaps (76 FR 76444 at 76467 to 76470):

    • Animal ADME • Dermal carcinogenicity • Data regarding the potential for formation of photodegradation products on human skin and their effects on the skin • Potential hormonal effects • Data to clarify the relevance of antimicrobial resistance laboratory findings to the consumer setting

    (Comment 30) In response to the 2013 Consumer Wash PR, several comments were submitted regarding the safety data gaps for triclosan. One comment argued that recent and existing studies on triclosan in each of the safety categories prove that the existing studies, including additional studies that were not cited in the 2013 Consumer Wash PR, are adequate to classify triclosan as GRAS.

    (Response 30) FDA has conducted a thorough review of all existing and new data that have been submitted to the docket for this rulemaking, including recent studies, as well as opinion papers published by other regulatory agencies regarding the safety of triclosan. In some cases, we identified new data that have been published since the 2013 Consumer Wash PR—for example, the new animal ADME dermal data discussed in the following section. In other cases, no new data having an impact on the safety profile of triclosan were identified—for example, we found that certain references submitted in one of the comments did not provide additional information that would have an impact on the safety assessment of triclosan (Refs. 65 through 67). In sum, the total available data regarding the safety profile of triclosan does not contain sufficient information to determine that triclosan is GRAS for use in consumer antiseptic wash products.

    In the following sections, we discuss comments addressing the specific safety data gaps for triclosan.

    a. Absorption, Distribution, Metabolism, and Excretion (ADME) Data

    The 2013 Consumer Wash PR discussed in detail the animal ADME data available for triclosan (78 FR 76444 at 76467) and the data that were still lacking. FDA requested that additional ADME data be submitted to allow bridging of animal data to human exposure.

    (Comment 31) Several comments were submitted regarding animal ADME data for triclosan. Some of the comments asserted that oral absorption, metabolism, and excretion are comparable between hamsters and humans, justifying data extrapolation. They also asserted that oral absorption data are complete in all species tested and that metabolism is similar for both dermal and oral exposure. In addition, some of the comments urged FDA to evaluate key toxicokinetic studies in hamsters, mice, and rats that have been submitted as part of the European Union's Registration, Evaluation, Authorisation, and Restriction of Chemicals registration, as well as evaluate other referenced publications of regulatory agencies.

    (Response 31) We agree that there are a number of similarities in pharmacokinetic parameters between humans and hamsters; however, the hamster data available do not include dermal ADME data that can be compared to the metabolic profile in humans following dermal exposure to triclosan.

    We have reviewed data that were submitted to the docket for this rulemaking, including recent studies that were published after the 2013 Consumer Wash PR, as well as opinion papers published by other regulatory agencies regarding the safety of triclosan (Ref. 68). With the exception of one study that we have identified that provided new animal dermal ADME data, there were no additional ADME data for triclosan that were submitted to the docket. The ADME study that was identified has been recently published by National Center for Toxicology Research (NCTR) scientists (Ref. 68) where a 13-week dermal-dose range-finding toxicity study was conducted to determine the ADME profile of triclosan after dermal exposure in mice. Based on a previous dermal toxicity study in the mouse where a no observed adverse effect level of 12.5 milligram (mg)/kilogram (kg) of body weight (bw)/day was shown, doses of 10 and 100 mg/kg bw triclosan were used. In this study, mice of both sexes were exposed to topical application of [14C(U)]triclosan (10 or 100 mg triclosan/kg body weight) in 95 percent ethanol up to 72 hours post exposure. Treated mice were covered with Elizabethan collars to prevent inadvertent oral ingestion of triclosan. As a comparator group, mice of both sexes were dosed with 100 mg/kg bw where Elizabethan collars were not placed on their necks to determine the extent of oral ingestion because of the normal grooming behavior in mice. The study reported a dose-dependent increase in absorption was noted when comparing the 10 mg/kg bw to the 100 mg/kg bw. The study also reported that distribution of radiolabeled [14C(U)]triclosan was evaluated to determine distribution up to 72 hours after dosing in the plasma and liver. The earliest radioactivity measureable was seen as early as 30 minutes post dosing, while maximum distribution was reached at approximately 8 to 12 hours after dosing for both plasma and liver. The major metabolite detected in the plasma and liver was triclosan sulfate, whereas the minor metabolite was triclosan glucuronide. Maximum levels occurred 12 to 24 hours after dosing, and the excretion half-life (t1/2E) ranged from 9.3 to 23.1 hours. The study also reported that the majority of the excretion monitored over 72 hours occurred via the feces in both sexes and that fecal excretion of the absorbed triclosan was ~2.5 to 6-fold greater than urinary excretion.

    The data obtained from this study can be used to extrapolate a safety margin for humans following chronic dermal exposure once the dermal carcinogenicity study in the mouse, which is currently ongoing at the NCTR, is completed. No further data is needed for the animal ADME for triclosan.

    b. Photodegradation and Phototoxicity

    (Comment 32) Several comments were submitted regarding the phototoxicity of triclosan. One comment explained that a study is currently ongoing at the NTP in response to the data gap on dermal photocarcinogenicity from dioxins formed by light-induced degradation of triclosan. The comments urged FDA to await the results of this study before any further studies are conducted. Two other comments argued that concern about triclosan dermal photolysis to “dioxins” is unfounded, and that the most likely photolysis product, 2, 8-dichlorbenzodioxin is toxicologically inert based on the toxicology equivalency factor (TEF) concept (which compares the toxicity of known members for a given chemical family and attributes a specific TEF for each compound compared to the most toxic chemical of that family).

    (Response 32) We note that the comments did not provide any further justification or calculation of the TEF for the photolysis product, 2, 8-dichlorbenzodioxin, to support the claim that FDA's concern about triclosan dermal photolysis to “dioxins” is unfounded. Instead, an assumption was made that 2, 8-dichlorbenzodioxin is toxicologically inert based on the TEF concept. The TEF concept refers only to adverse effects (e.g., cancer) following interactions with their targets (e.g., cellular aryl hydrocarbon receptors). Other toxic effects of dioxins and dioxin-like compounds are not quantified by this method. In addition, TEF values vary for different animal species. Therefore, the ability of triclosan degradants, which belong to the dioxin family, to form photodegradation products on human skin cannot be assessed using the TEF concept. Furthermore, it is currently unknown whether the photoactivity of triclosan is caused by one of the photoproducts or caused by the interaction of triclosan itself with ultraviolet (UV) light.

    (Comment 33) Another comment stated that triclosan has been found to degrade into four different byproducts under certain conditions: 2, 7-dibenzodichloro-p-dioxin; 2, 8-dibenzodichloro-p-dioxin; 2, 4-dichlorophenol (DCP); and 2, 4, 6- trichlorophenol (TCP). In the presence of UV light (sunlight), triclosan has been shown to degrade into two dioxins: 2, 7-dibenzodichloro-p-dioxin; and 2, 8-dibenzodichloro-p-dioxin. The comment suggested that although the concentrations of the degradants are low, dioxin byproducts raise some concern because of their potential to accumulate in the human body because of their lipophilicity. Both 2, 4-DCP and 2, 4, 6-TCP are more stable than triclosan, suggesting that the degradants may have longer half-lives than the parent drug, triclosan.

    (Response 33) Regardless of the causative chemical, it is unknown at this time whether exposure to triclosan under UV light will lead to phototoxicity or photocarcinogenicity events. In conclusion, the comments provided insufficient data and information for assessing the photodegradation of triclosan on human skin. Accordingly, the safety data gap for triclosan regarding the potential for formation of photodegradation products on human skin and their effects on the skin has not been filled.

    c. Dermal Carcinogenicity

    (Comment 34) Several comments were received regarding the dermal carcinogenicity of triclosan. One comment argued that, based on FDA and EPA assessments, oral carcinogenicity studies in hamsters, rats, and mice, supported by negative in vitro and in vivo mutagenicity studies show that triclosan is not a carcinogen. Therefore, the comments argued that the ongoing dermal carcinogenicity study is unnecessary. Another comment stated that dermal carcinogenicity is not supported by existing data, and no chemical having negative mutagenicity and oral carcinogenicity data should be expected to demonstrate dermal carcinogenicity potential.

    (Response 34) We disagree that no dermal carcinogenicity study is needed for triclosan based only on the negative mutagenicity and oral carcinogenicity studies. The requirement for dermal assessment is based on several factors: First, the dose available to the skin tissue resulting from a topically applied drug product can be much higher than that from a dose resulting from systemic exposure. In addition, systemic exposure to the parent drug and metabolites can differ significantly in topically applied products compared to orally administered products because the skin has its own metabolic capability, and the first-pass metabolism, which is available following oral exposure, is bypassed in the topical route of administration. As was explained in the 2013 Consumer Wash PR, we reiterate here that short-term dermal toxicity studies do not meet the chronic duration requirement for a given drug to cause an increase in the carcinogenic potential resulting from a lifelong exposure to a drug, such as triclosan, which is used by consumers from various products over a lifetime. In addition, we note that the 13-week dermal toxicity study showed dose-related dermal adverse effects, which further amplifies the need to evaluate longer term toxicity studies, such as the 2-year dermal carcinogenicity bioassay. A dermal carcinogenicity study is currently ongoing at NCTR but has not been completed at this time. Although this ongoing study may provide important information on triclosan, there are still other missing data gaps for triclosan for which information has not been submitted and no interested parties have committed to filling these data gaps. In sum, no new data or information were submitted to the docket to fill the dermal carcinogenicity safety data gap for triclosan.

    d. Hormonal Effects

    In the 2013 Consumer Wash PR, we stated that recent studies have demonstrated that triclosan showed effects on the thyroid, estrogen, and testosterone systems in several animal species, including mammals, the implications of which on human health, especially for children, are still not well understood (78 FR 76444 at 76468).

    (Comment 35) One comment stated that the Organisation for Economic Co-operation and Development (OECD) TG 443 extended one-generation reproductive toxicity assay provides an alternative to animal studies and includes endocrine-sensitive endpoints. The comment asserted that the OECD TG 443 study design allows for investigation of developmental toxicity, developmental immunotoxicity, or developmental neurotoxicity in the same study, and that non-animal methods, when used in an integrated system, can provide embryotoxicity and teratogenicity information. The comment also referenced several other non-animal assays that were conducted to assess the reproductive toxicity potential for triclosan.

    (Response 35) We reviewed all available data on the hormonal effects of triclosan, including those generated from the extended one-generation reproductive toxicity assay mentioned previously in this document. We also reviewed the previously conducted studies for triclosan (general toxicity and reproductive toxicity) where reproductive toxicity endpoints were evaluated; however, we note that the previously conducted studies were not designed to investigate specific endpoints for evaluating the hormonal effects of triclosan, especially with respect to the thyroid findings. In terms of the alternative animal model argument, it is possible that in some instances that non-animal assays, such as those referenced in comment 35, can be used to explore potential DART findings for a new chemical entity. However, in the case of triclosan, there are many in vivo studies that have assessed DART endpoints, thus making the reliance on findings from the referenced non-animal assays unnecessary.

    (Comment 36) Several other comments asserted that the existing database of in vitro and in vivo animal and human studies does not support a conclusion that triclosan causes hormonal effects in humans at actual relevant exposure concentrations. The comments asserted that the reports of high throughput screening and animal studies showing thyroid or other hormonal activity demonstrated conflicting results for the effects of triclosan on various hormonal endpoints (androgen-, estrogen-, and thyroid-related toxicity). One comment also argued that additional testing for potential hormonal effects is not justified because of the existence of adequate reproductive toxicity data that, given the doses used, endpoints measured and study duration, should have detected a potential for the indication of biologically significant androgen-, estrogen-, or thyroid-related toxicity if such toxicity occurred. The comment maintained that available in vitro high throughput screen information on these endpoints fails to indicate a justifiable level of concern.

    (Response 36) We agree that some data for hormonal effects for triclosan can be gleaned from previously conducted studies (chronic toxicity, DART, and multigenerational studies). Although we concur that the previously conducted toxicology and reproductive studies can be useful, we note that the previously conducted studies were not designed to investigate specific endpoints for evaluating the hormonal effects of triclosan. In particular, the effects of triclosan on the thyroid gland during critical windows of growth and development when subtle functional and/or histopathologic changes are taking place could result in disturbing the normal homeostasis of the organism; for example, whether long-term exposure to triclosan is associated with an adverse impact on the growth or neurobehavioral aspects of animals treated during critical windows of development is currently unknown.

    We have evaluated the recently published articles in the literature reporting on the endocrine effects of triclosan in mammalian species. Data available to date do not provide conclusive evidence regarding the effects of triclosan on the levels of estrogen, androgen, and thyroid hormones and whether a link between the hormonal effects and the biologically relevant outcomes on the tested animal model can be drawn. Although no significant findings were noted for reproductive endpoints, the thyroid gland may be a potential target for triclosan in animals exposed to high doses of triclosan. The reported findings in the thyroid included a dose dependent decrease in the levels of some thyroid hormones in the rat model (T3 & T4) (Ref. 69). This observation was seen in pubertal males and females, in pregnant dams and their pre-weaned exposed pups, as well as in young male and female rats (up to day 53 postpartum age). It is also important to note that the available rat studies for which the thyroid effects were investigated in detail only covered a short duration (up to 30 days of exposure). These changes seen in thyroid hormone levels in the rat do not necessarily predict a similar scenario in humans because of differences in the physiology and metabolic characteristics that triclosan imparts on the hormonal homeostasis in the two species. Based on the available data, a conclusion regarding the significance of the thyroid findings in the rat to that in humans cannot be made. Using a weight-of-evidence approach for the thyroid findings, we find that no further nonclinical data are recommended for the characterization of potential hormonal effects of triclosan in humans. Available in vitro and in vivo animal studies cannot be used to predict a potential human hormonal signal. Clinical studies may be better able to evaluate the effects of triclosan on the endocrine system in humans.

    e. Resistance

    (Comment 37) Comments from a manufacturer of consumer antiseptic products containing triclosan asserted that there is no proof of triclosan resistance or confirmation that triclosan/antibiotic cross-resistance is becoming a problem in the real world. The comment also noted that although bacteria can develop reduced susceptibilities to triclosan in the laboratory, the level of sensitivity is still well below the at-use concentration. However, other comments disagreed and argued that recent studies provide evidence of the development of resistance to triclosan (Refs. 29 and 30).

    (Response 37) We agree that currently there is no evidence of bacterial resistance to actual-use concentrations of triclosan. However, bacterial exposure to triclosan is not limited to actual-use concentrations. In a natural setting, bacteria are exposed to sublethal concentrations of the antiseptic active ingredient that can trigger the expression of bacterial resistance mechanisms. The European Commission's Subcommittee on Consumer Safety noted that there are environmental concentrations of triclosan in a number of geographically distinct areas that were high enough to suggest that this triggering of bacterial resistance could occur (Ref.70). Furthermore, as previously discussed, there are data that document the existence of numerous bacterial resistance mechanisms to triclosan, and there is some expression of these mechanisms in the natural microbial populations. Although the available studies do not prove definitively that triclosan/antibiotic resistance currently poses a public health risk, they do suggest that susceptibility to triclosan may be decreasing. Data are not currently available to assess the magnitude of this risk that triclosan poses for the development of resistance. As we stated in the in the 2013 Consumer Wash PR, data to clarify the relevance of antimicrobial resistance laboratory findings to the consumer setting would be necessary to determine the GRAS status of triclosan.

    f. Other Issues

    (Comment 38) Several comments expressed concern that antiseptic chemicals, including triclosan, are contaminating waterways and aquatic wildlife, and are having a negative impact on the wastewater treatment process and the environment. The comments supported restrictions on the use of triclosan in consumer antiseptic washes and urged FDA and EPA to coordinate their evaluation of chemicals like triclosan to better protect human health and the environment, as well as protect the wastewater treatment process.

    (Response 38) We do not address these comments in this final rule because they are outside the scope of this rulemaking. We note, however, that we have conferred with EPA, wherever there were issues in common between the two Agencies (e.g., some of the animal toxicology studies were independently reviewed by both EPA and FDA), at various stages of the antiseptic proceedings on matters applicable to these rulemakings.

    In sum, the total available data regarding the safety profile of triclosan do not contain sufficient information to find that triclosan is GRAS for use in consumer antiseptic wash products. Moreover, we reviewed studies submitted in the comments to support efficacy for triclosan. These studies are not designed as adequate and well-controlled clinical outcome studies and are not sufficient to determine the GRAE status of triclosan as a topical antiseptic. Moreover, these studies lack an adequate vehicle or placebo controls, which makes it difficult to determine the contribution of antiseptic hand wash implementation to reduction of methicillin-resistance Staphylococcus aureus infections. Thus, we find that insufficient data were submitted to the docket to demonstrate the effectiveness of triclosan for use as a consumer antiseptic wash product. Therefore, triclosan is not GRAS/GRAE for use in consumer antiseptic wash products.

    F. Comments on the Preliminary Regulatory Impact Analysis and FDA Response

    (Comment 39) Several comments raised issues concerning the preliminary regulatory impact analysis and the Agency's assessment of the net benefit of the rulemaking.

    (Response 39) Our response is provided in the full discussion of economic impacts, available in the docket for this rulemaking (Docket No. 1975-N-0012, http://www.regulations.gov) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    IV. Ingredients Not Generally Recognized as Safe and Effective

    In addition to the individual active ingredients discussed in section III.E, no additional safety or effectiveness data have been submitted to support a GRAS/GRAE determination for the remaining consumer antiseptic wash active ingredients. Thus, the following active ingredients are not GRAS/GRAE for use as a consumer antiseptic wash:

    • Cloflucarban • Fluorosalan • Hexachlorophene • Hexylresorcinol • Iodophors (Iodine-containing ingredients) ○ Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) ○ Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) ○ Nonylphenoxypoly (ethyleneoxy) ethanoliodine ○ Poloxamer—iodine complex ○ Povidone-iodine 5 to 10 percent ○ Undecoylium chloride iodine complex • Methylbenzethonium chloride • Phenol (greater than 1.5 percent) • Phenol (less than 1.5 percent) • Secondary amyltricresols • Sodium oxychlorosene • Tribromsalan • Triclocarban • Triclosan • Triple dye

    Accordingly, OTC consumer antiseptic wash drug products containing these active ingredients are misbranded, and are new drugs for which approved new drug applications are required for marketing.

    V. Effective Date

    In the 2013 Consumer Wash PR, we recognized, based on the scope of products subject to this final rule, that manufacturers would need time to comply with this final rule. Thus, as proposed in the 2013 Consumer Wash PR (78 FR 76444 at 76470), this final rule will be effective 1 year after the date of the final rule's publication in the Federal Register. On or after that date, any OTC consumer antiseptic wash drug product containing an ingredient that we have found in this final rule to be not GRAS/GRAE or to be misbranded, cannot be initially introduced or initially delivered for introduction into interstate commerce unless it is the subject of an approved new drug application.

    VI. Economic Analysis of Impacts

    The summary analysis of benefits and costs included in this final rule is drawn from the detailed Regulatory Impact Analysis that is available at http://www.regulations.gov, Docket No. FDA-1975-N-0012 (formerly Docket No. 1975N-0183H).

    A. Introduction

    We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The Office of Management and Budget (OMB) has determined that this final rule is a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because a majority of firms that will be affected by this rule are defined as small businesses, we find that the final rule will have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would result in an expenditure in any year that meets or exceeds this amount.

    B. Summary of Costs and Benefits

    As discussed in the preamble of this final rule, this rule establishes that 19 active ingredients, including triclosan and triclocarban, are not generally recognized as safe and effective and are misbranded for use in OTC consumer antiseptic washes. Regulatory action is being deferred on three active ingredients that were included in the 2013 Consumer Wash PR: Benzalkonium chloride, benzethonium chloride, and chloroxylenol. The costs and benefits of the final rule are summarized in table 3, entitled Economic Data: Costs and Benefits Statement. As table 3 shows, the primary estimated benefits come from reduced exposure to antiseptic active ingredients by 2.2 million pounds per year. We note that triclosan and triclocarban, are the most widely used OTC consumer antiseptic wash active ingredients on the market, based on available data, thus, our analysis focuses on these two products. Using the primary estimates, the combined total consists of a reduction in triclosan exposure by 799,426 pounds per year, and triclocarban exposure by 1.4 million pounds per year. Limitations in the available data characterizing the health effects resulting from widespread long-term exposure to these ingredients prevent us from translating the estimated reduced exposure into monetary equivalents of health effects.

    The primary estimate of costs annualized over 10 years is approximately $23.6 million at a 3 percent discount rate and $27.6 million at a 7 percent discount rate. These costs consist of total one-time costs of relabeling and reformulation ranging from $106.3 to $402.8 million. Under the final rule, we estimate that each pound of reduced exposure to antiseptic active ingredients will cost $12.97 to $14.28 at a 3 percent discount rate and $16.36 to $18.02 at a 7 percent discount rate.

    Table 3—Economic Data: Costs and Benefits Statement Economic Data: Costs and Benefits Statement Category Primary
  • estimate
  • Low
  • estimate
  • High
  • estimate
  • Units Year
  • dollars
  • Discount rate
  • (%)
  • Period covered Notes
    Benefits Annualized Monetized $millions/year
  • 7
  • 3
  • Annual.
  • Annual.
  • Annualized Quantified 2,197,737
  • 2,197,737
  • 989,856
  • 989,856
  • 3,405,619
  • 3,405,619
  • 7
  • 3
  • Annual
  • Annual.
  • Reduced antiseptic active ingredient exposure (in pounds).
    Qualitative Costs Annualized Monetized $millions/year 27.6
  • 23.6
  • 14.1
  • 12.1
  • 53.6
  • 45.8
  • 2014
  • 2014
  • 7
  • 3
  • Annual
  • Annual.
  • Annualized costs of relabeling and reformulation. Range of estimates captures uncertainty.
    Annualized Quantified
  • 7
  • 3
  • Qualitative Transfers Federal Annualized Monetized $millions/year
  • 7
  • 3
  • None. From/To From: To: Other Annualized Monetized $millions/year
  • 7
  • 3
  • From/To From: To: Effects State, Local, or Tribal Government: Not applicable. Small Business Annual cost per affected small entity estimated as $0.11-$0.41 million, which will represent 0.28-1.10 percent of annual shipments. Wages: No estimated effect. Growth: No estimated effect.

    The full analysis of economic impacts is available in the docket for this final rule (Docket No. FDA-1975-N-0012) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.

    VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IX. Federalism

    We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” The sole statutory provision giving preemptive effect to the final rule is section 751 of the FD&C Act (21 U.S.C. 379r). We have complied with all of the applicable requirements under the Executive order and have determined that the preemptive effects of this rule are consistent with Executive Order 13132.

    X. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified all Web site addresses as of the date of this document, but Web sites are subject to change over time.

    1. Transcript of the January 22, 1997, Meeting of the Joint Nonprescription Drugs and Anti-Infective Drugs Advisory Committees, OTC. Available at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4098T1.htm. 2. Comment submitted in Docket No. FDA-1975-N-0012, available at http://www.regulations.gov with Comment No. FDA-1975-N-0012-0081. 3. Transcript of the March 23, 2005, Nonprescription Drugs Advisory Committee. Available at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4184T1.pdf. 4. Transcript of the October 20, 2005, Meeting of the Nonprescription Drugs Advisory Committee 2005. Available at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4184T1.pdf. 5. Summary Minutes of the November 14, 2008, Feedback Meeting with Personal Care Products Council and Soap and Detergent Association, OTC Vol. 230002. Available at https://www.regulations.gov/document?D=FDA-1980-N-0006-0031. 6. Transcript of the September 3, 2014, Meeting of the Nonprescription Drugs Advisory Committee 2014. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM421121.pdf. 7. Part 130-New Drugs, Procedures for Classification of Over-the-Counter Drugs, 37 FR 9464 (1972). Available at https://www.federalregister.gov/agencies/library-of-congress. 8. Luby, S. P., et al., “Effect of Handwashing on Child Health: A Randomised Controlled Trial,” Lancet, 366(9481): p. 321-329, 2005. Available at http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(05)66912-7.pdf. 9. Larson, E. L., et al., “Effect of Antibacterial Home Cleaning and Handwashing Products on Infectious Disease Symptoms: A Randomized, Double-Blind Trial,” Annals of Internal Medicine, 140(5): p. 321-9, 2004. Available at http://annals.org/article.aspx?articleid=717252. 10. Webster, J., J. L. Faoagali, and D. Cartwright, “Elimination of Methicillin-Resistant Staphylococcus aureus from a Neonatal Intensive Care Unit After Hand Washing with Triclosan,” Journal of Paediatrics and Child Health, 30(1): p. 59-64, 1994. Available at http://www.ncbi.nlm.nih.gov/pubmed/8148192. 11. Zafar, A. B., et al., “Use of 0.3% Triclosan (Bacti-Stat) to Eradicate an Outbreak of Methicillin-Resistant Staphylococcus aureus in a Neonatal Nursery,” American Journal of Infection Control, 23(3): p. 200-8, 1995. Available at http://www.ajicjournal.org/article/0196-6553(95)90042-X/pdf. 12. Schaffner, D. W., et al., “Quantitative Microbial Risk Assessment of Antibacterial Hand Hygiene Products on Risk of Shigellosis,” Journal of Food Protection, 77(4): p. 574-82, 2014. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Quantitative+microbial+risk+assessment+of+antibacterial+hand+hygiene+products+on+risk+of+shigellosis. 13. Chen, Y., et al., “Quantification and Variability Analysis of Bacterial Cross-Contamination Rates in Common Food Service Tasks,” Journal of Food Protection, 64(1): p. 72-80, 2001. Available at http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.492.3167&rep=rep1&type=pdf. 14. Chen, Y., et al., “FDA-iRISK—A Comparative Risk Assessment System for Evaluating and Ranking Food-Hazard Pairs: Case Studies on Microbial Hazards,” Journal of Food Protection, 76(3): p. 376-85, 2013. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=FDA-iRISK-a+comparative+risk+assessment+system+for+evaluating+and+ranking+food-hazard+pairs%3A+case+studies+on+microbial+hazards. 15. Ball, R., et al., “Statistical, Epidemiological, and Risk-Assessment Approaches to Evaluating Safety of Vaccines Throughout The Life Cycle at the Food and Drug Administration,” Pediatrics, 127 Suppl 1: p. S31-8, 2011. Available at http://pediatrics.aappublications.org/content/pediatrics/127/Supplement_1/S31.full.pdf. 16. Oggioni, M. R., et al., “Recent Advances in the Potential Interconnection Between Antimicrobial Resistance to Biocides and Antibiotics,” Expert Review of Anti-Infective Therapy, 11(4): p. 363-6, 2013. Available at http://www.ncbi.nlm.nih.gov/pubmed/23566146. 17. Hansen, L. H., et al., “Substrate Specificity of the OqxAB Multidrug Resistance Pump in Escherichia coli and Selected Enteric Bacteria,” Journal of Antimicrobial Chemotherapy, 60(1): p. 145-7, 2007. Available at http://pediatrics.aappublications.org/content/127/Supplement_1/S31. 18. Mavri, A. and S. S. Mozina, “Involvement of Efflux Mechanisms in Biocide Resistance of Campylobacter jejuni and Campylobacter coli,” Journal of Medical Microbiology, 61(Pt. 6): p. 800-8, 2012. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Involvement+of+efflux+mechanisms+in+biocide+resistance+of+Campylobacter+jejuni+and+Campylobacter+coli8. 19. Mavri, A. and S. S. Mozina, “Development of Antimicrobial Resistance in Campylobacter jejuni and Campylobacter coli Adapted to Biocides,” International Journal of Food Microbiology, 160(3): p. 304-12, 2013. Available at http://www.ncbi.nlm.nih.gov/pubmed/23290239. 20. Curiao, T., et al., “Polymorphic Variation in Susceptibility and Metabolism of Triclosan-Resistant Mutants of Escherichia coli and Klebsiella pneumoniae clinical Strains Obtained After Exposure to Biocides and Antibiotics,” Antimicrobial Agents and Chemotherapy, 59(6): p. 3413-23, 2015. Available at http://aac.asm.org/content/59/6/3413.full. 21. Rensch, U., et al., “Salmonella enterica Serovar Typhimurium Multidrug Efflux Pumps EmrAB and AcrEF Support the Major Efflux System AcrAB in Decreased Susceptibility to Triclosan,” International Journal of Antimicrobial Agents, 44(2): p. 179-80, 2014. Available at http://www.ncbi.nlm.nih.gov/pubmed/25059442. 22. Rensch, U., G. Klein, and C. Kehrenberg, “Analysis of Triclosan-Selected Salmonella enterica Mutants of Eight Serovars Revealed Increased Aminoglycoside Susceptibility and Reduced Growth Rates,” PLOS One, 8(10): p. e78310, 2013. Available at http://journals.plos.org/plosone/article/authors?id=10.1371%2Fjournal.pone.0078310. 23. Fernando, D. M., et al., “Triclosan Can Select for an AdeIJK-Overexpressing Mutant of Acinetobacter baumannii ATCC 17978 that Displays Reduced Susceptibility to Multiple Antibiotics,” Antimicrobial Agents and Chemotherapy, 58(11): p. 6424-31, 2014. Available at http://aac.asm.org/content/58/11/6424.full.pdf+html. 24. Grandgirard, D., et al., “Mutations Upstream of fabI in Triclosan Resistant Staphylococcus aureus Strains are Associated with Elevated fabI Gene Expression,” BMC Medical Genomics, 16: p. 345, 2015. Available at http://bmcgenomics.biomedcentral.com/articles/10.1186/s12864-015-1544-y. 25. Buffet-Bataillon, S., et al., “Molecular Mechanisms of Higher MICs of Antibiotics and Quaternary Ammonium Compounds for Escherichia coli Isolated From Bacteraemia,” Journal of Antimicrobial Chemotherapy, 67(12): p. 2837-42, 2012. Available at http://jac.oxfordjournals.org/content/67/12/2837.full.pdf+html. 26. Guo, W., et al., “Resistant Mechanism Study of Benzalkonium Chloride Selected Salmonella Typhimurium Mutants,” Microbial Drug Resistance, 20(1): p. 11-6, 2014. Available at http://online.liebertpub.com/doi/abs/10.1089/mdr.2012.0225. 27. Bore, E., et al., “Adapted Tolerance to Benzalkonium Chloride in Escherichia coli K-12 Studied by Transcriptome and Proteome Analyses,” Microbiology, 153(Pt. 4): p. 935-46, 2007. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Adapted+tolerance+to+benzalkonium+chloride+in+Escherichia+coli+K-12+studied+by+transcriptome+and+proteome+analyse. 28. Morrissey, I., et al., “Evaluation of Epidemiological Cut-Off Values Indicates that Biocide Resistant Subpopulations are Uncommon in Natural Isolates of Clinically-Relevant Microorganisms,” PLOS One, 9(1): p. e86669, 2014. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0086669. 29. Copitch, J. L., R. N. Whitehead, and M. A. Webber, “Prevalence of Decreased Susceptibility to Triclosan in Salmonella enterica Isolates from Animals and Humans and Association with Multiple Drug Resistance,” International Journal of Antimicrobial Agents, 36(3): p. 247-51, 2010. Available at http://www.ncbi.nlm.nih.gov/pubmed/20541914. 30. Skovgaard, S., et al., “Staphylococcus epidermidis Isolated in 1965 Are More Susceptible to Triclosan than Current Isolates,” PLOS One, 8(4): p. e62197, 2013. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0062197. 31. Cole, E. C. et al., “Investigation of Antibiotic and Antibacterial Susceptibility and Resistance in Staphylococcus from the Skin of Users and Non-users of Antibacterial Wash Products in Home Environments,” International Journal of Microbiology Research 3 (2): p 90-96, 2003. Available at http://www.bioinfopublication.org/files/articles/3_2_4_IJMR.pdf. 32. Lear, J. C., “Chloroxylenol- and Triclosan-Tolerant Bacteria from Industrial Sources—Susceptibility to Antibiotics and Other Biocides,” International Biodeterioration and Biodegradation, 2006. Available at http://www.sciencedirect.com/science/article/pii/S096483050500137X. 33. Lear, J. C., et al., “Chloroxylenol- and Triclosan-Tolerant Bacteria from Industrial Sources,” Journal of Industrial Microbiology and Biotechnology, 29(5): p. 238-42, 2002. Available at http://link.springer.com/article/10.1038/sj.jim.7000320#page-1. 34. Aiello, A. E., et al., “Relationship Between Triclosan and Susceptibilities of Bacteria Isolated from Hands in the Community,” Antimicrobial Agents and Chemotherapy, 48(8): p. 2973-9, 2004. Available at http://aac.asm.org/content/48/8/2973.full.pdf+html. 35. Aiello, A. E., et al., “Antibacterial Cleaning Products and Drug Resistance,” Emerging Infectious Diseases, 11(10): p. 1565-70, 2005. Available at http://www.thelancet.com/pdfs/journals/laninf/PIIS1473-3099(03)00723-0.pdf. 36. Cole, E. C., et al., “Investigation of Antibiotic and Antibacterial Agent Cross-Resistance in Target Bacteria From Homes of Antibacterial Product Users and Nonusers,” Journal of Applied Microbiology, 95(4): p. 664-676, 2003. Available at http://www.ncbi.nlm.nih.gov/pubmed/12969278. 37. Marshall, B. M., et al., “The Frequency of Antibiotic-Resistant Bacteria in Homes Differing in Their Use of Surface Antibacterial Agents,” Current Microbiology, 65(4): p. 407-15, 2012. Available at http://www.ncbi.nlm.nih.gov/pubmed/22752336. 38. Carson, R. T., et al., “Use of Antibacterial Consumer Products Containing Quaternary Ammonium Compounds and Drug Resistance in the Community,” Journal of Antimicrobial Chemotherapy, 62(5): p. 1160-2, 2008. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Carson+RT%2C+Larson+E%2C+Levy+SB%2C+Marshall+BM%2C+Aiello+AE. 39. Coelho, J. R., et al., “The Use of Machine Learning Methodologies to Analyse Antibiotic and Biocide Susceptibility in Staphylococcus aureus,” PLOS One, 8(2): p. e55582, 2013. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Coelho+JR%2C+Carri%C3%A7o+JA%2C+Knight+D%2C+Mart%C3%ADnez+JL%2C+Morrissey+I%2C+Oggioni+MR%2C+Freitas+AT. 40. Braoudaki, M. and A. C. Hilton, “Adaptive Resistance to Biocides in Salmonella enterica and Escherichia coli O157 and Cross-Resistance to Antimicrobial Agents,” Journal of Clinical Microbiology, 42(1): p. 73-8, 2004. Available at http://www.ncbi.nlm.nih.gov/pubmed/14715734. 41. Brenwald, N. P. and A. P. Fraise, “Triclosan Resistance in Methicillin-Resistant Staphylococcus aureus (MRSA),” Journal of Hospital Infections, 55(2): p. 141-4, 2003. Available at http://www.ncbi.nlm.nih.gov/pubmed/14529640. 42. Langsrud, S., G. Sundheim, and A. L. Holck, “Cross-Resistance to Antibiotics of Escherichia coli Adapted to Benzalkonium Chloride or Exposed to Stress-Inducers,” Journal of Applied Microbiology, 96(1): p. 201-8, 2004. Available at http://www.ncbi.nlm.nih.gov/pubmed/14678175. 43. Birosova, L. and M. Mikulasova, “Development of Triclosan and Antibiotic Resistance in Salmonella enterica serovar Typhimurium,” Journal of Medical Microbiology, 58(Pt. 4): p. 436-41, 2009. Available at http://www.ncbi.nlm.nih.gov/pubmed/19273638. 44. Joynson, J. A., B. Forbes, and R. J. Lambert, “Adaptive Resistance to Benzalkonium Chloride, Amikacin and Tobramycin: The Effect on Susceptibility to Other Antimicrobials,” Journal of Applied Microbiology, 93(1): p. 96-107, 2002. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Joynson+JA%2C+Forbes+B%2C+Lambert+RJ. 45. International Conference on Harmonization S1B. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S1B/Step4/S1B_Guideline.pdf. 46. Guidance for IndustryS1B Testing for Carcinogenicity of Pharmaceuticals. Available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm074916.pdf. 47. Citizen Petition submitted by Comprehensive Technology Center, FDA Docket No. 1996-P-0205-005, Aug. 9, 1996. Available at https://www.regulations.gov/document?D=FDA-1996-P-0205-0001. 48. “NTP Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol (CAS No. 136-77-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies),” National Toxicology Program Technical Rep Series, 330: p. 1-166, 1988. Available at http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr300399/abstracts/tr330/index.html. 49. Schreier, H., et al., “Molecular Effects of Povidone-Iodine on Relevant Microorganisms: An Electron-Microscopic and Biochemical Study,” Dermatology, 195 Suppl 2: p. 111-6, 1997. Available at http://www.ncbi.nlm.nih.gov/pubmed/9403268. 50. Reimer, K., et al., “Antimicrobial effectiveness of povidone-iodine and consequences for new application areas,” Dermatology, 204 Suppl 1: p. 114-20, 2002. Available at http://www.ncbi.nlm.nih.gov/pubmed/12011534. 51. Durani, P. and D. Leaper, “Povidone-Iodine: Use in Hand Disinfection, Skin Preparation and Antiseptic Irrigation,” International Wound Journal, 5(3): p. 376-87, 2008. Available at http://www.ncbi.nlm.nih.gov/pubmed/18593388. 52. Barabas, E. G. and H. G. Brittain., “Povidone-Iodine in 25 Analytical Profiles and Excipients—Volume 25,” Academic Press, Inc., 25: p. 341-387, 1998. Available at https://books.google.com/books?id=kia7bq8EM9IC&pg=PA341&lpg=PA341&dq=Barabas;+Povidone-Iodine+in+25+Analytical+Profiles+and+Excipients%E2%80%94Volume+25,%E2%80%9D+Academic+Press,+Inc&source=bl&ots=ba5Vqlsbem&sig=z87Vk2drikzKZ9cVuO4ZhAxoZYI&hl=en&sa=X&ved=0ahUKEwiz177BtYfOAhWCGT4KHTQ7BSoQ6AEIHjAA#v=onepage&q=Barabas%3B%20Povidone-Iodine%20in%2025%20Analytical%20Profiles%20and%20Excipients%E2%80%94Volume%2025%2C%E2%80%9D%20Academic%20Press%2C%20Inc&f=false. 53. Michel, D. and G. A. Zach, “Antiseptic Efficacy of Disinfecting Solutions in Suspension Test in vitro Against Methicillin-Resistant Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli in Pressure Sore Wounds After Spinal Cord Injury,” Dermatology, 195 Suppl 2: p. 36-41, 1997. Available at http://www.karger.com/Article/PDF/246028. 54. Block, C., et al., “Evaluation of Chlorhexidine and Povidone Iodine Activity Against Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus faecalis Using a Surface Test,” Journal of Hospital Infections, 46(2): p. 147-52, 2000. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Evaluation+of+chlorhexidine+and+povidone+iodine+activity+against+methicillin-resistant+Staphylococcus+aureus+and+vancomycin-resistant+Enterococcus+faecalis+using+a+surface+test. 55. Block, S. S., “Disinfection, Sterilization, and Preservation,” Philadelphia: Lippincott Williams & Wilkins, 2001. Available at. Available at https://books.google.com/books?id=3f-kPJ17_TYC&printsec=frontcover&dq=Disinfection,+Sterilization,+and+Preservation&hl=en&sa=X&ved=0ahUKEwiNxurX6JHOAhWTix4KHVcKDKcQ6AEIHjAA#v=onepage&q=Disinfection%2C%20Sterilization%2C%20and%20Preservation&f=false. 56. Houang, E. T., et al., “Absence of Bacterial Resistance to Povidone Iodine,” Journal of Clinical Pathology, 29(8): p. 752-5, 1976. Available at http://jcp.bmj.com/content/29/8/752.long. 57. Prince, H. N., et al., “Drug resistance studies with topical antiseptics,” Journal of Pharmaceutical Sciences, 67(11): p. 1629-31, 1978. Available at http://www.ncbi.nlm.nih.gov/pubmed/712607. 58. Panlilio, A. L., et al., “Infections and pseudoinfections due to povidone-iodine solution contaminated with Pseudomonas cepacia,” Clinical Infectious Diseases, 14(5): p. 1078-83, 1992. Available at http://www.jstor.org/stable/4456469?seq=1#page_scan_tab_contents. 59. Jarvis, W. R., “Nosocomial Outbreaks: The Centers for Disease Control's Hospital Infections Program Experience, 1980-1990. Epidemiology Branch, Hospital Infections Program,” American Journal of Medicine, 91(3B): p. 101S-106S, 1991. Available at http://www.ncbi.nlm.nih.gov/pubmed/1656744. 60. Prevention, CDC, “Contaminated Povidone-Iodine Solution—Texas,” in Morbidity and Mortality Weekly Report, p. 133-4, 1989. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00001358.htm. 61. Berkelman, R. L., et al., “Pseudobacteremia Attributed to Contamination of Povidone-Iodine with Pseudomonas cepacia,” Annals of Internal Medicine, 95(1): p. 32-6, 1981. Available at http://annals.org/article.aspx?articleid=694897. 62. Craven, D. E., et al., “Pseudobacteremia Caused by Povidone-Iodine Solution Contaminated with Pseudomonas cepacia,” New England Journal of Medicine, 305(11): p. 621-3, 1981. Available at http://www.nejm.org/doi/full/10.1056/NEJM198109103051106. 63. Triclocarban (TCC) Consortium, Soap and Detergent Association. IUCLID Data Set: Triclocarban. December 12, 2002. Available at http://www.aciscience.org/docs/Triclocarban_HPV_Robust_Study_Summaries.pdf. 64. Sutherland, V., “NTP Research Concept: Triclocarban.” Available at http://ntp.niehs.nih.gov/ntp/about_ntp/bsc/2014/june/triclocarban_concept_508.pdf, 2014. 65. Scientific Committee on Consumer Products (SCCP) opinion on Triclosan COLIPA n° P32. Available at http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_166.pdf. 66. Addendum to the SCCP Opinion on Triclosan. Available at http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_054.pdf. 67. Registered substances. Available at http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances. 68. Fang, J. L., et al., “Absorption and Metabolism of Triclosan After Application to the Skin of B6C3F1 Mice,” Environmental Toxicology, 2014. Avilable at http://www.ncbi.nlm.nih.gov/pubmed/?term=Absorption+and+metabolism+of+triclosan+after+application+to+the+skin+of+B6C3F1+mice. 69. Crofton, K. M., et al., “Short-Term in vivo Exposure to the Water Contaminant Triclosan: Evidence for Disruption of Thyroxine, ” Environmental Toxicology and Pharmacology, 24(2): p. 194-7, 2007. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Short-term+in+vivo+exposure+to+the+water+contaminant+triclosan%3A+Evidence+for+disruption+of+thyroxine. 70. European Commission Scientific Committee on Consumer Safety, Final Opinion on Triclosan (Antimicrobial Resistance), cited March 24, 2016, available at http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm. List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 310 is amended as follows:

    PART 310—NEW DRUGS 1. The authority citation for part 310 is revised to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.

    2. In § 310.545, add paragraphs (a)(27)(iii) and (iv) and (d)(41), and remove from paragraph (d) introductory text the number “(39)” and add in its place the number “(41)” to read as follows:
    § 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

    (a) * * *

    (27) * * *

    (iii) Consumer antiseptic hand wash drug products. Approved as of September 6, 2017.

    Cloflucarban Fluorosalan Hexachlorophene Hexylresorcinol Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) Methylbenzethonium chloride Nonylphenoxypoly (ethyleneoxy) ethanoliodine Phenol (greater than 1.5 percent) Phenol (less than 1.5 percent) Poloxamer iodine complex Povidone-iodine (5 to 10 percent) Secondary amyltricresols Sodium oxychlorosene Tribromsalan Triclocarban Triclosan Triple Dye Undecoylium chloride iodine complex

    (iv) Consumer antiseptic body wash drug products. Approved as of September 6, 2017.

    Cloflucarban Fluorosalan Hexachlorophene Hexylresorcinol Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) Iodine tincture Methylbenzethonium chloride Nonylphenoxypoly (ethyleneoxy) ethanoliodine Phenol (greater than 1.5 percent) Phenol (less than 1.5 percent) Poloxamer iodine complex Povidone-iodine (5 to 10 percent) Secondary amyltricresols Sodium oxychlorosene Tribromsalan Triclocarban Triclosan Triple Dye Undecoylium chloride iodine complex

    (d) * * *

    (41) September 6, 2017, for products subject to paragraph (a)(27)(iii) or (iv) of this section.

    Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21337 Filed 9-2-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-433] Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA into Schedule I AGENCY:

    Drug Enforcement Administration, Department of Justice.

    ACTION:

    Final rule.

    SUMMARY:

    With the issuance of this final rule, the Drug Enforcement Administration places quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA.

    DATES:

    Effective date: September 6, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

    SUPPLEMENTARY INFORMATION:

    Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purposes of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II.

    The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

    Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c) and the current list of scheduled substances is published at 21 CFR part 1308. 21 U.S.C. 812(a).

    Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he * * * finds that such drug or other substance has a potential for abuse, and * * * makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed * * *.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA, 28 CFR 0.100, who in turn has redelegated that authority to the Deputy Administrator of the DEA, 28 CFR part 0, appendix to subpart R.

    The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on her own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS); 1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated by the former Deputy Administrator of the DEA on his own motion and is supported by a recommendation from the Assistant Secretary of the HHS and an evaluation of all other relevant data by the DEA. This action imposes the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles, or proposes to handle, PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA.

    1 As set forth in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. Accordingly, all subsequent references to “Secretary” have been replaced with “Assistant Secretary.”

    Background

    On January 10, 2014, the DEA published a notice of intent to temporarily place quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) into schedule I pursuant to the temporary scheduling provisions of the CSA. 79 FR 1776. On February 10, 2014, the DEA published a final order amending 21 CFR 1308.11(h) to temporarily place these four synthetic cannabinoids into schedule I of the CSA. 79 FR 7577. That final order was effective on the date of publication, and was based on findings by the DEA that the temporary scheduling of these four synthetic cannabinoids was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA requires that the temporary control of these substances expires two years from the effective date of the scheduling order, or on or before February 9, 2016. 21 U.S.C. 811(h)(2). However, the CSA also provides that the temporary scheduling may be extended for up to one year during the pendency of proceedings under 21 U.S.C. 811(a)(1). Id. Accordingly, on February 5, 2016, the DEA extended the temporary scheduling of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA by one year, until February 9, 2017. 81 FR 6175. Also, on February 5, 2016, DEA published a notice of proposed rulemaking (NPRM) to permanently control PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA in schedule I of the CSA. 81 FR 6190.

    DEA and HHS Eight Factor Analyses

    On January 19, 2016, the HHS provided the DEA with four scientific and medical evaluation documents prepared by the FDA entitled “Basis for the recommendation to place 1-pentyl-1H-indole-3-carboxylic acid 8-quinolinyl ester or quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22) and its salts in Schedule 1 of the Controlled Substances Act (CSA);” “Basis for the recommendation to place quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5F-PB-22) and its salts in Schedule 1 of the Controlled Substances Act (CSA);” “Basis for the recommendation to place N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and its salts in Schedule 1 of the Controlled Substances Act (CSA);” and “Basis for the recommendation to place N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) and its salts in Schedule 1 of the Controlled Substances Act (CSA).” After considering the eight factors in 21 U.S.C. 811(c), including consideration of each substance's abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA be controlled in schedule I of the CSA. In response, the DEA conducted its own eight-factor analysis of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA and concluded that these substances warrant control in schedule I of the CSA. Both the DEA and HHS analyses are available in their entirety in the public docket for this rule (Docket Number DEA-433/DEA-2016-0002) at http://www.regulations.gov under “Supporting Documents.”

    Determination To Schedule PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA

    After a review of the available data, including the scientific and medical evaluations and the scheduling recommendations from the HHS, the DEA published an NPRM entitled “Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA into Schedule I,” proposing to control PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA in schedule I of the CSA. 81 FR 6190. The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with the DEA regulations on or before March 7, 2016. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before March 7, 2016.

    Comments Received

    The DEA received three comments on the proposed rule to control PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA in schedule I of the CSA.

    1. Request for Alternate Manufacturing/Packaging of Opiate Pills: One commenter stated that alternate manufacturing and packaging of opiate pills would reduce access to these drugs. The comment was addressed to the FDA.

    DEA Response: PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA are synthetic cannabinoid substances. Opiate pills are not addressed or affected by this rulemaking.

    2. Support for rulemaking: One commenter gave support for the rulemaking stating that the rule was a step in the right direction.

    DEA Response: The DEA appreciates the comment in support of this rulemaking.

    3. Mixed Support and Dissent: One commenter supported in part and dissented in part, suggesting that research into potential medical uses of these substances be conducted prior to scheduling.

    DEA Response: On February 10, 2014, the DEA published a final order amending 21 CFR 1308.11(h) to temporarily place these four synthetic cannabinoids into schedule I of the CSA. 79 FR 7577. That final order was based on findings by the DEA that the temporary scheduling of these four synthetic cannabinoids was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Adverse effects following ingestion of these substances have included: Seizures, neurotoxicity, and death for PB-22; respiratory failure, organ failure, and death for 5F-PB-22; diaphoresis, nausea, confusion, tachycardia, and death for AB-FUBINACA; and anxiety, delirium, psychosis, aggression, and seizures for ADB-PINACA. There is no currently accepted medical use for these four substances in treatment in the United States, and the substances fulfill all requirements for placement into schedule I of the CSA.

    After considering the eight factors in 21 U.S.C. 811(c), including consideration of each substance's abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA be controlled in schedule I of the CSA. In response, the DEA reviewed the scientific and medical evaluations of HHS and all other relevant data on PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA and concurs with the HHS evaluations and findings. The current scientific, medical and other evidence on PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA warrant control of these substances in schedule I of the CSA.

    Scheduling Conclusion

    Based on consideration of all comments, the scientific and medical evaluations and accompanying recommendations of the HHS, and the DEA's consideration of its own eight-factor analyses, the DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA. As such, the DEA is scheduling PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA as controlled substances under the CSA.

    Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analyses and recommendations of the Assistant Secretary for HHS and review of all other available data, the Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:

    (1) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) have a high potential for abuse that is comparable to other schedule I substances such as delta-9-tetrahydrocannabinol (Δ9-THC) and JWH-018;

    (2) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) have no currently accepted medical use in treatment in the United States; and

    (3) There is a lack of accepted safety for use of quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) under medical supervision.

    Based on these findings, the Administrator of the DEA concludes that quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) including their salts, isomers and salts of isomers, including optical, positional and geometric isomers, whenever the existence of such salts, isomers, salts of isomers, optical isomers, positional isomers, and geometric isomers is possible, warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

    Requirements for Handling PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA

    Upon the effective date of this final rule, any person who handles PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA continues 2 to be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research and conduct of instructional activities or chemical analysis, and possession of schedule I controlled substances, including those listed below. These controls will continue on a permanent basis:

    2 PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 81 FR 6175, Feb. 5, 2016.

    1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA, or who desires to handle PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312 as of September 6, 2016. Any person who currently handles PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA and is not registered with the DEA must submit an application for registration and may not continue to handle PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA as of September 6, 2016 unless the DEA has approved that application, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

    2. Disposal of Stocks. PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA must be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws.

    3. Security. PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA continue to be subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 823, and and in accordance with 21 CFR 1301.71-1301.93 as of September 6, 2016.

    4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA must continue to comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302 as of September 6, 2016.

    5. Quota. Only registered manufacturers are permitted to manufacture PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of September 6, 2016.

    6. Inventory. Every DEA registrant whose registration currently authorizes handling of these substances and who possesses any quantity of PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA on the effective date of this final rule is required to continue to maintain an inventory of all stocks of PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

    Any person who becomes registered with the DEA on or after the effective date of the final rule is required to take an initial inventory of all stocks of PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA on hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

    After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA) on hand every two years pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

    7. Records and Reports. Every DEA registrant must maintain records and submit reports pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317 as of September 6, 2016. Manufacturers and distributors must submit reports regarding PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA to the Automation of Reports and Consolidated Order System (ARCOS) pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304 and 1312 as of September 6, 2016.

    8. Order Forms. Every DEA registrant who distributes PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA must continue to comply with the order form requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305, as of September 6, 2016.

    9. Importation and Exportation. All importation and exportation of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA must continue to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312 as of September 6, 2016.

    10. Liability. Any activity involving PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA not authorized by, or in violation of, the CSA or its implementing regulations continues to be unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

    Regulatory Analyses Executive Orders 12866, Regulatory Planning and Review, and 13563, Improving Regulation and Regulatory Review

    In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.

    Executive Order 12988, Civil Justice Reform

    This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

    Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

    Executive Order 13175, Consultation and Coordination With Indian Tribal Governments

    This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects 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.

    Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On February 10, 2014, the DEA published a final order amending 21 CFR 1308.11(h) to temporarily place these four synthetic cannabinoids into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 79 FR 7577. On February 5, 2016, the DEA published a final order extending the temporary placement of these substances in schedule I of the CSA for up to one year pursuant to 21 U.S.C. 811(h)(2). 81 FR 6175. Accordingly, all entities that currently handle or plan to handle these synthetic cannabinoids are estimated to have already established and implemented the systems and processes required to handle PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA. Therefore, the DEA anticipates that this rule will impose minimal or no economic impact on businesses that currently handle PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA for lawful purposes. This estimate applies to entities large and small. Accordingly, the DEA has concluded that this rule will not have a significant effect on a substantial number of small entities.

    Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the “Regulatory Flexibility Act” section above, the DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., that this action will not result in any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of the UMRA of 1995.

    Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    Congressional Review Act

    This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: “an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets.” However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

    List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1308 is amended as follows:

    PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority:

    21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    2. Amend § 1308.11 as follows: a. Add paragraphs (d)(51) through (54); b. Remove paragraphs (h)(4) through (7); c. Redesignate paragraphs (h)(8) through (22) as paragraphs (h)(4) through (18); and d. Redesignate paragraphs (h)(26) and (27) as paragraphs (h)(19) and (20).

    The additions read as follows:

    § 1308.11 Schedule I.

    (d) * * *

    (51) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC) (7222) (52) quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22) (7225) (53) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) (7012) (54) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) (7035)
    Dated: August 30, 2016. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2016-21345 Filed 9-2-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0241] RIN 1625-AA00 Safety Zone; Swim Around Charleston; Charleston, SC AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary moving safety zone during the Swim Around Charleston, a swimming race occurring on the Wando River, the Cooper River, Charleston Harbor, and the Ashley River, in Charleston, South Carolina on September 25, 2016. The temporary safety zone is necessary for the safety of the swimmers, participant vessels, spectators, and the general public during the event. The temporary safety zone will restrict vessel traffic in portions of the Charleston Harbor and surrounding rivers. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Charleston or a designated representative.

    DATES:

    This rule is effective on September 25, 2016 from 8:45 a.m. until 3:45 p.m.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov type USCG-2016-0241 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 John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone (843) 740-3184, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    On March 17, 2016, Kathleen Wilson notified the Coast Guard that she will be sponsoring the Swim Around Charleston from 9 a.m. to 3:30 p.m. on September 25, 2016. In response, on June 6, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone, Swim Around Charleston; Charleston, SC. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this special local regulation. During the comment period that ended July 7, 2016, we received no comments.

    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 due to the date of the event. The Coast Guard did not receive any adverse comments during the period outlined in the NPRM with regard to this rule.

    III. Legal Authority and Need for Rule

    The legal basis for this rule is the Coast Guard's Authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; and Department of Homeland Security Delegation No. 0170.1.

    The purpose of the rule is to ensure the safety of the swimmers, participant vessels, spectators, and the general public life during the Swim Around Charleston.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published June 6, 2016. 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 8:45 a.m. to 3:45 p.m. on September 25, 2016. The safety zone will cover a portion of the waters of the Wando River, Cooper River, Charleston Harbor, and Ashley River, in Charleston, South Carolina. Approximately 120 swimmers are anticipated to participate in the race. Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the safety zone 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 protesters.

    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.

    The economic impact of this rule is not significant for the following reasons: (1) The temporary safety zone will be enforced for a total of seven hours; (2) the safety zone will move with the participant vessels so that once the swimmers clear a portion of the waterway, the safety zone will no longer be enforced in that portion of the waterway; (3) although persons and vessels may not enter, transit through, anchor in, or remain within the safety zone without authorization from the Captain of the Port Charleston or a designated representative; they may operate in the surrounding area during the enforcement period; (4) persons and vessels may still enter, transit through, anchor in, or remain within the safety zone if authorized by the Captain of the Port Charleston or a designated representative; and (5) the Coast Guard will provide advance notification of the safety zone to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

    B. Impact on Small Entities

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

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (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, above.

    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 a temporary safety zone. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist and a Categorical Exclusion Determination was completed for 2016. The environmental analysis checklist and Categorical Exclusion Determination are available in the docket folder where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

    33 U.S.C. 1226, 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 160.5; and Department of Homeland Security Delegation No. 0170.1.

    2 . Add § 165.T07-0241 to read as follows:
    § 165.T07-0241 Safety Zone; Swim Around Charleston, Charleston, SC.

    (a) Regulated area. The following regulated area is a moving safety zone: All waters within a 50-yard radius in front of the lead safety vessel preceding the first race participants, 50 yards behind the safety vessel trailing the last race participants, and at all times extend 100 yards on either side of safety vessels. The Swim Around Charleston swimming race consists of a 12 mile course that starts at Remley Point on the Wando River in approximate position 32°48′49″ N., 79°54′27″ W., crosses the main shipping channel of Charleston Harbor, and finishes at the General William B. Westmoreland Bridge on the Ashley River in approximate position 32°50′14″ N., 80°01′23″ W. All coordinates are 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 Charleston in the enforcement of the regulated areas.

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

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

    (d) Effective date. This rule will is effective on September 25, 2016 and will be enforced from 8:45 a.m. until 3:45 p.m.

    B.D. Falk, Commander, U.S. Coast Guard, Acting Captain of the Port Charleston.
    [FR Doc. 2016-21272 Filed 9-2-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-HQ-OAR-2012-0918; FRL-9951-91-OAR] Air Quality Designations for the 2012 Primary Annual Fine Particle (PM2.5) National Ambient Air Quality Standard (NAAQS) for Areas in Georgia and Florida AGENCY:

    Environmental Protection Agency.

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is establishing air quality designations in the United States (U.S.) for the 2012 primary annual fine particle (PM2.5) National Ambient Air Quality Standard (NAAQS) for three areas in Georgia and 62 counties in Florida. When the EPA designated the majority of areas in the country in December 2014, and March 2015, the EPA deferred initial area designations for several locations, including these areas, because the EPA could not determine using available data whether the areas were meeting or not meeting the NAAQS, but we believed that forthcoming data in 2015 would allow the EPA to make that determination. Georgia and Florida have recently submitted complete, quality-assured, and certified air quality monitoring data for 2015 for the areas identified in this notice, and based on these data, the EPA is designating these areas as unclassifiable/attainment for the 2012 primary annual PM2.5 NAAQS.

    DATES:

    This final rule is effective on October 6, 2016.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2012-0918. All documents in the docket are listed in the http://www.regulations.gov Web site. Although listed in the index, some information is not 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 in http://www.regulations.gov.

    In addition, the EPA has established a Web site for the rulemakings to initially designate areas for the 2012 primary annual PM2.5 NAAQS at: https://www3.epa.gov/pmdesignations/2012standards/index.htm. This Web site includes the EPA's final area designations for the PM2.5 NAAQS, as well as state and tribal initial recommendation letters, the EPA's modification letters, technical support documents, responses to comments and other related technical information.

    FOR FURTHER INFORMATION CONTACT:

    For general questions concerning this action, please contact Carla Oldham, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Planning Division, C539-04, Research Triangle Park, North Carolina 27711, telephone (919) 541-3347, email at [email protected]. The Region 4 contact is Madolyn Sanchez, U.S. EPA, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960, telephone (404) 562-9644, email at [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    On December 14, 2012, the EPA promulgated a revised primary annual PM2.5 NAAQS to provide increased protection of public health from fine particle pollution (78 FR 3086; January 15, 2013). In that action, the EPA strengthened the primary annual PM2.5 standard from 15.0 micrograms per cubic meter (μg/m3) to 12.0 μg/m3, which is attained when the 3-year average of the annual arithmetic means does not exceed 12.0 μg/m3.

    Section 107(d) of the Clean Air Act (CAA), 42 U.S.C. 7407(d), governs the process for initial area designations after the EPA establishes a new or revised NAAQS. Under CAA section 107(d), each governor is required to, and each tribal leader may, if they so choose, recommend air quality designations, including the appropriate boundaries for “nonattainment” areas, to the EPA by a date which cannot be later than 1 year after the promulgation of a new or revised NAAQS. The EPA considers these recommendations as part of its duty to promulgate the area designations and boundaries for the new or revised NAAQS. If, after careful consideration of these recommendations, the EPA believes that it is necessary to modify a state's recommendation and intends to promulgate a designation different from a state's recommendation, the EPA must notify the state at least 120 days prior to promulgating the final designation and the EPA must provide the state an opportunity to demonstrate why any proposed modification is inappropriate. These modifications may relate either to an area's designation or boundaries.

    On December 18, 2014, the Administrator of the EPA signed a final action promulgating initial designations for the 2012 PM2.5 NAAQS for the majority of the U.S., including areas of Indian country (80 FR 2206 FR; January 15, 2015). That action designated 14 areas in six states, including two multi-state areas, as nonattainment for the 2012 PM2.5 NAAQS. The EPA also designated three areas, including the entire state of Illinois, as “unclassifiable” because the ambient air quality monitoring sites in these areas lacked complete data for the relevant period from 2011-2013. In the absence of complete monitoring data, the EPA could not determine, based on available information, whether these areas meet or do not meet the NAAQS, and also could not determine whether these areas contribute to a nearby violation. Consistent with the EPA's “Policy for Establishing Separate Air Quality Designations for Areas of Indian Country” (December 20, 2011), the EPA designated the lands of the Pechanga Band of Luiseño Mission Indians in Southern California as an unclassifiable/attainment area separate from its adjacent/surrounding state areas. Except for the 10 areas discussed in the next paragraph, the EPA designated all the remaining state areas and areas of Indian country as unclassifiable/attainment.

    The EPA deferred initial area designations for 10 areas where available data, including air quality monitoring data, were insufficient to determine whether the areas met or did not meet the NAAQS, but where forthcoming data were likely to result in complete and valid air quality data sufficient to determine whether these areas meet the NAAQS. Accordingly, the EPA stated that it would use the additional time available as provided under section 107(d)(1)(B) of the CAA to assess relevant information and subsequently promulgate initial designations for the identified areas through a separate rulemaking action or actions. The 10 deferred areas included: Eight areas in the state of Georgia, including two neighboring counties in the bordering states of Alabama and South Carolina; the entire state of Tennessee, excluding three counties in the Chattanooga area; the entire state of Florida; and areas of Indian country located in these areas.

    In the action published on January 15, 2015, the EPA also described a process by which we would evaluate any complete, quality-assured, certified air quality monitoring data from 2014 that a state submitted for consideration before February 27, 2015 (80 FR 2209). The EPA stated that it would evaluate whether, with the inclusion of certified 2014 data, the 3-year design value for 2012-2014 suggests that a change in the initial designation would be appropriate for an area. If the EPA agreed that a change in the initial designation would be appropriate, the EPA would withdraw the designation announced in the January 15, 2015, action for such area before the effective date and issue another designation reflecting the inclusion of 2014 data (80 FR 2209).

    In the follow-up designation action, published on April 15, 2015 (80 FR 18535), the EPA designated five areas in the state of Georgia, including two neighboring counties in the bordering states of Alabama and South Carolina, that were initially deferred in the EPA's January 15, 2015, rulemaking. In the same action, the EPA changed the designation of one area in Ohio, two areas in Pennsylvania, one area shared between Indiana and Kentucky, and one area shared between Kentucky and Ohio. Following that action, designations remained deferred for three areas (covering 14 counties) in Georgia, the entire state of Tennessee (covering 92 counties, excluding three counties in the Chattanooga area), the entire state of Florida (covering 67 counties), and areas of Indian country located in those areas.

    II. Purpose and Designation Decisions Based on 2013-2015 Data

    The purpose of this action is to announce and promulgate initial area designations of unclassifiable/attainment for the 2012 PM2.5 NAAQS for three areas in Georgia,1 62 counties in Florida, and Indian country located at least partially in these areas. All of these areas were initially deferred in the EPA's January 15, 2015, rulemaking.2 Since then, the states of Georgia and Florida submitted to the EPA complete, quality-assured, and certified air quality monitoring data from 2013-2015 for these deferred areas. These data provide the EPA with sufficient information to promulgate initial designations for the three areas in Georgia, 62 counties in Florida, and the associated areas of Indian country at issue in this action. Air quality data collected and submitted to the EPA for 2013-2015 for these areas indicate that the areas are attaining the 2012 PM2.5 NAAQS and are not causing or contributing to a violation of the NAAQS in a nearby area. Therefore, the EPA is designating the three areas in Georgia as unclassifiable/attainment. Also, consistent with the EPA's practice in prior rounds of initial area designations for the 2012 PM2.5 NAAQS, EPA is designating 62 counties in Florida as unclassifiable/attainment.3 Areas of Indian country located in these areas are also being designated as unclassifiable/attainment. These designations are consistent with Georgia's and Florida's recommended area designations and boundaries for these areas for the 2012 PM2.5 standard. The tables at the end of this final rule (amendments to 40 CFR 81.310—Florida and 40 CFR 81.311—Georgia) list all areas for which the EPA has promulgated an initial designation in each of these two states. Areas of Indian country located in the listed areas are included in the designated area.

    1 The areas in Georgia are Albany (Dougherty County); Atlanta (Bartow, Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Forsyth, Fulton, Gwinnett, Henry, and Paulding Counties); and Brunswick (Glynn County).

    2See also the technical support documents for the deferred Georgia and Florida areas in the rulemaking docket, documents numbered EPA-HQ-OAR-2012-0918-0324 and EPA-HQ-OAR-2012-0918-0156 (Georgia); and EPA-HQ-OAR-2012-0918-0323 and EPA-HQ-2012-0918-0332 (Florida).

    3 The EPA has used a weight-of-evidence evaluation to determine an appropriate designation for counties that are adjacent to areas that remain undesignated. See Docket No. EPA-HQ-OAR-2012-0918-0324, Georgia Deferred Area Memorandum, discussing certain types of counties “most likely to contribute to a violation of the NAAQS”.

    III. Environmental Justice Considerations

    The CAA requires the EPA to determine through a designation process whether an area meets or does not meet any new or revised national primary or secondary ambient air quality standard. This action includes initial designation determinations for several areas of the U.S. for the 2012 annual PM2.5 NAAQS. Area designations ensure that the public is properly informed about the air quality in an area and that, in locations where air quality does not meet the NAAQS, the relevant state authorities are required to initiate appropriate air quality management actions under the CAA to ensure that all those residing, working, attending school or otherwise present in those areas are protected, regardless of minority and economic status.

    IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is exempt from review by the Office of Management and Budget because it responds to the CAA requirement to promulgate air quality designations after promulgation of a new or revised NAAQS.

    B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under the PRA. This action fulfills the non-discretionary duty for the EPA to promulgate air quality designations after promulgation of a new or revised NAAQS and does not contain any information collection activities.

    C. Regulatory Flexibility Act (RFA)

    This designation action under CAA 107(d) is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. Section 107(d)(2)(B) of the CAA explicitly provides that designations are exempt from the notice and comment provisions of the APA. In addition, designations under section 107(d) are not among the list of actions that are subject to the notice and comment procedures of CAA section 307(d).

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect small governments. The action implements mandates specifically and explicitly set forth in the CAA for the 2012 PM2.5 NAAQS (40 CFR 50.18). The CAA establishes the process whereby states take primary responsibility for developing plans to meet the 2012 PM2.5 NAAQS.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have a substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. Areas of Indian country are being designated unclassifiable/attainment as part of this action.

    The EPA offered consultation to tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process to designate areas for the 2012 PM2.5 NAAQS to permit them to have meaningful and timely input. In letters dated May 29, 2014, the EPA encouraged tribes to participate in the designations process, request consultation, and submit recommendations. The EPA again offered the opportunity for consultation in letters sent on August 19, 2014. The Seminole Tribe of Florida, which has areas of Indian country affected by this designation action, did not request consultation, nor did they provide a recommendation for designations. Therefore, the EPA did not initiate the consultation process with the tribe for this designation action.

    G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

    H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on any population, including any minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. The results of this evaluation of environmental justice considerations is contained in Section III of this preamble titled, “Environmental Justice Considerations.”

    K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the U.S. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    L. Judicial Review

    Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the Court of Appeals for the District of Columbia Circuit: (i) When the agency action consists of “nationally applicable regulations promulgated, or final actions taken by the Administrator,” or (ii) when such action is locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”

    This final action designating areas across the U.S. for the 2012 annual PM2.5 NAAQS is “nationally applicable” within the meaning of CAA section 307(b)(1). At the core of this final action is the EPA's interpretations of the definitions of nonattainment, attainment and unclassifiable under section 107(d)(1) of the CAA, and its application of those interpretations to areas across the country. For the same reasons, the Administrator is also determining that the final designations are of nationwide scope and effect for the purposes of CAA section 307(b)(1). This is particularly appropriate because, in the report on the 1977 Amendments that revised section 307(b)(1) of the CAA, Congress noted that the Administrator's determination that an action is of “nationwide scope or effect” would be appropriate for any action that has a scope or effect beyond a single judicial circuit. H.R. Rep. No. 95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03. Here, the scope and effect of this final action extends to numerous judicial circuits since the designations apply to areas across the country. In these circumstances, CAA section 307(b)(1) and its legislative history calls for the Administrator to find the action to be of “nationwide scope or effect” and for venue to be in the D.C. Circuit.

    Thus, any petitions for review of final designations must be filed in the Court of Appeals for the District of Columbia Circuit within 60 days from the date final action is published in the Federal Register.

    List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks, Wilderness areas.

    Dated: August 30, 2016. Gina McCarthy, Administrator.

    For the reasons set forth in the preamble, 40 CFR part 81 is amended as follows:

    PART 81—DESIGNATIONS OF AREAS FOR AIR QUALITY PLANNING PURPOSES 1. The authority citation for part 81 continues to read as follows: Authority:

    42 U.S.C. 7401, et. seq.

    Subpart C—Section 107 Attainment Status Designations 2. Section 81.310 is amended by revising the table entitled “Florida—2012 Annual PM2.5 NAAQS (Primary)” to read as follows:
    § 81.310 Florida. Florida—2012 Annual PM2.5 NAAQS [Primary] Designated area 1 Designation Date 2 Type Classification Date 2 Type Statewide: Alachua County Baker County Unclassifiable/Attainment. Bay County Unclassifiable/Attainment. Bradford County Unclassifiable/Attainment. Brevard County Unclassifiable/Attainment. Broward County Calhoun County Unclassifiable/Attainment. Charlotte County Unclassifiable/Attainment. Citrus County Unclassifiable/Attainment. Clay County Unclassifiable/Attainment. Collier County Unclassifiable/Attainment. Columbia County Unclassifiable/Attainment. DeSoto County Unclassifiable/Attainment. Dixie County Unclassifiable/Attainment. Duval County Unclassifiable/Attainment. Escambia County Unclassifiable/Attainment. Flagler County Unclassifiable/Attainment. Franklin County Unclassifiable/Attainment. Gadsden County Unclassifiable/Attainment. Gilchrist County Glades County Unclassifiable/Attainment. Gulf County Unclassifiable/Attainment. Hamilton County Unclassifiable/Attainment. Hardee County Unclassifiable/Attainment. Hendry County 3 Unclassifiable/Attainment. Hernando County Unclassifiable/Attainment. Highlands County Unclassifiable/Attainment. Hillsborough County Unclassifiable/Attainment. Holmes County Unclassifiable/Attainment. Indian River County Unclassifiable/Attainment. Jackson County Unclassifiable/Attainment. Jefferson County Unclassifiable/Attainment. Lafayette County Unclassifiable/Attainment. Lake County Unclassifiable/Attainment. Lee County Unclassifiable/Attainment. Leon County Unclassifiable/Attainment. Levy County Unclassifiable/Attainment. Liberty County Unclassifiable/Attainment. Madison County Unclassifiable/Attainment. Manatee County Unclassifiable/Attainment. Marion County Unclassifiable/Attainment. Martin County Unclassifiable/Attainment. Miami-Dade County Monroe County Unclassifiable/Attainment. Nassau County Unclassifiable/Attainment. Okaloosa County Unclassifiable/Attainment. Okeechobee County Unclassifiable/Attainment. Orange County Unclassifiable/Attainment. Osceola County Unclassifiable/Attainment. Palm Beach County Pasco County Unclassifiable/Attainment. Pinellas County Unclassifiable/Attainment. Polk County Unclassifiable/Attainment. Putnam County Unclassifiable/Attainment. St. Johns County Unclassifiable/Attainment. St. Lucie County Unclassifiable/Attainment. Santa Rosa County Unclassifiable/Attainment. Sarasota County Unclassifiable/Attainment. Seminole County Unclassifiable/Attainment. Sumter County Unclassifiable/Attainment. Suwanee County Unclassifiable/Attainment. Taylor County Unclassifiable/Attainment. Union County Unclassifiable/Attainment. Volusia County Unclassifiable/Attainment. Wakulla County Unclassifiable/Attainment. Walton County Unclassifiable/Attainment. Washington County Unclassifiable/Attainment. 1 Includes areas of Indian country located in each county or area, except as otherwise specified. 2 This date is October 6, 2016, unless otherwise noted. 3 Includes the Seminole Tribe of Florida Big Cypress Indian Reservation in its entirety.
    3. Section 81.311 is amended by revising the table entitled “Georgia—2012 Annual PM2.5 NAAQS (Primary)” to read as follows:
    § 81.311 Georgia. Georgia—2012 Annual PM2.5 NAAQS [Primary] Designated area 1 Designation Date 2 Type Classification Date 2 Type Statewide: Appling County Unclassifiable/Attainment Atkinson County Unclassifiable/Attainment Bacon County Unclassifiable/Attainment Baker County Unclassifiable/Attainment Baldwin County Unclassifiable/Attainment Banks County Unclassifiable/Attainment Barrow County Unclassifiable/Attainment Bartow County October 6, 2016 Unclassifiable/Attainment Ben Hill County Unclassifiable/Attainment Berrien County Unclassifiable/Attainment Bibb County Unclassifiable/Attainment Bleckley County Unclassifiable/Attainment Brantley County Unclassifiable/Attainment Brooks County Unclassifiable/Attainment Bryan County Unclassifiable/Attainment Bulloch County Unclassifiable/Attainment Burke County Unclassifiable/Attainment Butts County Unclassifiable/Attainment Calhoun County Unclassifiable/Attainment Camden County Unclassifiable/Attainment Candler County Unclassifiable/Attainment Carroll County Unclassifiable/Attainment Catoosa County Unclassifiable/Attainment Charlton County Unclassifiable/Attainment Chatham County Unclassifiable/Attainment Chattahoochee County Unclassifiable/Attainment Chattooga County Unclassifiable/Attainment Cherokee County October 6, 2016 Unclassifiable/Attainment Clarke County Unclassifiable/Attainment Clay County Unclassifiable/Attainment Clayton County October 6, 2016 Unclassifiable/Attainment Clinch County Unclassifiable/Attainment Cobb County October 6, 2016 Unclassifiable/Attainment Coffee County Unclassifiable/Attainment Colquitt County Unclassifiable/Attainment Columbia County Unclassifiable/Attainment Cook County Unclassifiable/Attainment Coweta County October 6, 2016 Unclassifiable/Attainment Crawford County Unclassifiable/Attainment Crisp County Unclassifiable/Attainment Dade County Unclassifiable/Attainment Dawson County Unclassifiable/Attainment Decatur County Unclassifiable/Attainment DeKalb County October 6, 2016 Unclassifiable/Attainment Dodge County Unclassifiable/Attainment Dooly County Unclassifiable/Attainment Dougherty County October 6, 2016 Unclassifiable/Attainment Douglas County October 6, 2016 Unclassifiable/Attainment Early County Unclassifiable/Attainment Echols County Unclassifiable/Attainment Effingham County Unclassifiable/Attainment Elbert County Unclassifiable/Attainment Emanuel County Unclassifiable/Attainment Evans County Unclassifiable/Attainment Fannin County Unclassifiable/Attainment Fayette County Unclassifiable/Attainment Floyd County Unclassifiable/Attainment Forsyth County October 6, 2016 Unclassifiable/Attainment Franklin County Unclassifiable/Attainment Fulton County October 6, 2016 Unclassifiable/Attainment Gilmer County Unclassifiable/Attainment Glascock County Unclassifiable/Attainment Glynn County October 6, 2016 Unclassifiable/Attainment Gordon County Unclassifiable/Attainment Grady County Unclassifiable/Attainment Greene County Gwinnett County October 6, 2016 Unclassifiable/Attainment Habersham County Unclassifiable/Attainment Hall County Unclassifiable/Attainment Hancock County Unclassifiable/Attainment Haralson County Unclassifiable/Attainment Harris County Unclassifiable/Attainment Hart County Unclassifiable/Attainment Heard County Unclassifiable/Attainment Henry County October 6, 2016 Unclassifiable/Attainment Houston County Unclassifiable/Attainment Irwin County Unclassifiable/Attainment Jackson County Unclassifiable/Attainment Jasper County Unclassifiable/Attainment Jeff Davis County Unclassifiable/Attainment Jefferson County Unclassifiable/Attainment Jenkins County Unclassifiable/Attainment Johnson County Unclassifiable/Attainment Jones County Unclassifiable/Attainment Lamar County Unclassifiable/Attainment Lanier County Unclassifiable/Attainment Laurens County Unclassifiable/Attainment Lee County Unclassifiable/Attainment Liberty County Unclassifiable/Attainment Lincoln County Unclassifiable/Attainment Long County Unclassifiable/Attainment Lowndes County Unclassifiable/Attainment Lumpkin County Unclassifiable/Attainment McDuffie County Unclassifiable/Attainment McIntosh County Unclassifiable/Attainment Macon County Unclassifiable/Attainment Madison County Unclassifiable/Attainment Marion County Unclassifiable/Attainment Meriwether County Unclassifiable/Attainment Miller County Unclassifiable/Attainment Mitchell County Unclassifiable/Attainment Monroe County Unclassifiable/Attainment Montgomery County Unclassifiable/Attainment Morgan County Unclassifiable/Attainment Murray County Unclassifiable/Attainment Muscogee County Unclassifiable/Attainment Newton County Unclassifiable/Attainment Oconee County Unclassifiable/Attainment Oglethorpe County Unclassifiable/Attainment Paulding County October 6, 2016 Unclassifiable/Attainment Peach County Unclassifiable/Attainment Pickens County Unclassifiable/Attainment Pierce County Unclassifiable/Attainment Pike County Unclassifiable/Attainment Polk County Unclassifiable/Attainment Pulaski County Unclassifiable/Attainment Putnam County Unclassifiable/Attainment Quitman County Unclassifiable/Attainment Rabun County Unclassifiable/Attainment Randolph County Unclassifiable/Attainment Richmond County Unclassifiable/Attainment Rockdale County Unclassifiable/Attainment Schley County Unclassifiable/Attainment Screven County Unclassifiable/Attainment Seminole County Unclassifiable/Attainment Spalding County Unclassifiable/Attainment Stephens County Unclassifiable/Attainment Stewart County Unclassifiable/Attainment Sumter County Unclassifiable/Attainment Talbot County Unclassifiable/Attainment Taliaferro County Unclassifiable/Attainment Tattnall County Unclassifiable/Attainment Taylor County Unclassifiable/Attainment Telfair County Unclassifiable/Attainment Terrell County Unclassifiable/Attainment Thomas County Unclassifiable/Attainment Tift County Unclassifiable/Attainment Toombs County Unclassifiable/Attainment Towns County Unclassifiable/Attainment Treutlen County Unclassifiable/Attainment Troup County Unclassifiable/Attainment Turner County Unclassifiable/Attainment Twiggs County Unclassifiable/Attainment Union County Unclassifiable/Attainment Upson County Unclassifiable/Attainment Walker County Unclassifiable/Attainment Walton County Unclassifiable/Attainment Ware County Unclassifiable/Attainment Warren County Unclassifiable/Attainment Washington County Unclassifiable/Attainment Wayne County Unclassifiable/Attainment Webster County Unclassifiable/Attainment Wheeler County Unclassifiable/Attainment White County Unclassifiable/Attainment Whitfield County Unclassifiable/Attainment Wilcox County Unclassifiable/Attainment Wilkes County Unclassifiable/Attainment Wilkinson County Unclassifiable/Attainment Worth County Unclassifiable/Attainment 1 Includes areas of Indian country located in each county or area, except as otherwise specified. 2 This date is April 15, 2015, unless otherwise noted.
    [FR Doc. 2016-21338 Filed 9-2-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150818742-6210-02] RIN 0648-XE854 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher/Processors Using Trawl Gear in the Central Regulatory Area of the Gulf of Alaska AGENCY:

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

    ACTION:

    Temporary rule; modification of a closure.

    SUMMARY:

    NMFS is opening directed fishing for Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to fully use the 2016 total allowable catch apportioned to catcher/processors using trawl gear in the Central Regulatory Area of the GOA.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), September 1, 2016, through 2400 hours, A.l.t., December 31, 2016. Comments must be received at the following address no later than 4:30 p.m., A.l.t., September 21, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2015-0110, 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-2015-0110, 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). Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF file formats only.

    FOR FURTHER INFORMATION CONTACT:

    Obren Davis, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    NMFS closed directed fishing for Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA under § 679.20(d)(1)(iii) on January 1, 2016 pursuant to the final 2016 and 2017 harvest specifications for groundfish of the Gulf of Alaska (81 FR 14740, March 18, 2016).

    NMFS has determined that as of August 30, 2016, approximately 1,171 metric tons of Pacific cod remain in the 2016 Pacific cod apportionment for catcher/processors using trawl gear in the Central Regulatory Area of the GOA. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully use the 2016 total allowable catch (TAC) of Pacific cod in the Central Regulatory Area of the GOA, NMFS is terminating the previous closure and is opening directed fishing for Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA. The Administrator, Alaska Region, NMFS, (Regional Administrator) considered the following factors in reaching this decision: (1) The current catch of Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels in participating in this fishery.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of directed fishing for Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 30, 2016.

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

    Without this inseason adjustment, NMFS could not allow the fishery for Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until September 21, 2016.

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 31, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-21316 Filed 8-31-16; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150916863-6211-02] RIN 0648-XE851 Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; reallocation.

    SUMMARY:

    NMFS is reallocating the projected unused amounts of Pacific cod from American Fisheries Act (AFA) trawl catcher/processors (C/Ps) to Amendment 80 C/Ps in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2016 total allowable catch of Pacific cod to be harvested.

    DATES:

    Effective August 31, 2016, through 2400 hrs., Alaska local time (A.l.t.), December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    The 2016 Pacific cod total allowable catch (TAC) specified for AFA trawl C/Ps in the BSAI is 5,166 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016). The Regional Administrator has determined that AFA trawl C/Ps will not be able to harvest 500 mt of the remaining 2016 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(7). Therefore, in accordance with § 679.20(a)(7)(iii)(A) and § 679.20(a)(7)(iii)(B), NMFS reallocates 500 mt of Pacific cod to Amendment 80 C/Ps in the Bering Sea and Aleutian Islands management area.

    The harvest specifications for Pacific cod included in the final 2016 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) are revised as follows: 4,666 mt to AFA trawl C/Ps and 30,597 mt to Amendment 80 C/Ps.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Pacific cod specified from AFA trawl C/Ps to Amendment 80 C/Ps in the Bering Sea and Aleutian Islands management area. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 26, 2016.

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

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 31, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-21315 Filed 8-31-16; 4:15 pm] BILLING CODE 3510-22-P
    81 172 Tuesday, September 6, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Office of the Secretary 14 CFR Part 382 [Docket No. DOT-OST-2015-0246] RIN 2105-AE12 Nondiscrimination on the Basis of Disability in Air Travel: Negotiated Rulemaking Committee Fifth Meeting AGENCY:

    Office of the Secretary, Department of Transportation.

    ACTION:

    Notice of fifth public meeting of advisory committee.

    SUMMARY:

    This notice announces the fifth meeting of the Advisory Committee on Accessible Air Transportation (ACCESS Advisory Committee).

    DATES:

    The fifth meeting of the ACCESS Advisory Committee will be held on September 21-23, from 9:00 a.m. to 5:00 p.m., Eastern Daylight Time.

    ADDRESSES:

    The meeting will be held at the Ritz Carlton, Pentagon City, 1250 Hayes Street, Arlington, VA 22202. Attendance is open to the public up to the room's capacity of 150 attendees. Since space is limited, any member of the general public who plans to attend this meeting must notify the registration contact identified below no later than September 14, 2016.

    FOR FURTHER INFORMATION CONTACT:

    To register to attend the meeting, please contact Kyle Ilgenfritz ([email protected]; 703-442-4575 extension 128). For other information, please contact Livaughn Chapman or Vinh Nguyen, Office of the Aviation Enforcement and Proceedings, U.S. Department of Transportation, by email at [email protected] or [email protected] or by telephone at 202-366-9342.

    SUPPLEMENTARY INFORMATION:

    I. Fifth Public Meeting of the ACCESS Committee

    The fifth meeting of the ACCESS Advisory Committee will be held on September 21-23, 2016, from 9:00 a.m. to 5:00 p.m., Eastern Daylight Time. The meeting will be held at the Ritz Carlton, Pentagon City, 1250 Hayes Street, Arlington, VA 22202. At the meeting, the ACCESS Advisory Committee will continue to address whether to require accessible inflight entertainment (IFE) and strengthen accessibility requirements for other in-flight communications, whether to require an accessible lavatory on new single-aisle aircraft over a certain size, and whether to amend the definition of “service animals” that may accompany passengers with a disability on a flight. We expect to negotiate on proposals to amend the Department's disability regulation regarding one or more of these issues. Prior to the meeting, the agenda will be available on the ACCESS Advisory Committee's Web site, www.transportation.gov/access-advisory-committee. Information on how to access advisory committee documents via the FDMC is contained in Section III, below.

    The meeting will be open to the public. Attendance will be limited by the size of the meeting room (maximum 150 attendees). Because space is limited, we ask that any member of the public who plans to attend the meeting notify the registration contact, Kyle Ilgenfritz ([email protected]; 703-442-4575 extension 128) at Linkvisum, no later than September 14, 2016. At the discretion of the facilitator and the Committee and time permitting, members of the public are invited to contribute to the discussion and provide oral comments.

    II. Submitting Written Comments

    Members of the public may submit written comments on the topics to be considered during the meeting by September 15, 2016, to FDMC, Docket Number DOT-OST-2015-0246. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. DOT recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that DOT can contact you if there are questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov, put the docket number, DOT-OST-2015-0246, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing.

    III. Viewing Comments and Documents

    To view comments and any documents mentioned in this preamble as being available in the docket, go to www.regulations.gov. Enter the docket number, DOT-OST-2015-0246, in the keyword box, and click “Search.” Next, click the link to “Open Docket Folder” and choose the document to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays.

    IV. ACCESS Advisory Committee Charter

    The ACCESS Advisory Committee is established by charter in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2. Secretary of Transportation Anthony Foxx approved the ACCESS Advisory Committee charter on April 6, 2016. The committee's charter sets forth policies for the operation of the advisory committee and is available on the Department's Web site at www.transportation.gov/office-general-counsel/negotiated-regulations/charter.

    V. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

    VI. Future Committee Meeting

    DOT anticipates that the ACCESS Advisory Committee will have one additional three-day meeting in Washington, DC. The sixth and final meeting is tentatively scheduled for October 12-14. Notices of all future meetings will be published in the Federal Register at least 15 calendar days prior to each meeting.

    Notice of this meeting is being provided in accordance with the Federal Advisory Committee Act and the General Services Administration regulations covering management of Federal advisory committees. See 41 CFR part 102-3. Issued under the authority of delegation in 49 CFR 1.27(n).

    Dated: August 29, 2016. Molly J. Moran, Acting General Counsel.
    [FR Doc. 2016-21357 Filed 9-2-16; 8:45 am] BILLING CODE 4910-9X-P
    CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1500 [Docket No. CPSC-2016-0020] Statement of Policy on the Commission's Interpretation of Intent To Produce Audible Effects Within the Meaning of the Commission's Fireworks Regulations Under the Federal Hazardous Substances Act AGENCY:

    U.S. Consumer Product Safety Commission.

    ACTION:

    Proposed interpretive rule.

    SUMMARY:

    The Consumer Product Safety Commission (CPSC) has approved a Proposed Statement of Policy regarding the Commission's interpretation of the phrase “intended to produce audible effects” that appears in the Commission's fireworks regulations.

    DATES:

    Submit comments by October 6, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC-2016-0020 by any of the following methods:

    Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

    Written Submissions: Submit written comments by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

    Instructions: All submissions received must include the agency name and docket number. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing by mail/hand delivery/courier.

    FOR FURTHER INFORMATION CONTACT:

    DeWane Ray, Deputy Executive Director for Safety Operations, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: (301)-504-7547; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Federal Hazardous Substances Act (FHSA),1 the Consumer Product Safety Commission (CPSC or Commission) has banned all “[f]ireworks devices intended to produce audible effects . . . if the audible effect is produced by a charge of more than 2 grains of pyrotechnic composition.” 2 Pursuant to staff's Consumer Fireworks Testing Manual (Manual), Commission staff determine whether a fireworks device was intended to produce an audible effect by evaluating the relative intensity of the sound produced by such device (the Sound Test).

    1 Pub. L. 86-613, 74 Stat. 372 (July 12, 1960) (codified as amended at 15 U.S.C. 1261-78).

    2 16 CFR 1500.17(a)(3).

    Through this publication, the Commission proposes to interpret the “audible effects” provision such that staff will consider the presence of metallic powder less than 100 mesh in particle size within the burst (or break) charge of a fireworks device to mean the device is intended to produce an audible effect, consistent with the American Pyrotechnic Association Standard 87-1 definition.

    The Commission notes that this interpretation is not a binding rule and would not change any person's rights, duties, or obligations under the FHSA or any other Act administered by the Commission. The Commission invites comment on this proposed interpretation.

    A. Background

    The FHSA empowers the Consumer Product Safety Commission (CPSC or Commission) to, “by regulation[,] declare to be a hazardous substance . . . any substance or mixture of substances” 3 which the Commission finds meets a series of statutory requirements. Under the FHSA, the Commission prohibits, as banned hazardous substances, the introduction into interstate commerce of all

    3 15 U.S.C. 1262(a)(1).

    Fireworks devices intended to produce audible effects (including but not limited to cherry bombs, M-80 salutes, silver salutes, and other large firecrackers, aerial bombs, and other fireworks designed to produce audible effects, and including kits and components intended to produce such fireworks) if the audible effect is produced by a charge of more than 2 grains of pyrotechnic composition.4

    4 16 CFR 1500.17(a)(3). This rule provides an exception for devices intended and sold for bona fide agricultural use. Id. at § 1500.17(a)(3)(i)-(ii).

    The goal of this ban was to remove from consumer use the kinds of devices that had, as noted in the 1970 Food and Drug Administration (FDA) rulemaking that imposed the ban, “caused eight fatalities (six were teenage or younger) and a large number of serious injuries ranging from puncture wounds to broken bones and shattered hands.” 5

    5 Fireworks Devices, 35 FR 7415 (May 13, 1970).

    The Commission's rules do not further define or describe “devices intended to produce audible effects,” nor do they define how the Commission will determine whether a product falls under this category. The Manual directs Commission staff to evaluate the relative intensity of any sound produced by a firework device to determine whether such sound is an intended effect or merely incidental to the operation of the device. Any device in the former category must comply with the two grain limitation stated in the regulation.

    Since the adoption of the Sound Test, there have been many developments in the fireworks market, including the use of fine-mesh metallic fuels to intensify device operation. Voluntary standards bodies, including the APA, have addressed the use of metallic fuels directly.6

    6 Amer. Pyrotechnics Assoc., APA Standard 87-1: Standard for Construction and Approval for Transportation of Fireworks, Novelties, and Theatrical Pyrotechnics § 2.5 (2001).

    Under the APA standard, “any burst [or break] charge containing metallic powder (such as magnalium or aluminum) less than 100 mesh in particle size, is considered to be intended to produce an audible effect, and is limited to 130 mg [the equivalent of two grains] in [consumer] fireworks.” 7 This provides a bright-line standard with a highly reproducible measure.

    7Id.

    Aside from the clarity of its use as an enforcement tool, the APA standard is also familiar to industry. Not only does it reflect the work of a voluntary standard development organization in which industry members participated, it has been incorporated by reference into the Department of Transportation's regulations for the shipment of fireworks.8 Under this interpretation, CPSC will be testing fireworks devices in line with the APA standard when determining which devices are intended to produce an audible effect.

    8 49 CFR 173.65.

    B. Interpretive Rule

    For the foregoing reasons, the Commission proposes to interpret the phrase “Fireworks devices intended to produce audible effects” in a manner consistent with the APA voluntary standard and DOT regulations. Under this interpretation, the Commission will consider the presence in the burst (or break) charge of a fireworks device of metallic powder less than 100 mesh in particle size to mean that the device is intended to produce an audible effect. Likewise, if the device lacks such metallic powder, staff will consider it as not intended to produce an audible effect. This change, as noted above, will not alter the rule or any party's obligations under it in any way, but it will allow the Commission to enforce that rule more efficiently.

    C. Request for Comment

    The Commission requests comments on all aspects of the proposed interpretation. In particular, given the handmade nature of these products, the Commission requests comments on whether there should be an allowance for contamination at a level that would not pose an injury hazard to fireworks users or bystanders. We seek comments to determine whether we can exercise some flexibility in enforcement. We would not be setting an enforceable contamination allowance but, in an enforcement proceeding, we may consider allowing some contamination if we receive information supporting the position that inadvertent low level contamination by these metals can occur in the manufacturing process.

    If so, please provide the CPSC information and data regarding what an appropriate allowance should be.

    Dated: August 26, 2016. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2016-21014 Filed 9-2-16; 8:45 am] BILLING CODE 6355-01-P
    COMMODITY FUTURES TRADING COMMISSION 17 CFR Part 4 RIN 3038-AE47 Commodity Pool Operator Annual Report AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice of proposed rulemaking; extension of comment period.

    SUMMARY:

    On August 5, 2016, the Commodity Futures Trading Commission (Commission or CFTC) published in the Federal Register a notice of proposed rulemaking (Proposal) to amend certain of its regulations applicable to the Annual Report that each person registered or required to be registered as a commodity pool operator (CPO) must distribute for each commodity pool that it operates. As is explained below, the Commission is extending for two weeks the comment period for the Proposal.

    DATES:

    The comment period for the Proposal published on August 5, 2016, at 81 FR 51828, is extended until September 20, 2016.

    ADDRESSES:

    You may submit comments, identified by RIN 3038-AE47 and “Commodity Pool Operator Annual Report,” by any of the following methods:

    CFTC Web site: http://comments.cftc.gov. Follow the instructions for submitting comments through the Comments Online process on the Web site.

    Mail: Send to Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.

    Hand Delivery/Courier: Same as Mail, above.

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Please submit your comments using only one of these methods.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that may be exempt from disclosure under the Freedom of Information Act (FOIA), a petition for confidential treatment of the exempt information may be submitted according to the procedures established in Commission Regulation 145.9.1

    1 17 CFR 145.9 (2016). The Commission's regulations are found at 17 CFR Ch. I (2016). They are accessible through the Commission's Web site.

    The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse, or remove any or all of a submission from www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the rulemaking will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the FOIA.

    FOR FURTHER INFORMATION CONTACT:

    Christopher W. Cummings, Special Counsel, 202-418-5445, [email protected] or Barbara S. Gold, Associate Director, 202-418-5441, [email protected], Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.

    SUPPLEMENTARY INFORMATION:

    The Proposal concerns certain provisions of the Annual Report that registered CPOs are required to distribute and submit under Regulation 4.22. Among other things, it would amend these provisions: To permit the use of additional alternative generally accepted accounting principles, standards or practices; to provide for an exemption from the Annual Report audit requirement where the first fiscal year of a pool consists of a period of three months or less from the date of formation of the pool; and to clarify that a CPO must distribute and submit an audited Annual Report at least once during the life of the pool. The comment period for the Proposal is due to expire on September 6, 2016.

    By letter dated August 26, 2016, the Managed Funds Association (MFA), a membership organization representing many persons who would be affected by the Proposal, requested a two-week extension of the comment period for the Proposal, such that, as extended, the comment period would expire on September 20, 2016. In support of its request, MFA explained that it is drafting comments in response to the Commission's request for comments on the Proposal and, in this regard, is seeking to provide comments representative of the views of its membership. MFA further explained that it is finding it challenging to ensure that its members have adequate time to review comments for submission by September 6, 2016, in light of previously scheduled family-related commitments which find them out-of-office during the last two weeks of August.

    In light of the foregoing, and in response to the MFA request, by this Federal Register release the Commission is extending the comment period for the Proposal for two weeks, until September 20, 2016.

    Issued in Washington, DC, on August 30, 2016, by the Commission. Christopher J. Kirkpatrick, Secretary of the Commission. Appendix to Commodity Pool Operator Annual Report—Commission Voting Summary

    On this matter, Chairman Massad and Commissioners Bowen and Giancarlo voted in the affirmative. No Commissioner voted in the negative.

    [FR Doc. 2016-21153 Filed 9-2-16; 8:45 am] BILLING CODE 6351-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2016-0500] RIN 1625—AA08 Special Local Regulation; Little Annemessex River and Somers Cove, Crisfield, MD AGENCY:

    Coast Guard, DHS.

    ACTION:

    Proposed rule; withdrawal.

    SUMMARY:

    The Coast Guard is withdrawing its proposed rule concerning amendments to the regattas and marine parades regulations. The rulemaking was initiated to establish special local regulations during the swim segment of the “Crisfield CrabMan Triathlon,” a marine event to be held on the waters of the Little Annemessex River and Somers Cove in Somerset County at Crisfield, MD on September 17, 2016. The Coast Guard was notified on July 25, 2016 that the event had been cancelled.

    DATES:

    The proposed rule is withdrawn on September 6, 2016.

    ADDRESSES:

    The docket for this withdrawn rulemaking is available for inspection using the Federal eRulemaking Portal at http://www.regulations.gov and can be viewed by following that Web site's instructions.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice, call or email Mr. Ronald Houck, Waterways Management Division, U.S. Coast Guard Sector Maryland-National Capital Region; telephone 410-576-2674, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    On July 27, 2016, we published a notice of proposed rulemaking entitled “Special Local Regulation; Little Annemessex River and Somers Cove, Crisfield, MD” in the Federal Register (81 FR 17774). The rulemaking concerned the Coast Guard's proposal to establish temporary special local regulations on specified waters of Little Annemessex River and Somers Cove at Crisfield, MD, effective from 5:30 a.m. on September 17, 2016 until 10 a.m. on September 18, 2016. The regulated area included all navigable waters of the Little Annemessex River and Somers Cove, from shoreline to shoreline, bounded to the north by a line drawn from the eastern shoreline of Janes Island at latitude 37°58′39″ N., longitude 075°52′05″ W., and thence eastward to the Crisfield City Dock at latitude 37°58′39″ N., longitude 075°51′50″ W., and bounded to the south by a line drawn from Long Point on Janes Island at latitude 37°58′12″ N., longitude 075°52′42″ W., and thence eastward to Hammock Point at latitude 37°57′58″ N., longitude 075°51′58″ W., located at Crisfield, MD. The regulations were needed to temporarily restrict vessel traffic during the event to provide for the safety of participants, spectators and other transiting vessels.

    Withdrawal

    The Coast Guard is withdrawing this rulemaking because the event has been cancelled.

    Authority

    We issue this notice of withdrawal under the authority of 33 U.S.C. 1233.

    Dated: August 24, 2016. Lonnie P. Harrison, Jr., Captain, U.S. Coast Guard, Captain of the Port Maryland-National Capital Region.
    [FR Doc. 2016-21173 Filed 9-2-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF EDUCATION 34 CFR Part 200 RIN 1810-AB33 [Docket ID ED-2016-OESE-0056] Title I—Improving the Academic Achievement of the Disadvantaged—Supplement Not Supplant AGENCY:

    Office of Elementary and Secondary Education, Department of Education.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Secretary proposes to establish regulations governing programs administered under title I, part A of the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the Every Student Succeeds Act (ESSA). These proposed regulations are needed to implement recent changes made by the ESSA to the supplement not supplant requirement of title I, part A of the ESEA. Unless otherwise specified, references to the ESEA mean the ESEA, as amended by the ESSA.

    DATES:

    We must receive your comments on or before November 7, 2016.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “How to use Regulations.gov.”

    Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about these proposed regulations, address them to James Butler, U.S. Department of Education, 400 Maryland Avenue SW., Room 3W246, Washington, DC 20202.

    Privacy Note: The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    James Butler, U.S. Department of Education, 400 Maryland Avenue SW., Room 3W246, Washington, DC 20202. Telephone: (202) 260-9737 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: Executive Summary

    Purpose of This Regulatory Action: On December 10, 2015, President Barack Obama signed the ESSA into law. The ESSA reauthorizes the ESEA, which provides Federal funds to improve elementary and secondary education in the Nation's public schools. ESSA builds on the ESEA's legacy as a civil rights law and seeks to ensure every child, regardless of race, national origin, socioeconomic status, background, or zip code, receives the support needed to succeed in school.

    As the statute affirms, the purpose of title I, part A of the ESEA is to “provide all children significant opportunity to receive a fair, equitable, and high-quality education, and to close educational achievement gaps.” 1 The requirement that title I, part A funds supplement State and local funds, and not supplant them, is a longstanding provision of ESEA intended to ensure that Federal funds provide the additional educational resources that students and teachers in high-poverty schools need to succeed. Consequently, if title I schools do not receive their fair share of State and local dollars before title I dollars are added, title I, part A funds do not serve their intended purpose of providing additional educational resources. In this situation, instead of providing the extra, supplemental funding needed to serve disadvantaged students, they simply compensate for shortfalls in the State and local funds that title I schools receive. Failure to ensure compliance with the supplement not supplant provisions in the law hurts students in title I schools, who are among those most in need of additional support. This principle is fundamental to the law and to its legacy as a civil rights law.

    1 Section 1001 of the ESEA.

    Data show that approximately 90 percent of local educational agencies (LEAs) provide each title I school as much per pupil as the average of non-title I schools in the LEA. However, in hundreds of LEAs across the country, title I schools are receiving, on average, hundreds of thousands of dollars less in State and local funding than the average non-Title I school. These are critical funds that could be spent on, for example, wrap-around services, high-quality preschool, access to advanced coursework, or incentive pay for educators who choose to work in high-need schools. The general requirement that title I, part A funds supplement and do not supplant State and local funds has been part of title I, part A of the ESEA since 1970. This requirement in the law is intended to provide disadvantaged students with additional resources over and above what they receive through State and local funding streams for education. The requirement arose from the findings of a landmark report published in 1969 with support from the National Association for the Advancement of Colored People (NAACP) Legal Defense and Education Fund titled: Title I of ESEA: Is it Helping Poor Children?. 2 That report revealed case after case of egregious misuses of title I funds by States and LEAs, including one example from Mississippi where a superintendent averred in Federal court that the highest per-pupil expenditure for schools serving black students in the district was about half of the lowest per-pupil expenditure in schools attended primarily by white students. Due in large measure to the findings from this report, the supplement not supplant provisions for title I, part A were added to the law during the 1970 reauthorization of the ESEA. However, in the years subsequent to the inclusion of this critical safeguard, LEAs struggled with ways to demonstrate compliance with the provision in the statute and oftentimes relied on burdensome practices that worked against the intended purpose of title I funding.

    2http://files.eric.ed.gov/fulltext/ED036600.pdf.

    The ESSA presents a significant, positive improvement in this respect, as it changed the manner in which an LEA must comply with this requirement. Prior to the passage of the ESSA, the statute lacked a clear standard for how to demonstrate compliance with the supplement not supplant requirement. Most LEAs met the requirement by demonstrating that each cost or service paid for using title I, part A funds was supplemental. This burdensome practice often limited local education officials' ability to spend title I funds in ways that would best meet the needs of low-achieving students. For example, an LEA often pulled students out of their regular classroom to provide remedial services in order to clearly demonstrate that they were supplemental, regardless of whether this was in the best interest of the students receiving those services.

    The new ESSA statutory language focuses not on costs and services, but on funds. Specifically, section 1118(b) of the ESEA requires that an LEA “demonstrate that the methodology used to allocate State and local funds to each [title I school] ensures that such school receives all of the State and local funds it would otherwise receive if it were not receiving assistance under [title I].”

    Importantly, States and LEAs need not shift resources among schools in order to comply with this provision, but instead may elect to provide additional State and local educational funding to title I schools to ensure compliance with the supplement not supplant provision of the law.

    This is the first time that the supplement not supplant requirement contains a statutory directive regarding how an LEA must demonstrate compliance with the requirement. For this reason, the Department proposes these regulations to provide clarity about how LEAs can demonstrate that the distribution of State and local funds satisfies the funds-based compliance test introduced in the law.

    At the same time, the ESSA prohibits the Secretary from prescribing the specific methodology an LEA uses to allocate State and local funds to each school, and the proposed regulations would not establish such a specific methodology. Instead, they would clarify that an LEA must publish its methodology for allocating State and local funds and clarify how the LEA can make the demonstration required by this section of the ESEA and ensure that funds under title I, part A are used to supplement, and not supplant, State and local funds, while also providing the flexibility needed to implement the requirement in a meaningful way. The proposed regulations reflect input provided by negotiators during negotiated rulemaking and feedback received from the public subsequent to the final negotiated rulemaking session, while also building upon the non-regulatory guidance the Department issued in 2015 on the supplement not supplant requirement as applied to schoolwide title I, part A programs, which can be accessed at: http://www2.ed.gov/policy/elsec/guid/eseatitleiswguidance.pdf.

    Summary of the Major Provisions of This Regulatory Action: For the title I, part A program, we propose new regulations governing supplement not supplant that would:

    • Restate the general requirement under section 1118(b)(1) that a State educational agency (SEA) or an LEA use title I, part A funds only to supplement, and not supplant, State and local funds.

    • Incorporate the requirement under section 1118(b)(2) of the ESEA that an LEA must demonstrate that the methodology used to allocate State and local funds to each title I school ensures that such school receives all of the State and local funds it would otherwise receive if it were not a title I school.

    • Clarify that an LEA may demonstrate compliance with the preceding requirement under the ESEA in a number of ways.

    • Provide numerous flexibilities to ensure that an LEA can implement the requirement in a way that reflects local needs, circumstances, and decision-making.

    • Clarify the implementation timeline for the proposed regulations.

    Costs and Benefits: Although the Department estimates approximately 90 percent of LEAs already meet the requirements of this proposed regulation through the special rule, some LEAs would need to increase funding for some title I schools either by increasing total funding or by redirecting funding within the LEA. Given that some LEAs would need to increase funding for some title I schools, this regulation meets the test for economic significance, as explained in the Regulatory Impact Analysis section of this document, which describes costs, transfers, and benefits of the proposed regulations. We further believe that the proposed regulations would provide a significant benefit by promoting transparency in State and local education spending, and by simplifying and clarifying the test for compliance with the supplement not supplant requirement in the ESEA, which is designed to ensure that Federal education funds provided through the title I, part A program meet their statutory purpose. Please refer to the Regulatory Impact Analysis section of this document for a more detailed discussion of costs and benefits. Consistent with Executive Order 12866, the Office of Management and Budget has determined that this action is economically significant.

    Invitation to Comment: We invite you to submit comments regarding these proposed regulations. To ensure that your comments have maximum effect in developing the final regulations, we urge you to identify clearly the specific section or sections of the proposed regulations that each of your comments addresses and to arrange your comments in the same order as the proposed regulations.

    We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from these proposed regulations. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the Department's programs and activities.

    During and after the comment period, you may inspect all public comments about these proposed regulations by accessing Regulations.gov. You may also inspect the comments in person in 3W246, 400 Maryland Ave. SW., Washington, DC, between 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays. Please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Particular Issues for Comment: We request comments from the public on any issues related to these proposed regulations. However, we particularly request the public to comment on, and provide additional information regarding, the following issue. Please provide a detailed rationale for your response.

    • Whether we should expand the flexibility available to an LEA that chooses to use the special rule, including to expand the categories of expenditures that disproportionately affect the amount of State and local funds allocated on average for non-title I schools, as contemplated in § 200.72(b)(1)(iii)(C).

    Assistance to Individuals with Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these proposed regulations. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Background Public Participation

    On December 22, 2015, the Department published a request for information in the Federal Register soliciting advice and recommendations from the public on the implementation of title I of the ESEA. We received 369 comments. We also held two public meetings with stakeholders—one on January 11, 2016, in Washington, DC and one on January 19, 2016, in Los Angeles, California—at which we heard from over 100 speakers regarding the development of regulations, guidance, and technical assistance related to the implementation of title I. In addition, Department staff have held more than 200 meetings with education stakeholders and leaders across the country to hear about areas of interest and concern regarding implementation of the new law.

    Negotiated Rulemaking

    Section 1601(b) of the ESEA requires the Secretary, before publishing proposed regulations for programs authorized by title I, part A of the ESEA, to obtain public involvement in the development of the proposed regulations. After obtaining advice and recommendations from individuals and representatives of groups involved in, or affected by, the proposed regulations, the Secretary must subject any proposed regulations related to standards or assessments under section 1111(b)(2) of the ESEA, as well as the requirement under section 1118(b) that funds under part A be used to supplement, and not supplant, State and local funds, to a negotiated rulemaking process.

    On February 4, 2016, the Department published a notice in the Federal Register (81 FR 5969) announcing our intent to establish a negotiated rulemaking committee to develop proposed regulations to implement certain changes made to the ESEA by the ESSA. We announced our intent to establish a negotiating committee to prepare proposed regulations related to the requirement under section 1118(b) of the ESEA that title I, part A funds be used to supplement, and not supplant, non-Federal funds, specifically:

    (i) Regarding the methodology an LEA uses to allocate State and local funds to each title I school to ensure compliance with the supplement not supplant requirement; and

    (ii) The timeline for compliance.

    The committee met in three sessions to develop proposed regulations, which also included proposals related to assessments under section 1111(b)(2) of the ESEA: Session 1, March 21-23, 2016; session 2, April 6-8, 2016; and session 3, April 18-19, 2016.

    The committee included the following members:

    Tony Evers and Marcus Cheeks, representing State administrators and State boards of education.

    Alvin Wilbanks, Derrick Chau, and Thomas Ahart (alternate), representing local administrators and local boards of education.

    Aaron Payment and Leslie Harper (alternate), representing tribal leadership.

    Lisa Mack and Rita Pin-Ahrens, representing parents and students, including historically underserved students.

    Audrey Jackson, Ryan Ruelas, and Mary Cathryn Ricker (alternate), representing teachers.

    Lara Evangelista and Aqueelha James, representing principals.

    Eric Parker and Richard Pohlman (alternate), representing other school leaders, including charter school leaders.

    Lynn Goss and Regina Goings (alternate), representing paraprofessionals.

    Delia Pompa, Ron Hager, Liz King (alternate), and Janel George (alternate), representing the civil rights community, including representatives of students with disabilities, English learners, and other historically underserved students.

    Kerri Briggs, representing the business community.

    Patrick Rooney and Ary Amerikaner (alternate), representing the U.S. Department of Education.

    The committee's protocol provided that it would operate by consensus, which meant unanimous agreement; that is, without dissent by any voting member. During its meetings, the committee reviewed and discussed drafts of proposed regulations. At the final meeting in April 2016, the committee did not reach consensus on the proposed regulations relating to the requirement under section 1118(b) of the ESEA that title I, part A funds be used to supplement, and not supplant, State and local funds.

    Because consensus was not reached, the Department may use regulatory language developed during the negotiations as the basis for the proposed regulations, or develop new regulatory language for all or a portion of the proposed regulations; and all parties who participated or were represented in the negotiated rulemaking, as well as all members of the public, may comment freely on the proposed regulations. In addition, as required under section 1601(c)(1) of the ESEA, on August 12, 2016, the Department submitted the proposed regulations to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Education and the Workforce in the House of Representatives for a 15 business-day comment period. The Department will include and seek to address comments received from Congress in the public rulemaking record for these regulations. Further information on the negotiated rulemaking process may be found at: http://www2.ed.gov/policy/elsec/leg/essa/index.html.

    Proposed Regulations

    The Secretary proposes new regulations in 34 CFR part 200 to implement programs under title I, part A of the ESEA. We discuss substantive issues under the sections of the proposed regulations to which they pertain.

    Section 200.72 Supplement Not Supplant

    Statute: Section 1118(b) of the ESEA requires that an SEA and LEA use the funds that each receives under part A of title I only to supplement, and not supplant, the funds made available from State and local sources for the education of students in title I schools.

    According to the statutory language of the ESEA, to meet the supplement not supplant requirement an LEA must demonstrate that the methodology it selects for allocating State and local funds results in each title I school receiving all of the State and local funds that it would otherwise receive if it were not receiving title I funds. The statute also clarifies that an LEA is not required to: (1) Identify that an individual cost or service supported with funds it receives under title I, part A is supplemental; or (2) provide services through a particular instructional method or in a particular instructional setting. Further, the statute specifically prohibits the Department from prescribing the specific methodology that an LEA must use to allocate State and local funds.

    Section 1118(b)(5) establishes December 10, 2017, as the deadline by which an LEA must demonstrate to its SEA compliance with the supplement not supplant requirement. Before December 10, 2017, an LEA may continue to use its existing method for complying with the supplement not supplant requirement.

    Current Regulations: None.

    Proposed Regulations: The proposed regulations would incorporate new statutory provisions and clarify the basic responsibilities an SEA or LEA has in ensuring that the funds received under title I, part A are used only to supplement, and not to supplant, State and local funds that are made available to support the education of students in title I schools.

    Proposed § 200.72(a)(1)(i) would incorporate the statutory requirement that an SEA or LEA must use title I, part A funds only to supplement State and local funds that would, in the absence of title I, part A funds, be made available for the education of students in title I schools. Proposed § 200.72(a)(1)(ii) would establish that an SEA or LEA may not use title I, part A funds to supplant State and local funds.

    Proposed § 200.72(a)(2)(i) would make clear that an LEA is not required to identify an individual cost or service supported with funds under title I, part A as supplemental, and proposed § 200.72(a)(2)(ii) would clarify that an LEA is not required to use title I, part A funds to provide services through a particular instructional method or in a particular instructional setting.

    Proposed § 200.72(b)(1)(i) would clarify that an LEA must demonstrate annually to its SEA that the methodology it uses to allocate State and local funds to each title I school ensures that each title I school receives all of the State and local funds that it would receive if it were a non-title I school. Under the proposed regulations, an SEA must establish the time and form for the annual LEA demonstration. Also, an LEA would need to publish its methodology in a manner easily accessible to the public.

    Proposed § 200.72(b)(1)(ii) would clarify that an LEA must allocate almost all State and local education funds to all of its public schools—regardless of title I status—in a way that meets one of the following tests: (A) The actual distribution of funds is based on the characteristics of students in each school, providing more funding for students with characteristics associated with educational disadvantage including students living in poverty, English learners, students with disabilities, and other such subgroups of students chosen by the LEA; (B) the actual distribution of funds is based on a districtwide formula for allocation of personnel and non-personnel resources, provided that the total amount going to each title I school is at least equal to the sum of the amount of personnel costs expected based on the districtwide average salary for each category of school personnel and the average district-wide per pupil expenditure for non-personnel costs; or (C) the distribution of funds through any other approach that meets a funds-based compliance test established by the SEA that is as rigorous as (A) or (B) and is approved through Federal peer review that relies on peers such as professionals with expertise in school finance, State and local education officials, and individuals who represent the interests of special populations of students. An SEA would not be required to establish such a test. Moreover, an LEA would not be required to use the SEA's test if the LEA complies with one of the other two options or the special rule discussed below.

    To meet one of these tests, an LEA may create a specific funding methodology to best address its local context and need. Under any methodology, an LEA may exclude certain funding used for districtwide activities, as provided in proposed § 200.72(b)(2)(iv), provided that each title I school receives a share of those activities equal to or greater than the share it would otherwise receive if it were not a title I school. For example, an LEA might exclude State or local funds used for districtwide administrative costs, to implement a districtwide summer school or preschool program, or personnel providing districtwide services such as curriculum development or data analysis.

    In addition, proposed § 200.72(b)(1)(iii) establishes a “special rule” that an LEA may use to meet the compliance test, rather than using one of the three options described above. Recent school-level expenditure data from the 2013-2014 school year show that approximately 90 percent of LEAs currently would meet the special rule. However, in approximately 1,500 LEAs, 5,750 title I schools spend significantly less State and local funding than non-title I schools in the same grade span (e.g., high schools or elementary schools) in the same LEA. Each year, these title I schools receive hundreds of thousands of dollars less in State and local funding than their non-title I counterparts in the same LEA—$440,000 per year, on average, or a median of roughly $200,000 per year.3 These data suggest that in thousands of schools serving high-need students, title I, part A funds are being used, at least in part, to make up for underfunding at the State and local level, rather than providing truly supplemental funds.4

    3 These estimates are based on U.S. Department of Education (Department) analyses of data from the 2013-2014 Civil Rights Data Collection, and calculated in a manner consistent with the “special rule” provision of the regulations proposed in this notice. Accordingly, the 90 percent figure includes in the denominator districts to which the supplement not supplant compliance test would not apply (e.g., districts with all title I schools or no title I schools). A public-use version of the collection can be found here.

    4 This practice did not per se result in non-compliance with the supplement not supplant requirement in section 1120A(b) of the ESEA, as amended by the No Child Left Behind Act of 2001, which did not contain statutory provisions relating to how LEAs must demonstrate compliance with the supplement not supplant requirement. In the absence of that clarity, the Department relied on a set of presumptions of supplanting for monitoring and enforcement purposes. However, these presumptions are no longer relevant because the new supplement not supplant requirement under section 1118(b) of the ESEA for the first time clarifies that compliance relies on an LEA's methodology for allocating State and local funds and discourages the use of past and onerous practices by prohibiting LEAs from being required to demonstrate that an individual cost or service is supplemental.

    Under the “special rule” option, the LEA simply would demonstrate, regardless of the methodology it uses to allocate State and local funds to title I schools, that it spends an amount of State and local funds on a per-pupil basis in each title I school that is equal to or greater than the average per-pupil amount spent in non-title I schools, using data reported under section 1111(h)(1)(C)(x) of the ESEA. The proposed special rule also would allow for de minimis variations in annual expenditures, such that an LEA would be in compliance with the special rule provision if the amount it spends per pupil in each title I school is no more than 5 percent below the average amount it spends per pupil in non-title I schools. In addition, proposed § 200.72(b)(1)(iii)(B) would allow an LEA using the special rule provision to exclude from the calculation of its per-pupil spending funds spent in a school that enrolls fewer than 100 students, while proposed § 200.72(b)(1)(iii)(C) would allow such an LEA to comply using the special rule provision if a non-title I school serving high proportions of students with disabilities, English learners, or students from low-income families has higher per-pupil expenditures due to serving those students and disproportionately affects the average amount of State and local funds spent in non-title I schools in the LEA or grade span.

    Proposed § 200.72(b)(2) provides flexibilities that an LEA may use in demonstrating compliance with the ESEA's supplement not supplant requirement. Specifically:

    • Proposed § 200.72(b)(2)(i) would establish that an LEA may comply with the supplement not supplant requirement on a districtwide or grade-span basis (e.g., high schools, elementary schools).

    • Proposed § 200.72(b)(2)(ii) would exempt an LEA from complying with the supplement not supplant requirement if it serves only a single school or in any grade span in which it serves only a single school.

    • Proposed § 200.72(b)(2)(iii) would clarify that, consistent with section 1118(d) of the ESEA, an LEA may exclude from its demonstration of compliance supplemental State and local funds expended in any school—including a non-title I school—for programs that meet the intent and purposes of title I, part A (e.g., a State-funded program providing additional services only for students most at risk of not meeting challenging State academic standards).

    • Proposed § 200.72(b)(2)(iv) would allow an LEA that spends State or local funds for certain districtwide activities to exclude those funds from its demonstration of compliance, provided that each title I school receives a share of those activities equal to or greater than it would otherwise receive if it were not a title I school and that the LEA distributes to schools under paragraph (b)(1) almost all of the State and local funds available to it. It would further clarify that districtwide activities may include, for example, districtwide administrative costs, districtwide programs such as summer school or preschool, and personnel providing districtwide services such as curriculum development or data analyses but may not include personnel or non-personnel resources associated with an individual school.

    Proposed § 200.72(b)(3)(i) would clarify the timeline for meeting the new compliance test required by the ESEA. By December 10, 2017, an LEA would be required to either (1) demonstrate to its SEA that its current methodology for allocating State and local funds meets the new supplement not supplant requirement, or (2) provide to its SEA a plan describing how it would meet that requirement no later than the 2019-2020 school year.

    Proposed § 200.72(b)(3)(ii) would clarify that, during the transition to the new title I, part A supplement not supplant requirement under the ESEA, an LEA would be able to use either (1) the methodology it will use to comply with the new supplement not supplant requirement, or (2) the methodology it used for complying with the requirement as it existed prior to enactment of the ESSA.

    Proposed § 200.72(b)(4) would clarify that nothing in the proposed regulation shall be construed to require the forced or involuntary transfer of school personnel. It would further clarify that, consistent with section 1605 of the ESEA, the proposed regulation would not require equalized per-pupil spending for a State, LEA, or school. It would make clear that nothing in the proposed regulations would require an LEA to adopt a specific methodology to allocate State and local funds to comply with the supplement not supplant requirement. Finally, proposed § 200.72(b)(4) would make clear that nothing in the proposed regulations would alter or otherwise affect the rights, remedies, and procedures afforded to school or LEA employees under Federal, State, or local laws (including applicable regulations or court orders) or under the terms of collective bargaining agreements, memoranda of understanding, or other agreements between such employers and their employees.

    Reasons: We propose these regulations to implement the changes made by the ESSA to the supplement not supplant requirement of title I, part A of the ESEA. The proposed regulations would ensure that title I funds are used to fulfill their statutory purpose—that is, to “provide all children significant opportunity to receive a fair, equitable, and high-quality education, and to close educational achievement gaps”—instead of making up for inequitable allocations of State and local funding to title I schools. The proposed regulations also would provide LEAs the flexibility necessary to implement this requirement in a manner that accounts for local needs and circumstances while respecting the core purpose of the statute. Finally, the proposed regulations would clarify that previous burdensome compliance tests—related to justifying individual expenditures of title I funds—are no longer required.

    While section 1118(b) of the ESEA establishes that, to comply with the supplement not supplant requirement, an LEA must demonstrate that it uses a methodology to allocate State and local funds that ensures that each title I school receives the same amount of those funds as it would if it were not receiving title I funding, the statute does not indicate how an LEA is to make this demonstration. Some stakeholders, including some members of the negotiating committee, expressed an interest in clear requirements so that LEAs know exactly how they are expected to comply, and so that auditors are not forced to make ad hoc decisions on what constitutes an appropriate demonstration of compliance with the statute that could vary significantly from LEA to LEA and potentially have an unfair impact on students, schools, and LEAs. Some stakeholders expressed support for the Department's proposal during the negotiated rulemaking process that would have required that an LEA receiving title I funds demonstrate that each title I school spend at least as much per pupil in State and local funding as the average spent in non-title I schools in the LEA. However, other negotiators expressed strong concern that this may not be the only appropriate test of compliance with the supplement not supplant requirement. Many of those who expressed such concern also expressed support for the examples in the supplement not supplant section of the Department's 2015 non-regulatory guidance on schoolwide title I, part A programs, from which we drew in the development of this proposed rule. Some negotiators also expressed support for using a proposed rule to simply ensure transparency regarding an LEA's methodology for allocating State and local funds. Finally, some negotiators recommended not regulating on this provision of the law at all.

    The proposed regulations would require transparency in how an LEA allocates State and local funds, and would provide LEAs with three distinct options to demonstrate compliance with the requirement, including the two options outlined in the 2015 schoolwide program guidance as well as an SEA-developed funds-based compliance test that would be approved through a Federal peer review process. The first two options would allow for the demonstration of compliance through funds-based methodologies that direct resources to all public schools in an LEA on the basis of student characteristics or through the allocation of staffing and supplies. The third option was added in order to maximize flexibility for innovative approaches, consistent with the funds-based requirement established by the ESSA, that ensure LEAs are using title I funds to supplement State and local funds.

    The proposed regulations would require that an LEA distribute almost all State and local funds through one of the three methodologies. This recognizes that some portion of State and local funding may not be allocated through general formulas because it is used for districtwide activities under proposed § 200.72(b)(2)(iv).

    The proposed regulations would also provide an LEA the choice of complying with the supplement not supplant requirement via a “special rule” instead of one of the three options described above. The special rule builds upon the Department's proposal from negotiated rulemaking. During the negotiated rulemaking process, the negotiators raised important considerations about special circumstances that would require flexibility when implementing the special rule of the proposed regulations. To address these concerns, proposed § 200.72(b)(1)(iii) would:

    • Provide that the special rule is met if the amount an LEA spends per pupil in each title I school is no more than 5 percent below the average amount it spends in non-title I schools, which would enable LEAs to develop and implement a methodology consistent with the supplement not supplant requirement while allowing for small and unpredictable shifts in costs from year to year;

    • Allow an LEA electing to use the special rule to exclude the costs of educating students in schools that enroll fewer than 100 students. Data collected by the Department indicate that schools that educate between 1 and 49 students spend about 60 percent more per student than the national average, and schools that educate 50 to 99 students spend about 45 percent more than the national average; 5 and

    5 These data are based on Department analyses of data from the 2013-2014 Civil Rights Data Collection.

    • Provide an opportunity for an LEA to comply with the special rule if the average per-pupil expenditures in non-title I schools is disproportionately impacted by a school serving a high proportion of students with disabilities, English learners, or students from low-income families. This opportunity is designed to ensure that an LEA may continue providing such additional support in a school that serves a disproportionate proportion of these high-need students and is not receiving title I funds.

    The negotiators also identified possible complexities in LEA funding systems that merit additional flexibility. Consequently, all of the options provided in proposed § 200.72(b)(1)(ii) as well as the special rule provision in proposed § 200.72(b)(1)(iii) include flexibilities in § 200.72(b)(2) that would:

    • Allow an LEA to demonstrate compliance on a districtwide or grade-span basis, because the costs of operating a high school frequently differ from the costs of operating an elementary school;

    • Exempt an LEA with a single school or a single school per grade span from the requirement;

    • Consistent with section 1118(d) of the ESEA, allow an LEA to exclude supplemental State or local funds spent for programs that are consistent with the intent and purposes of title I, part A (e.g., a State-funded program providing additional services only for students most at risk of not meeting State standards) from its demonstration of compliance with the ESEA's supplement not supplant requirement; and

    • Allow an LEA to exclude funds used for districtwide activities from its demonstration of compliance, provided that the LEA ensures that each title I school receives an equal or greater share of those districtwide activities as it would receive if it were a non-title I school and the LEA distributes to schools under paragraph (b)(1) almost all of the State and local funds available to it.

    The Department acknowledges that, in some LEAs, compliance with the new supplement not supplant requirement under the ESEA will require shifts in spending and budgeting practices, and that making these shifts may not be possible before December 10, 2017. Therefore, the proposed regulations would allow an LEA unable to comply by December 10, 2017, to provide and implement a plan to come into compliance by the 2019-2020 school year.

    Finally, the Department includes four rules of construction. The first would clarify that these regulations should not be construed to require the forced or involuntary transfer of any school personnel. We encourage an LEA to consider all available options to meet the supplement not supplant requirement under the ESEA, including, for example, improving working conditions in high-poverty and hard-to-staff schools to attract the best and best-paid educators, providing additional compensation or some other incentive to educators in high-poverty and hard-to-staff schools, and increasing wrap-around services or other resources in high-poverty and hard-to-staff schools, such as school counselors, school-based health providers, extended learning time, or high-quality preschool opportunities. Whichever strategies an LEA chooses, the Department encourages the LEA to comply with this requirement through increasing funding focused on high-poverty, hard-to-staff schools.

    The second rule of construction would clarify that the proposed regulations do not require equalized spending per-pupil for a State, LEA, or school. The proposed regulations contemplate variations in per-pupil spending across schools—for example, an LEA taking advantage of the special rule provision would likely have (1) variation in spending among title I schools, so long as each was above the average per pupil expenditures for non-title I schools, (2) variation in spending among non-title I schools, which would be averaged to determine the average per pupil expenditures in non-title I schools, (3) variation in spending across grade-spans, and (4) higher spending in very small schools that are exempted from the calculations altogether. Similarly, an LEA choosing to use a weighted student funding formula would have variation across schools depending on the characteristics of each school's student population. And an LEA choosing to allocate personnel and non-personnel resources is likely to have wide variation in spending depending upon the specifics of the district's formula (e.g., whether the formula allocates varied numbers of staff per student in elementary schools compared to high schools; whether the formula “counts” students with disabilities as “1.2” students or “1.4” students). The rule of construction would clarify that an LEA is not limited to formulations that would require spending identical sums of money per pupil in each school. The third rule of construction would make clear that nothing in the proposed regulations would require an LEA to adopt a specific methodology to allocate State and local funds to comply with the supplement not supplant requirement in violation of section 1118(b)(4) of the ESEA.

    The fourth rule of construction would clarify that nothing in the proposed regulations would alter or otherwise affect the rights, remedies, and procedures afforded to school or LEA employees under Federal, State, or local laws (including applicable regulations or court orders) or under the terms of collective bargaining agreements, memoranda of understanding, or other agreements between such employers and their employees.

    Executive Orders 12866 and 13563 Regulatory Impact Analysis

    Under Executive Order 12866, the Office of Management and Budget must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

    (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

    (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

    This proposed regulatory action is an economically significant regulatory action subject to review by OMB under section 3(f)(1) of Executive Order 12866. This determination is based on the Department's estimate that LEAs currently not able to demonstrate compliance with the supplement not supplant requirements of the proposed rule may have to transfer approximately $800 million in existing State and local education funds to demonstrate such compliance. This potential transfer is deemed an economically significant transfer under section 3(f)(1) of Executive Order 12866.

    We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

    (1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

    (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

    (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

    (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

    (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

    Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

    We are issuing these proposed regulations only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that these proposed regulations are consistent with the principles in Executive Order 13563.

    We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

    In accordance with both Executive orders, we have assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action and have determined that the benefits would justify the costs.

    The potential costs associated with the proposed regulations are those resulting from statutory requirements and those we have determined as necessary for administering these programs effectively and efficiently. The proposed regulations would implement new statutory requirements in the ESEA related to demonstrating compliance with the longstanding supplement not supplant requirement. More specifically, under the ESEA, an LEA must “demonstrate that the methodology used to allocate State and local funds for each [title I school] ensures that such school receives all of the State and local funds it would otherwise receive if it were not receiving assistance under [title I, part A].” The proposed regulations would not require a specific methodology for allocating funds, but would require that the methodology selected and used by each LEA results in an actual distribution of funds consistent with the statutory requirement that each school participating in title I, part A receives all of the State and local funds it would otherwise receive if it were not a title I school, while also providing flexibility designed to accommodate local circumstances that might reasonably affect an LEA's ability to meet the supplement not supplant requirement.

    The Department estimates that at least 90 percent of LEAs would comply with the proposed regulations without any change in current allocation practices.6 These LEAs would be able to demonstrate compliance through the special rule option, which allows an LEA to choose any methodology that results in the LEA spending an amount of State and local funds per pupil in each title I school that is equal to or greater than the average amount of State and local funds spent per pupil in non-title I schools, using per-pupil expenditure data they will be required to collect and report under section 1111(h)(1)(C)(x) of the ESEA. In general, the Department believes that the flexibility afforded to LEAs by the proposed regulations in demonstrating compliance with the title I, part A supplement not supplant requirement would minimize the administrative costs and burdens of complying with the proposed regulations. The Department also believes that, once fully implemented, the proposed regulations would be significantly less burdensome and costly in comparison to the requirements of current law, which often involve detailed tracking and documentation of individual education expenditures.

    6 These estimates are based on Department analyses of data from the 2013-2014 Civil Rights Data Collection, and are calculated in a manner consistent with the special rule provisions of the regulations proposed in this notice.

    The proposed regulations would not require the expenditure of additional State or local funds in title I schools; rather, an LEA could meet one of the proposed compliance tests through the reallocation of existing State and local resources. For example, the Department estimates that the approximately 1,500 LEAs currently spending, on average, more State and local funds in their non-title I schools than their title I schools would need to transfer approximately $800 million in State and local education funds to their title I schools in order to meet the special rule in the proposed regulations. The average percentage of State and local dollars that would need to be reallocated by affected LEAs is estimated to be 1 percent. We note that the total dollars that would be required to be redistributed under the proposed regulations represent just over one-tenth of one percent of the more than $600 billion that State and local communities spend annually on public elementary and secondary education.

    Instead of transferring funds, affected LEAs and the States in which they are located may elect to increase State and local expenditures to meet the supplement not supplant requirement of the proposed regulations. If all affected LEAs do this, the total additional funding required is estimated to be approximately $2.2 billion, or an increment of roughly one-third of one percent over current State and local spending on public elementary and secondary schools. The Department notes that while the proposed regulations would not require the expenditure of additional State or local funds to demonstrate compliance, doing so would ensure additional support for students and teachers in title I schools consistent with the supplement not supplant requirement, while avoiding any reduction in financial support for students and teachers in non-title I schools.

    The Department does not have sufficient data to support detailed estimates of the impact of using either the districtwide pupil characteristics formula test or the districtwide personnel and non-personnel resource formula test to demonstrate compliance with the proposed supplement not supplant requirement. However, the Department believes that under either approach, the total amount of existing funds that affected LEAs would have to transfer, or the additional expenditure of State or local funds that would be required, would be similar to the estimates provided for the special rule, based on estimating the differences in funding between each title I school and the districtwide average funding. Similarly, the Department cannot provide an estimate of the impact of any State-determined option for compliance, but also believes that the total amount of existing funds that affected districts would have to transfer, or the additional expenditure of State or local funds that would be required, would be similar under this option, given that any such State-determined option must be “as rigorous” as the other options.

    States and LEAs would incur certain administrative costs under the proposed regulations. For example, while it is difficult to predict the number of States that would elect to develop their own, alternative compliance tests, the Department estimates that 15 States would incur additional one-time costs of developing or adopting and submitting an alternative funds-based compliance test for Federal peer review and approval that then could be used by LEAs to demonstrate compliance with the proposed supplement not supplant requirements. The Department further estimates that these 15 States would need, on average, 48 hours to prepare and submit such an alternative funds-based compliance test for peer review. At $40 per hour, the average cost per State would be $1,920, resulting in a total cost across the estimated 15 States of $28,800. We expect that States generally would use Federal education program funds they reserve for State administration under title I, part A to cover these one-time costs.

    The Department also estimates that the approximately 1,500 LEAs that we estimate currently would not comply with the special rule in the proposed regulations would need, on average, 24 hours to develop or adopt an alternative funds-based compliance test consistent with one of the options in the proposed regulations. We further estimate that, assuming a $35 hourly cost, these LEAs would spend an average of $840 to develop or adopt a test for demonstrating compliance with the proposed supplement not supplant regulations, for a total estimated cost across 1,500 LEAs of $1,260,000. As under the State example, we anticipate that most LEAs would use a portion of Federal program funds received under title I, part A to pay these one-time development costs.

    The Department also believes that for most LEAs, adjusting allocations of State and local education resources to demonstrate compliance with the proposed regulations generally would not entail significant new administrative burden because such adjustments could be accomplished through their normal annual budget processes. However, we estimate that approximately one third of LEAs that currently would not comply with the proposed special rule would need to transfer more than 1 percent of State and local funds in order to demonstrate compliance with the proposed regulations, and that these 500 LEAs would need to (1) develop multi-year plans for meeting their selected compliance tests and (2) integrate these plans into their annual budget processes. The Department estimates that these 500 LEAs would need, on average, 28 hours at a cost of $35 per hour to develop and integrate these plans into their annual budget processes, for a total estimated cost of $490,000. We note that there is likely substantial variation around the 28-hour average, with some LEAs potentially requiring significantly more time to develop and implement their compliance plans.

    The estimated administrative costs of the proposed regulations, which total less than $2 million for States and LEAs, are a small fraction of the more than $15 billion provided by the title I, part A program. Moreover, these costs are outweighed by the fact that for the vast majority of LEAs (i.e., the more than 90 percent of LEAs that are likely to already comply through the special rule), demonstrating compliance with the proposed regulations would be significantly less complex and burdensome than the supplement not supplant requirements of current law, which typically have involved detailed tracking of education expenditures in order to demonstrate that Federal title I funds are not supplanting State or local funds. Thousands of LEAs no longer would incur the annual costs of tracking, reporting, and auditing individual education expenditures that are the predominant practice for complying with supplement not supplant under current law. For all of these reasons, we believe the proposed regulations generally would not impose significant costs on either States or LEAs, and that for the minority of LEAs that do experience additional, mostly one-time implementation costs, such costs would be substantially offset by reduced administrative burdens once the proposed regulations are fully implemented.

    Equally important, the proposed regulations would provide a significant benefit for the vast majority of LEAs by simplifying and clarifying the test for compliance with the supplement not supplant requirement in the ESEA while ensuring that Federal education funds provided through the title I, part A program meet their statutory purpose of providing students in high-poverty schools the extra resources they need to meet challenging State academic standards.

    Clarity of the Regulations

    Executive Order 12866 and the Presidential memorandum “Plain Language in Government Writing” require each agency to write regulations that are easy to understand.

    The Secretary invites comments on how to make these proposed regulations easier to understand, including answers to questions such as the following:

    • Are the requirements in the proposed regulations clearly stated?

    • Do the proposed regulations contain technical terms or other wording that interferes with their clarity?

    • Does the format of the proposed regulations (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity?

    • Would the proposed regulations be easier to understand if we divided them into more (but shorter) sections? (A “section” is preceded by the symbol “§ ” and a numbered heading; for example, § 200.72 Supplement Not Supplant.)

    • Could the description of the proposed regulations in the SUPPLEMENTARY INFORMATION section of this preamble be more helpful in making the proposed regulations easier to understand? If so, how?

    • What else could we do to make the proposed regulations easier to understand?

    To send any comments that concern how the Department could make these proposed regulations easier to understand, see the instructions in the ADDRESSES section.

    Regulatory Flexibility Act Certification

    The Secretary certifies that these proposed regulations would not have a significant economic impact on a substantial number of small entities. Under the U.S. Small Business Administration's Size Standards, small entities include small governmental jurisdictions such as cities, towns, or school districts (LEAs) with a population of less than 50,000. Although the majority of LEAs that receive ESEA funds qualify as small entities under this definition, the proposed regulations would not have a significant economic impact on these small LEAs because they would not require the expenditure of additional State and local education funds, only that existing State and local funding be allocated fairly to all schools, including both title I and non-title I schools. The Department believes the benefits of this proposed regulatory action would outweigh the burdens on these small LEAs of complying with the proposed regulations. In particular, the proposed regulations would clarify the supplement not supplant requirements in the ESEA while ensuring that Federal education funds meet their statutory purpose. The proposed regulations recognize the circumstances that small LEAs might face with respect to supplement not supplant requirements, allowing an LEA that uses the “special rule” option to exclude from the calculation of its average per-pupil spending funds spent in a school that enrolls fewer than 100 students. The Secretary invites comments from small LEAs as to whether they believe the proposed regulations would have a significant economic impact on them and, if so, requests evidence to support that belief.

    Paperwork Reduction Act of 1995

    As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps ensure that: the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.

    Proposed § 200.72(b)(1)(i)(A) and § 200.72(b)(1)(ii)(C) contains an information collection requirements. Under the PRA, the Department has submitted a copy of these sections to OMB for its review.

    A Federal agency may not conduct or sponsor a collection of information unless OMB approves the collection under the PRA and the corresponding information collection instrument displays a currently valid OMB control number. Notwithstanding any other provision of law, no person is required to comply with, or is subject to penalty for failure to comply with, a collection of information if the collection instrument does not display a currently valid OMB control number.

    In the final regulations, we will display the control number assigned by OMB to any information collection requirements proposed in this NPRM and adopted in the final regulations.

    Proposed § 200.72(b)(1)(i)(A) would require each LEA to annually publish its methodology for allocating State and local funds in a manner easily accessible to the public. We estimate that during the three year period for which we seek information collection approval, 14,000 LEAs would devote five hours to publishing a methodology for allocating State and local funds. Therefore, we estimate for this section a total burden over three years for all respondents would be 70,000 hours, resulting in an average annual burden of 23,333 hours.

    Proposed § 200.72(b)(1)(ii)(C) would allow States to—at their discretion—submit an alternate funds-based compliance test for Federal peer review that then could be used by LEAs to demonstrate compliance with the proposed supplement not supplant requirements. We estimate over the three year period for which we seek information collection approval, 15 States would choose to submit an alternate funds-based compliance test for Federal peer review, and that each State would devote 48 hours to preparing and submitting the alternate funds-based compliance test. Therefore, we anticipate the total burden over three years for all respondents would be 720 hours, resulting in an average annual burden of 240 hours for this section. In total, we estimate a burden of 23,573 hours for this proposed regulation.

    Collection of Information Regulatory section Information collection OMB Control No. and estimated burden § 200.72(b)(1)(i)(A) This proposed regulatory provision would require each LEA to annually publish its methodology for allocating State and local funds OMB 1810-NEW. We estimate this would require 23,333 burden hours. § 200.72(b)(1)(ii)(C) This proposed regulatory provision would allow States to submit an alternate funds-based compliance test for Federal peer review OMB 1810-NEW. We estimate this would require 240 burden hours.

    If you want to comment on the proposed information collection requirements, please send your comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for U.S. Department of Education. Send these comments by email to [email protected] or by fax to (202) 395-6974. You may also send a copy of these comments to the Department contact named in the ADDRESSES section of this preamble.

    We have prepared an Information Collection Request (ICR) for this collection. In preparing your comments you may want to review the ICR, which is available at www.reginfo.gov. Click on Information Collection Review. This proposed collection is identified as proposed collection 1810-NEW.

    We consider your comments on this proposed collection of information in—

    • Deciding whether the proposed collection is necessary for the proper performance of our functions, including whether the information will have practical use;

    • Evaluating the accuracy of our estimate of the burden of the proposed collection, including the validity of our methodology and assumptions;

    • Enhancing the quality, usefulness, and clarity of the information we collect; and

    • Minimizing the burden on those who must respond. This includes exploring the use of appropriate automated, electronic, mechanical, or other technological collection techniques.

    OMB is required to make a decision concerning the collection of information contained in these proposed regulations between 30 and 60 days after publication of this document in the Federal Register. Therefore, to ensure that OMB gives your comments full consideration, it is important that OMB receives your comments by October 6, 2016. This does not affect the deadline for your comments to us on the proposed regulations.

    Intergovernmental Review

    This program is not subject to Executive Order 12372 and the regulations in 34 CFR part 79.

    Federalism

    Executive Order 13132 requires us to ensure meaningful and timely input by State and local elected officials in the development of regulatory policies that have federalism implications. “Federalism implications” means substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Although we do not believe the proposed regulations would have federalism implications, we encourage State and local elected officials to review and provide comments on these proposed regulations.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., Braille, large print, audiotape, or compact disc) on request to the person listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    List of Subjects in 34 CFR Part 200

    Education of disadvantaged, Elementary and secondary education, Grant programs—education, Indians—education, Infants and children, Juvenile delinquency, Migrant labor, Private schools, Reporting and recordkeeping requirements.

    Dated: August 26, 2016. John B. King, Jr., Secretary of Education.

    For the reasons discussed in the preamble, the Secretary proposes to amend part 200 of title 34 of the Code of Federal Regulations as follows:

    PART 200—TITLE I—IMPROVING THE ACADEMIC ACHIEVEMENT OF THE DISADVANTAGED 1. The authority citation for part 200 continues to read as follows: Authority:

    20 U.S.C. 6301-6576 (unless otherwise noted).

    2. Section 200.72 is revised to read as follows:
    § 200.72 Supplement not supplant.

    (a) In general. (1) An SEA or LEA—

    (i) Must use title I, part A funds only to supplement the funds that would, in the absence of the title I, part A funds, be made available from State and local sources for the education of students participating in title I programs; and

    (ii) May not use title I, part A funds to supplant the funds from State and local sources.

    (2) An LEA is not required under this section to—

    (i) Identify that an individual cost or service supported with title I, part A funds is supplemental; or

    (ii) Provide services with title I, part A funds through a particular instructional method or in a particular instructional setting.

    (b) Compliance—(1) Annual demonstration—(i) In general. To comply with paragraph (a) of this section, an LEA must annually—

    (A) Publish its methodology for allocating State and local funds in a format and language, to the extent practicable, that parents and the public can understand; and

    (B) Demonstrate, at such time and in such form as the SEA may reasonably require, that the methodology it uses to allocate State and local funds to each title I school ensures that the school receives all of the State and local funds it would otherwise receive if it were not a title I school.

    (ii) LEA options. In order to demonstrate that an LEA meets this requirement, the LEA must distribute almost all State and local funds available to the LEA in a way that meets one of the following tests:

    (A) Distribution of State and local funds based on characteristics of students. An LEA distributes State and local funds to its schools according to a consistent districtwide per-pupil formula based on the characteristics of students in each school, such that—

    (1) Students with characteristics associated with educational disadvantage, including students living in poverty, English learners, students with disabilities, and other such groups of students the LEA determines are associated with educational disadvantage, generate additional funding for their school; and

    (2) Each title I school receives for its use all of the funds to which it is entitled under the formula.

    (B) Distribution of State and local funds based on personnel and non-personnel resources. An LEA distributes State and local funds to its schools based on a consistent districtwide personnel and non-personnel resource formula such that each Title I school receives for its use an amount of actual State and local funds at least equivalent to the sum of—

    (1) The average districtwide salary for each category of school personnel (e.g., teachers, principals, librarians, school counselors), multiplied by the number of school personnel in each category assigned by the districtwide formula to the school; and

    (2) The average districtwide per-pupil expenditure for non-personnel resources, multiplied by the number of students in the school.

    (C) Distribution of State and local funds based on an SEA-established compliance test. (1) An LEA distributes State and local funds in a manner chosen by the LEA that—

    (i) Is applied consistently districtwide; and

    (ii) Meets a funds-based compliance test established by the SEA that is as rigorous as the approaches described in paragraph (b)(1)(ii)(A) or (B) of this section and has been approved through a Federal peer review process that relies upon peers such as professionals with expertise in school finance, State education officials, local education officials, and individuals who represent the interests of special populations of students. An SEA is not required to establish such a test; nor is an LEA required to use such a test if the LEA complies with paragraphs (b)(1)(ii)(A) or (B) or (b)(1)(iii) of this section.

    (2) A funds-based compliance test that is “as rigorous as the approaches described in paragraph (b)(1)(ii)(A) or (B)” is one that results in substantially similar amounts of State and local funding for title I schools in the district as would the use of approaches described in paragraph (b)(1)(ii)(A) or (B), as determined by a Federal peer review process.

    (iii) Special Rule. Notwithstanding paragraph (b)(1)(ii) of this section, an LEA may distribute State and local funds using any methodology that results in the LEA spending an amount of State and local funds per pupil in each title I school that is equal to or greater than the average amount of State and local funds spent per pupil in non-title I schools, as reported under section 1111(h)(1)(C)(x) of the ESEA.

    (A) De minimis annual variation. An LEA may be considered in compliance with the special rule in paragraph (b)(1)(iii) of this section in a specific year if the amount of State and local funds each title I school receives is no more than 5 percent less than the average amount received by non-title I schools in that year.

    (B) Schools with fewer than 100 students. In demonstrating compliance with the special rule in paragraph (b)(1)(iii) of this section, an LEA may exclude from its calculations any school that enrolls fewer than 100 students.

    (C) Demonstrating compliance. An LEA may demonstrate compliance with the special rule in paragraph (b)(1)(iii) of this section if it demonstrates to the SEA that—

    (1) One or more non-title I schools in the LEA receive additional funding to serve a high proportion of students with disabilities, English learners, or students from low-income families and these additional expenditures disproportionately affect the amount of State and local funds allocated, on average, to non-title I schools in the LEA or in a particular grade span within the LEA; and

    (2) Absent such school or schools, the LEA would be in compliance.

    (2) Flexibilities. (i) An LEA may demonstrate compliance with paragraph (b)(1) of this section on a districtwide or a grade-span basis.

    (ii) An LEA is not required to meet the requirements in paragraph (b)(1) of this section—

    (A) If it has a single school; or

    (B) In any grade span in which it has a single school.

    (iii) For purposes of demonstrating compliance under paragraph (b)(1) of this section, an LEA may exclude supplemental State or local funds expended for programs that meet the intent and purposes of title I, part A.

    (iv)(A) To the extent that an LEA spends State or local funds for districtwide activities, the LEA may exclude those funds from its demonstration of compliance with paragraph (b)(1) of this section, provided that each title I school receives a share of those activities equal to or greater than the share it would otherwise receive if it were not a title I school, and the LEA distributes to schools under paragraph (b)(1) of this section almost all of the State and local funds available to it for current expenditures as defined in section 8101(12) of the ESEA.

    (B) Districtwide activities—

    (1) May include, for example, districtwide administrative costs, districtwide programs such as summer school or preschool, and personnel providing districtwide services such as curriculum development or data analyses; but

    (2) May not include personnel or non-personnel resources associated with an individual school.

    (3) Transition timeline. (i) No later than December 10, 2017, an LEA must—

    (A) Demonstrate to the SEA that it has a methodology for allocating State and local funds to schools that meets the requirements in paragraph (b) of this section that the LEA will use no later than the 2018-2019 school year; or

    (B) Submit a plan to the SEA for how it will fully implement a methodology that meets the requirements in paragraph (b) of this section beginning no later than the 2019-2020 school year.

    (ii) Prior to either the 2018−2019 or 2019−2020 school year, as applicable under paragraph (b)(3)(i) of this section, an LEA may use either—

    (A) The method of compliance it will use to comply with paragraph (b) of this section; or

    (B) The method of compliance it used for complying with the applicable title I supplement not supplant requirement in effect on December 9, 2015.

    (4) Rules of construction. (i) Nothing in this section shall be construed to require the forced or involuntary transfer of any school personnel.

    (ii)(A) Nothing in this section shall be construed to require equalized spending per pupil for a State, LEA, or school.

    (B) Equalized spending per pupil means equal expenditures per pupil as reported under section 1111(h)(1)(C)(x) of the ESEA.

    (iii) Nothing in this section requires an LEA to adopt a specific methodology to allocate State and local funds to comply with the supplement not supplant requirement.

    (iv) Nothing in this section shall be construed to alter or otherwise affect the rights, remedies, and procedures afforded to school or LEA employees under Federal, State, or local laws (including applicable regulations or court orders) or under the terms of collective bargaining agreements, memoranda of understanding, or other agreements between such employers and their employees.

    (Authority: 20 U.S.C. 6321(b) and (d))
    [FR Doc. 2016-20989 Filed 9-2-16; 8:45 am] BILLING CODE 4000-01-P
    POSTAL SERVICE 39 CFR Part 501 Revisions to the Requirements for Authority To Manufacture and Distribute Postage Evidencing Systems AGENCY:

    Postal ServiceTM.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Postal Service proposes a further revision to the rules concerning PC postage payment methodology. This change would add supplementary information to clarify the revenue assurance guidelines.

    DATES:

    Submit comments on or before October 6, 2016.

    ADDRESSES:

    Mail or deliver written comments to the Manager, Payment Technology, U.S. Postal Service®, 475 L'Enfant Plaza SW., Room 3500, Washington DC 20260. You may inspect and photocopy all written comments at the Payment Technology office by appointment only between the hours of 9 a.m. and 4 p.m., Monday through Friday by calling 1-202-268-7613 in advance. Email and faxed comments are not accepted.

    FOR FURTHER INFORMATION CONTACT:

    Marlo Kay Ivey, Business Systems Analyst, Payment Technology, U.S. Postal Service, (202) 268-7613.

    SUPPLEMENTARY INFORMATION:

    On July 17, 2015, the United States Postal Service published a final rule to revise the rules concerning authorization to manufacture and distribute postage evidencing systems and to reflect new revenue assurance practices (80 FR 42392). Postage collection under the new rules will start on March 20, 2017. This document proposes additional changes with regard to revenue assurance which would support our efforts to collect the appropriate revenue on mail pieces in a more automated fashion. If adopted, the proposed clarifying changes would also be implemented on March 20, 2017. The revenue assurance guidelines can be found in 39 CFR 501.16, and on https://ribbs.usps.gov in the site index of Automated Package Verification (APV) documents, named APV Standard Operating Procedure (SOP).

    List of Subjects in 39 CFR Part 501

    Administrative practice and procedure.

    Accordingly, for the reasons stated, the Postal Service proposes to amend 39 CFR part 501 as follows:

    PART 501—AUTHORIZATION TO MANUFACTURE AND DISTRIBUTE POSTAGE EVIDENCING SYSTEMS 1. The authority citation for 39 CFR part 501 continues to read as follows: Authority:

    5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 404, 410, 2601, 2605, Inspector General Act of 1978, as amended (Pub. L. 95-452, as amended); 5 U.S.C. App. 3.

    2. In § 501.16, revise paragraph (i) to read as follows:
    § 501.16 PC postage payment methodology.

    (i) Revenue assurance. (1) The PC Postage provider must support business practices to assure Postal Service revenue and accurate payment from customers. For purposes of this paragraph and the Automated Package Verification (APV) Standard Operating Procedure (SOP) document available at https://ribbs.usps.gov/index.cfm?page=apvs, PC Postage provider and PC Postage vendor shall mean providers who offer PC Postage products (as such terms are defined in § 501.1) and shall also include Click-N-Ship and postage resellers when such resellers transmit postage revenue to the Postal Service in any manner other than through a PC Postage provider. With respect to such transactions, the resellers, and not the PC Postage providers who provide the labels, are responsible for complying with this paragraph. For the purpose of this paragraph, a reseller is an entity that obtains postage through a PC Postage provider and is authorized to resell such postage to its customers pursuant to an agreement with the Postal Service. For example, an entity that sells postage to its customers, but uses a PC Postage provider to enable its customers to print postage labels, is a “reseller” hereunder. If that entity collects postage revenue from its customers and transmits it to the Postal Service directly (instead of through the PC Postage provider) that entity shall be deemed a “PC Postage provider” hereunder.

    (2)(i) For the purposes of this paragraph, a postage adjustment is defined as the difference between the postage or fee paid for a service offered by the Postal Service and the published or negotiated rate for that service indicating the postage due to the Postal Service, at the time the mail piece is entered into the mailstream.

    (ii) When the collection of a postage adjustment or the provision of a refund is appropriate because a customer has underpaid or overpaid the amount of postage that should have been paid, and such postage adjustment exceeds a threshold amount to be set by the Postal Service from time to time in its sole discretion, the PC Postage provider shall, upon the Postal Service's request, take steps to pay, collect, or refund, as applicable, the postage adjustment. The Postal Service will supply the PC Postage provider with the details necessary to explain the correction and the amount of the postage adjustment to be used in the adjustment process. As part of this process, the PC Postage provider shall enable customers to submit electronic disputes of postage collections to the Postal Service.

    (iii)(A) In the case of an underpayment that exceeds the threshold amount, the PC Postage provider is required to pay the postage adjustment directly to the Postal Service; notify the customer and take steps to collect the postage adjustment, including but not limited to adjusting the funds available to the customer in the Postage Evidencing System; or (if directed by the Postal Service) facilitate customer payment by invoicing the customer or using other methods available to access funds of the customer.

    (B) In the case of an overpayment that exceeds the threshold amount, the PC Postage provider is required to notify the customer and take steps to refund the postage adjustment or provide a credit to the customer.

    (C) In either case, the PC Postage provider is required to address any postage discrepancies within a time period to be set by the Postal Service not to exceed 60 calendar days after initial notification by the Postal Service, subject to any applicable notification periods and dispute mechanisms that may be available to customers for these corrections.

    (iv)(A) When an underpayment has occurred, the PC Postage provider shall prohibit the customer from printing additional postage labels until the postage adjustment is satisfied. The Postal Service may, in its sole discretion, waive or delay this prohibition in specific instances.

    (B) Separately, in certain cases, such as where a customer is suspected of having intentionally or repeatedly underpaid postage, the Postal Service may, in its sole discretion, instruct the PC Postage provider to temporarily suspend or permanently shut down a customer's ability to print PC Postage, and the PC Postage provider shall promptly comply with such instruction.

    (v) The Postal Service, in its sole discretion, may adopt and modify from time to time, and the PC Postage providers shall comply with, business rules, developed in conjunction with the PC Postage providers setting forth processes (including time constraints) for payments, refunds, collections, notifications, dispute resolutions and other activities to be performed hereunder.

    (3)(i) Without regard to any threshold, if the PC Postage provider incorrectly programmed postage rates, delayed programming postage rate changes, or otherwise provided systems or software which caused customers to pay incorrect postage amounts, then within two calendar weeks of the PC Postage provider being made aware of such error, the PC Postage provider shall:

    (A) Correct the programming error; and

    (B) Provide the Postal Service with a detailed breakdown of how the error affected the PC Postage provider's collection of revenue.

    (ii) Without regard to any threshold, in the event of an underpayment, the PC Postage provider shall pay the Postal Service for the postage deficiency, except in instances where the error was caused by the Postal Service.

    (4) The PC Postage provider is responsible for ensuring that:

    (i) All customers pay (and the Postal Service receives) the current published prices or their negotiated contracted prices that are available to mailers who purchase postage through an approved PC Postage provider, in accordance with this paragraph; and

    (ii) All payments to the Postal Service (or the log files necessary for the Postal Service to collect payments directly from customers) are complete and accurate and are initiated or transmitted, as applicable, to the Postal Service each day.

    (5) Each PC Postage provider:

    (i) Is responsible for informing customers and obtaining electronic acceptance from customers to ensure that customers are informed, understand and agree to these payment terms, including that customers may be charged for deficient payments before their initial software installation is completed;

    (ii) Shall comply with applicable laws, rules and regulations and ensure that its Postage Evidencing System, software, interfaces, communications and other properties that are used to sell or market postal products accurately describe such products;

    (iii) Shall cover any costs that the Postal Service may incur as a result of such PC Postage provider or its employees, contractors, or representatives failing to comply with the terms of this section; or any applicable law, regulation, rule, or government policy; and

    (iv) In performing its obligations hereunder, shall comply with the APV SOP and all agreed-to interface documentation (as updated from time to time).

    Stanley F. Mires, Attorney, Federal Compliance.
    [FR Doc. 2016-21258 Filed 9-2-16; 8:45 am] BILLING CODE 7710-12-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 217 [Docket No. 160405311-6664-01] RIN 0648-BF95 Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Rehabilitation of the Jetty System at the Mouth of the Columbia River: Jetty A, North Jetty, and South Jetty, in Washington and Oregon; Correction AGENCY:

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

    ACTION:

    Proposed rule; correction; extension of public comment period.

    SUMMARY:

    This document corrects a typographical error in the ADDRESSES section to a proposed rule published on August 25, 2016.

    DATES:

    Comments on the proposed rule must be submitted no later than October 6, 2016.

    ADDRESSES:

    You may submit comments on this document identified by NOAA-NMFS-2016-0108, by any of the following methods:

    Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov, enter NOAA-NMFS-2016-0108 in the “Search” box, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910.

    Instructions: Comments must be submitted by one of the above methods to ensure that the comments are received, documented, and considered by NMFS. 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. 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, etc.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    FOR FURTHER INFORMATION CONTACT:

    Rob Pauline, NMFS, (301) 427-8408, [email protected]

    SUPPLEMENTARY INFORMATION:

    Need for Correction

    In the ADDRESSES section of a proposed rule (81 FR 58443; August 25, 2016) on page 58443, in the first column, NMFS used an incorrect document identifier number “NOAA-NMFS-2014-0144” rather than the correct document identifier of “NOAA-NMFS-2016-0108” in the Federal e-Rulemaking Portal hyperlink. The ADDRESSES section has been corrected in this document.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 30, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2016-21275 Filed 9-2-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 151116999-6759-01] RIN 0648-BF52 Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Electronic Monitoring Program AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes approval of, and regulations to implement, measures in a regulatory amendment to the Pacific Coast Groundfish Fishery Management Plan (FMP). The regulatory amendment was developed by the Pacific Fishery Management Council (Council) to implement an electronic monitoring (EM) program for two sectors of the limited entry trawl fishery. The regulatory amendment proposes to allow catcher vessels in the Pacific whiting fishery and fixed gear vessels in the shorebased Individual Fishing Quota (IFQ) fishery to use EM in place of observers to meet the requirements of the Trawl Rationalization Program for 100-percent at-sea observer coverage. This action is intended to increase operational flexibility and reduce monitoring costs for vessels in the trawl fishery by providing an alternative to observers. Data from the EM program would be used to debit discards of IFQ species from IFQs and mothership cooperative allocations. The regulatory amendment would establish an application process for interested vessel owners, performance standards for EM systems, requirements for vessel operators, and a permitting process and standards for EM service providers. The regulatory amendment would also establish requirements for processors (first receivers) for receiving and disposing of prohibited and protected species from EM trips.

    DATES:

    Comments must be received by October 6, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2016-0115, 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-2016-0115, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Barry Thom, Acting Regional Administrator, West Coast Region, NMFS, 7600 Sandpoint Way NE., Seattle, WA 98115-0070; Attn: Melissa Hooper.

    Fax: 206-526-4461; Attn: Melissa Hooper.

    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, etc.), 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).

    Copies of the regulatory amendment and draft analysis prepared by the Council are available from Chuck Tracy, Executive Director, Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384. The Regulatory Impact Review (RIR), draft environmental assessment (EA), and Initial Regulatory Flexibility Analysis (IRFA) prepared for this action are accessible via the Internet at http://www.westcoast.fisheries.noaa.gov/fisheries/groundfish_catch_shares/electronic_monitoring.html. The IRFA assessing the impacts of the proposed measures on small entities and describing steps taken to minimize any significant economic impact on such entities is summarized in the Classification section of this proposed rule. Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule should be submitted to the Acting Regional Administrator at the address above and to the Office of Management and Budget (OMB) by email to [email protected], or fax to (202) 395-7285.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Hooper, Fishery Policy Analyst, phone: 206-526-4357, fax: 206-526-4461.

    SUPPLEMENTARY INFORMATION: Background

    The Pacific Coast Groundfish FMP specifies management measures for over 90 different species of rockfish, flatfish, roundfish, sharks, skates, and other species, in Federal waters off the West Coast states. Target species in the commercial fishery include Pacific hake (whiting), sablefish, dover sole, and rockfish, which are harvested by vessels using primarily midwater and bottom trawl gear, but also fish pots and hook and line. The trawl fishery is managed under a catch share program called the Trawl Rationalization Program, which was implemented through Amendment 20 to the FMP in January 2011. The Program consists of an IFQ program for the shorebased trawl fleet (including whiting and non-whiting sectors), and cooperatives for the at-sea mothership and catcher/processor trawl fleets (whiting only). Concurrently, Amendment 21 established long-term allocations of certain groundfish species for the limited entry trawl sectors, which are used to determine what proportion of each species individual cooperatives and vessels can harvest. Annual catch limits are set on a two-year cycle through the biennial harvest specifications process. The 2017-2019 harvest specifications are under development by the Council and NMFS and intended to take effect January 1, 2017.

    As part of the catch share program, Amendment 20 implemented requirements for 100 percent monitoring at-sea and dockside in order to ensure accountability for all landings and discards of allocated species. Catcher processors and motherships are required to carry two observers at all times, depending on the length of the vessel, and catcher vessels are required to carry one observer, including while in port until all fish are offloaded. In addition, first receivers, which are processors that are licensed to receive IFQ landings, are required to have catch monitors to monitor 100-percent of IFQ offloads. Vessel owners and first receivers are responsible for obtaining and funding catch share observers and catch monitors as a necessary condition of their participation in the program. However, NMFS subsidized the cost of observers for the first 5 years of the program to assist the industry in transitioning to the catch share program. The amount of the subsidy declined each year and ended in September 2015.

    Faced with the costs of 100-percent monitoring, the industry raised concerns about their ability to support these costs and the need for an alternative to meet the monitoring requirements of the program. EM uses cameras and associated sensors to passively record and monitor fishing activities. The video can be reviewed by an analyst onshore at a later time to collect catch and effort information. EM has the potential to reduce monitoring costs because it does not require deploying a person on the vessel and the logistical and travel expenses that generates. EM was tested by the whiting fishery through Exempted Fishing Permits (EFPs) from 2004 to 2011 and by the Pacific States Marine Fisheries Commission (PSMFC) in the whiting fishery and with other gear types in 2012-2014. EM has been successfully deployed in British Columbia, Canada, to monitor fishing operations, and more recently in the U.S. Atlantic highly migratory species (HMS) fishery.

    In response to industry's concerns, the Council initiated development of a regulatory amendment in November 2012 to implement an EM program for the shorebased and mothership sectors that would allow catcher vessels to use EM in place of observers to meet the at-sea monitoring requirements of the catch share program. Prior to Amendment 20, the Council had been developing an EM program for the Pacific whiting fishery in Amendment 10, but had set the action aside to prioritize work on the catch share program. The Council incorporated the Amendment 10 program in Amendment 20, making the whiting fishery a maximized retention fishery (all catch, with few exceptions, must be landed), and allowing for EM to be used in place of observers. However, the requirements of the EM program were not sufficiently developed to be implemented with the rest of the catch share program at that time. This regulatory amendment would specify the detailed requirements necessary to implement this provision of Amendment 20 for two components of the trawl fishery—catcher vessels using midwater trawl gear to target whiting in the mothership and shorebased sectors and trawl-permitted vessels using fixed gear to target other species in the shorebased sector. The regulatory amendment originally contemplated measures for all gear types, but the Council chose to postpone measures for bottom trawl and non-whiting midwater trawl vessels to a subsequent action to allow more time for development and analysis.

    The Council had completed development of these measures in 2014, but postponed final action and instead approved four EFPs to test the proposed measures in the fishery. These EFPs would be used to provide data to analyze the effectiveness of the measures and to develop detailed requirements and procedures that would be necessary to implement the program. NMFS approved and issued the EFPs in May, 2015. A total of 34 vessels using a range of gear types participated in 2015, and 47 signed up in 2016. The Council reviewed the results of the 2015 EFPs at their meetings during the fall 2015-spring 2016 and took final action on the measures for whiting and fixed gear vessels at their April, 2016 meeting. Implementation of this action is targeted for November, 2016, with the intent for vessels to begin fishing with EM under the regulations in January, 2017.

    Proposed Measures

    The measures proposed by the regulatory amendment are described below. To implement these measures NMFS is proposing to revise the trawl fishery regulations in §§ 660.13, 660.19, 660.130, 660.140, and 660.150, to allow for vessel owners to use EM in place of an observer and establishes new regulations in §§ 660.600-660.604 governing its use. The proposed regulations were deemed by the Council to be consistent with the regulatory amendment and necessary to implement such provisions pursuant to section 303(c) of the Magnuson-Stevens Act through an August 16, 2016, letter from the Council Chairman to the NMFS Regional Administrator.

    1. Overview of the EM Program

    The regulatory amendment proposes to implement an EM program for Pacific whiting catcher vessels in the shorebased and mothership sectors and fixed gear vessels in the shorebased sector of the groundfish fishery. Vessel owners would be able to apply to NMFS to receive an exemption from the 100-percent observer coverage requirement, provided that they use an EM system and follow the catch handling, reporting, and other requirements of the EM program. Vessel owners authorized to use EM would be required to obtain an EM system from a NMFS-permitted service provider, as well as services to install and maintain the EM system, and to process, store, and report EM data to NMFS. Vessel operators would be required to submit a logbook reporting their discards of IFQ species. NMFS would use the logbook data to debit discards of IFQ species from IFQs and cooperative allocations, and use the EM data to audit the logbook data. EM data would also be used to monitor compliance with the requirements of the catch share program. NMFS's incremental costs to administer the EM program would be recoverable through Trawl Program cost recovery fees. The requirements of the program for vessel owners, operators, first receivers, and service providers, are described in more detail in the following sections.

    As proposed in the Council's regulatory amendment, vessel owners would be responsible for the costs of procuring EM equipment and services from NMFS-permitted EM service providers. However, NMFS is still developing the standards and protocols that it would use to oversee service providers processing the EM data to ensure adequate data quality. Therefore, NMFS intends to conduct the data processing itself during 2017-2019 through PSMFC, contingent on available appropriations. Provided NMFS has sufficient funding, during 2017-2019 vessel operators would be responsible for procuring EM equipment and maintenance services from EM service providers. The requirement for vessel owners to obtain and fund data processing, storage, and reporting services would take effect January 1, 2020. This phased approach is reflected in the proposed regulations. In addition, because NMFS's ability to fund the video review is contingent upon appropriations which are not guaranteed, NMFS retains the ability in the regulations to implement the requirement for vessel owners to obtain data services earlier. In such a case, NMFS would provide at least six months prior notice to service providers and vessel owners before implementing the requirements.

    In the proposed EM program, vessel operators would submit logbook reports which would be used initially to debit discards from IFQ vessel accounts and cooperative allocations. The video would later be reviewed by an analyst to determine an estimate of discards to use to audit the logbook reports. The Council also considered using EM discard estimates as the primary source for debiting discards in the whiting fishery, because it was thought that logbooks would be an unnecessary burden to vessels operators in the whiting fishery where estimating discards from the video is relatively quick. In addition, whiting industry representatives supported reviewing 100-percent of the video, and logbooks are primarily employed to allow a subsample of video to be reviewed in an audit model. However, through the 2015 EFPs, the Council and NMFS realized the value of the logbooks for communication between the vessel operator and the video reviewer about system malfunctions, for data quality assurance, and for aligning discard estimates. Therefore, the Council proposed a logbook audit model for both fixed gear and whiting vessels.

    The Council proposes that initially 100 percent of the video be reviewed to audit the logbooks, but that NMFS may modify this percentage over time based on performance and in consultation with the Council. The Council also considered requiring 100 percent of the video to always be reviewed, because it would provide more certainty for discard estimates than extrapolating total discards from a subsample. However, reviewing 100 percent of the video is generally more costly than reviewing a subsample and erodes the potential savings that EM can provide relative to observers. For this reason, other EM programs implemented to date, such as the U.S. Atlantic HMS, British Columbia groundfish, and Australian programs, review a percentage of the video to audit vessel reports. Because an objective of the regulatory amendment was to reduce monitoring costs for the fleet, the Council also selected an audit approach for the west coast EM program. However, the Council also tied the level of review to program performance to ensure that data quality for catch accounting is maintained.

    Discards estimated by the EM program, from logbook or EM data, would be debited from IFQs and cooperative allocations. The Council considered other alternatives for whiting trips that would have deducted small amounts of discards from ACLs, sector-wide, or cooperative allocations, preseason using estimates developed from historical observer data. It was believed that allowing video reviewers to ignore many small events during the video review might expedite the video review and reduce data processing costs. However, through the 2015 EFPs, the Council and NMFS learned that whiting hauls can be reviewed very quickly and that eliminating these discard events from review would not result in much cost savings. Therefore, the Council proposed debiting all discards from IFQs and cooperative allocations to provide the strongest incentive to minimize bycatch and discards.

    Under the proposed EM program, Pacific halibut discards would be debited using discard mortality rates rather than viability assessments. Currently, observers on IFQ trips conduct viability assessments of all or a subsample of discarded halibut, which are a bycatch species in the groundfish fishery. Observers assign a score to the discarded halibut based on the results of the viability assessment which are used as an indication of whether the halibut is likely to survive after release. Based on the score given, a portion of the halibut's weight, rather than the total weight, may be deducted from a vessel's halibut Individual Bycatch Quota (IBQ). Observers will no longer be present to conduct viability assessments on EM trips, so NMFS would instead use discard mortality rates developed by the International Pacific Halibut Commission (IPHC) to deduct halibut IBQ from vessel accounts (18 percent for pots, 16 percent for longline, and 100 percent for midwater trawl). The West Coast Groundfish Observer Program (WCGOP) currently uses these rates to estimate mortality of halibut caught as bycatch in other west coast fisheries that have less than 100-percent observer coverage. PSMFC is currently conducting a study on bottom trawl trips to determine if viability can be estimated from information that can be collected from EM and logbooks. NMFS may revise the discard mortality rates at a future time to incorporate the results of this project or other new information, in consultation with the IPHC, to continue to use the best scientific information available to estimate halibut mortality.

    Although vessel owners would be exempt from the requirement to obtain a catch share observer while using EM, vessel owners would still be required to carry an observer if requested by NMFS. Prior to the catch share program, NMFS deployed WCGOP observers on a percentage of trips in the trawl fishery to collect information for estimating mortality and bycatch, and to collect biological samples and other information. When the catch share program was implemented with a requirement for 100-percent industry-funded observer coverage, NMFS suspended its WCGOP coverage and reallocated these resources to monitor other fisheries; the catch share observers were able to serve dual purposes, collecting the information necessary to monitor compliance with the catch share program as well as other information such as biological samples and bycatch data. With the implementation of EM, NMFS is reinstituting the WCGOP coverage in the trawl fishery for EM trips. The EM program is intended to monitor discards of IFQ species for catch accounting, as well as compliance with the regulations. The EM program is not intended to collect all the other information that an observer collects, such as biological samples and bycatch information. Therefore, NMFS would use WCGOP coverage to continue to collect such information from the trawl fishery for use in groundfish mortality and bycatch estimates, stock assessments, and the standardized bycatch reporting methodology (SBRM). At this time, NMFS intends to deploy WCGOP observers on fixed gear trips, but not whiting trips because bycatch rates in the whiting fishery are low and nearly all catch is delivered and sampled by port samplers and mothership observers. However, NMFS would retain the authority in the regulations to deploy observers on whiting trips in a future fishing year with prior notice, if it was determined to be necessary.

    2. Measures for Which NMFS Is Specifically Requesting Comments Catch Retention Requirements

    Under the proposed EM program, whiting vessels would continue to fish under the maximized retention requirements implemented in Amendment 20. However, NMFS is proposing to clarify the existing definition of “maximized retention” for the purposes of the EM program to make clear what types of discards are allowed (see proposed 50 CFR 660.604(p)(1)). The following discards would be permitted on whiting trips as “minor operational discards”: Mutilated fish, large animals (longer than 6 feet (1.8 meters) in length), fish spilled from the codend during transfer to the mothership, fish picked from the gear or washed from the deck during cleaning, and fish vented from an overfull codend. Discards of invertebrates, trash, and debris, and discard events outside the control of the vessel operator would also be allowed. Minor operational discards would not include discards as a result from taking more catch than is necessary to fill the hold (a.k.a. “topping off”), which would continue to be prohibited. Minor operational discards would also not include discards of fish from a tow that was not delivered. This occurs when there is not enough catch worth delivering to a mothership, or not of the desired species composition, sometimes called “test tows” or “water tows.” These discards are currently allowed if first sampled by an observer, but in an EM program, an observer would no longer be onboard to sample the catch before discarding. In addition, as no catch from the haul would be delivered to either a mothership or a plant, there would be no species composition to extrapolate to the discarded weight. Because these tows can sometimes include overfished or endangered species, these discards will be prohibited under the EM program. All discards, regardless of the source, would be required to be reported in a discard logbook and included in mortality estimates or debited from allocations (for IFQ species).

    This revised definition was not included in the version of the regulations that the Council deemed, because the need for clarification was not clear to NMFS until after the April Council meeting. Therefore, NMFS is proposing to revise the definitions here using its authority under section 305(d) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), which allows the Secretary of Commerce to implement regulations necessary to ensure that fishery management plans or amendments are carried out consistent with the Magnuson-Stevens Act. NMFS is specifically requesting comment on this proposed definition.

    NMFS is also requesting comment on catch retention rules for fixed gear vessels. The Council's regulatory amendment proposed “optimized retention” for fixed gear vessels, in which vessels would be able to discard any species that could be differentiated on camera. The measure provided for the list of allowable discard species to be revised as technology and methods improve through the “routine process” under the FMP (see § 660.60(c)). At the time of the Council's final action, NMFS only had data from the 2015 EFPs in which fixed gear vessels tested maximized retention, retaining all catch until landing. NMFS was proposing to allow fixed gear vessels to test optimized retention in 2016, but the results were not yet available. As a result, the proposed regulations reflect the more conservative, and restrictive, maximized retention rules that were based on 2015 EFP results and that were deemed by the Council (see proposed § 660.604(p)(2)). Under the maximized retention option, fixed gear vessels would be required to retain IFQ species salmon, and non-IFQ rockfish, flatfish, and roundfish.

    However, NMFS is also considering the optimized retention option and seeks public comment on both options. Under the optimized retention option, fixed gear vessels may discard all fish, except salmon. NMFS will select a final option, based on public comment and the results of the 2016 EFPs, in the final rule, if the proposed measures are approved. Under either option, fixed gear vessels would be required to retain salmon in order to ensure complete accounting for the incidental take statement (ITS), although fixed gear vessels rarely catch salmon.

    Switching Between Observers and EM

    The Council proposed a limit on the number of times a vessel may switch between using observers and using EM in the same year. Observer providers and the WCGOP expressed concerns during the development of the regulatory amendment that some vessels may try to maximize their flexibility by using an observer on some trips and EM on others. It may be advantageous for a captain to use an observer where they have higher bycatch of a species they would like to discard, and EM on other trips with lower bycatch. Observer providers and WCGOP try to match the number of trained observers and their distribution across ports to the needs of the fleet. Frequent switching would disrupt deployment planning for observers and potentially result in observers not being available when needed in a particular port. Although it is in a vessel owner's interest to plan ahead with their provider in order to ensure an observer is available to meet their needs, this does not always occur. The Council considered alternatives for limiting switching in order to minimize disruption.

    During the Council's consideration of final action for fixed gear, NMFS proposed that vessel owners submit a tentative fishing plan each year that would describe their intentions to use EM or observers for the upcoming fishing year. The WCGOP and observer providers could then use this information for planning purposes. The fishing plan would not be binding on vessel owners, maintaining their operational flexibility, but would provide the information needed for planning observer demand. The Council supported this idea and, therefore, recommended no limit on switching for fixed gear vessels. However, the Council did not make this change to the whiting alternatives and, as a result, the proposed regulations include a limit on switching for whiting vessels (see proposed § 660.604(m). Whiting industry members did not anticipate switching between observers and EM and so did not oppose this measure at the April meeting.

    NMFS believes the proposed limit on switching for whiting may be ineffective at preventing disruptions to observer planning, because it would still allow for last-minute switching. NMFS believes requiring whiting vessel owners to submit a tentative fishing plan as for fixed gear vessels would provide the information NMFS needs and with more notice. NMFS believes not revising this alternative for whiting was an oversight by the Council and is concerned there is a not a clear rationale for why this limit should be implemented for whiting, but not fixed gear vessels. Therefore, NMFS is specifically requesting comments on having a limit on switching for the whiting fishery and, if there is a limit, whether twice a year is an appropriate limit (with additional exceptions for EM system malfunctions).

    Video Data Retention

    As part of the data services provided to vessel owners by EM service providers beginning in 2020, EM service providers would be required to maintain records and EM data for a minimum of three years (see proposed § 660.603(m)(6)). Vessel owners would be responsible for the costs of this data storage, along with the other services rendered by the EM provider, as a condition of their participation in the program. This measure was discussed at the November 2015 and April 2016 Council meetings. NMFS initially recommended a five year retention period, based on the five year statute of limitations for violations of the Magnuson-Stevens Act, to provide NMFS and law enforcement personnel sufficient time to review discard data reported by vessels and service providers, detect compliance issues, and to determine if any of the video should be retained for additional time and uses. Some industry members are concerned about the costs of storing such a large amount of video data, as well as the potential for enforcement personnel or other entities to access it for other purposes. They would prefer the video data be destroyed after one year, and only the reports resulting from the video review be retained. As a compromise, NMFS proposed and the Council supported a three year retention period in the draft regulations. However, the Council also recommended that NMFS review this requirement before 2020 to determine if it can be reduced. NMFS is specifically requesting comment on whether a one, three, or five year, retention period is appropriate for video data.

    3. Vessel Owner Responsibilities

    Vessel owners interested in using EM would be required to obtain authorization from NMFS. There would be a two-step application process, starting with an initial application that NMFS would use to assess a vessel owner's eligibility (see proposed § 660.604(e)). After reviewing the application, NMFS would notify the vessel owner of their eligibility to use EM and to submit a final application. The final application would include a form signed by a representative of the EM service provider certifying that the EM system was installed according to the performance standards in the regulations (see proposed §§ 660.604(e)(3)(i) and 660.604(j)). The final application would also include a tentative fishing plan (see proposed § 660.604(e)(3)(ii)), which would be used by NMFS to plan WCGOP sampling and observer deployments, and a vessel monitoring plan (VMP), which would document the configuration of equipment and catch handling protocols on that particular vessel (see proposed § 660.604(e)(3)(iii)). NMFS would notify the vessel owner of its final decision after reviewing the final application and, if approved, issue the vessel an EM authorization. If an initial or final application is denied, a vessel owner would be able to appeal NMFS's decision following the permits appeals process at § 660.25(g). The EM authorization would be effective until a change in vessel ownership, until NMFS notifies the owner that they are no longer eligible for it, or if the vessel owner fails to renew it. The EM authorization would be automatically renewed provided a vessel owner submits a renewal form verifying their vessel monitoring plan and providing an updated fishing plan. If a renewal form is not submitted, the authorization would expire on December 31 of that year.

    NMFS is proposing that vessel owners that participated in the EM EFPs only be required to complete a renewal form, because NMFS already has vessel monitoring plans and a performance history for these vessels, making a complete application process unnecessary. If approved, NMFS would mail renewal forms to EFP vessel owners upon publication of the final rule. New vessel owners interested in using EM in 2017 would be required to submit an application after publication of the final rule. Draft application materials may be viewed on the West Coast Region's Web site: http://www.westcoast.fisheries.noaa.gov/fisheries/groundfish_catch_shares/electronic_monitoring.html.

    NMFS would develop and maintain EM Program Guidelines, which would document best practices and other information that NMFS would use to evaluate vessel monitoring plans submitted by vessel owners (see proposed § 660.600(b)). New applicants for an EM authorization this fall may view draft EM Program Guidelines on the West Coast Region's Web site: http://www.westcoast.fisheries.noaa.gov/fisheries/groundfish_catch_shares/electronic_monitoring.html. The draft guidelines provide guidance and a template for developing individual vessel monitoring plans.

    Vessel owners would be able to make changes to the vessel monitoring plan at any time by submitting an amendment to NMFS (see proposed § 660.604(f)). The vessel monitoring plan is intended to be a living document and would be modified over time to reflect changes to the vessel's equipment and operations, provided that NMFS has accepted the amendments in writing.

    4. Vessel Operator Responsibilities

    An operator of a vessel with EM would be required to attend a mandatory training on EM requirements prior to beginning fishing with EM (see proposed § 660.604(b)(5)). NMFS may waive this requirement on a case-by-case basis, such as for those captains that successfully participated in the EM EFP. Vessel operators would also be required to maintain the EM system in good working order, including ensuring the EM system is powered and functioning throughout the trip, keeping cameras clean and unobstructed, and ensuring the system is not tampered with (see proposed § 660.604(l)(1). The vessel operator would be required to declare their intent to use EM to the Office of Law Enforcement (OLE) via the existing declaration process at § 660.13(d)(5) (also see proposed § 660.604(m)). The vessel operator would also be required to notify WCGOP 48-hours before each EM trip for purposes of planning observer coverage (see proposed § 660.604(n)). If selected to carry an observer, the vessel operator would not be able to depart on the trip without the observer, and would be required to accommodate the observer on that trip. The vessel operator would also be required to conduct a system functionality test before each trip to ensure the EM system is working properly before departing (see proposed § 660.604(l)(2)). If the EM system malfunctions, a vessel operator may be prevented from fishing or required to return to port until the EM system is repaired, depending on the nature of the malfunction (see proposed § 660.604(l)(3)). An EM vessel would not be allowed to fish with an EM system that is not able to record fishing activity, unless an observer is onboard. A vessel operator would always be allowed to obtain an observer at their own expense to continue fishing while the EM system is repaired. The vessel operator would also be responsible for ensuring the crew follow the catch handling instructions in the VMP (see proposed § 660.604(r)), for completing a logbook for each trip and submitting logbooks and hard drives to PSMFC according to the deadlines in the regulations (see proposed § 660.604(s)), and maintaining records for a minimum of three years (see proposed § 660.604(t)).

    5. First Receiver Responsibilities

    First receivers would be required to sort and dispose of any prohibited or protected species retained by EM vessels (see proposed § 660.604(u)). First receivers already have such disposition requirements for landings from Pacific whiting maximized retention trips. This action would expand the existing whiting sorting and disposition requirements to landings from all EM trips, including fixed gear trips. The first receiver would be required to do the following:

    • Record all prohibited species on the electronic fish ticket and provide them to the catch monitor for recording.

    • Dispose of prohibited and protected species in a manner that ensures it will not enter a commercial market.

    • Sort eulachon and green sturgeon to species and report them on the electronic fish ticket. Whole green sturgeon would be required to be transferred to the NMFS Southwest Fisheries Science Center within 72-hours.

    • Report and surrender albatross to the U.S. Fish and Wildlife Service (FWS).

    • Report and surrender marine mammals and sea turtles to NMFS.

    Neither prohibited nor protected species would be allowed to be retained for personal use, including by a vessel owner or crew member, or first receiver or processing crew member. Prohibited species suitable for human consumption may be donated if appropriate to a surplus food collection and distribution system or nonprofit charitable organization for the purpose of reducing hunger and meeting nutritional needs.

    6. EM Service Provider Responsibilities

    EM service providers interested in supplying EM equipment and services to the fishery would be able to apply to receive a permit from NMFS. A service provider would be able to apply to NMFS by submitting an application package that contains, among other things, information about the company's organizational structure, prior experience, criminal convictions, conflicts of interest, and an EM service plan describing how the EM service provider proposes provide services to the fishery to meet the requirements of the program (see proposed § 660.603(b)). The EM service plan contains a number of components (see proposed § 660.603(b)(1)(vii)), including a description of the applicant's plan for provision of services, communications, procedures for hiring and training staff, and procedures for tracking hard drives, data processing, reporting, archiving EM data. The EM Service Plan would also include detailed descriptions of the EM system to be deployed and software to be used for analysis. An applicant may be required to provide NMFS with copies of the equipment and software for testing and evaluation (see proposed § 660.603(b)(1)(viii)). NMFS would evaluate the application against the regulations and, if approved, issue the provider a permit. If denied, the provider may appeal NMFS's decision using the provider permit appeal process described at § 660.19. The provider permit would be effective until the company changes ownership, NMFS notifies the provider that the permit is no longer valid, or if the provider fails to renew it. A provider's permit would be automatically renewed provided it submits a complete renewal form attesting to the accuracy of the current EM service plan and other information. The EM service provider would be able to modify its service plan by submitting an amendment to NMFS (see proposed § 660.603(c)). The EM service plan is intended to be a living document and would be updated over time to reflect changes to the provider's operations. NMFS would maintain EM Program Guidelines for the EM service plan on its Web site to assist providers in developing their plans (see proposed § 660.600(b)). NMFS has posted draft application materials and EM Program Guidelines on its Web site: http://www.westcoast.fisheries.noaa.gov/fisheries/groundfish_catch_shares/electronic_monitoring.html.

    As with observer and catch monitor providers, an EM service provider would be required to be free of any conflicts of interest and to have insurance coverage for their employees that provide services on the vessels (see proposed § 660.603(h)).

    EM service providers would be required to provide field and technical support services to vessels with which they have a contract, including installing equipment to meet NMFS's performance standards and providing technical assistance and repair services (see proposed § 660.603(k)). The EM service provider would also be required to provide support to NMFS, including assistance in diagnosing and resolving technical issues and litigation support, free of charge to NMFS (see proposed § 660.603(l)).

    Beginning in 2020, or when NMFS transitions video review responsibilities to third party providers, the EM service provider would responsible for processing EM datasets; submitting reports to NMFS of catch data, compliance issues, and technical issues; communicating feedback to vessel operators to improve data quality; maintaining EM program records, including raw video and processed EM datasets; and maintaining the confidentiality and security of EM data (see proposed § 660.603(m)). EM data would be confidential, as are observer data, consistent with Magnuson-Stevens Act requirements. The service provider would be responsible for ensuring its staff are fully trained to successfully execute these duties.

    Classification

    Except for those measures identified above where NMFS is requesting specific comment, NMFS has made a preliminary determination that the measures this proposed rule would implement are consistent with the Pacific Coast Groundfish FMP, Magnuson-Stevens Act and other applicable laws. In making the final determination, NMFS will take into account the data, views, and comments received during the comment period.

    This proposed rule has been determined to be not significant for the purposes of Executive Order (E.O.) 12866.

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

    An IRFA was prepared, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA, which includes this section of the preamble to this rule and analyses contained in its accompanying EA and RIR/IRFA, describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble.

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

    This regulatory amendment impacts mainly commercial harvesting entities engaged in the groundfish limited entry trawl fishery. Although this action proposes an EM program for only two components of the limited entry trawl fishery—the Pacific whiting fishery and the fixed gear shorebased IFQ fishery—any limited entry trawl vessel may participate in these components, provided they comply with its requirements, and therefore may be eligible to use EM. In addition, vessels deploying EM are likely to be a subset of the overall trawl fleet, as some vessels would likely choose to continue to use observers. However, as all trawl vessels could potentially use EM in the future, this IRFA analyzes impacts to the entire trawl fleet.

    A general description of the limited entry trawl fishery and catch share program is contained in the preamble to this section. Most recent permit information indicates that there are approximately 175 limited entry trawl permits. According to information from the Northwest Fishery Science Center Economic Data Collection Program, in 2014, the fourth year of the catch share program, there were 102 catcher vessels that participated in the West Coast Groundfish Trawl Catch Share program. Catcher vessels generated $85 million in income and 954 jobs from deliveries of fish caught in the catch share program. Catcher vessels spent an average of 62 days fishing in the catch share program and spent an average of 80 additional days fishing in non-catch share fisheries. West Coast catcher vessels deliver to ports in Washington, Oregon, California, and at-sea; the two ports with the highest landings in 2014 were Astoria and Newport, both in Oregon. An average of 2.4 crew members worked aboard each West Coast catcher vessel, each earning an average compensation of $54,500. In 2014, 31 percent of vessels were owner-operated at least part of the year. The average ex-vessel revenue per vessel from participation in the catch share program was $646,000. Average variable cost net revenue (ex-vessel revenue minus variable costs) per vessel was $256,000 from participation in the catch share program, and the fleet-wide variable cost net revenue was $26.2 million. Average total cost net revenue (ex-vessel revenue minus variable costs and fixed costs) per vessel was $127,000 and the fleet-wide total cost net revenue was $12.9 million (NWFSC, 2014; http://www.pcouncil.org/wp-content/uploads/2016/06/G5b_NMFS_Rpt4_MS_ElecVer_JUN2016BB.pdf). These are preliminary results and it should be noted that some industry members have questioned the results of EDC data which is based on cost-earnings surveys where all participants are required to respond to. Via the Pacific Fishery Management Council's Five Year IFQ Trawl Program Review, the NWFSC economists will be meeting with the industry to further validate their results with the industry.

    With respect to monitoring costs, the NWFSC 2014 EDC report states the following: “One other change resulting from the implementation of the catch share program was a shift to 100% observer coverage with partial industry funding. Prior to catch shares, there was approximately 20% observer coverage, paid for by NMFS. In order to lessen the cost of transitioning to the required 100 percent observer coverage, catcher vessels received a maximum subsidy of $328.50 per day in 2011 and 2012. This subsidy decreased in 2013 to $256 per day and in 2014 to $216 per day. Catcher vessels spent on average $14,400 on observer coverage (excluding the NMFS subsidy payments) while operating in the catch share program in 2014. In 2011, observer costs represented 0.6% of total costs, and increased to 2.8 percent in 2014. Note that as observer subsidies have decreased over time, the average expenses per vessel have increased. For this reason, the average 2014 costs reported will not reflect the costs currently incurred by the fleet.” It should be noted that the 2015 observer subsidy was about $108 per day. The subsidy program ended in September 2015. Currently the industry is paying about $500 per day for observers.

    This rule would apply to those entities that elect to use EM in lieu of observers. In 2015, a total of 36 vessels participated in the EM program. This total includes 20 vessels that participated in the Pacific whiting fishery (11 that participated in both the shorebased and mothership sectors, 9 that fished only in mothership) and 7 fixed gear vessels. This is likely an underestimate of the number of vessels that would use EM in the future. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS 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 receipts not in excess of $11 million for all its affiliated operations worldwide. For for-hire fishing and fish processing entities, the Small Business Administration (SBA) defines a small business as one that is: Independently owned and operated; not dominant in its field of operation; has annual receipts not in excess of $7.0 million in the case of for-hire fishing entities; or if it has fewer than 500 employees in the case of fish processors, or 100 employees in the case of fish dealers. When applying for their permits, entities were asked to classify themselves as a small business based on the finfish standard of $20.5 million. Only 5 indicated that they were “large” businesses and thus would continue to be large businesses under the $11.0 million standard. In 2015, ex-vessel revenues for all west coast fisheries for the remaining vessels ranged from $1,000 to $1.4 million. In 2014, “other fisheries revenue” collected on these vessels ranged from $0 to $5.0 million. Based on these ranges, NMFS concludes that the remaining vessels would be considered “small” even after factoring in the possibility of the vessels participating in Alaska fisheries.

    Impacts of the Action on Small Entities

    This action contains two major alternatives—the Council's preferred alternative and proposed action, to allow vessels in the groundfish fishery to use EM in place of observers, and the no action alternative, which would not create an EM option. The regulatory amendment also considered several sub-options for design elements within the preferred alternative, which are described in the accompanying EA and summarized in the preamble. This rule proposes to implement the Council's preferred alternative.

    The proposed action is presenting a choice to fishermen—they can either continue to pay for 100-percent observer coverage or elect to pay for EM (i.e., equipment, maintenance, and video review). Using 2015 EFP cost estimates developed jointly by PSMFC and NMFS, NMFS developed a model for assessing the vessel, fleet, and government costs from the preferred alternative. The results indicate economic impacts on small entities from the preferred alternative would be positive as these entities would have a choice of between hiring an observer and using EM. The current cost of an observer is approximately $500 per day. Presumably, vessel owners would choose between using an observer or EM based on relative costs and operational flexibility. NMFS estimates indicate fixed gear vessels will save approximately $98 per day, mothership catcher vessels $159 per day, and shoreside vessels $330, using EM. Vessels that participated in the EFPs already own EM systems (most whiting vessels and approximately half of the fixed gear vessels), so they may see a greater cost savings compared to new entrants, until such time that the cameras need to be replaced. Annual vessel estimates show fixed gear and mothership catcher vessels saving $3,000 to $4,000 and shoreside whiting vessels saving $24,000 per year, relative to the cost of observers. Annual fleet estimates show similar results.

    In addition to the direct costs of the program, vessel owners would be responsible for reimbursing NMFS for its incremental costs for administering the EM program. NMFS collects cost recovery fees to cover the incremental costs of management, data collection, and enforcement of the trawl rationalization program. Fees are limited to a maximum of 3 percent of ex-vessel revenues. NMFS's incremental costs for administering the shorebased sector already exceed 3 percent, so the shorebased sector would not be likely to see an increase in fees from the preferred alternative in the short term. The mothership sector fees are currently 1.25 percent of ex-vessel revenue, so NMFS would be able to recover this sector's portion of EM program costs by increasing the fees.

    As mentioned in the preamble to this proposed rule, NMFS intends to conduct the video review itself for 2017-2019, contingent on available funding, while the standards and protocols that would be used to certify and oversee third party service providers are developed. The requirement for industry to fund the video review would take effect in 2020, or earlier if NMFS does not have funding to process the data itself. When video review responsibilities shift to third party providers, NMFS's and PSMFC's responsibilities would be reduced to oversight and quality assurance, which may include auditing the service providers' video review results. To conservatively estimate government costs and corresponding fee increases, NMFS assumes that service providers would review 100 percent of the video and that NMFS would audit 50 percent of the video. Government costs include video review and storage costs, as well as program management costs, statistician costs, database management, and overhead. With the full transition in 2020, NMFS estimates the government costs would be approximately $286,000 per year. Under current fee rates, only the portion of the costs related to the mothership catcher vessel fleet would be recouped by the cost recovery fee, which would result in an increase of 0.02 percent. NMFS estimates that compared to the costs of observers, the preferred alternative would still present a lower cost option for whiting and fixed gear vessels.

    Under Alternative 2, seven sub-options were developed to address various aspects of program design. These sub-options are summarized in the preamble to this proposed rule. Generally speaking, the Council's sub-options would either have no effect on the overall cost of the program (sub-options A2, D1, E1), reduce the cost of the program (sub-options E1, B1), or provide industry additional flexibility (sub-options C2, F1, G1-Fixed Gear, G2-Whiting).

    Measures Proposed To Mitigate Adverse Economic Impacts of the Proposed Action

    There are no significant alternatives to the proposed action that would accomplish the stated objectives and that minimize any significant economic impact of the proposed rule on small entities. Alternatives that were considered and rejected, and the reason the Council or NMFS rejected them, are summarized in Section 3.3 of the EA. The other sub-options considered, and the reasons the Council and NMFS did not propose them, are summarized in the preamble to this proposed rule. As fishermen would be given a choice between two alternative monitoring systems (observers versus EM), this rule is likely to have positive effects on small entities. NMFS believes that the preferred alternative for this rule would not have a significant impact when comparing small versus large businesses in terms of disproportionality and profitability given available information. These regulations are likely to reduce fishing costs for both small and large businesses. Nonetheless, NMFS has prepared this IRFA. Through this proposed rule, NMFS is requesting comments on this conclusion. The proposed action and alternatives are described in detail in the Council's regulatory amendment and the accompanying EA and RIR/IRFA (see ADDRESSES).

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

    The proposed action contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement will be submitted to OMB for approval. The proposed action does not duplicate, overlap, or conflict with any other Federal rules.

    This action proposes to adjust notification requirements for groundfish vessels using EM and first receivers receiving catch from EM trips. Vessels would now be required to declare the type of monitoring they will use on a given trip—observer or EM. This change is necessary to provide vessels the flexibility to switch between different types of monitoring, depending on what is most cost effective and efficient for their operation at that time, while allowing NMFS to track which fleets vessels are participating in. The proposed change would only add additional potential answers to an existing question and not affect the number of entities required to comply with the declaration requirement (OMB Control Number 0648-0573). Therefore, the proposed change would not be expected to increase the time or cost burden associated with this requirement. Similarly, the requirement for EM vessels to notify the observer program before each trip would be in place of the existing notification to an individual vessel's observer provider when using a catch share observer, and would not be expected to increase the time or cost burden associated with the existing notification requirements approved under OMB Control Number 0648-0593. The requirement for first receivers to report protected and prohibited species landings was previously approved under OMB Control Number 0648-0619 and this action would not be expected to change the time or cost burden or number of entities associated with this requirement.

    This action proposes to require vessel owners to submit an application to NMFS to be approved to use EM in place of an observer. This application would include an application form, the purchase or lease and installation of an EM system, a VMP, and attendance of a mandatory training session. The time burden associated with these requirements is estimated to be approximately 10 hours per vessel owner to prepare and submit the application package, install the EM system, and attend training. The training would be given via webinar to maximize convenience and minimize travel costs for vessel captains. Based on comments from industry participants during the development of the regulations, NMFS is proposing that vessel owners and captains that participated in the EFPs complete an abbreviated application process for 2017 to reduce the time burden to them. The cost of an EM system and installation is estimated at $12,000 per vessel. Approximately half the active vessels in the fleet have already received EM units through their participation in the EFPs and would not need to purchase a new unit to participate in the program. Vessel owners would likely have to purchase new EM units every 5-10 years, depending on the life of the equipment. Vessel owners would also be responsible for maintaining the EM units in good working order, likely through a service contract with a NMFS-permitted EM service provider. NMFS estimates the annual average cost burden per vessel from this requirement to be approximately $5,600.

    If denied an EM Authorization, vessel owners would be able to appeal NMFS's decision through the existing appeal process at § 660.25(g). NMFS estimates the time burden associated with preparing and submitting an appeal to be approximately 4 hours per entity, with a cost of $3.00 for copies and postage. Vessel owners would be able to make modifications to their VMPs during the year by submitting a request and amended VMP to NMFS. These requests would be made electronically via email and, therefore, would not be expected to have a cost burden associated with them. NMFS estimates the time burden associated with this requirement from preparing and submitting the request to be 0.5 hours per request per entity.

    Vessel owners would be required to renew their EM authorization annually. This is necessary to ensure that the vessel owners' contact information, VMPs, and fishing plans remain up to date. Industry participants raised concerns with the time burden associated with having to complete the application process each year, as was proposed in an earlier draft of the regulations. To address these concerns, NMFS is proposing to instead provide vessel owners with pre-filled renewal forms and their current VMPs to review and certify as correct in a simplified renewal process. NMFS estimates a time burden of approximately 0.5 hours per entity to review and return the pre-filled package.

    Vessel operators would be required to complete and submit a logbook for each trip, with an estimated time burden of 10 minutes per submission. The logbooks are provided by NMFS and state agencies, so the cost of requirement mainly derives from postage at $0.46 per submission. To eliminate duplication, NMFS would allow vessel operators to submit a state logbook that contains all the required information. Vessel operators would also be required to submit the hard drive containing video data to NMFS (in 2017-2019) or the EM service provider (2020-beyond) using a method that provides a return receipt. This is necessary for NMFS and vessel operators to be able to track submissions. This requirement has an average cost of $15.00 per submission and a time burden of 10 min to retrieve and package the hard drive for mailing.

    EM service providers would be required to apply to receive a permit from NMFS to provide EM services in the fishery. EM service providers would be required to submit an application to NMFS that includes an application form, an EM Service Plan that describes how they plan to provide services to the fishery, and statements of prior experience and qualifications. If requested, the EM service provider may also be required to provide NMFS copies of contracts with vessel owners and standard operating procedures and manuals describing their operations in more detail. In an earlier draft of the regulations, NMFS proposed requirements very similar to those for observer service providers, with minimal requirements for the provider and NMFS training and certifying individual observers. However, at the November 2015 Council meeting EM service providers commented that different service providers may have different models and that this model is not appropriate for EM services providers. Some EM service providers may employ less highly trained analysts to initially review video and a biologist to verify species identification. Whereas another service provider may employ highly trained biologists to do it all. They recommended that the regulations provide more flexibility for different business models. This proposed rule contains an expanded application process, incorporating an EM Service Plan, to provide the flexibility that service providers seek. The addition of an EM Service Plan allows NMFS to consider different business models proposed by different providers as meeting the EM program requirements. However, this requires EM service providers prepare and submit a detailed service plan and other documents, in order to provide NMFS with sufficient information to evaluate them. NMFS estimates the time and cost burden associated with preparing and submitting the permit application to be 47 hours and $30 (for copies and postage). Most likely much of this information would be submitted electronically. If requested by NMFS, EM service providers would be required to provide NMFS two EM units and two copies of any software for EM data analysis for a minimum of 90 days for evaluation. Due to their use by NMFS, the value of the EM units may depreciate and the EM service providers may not be able to resell the EM units for their full value. NMFS estimates the EM providers would be able to recoup 50 percent of the EM unit value at approximately $5,000 per unit. This results in a total cost associated with this requirement at $10,215 per provider (including $215 in materials and postage to send the equipment to NMFS).

    An EM service provider would be able to appeal a permit decision to NMFS following the procedures at § 660.19. NMFS estimates the time and cost burden of preparing and submitting an appeal to be 4 hours and $5 per entity. EM service providers would be able to make modifications to their EM Service Plans during the year by submitting a request and amended EM Service Plan to NMFS via email (2 hours per submission). EM service providers would be required to renew their permits annually. At the April 2016 Council meeting, EM service providers requested a longer effective period to provide more stability for planning for future fishing years. Therefore, in this proposed rule NMFS is proposing an abbreviated renewal process in which NMFS would provide pre-filled renewal forms and the current EM Service Plan for the EM service provider to review and certify. This would reduce the time burden for EM service providers, while ensuring NMFS has up-to-date information. NMFS estimates the annual time and cost burden of the renewal to be 1 hour and $5 per entity.

    In 2017-2019, EM service providers would be responsible for providing technical assistance and maintenance services to EM vessels. EM service providers would be required to provide technical support to vessels at sea, with an annual time burden of approximately 7 hours per entity. EM service providers and their employees would also be required to report instances of non-compliance by vessel owners and intimidation or harassment of EM technicians to NMFS. The estimated burden for reporting these events is 30 minutes per report (18 hours per entity per year). Employees of EM service providers may be debriefed by NMFS or OLE on technical or compliance issues with an estimated burden of 1 hour per trip (350 hours per entity per year).

    Beginning in 2020, EM service providers would also be responsible for reviewing video from trips, preparing and submitting catch data and compliance reports to NMFS, and providing feedback to vessel operators on their catch handling, camera views, etc. NMFS would prepare burden estimates for these requirements for OMB approval and public comment through a Federal Register notice in 2019 or earlier.

    Public reporting burden for these requirements includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

    List of Subjects in 50 CFR Part 660

    Fisheries, Fishing, and Indian fisheries.

    Dated: August 26, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons stated in the preamble, NMFS proposes to amend 50 CFR part 660 as follows:

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

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

    2. In § 660.13, revise paragraphs (d)(5)(ii) through (iv) to read as follows:
    § 660.13 Recordkeeping and reporting.

    (d) * * *

    (5) * * *

    (ii) The vessel operator must send a new declaration report, consistent with paragraph (d)(5)(iv) before leaving port on a trip in which a gear type and monitoring type, if applicable, that is different from the gear type and monitoring type most recently declared for the vessel will be used. A declaration report will be valid until another declaration report revising the existing gear and monitoring declaration is received by NMFS OLE.

    (iii) During the period of time that a vessel has a valid declaration report on file with NMFS OLE, it cannot fish with a gear and monitoring type other than a gear type and monitoring type declared by the vessel.

    (iv) Declaration reports will include: The vessel name and/or identification number, gear type, and monitoring type where applicable, (as defined in paragraph (d)(5)(iv)(A) of this section). Upon receipt of a declaration report, NMFS will provide a confirmation code or receipt to confirm that a valid declaration report was received for the vessel. Retention of the confirmation code or receipt to verify that a valid declaration report was filed and the declaration requirement was met is the responsibility of the vessel owner or operator. Vessels using nontrawl gear may declare more than one gear type with the exception of vessels participating in the Shorebased IFQ Program (i.e. gear switching), however, vessels using trawl gear may only declare one of the trawl gear types listed in paragraph (d)(5)(iv)(A) of this section on any trip and may not declare nontrawl gear on the same trip in which trawl gear is declared.

    (A) One of the following gear types or sectors, and monitoring type where applicable, must be declared:

    (1) Limited entry fixed gear, not including shorebased IFQ,

    (2) Limited entry groundfish non-trawl, shorebased IFQ, observer,

    (3) Limited entry groundfish non-trawl, shorebased IFQ, electronic monitoring,

    (4) Limited entry midwater trawl, non-whiting shorebased IFQ,

    (5) Limited entry midwater trawl, Pacific whiting shorebased IFQ, observer,

    (6) Limited entry midwater trawl, Pacific whiting shorebased IFQ, electronic monitoring,

    (7) Limited entry midwater trawl, Pacific whiting catcher/processor sector,

    (8) Limited entry midwater trawl, Pacific whiting mothership sector (catcher vessel or mothership), observer,

    (9) Limited entry midwater trawl, Pacific whiting mothership sector (catcher vessel), electronic monitoring,

    (10) Limited entry bottom trawl, shorebased IFQ, not including demersal trawl,

    (11) Limited entry demersal trawl, shorebased IFQ,

    (12) Non-groundfish trawl gear for pink shrimp,

    (13) Non-groundfish trawl gear for ridgeback prawn,

    (14) Non-groundfish trawl gear for California halibut,

    (15) Non-groundfish trawl gear for sea cucumber,

    (16) Open access longline gear for groundfish,

    (17) Open access Pacific halibut longline gear,

    (18) Open access groundfish trap or pot gear,

    (19) Open access Dungeness crab trap or pot gear,

    (20) Open access prawn trap or pot gear,

    (21) Open access sheephead trap or pot gear,

    (22) Open access line gear for groundfish,

    (23) Open access HMS line gear,

    (24) Open access salmon troll gear,

    (25) Open access California Halibut line gear,

    (26) Open access Coastal Pelagic Species net gear,

    (27) Other gear,

    (28) Tribal trawl, or

    (29) Open access California gillnet complex gear.

    3. In § 660.19, revise paragraph (a) introductory text to read as follows:
    § 660.19 Appeals process for catch monitors, observers, and provider permits.

    (a) Allowed appeals. This section describes the procedure for appealing IADs described at §§ 660.17(g), 660.18(d) and (f), 660.140(h), 660.150(j), 660.160(g), 660.603(b)(3) for catch monitor decertification, observer decertification, provider permit expirations due to inactivity, and EM service provider permit denials. Any person whose interest is directly and adversely affected by an IAD may file a written appeal. For purposes of this section, such person will be referred to as the “applicant.”

    4. In § 660.130, revise paragraphs (d)(2)(ii) and (d)(3)(ii) to read as follows:
    § 660.130 Trawl fishery—management measures.

    (d) * * *

    (2) * * *

    (ii) Catcher vessels. All catch must be sorted to the species groups specified in paragraph (d)(1) of this section for vessels with limited entry permits, except those engaged in maximized retention while declared into a Pacific whiting IFQ trip. The catch must not be discarded from the vessel and the vessel must not mix catch from hauls until the observer has sampled the catch, unless otherwise allowed under the EM Program requirements at § 660.604 of subpart J. Prohibited species must be sorted according to the following species groups: Dungeness crab, Pacific halibut, Chinook salmon, other salmon. Non-groundfish species must be sorted as required by the state of landing.

    (3) * * *

    (ii) If sorting occurs on a catcher vessel in the MS Coop Program, the catch must not be discarded from the vessel and the vessel must not mix catch from hauls until the observer has sampled the catch, or unless otherwise allowed under the EM Program requirements at § 660.604 of subpart J.

    5. In § 660.140, revise paragraph (g)(1) introductory text and add paragraph (h)(1)(i)(A)(4) to read as follows:
    § 660.140 Shorebased IFQ Program.

    (g) * * *

    (1) General. Shorebased IFQ Program vessels may discard IFQ species/species groups, provided such discards are accounted for and deducted from QP in the vessel account. With the exception of vessels on a declared Pacific whiting IFQ trip and engaged in maximized retention, and vessels fishing under a valid EM Authorization in accordance with § 660.604 of subpart J, prohibited and protected species must be discarded at sea; Pacific halibut must be discarded as soon as practicable and the discard mortality must be accounted for and deducted from IBQ pounds in the vessel account. Non-IFQ species and non-groundfish species may be discarded at sea, unless otherwise required by EM Program requirements at § 660.604 of subpart J. The sorting of catch, the weighing and discarding of any IBQ and IFQ species, and the retention of IFQ species must be monitored by the observer.

    (h) * * *

    (1) * * *

    (i) * * *

    (A) * * *

    (4) Is exempt from the requirement to carry an observer if the vessel has a valid EM Authorization and is fishing with EM under § 660.604 of subpart J.

    6. In § 660.150, revise paragraphs (i) and (j)(1)(i)(B) to read as follows:
    § 660.150 Mothership (MS) Coop Program.

    (i) Retention requirements. Catcher vessels participating in the MS Coop Program may discard minor operational amounts of catch at sea if the observer or EMS has accounted for the discard (i.e., a maximized retention fishery).

    (j) * * *

    (1) * * *

    (i) * * *

    (A) * * *

    (B) Catcher vessels. Any vessel delivering catch to any MS vessel must carry one certified observer each day that the vessel is used to take groundfish, unless the catcher vessel has a valid EM Authorization and is fishing with EM under § 660.604 of subpart J.

    7. Add subpart J to read as follows: Subpart J—West Coast Groundfish Electronic Monitoring Program. Sec. 660.600 Applicability. 660.601 Definitions. 660.602 Prohibitions. 660.603 Electronic monitoring provider permits and responsibilities. 660.604 Vessel and first receiver responsibilities. 660.600 Applicability. Subpart J—West Coast Groundfish Electronic Monitoring Program

    (a) General. This subpart contains requirements for vessels using EM in lieu of observers, as authorized under § 660.140(h)(1)(i) (Shorebased IFQ Program) and § 660.150(j)(1)(i) (MS Coop Program), and requirements for EM service providers. Vessel owners, operators, and managers are jointly and severally liable for a vessel's compliance with EM requirements under this subpart. This subpart also contains requirements for a first receiver receiving catch from a trip monitored by EM (see § 660.604(u)). The table below provides references to the sections that contain vessel owner, operator, first receiver, and service provider responsibilities. Certain requirements for vessel owners and operators and EM service providers will be different in 2020 and beyond.

    West Coast groundfish
  • fishery
  • Section
    (1) Limited entry trawl fishery (i) Vessel owners § 660.604 (ii) Vessel operators § 660.604 (iii) First receivers § 660.604 (iv) Service providers § 660.603 (2) [Reserved]

    (b) EM program guidelines. NMFS will develop EM Program Guidelines, which will document best practices and other information that NMFS will use to evaluate proposed service and vessel monitoring plans submitted by EM service providers and vessel owners under this subpart. NMFS will develop the EM Program Guidelines in consultation with the Council and publish notice of their availability in the Federal Register. NMFS will maintain the EM Program Guidelines on its Web site and make them available to vessel owners and operators and EM service providers to assist in developing service plans and vessel monitoring plans that comply with the requirements of this subpart.

    § 660.601 Definitions.

    These definitions are specific to this subpart. General groundfish definitions are found at § 660.11, subpart C, and trawl fishery definitions are found at § 660.111, subpart D.

    Active sampling unit means the portion of the groundfish fleet in which an observer coverage plan is being applied.

    Discard control point means the location on the vessel designated by a vessel operator where allowable discarding may occur.

    Discard event means a single occurrence of discarding of fish or other species.

    Electronic Monitoring or EM consists of the use of an electronic monitoring system (EMS) to passively monitor fishing operations through observing or tracking.

    Electronic Monitoring Authorization means the official document provided by NMFS that allows a vessel with a limited entry trawl permit to use electronic monitoring under the provisions of this subpart.

    Electronic Monitoring System Certification Form means the official document provided by NMFS, signed by a representative of a NMFS-permitted electronic monitoring service provider that attest that an EM system and associated equipment meets the performance standards defined at § 660.604(j) of this subpart, as required by § 660.604(e)(3)(i).

    EM data processing means the review, interpretation, and analysis of EM data (i.e., video and sensor data).

    EM Program means the Electronic Monitoring Program of the West Coast Region, National Marine Fisheries Service.

    EM Program Manager means the Chief of the Permits and Monitoring Branch of the West Coast Region, National Marine Fisheries Service, or his designee.

    EM Service Plan means the document that describes in detail how the EM service provider will provide EM services to the fishery to successfully achieve the purpose of the EM Program.

    EM service provider means any person, including their employees or agents, that is granted a permit by NMFS to provide EM services as required under § 660.603 and § 660.604.

    Electronic Monitoring System or EMS means a data collection tool that uses a software operating system connected to an assortment of electronic components, including video recorders, to create a collection of data on vessel activities.

    EM technician means an employee of the EM service provider that provides support for EM systems and technical assistance to vessels and NMFS.

    EM trip means any fishing trip for which electronic monitoring is the declared monitoring type.

    Initial Administrative Determination (IAD) means a formal, written determination made by NMFS on an application or permit request that is subject to an appeal within NMFS.

    Non-trawl shorebased IFQ vessel means a vessel on a declared limited entry groundfish non-trawl, shorebased IFQ trip.

    Pacific whiting fishery refers to the Pacific whiting primary season fisheries described at § 660.131. The Pacific whiting fishery is composed of vessels participating in the C/P Coop Program, the MS Coop Program, or the Pacific whiting IFQ fishery.

    Pacific whiting IFQ fishery is composed of vessels on Pacific whiting IFQ trips.

    Pacific whiting IFQ trip means a trip in which a vessel uses midwater groundfish trawl gear during the dates of the Pacific whiting primary season to target Pacific whiting, and Pacific whiting constitutes 50 percent or more of the catch by weight at landing as reported on the state landing receipt. Vessels on Pacific whiting IFQ trips must have a valid declaration for limited entry midwater trawl, Pacific whiting shorebased IFQ.

    Shorebased IFQ Program or Shorebased IFQ sector, refers to the fishery described at § 660.140, subpart D, and includes all vessels on IFQ trips.

    Vessel Monitoring Plan (VMP) means the document that describes how fishing operations on the vessel will be conducted and how the EM system and associated equipment will be configured to meet the performance standards and purpose of the EM Program.

    § 660.602 Prohibitions.

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

    (a) Electronic monitoring program.—(1) Make a false statement on an application for issuance, renewal, or changes to an EM Authorization or NMFS-accepted VMP.

    (2) Fish for or land fish from a trip without electronic monitoring or observer coverage when a vessel is required to carry electronic monitoring or an observer under §§ 660.140(h) or 660.150(j).

    (3) Fish for or land fish from a trip taken under electronic monitoring without a valid EM Authorization and NMFS-accepted vessel monitoring plan onboard, and a valid gear and monitoring declaration with NMFS OLE as required by § 660.604(c)(1) and § 660.604(m).

    (4) Fail to comply with a NMFS-accepted VMP.

    (5) Fail to notify the West Coast Groundfish Observer Program at least 48-hours prior to departing port of the vessel operator's intent to take a trip under EM, as required by § 660.604(n).

    (6) Fail to conduct a pre-departure test prior to departing port as required by § 660.604(l)(2).

    (7) Fish on an EM trip without a fully functional EM system, unless authorized by a NMFS-accepted VMP as required by § 660.604(l)(3).

    (8) Fail to make the EM system, associated equipment, logbooks and other records available for inspection immediately upon request by NMFS OLE personnel or other authorized officers, as required by §§ 660.604(o) and 660.604(t).

    (9) Discard species other than those allowed to be discarded as specified at § 660.604(p).

    (10) Fail to handle fish and other marine organisms in a manner that enables the EM system to record it as required by § 660.604(r).

    (11) Fail to submit complete and accurate logbook(s) and hard drive(s) for each EM trip as specified at § 660.604(s),

    (12) Tamper with, disconnect, damage, destroy, alter, or in any way distort, render useless, inoperative, ineffective, or inaccurate any component of the EM system or associated equipment.

    (13) Assault, resist, oppose, impede, intimidate, harass, sexually harass, bribe, or interfere with an EM service provider, EM field services staff, or EM data processing staff.

    (14) Interfere with or bias the sampling procedure employed by EM data processing staff including either mechanically or manually sorting or discarding catch outside of camera view or inconsistent with the NMFS-accepted VMP.

    (15) Fail to meet the vessel owner or operator responsibilities specified in section 660.604.

    (16) Fail to meet the first receiver responsibilities specified at § 660.604(u).

    (17) Fail to meet the EM service provider responsibilities specified in section 660.603.

    (18) Fish when a vessel is required to carry an observer under subpart J of this part if:

    (i) The vessel is inadequate for observer deployment as specified at § 600.746 of this chapter;

    (ii) The vessel does not maintain safe conditions for an observer as specified at § 660.604(n);

    (iii) NMFS, the observer provider, or the observer determines the vessel is inadequate or unsafe pursuant to vessel responsibilities to maintain safe conditions as specified at § 660.604(n);

    (19) Fail to meet the vessel responsibilities and observer coverage requirements specified at § 660.604(n).

    (b) [Reserved]

    § 660.603 Electronic monitoring provider permits and responsibilities.

    (a) General. This section contains requirements for EM service providers providing EM services to vessels operating in the Shorebased IFQ Program (§ 660.140) or the MS Coop Program (§ 660.150) and using EM under this subpart. A person must obtain a permit and endorsement as provided under § 660.603(b) in order to be an EM service provider. An EM service provider must:

    (1) Operate under a NMFS-accepted EM Service Plan (see § 660.603(b)(3)(vii)).

    (2) Provide and manage EM systems, field services, and technical assistance as required under § 660.603(k);

    (3) Provide technical and litigation support to NMFS or its agent (see § 660.603(l)).

    (4) Provide technical support to fishing vessels 24-hours per day, seven days per week, and year-round as provided under § 660.603(k)(4);

    (5) Beginning on January 1, 2020, or earlier if notified by NMFS, provide EM data processing, reporting, and record retention services to vessels using EM (see § 660.603(m)).

    (6) Comply with data integrity and security requirements, including requirements pertaining to hard drives containing EM data, (see § 660.603(n)).

    (b) Provider permits. To be an EM service provider, a person must obtain an EM service provider permit and endorsement by submitting an application to the NMFS West Coast Region Fisheries Permit Office. A person may meet some requirements of this section through a partnership or subcontract with another entity, in which case the application for an EM service provider permit must include information about the partnership. An applicant may submit an application at any time. If a new EM service provider, or an existing EM service provider seeking to deploy a new EMS or software version, submits an application by June 1, NMFS will issue a new permit by January 1 of the following calendar year. Applications submitted after June 1 will be processed as soon as practicable. NMFS will only process complete applications. Additional endorsements to provide observer or catch monitor services may be obtained under § 660.18.

    (1) Contents of provider application. To be considered for an EM service provider permit and endorsement, the service provider must submit a complete application that includes the following information. The same information must be included for any partners or subcontractors if the applicant intends to satisfy any of the EM service provider requirements through a partnership or contractual relationship with another entity.

    (i) Certify that the applicant meets the following eligibility criteria:

    (A) The EM service provider and its employees do not have a conflict of interest as defined at § 660.603(h), and,

    (B) The EM service provider is willing and able to comply with all applicable requirements of this section and to operate under a NMFS-accepted EM Service Plan.

    (ii) Applicant's contact information.

    (iii) Legal name of applicant organization. If the applicant organization is United States business entity, include the state registration number.

    (iv) Description of the management, organizational structure, and ownership structure of the applicant's business, including identification by name and general function of all controlling management interests in the company, including but not limited to owners, board members, officers, authorized agents, and employees. List all office locations and their business mailing address, business phone, fax number, and email addresses. If the applicant is a corporation, the articles of incorporation must be provided. If the applicant is a partnership, the partnership agreement must be provided.

    (v) A narrative statement describing prior relevant experience in providing EM services, technical support, or fishery data analysis services, including recruiting, hiring, training, deploying, and managing of individuals in marine work environments and of individuals working with fishery data, in the groundfish fishery or other fisheries of similar scale.

    (vi) A statement signed under penalty of perjury by an authorized agent of the applicant about each owner, or owners, board members, and officers if a corporation, authorized agents, and employees, regarding:

    (A) Conflict of interest as described in § 660.603(h),

    (B) Criminal convictions,

    (C) Federal contracts they have had and the performance rating they received on each contract, and

    (D) Any previous history of decertification or permit sanction action while working as an observer, catch monitor, observer provider, catch monitor provider, or electronic monitoring provider.

    (vii) EM Service Plan. An EM Service Plan that describes in detail how the applicant will provide EM services to the fishery sufficient to provide NMFS with the best scientific information available to determine individual accountability for catch, including discards, of IFQ species and compliance with requirements of the Shorebased IFQ Program (§ 660.140) and MS Coop Program (§ 660.150). NMFS will develop EM Program Guidelines containing best practices and templates and make them available on NMFS's Web site to assist EM service providers in developing EM Service Plans (see § 660.600(b)). The EM Service Plan must include descriptions of the following (using pictures and diagrams where appropriate):

    (A) Contact information for a primary point of contact for program operations inseason;

    (B) A plan for provision of services including communications, service locations, response timelines, and procedures for services, repairs, technical support, and other program services;

    (C) Procedures for hiring and training of competent program staff to carryout EM field services and data services, including procedures to maintain the skills of EM data processing staff in:

    (1) Use of data processing software;

    (2) Species identification;

    (3) Fate determination and metadata reporting requirements;

    (4) Data processing procedures;

    (5) Data tracking; and,

    (6) Reporting and data upload procedures.

    (D) Procedures for tracking hard drives throughout their use cycle, including procedures to ensure the integrity and security of hard drives in transit, and for removing confidential data from hard drives before returning them to the field;

    (E) Procedures for data processing, including tracking of EM datasets throughout their processing cycle and documenting any access and modifications;

    (F) Procedures for correction and resubmission of EM datasets that NMFS has determined are not sufficient, as described at § 660.603(m)(5), and to ensure that future datasets are sufficient for use by NMFS.

    (G) Policies on data access, handling, and release to maintain the confidentiality of the EM Program data;

    (H) Procedures for archiving of EM datasets and raw video, sensor and GPS data, etc., after reports have been submitted to NMFS;

    (I) Identifying characteristics of the EMS to be deployed and the video review software to be used in the fishery, including but not limited to: Manufacturer, brand name, model name, model number, software version and date, firmware version number and date, hardware version number and date, monitor/terminal number and date, pressure sensor model number and date, drum rotation sensor model number and date, and GPS model number and date.

    (J) EM system and software specifications, including a narrative statement describing how the EM system and associated equipment meets the performance standards at § 660.604(j).

    (K) EM video review software specifications, including a narrative statement describing how the software is sufficient to provide NMFS with the best available information to determine individual accountability for catch, including discards, of IFQ species and compliance with requirements of the Shorebased IFQ Program (§ 660.140) and MS Coop Program (§ 660.150).

    (viii) Provide NMFS the following, if requested:

    (A) Two EM system units loaded with software for a minimum of 90 calendar days for testing and evaluation.

    (B) Thorough documentation for the EM system, including: User manuals, any necessary interfacing software, performance specifications, technical support information, and tamperproof or tamper evident features.

    (C) The results of at-sea trials of the EM system.

    (D) Two copies of video review and analysis software for a minimum of 90 calendar days for testing and evaluation.

    (E) Thorough documentation for the video review and analysis software, including: User manuals, performance specifications, and technical support information.

    (F) Descriptions of database models and analysis procedures for program and fishery data to produce required reports.

    (2) Application evaluation. NMFS may request additional information or revisions from the applicant until NMFS is satisfied that the application is complete. Complete applications will be forwarded to the EM Program for review and evaluation by the EM provider permit review board. If the applicant is an entity, the review board also will evaluate the application criteria for each owner, board member, officer, authorized agent, and employee. NMFS will evaluate the application based on the EM Program Guidelines (see § 660.600(b)) and the following criteria:

    (i) The applicant's relevant experience and qualifications;

    (ii) Review of any conflict of interest as described in § 660.603(h);

    (iii) Review of any criminal convictions;

    (iv) Review of the proposed EM Service Plan, including evaluation of EM equipment and software;

    (v) Satisfactory performance ratings on any federal contracts held by the applicant;

    (vi) Review of any history of decertification or permit sanction as an observer, catch monitor, observer provider, catch monitor provider, or EM service provider; and,

    (vii) Review of any performance history as an EM service provider.

    (3) Agency determination on an application. Based on a complete application, if NMFS determines that the applicant has met the requirements of this section, NMFS will issue an initial administrative determination (IAD). If the application is approved, the IAD will serve as the EM service provider's permit and endorsement. If the application is denied, the IAD will provide an explanation of the denial in writing. The applicant may appeal NMFS's determination following the process at § 660.19.

    (4) Effective dates. The provider permit is valid from the effective date until occurrence of any one or more of the following:

    (i) The EM service provider changes ownership;

    (ii) December 31 of that year if the EM service provider fails to submit a complete renewal form for the following year; or,

    (iii) NMFS notifies the EM service provider that its permit is invalid. NMFS may invalidate an EM service provider permit if NMFS determines that the EM service provider no longer meets the eligibility criteria defined at paragraph (b)(1)(i). NMFS will first notify the EM service provider of the deficiencies in writing and the EM service provider must correct the deficiencies following the instructions provided. If the deficiencies are not resolved upon review of the first trip following the notification, NMFS will notify the EM service provider in writing that the provider permit is invalid and that the EM service provider is no longer eligible to provide EM services to the fishery for the remainder of that calendar year. The EM service provider may reapply for an EM service provider permit and endorsement for the following calendar year.

    (c) Changes to a NMFS-accepted EM Service Plan. An EM service provider may make changes to a NMFS-accepted EM Service Plan by submitting a revised plan or plan addendum to NMFS in writing. NMFS will review and accept the change if it meets all the requirements of this section. A plan addendum must contain:

    (1) The date and the name and signature of an authorized agent of the EM service provider;

    (2) Address, telephone number, fax number and email address of the person submitting the addendum;

    (3) A complete description of the proposed EM Service Plan change.

    (d) Change of provider permit ownership and transfer restrictions. If an EM service provider changes ownership during the term of an EM service provider permit, the new owner must apply for a new provider permit.

    (e) Provider permit sanctions. Procedures governing sanctions of permits are found at subpart D of 15 CFR part 904.

    (f) Renewing a provider permit. NMFS will mail renewal forms to existing EM service providers each year on or about April 15. If an EM service provider submits the completed renewal form by June 1, the EM service provider's permit and endorsement will be automatically renewed for the following calendar year.

    (g) Fees. NMFS may charge a fee to cover administrative expenses related to issuance of permits including initial issuance, renewal, replacement, and appeals.

    (h) Limitations on conflict of interest for providers and employees.—(1) EM service providers and their employees must not have a direct financial interest, other than the provision of observer, catch monitor, EM, or other biological sampling services, in any federal or state managed fisheries, including but not limited to:

    (i) Any ownership, mortgage holder, or other secured interest in a vessel, first receiver, shorebased or floating stationary processor facility involved in the catching, taking, harvesting or processing of fish;

    (ii) Any business involved with selling supplies or services to any vessel, first receiver, shorebased or floating stationary processing facility; or

    (iii) Any business involved with purchasing raw or processed products from any vessel, first receiver, shorebased or floating stationary processing facilities.

    (2) EM service providers and their employees must not solicit or accept, directly or indirectly, any gratuity, gift, favor, entertainment, loan, employment, or anything of monetary value from any person who conducts fishing or fish processing activities that are regulated by NMFS, or who has interests that may be substantially affected by the performance or nonperformance of the official duties of the provider.

    (3) The EM service provider may not employ any person to handle hard drives or EM data from a vessel by which the person was previously employed in the last two years.

    (4) Provisions of contracts or agreements for remuneration of EM services under this section do not constitute a conflict of interest.

    (i) Insurance. The EM service provider must maintain adequate insurance (copies of which shall be provided to the vessel owner, operator, or vessel manager, when requested) to cover injury, liability, and accidental death to cover vessel owner, and the EM service provider and its employees, including the following:

    (1) Maritime Liability to cover “seamen's” claims under the Merchant Marine Act (Jones Act) and General Maritime Law ($1 million minimum).

    (2) Coverage under the U.S. Longshore and Harbor Workers' Compensation Act ($1 million minimum).

    (3) States Worker's Compensation as required.

    (4) Commercial General Liability.

    (j) Warranties. None of the provisions of this section are intended to preclude any state or federal statutes or regulations governing warranties.

    (k) Field and technical support services. The EM service provider must provide and manage EM systems, installation, maintenance and technical support, as described below, according to a NMFS-accepted EM Service Plan and such that the EM Program is sufficient to provide NMFS with the best scientific information available to determine individual accountability for catch, including discards, of IFQ species and compliance with requirements of the Shorebased IFQ Program (§ 660.140) and MS Coop Program (§ 660.150).

    (1) At the time of installation, the EM service provider must:

    (i) Install an EM system that meets the performance standards under § 660.604(j);

    (ii) Ensure that the EM system is set up, wires run, system powered, and tested with the vessel in operation;

    (iii) Brief the vessel operator on system operation, maintenance, and procedures to follow for technical support or field service;

    (iv) Provide necessary information for the vessel operator to complete the VMP, such as images and diagrams of camera views and vessel layout, specific information about system settings, and designated discard control points; and,

    (v) Complete an EM System Certification Form for the vessel owner.

    (2) The EM service provider must communicate with vessel operators and NMFS to coordinate service needs, resolve specific program issues, and provide feedback on program operations.

    (3) The EM service provider must provide maintenance and support services, including maintaining an EM equipment inventory, such that all deployed EM systems perform according to the performance standards at § 660.604(j) and that field service events are scheduled and carried out with minimal delays or disruptions to fishing activities.

    (4) The EM service provider must provide technical assistance to vessels, upon request, in EM system operation, the diagnosis of the cause of malfunctions, and assistance in resolving any malfunctions. Technical support must be available 24-hours per day, seven days per week, and year-round.

    (5) The EM service provider must submit to NMFS reports of requests for technical assistance from vessels, including when the call or visit was made, the nature of the issue, and how it was resolved.

    (l) Program and technical support for NMFS. The EM service provider must provide the following to NMFS or its agent, upon request, free of charge unless otherwise specified by contract.

    (1) Assistance in EM system operation, diagnosing and resolving technical issues, and recovering corrupted or lost data.

    (2) Support for inquiries related to data summaries, analyses, reports, and operational issues with vessel representatives

    (3) Litigation support to NMFS if the EM system/data is being admitted as evidence in a court of law. All technical aspects of a NMFS-approved EM system are subject to being admitted as evidence in a court of law, if needed. The reliability of all technologies utilized in the EM system may be analyzed in court for, inter alia, testing procedures, error rates, peer review, technical processes and general industry acceptance. The EM service provider must, as a requirement of the provider's permit, provide technical and expert support for litigation to substantiate the EM system capabilities or other relevant information to investigate or establish potential violations of this chapter or other applicable law, as needed, including:

    (i) If the technologies have previously been subject to such scrutiny in a court of law, the EM service provider must provide NMFS with a brief summary of the litigation and any court findings on the reliability of the technology.

    (ii) Sign a non-disclosure agreement limiting the release of certain information that might compromise the effectiveness of the EM system operations.

    (4) Supply all software necessary for accessing, viewing, and interpreting the data generated by the EM system, including maintenance releases to correct errors in the software or enhance the functionality of the software.

    (5) Notify NMFS within 24 hours after the EM service provider becomes aware of the following:

    (i) Any information regarding possible harassment of EM provider staff;

    (ii) Any information regarding possible EM system tampering;

    (iii) Any information regarding any action prohibited under §§ 660.12(f) or 660.602(a)(13); and,

    (iv) Any information, allegations or reports regarding EM service provider staff conflicts of interest.

    (6) Notify NMFS of any change of management or contact information or a change to insurance coverage.

    (7) If requested, provide NMFS with the following:

    (i) A copy of any contract between the service provider and entities requiring EM services;

    (ii) Proof of adequate insurance as defined in paragraph (i);

    (iii) Copies of any information developed and used by the EM service provider and distributed to vessels, including, but not limited to, informational pamphlets, payment notifications, and description of EM service provider duties; and,

    (iv) Access to and submit to NMFS raw EM imagery, sensor, GPS, or other data, processed data, copies of EM data, meta data, and other associated records.

    (m) Data services. Beginning on January 1, 2020, or earlier if notified by NMFS in the Federal Register with six months prior notice, the EM service provider must provide and manage data processing, reporting, and record retention services, as described below, according to a NMFS-approved EM Service Plan and such that the EM Program is sufficient to provide NMFS with the best scientific information available to determine individual accountability for catch, including discards, of IFQ species and compliance with requirements of the Shorebased IFQ Program (§ 660.140) and MS Coop Program (§ 660.150).

    (1) The EM service provider must process sensor and image datasets, interpret, and analyze EM data sets from EM trips. The EM provider must review EM data according to a prescribed coverage level or sampling scheme, as specified by NMFS, and determine an estimate of discards for each trip using standardized estimation methods specified by NMFS. NMFS will maintain manuals for EM data processing protocols on its Web site.

    (2) The EM service provider must ensure that data processing staff are fully trained in:

    (i) Use of data processing software;

    (ii) Species identification;

    (iii) Fate determination and metadata reporting requirements;

    (iv) Data processing procedures;

    (v) Data tracking; and,

    (vi) Reporting and data upload procedures.

    (3) The EM service provider must track hard drives and EM datasets throughout their cycles, including documenting any access and modifications. EM hard drives must be erased to remove confidential data before returning them to the field.

    (4) The EM service provider must communicate with vessel operators and NMFS to coordinate data service needs, resolve specific program issues, and provide feedback on program operations. The EM service provider must provide feedback to vessel representatives, field services staff, and NMFS regarding:

    (i) Adjustments to system settings;

    (ii) Changes to camera positions;

    (iii) Advice to vessel personnel on duty of care responsibilities;

    (iv) Advice to vessel personnel on catch handling practices; and,

    (v) Any other information that would improve the quality and effectiveness of data collection on the vessel.

    (5) The EM service provider must submit to NMFS processed EM datasets and summaries, including discard estimates, fishing activity information, and meta data (e.g., image quality, reviewer name), and incident reports of compliance issues as instructed by NMFS. EM datasets and reports must be sufficient to provide NMFS with the best scientific information avaialble to determine individual accountability for catch, including discards, of IFQ species and compliance with requirements of the Shorebased IFQ Program (§ 660.140) and MS Coop Program (§ 660.150). If NMFS determines that the information is not sufficient, NMFS may require the EM service provider to correct and resubmit the reports.

    (6) Retention of records. Following an EM trip, the EM service provider must maintain all EM data and other records specified in this section, or used in the preparation of records or reports specified in this section or corrections to these reports, for a period of not less than three years after the date of landing for that trip. EM records must be stored such that the integrity and security of the records is maintained for the duration of the retention period. The EM service provider must produce EM records immediately upon request by the EM Program Manager or an authorized officer.

    (n) Data integrity and security. The EM service provider must ensure the integrity and security of EM data and other records specified in this section.

    (1) The EM service provider must not handle or transport hard drives containing EM data except to carry out EM services required by this section in accordance with a NMFS-accepted EM Service Plan.

    (2) The EM service provider must not write to or modify any EM hard drive that contains raw EM data before it has been copied and catalogued.

    (3) Consistent with the Magnuson-Stevens Act, an EM service provider and its employees must not disclose data and observations made on board a vessel to any person except the owner or operator of the observed vessel, an authorized state or an OLE agent or officer, NMFS or its designated agent.

    § 660.604 Vessel and first receiver responsibilities.

    (a) General. This section lays out the requirements for catcher vessels to obtain an exemption to use electronic monitoring (EM) in place of 100-percent observer coverage required by the Shorebased IFQ Program (§ 660.140(h)(1)(i)) and MS Coop Program (§ 660.150(j)(1)(i)(B)). Requirements are also described for first receivers receiving landings from EM trips.

    (b) Vessel Owner Responsibilities. To use EM under this section, vessel owners must:

    (1) Obtain an EM Authorization from the NMFS West Coast Region Fisheries Permit Office (see § 660.604(e));

    (2) Install an EM system using a NMFS-permitted EM service provider that meets performance standards under § 660.604(j);

    (3) Have a signed EM system certification form (see § 660.604(e)(3)(i));

    (4) Have a NMFS-accepted vessel monitoring plan (see § 660.604(e)(3)(iii));

    (5) Ensure that the vessel operator attends a mandatory EM orientation session provided by the NMFS West Coast Region EM Program (NMFS may waive this requirement on a case-by-case basis, such as when the vessel operator has prior EM experience);

    (6) Maintain logbooks and other records for three years and provide them to NMFS or authorized officers for inspection (see § 660.604(t)).

    (7) Beginning January 1, 2020, or earlier if notified by NMFS, obtain EM data processing and recordkeeping services from a NMFS-permitted EM service provider (see § 660.604(k)).

    (c) Vessel Operator Responsibilities. To use EM under this section, vessel operators must:

    (1) Maintain a valid EM Authorization and NMFS-accepted vessel monitoring plan onboard the vessel at all times that the vessel is fishing on an EM trip or when fish harvested during an EM trip are onboard the vessel;

    (2) Ensure that the EM system is installed, operated, and maintained consistent with performance standards (see § 660.604(l));

    (3) Comply with a NMFS-accepted vessel monitoring plan (see § 660.604(e)(3)(iii));

    (4) Make declaration reports to OLE prior to leaving port (see § 660.604(m));

    (5) Provide advance notice to the Observer Program at least 48 hours prior to departing port (see § 660.604(n));

    (6) Comply with observer requirements, if NMFS notifies the vessel owner, operator, or manager that the vessel is required to carry an observer (see § 660.604(n));

    (7) Ensure retention and handling of all catch as provided under §§ 660.604(p) and 660.604(r);

    (8) Comply with recordkeeping, reporting and inspection requirements (see §§ 660.604(o), (s) and (t)); and,

    (d) First receiver responsibilities. First receivers receiving catch from trips taken under EM must follow special disposition and sorting requirements for prohibited and protected species (see § 660.604(u)).

    (e) Electronic Monitoring Authorization. To obtain an EM Authorization, a vessel owner must submit an initial application to the NMFS West Coast Region Fisheries Permit Office, then a final application that includes an EM system certification and a vessel monitoring plan (VMP). NMFS will only review complete applications. A vessel owner may submit an application at any time. Vessel owners that want to have their Authorizations effective for January 1 of the following calendar year must submit their complete application to NMFS by October 1. Vessel owners that want to have their Authorizations effective for May 15 must submit their complete application to NMFS by February 15 of the same year. Vessel owners that participated in the 2015 or 2016 EM Exempted Fishing Permit project may submit a completed renewal form to receive an EM Authorization for 2017, following the process at § 660.604(i).

    (1) Initial application. To be considered for an EM Authorization, the vessel owner must submit a completed application form provided by NMFS, signed and dated by an authorized representative of the vessel, and meet the following eligibility criteria:

    (i) The applicant owns the vessel proposed to be used;

    (ii) The vessel has a valid Pacific Coast Groundfish limited entry, trawl-endorsed permit registered to it;

    (iii) If participating in the mothership sector, the vessel has a valid MS/CV endorsement;

    (iv) The vessel is participating in the Pacific whiting IFQ fishery, mothership sector, or the Shorebased IFQ sector using groundfish non-trawl gear;

    (v) The vessel is able to accommodate the EM system, including providing sufficient uninterrupted electrical power, suitable camera mounts, adequate lighting, and fittings for hydraulic lines to enable connection of a pressure transducer;

    (vi) The vessel owner and operator are willing and able to comply with all applicable requirements of this section and to operate under a NMFS-accepted vessel monitoring plan.

    (2) Review of initial application. Based on a complete initial application, if NMFS determines that the applicant meets the eligibility criteria in paragraph (e)(1) of this section, NMFS will notify the applicant in writing that the initial application has been accepted for further consideration. An applicant who receives such notice may install an EM system on his or her vessel and proceed with submission of a final application as provided under paragraph (e)(3). If an initial application has not been accepted, NMFS will provide the applicant an explanation of the denial in writing. The applicant may appeal NMFS's determination following the process at § 660.25(g).

    (3) Final application. A final application must be complete and must include:

    (i) EM system certification. A certification form, provided by NMFS, signed by a representative of a NMFS-permitted EM service provider that attests that an EM system and associated equipment that meets the performance standards at paragraph (k) was installed on the vessel, that the system was tested while the vessel was underway, and that the vessel operator was briefed on the EM system operation and maintenance. NMFS will maintain a list of permitted EM service providers on its Web site.

    (ii) Tentative fishing plan. A description of the vessel owner's fishing plans for the year, including which fishery the vessel owner plans to participate in, from what ports, and when the vessel owner intends to use EM and observers. This information is for purposes of planning observer deployments and is not binding.

    (iii) Vessel monitoring plan. A complete vessel monitoring plan for the vessel that accurately describes how fishing operations on the vessel will be conducted and how the EM system and associated equipment will be configured to meet the performance standards at paragraph (k). NMFS will develop EM Program Guidelines containing best practices and templates and make them available on NMFS's Web site to assist vessel owners in developing VMPs (see § 660.600(b)). An EM service provider may prepare and submit a VMP on behalf of the applicant. The VMP must include descriptions of the following (using pictures and diagrams where appropriate):

    (A) General vessel information including the vessel name, hull number, gear type(s), home port, captain name, and target fishery or sector;

    (B) The coordinates of the home port box, if a geo-referenced port box will be used to trigger data collection;

    (C) A diagram of the vessel layout with measurements of the deck and denoting the location of any designated discard control points;

    (D) The number and location of cameras and with images of corresponding views;

    (E) The location of lighting, control center, GPS, sensors, monitor, and other EM equipment;

    (F) Frame rates, image resolution, frequency of data logging, sensor trigger threshold values, and other EM system specifications;

    (G) The location and procedures for any catch handling, including designated discard control points within camera view, procedures for sorting and measuring discards, the number of crew sorting catch, and what steps will be taken to ensure that all catch remains in camera view;

    (H) The measurements of all bins, baskets and compartments that will be used to calculate volumetric estimates of weight;

    (I) The detailed steps that will be taken to minimize the potential for EM system malfunctions and the steps will be taken, when malfunctions occur, to ensure the adequate monitoring of catch;

    (J) The name, address, phone number, and email address of a primary point of contact for vessel operations;

    (K) The name, address, and phone number of the vessel's EM service provider, and contact information for a primary point of contact at the EM service provider;

    (L) The name, address, phone number, and signature of the applicant, and the date of the application; and,

    (M) Any other information required by the EM Program Manager.

    (iv) Any updates to information submitted in the initial application, including updates to proposed, self-enforcing agreements, if applicable (see paragraph (e)(5)).

    (4) Review of final application. NMFS may request additional information or revisions from the applicant until NMFS is satisfied that the application is complete. Based on a complete application, if NMFS determines that the applicant has met the requirements of this section, NMFS will issue an IAD and an EM Authorization. If the application is denied, the IAD will provide an explanation of the denial in writing. The applicant may appeal NMFS's determination following the process at § 660.25(g). NMFS will evaluate an application based on the EM Program Guidelines (see § 660.600(b)) and the following criteria, at a minimum:

    (i) Review of the vessel owner's and operator's eligibility based on the eligibility criteria at paragraph (e)(1);

    (ii) Review of the proposed vessel monitoring plan; and,

    (iii) Review of the proposed self-enforcing agreement, if applicable.

    (5) Self-enforcing agreement. In the future, through a proposed and final rulemaking, NMFS may allow for and provide requirements related to the use of voluntary self-enforcing agreements. This agreement would allow a group of eligible vessels to encourage compliance with the requirements of this section through private, contractual arrangements. If such arrangements are used, participating vessel owners must submit the proposed agreement to NMFS for review and acceptance as part of the application process as provided under paragraphs (e)(1) and (3). The existence of a self-enforcing agreement among EM vessels does not foreclose the possibility of independent enforcement action by NMFS OLE or authorized officers.

    (f) Changes to a NMFS-accepted VMP. A vessel owner may make changes to a NMFS-accepted VMP by submitting a revised plan or plan addendum to NMFS in writing. NMFS will review and accept the change if it meets all the requirements of this section. A vessel monitoring plan addendum must contain:

    (1) The date and the name and signature of the vessel owner;

    (2) Address, telephone number, fax number and email address of the person submitting the addendum;

    (3) A complete description of the proposed VMP change.

    (g) Change in ownership of a vessel. If a vessel changed ownership, the new owner must apply for a new EM Authorization.

    (h) Effective dates. The EM Authorization is valid from the effective date until occurrence of one or more of the following:

    (1) December 31 if the vessel owner fails to submit a complete renewal form for the following year;

    (2) The vessel changes ownership; or,

    (3) NMFS notifies the vessel owner that its EM Authorization is invalid. NMFS may invalidate an EM Authorization if NMFS determines that the vessel, vessel owner, and/or operator no longer meets the eligibility criteria specified at paragraph (e)(1). NMFS would first notify the vessel owner of the deficiencies in writing and the vessel owner must correct the deficiencies following the instructions provided. If the deficiencies are not resolved upon review of the first trip following the notification, NMFS will notify the vessel owner in writing that the EM Authorization is invalid and that the vessel is no longer exempt from observer coverage at §§ 660.140(h)(1)(i) and 660.150(j)(1)(i)(B) for that authorization period. The holder may reapply for an EM Authorization for the following authorization period.

    (i) Renewing an EM Authorization. NMFS will mail EM Authorization renewal forms to existing EM Authorization holders each year on or about: September 1 for non-trawl shorebased IFQ vessels and January 1 for Pacific whiting IFQ and MS/CV vessels. If vessel owners submit completed renewal forms by October 15 for non-trawl shorebased IFQ vessels and February 15 for Pacific whiting IFQ and MS/CV vessels, their EM Authorization will be automatically renewed for the following authorization period.

    (j) EM System Performance Standards. The specifications (e.g., image resolution, frame rate, user interface) and configuration of an EM system and associated equipment (e.g., number and placement of cameras, lighting) used to meet the requirements of this section must be sufficient to:

    (1) Allow easy and complete viewing, identification, and quantification, of catch items discarded at sea, including during low light conditions;

    (2) Continuously record vessel location (latitude/longitude coordinates), velocity, course, and sensor data (i.e, hydraulic and winch activity);

    (3) Allow the identification of the time, date, and location of a haul/set or discard event;

    (4) Record and store image data from all hauls/sets and the duration that fish are onboard the vessel until offloading begins;

    (5) Continuously record and store raw sensor data (i.e., GPS and gear sensors) for the entire fishing trip;

    (6) Prevent radio frequency interference (RFI) with vessel monitoring systems (VMS) and other equipment;

    (7) Allow the vessel operator to test and monitor the functionality of the EM system prior to and during the fishing trip to ensure it is fully functional;

    (8) Prevent tampering or, if tampering does occur, show evidence of tampering; and,

    (9) Provide image and sensor data in a format that enables their integration for analysis.

    (k) EM data services. Beginning January 1, 2020, or earlier if notified by NMFS in the Federal Register with six months prior notice, a vessel owner with a valid EM Authorization must obtain EM data processing, reporting, and record retention services from a NMFS-permitted EM service provider, as described at § 660.603(m). If the vessel owner changes EM service providers, the vessel owner must ensure the continuity of EM data retention for the entire duration of the required retention period as specified § 660.603(m)(6). NMFS will maintain a list of permitted EM service providers on its Web site.

    (l) EM system operation and maintenance. The EM system must be recording imagery and sensor data at all times that fish harvested during an EM trip are onboard the vessel until offloading begins. For the purposes of this section, a fully functional EM system is defined as an EM system and associated equipment that meets the performance standards listed in paragraph (k).

    (1) Duties of care. The operator of a vessel with a valid EM Authorization must maintain the EM system in good working order, including:

    (i) Ensuring the EM system is powered continuously during the fishing trip;

    (ii) Ensuring the system is functioning for the entire fishing trip and that camera views are unobstructed and clear in quality, such that the performance standards listed in paragraph (j) are met; and,

    (iii) Ensuring EM system components are not tampered with, disabled, destroyed, operated or maintained improperly.

    (2) Pre-departure test. Prior to departing port, the operator of a vessel with a valid EM Authorization must turn the EM system on and conduct a system function test following the instructions from the EM service provider. The vessel operator must verify that the EM system has adequate memory to record the entire trip and that the vessel is carrying one or more spare hard drives with sufficient capacity to record the entire trip.

    (3) EM system malfunctions. The operator of a vessel with a valid EM Authorization is prohibited from fishing on an EM trip without a fully functional EM system, unless an alternate arrangement has been specified in the NMFS-accepted VMP. In the event of an EM system malfunction, the vessel operator may voluntarily obtain observer coverage and revise the vessel's declaration following the process at § 660.13(d)(5), in which case the vessel operator is no longer exempt from the observer requirements at §§ 660.140(h) and 660.150(j).

    (m) Declaration reports. The operator of a vessel with a valid EM Authorization must make a declaration report to NMFS OLE prior to leaving port following the process described at § 660.13(d)(5). A declaration report will be valid until another declaration report revising the existing gear or monitoring declaration is received by NMFS OLE. A vessel operator declaring a limited entry midwater trawl, Pacific whiting shorebased IFQ trip or limited entry midwater trawl, Pacific whiting mothership sector (catcher vessel or mothership) trip may only revise the existing monitoring declaration twice during the same calendar year. NMFS may waive this limitation with prior notice if it is determined to be unnecessary for purposes of planning observer deployments. Additional revisions may be made if the EM system has malfunctioned and the vessel operator has chosen to carry an observer, as allowed under paragraph (m)(3); or subsequently, the EM system has been repaired; and upon expiration or invalidation of the vessel's EM Authorization.

    (n) Observer requirements. The operator of a vessel with a valid EM Authorization must provide advanced notice to NMFS, at least 48 hours prior to departing port, of the vessel operator's intent to take a trip under EM, including: Vessel name, permit number; contact name and telephone number for coordination of observer deployment; date, time, and port of departure; and the vessel's trip plan, including area to be fished and gear type to be used. NMFS may waive this requirement for vessels declared into the Pacific whiting IFQ fishery or mothership sector with prior notice. If NMFS notifies the vessel owner, operator, or manager of any requirement to carry an observer, the vessel may not be used to fish for groundfish without carrying an observer. The vessel operator must comply with the following requirements on a trip that the vessel owner, operator, or manager has been notified is required to carry an observer.

    (1) Notice of departure basic rule. At least 24 hours (but not more than 36 hours) before departing on a fishing trip, a vessel operator that has been notified by NMFS that his vessel is required to carry an observer, or that is operating in an active sampling unit, must notify NMFS (or its designated agent) of the vessel's intended time of departure. Notice will be given in a form to be specified by NMFS.

    (2) Optional notice—weather delays. A vessel operator that anticipates a delayed departure due to weather or sea conditions may advise NMFS of the anticipated delay when providing the basic notice described in paragraph (n)(1) of this section. If departure is delayed beyond 36 hours from the time the original notice is given, the vessel operator must provide an additional notice of departure not less than 4 hours prior to departure, in order to enable NMFS to place an observer.

    (3) Optional notice—back-to-back fishing trips. A vessel operator that intends to make back-to-back fishing trips (i.e., trips with less than 24 hours between offloading from one trip and beginning another), may provide a notice of departure as described in paragraph (n)(1) for both trips, prior to making the first trip. A vessel operator that has given such notice is not required to give additional notice of the second trip.

    (4) Cease fishing report. Within 24 hours of ceasing the taking and retaining of groundfish, vessel owners, operators, or managers must notify NMFS or its designated agent that fishing has ceased. This requirement applies to any vessel that is required to carry an observer, or that is operating in a segment of the fleet that NMFS has identified as an active sampling unit.

    (5) Waiver. The West Coast Regional Administrator may provide written notification to the vessel owner stating that a determination has been made to temporarily waive coverage requirements because of circumstances that are deemed to be beyond the vessel's control.

    (6) Accommodations and food.—(i) Accommodations and food for trips less than 24 hours must be equivalent to those provided for the crew.

    (ii) Accommodations and food for trips of 24 hours or more must be equivalent to those provided for the crew and must include berthing space, a space that is intended to be used for sleeping and is provided with installed bunks and mattresses. A mattress or futon on the floor or a cot is not acceptable if a regular bunk is provided to any crew member, unless other arrangements are approved in advance by the Regional Administrator or designee.

    (7) Safe conditions.—(i) The vessel operator must maintain safe conditions on the vessel for the protection of observers including adherence to all U.S. Coast Guard and other applicable rules, regulations, statutes, and guidelines pertaining to safe operation of the vessel, including, but not limited to rules of the road, vessel stability, emergency drills, emergency equipment, vessel maintenance, vessel general condition and port bar crossings, and provisions at §§ 600.725 and 600.746 of this chapter. An observer may refuse boarding or reboarding a vessel and may request a vessel to return to port if operated in an unsafe manner or if unsafe conditions are identified.

    (ii) The vessel operator must have on board a valid Commercial Fishing Vessel Safety Decal that certifies compliance with regulations found in 33 CFR chapter I and 46 CFR chapter I, a certificate of compliance issued pursuant to 46 CFR 28.710 or a valid certificate of inspection pursuant to 46 U.S.C. 3311.

    (8) Observer communications. The vessel operator must facilitate observer communications by:

    (i) Allowing observer(s) to use the vessel's communication equipment and personnel, on request, for the entry, transmission, and receipt of work related messages, at no cost to the observer(s) or the U.S. or designated agent; and

    (ii) Ensuring that the vessel's communications equipment, used by observers to enter and transmit data, is fully functional and operational.

    (9) Vessel position. The vessel operator must allow observer(s) access to the vessel's navigation equipment and personnel, on request, to determine the vessel's position.

    (10) Access. The vessel operator must allow observer(s) free and unobstructed access to the vessel's bridge, trawl or working deck, holding bins, sorting areas, cargo hold, and any other space that may be used to hold, process, weigh, or store fish at any time.

    (11) Prior notification. The vessel operator must notify observer(s) at least 15 minutes before fish are brought on board, or fish and fish products are transferred from the vessel, to allow sampling the catch or observing the transfer.

    (12) Records. The vessel operator must allow observer(s) to inspect and copy any state or federal logbook maintained voluntarily or as required by regulation.

    (13) Assistance. The vessel operator must provide all other reasonable assistance to enable observer(s) to carry out their duties, including, but not limited to:

    (i) Measuring decks, codends, and holding bins.

    (ii) Providing a designated safe working area on deck for the observer(s) to collect, sort and store catch samples.

    (iii) Collecting samples of catch.

    (iv) Collecting and carrying baskets of fish.

    (v) Allowing the observer(s) to collect biological data and samples.

    (vi) Providing adequate space for storage of biological samples.

    (vii) Providing time between hauls to sample and record all catch.

    (viii) Sorting retained and discarded catch into quota pound groupings.

    (ix) Stowing all catch from a haul before the next haul is brought aboard.

    (14) Sampling station. To allow the observer to carry out the required duties, the vessel operator must provide an observer sampling station that meets the following requirements so that the observer can carry out required duties.

    (i) The observer sampling station must be available to the observer at all times.

    (ii) The observer sampling station must be located within 4 m of the location from which the observer samples unsorted catch. Unobstructed passage must be provided between the observer sampling station and the location where the observer collects sample catch. To the extent possible, the area should be free and clear of hazards including, but not limited to, moving fishing gear, stored fishing gear, inclement weather conditions, and open hatches.

    (15) Transfers at sea. Observers may be transferred at-sea between a MS vessel and a catcher vessel. Transfers at-sea between catcher vessels is prohibited. For transfers, both vessels must:

    (i) Ensure that transfers of observers at sea via small boat under its own power are carried out during daylight hours, under safe conditions, and with the agreement of observers involved.

    (ii) Notify observers at least 3 hours before observers are transferred, such that the observers can finish any sampling work, collect personal belongings, equipment, and scientific samples.

    (iii) Provide a safe pilot ladder and conduct the transfer to ensure the safety of observers during transfers.

    (iv) Provide an experienced crew member to assist observers in the small boat in which any transfer is made.

    (16) Housing on vessel in port. During all periods an observer is housed on a vessel, the vessel operator must ensure that at least one crew member is aboard.

    (o) Inspection. The operator of a vessel with a valid EM Authorization must make the EM system and associated equipment available for inspection immediately upon request by NMFS OLE personnel, USCG personnel, state enforcement personnel, or any authorized officer.

    (p) Retention requirements.—(1) Pacific whiting IFQ and MS/CV vessels. The operator of a vessel on a declared limited entry midwater trawl, Pacific whiting shorebased IFQ trip or limited entry midwater trawl, Pacific whiting mothership sector (catcher vessel or mothership) trip, EM trip must retain all fish until landing, with exceptions listed below.

    (i) Minor operational discards are permitted. Minor operational discards include mutilated fish; fish vented from an overfull codend, fish spilled from the codend during preparation for transfer to the mothership; and fish removed from the deck and fishing gear during cleaning. Minor operational discards do not include discards that result when more catch is taken than is necessary to fill the hold or catch from a tow that is not delivered.

    (ii) Large individual marine organisms (i.e., all marine mammals, sea turtles, and seabirds, and fish species longer than 6 ft (1.8 m) in length) may be discarded.

    (iii) Crabs, starfish, coral, sponges, and other invertebrates may be discarded.

    (iv) Trash, mud, rocks, and other inorganic debris may be discarded.

    (iv) A discard that is the result of an event that is beyond the control of the vessel operator or crew, such as a safety issue or mechanical failure, is permitted.

    (2) Non-trawl shorebased IFQ. A vessel operator on a declared limited entry groundfish non-trawl, shorebased IFQ trip must retain all IFQ species (as defined at § 660.140(c)), salmon, and non-IFQ rockfish, flatfish, and roundfish, with exceptions listed below. The operator of a non-trawl shorebased IFQ vessel must discard Pacific halibut, Dungeness crab caught seaward of Washington or Oregon, green sturgeon, eulachon, seabirds, sea turtles, and marine mammals.

    (i) Mutilated and depredated fish may be discarded.

    (ii) Crabs, starfish, coral, sponges, and other invertebrates may be discarded.

    (iii) Trash, mud, rocks, and other inorganic debris may be discarded.

    (iv) A discard that is the result of an event that is beyond the control of the vessel operator or crew, such as a safety issue or mechanical failure, is permitted.

    (q) Changes to retention requirements. Retention requirements for non-trawl shorebased IFQ vessels have been designated as “routine,” which means that they can be changed after a single Council meeting following the procedures described at § 660.60(c).

    (r) Catch handling. The vessel operator of a vessel on an EM trip must ensure that all catch is handled in a manner that enables the EM system to record it and that is consistent with the specific catch handling instructions in the NMFS-accepted VMP.

    (s) Reporting requirements.—(1) Discard logbook. The operator of a vessel with a valid EM Authorization must complete, submit, and maintain onboard the vessel an accurate federal discard logbook for each EM trip on forms supplied by or approved by NMFS. If authorized in writing by the NMFS, a vessel owner or operator may submit reports electronically, for example by using a VMS or other media. A state logbook that contains all the required information may be submitted in place of a federal discard logbook. If operating an MS/CV vessel, the vessel operator must provide logbook information to the mothership observer by transmitting the logbook information via radio or email to the mothership at the completion of each haul.

    (2) Submission of logbooks. Vessel operators must submit copies of the federal discard logbook and state retained logbook to NMFS or its agent within 24-hours of the end of each EM trip.

    (3) Submission of hard drives. Vessel operators must submit hard drives to NMFS or its agent using a method that requires a signature for delivery and provides a return receipt or delivery notification to the sender. Beginning January 1, 2020, or earlier if announced by NMFS in the Federal Register with six months prior notice, a vessel operator must submit hard drives to the vessel owner's contracted EM service provider. Deadlines for submission are as follows:

    (i) Pacific whiting IFQ vessels. Hard drives containing data from an EM trip must be postmarked within 10 calendar days of the end of that EM trip.

    (ii) Mothership catcher vessels. Hard drives containing data from an EM trip must be postmarked within 24-hours of the catcher vessel's return to port.

    (iii) Non-trawl shorebased IFQ vessels. Hard drives containing data from an EM trip must be postmarked within 10 calendar days of the end of that EM trip.

    (t) Retention of records. The operator of a vessel with a valid EM Authorization must maintain federal discard logbooks onboard the vessel until the end of the fishing year during which the EM trips were conducted, and make the report forms available to observers, NMFS staff, or authorized officers, immediately upon request. The vessel owner must maintain the federal discard logbooks and other records specified in this section, or used in the preparation of records or reports specified in this section or corrections to these reports, for a period of not less than three years after the date of landing from an EM trip. The vessel owner must make such records available for inspection by NMFS staff or authorized officers, immediately upon request.

    (u) First receiver requirements. (1) Prohibited species handling and disposition. To ensure compliance with fishery regulations at 50 CFR part 300, subparts E and F, and part 600, subpart H; with the Pacific Salmon Fishery Management Plan; and with the Pacific Halibut Catch Share Plan; the handling and disposition of all prohibited species in EM trip landings are the responsibility of the first receiver and must be consistent with the following requirements:

    (i) Any prohibited species landed at first receivers must not be transferred, processed, or mixed with another landing until the catch monitor has: Recorded the number and weight of salmon by species; inspected all prohibited species for tags or marks; and, collected biological data, specimens, and genetic samples.

    (ii) No part of any prohibited species may be retained for personal use by a vessel owner or crew member, or by a first receiver or processing crew member. No part of any prohibited species may be allowed to reach commercial markets.

    (iii) Prohibited species suitable for human consumption at landing must be handled and stored to preserve the quality. Priority in disposition must be given to the donation to surplus food collection and distribution system operated and established to assist in bringing donated food to nonprofit charitable organizations and individuals for the purpose of reducing hunger and meeting nutritional needs.

    (iv) The first receiver must report all prohibited species landings on the electronic fish ticket and is responsible for maintaining records verifying the disposition of prohibited species. Records on catch disposition may include, but are not limited to: Receipts from charitable organizations that include the organization's name and amount of catch donated; cargo manifests setting forth the origin, weight, and destination of all prohibited species; or disposal receipts identifying the recipient organization and amount disposed. Any such records must be maintained for a period not less than three years after the date of disposal and such records must be provided to NMFS OLE immediately upon request.

    (2) Protected Species handling and disposition. All protected species must be abandoned to NMFS or the US Fish and Wildlife Service or disposed of consistent with paragraphs (u)(2)(i) and (ii) of this section. No part of any protected species may be retained for personal use by a vessel owner or crew member, or by a first receiver or processing crew member. No part of any protected species may be allowed to reach commercial markets.

    (i) Eulachon and green sturgeon. Must be sorted and reported by species on electronic fish tickets and state landing receipts and may not be reported in unspecified categories. Whole body specimens of green sturgeon must be retained, frozen, stored separately by delivery, and labeled with the vessel name, electronic fish ticket number, and date of landing. Arrangements for transferring the specimens must be made by contacting NMFS Southwest Fisheries Science Center at 831-420-3903 within 72 hours after the completion of the offload.

    (ii) Seabirds, marine mammals, and sea turtles. Albatross must reported to the U.S. Fish and Wildlife Service 541-867-4558 extension 237 or 503-231-6179) as soon as possible and directions for surrendering must be followed. Marine mammals and sea turtles must be reported to NMFS as soon as possible (206-526-6550) and directions for surrendering or disposal must be followed. Whole body specimens must labeled with the vessel name, electronic fish ticket number, and date of landing. Whole body specimens must be kept frozen or on ice until arrangements for surrendering or disposing are completed. Unless directed otherwise, after reporting is completed, seabirds, marine mammals, and sea turtles may be disposed by incinerating, rendering, composting, or returning the carcasses to sea.

    [FR Doc. 2016-21058 Filed 9-2-16; 8:45 am] BILLING CODE 3510-22-P
    81 172 Tuesday, September 6, 2016 Notices DEPARTMENT OF AGRICULTURE Re-Establishment of and Notice for Solicitation for the Council for Native American Farming and Ranching AGENCY:

    Office of the Secretary, USDA.

    ACTION:

    Notice of amended call for nominations.

    SUMMARY:

    The USDA announces that it is extending the solicitation period for applications published in notice FR Doc. 2016-16099 for individuals to be considered for membership. Candidates who wish to be apply and be considered on the Council for Native American Farmers and Ranchers must submit an AD-755 application form and resume to the Secretary of Agriculture. Cover letters should be addressed to the Secretary of Agriculture. The application form can be found at: http://www.usda.gov/documents/OCIO_AD_755_Master_2012.pdf.

    DATES:

    Submit nominations on or before September 22, 2016.

    ADDRESSES:

    All nomination materials should be mailed in a single, complete package and postmarked by 45 days of this announcement. All nominations for membership should be sent to: Thomas Vilsack, Secretary, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250, Attn: Office of Tribal Relations. Send comments to the Office of Tribal Relations, 500A Whitten Building, 1400 Independence Avenue SW., Washington DC 20250.

    FOR FURTHER INFORMATION CONTACT:

    Josiah Griffin, Acting Designated Federal Officer, Council for Native American Farming and Ranching. Email your questions to Josiah Griffin at [email protected] or call 202-205-2249.

    SUPPLEMENTARY INFORMATION:

    In accordance with the provisions of the Federal Advisory Council Act (FACA) as amended (5 U.S.C. App. 2) and with the concurrence of the General Services Administration, the Department of Agriculture (USDA) is announcing the re-establishment of the advisory Council for Native American Farmers and Ranchers (Council). The Council is a discretionary advisory committee that operates under the provisions of the FACA and reports to the Secretary of Agriculture. The purpose of this Council is: (1) To advise the Secretary of Agriculture on issues related to the participation of Native American farmers and ranchers in USDA programs; (2) to transmit recommendations concerning any changes to regulations or internal guidance or other measures that would eliminate barriers to program participation for Native American farmers and ranchers; (3) to examine methods of maximizing the number of new farming and ranching opportunities created through enhanced extension, sound conservation practices, targeted rural business services, and financial literacy services; (4) to examine methods of encouraging intergovernmental cooperation to mitigate the effects of land tenure and probate issues on the delivery of USDA programs; (5) to evaluate other methods of creating new farming or ranching opportunities for Native American producers; and (6) to address other Native American related issues as deemed appropriate.

    The Council has 15 members, 11 of whom will be Native American leaders or persons who represent the interests of Native American tribes or Native American organizations. The term “Native American leaders” is not limited to elected Tribal representatives or members or persons with Native American ancestry. The remaining four members are the following high-ranking USDA officials: (1) Director, Office of Tribal Relations; (2) Administrator, Farm Service Agency; (3) Chief, Natural Resources and Conservation Services; and (4) Assistant Secretary, Office of the Assistant Secretary for Civil Rights.

    Members serve without compensation, but may receive reimbursement for travel expenses and per diem in accordance with USDA travel regulations for attendance at Council functions. Council members who represent the interests of Native American farmers and ranchers may also be paid an amount not less than $100 per day for time spent away from their employment or farming or ranching operation, subject to the availability of funds. Members may include:

    (1) Native American farmers or ranchers who have participated in USDA loan, grant, conservation, or payment programs;

    (2) Representatives of organizations with a history of working with Native American farmers or ranchers;

    (3) Representatives of tribal governments with demonstrated experience working with Native American farmers or ranchers; and

    (4) Such other persons as the Secretary considers appropriate.

    The Secretary of Agriculture invites those individuals, organizations, and groups affiliated with the categories listed above or who have knowledge of issues related to the purpose of the Council to nominate individuals for membership on the Council. Individuals and organizations who wish to nominate experts for this or any other USDA advisory committee should submit a letter to the Secretary listing these individuals' names and business address, phone, and email contact information. The Secretary of Agriculture seeks a diverse group of members representing a broad spectrum of persons interested in providing suggestions and ideas on how USDA can tailor its farm programs to meet the needs of Native American farmers and ranchers. Individuals receiving nominations will be contacted and asked to return the AD-755 application form and a resume within 10 business days of notification. All candidates will be vetted and considered for appointment by the Secretary of Agriculture. Equal opportunity practices will be followed in all appointments to the Council in accordance with USDA policies. The Council will meet at least once per fiscal year.

    Dated: August 29, 2016. Sedelta Oosahwee, Acting Director.
    [FR Doc. 2016-21280 Filed 9-2-16; 8:45 am] BILLING CODE 3410-01-P
    DEPARTMENT OF AGRICULTURE Forest Service Eastern Washington Cascades Provincial Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Eastern Washington Cascades Provincial Advisory Committee (PAC) will meet in Wenatchee, Washington. The committee is authorized pursuant to the implementation of E-19 of the Record of Decision and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to provide advice and make recommendations to promote a better integration of forest management activities between Federal and non-Federal entities to ensure that such activities are complementary. PAC information can be found at the following Web site: http://www.fs.usda.gov/main/okawen/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held on Wednesday, September 28, 2016, from 9 a.m. to 3 p.m.

    All PAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Okanogan-Wenatchee National Forest (NF) Headquarters Office, 215 Melody Lane, Wenatchee, Washington.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Okanogan-Wenatchee NF Headquarters Office. Please call ahead at 509-664-9292 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Robin DeMario, PAC Coordinator by phone at 509-664-9292, or by email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to update members on the:

    1. Year end accomplishments and key project plans for Fiscal Year 2016,

    2. I-90 Wildlife Project,

    3. Yakima Basin Integrated Plan, and

    4. Strategic prioritization of watershed restoration projects.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 21, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Robin DeMario, PAC Coordinator, 216 Melody Lane, Wenatchee, Washington 98801; or by email to [email protected], or via facsimile to 509-664-9286.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: August 30, 2016. Michael R. Williams, Forest Supervisor, Okanogan-Wenatchee National Forest.
    [FR Doc. 2016-21302 Filed 9-2-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Medicine Bow-Routt National Forest and Thunder Basin National Grassland; Routt County, Colorado; Steamboat Ski Resort, Steamboat EIS AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of intent to prepare an environmental impact statement.

    SUMMARY:

    The United States Forest Service (Forest Service), Medicine Bow-Routt National Forests and Thunder Basin National Grassland (MBRTB), is preparing an Environmental Impact Statement (EIS) to consider and disclose the anticipated environmental effects of implementing projects proposed by Steamboat Ski and Resort Corporation (SSRC) at Steamboat Ski Resort (Steamboat). The proposal would occur within the resort's existing Special Use Permit area (Permit Boundary) that is located on National Forest System (NFS) lands, and would be consistent with the 2011 Steamboat Master Development Plan Amendment (MDPA). These projects are proposed to improve the quality of guest services, increase operational efficiencies, and enhance the recreation experience for all skier ability levels.

    DATES:

    Comments concerning the scope of the analysis must be received by September 19, 2016. A public open house regarding this proposal will be held at the Steamboat Springs Community Center located at 1605 Lincoln Avenue, Steamboat Springs, CO 80427 on August 25th, 2016 from 5:00pm to 7:00pm. The draft environmental impact statement is expected to be available for public review in January 2017, and the final environmental impact statement is expected September 2017.

    ADDRESSES:

    Send written comments to: Dennis Jaeger, Forest Supervisor, c/o Erica Dickerman, Project Leader, Medicine Bow-Routt National Forests and Thunder Basin National Grassland; 2468 Jackson Street, Laramie, WY 82070; FAX (307) 745-2398 or by email to: [email protected] (please include “Steamboat EIS” in the subject line). Electronic comments must be submitted in Word (.doc), Rich Text (.rtf), or Adobe Acrobat (.pdf) format.

    FOR FURTHER INFORMATION CONTACT:

    Additional information related to the proposed project can be obtained from: Erica Dickerman, Recreation Specialist, Hahns Peak Bears Ears Ranger District, who can be reached by phone at (970) 870-2185 or by email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    Purpose and Need for Action

    The purpose and need for the action is to: improve the teaching terrain for beginner ability level guests to provide for an effective and comfortable learning progression; address operational inefficiencies and circulation of existing terrain; and provide additional lift-served terrain to meet guest expectations for diverse terrain offerings.

    Proposed Action

    The proposed action consists of the following specific projects:

    Rough Rider and Bashor Bowl

    Creation of the Rough Rider Learning Center would include installation of a gondola (Bashor Gondola, located on private lands), construction of the Bashor Children's Facility and Restaurant (located on private lands), removal of the existing Bashor Pavilion and bathroom facilities, installation of multiple moving carpet lifts, installation of a fixed grip chairlift (Rough Rider lift), removal of the existing Rough Rider platter lift, construction of a new skier bypass from Boulevard to the Rough Rider Learning Center, re-grading of associated novice and beginner terrain, and installation of snowmaking infrastructure.

    Proposed improvements within Bashor Bowl include replacement and realignment of the outdated Bashor lift (located on both private and NFS lands), construction of two new skiways from the realigned Bashor lift top terminal, grading at the base of Bashor Bowl, expansion of the Rabbit Ears Terrain Park, removal of the Mavericks Superpipe, construction of a new novice trail connecting Yoo Hoo to Big Foot, and reconfiguration of existing snowmaking infrastructure.

    Pony Express

    Proposed improvements within the Pony Express area include: Enhancements to trail corridors through vegetation removal, grading, and rock blasting; increased capacity of the Pony Express lift by adding carriers to the existing lift; construction of a ski patrol and restroom facility near the top terminal of the Pony Express lift; installation of winch cat anchors; construction of a ski-way from the junction of Lower Middle Rib and Chaps ski trails to the Storm Peak Express chairlift; and installation of snowmaking infrastructure and coverage to Upper and Lower Middle Rib, the Crux, Upper and Lower Longhorn, Lower Pony Express lift line, Upper and Lower Storm Peak Express Connectors, BC Ski Way, and Chaps.

    Pioneer Ridge

    Steamboat proposes to expand the operational boundary by approximately 355 acres to encompass Pioneer Ridge, construct a new detachable quad chair lift (Pioneer 2 lift), create 95 acres of gladed skiing, conduct 40 acres of hazard tree removal and vegetation management, install a bridge over Burgess Creek and construct an associated collector skiway, and define multiple gladed trails and egress routes to connect with existing and proposed terrain and facilities.

    Responsible Official

    The Responsible Official is Dennis Jaeger, Forest Supervisor for the MBRTB.

    Nature of Decision To Be Made

    Based on the analysis that will be documented in the forthcoming EIS, the Responsible Official will decide whether or not to implement, in whole or in part, the Proposed Action or another alternative that may be developed by the Forest Service as a result of scoping. The Responsible Official will also decide what, if any, mitigation measures, and monitoring requirements should be made part of the decision.

    Scoping Process

    This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. The Forest Service is soliciting comments from Federal, State and local agencies and other individuals or organizations that may be interested in or affected by implementation of the proposed projects. A public open house for this proposal will be held at the Steamboat Springs Community Center located at 1605 Lincoln Avenue, Steamboat Springs, CO 80427 on August 25 from 5:00 p.m. to 7:00 p.m. Representatives from the MBRTB, Hahns Peak Bears Ears Ranger District, and SSRC will be present to answer questions and provide additional project information.

    To be most helpful, comments should be specific to the project area and should identify resources or effects that should be considered by the Forest Service. Submitting timely, specific written comments during this scoping period or any other official comment period establishes standing for filing objections under 36 CFR 218 subparts A and B. Additional information and maps of this proposal can be found at: http://www.fs.usda.gov/project/?project=48246.

    It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.

    Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered.

    Dated: August 10, 2016. Carolyn Upton, Acting Forest Supervisor.
    [FR Doc. 2016-21236 Filed 9-2-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE U.S. Census Bureau Proposed Information Collection; Comment Request; 2016-2018 Business R&D and Innovation Surveys AGENCY:

    U.S. Census Bureau, 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 comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

    DATES:

    To ensure consideration, written or on-line comments must be submitted on or before November 7, 2016.

    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]gov).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Michael Flaherty, U.S. Census Bureau, HQ-6H149, 4600 Silver Hill Rd., Suitland, MD 20746 (301) 763-7699 (or via the internet at [email protected]).

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    The U.S. Census Bureau, with support from the National Science Foundation (NSF), plans to conduct the Business R&D and Innovation Survey (BRDIS) for the 2016-2018 survey years. The BRDIS covers all domestic, non-farm, for-profit businesses with at least one paid employee. The BRDIS provides the only comprehensive data on research and development costs and detailed expenses by type and industry.

    The Census Bureau has conducted an R&D survey since 1957 (the Survey of Industrial Research and Development (SIRD) from 1957-2007 and BRDIS from 2008-present), collecting primarily financial information on the systematic work companies undertake to discover new knowledge or use existing knowledge to develop new or improved goods and services.

    Prior to 2016, only companies with a minimum of five employees were in scope to the BRDIS. Beginning in 2016, the BRDIS will increase it's scope to include microbusinesses, or firms with fewer than five employees. Sampled companies in this target population will receive a BRDI-M form. Companies with five or more employees will receive the standard form (BRDI-1) or if selected for the screener questionnaire, the BRDI-1(S) form. Expanding the coverage of the BRDIS will help policymakers address issues such as how small businesses are affected by the rapid changes in our economy and what the smallest businesses are doing to be competitive.

    The 2016-2018 BRDIS will continue to collect the following types of information:

    • R&D expense based on accepted accounting standards.

    • Worldwide R&D of domestic companies.

    • Business segment detail.

    • R&D-related capital expenditures.

    • Detailed data about the R&D workforce.

    • R&D strategy and data on the potential impact of R&D on the market.

    • R&D directed to application areas of particular national interest.

    • Data measuring innovation, intellectual property protection activities and technology transfer.

    The BRDI-1 form utilizes a booklet instrument that facilitates the collection of information from various contacts within each company who have the best understanding of the concepts and definitions being presented as well as access to the information necessary to provide the most accurate response. The sections of the booklet correspond to areas within the company and currently include: A company information section that includes detailed innovation questions; a financial section focused on company R&D expenses; a human resources section; an R&D strategy and management section; an IP and technology transfer section; and a section focused on R&D that is funded or paid for by third parties. A web instrument is also available to respondents. The web instrument for the BRDI-1 form incorporates Excel spreadsheets that are provided to facilitate the electronic collection of information from various areas of the companies. Respondents have the capability to download the spreadsheets from the Census Bureau's Web site. A consolidator spreadsheet is also available to assist companies that need to gather information from business units and then compile the information into one company report.

    Domestic and foreign researchers in academia, business, and government analyze and cite data from the BRDIS. Among the federal government users are the Bureau of Economic Analysis (BEA) and the White House's Office of Science and Technology Policy (OSTP). BEA includes R&D in the system of national accounts that measures the economic well-being of the country. BRDIS data are key inputs into these accounts, which feed into the calculation of the U.S. Gross Domestic Product (GDP). The White House, in 2006, issued the American Competitiveness Initiative to “increase investments in research and development, strengthen education, and encourage entrepreneurship.” In support of this initiative and in response to legislative mandates, data on R&D are delivered to OSTP, primarily in the biennial National Science Board report Science and Engineering Indicators. Also, the National Science Foundation (NSF) produces a series of publications containing R&D data including the National Patterns of R&D Resources series, the S&E State Profile series, and the annual Business R&D and Innovation series. Special reports and other publications are also prepared.

    II. Method of Collection

    The Census Bureau will use a paperless strategy for the standard form (BRDI-1). Respondents will be mailed a letter referring them to the Census Bureau's Business Help Site where they can report online. Some companies selected for the screener form [BRDI-1(S)] will receive a letter only in initial mail out, directing them to report online. Others will receive a paper form in initial mailout that they can mail back. The microbusiness form (BRDI-M) is a mail out/mail back survey form. Respondents to all form types will have the option to report electronically. The due date for the standard form will be approximately 60 days from receipt. The due date for all other form types will be approximately 30 days from receipt.

    III. Data

    OMB Control Number: 0607-0912.

    Form Number: BRDI-1, BRDI-1(S), and BRDI-M.

    Type of Review: Regular submission.

    Affected Public: All domestic, non-farm, for-profit (public or private) businesses with at least one paid employee.

    Estimated Number of Respondents:

    BRDI-1—(Standard Form) 7,000 BRDI-1(S)—(Screener Form) 38,000 BRDI-M—(Microbusiness Form) 200,000 Total 245,000

    Estimated Time per Response:

    BRDI-1—(Standard Form) 14.85 hours. BRDI-1(S)—(Screener Form) 0.59 hours. BRDI-M—(Microbusiness Form) 0.25 hours.

    Estimated Total Annual Burden Hours: 176,370.

    Estimated Total Annual Cost: $0.

    Respondent's Obligation: Mandatory.

    Legal Authority: Title 13, United States Code, Sections 8(b), 131, and 182, and Title 42, United States Code, Sections 1861-76 (National Science Foundation Act of 1950, as amended).

    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: August 31, 2016 Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2016-21281 Filed 9-2-16; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-30-2016] Foreign-Trade Zone (FTZ) 125—South Bend, Indiana; Authorization of Proposed Production Activity; LionsHead Specialty Tire & Wheel, LLC (Wheel Assemblies for Specialty Applications); Goshen, Indiana

    On May 3, 2016, LionsHead Specialty Tire & Wheel, LLC, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility within FTZ 125—Site 3, in Goshen, Indiana.

    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 (81 FR 29527-29528, May 12, 2016). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: August 31, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-21342 Filed 9-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-33-2016] Foreign-Trade Zone (FTZ) 281—Miami, Florida; Authorization of Production Activity; Alpha Marketing Network, Inc. d/b/a AMN Distributors (Kitting-Wine Gift Sets); Miami, Florida

    On May 3, 2016, Miami-Dade County, grantee of FTZ 281, submitted a notification of proposed production activity to the FTZ Board on behalf of Alpha Marketing Network, Inc. d/b/a AMN Distributors, within Site 41 in Miami, Florida.

    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 (81 FR 30517, May 17, 2016). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: August 30, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-21339 Filed 9-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-045] 1-Hydroxyethylidene-1, 1-Diphosphonic Acid From People's Republic of China: Postponement of Preliminary Determination of Antidumping Duty Investigation AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Effective September 6, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Omar Qureshi or Kenneth Hawkins, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5307, or (202) 482-6491, respectively.

    SUPPLEMENTARY INFORMATION: Postponement of Preliminary Determination

    On April 20, 2016, the Department of Commerce (“Department”) initiated an antidumping duty investigation of 1-hydroxyethylidene-1, 1-diphosphonic acid from the People's Republic of China.1 Section 733(b)(1)(A) of the Tariff Act of 1930, as amended (“the Act”), and 19 CFR 351.205(b)(1) state that the Department will make a preliminary determination no later than 140 days after the date of the initiation (i.e., April 20, 2016). Accordingly, the preliminary determination of this antidumping duty investigation is currently due no later than September 7, 2016.

    1See 1-Hydroxyethylidene-1, 1-Diphosphonic Acid from the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation, 81 FR 25377 (April 28, 2016).

    Sections 733(c)(1)(B)(i) and (ii) of the Act permit the Department to postpone the time limit for the preliminary determination if it concludes that the parties concerned are cooperating and determines that the case is extraordinarily complicated by reason of the number and complexity of the transactions to be investigated or adjustments to be considered, the novelty of the issues presented, or the number of firms whose activities must be investigated, and additional time is necessary to make the preliminary determination. Under this section of the Act, the Department may postpone the preliminary determination until no later than 190 days after the date on which the Department initiated the investigation.

    The Department determines that the parties concerned are cooperating and that the case is extraordinarily complicated. Additional time is necessary to issue and analyze supplemental questionnaires and to make a preliminary determination in this investigation.

    Therefore, in accordance with section 733(c)(1)(B) of the Act, the Department is postponing the deadline for the preliminary determination by 50 days, to October 27, 2016. In accordance with section 735(a)(1) of the Act, the deadline for the final determination of this investigation will continue to be 75 days after the date of the preliminary determination, unless postponed at a later date.

    This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).2

    2 We acknowledge that the Department inadvertently did not notify the parties to this investigation of this postponement within the time frame provided in section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).

    Dated: August 30, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-21331 Filed 9-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-821-811] Solid Fertilizer Grade Ammonium Nitrate From the Russian Federation: Rescission of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) is rescinding the administrative review of the antidumping duty order on solid fertilizer grade ammonium nitrate (ammonium nitrate) from the Russian Federation (Russia). The review covers the following producers/exporters of the subject merchandise: (1) JSC Acron/JSC Dorogobuzh (collectively, “Acron”) and (2) MCC EuroChem and its affiliates OJSC NAK Azot and OJSC Nevinnomyssky Azot (collectively, “EuroChem”). The period of review (POR) is April 1, 2015, through March 31, 2016.

    DATES:

    Effective September 6, 2016.

    FOR FURTHER INFORMATION CONTACT:

    David Crespo, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3693.

    Background

    On April 28, 2016, the Department received a timely request, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), from CF Industries, Inc. and El Dorado Chemical Company (collectively, petitioners) to conduct an administrative review of the sales of Acron and EuroChem.1 On June 6, 2016, the Department published in the Federal Register a notice of initiation of an administrative review of the antidumping duty order on ammonium nitrate from Russia with respect to Acron and EuroChem.2 On June 30, 2016, the Department received a timely notice from Acron notifying the Department that it had no shipments of subject merchandise to the United States during the POR.3 On August 18, 2016, the petitioners withdrew their request for an administrative review with respect to Acron and EuroChem.4

    1See the letter from the petitioners to the Department, entitled, “Ammonium Nitrate from the Russian Federation: Request for Review,” dated April 28, 2016.

    2See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 36268 (June 6, 2016).

    3See the letter from Acron to the Department, entitled, “Solid Fertilizer Grade Ammonium Nitrate from the Russian Federation: No Shipment Letter,” dated June 30, 2016.

    4See the letter from the petitioners to the Department, entitled, “Ammonium Nitrate from the Russian Federation: Withdrawal of Request for Administrative Review,” dated August 18, 2016.

    Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if a party that requested the review withdraws the request within 90 days of the date of publication of notice of initiation of the requested review. The petitioners withdrew their request for review by the 90-day deadline, and no other party requested an administrative review of the antidumping duty order on ammonium nitrate from Russia for the POR. Accordingly, the Department is rescinding the administrative review of the antidumping order on ammonium nitrate from Russia covering the period April 1, 2015 through March 31, 2016.

    Assessment

    The Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after the date of publication of this notice in the Federal Register.

    Notification to Importers

    This notice serves as the only reminder to importers of their responsibility, under 19 CFR 351.402(f)(2), to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement may result in the presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    Notification Regarding Administrative Protective Order

    This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    This notice is issued and published in accordance with section 751 of the Act and 19 CFR 351.213(d)(4).

    Dated: August 26, 2016. Gary Tavernman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2016-21332 Filed 9-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-040] Truck and Bus Tires From the People's Republic of China: Preliminary Affirmative Determinations of Sales at Less Than Fair Value and Critical Circumstances, and Postponement of Final Determination AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that imports of truck and bus tires from the People's Republic of China (the PRC) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is July 1, 2015, through December 31, 2015. The estimated margins of sales at LTFV are shown in the “Preliminary Determination” section of this notice. Interested parties are invited to comment on this preliminary determination.

    DATES:

    Effective September 6, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Yang Jin Chun or Andre Gziryan, AD/CVD Operations Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5760 and (202) 482-2201, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    The Department initiated this investigation on February 18, 2016.1 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum dated concurrently with and hereby adopted by this notice.2 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and to all parties in the Department's Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/.

    1See Truck and Bus Tires From the People's Republic of China: Initiation of Antidumping Duty Investigation, 81 FR 9434 (February 25, 2016) (Initiation Notice).

    2See Memorandum from Associate Deputy Assistant Secretary Gary Taverman to Assistant Secretary Paul Piquado entitled, “Truck and Bus Tires from the People's Republic of China: Decision Memorandum for Preliminary Affirmative Determinations of Sales at Less Than Fair Value and Critical Circumstances, and Postponement of Final Determination” dated concurrently with and hereby adopted by this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are truck and bus tires. For a full description of the scope of this investigation, see the “Scope of the Investigation” in Appendix I of this notice.

    Scope Comments

    In accordance with the Preamble to the Department's regulations,3 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).4 Certain interested parties commented on the scope of the investigation, as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted to the record, and an accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum issued concurrently with this notice.5

    3See Antidumping Duties; Countervailing Duties, 62 FR 27296, 27323 (May 19, 1997) (Preamble).

    4See Initiation Notice, 81 FR at 9435.

    5See Memorandum entitled “Truck and Bus Tires from the People's Republic of China: Preliminary Scope Decision Memorandum,” dated concurrently with this notice (Preliminary Scope Decision Memorandum).

    Postponement of Deadline for the Preliminary Determination

    The Department published the notice of postponement of preliminary determination of this investigation on June 2, 2016.6 Pursuant to sections 733(c)(1)(B)(i) and (ii) of the Tariff Act of 1930, as amended (the Act), we postponed the preliminary determination by 50 days.7 As a result of the postponement, the deadline for the preliminary determination of this investigation is August 26, 2016.

    6See Truck and Bus Tires from the People's Republic of China: Postponement of Preliminary Determinations of Antidumping Duty Investigation, 81 FR 35332 (June 2, 2016).

    7Id.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. We calculated export prices in accordance with section 772 of the Act. Because the PRC is a non-market economy, within the meaning of section 771(18) of the Act, we calculated normal value (NV) in accordance with section 773(c) of the Act. For a full discussion of the Department's methodology, see the Preliminary Decision Memorandum.

    Affirmative Preliminary Determination of Critical Circumstances

    On August 2, 2016, in accordance with section 733(e)(1) of the Act and 19 CFR 351.206, the petitioner 8 timely filed an allegation that critical circumstances exist with respect to all imports of truck and bus tires from the PRC.9 We preliminarily determine that critical circumstances exist for mandatory respondent Prinx Chengshan (Shandong) Tire Co., Ltd. (PCT), the non-selected separate rate respondents, and the PRC-wide entity.10

    8 United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO-CLC (the petitioner).

    9See Letter from the petitioner, “Truck and Bus from the People's Republic of China (A-570-040): Petitioner's Critical Circumstances Allegation,” dated August 2, 2016.

    10See Preliminary Decision Memorandum at 5-9.

    Combination Rates

    In the Initiation Notice, the Department stated that it would calculate combination rates for the respondents that are eligible for a separate rate in this investigation.11 Policy Bulletin 05.1 describes this practice.12

    11See Initiation Notice, 81 FR at 9438-39.

    12See Enforcement and Compliance's Policy Bulletin No. 05.1, regarding, “Separate-Rates Practice and Application of Combination Rates in Antidumping Investigations involving Non-Market Economy Countries,” dated April 5, 2005 (Policy Bulletin 05.1), available on the Department's Web site at http://enforcement.trade.gov/policy/bull05-1.pdf.

    Preliminary Determination

    The Department preliminarily determines that the following weighted-average dumping margins exist:

    Exporter Producer Weighted
  • average
  • margin
  • (%)
  • Prinx Chengshan (Shandong) Tire Co., Ltd Prinx Chengshan (Shandong) Tire Co., Ltd 20.87 Actyon Tyre Resources Co., Limited Chao Yang Long March Tyre Co., Ltd 20.87 Actyon Tyre Resources Co., Limited Shandong Haohua Tires Co., Ltd 20.87 Actyon Tyre Resources Co., Limited Shandong Longyue Rubber Co., Ltd 20.87 Aosen Tire Co., Ltd Qingdao Taifa Group Co., Ltd 20.87 Aosen Tire Co., Ltd Shandong Chuanghua Tire Co., Ltd 20.87 Aosen Tire Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Aosen Tire Co., Ltd Shandong Hugerubber Co., Ltd 20.87 Aosen Tire Co., Ltd Shandong Yongsheng Rubber Group Co., Ltd 20.87 Aosen Tire Co., Ltd Shandong Zhentai Group Co., Ltd 20.87 Beijing BOE Commerce Co., Ltd China National Tyre & Rubber Guilin Co., Ltd 20.87 Beijing BOE Commerce Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Best Choice International Trade Co., Ltd Aeolus Tyre Co., Ltd 20.87 Best Choice International Trade Co., Ltd Qingdao Yellow Sea Rubber Co., Ltd 20.87 Best Choice International Trade Co., Ltd Shan Dong Kaixuan Rubber Co., Ltd 20.87 Best Choice International Trade Co., Ltd Sichuan Kalevei Technology Co., Ltd 20.87 Best Choice International Trade Co., Ltd ZC Rubber Group Co., Ltd 20.87 Bestyre International Industrial Limited Chaoyang Long March Tyre Co., Ltd 20.87 Bestyre International Industrial Limited Chaoyang Long March Tyre New Co., Ltd 20.87 BOE Commerce Co., Ltd Aeolus Tyre Co., Ltd 20.87 BOE Commerce Co., Ltd China National Tyre & Rubber Guilin Co., Ltd 20.87 BOE Commerce Co., Ltd Shandong Anchi Tyres Co., Ltd 20.87 BOE Commerce Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 BOE Commerce Co., Ltd Shandong Hengyu Rubber Co., Ltd 20.87 BOE Commerce Co., Ltd Shandong Hengyu Science & Technology Co., Ltd 20.87 BOE Commerce Co., Ltd Shandong Jinyu Tyre Co., Ltd 20.87 BOE Commerce Co., Ltd Zhucheng Guoxin Rubber Co., Ltd 20.87 Briway Tire Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Briway Tire Co., Ltd Shandong Province Sanli Tire Manufactured Co., Ltd 20.87 Briway Tire Co., Ltd Shandong Vheal Group Co., Ltd 20.87 Briway Tire Co., Ltd Shandong Wanda Boto Tyre Co., Ltd 20.87 Briway Tire Co., Ltd Shandong Yinbao Tyre Group Co., Ltd 20.87 Briway Tire Co., Ltd Shandong Yuelong Group 20.87 Briway Tire Co., Ltd Sichuan Tyre & Rubber Co., Ltd 20.87 Briway Tire Co., Ltd Weifang Shunfuchang Rubber and Plastic Products Co., Ltd 20.87 Briway Tire Co., Ltd Sichuan Kalevei Technology Co., Ltd 20.87 Chonche Auto Double Happiness Tyre Corp. Ltd Chonche Auto Double Happiness Tyre Corp. Ltd 20.87 Chongqing Hankook Tire Co., Ltd Chongqing Hankook Tire Co., Ltd 20.87 Cooper Tire (China) Investment Co., Ltd Qingdao Ge Rui Da Rubber Co., Ltd 20.87 Daking Industrial Co., Limited Shandong Huasheng Rubber Co., Ltd 20.87 Fleming Limited Qingdao Doublestar Tire Industrial Co., Ltd 20.87 Fleming Limited Qingdao Yellow Sea Rubber Co., Ltd 20.87 Fleming Limited Shandong Wanshine Tire Co., Ltd 20.87 Fleming Limited Shandong Yinbao Tyre Group Co., Ltd 20.87 Giti Tire (Anhui) Company Ltd Giti Tire (Anhui) Company Ltd 20.87 Giti Tire (Anhui) Company Ltd Giti Tire (Fujian) Company Ltd 20.87 Giti Tire (Anhui) Company Ltd Giti Tire (Yinchuan) Company Ltd 20.87 Giti Tire (Fujian) Company Ltd Giti Tire (Anhui) Company Ltd 20.87 Giti Tire (Fujian) Company Ltd Giti Tire (Fujian) Company Ltd 20.87 Giti Tire (Fujian) Company Ltd Giti Tire (Yinchuan) Company Ltd 20.87 Giti Tire (Yinchuan) Company Ltd Giti Tire (Anhui) Company Ltd 20.87 Giti Tire (Yinchuan) Company Ltd Giti Tire (Fujian) Company Ltd 20.87 Giti Tire (Yinchuan) Company Ltd Giti Tire (Yinchuan) Company Ltd 20.87 Giti Tire Global Trading Pte. Ltd Giti Tire (Anhui) Company Ltd 20.87 Giti Tire Global Trading Pte. Ltd Giti Tire (Fujian) Company Ltd 20.87 Giti Tire Global Trading Pte. Ltd Giti Tire (Yinchuan) Company Ltd 20.87 Goodyear Dalian Tire Co., Ltd Goodyear Dalian Tire Co., Ltd 20.87 Hongkong Tiancheng Investment & Trading Co., Limited Shandong Linglong Tyre Co., Ltd 20.87 Hongtyre Group Co. Prinx Chengshan (Shandong) Tire Co., Ltd 20.87 Hongtyre Group Co. Shandong Bayi Tyre Manufacture Co., Ltd 20.87 Jiangsu General Science Technology Co., Ltd Jiangsu General Science Technology Co., Ltd 20.87 Jiangsu Hankook Tire Co., Ltd Jiangsu Hankook Tire Co., Ltd 20.87 Koryo International Industrial Limited Chaoyang Long March Tyre Co., Ltd 20.87 Koryo International Industrial Limited Shandong Anchi Tyres Co., Ltd 20.87 Koryo International Industrial Limited Shandong Hugerubber Co., Ltd 20.87 Koryo International Industrial Limited Shandong Sangong Rubber Co., Ltd 20.87 Koryo International Industrial Limited Shandong Wanshine Tire Co., Ltd 20.87 Koryo International Industrial Limited Sichuan Tyre & Rubber Co., Ltd 20.87 Kumho Tire Co., Inc. Nanjing Kumho Tire Co., Ltd 20.87 Longkou Xinglong Tyre Co., Ltd Longkou Xinglong Tyre Co., Ltd 20.87 Maxon Int'l Co., Limited Shandong Anchi Tyres Co., Ltd 20.87 Maxon Int'l Co., Limited Triangle Tyre Co., Ltd 20.87 Megalith Industrial Group Co., Ltd Ningxia Shenzhou Tire Co., Ltd 20.87 Megalith Industrial Group Co., Ltd Shaanxi Yanchang Petroleum Group Rubber Co., Ltd 20.87 Megalith Industrial Group Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Megalith Industrial Group Co., Ltd Shandong Huasheng Rubber Co., Ltd 20.87 Megalith Industrial Group Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Megalith Industrial Group Co., Ltd Sichuan Kalevei Technology Co., Ltd 20.87 Megalith Industrial Group Co., Ltd Xingyuan Tire Group Co., Ltd 20.87 Michelin Asia-Pacific Export (HK) Limited Michelin Shenyang Tire Co., Ltd 20.87 Newland Tyre Int'l Limited Shandong Hawk International Rubber Industry Co., Ltd 20.87 Noble Manufacture Co., Ltd Qingdao Hongchi Tyre Co., Ltd 20.87 Philixx Tyres and Accessories Limited Shandong Huasheng Rubber Co., Ltd 20.87 Philixx Tyres and Accessories Limited Xingyuan Tire Group Co., Ltd 20.87 Philixx Tyres and Accessories Limited Shandong Vheal Group Co., Ltd 20.87 Q&J Industrial Group Co., Limited Chaoyang Langma Co., Ltd 20.87 Q&J Industrial Group Co., Limited Qiangdao Huanghai Rubber Co., Ltd 20.87 Q&J Industrial Group Co., Limited Shandong Hongsheng Rubber Co., Ltd 20.87 Q&J Industrial Group Co., Limited Shandong Huasheng Rubber Co., Ltd 20.87 Q&J Industrial Group Co., Limited Shandong Xingyuan Group 20.87 Q&J Industrial Group Co., Limited Sichuan Kailiwei Technology Co., Ltd 20.87 Qingdao Au-Shine Group Co., Ltd Shandong Gulun Rubber Co., Ltd 20.87 Qingdao Champion International Trading Co., Ltd Shandong Cocrea Tyre Co., Ltd 20.87 Qingdao Champion International Trading Co., Ltd Shandong Huasheng Rubber Co., Ltd 20.87 Qingdao Champion International Trading Co., Ltd Zhucheng Sinoroad Rubber Co., Ltd 20.87 Qingdao Fudong Tyre Co., Ltd Qingdao Fudong Tyre Co., Ltd 20.87 Qingdao Fudong Tyre Co., Ltd Qingdao Xiyingmen Double Camel Tyre Co., Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Aeolus Tyre Co., Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Chaoyang Long March Tyre Co., Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Chonche Auto Double Happiness Tyre Corp. Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Double Coin Holdings Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Hangzhou Zhongce Rubber Co., Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Qingdao Yellow Sea Rubber Co., Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Qingdao Doublestar Tire Industrial Co., Ltd 20.87 Qingdao Fullrun Tyre Corp. Ltd Shandong Xingyuan International Trading Co., Ltd 20.87 Qingdao Ge Rui Da Rubber Co., Ltd Qingdao Ge Rui Da Rubber Co., Ltd 20.87 Qingdao Honghua Tyre Factory Qingdao Honghua Tyre Factory 20.87 Qingdao Jinhaoyang International Co., Ltd Double Coin Holdings Ltd 20.87 Qingdao Jinhaoyang International Co., Ltd Qingdao Fudong Tyre Co., Ltd 20.87 Qingdao Jinhaoyang International Co., Ltd Shaanxi Yanchang Petroleum Group Rubber Co., Ltd 20.87 Qingdao Jinhaoyang International Co., Ltd Zhucheng Guoxin Rubber Co., Ltd 20.87 Qingdao Keter International Co., Ltd Beijing Landy Tire & Tech Co., Ltd 20.87 Qingdao Keter International Co., Ltd Chaoyang Long March Tyre Co., Ltd 20.87 Qingdao Keter International Co., Ltd Chonche Auto Double Happiness Tyre Corp. Ltd 20.87 Qingdao Keter International Co., Ltd Deruibo Tire Co., Ltd 20.87 Qingdao Keter International Co., Ltd Qingdao Doublestar Tire Industrial Co., Ltd 20.87 Qingdao Keter International Co., Ltd Shandong Huasheng Rubber Co., Ltd 20.87 Qingdao Keter International Co., Ltd Shandong Huge Rubber Co., Ltd 20.87 Qingdao Keter International Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Chaoyang Long March Tyre Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Chonche Auto Double Happiness Tyre Corp. Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Doublestar Dongfeng Tyre Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Qingdao Doublestar Tire Industrial Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Qingdao Yellow Sea Rubber Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Shandong Xingyuan International Trading Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Shandong Yinbao Tyre Group Co., Ltd 20.87 Qingdao Lakesea Tyre Co., Ltd Sichuan Kalevei Technology Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Chaoyang Long March Tyre Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd China National Tyre And Rubber Guilin Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Ningxia Shenzhou Tire Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Qingdao Doublestar Tire Industrial Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Shandong Hengfeng Rubber & Plastic Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Shandong Hengyu Science & Technology Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Shandong Huasheng Rubber Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Shandong Wanda Boto Tyre Co., Ltd 20.87 Qingdao Nama Industrial Co., Ltd Shandong Wanshine Tyre Co., Ltd 20.87 Qingdao Odyking Tyre Co., Ltd Weifang Shunfuchang Rubber And Plastic Products Co., Ltd 20.87 Qingdao Qianzhen Tyre Co., Ltd Qingdao Qianzhen Tyre Co., Ltd 20.87 Qingdao Qizhou Rubber Co., Ltd Qingdao Qizhou Rubber Co., Ltd 20.87 Qingdao Rhino International Co., Ltd Dongying JinZheng Tyre Co., Ltd 20.87 Qingdao Rhino International Co., Ltd Qingdao Aonuo Group 20.87 Qingdao Rhino International Co., Ltd Shandong Jinwangda Tire Co., Ltd 20.87 Qingdao Rhino International Co., Ltd Weihai Ping'an Tyre Co., Ltd 20.87 Qingdao Taihao Tyre Co., Ltd Qingdao Taihao Tyre Co., Ltd 20.87 Qingdao Tanco Tire Industrial & Commercial Co., Ltd Hebei Tianrui Rubber Co., Ltd 20.87 Qingdao Tanco Tire Industrial & Commercial Co., Ltd Shandong Hawk International Rubber Co., Ltd 20.87 Qingdao Tanco Tire Industrial & Commercial Co., Ltd Xingyuan Tires Group 20.87 Qingdao Yellow Sea Rubber Co., Ltd Qingdao Yellow Sea Rubber Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Aeolus Tyre Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Bayi Rubber Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Chonche Auto Double Happiness Tyre Corp. Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Double Coin Holdings Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Guizhou Tyre Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Hangzhou Zhongce Rubber Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Qingdao Doublestar Tire Industrial Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Haohua Tire Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Hengfeng Rubber and Plastic Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Hengyu Science & Technology Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Huasheng Rubber Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Wosen Rubber Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shandong Yongtai Group Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Shengtai Group Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd South China Tire & Rubber Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Weifang Goldshield Tire Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Weifang Shunfuchang Rubber & Plastic Products Co., Ltd 20.87 Qingdao Yongdao International Trade Co., Ltd Xingyuan Tire Group Co., Ltd 20.87 Rodeo Tire Ltd Shandong Province Sanli Tire Manufactured Co., Ltd 20.87 Rodeo Tire Ltd Sichuan Tyre & Rubber Co., Ltd 20.87 Rover Tire Co., Ltd Aeolus Tyre Co., Ltd 20.87 Rover Tire Co., Ltd Dongying Fangxing Rubber Co., Ltd 20.87 Rover Tire Co., Ltd Double Coin Holdings Ltd 20.87 Rover Tire Co., Ltd Qingdao Doublestar Tire Industrial Co., Ltd 20.87 Rover Tire Co., Ltd Shandong Hengyu Science & Technology Co., Ltd 20.87 Rover Tire Co., Ltd Shandong Huasheng Rubber Co., Ltd 20.87 Rover Tire Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Rover Tire Co., Ltd Shandong Longyue Rubber Co., Ltd 20.87 Rover Tire Co., Ltd Shandong Yongsheng Rubber Group Co., Ltd 20.87 Rover Tire Co., Ltd Wanli Group Trade Limited 20.87 Rover Tire Co., Ltd Zhongce Rubber Group Company Limited 20.87 Sailun Jinyu Group Co., Ltd Sailun Jinyu Group Co., Ltd 20.87 Sailun Jinyu Group Co., Ltd Shenyang Peace Radial Tyre Manufacturing Co., Ltd 20.87 Shandong Anchi Tyres Co., Ltd Shandong Anchi Tyres Co., Ltd 20.87 Shandong Haohua Tire Co., Ltd Shandong Haohua Tire Co., Ltd 20.87 Shandong Haoyu Rubber Co., Ltd Shandong Haoyu Rubber Co., Ltd 20.87 Shandong Hawk International Rubber Industry Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Shandong Hengfeng Rubber & Plastic Co., Ltd Shandong Hengfeng Rubber & Plastic Co., Ltd 20.87 Shandong Hengyu Science & Technology Co., Ltd Shandong Hengyu Science & Technology Co., Ltd 20.87 Shandong Hengyu Science & Technology Co., Ltd Shandong Hengyu Rubber Co., Ltd 20.87 Shandong Homerun Tires Co., Ltd Good Friend Tyre Co., Ltd 20.87 Shandong Homerun Tires Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Shandong Homerun Tires Co., Ltd Shandong Wosen Rubber Co., Ltd 20.87 Shandong Homerun Tires Co., Ltd Shandong Yongsheng Rubber Group Co., Ltd 20.87 Shandong Homerun Tires Co., Ltd Weifang Shunfuchang Rubber and Plastic Products Co., Ltd 20.87 Shandong Huasheng Rubber Co., Ltd Shandong Huasheng Rubber Co., Ltd 20.87 Shandong Hugerubber Co., Ltd Shandong Hugerubber Co., Ltd 20.87 Shandong Huitong Tyre Co., Ltd Shandong Huitong Tyre Co., Ltd 20.87 Shandong Kaixuan Rubber Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Shandong Linglong Tyre Co., Ltd Shandong Linglong Tyre Co., Ltd 20.87 Shandong O'Green Tyres Co., Ltd Shandong O'Green Tyres Co., Ltd 20.87 Shandong Province Sanli Tire Manufactured Co., Ltd Shandong Province Sanli Tire Manufactured Co., Ltd 20.87 Shandong Sangong Rubber Co., Ltd Shandong Sangong Rubber Co., Ltd 20.87 Shandong Transtone Tyre Co., Ltd Shandong Haohua Tire Co., Ltd 20.87 Shandong Transtone Tyre Co., Ltd Shandong Hongyu Rubber Co., Ltd 20.87 Shandong Transtone Tyre Co., Ltd Shandong Kaixuan Rubber Co., Ltd 20.87 Shandong Transtone Tyre Co., Ltd Weifang Yuelong Rubber Co., Ltd 20.87 Shandong Vheal Group Co., Ltd Shandong Vheal Group Co., Ltd 20.87 Shandong Wanda Boto Tyre Co., Ltd Shandong Wanda Boto Tyre Co., Ltd 20.87 Shandong Wanshine Tire Co., Ltd Shandong Wanshine Tire Co., Ltd 20.87 Shandong Xingyuan Tire Group Co., Ltd Shandong Xingyuan Tire Group Co., Ltd 20.87 Shandong Yinbao Tyre Group Co., Ltd Shandong Yinbao Tyre Group Co., Ltd 20.87 Shandong Yongfeng Tyres Co., Ltd Shandong Yongfeng Tyres Co., Ltd 20.87 Shandong Yongsheng Rubber Group Co., Ltd Shandong Yongsheng Rubber Group Co., Ltd 20.87 Shandong Yongtai Group Co., Ltd Shandong Yongtai Group Co., Ltd 20.87 Shanghai Durotyre International Trading Co., Ltd Chaoyang Long March Tyre Co., Ltd 20.87 Shanghai Durotyre International Trading Co., Ltd Double Happiness Tyre Industrial Co., Ltd 20.87 Shengtai Group Co., Ltd Shengtai Group Co., Ltd 20.87 Shengtai Group Co., Ltd Shandong Zhushenghua Rubber Co., Ltd 20.87 Shenzhen Zhongjin Import & Export Co., Ltd Hefei Wanli Tire Co., Ltd 20.87 Shenzhen Zhongjin Import & Export Co., Ltd South China Tire & Rubber Co. 20.87 Shenzhen Zhongjin Import & Export Co., Ltd Weifang Shunfuchang Rubber And Plastics Products Co., Ltd 20.87 Shifeng Juxing Tire Co., Ltd Shifeng Juxing Tire Co., Ltd 20.87 Shuma Tyre International (Qingdao) Co., Ltd Shandong Wanshine Tire Co., Ltd 20.87 Sichuan Kalevei Technology Co., Ltd Sichuan Kalevei Technology Co., Ltd 20.87 Sinotyre International Group Co., Ltd Dongying City Fangxing Rubber Co., Ltd 20.87 Sinotyre International Group Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Sportrak Tire Group Limited Bayi Rubber Co., Ltd 20.87 Sportrak Tire Group Limited Shaanxi Yanchang Petroleum Group Rubber Co., Ltd 20.87 Sportrak Tire Group Limited Shandong Hawk International Rubber Industry Co., Ltd 20.87 Tianjin Leviathan International Trade Co., Ltd NDI Tire (Qingdao) Co., Ltd 20.87 Tianjin Leviathan International Trade Co., Ltd Qingdao Nama Industrial Co., Ltd 20.87 Tianjin Leviathan International Trade Co., Ltd Shandong Haohua Tire Co., Ltd 20.87 Tianjin Leviathan International Trade Co., Ltd Shandong Hawk International Rubber Industry Co., Ltd 20.87 Tianjin Leviathan International Trade Co., Ltd Xingyuan Tire Group Co., Ltd 20.87 Top Tyre Industry Co., Limited Shandong Hawk International Rubber Industry Co., Ltd 20.87 Toyo Tire (Zhucheng) Co., Ltd Toyo Tire (Zhucheng) Co., Ltd 20.87 Triangle Tyre Co., Ltd Triangle Tyre Co., Ltd 20.87 Tyrechamp Group Co., Limited South China Tire & Rubber Co., Ltd 20.87 Tyrechamp Group Co., Limited Zhongce Rubber Group Company Limited 20.87 Wanli Group Trade Limited South China Tire & Rubber Co., Ltd, 20.87 Weifang Shunfuchang Rubber And Plastic Products Co., Ltd Weifang Shunfuchang Rubber And Plastic Products Co., Ltd 20.87 Weihai Ping'an Tyre Co., Ltd Weihai Ping'an Tyre Co., Ltd 20.87 Weihai Zhongwei Rubber Co., Ltd Weihai Zhongwei Rubber Co., Ltd 20.87 Wendeng Sanfeng Tyre Co., Ltd Wendeng Sanfeng Tyre Co., Ltd 20.87 Xuzhou Xugong Tyres Co., Ltd Xuzhou Xugong Tyres Co., Ltd 20.87 Xuzhou Xugong Tyres Co., Ltd Armour Rubber Company Ltd 20.87 Yokohama Rubber Co., Ltd Suzhou Yokohama Tire Co., Ltd 20.87 Yongsheng Group Co., Ltd Shandong Yongsheng Rubber Group Co., Ltd 20.87 Zhongce Rubber Group Co., Ltd Zhongce Rubber Group Co., Ltd 20.87 Zhucheng Guoxin Rubber Co., Ltd Zhucheng Guoxin Rubber Co., Ltd 20.87 PRC-Wide Entity 22.57

    As detailed in the Preliminary Decision Memorandum, Double Coin Holdings Ltd., a mandatory respondent in this investigation, did not demonstrate that it was entitled to a separate rate. Accordingly, we consider this company to be part of the PRC-wide entity.

    Suspension of Liquidation

    In accordance with sections 733(e)(2)(A) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of truck and bus tires from the PRC, as described in Appendix I, that are entered, or withdrawn from warehouse, for consumption on or after 90 days prior to the date of publication of this notice in the Federal Register, and to require a cash deposit for such entries.

    Pursuant to 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit 13 equal to the weighted-average amount by which NV exceeds U.S. price as follows: (1) The cash deposit rate for the exporter/producer combinations listed in the table above will be the rate identified in the table; (2) for all combinations of PRC exporters/producers of merchandise under consideration that have not received their own separate rate above, the cash-deposit rate will be the cash deposit rate established for the PRC-wide entity; and (3) for all non-PRC exporters of merchandise under consideration which have not received their own separate rate above, the cash-deposit rate will be the cash deposit rate applicable to the PRC exporter/producer combination that supplied that non-PRC exporter. These suspensions of liquidation instructions will remain in effect until further notice.

    13See Modification of Regulations Regarding the Practice of Accepting Bonds During the Provisional Measures Period in Antidumping and Countervailing Duty Investigations, 76 FR 61042 (October 3, 2011).

    With respect to PCT, the non-selected respondents eligible for a separate rate, and the PRC-wide entity, we find that export subsidies constitute 0.41 percent 14 of the preliminarily calculated countervailing duty rate in the concurrent countervailing duty investigation. Thus, we will offset the rate of 20.87 percent for PCT and the non-selected respondents eligible for a separate rate and the rate of 22.57 percent for the PRC-wide entity by countervailing duty rate attributable to export subsidies, i.e., 0.41 percent, to calculate the cash deposit rate for this investigation. Accordingly, the cash deposit rates will be 20.46 percent for PCT and the non-selected respondents eligible for a separate rate and 22.16 percent for the PRC-wide entity.

    14 The Department preliminarily determined that Export Seller's Credit from the Export-Import Bank of China was export specific and, from this program, Double Coin and Guizhou Tyre Co., Ltd., respectively received countervailable subsidies of 0.40 percent ad valorem and 0.41 percent ad valorem. See Truck and Bus Tires From the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination, Preliminary Affirmative Critical Circumstances Determination, in Part, and Alignment of Final Determination With Final Antidumping Determination, 81 FR 43577 (July 5, 2016), and accompanying Preliminary Decision Memorandum at 29. We simple-averaged these two nearly identical export subsidy rates and calculated 0.41 percent (0.405 percent rounded up) for purposes of adjusting the cash deposit rate in this investigation. See Preliminary Decision Memorandum at 30-31 for more details.

    Disclosure

    We intend to disclose the calculations performed to parties in this proceeding within five days after public announcement of the preliminary determination in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i) of the Act, we intend to verify information relied upon in making our final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the final verification report is issued in this proceeding and rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.15 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

    15See 19 CFR 351.309. See also 19 CFR 351.303 (for general filing requirements).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. Eastern Time, within 30 days after the date of publication of this notice.16 Hearing requests should contain the party's name, address, and telephone number, the number of participants, and a list of the issues parties intend to present at the hearing. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and location to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    16See 19 CFR 351.310(c).

    Postponement of Final Determination and Extension of Provisional Measures

    Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by petitioners. Requests by respondents for postponement of a final antidumping determination must be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.17

    17See 19 CFR 351.210(e)(2).

    Pursuant to 19 CFR 351.210(e), we received requests from certain respondents that the Department postpone the final determination and that provisional measures be extended to a period not to exceed six months.18

    18See Letter from PCT, “Truck and Bus Tires from China: Extension Request for Final Determination by Prinx Chengshan (Shandong) Tire Co., Ltd.,” dated August 25, 2016, and Letter from Double Coin Holdings Ltd., “Double Coin's Request to Extend the Final Determination,” dated August 26, 2016.

    In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because (1) our preliminary determination is affirmative; (2) the requesting exporters account for a significant proportion of exports of the subject merchandise; 19 and (3) no compelling reasons for denial exist, we are postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, we will make our final determination no later than 135 days after the date of publication of this preliminary determination, pursuant to section 735(a)(2)(A) of the Act.20

    19See Memorandum to Deputy Assistant Secretary Christian Marsh entitled, “Antidumping Duty Investigation of Truck and Bus Tires from the People's Republic of China: Respondent Selection,” dated April 18, 2016.

    20See also 19 CFR 351.210(e).

    U.S. International Trade Commission Notification

    In accordance with section 733(f) of the Act, we will notify the U.S. International Trade Commission (ITC) of our affirmative preliminary determination of sales at LTFV. If our final determination in this investigation is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after our final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.21

    21See section 735(b)(2) of the Act.

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: August 26, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I Scope of the Investigation

    The scope of the investigation covers truck and bus tires. Truck and bus tires are new pneumatic tires, of rubber, with a truck or bus size designation. Truck and bus tires covered by this investigation may be tube-type, tubeless, radial, or non-radial.

    Subject tires have, at the time of importation, the symbol “DOT” on the sidewall, certifying that the tire conforms to applicable motor vehicle safety standards. Subject tires may also have one of the following suffixes in their tire size designation, which also appear on the sidewall of the tire:

    TR—Identifies tires for service on trucks or buses to differentiate them from similarly sized passenger car and light truck tires;

    MH—Identifies tires for mobile homes; and

    HC—Identifies a 17.5 inch rim diameter code for use on low platform trailers.

    All tires with a “TR,” “MH,” or “HC” suffix in their size designations are covered by this investigation regardless of their intended use.

    In addition, all tires that lack one of the above suffix markings are included in the scope, regardless of their intended use, as long as the tire is of a size that is among the numerical size designations listed in the “Truck-Bus” section of the Tire and Rim Association Year Book, as updated annually, unless the tire falls within one of the specific exclusions set out below.

    Truck and bus tires, whether or not mounted on wheels or rims, are included in the scope. However, if a subject tire is imported mounted on a wheel or rim, only the tire is covered by the scope. Subject merchandise includes truck and bus tires produced in the subject country whether mounted on wheels or rims in the subject country or in a third country. Truck and bus tires are covered whether or not they are accompanied by other parts, e.g., a wheel, rim, axle parts, bolts, nuts, etc. Truck and bus tires that enter attached to a vehicle are not covered by the scope.

    Specifically excluded from the scope of this investigation are the following types of tires: (1) Pneumatic tires, of rubber, that are not new, including recycled and retreaded tires; and (2) non-pneumatic tires, such as solid rubber tires.

    The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 4011.20.1015 and 4011.20.5020. Tires meeting the scope description may also enter under the following HTSUS subheadings: 4011.99.4520, 4011.99.4590, 4011.99.8520, 4011.99.8590, 8708.70.4530, 8708.70.6030, and 8708.70.6060. On August 26, 2016, the Department included HTSUS subheadings 4011.69.0020, 4011.69.0090, and 8716.90.5059 to the case reference files, pursuant to requests by U.S. Customs and Border Protection and the petitioner.22

    22See Memorandum to the File entitled, “Requests from Customs and Border Protection and the Petitioner to Update the ACE Case Reference File,” dated August 26, 2016.

    While HTSUS subheadings are provided for convenience and for customs purposes, the written description of the subject merchandise is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Selection of Respondents IV. Period of Investigation V. Scope Comments VI. Scope of the Investigation VII. Product Characteristics VIII. Critical Circumstances IX. Discussion of the Methodology A. Non-Market Economy Country B. Surrogate Country C. Surrogate Value Comments D. Separate Rates E. Dumping Margin for the Separate Rate Companies F. Combination Rates G. The PRC-Wide Entity H. Application of Facts Available and Adverse Inferences I. Date of Sale J. Fair Value Comparisons K. Export Price L. Normal Value M. Factor Valuation Methodology N. Currency Conversion X. Adjustment Under Section 777A(F) of the Act XI. Adjustment to Cash Deposit Rate for Export Subsidies XII. Verification XIII. U.S. ITC Notification XIV. Conclusion
    [FR Doc. 2016-21346 Filed 9-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Analysis and Review of Ocean Exploration Video Products 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 September 15, 2016.

    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 Nick Pawlenko, LTJG/NOAA. NOAA Office of Ocean Exploration and Research, 215 South Ferry Road, Narragansett, RI 02882 (401) 874-6478.

    SUPPLEMENTARY INFORMATION: I. Abstract

    This request is for a new information collection.

    Telepresence uses satellite communication from ship to shore to bring the unknown ocean to the screens of scientists and the general public in their homes, schools or offices. With technology constantly evolving it is important to address the needs of the shore based scientists and public to maintain a high level of participation. We will use voluntary surveys to identify the needs of users of data, best approaches to leverage expertise of shore based participants and to create a “Citizen Science” web portal for meaningful public engagement focused on ocean exploration.

    II. Method of Collection

    This will be a web-based survey.

    III. Data

    OMB Control Number: 0648-xxxx.

    Form Number(s): None.

    Type of Review: Regular (new information collection).

    Affected Public: Individuals or households; business or other for-profit organizations; not-for-profit institutions; Federal government.

    Estimated Number of Respondents: 1000.

    Estimated Time Per Response: 5 minutes.

    Estimated Total Annual Burden Hours: 83 hours.

    Estimated Total Annual Cost to Public: $0 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: August 31, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-21317 Filed 9-2-16; 8:45 am] BILLING CODE 3510-KD-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE858 Western Pacific Fishery Management Council; Public Meetings AGENCY:

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

    ACTION:

    Notice of a public meeting and hearing.

    SUMMARY:

    The Western Pacific Fishery Management Council (Council) will hold a meeting of its Commonwealth of the Northern Mariana Islands (CNMI) Mariana Archipelago Fishery Ecosystem Plan (FEP) Advisory Panel (AP) and Guam Mariana Archipelago FEP AP to discuss and make recommendations on fishery management issues in the Western Pacific Region.

    DATES:

    The CNMI Mariana Archipelago FEP AP will meet on Wednesday, September 21, 2016, between 6 p.m. and 9 p.m. and the Guam Mariana Archipelago FEP AP will meet on Saturday, September 24, 2016, between 1 p.m. and 5 p.m. All times listed are local island times. For specific times and agendas, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The CNMI Mariana Archipelago FEP AP will meet at the Hyatt Regency Saipan, Royal Palm Avenue, Micro Beach Road, Garapan, Saipan, CNMI 96950. The Guam Mariana Archipelago FEP AP will meet at the Hilton Guam Resort and Spa, 202 Hilton Road, Tumon Bay, Guam 96913.

    FOR FURTHER INFORMATION CONTACT:

    Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; telephone: (808) 522-8220.

    SUPPLEMENTARY INFORMATION:

    Public comment periods will be provided in the agenda. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.

    Schedule and Agenda for the CNMI Mariana Archipelago FEP AP Meeting Wednesday, September 21, 2016, 6 p.m.-9 p.m. 1. Welcome and Introductions 2. Outstanding Council Action Items 3. Council Issues A. 2017 U.S. Territory Bigeye Tuna Limits B. Council Coral Reef Projects C. Report on Military Activities and Issues 4. Update on Council Projects in the Marianas A. Coral Reef Projects B. Data Collection Projects C. Community-Based Projects 5. Mariana FEP Community Activities 6. Marianas FEP AP-CNMI Issues A. Report of the Subpanels i. Island Fisheries Subpanel ii. Pelagic Fisheries Subpanel iii. Ecosystems and Habitat Subpanel iv. Indigenous Fishing Rights Subpanel B. Other Issues 7. Public Comment 8. Discussion and Recommendations 9. Other Business Schedule and Agenda for the Guam Mariana Archipelago FEP AP Meeting Saturday, September 24, 2016, 1 p.m.-5 p.m. 1. Hafa Adai—Welcome and Introductions 2. Outstanding Council Action Items 3. Council Issues A. 2017 U.S. Territory Bigeye Tuna Limits B. Council Coral Reef Projects C. Report on Military Activities and Issues 4. Update on Council Projects in the Marianas A. Coral Reef Projects B. Data Collection Projects C. Community-Based Projects 5. Mariana FEP Community Activities 6. Marianas FEP AP-Guam Issues A. Report of the Subpanels i. Island Fisheries Subpanel ii. Pelagic Fisheries Subpanel iii. Ecosystems and Habitat Subpanel iv. Indigenous Fishing Rights Subpanel B. Other Issues 7. Public Comment 8. Discussion and Recommendations 9. “At the End of the Day”—Other Business Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 31, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-21314 Filed 9-2-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE Proposed Information Collection; Comment Request; Limited Access Death Master File Accredited Conformity Assessment Body Application for Firewalled Status AGENCY:

    National Technical Information Service, 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. The purpose of this notice is to allow for 60 days of public comment.

    DATES:

    Written comments must be submitted on or before November 7, 2016.

    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 John W. Hounsell, Business and Industry Specialist, Office of Product and Program Management, National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312, email: [email protected] or telephone: 703-605-6184

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This notice informs the public that the National Technical Information Service (NTIS) is requesting approval of a new information collection described in Section II for use in connection with the final rule entitled “Certification Program for Access to the Death Master File.” The final rule was published on June 1, 2016, and will become effective on November 28, 2016. The new information collection described in Section II, if approved, will become effective on the effective date of the final rule.

    II. Method of Collection

    Title of Information Collection: “Limited Access Death Master File Accredited Conformity Assessment Body Application for Firewalled Status” (Firewalled Status Application Form).

    Description of the need for the information and the proposed use: NTIS issued a final rule establishing a program through which persons may become eligible to obtain access to Death Master File (DMF) information about an individual within three years of that individual's death. The final rule was promulgated under Section 203 of the Bipartisan Budget Act of 2013, Public Law 113-67 (Act). The Act prohibits the Secretary of Commerce (Secretary) from disclosing DMF information during the three-year period following an individual's death (Limited Access DMF), unless the person requesting the information has been certified to access the Limited Access DMF pursuant to certain criteria in a program that the Secretary establishes. The Secretary delegated the authority to carry out Section 203 to the Director of NTIS.

    The final rule requires that, in order to become certified, a Person must submit a written attestation from an “Accredited Conformity Assessment Body” (ACAB), as defined in the final rule, that such Person has information security systems, facilities and procedures in place to protect the security of the Limited Access DMF, as required under Section 1110.102(a)(2) of the final rule. A Certified Person also must provide a new written attestation periodically for renewal of its certification as specified in the final rule. The ACAB must be independent of the Person or Certified Person seeking certification, unless it is a conformity assessment body which qualifies for “firewalled status” pursuant to Section 1110.502 of the final rule.

    The Firewalled Status Application Form collects information that NTIS will use to evaluate whether the respondent qualifies for “firewalled status” under the rule, and, therefore, can provide a written attestation in lieu of an independent ACAB's attestation. This information includes specific requirements of Section 1110.502(b) of the final rule, which the respondent ACAB must certify are satisfied, and the provision of specific information by the respondent ACAB, such as the identity of the Person or Certified Person that would be the subject of the attestation and the basis upon which the certifications were made.

    III. Data

    OMB Control Number: This is a new collection.

    Form Number(s): NTIS FM101.

    Type of Review: Regular.

    Affected Public: Accredited Conformity Assessment Bodies seeking firewalled status under 15 CFR 1110.502 because they are “owned, managed or controlled” by the Person or Certified Person for whom they are providing assessment(s) and or audit(s) under the final rule for the “Certification Program for Access to the Death Master File.”

    Estimated Number of Respondents: NTIS expects to receive approximately 560 applications and renewals for certification every year, of which it expects that approximately 20% of the required assessments will be provided by Accredited Conformity Assessment Bodies that will seek firewalled status in a given year. Accordingly, NTIS estimates that it will receive approximately 112 Firewalled Status Application Forms per year.

    Estimated Time per Response: 60 minutes.

    Estimated Total Annual Burden Hours: 112 (112 × 1 hour = 112 hours).

    Estimated Total Annual Cost to Public: NTIS expects to receive approximately 112 applications annually at a fee of $200 per application, for a total cost to the public of $22,400. The total annual cost reflects the cost to the Federal Government, which consists of the expenses associated with NTIS personnel reviewing and processing the Firewalled Status Application Forms. In addition, NTIS estimates that it will take a senior auditor within the organization one hour to complete the form at a rate of $135 per hour, for a total additional cost to the public of $15,120 (112 burden hours × $135/hour = $15,120). NTIS estimates the total annual cost to the public to be $22,400 in fees + $15,120 in staff time = $37,520.

    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: August 31, 2016. Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2016-21279 Filed 9-2-16; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO-P-2016-0027] Request for Comments on the Extended Missing Parts Pilot Program AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Request for comments.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO) has a pilot program (Extended Missing Parts Pilot Program) in which an applicant, under certain conditions, can request a 12-month time period to pay the search fee, the examination fee, any excess claim fees, and the surcharge (for the late submission of the search fee and the examination fee) in a nonprovisional application. The Extended Missing Parts Pilot Program is currently set to expire on December 31, 2016. The USPTO is seeking public comment on whether the Extended Missing Parts Pilot Program offers sufficient benefits to the patent community for it to be made permanent or whether the USPTO should permit the program to expire.

    DATES:

    Comment Deadline Date: Written comments must be received on or before November 7, 2016.

    ADDRESSES:

    Comments should be sent by electronic mail message over the Internet addressed to: [email protected] Comments may also be submitted by postal mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of Eugenia A. Jones.

    Although comments may be submitted by postal mail, the Office prefers to receive comments by electronic mail message over the Internet in order to facilitate posting on the USPTO's Internet Web site. Electronic comments are preferred to be submitted in plain text, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. Comments not submitted electronically should be submitted on paper in a format that facilitates convenient digital scanning into ADOBE® portable document format.

    The comments will be available for public inspection at the Office of the Commissioner for Patents, currently located in Madison East, Tenth Floor, 600 Dulany Street, Alexandria, Virginia 22314. Comments also will be available for viewing via the USPTO's Internet Web site (http://www.uspto.gov). Because comments will be made available for public inspection, information that the submitter does not desire to make public, such as an address or phone number, should not be included in the comments. It would be helpful to the USPTO if comments included information about: (1) The name and affiliation of the individual responding; and (2) an indication of whether the comments represent views of the respondent's organization or are the respondent's personal views.

    FOR FURTHER INFORMATION CONTACT:

    Eugenia A. Jones, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy, by telephone at (571) 272-7727, or Erin M. Harriman, Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy, by telephone at (571) 272-7747.

    SUPPLEMENTARY INFORMATION:

    I. Background

    On December 8, 2010, after considering written comments from the public, the USPTO implemented the Extended Missing Parts Pilot Program. See Pilot Program for Extended Time Period To Reply to a Notice to File Missing Parts of Nonprovisional Application, 75 FR 76401 (Dec. 8, 2010), 1362 Off. Gaz. Pat. Office 44 (Jan. 4, 2011). Over the course of the pilot program, the USPTO provided extensions of the Extended Missing Parts Pilot Program through notices published in the Federal Register. The most recent notice extended the program until December 31, 2016, to allow the USPTO time to seek public comment on whether the Extended Missing Parts Pilot Program offers sufficient benefits to the patent community for it to be made permanent. See Extension of Extended Missing Parts Pilot Program, 80 FR 80325 (Dec. 24, 2015), 1422 Off. Gaz. Pat. Office 192 (Jan. 19, 2016). Since the Extended Missing Parts Pilot Program has been in place for more than five years, it is now a good opportunity to seek public comment on whether the program offers sufficient benefits to the patent community for it to be made permanent or whether the USPTO should permit the program to expire.

    Summary of the Extended Missing Parts Pilot Program: In order for an applicant to be provided a 12-month (non-extendable) time period to pay the search and examination fees and any required excess claims fees in response to a Notice to File Missing Parts of Nonprovisional Application under the Extended Missing Parts Pilot Program, the applicant must satisfy the following conditions: (1) The applicant must submit a certification and request to participate in the Extended Missing Parts Pilot Program with the nonprovisional application on filing, preferably by using Form PTO/AIA/421, titled “Certification and Request for Extended Missing Parts Pilot Program”; (2) the application must be an original (i.e., not a Reissue) nonprovisional utility or plant application filed under 35 U.S.C. 111(a) within the duration of the pilot program; (3) the nonprovisional application must directly claim the benefit under 35 U.S.C. 119(e) and 37 CFR 1.78 of a prior provisional application filed within the previous 12 months, and the specific reference to the provisional application must be in an application data sheet under 37 CFR 1.76 (see 37 CFR 1.78(a)(3)); and (4) the applicant must not have filed a nonpublication request.

    As required for all nonprovisional applications, the applicant must satisfy filing date requirements and publication requirements. If the application submitted on filing does not meet the requirements for publication, or if the application is filed without any claims, the Office of Patent Application Processing will issue an appropriate notice setting a two-month (extendable) time period within which to respond. The Extended Missing Parts Pilot Program does not change the two-month time period set forth in any such notice. In accordance with 35 U.S.C. 122(b), the USPTO will publish the application promptly after the expiration of 18 months from the earliest filing date for which benefit is sought.

    If the applicant satisfies the requirements (discussed above) on filing of the nonprovisional application and the application is in condition for publication, the USPTO will send the applicant a Notice to File Missing Parts of Nonprovisional Application that sets a 12-month (non-extendable) time period to submit the search fee, the examination fee, any excess claims fees (under 37 CFR 1.16(h)-(j)), and the surcharge under 37 CFR 1.16(f) (for the late submission of the search fee and examination fee). If an applicant files a timely reply to the Notice to File Missing Parts within the 12-month time period and the nonprovisional application is completed, the nonprovisional application will be placed in the examination queue based on the actual filing date of the nonprovisional application.

    For additional discussion, see Pilot Program for Extended Time Period To Reply to a Notice to File Missing Parts of Nonprovisional Application, 75 FR 76401 (Dec. 8, 2010), 1362 Off. Gaz. Pat. Office 44 (Jan. 4, 2011), and Extension of the Extended Missing Parts Pilot Program, 80 FR 80325 (Dec. 24, 2015), 1422 Off. Gaz. Pat. Office 192 (Jan. 19, 2016).

    II. Request for Public Comments

    The USPTO is requesting written public comments on whether the Extended Missing Parts Pilot Program should be made permanent. The USPTO seeks input from the public on the following:

    1. Have you participated in the Extended Missing Parts Pilot Program? If so, please discuss what aspects of the program you think are beneficial and what aspects are not.

    2. Please discuss why an applicant would be discouraged from participating in the Extended Missing Parts Pilot Program.

    3. Do you think the USPTO should make the Extended Missing Parts Pilot Program permanent? Why or why not?

    4. Please provide any other input that you would like the USPTO to consider in determining whether the Extended Missing Parts Pilot Program should be made permanent.

    Dated: August 29, 2016. Russell Slifer, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office.
    [FR Doc. 2016-21306 Filed 9-2-16; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO-C-2016-0032] USPTO Cancer Moonshot Challenge AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO) publishes this notice to announce the Cancer Moonshot Challenge, which was launched on August 22, 2016, to enlist the public's help to leverage the USPTO's intellectual property data, often an early indicator of meaningful research and development, and combine it with other economic and funding data. This challenge supports the goals and objectives of the National Cancer Moonshot, a Presidential initiative to speed up cancer advances, make more therapies available to more patients, and improve the ability to prevent cancer and detect it at an early stage. This notice provides the public with information on participation and application requirements for the challenge, including the judging criteria, submission requirements, and rules of eligibility.

    DATES:

    Challenge Deadline: The deadline for submissions is September 12, 2016, 5:00 p.m. Eastern Standard Time (EST).

    ADDRESSES:

    All individuals or entities who wish to participate in the challenge must register and submit their entry through www.challenge.gov.

    FOR FURTHER INFORMATION CONTACT:

    For further information, please contact Thomas A. Beach, Office of the Under Secretary and Director, at 571-272-8600.

    SUPPLEMENTARY INFORMATION:

    I. About the Challenge Background

    Cancer is undoubtedly a disease that touches all our lives. Ending cancer as we know it requires the formation of new alliances. As President Obama noted, getting this done isn't just going to take the best and brightest across the medical, research, and data communities—but millions of Americans owning a stake of it. By harnessing the power of patent data and accelerating the process for protecting the intellectual property that leads to cancer immunotherapy breakthroughs, the USPTO is standing up and doing its part to help bring potentially life-saving treatments to patients, faster.

    The Challenge

    With data released through the USPTO Developer Hub, users are building rich visualizations of intellectual property data, an early indicator of meaningful innovation and research and development (R&D), and combining this data with other state or agency data, such as census and bureau of labor statistics, and/or economic and financial data. These types of visualizations demonstrate the power of telling complex stories that lead to impactful insights and ask why the data matters. Similarly, we challenge you to create and illuminate new trend lines and interactive mappings of innovation with visualizations for all types of cancer treatments and diagnostics by combining our data with other unique data. Be sure to list the sources of your data sets (i.e., orange book data from the FDA), tools, and assumptions used to form your conclusion and visualizations. Imagine your data visualizations will be the foundation to empower the Federal Government—as well as the medical, research, and data communities—to make more precise funding and policy decisions based on the commercialization lifecycle of the most promising treatments, while maximizing U.S. competitiveness in cancer investments.

    Using analytic tools, processes, and other interoperable data sets, we are challenging you to develop interactive visualizations and stories that can help reveal new insights to guide public policy and research to achieve the goal of doubling the rate of progress toward a cure. For example, you could address questions such as:

    Trending:

    • What new insights can be revealed by correlating R&D spending/funding to breakthrough technologies? How would you define or cluster the broad spectrum of cancer treatments, therapies, and/or diagnostics?

    • What would trace studies of commercially successful treatments from patent to product tell us? What data insights can be gleaned from understanding the time it takes bring patents to patients?

    • What are the peaks and valleys in the landscape of cancer treatment technologies?

    Policy:

    • If you were the Director of NIH or another agency, given what you have learned from this patent data and your research, how would you prioritize your cancer research budget? (The National Cancer Institute's FY2014 budget was $4.932 billion.)

    • Based on cluster mapping of cancer treatments, therapies, and/or diagnostics, what policy would you put in place to promote certain technologies? For example, would you promote treatment to make cancer a livable disease verses curing it?

    • Is there any measurable relationship between patent data, clinical trial data, and time to it takes for the technology to be in the hands of the patient? If so, how (and with what catalyst for innovation and policy changes) would you advise the VPOTUS for the Cancer Moonshot?

    Resources

    The USTPO has released a curated data set consisting of 269,353 patent documents (published patent applications and granted patents) spanning the 1976 to 2016 period. This data and associated documentation explaining our methodology can be found on the USPTO Developer Hub.

    Prizes First Place: $5,000.00 Second Place: $3,000.00 Third Place: $2,000.00 More Information About the Cancer Moonshot Initiative

    As the President's Cancer Moonshot Initiative looks to build public-private partnerships with industry, governments, health systems, non-profits, philanthropy, research institutes, patients, and academia, those interested in advancing the Cancer Moonshot can join today by visiting www.whitehouse.gov/CancerMoonshot.

    II. Judging Criteria • Creativity & Innovation (20%) ○ Uniqueness and innovation in approach to revealing new insights to guide public policy and research. ○ Concept should be original, fill a gap, or answer a question in a manner that is not already available. • Evidence Base & Effectiveness (20%) ○ Provide meaningful insight, including potential actions and discoveries, using patent-related data to better inform funding and policy decisions or uncover insights into the cancer R&D process. ○ How did you arrive at and validate your story? Did you include additional complimentary datasets to help solidify your story? What additional knowledge sources did you use? • Value to Public (20%) ○ Concept should add value to the medical, research, or data communities and policymakers, allowing them to make more informed funding and policy decisions based on the patterns and trends of innovation in cancer diagnosis and treatment. • Usability (20%) ○ The design elements should attract, engage, and influence actions from the public and policymakers. • Functional Product (20%) ○ The visualization should have demonstrable functionality as described in project description. III. How To Enter

    By September 12, 2016, 5:00 p.m. Eastern Standard Time, submit the following items through www.challenge.gov:

    • A story (maximum 1,000 words). Written in English, tell the story of your visualization and walk users through how to use your visualization. The document must describe how your visualization provides meaningful insight, including potential actions and/or discoveries.

    • Access to and testing instructions for your submission. This can be appended to your visualization description and does not count toward the 1,000 word maximum.

    • Link to the submission. We will not accept any submission without a link.

    IV. Rules

    To be eligible to win a prize under this challenge, an individual or entity:

    (1) Shall have registered to participate in the competition under the rules promulgated by the USPTO.

    (2) Shall have complied with all the requirements under this section.

    (3) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States; in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States.

    (4) Shall not be a federal entity or federal employee acting within the scope of their employment.

    (5) Shall not be a USPTO employee working on their applications or submissions during assigned duty hours.

    (6) In the case of a federal grantee, shall not use federal funds to develop applications unless consistent with the purpose of their grant award.

    (7) In the case of a federal contractor, shall not use federal funds from a contract to develop applications or to fund efforts in support of a challenge submission.

    An individual or entity shall not be deemed ineligible because the individual or entity used federal facilities or consulted with federal employees during a competition if the facilities and employees are made equitably available to all individuals and entities participating in the competition.

    Entrants must agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.

    Entrants must also agree to indemnify the Federal Government against third-party claims for damages arising from or related to competition activities. By entering into this competition, entrants represent that the they possess liability insurance or are otherwise financially responsible for: (1) Claims by a third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in the competition, with the Federal Government named as an additional insured under the Entrant's insurance policy, if any; and (2) claims by the Federal Government for damage or loss to government property resulting from such an activity.

    By submitting an entry to this competition you represent and warrant that your submission:

    • Is your own work and not copied (if we have reason to believe that your submission is not your own work then we may not consider it); • does not contain any third party intellectual property rights and/or content that you do not have permission to use; and • is not obscene, defamatory, or in breach of any applicable legislation or regulations.

    The USPTO reserves the right to cancel, suspend, and/or modify the challenge, or any part of it, for any reason, at the USPTO's sole discretion.

    Submission Requirements

    • Your submission must use at least the cancer research dataset provided by the USPTO.

    • Your submission must be relevant to a U.S. audience and must be in the English language only.

    • You are responsible for the cost and expense (if any) of sending your submission to us and, if your submission is selected, either attending an awards event demo at the USPTO on September 26, 2016, in person or submitting a video of your presentation to be shared at the event.

    • Only one project submission is permitted per person or group. In the event of a dispute over the identity of an entrant, the submission will be deemed submitted by the authorized account holder of the email address submitted during the registration process.

    Submissions that do not adhere to the requirements listed above will be automatically disqualified.

    Intellectual Property

    Ownership of intellectual property is determined by the following:

    • Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement.

    • By participating in the challenge, each entrant hereby irrevocably grants to sponsor and administrator a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publicly perform, publicly display, and use the submission to the extent necessary to administer the challenge, and to publicly perform and publicly display the submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

    • All entrants are encouraged to open source their code to the extent possible as a continuing contribution to cancer research.

    Dated: August 31, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2016-21349 Filed 9-2-16; 8:45 am] BILLING CODE 3510-16-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Information Collection; Submission for OMB Review, Comment Request AGENCY:

    Corporation for National and Community Service.

    ACTION:

    Notice.

    SUMMARY:

    The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled Senior Corps Project Progress Report (PPR)—OMB Control Number 3045-0033 for review and approval in accordance with the Paperwork Reduction Act of 1995. Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Jill Sears, at 202-606-7577 or email to [email protected] Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.

    DATES:

    Comments may be submitted, identified by the title of the information collection activity, within October 6, 2016.

    ADDRESSES:

    Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in the Federal Register:

    (1) By fax to: 202-395-6974, Attention: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service; or

    (2) By email to: [email protected]

    SUPPLEMENTARY INFORMATION:

    The OMB is particularly interested in comments which:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Propose ways to enhance the quality, utility, and clarity of the information to be collected; and

    • Propose 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

    A 60-day Notice requesting public comment was published in the Federal Register on 06/10/2016 at 81 FR 37582. This comment period ended August 9, 2016. No public comments were received from this Notice.

    Description: The Senior Corps PPR has two components: (1) Narratives and work plans, and (2) the Progress Report Supplement (PRS), which is an annual survey of volunteer demographics and grantee characteristics.

    Type of Review: Renewal.

    Agency: Corporation for National and Community Service.

    Title: Senior Corps Project Progress Report.

    OMB Number: 3045-0033.

    Agency Number: None.

    Affected Public: Sponsors of Senior Corps grants.

    Total Respondents: 1,250.

    Frequency: Work plans and narratives: Semi-Annual. Progress Report Supplement: Annual.

    Average Time per Response: Progress Report and Supplement: Twelve hours.

    Estimated Total Burden Hours: 15,000 hours.

    Total Burden Cost (capital/startup): None.

    Total Burden Cost (operating/maintenance): None.

    Authority:

    Pub. L. 104-13, (44 U.S.C. Chapter 35)

    Dated: August 30, 2016. Mikel Herrington, Director, Senior Corps.
    [FR Doc. 2016-21327 Filed 9-2-16; 8:45 am] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Department of the Air Force Notice Is Given of the Names of Members of the Performance Review Board for the Department of the Air Force AGENCY:

    United States Air Force, DOD.

    ACTION:

    Notice.

    SUMMARY:

    Notice is given of the names of members of the Performance Review Board for the Department of the Air Force.

    DATES:

    Effective on November 1, 2016.

    SUPPLEMENTARY INFORMATION:

    Pursuant to 5 U.S.C. 4314(c) (1-5), the Department of the Air Force (AF) announces the appointment of members to the AF's Senior Executive Service (SES) Performance Review Board (PRB). Appointments are made by the authorizing official. Each board member shall review and evaluate performance scores provided by the SES' immediate supervisor. Performance standards must be applied consistently across the AF. The board will make final recommendations to the authorizing official relative to the performance of the executive.

    The members of the 2016 Performance Review Board for the U.S. Air Force are: 1. Board President—Gen Pawlikowski, Commander, Air Force Material Command 2. Honorable Disbrow, Under Secretary of the Air Force 3. Honorable Ballentine, Assistant Secretary of the Air Force for Installations, Environment, and Logistics 4. Lt Gen McLaughlin, Deputy Commander at United States Cyber Command 5. Lt Gen Bunch, Deputy, Office of the Assistant Secretary of the Air Force for Acquisition 6. Lt Gen Grosso, Deputy Chief of Staff for Manpower, Personnel and Services 7. Ms. Young, Executive Director, Air Force Materiel Command 8. Ms. Thomas, Deputy Chief Management Officer of the Air Force 9. Mr. McDade, Principal Deputy General Counsel of the Air Force 10. Mr. Shelton, Deputy Administrative Assistant to the Secretary of the Air Force 11. Ms. Costello, Principal Deputy Assistant Secretary of the Air Force (Acquisition) 12. Mr. Salvatori, Director, Capabilities Management Office 13. Mr. Bridges, Assistant Deputy Chief of Staff for Logistics, Engineering and Force Protection 14. Ms. Miller, Deputy Assistant Secretary of the Air Force for Installations 15. Mr. Geurts, Acquisition Executive, U.S. Special Operations Command 16. Ms. Nolta, Deputy Director, Air Force Staff

    Additionally, all career status Air Force Tier 3 SES members not included in the above list are eligible to serve on the 2016 Performance Review Board and are hereby nominated for inclusion on an ad hoc basis in the event of absence(s).

    FOR FURTHER INFORMATION CONTACT:

    Please direct any written comments or requests for information to Ms. Dawn Rayner, Deputy Director, Senior Executive Management, AF/DPS, 1040 Air Force Pentagon, Washington DC 20330-1040 (PH: 703-695-7677; or via email at [email protected])

    Bao-Anh Trinh, Air Force Federal Register Liaison Officer.
    [FR Doc. 2016-21056 Filed 9-2-16; 8:45 am] BILLING CODE 5001-10-P
    DEPARTMENT OF DEFENSE United States Air Force Notice of Intent To Prepare an Environmental Impact Statement (EIS) for the Housing Program at Wright-Patterson Air Force Base (AFB), OH AGENCY:

    United States Air Force, Department of Defense.

    ACTION:

    Notice of intent.

    SUMMARY:

    The United States Air Force (Air Force) is issuing this notice to notify the public of its intent to prepare an Environmental Impact Statement (EIS) for the housing program at Wright-Patterson AFB. The EIS is being prepared in accordance with National Environmental Policy Act (NEPA) of 1969; 40 Code of Federal Regulations (CFR), Parts 1500-1508, the Council on Environmental Quality (CEQ) regulations for implementing NEPA; and the Air Force Environmental Impact Analysis Process (EIAP) [32 CFR part 989].

    This notice also serves to invite early public and agency participation in determining the scope of environmental issues and alternatives to be analyzed in the EIS and to identify and eliminate from detailed study the issues which are not significant. To effectively define the full range of issues and concerns to be evaluated in the EIS, the Air Force is soliciting scoping comments from interested local, state and federal agencies, interested American Indian tribes, and interested members of the public. This NOI also serves to invite stakeholder participation and comment as part of the National Historic Preservation Act (NHPA) and in support and furtherance of the NHPA Section 106 consultation process.

    Scoping comments may be submitted to the Air Force at the planned public scoping meetings and/or in writing.

    DATES:

    The Air Force plans to hold two public scoping meetings from 5:30 p.m. to 8:30 p.m., on the dates and at the locations listed below.

    • Monday, September 26, 2016: Fairborn High School Auditorium, 306 E. Whittier Avenue, Fairborn, OH 45324 • Tuesday, September 27, 2016: Fairborn High School Auditorium, 306 E. Whittier Avenue, Fairborn, OH 45324

    The agenda for each scoping meeting is as follows:

    • 5:30 p.m. to 6:30 p.m.—Open House and comment submission • 6:30 p.m. to 7:00 p.m.—Air Force Presentation • 7:00 p.m. to 8:30 p.m.—Open House and comment submission resumes

    Local notices announcing scheduled dates, locations, and addresses for each meeting will be published in the Dayton Daily News, Fairborn Daily Herald, Beavercreek News Current, Xenia Daily Gazette and other publications a minimum of fifteen (15) days prior to each meeting.

    Comments will be accepted at any time during the Environmental Impact Analysis Process (EIAP). However, to ensure the Air Force has sufficient time to consider public input in the preparation of the Draft EIS, scoping comments must be submitted no later than October 9, 2016.

    ADDRESSES:

    Information on the Wright-Patterson AFB housing project can be accessed at the project Web site at http://wpafbhousingeis.versar.com. The project Web site can be used to submit scoping comments to the Air Force, or comments and inquiries may also be submitted by mail or email to the 88th Air Base Wing Public Affairs Office, 5135 Pearson Road, Bldg. 10, Room 253A, Wright-Patterson AFB, OH 45433 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Currently, 100 homes remain in the USAF inventory at WPAFB. These homes include ten homes on Yount Drive built in 1975, 89 homes built in 1934-1937 within a planned thematic landscape now managed as the Brick Quarters Historic District (BQHD), and the NRHP-eligible Foulois House constructed in 1874. WPAFB presently operates and maintains the BQHD and Foulois House under provisions of the National Historic Preservation Act (NHPA) Sections 106 and 110. Environmental studies and impact analysis will evaluate options for new construction, conveyance to a private developer, lease, and demolition of these last remaining government-owned homes. Public scoping meetings will be held to assist in identifying reasonable alternatives, potential impacts, and the relative significance of impacts to be analyzed in the EIS.

    The purpose of the action is to provide housing that meets Air Force standards for key and essential (K&E) personnel and their dependents stationed at WPAFB. The need for this action stems from mission requirements, Department of Defense (DOD) policy, and the USAF's obligations under the NHPA and Executive Order (EO) 13287, Preserve America. At a minimum, this action must support the mission by providing residences for 30 K&E personnel and their dependents who are required to live on WPAFB. The current privatized housing inventory does not support these needs, as the homes are not of adequate square footage and are not proximate enough to K&E work locations to support the base's housing requirements for the identified K&E personnel.

    The EIS will address concerns associated with modification, conveyance, lease, and/or demolition of historic homes within the BQHD. The EIS will analyze alternatives that could include military construction and continued government ownership, housing privatization of all or a portion of the homes, NHPA Section 111 Lease, reuse as temporary lodging facilities, demolition, and the No Action Alternative. Within the framework of these alternatives, the EIS will support Air Force decisions by identifying and evaluating potential impacts to land use, safety, noise, hazardous materials and solid waste, earth resources, water resources, air quality, transportation, cultural resources, biological resources, socioeconomics, and environmental justice.

    The USAF intends to use the EIS process and documentation to aid in fulfilling its NHPA, Section 106 consultation requirements (36 CFR 800.8) particularly regarding public participation in the planning process associated with this EIS. In addition, extensive consultation under NHPA Sec. 106 is ongoing with the OHPO, ACHP and other interested parties. That consultation is expected to produce a Sec. 106 project Programmatic Agreement which will be executed prior to issuance of this EIS's Record of Decision (ROD).

    Henry Williams, Acting Air Force Federal Register Officer.
    [FR Doc. 2016-21274 Filed 9-2-16; 8:45 am] BILLING CODE 5001-10-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0056] National Environmental Policy Act Implementing Procedures AGENCY:

    Defense Threat Reduction Agency/USSTRATCOM Center for Combating Weapons of Mass Destruction, Department of Defense.

    ACTION:

    Final guidance.

    SUMMARY:

    The Defense Threat Reduction Agency/USSTRATCOM Center for Combating Weapons of Mass Destruction (DTRA/SCC-WMD or the Agency) is issuing procedures to implement the National Environmental Policy Act (NEPA), Executive Order (E.O.) 11514, and Council on Environmental Quality (CEQ) regulations for implementing the procedural provisions of NEPA.

    DATES:

    This final guidance is effective on September 6, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Sherry Davis, Director, Environment, Safety, and Occupational Health Department, at (703) 767-7122 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    On Thursday, May 5, 2016 (81 FR 27107-27122), the Department of Defense published proposed guidance titled “National Environmental Policy Act Implementing Procedures” for a 30-day public comment period. The public-comment period ended on June 6, 2016. No public comments were received.

    Further administrative edits were made to the final guidance. References to “J4/8C” were changed to “J4/8”, and references to the Environment, Safety, and Occupational Health (ESOH) Team Web site were removed throughout the final guidance.

    DTRA/SCC-WMD is a combat support agency that counters weapons of mass destruction (WMD). DTRA/SCC-WMD keeps WMD out of the hands of terrorists and other enemies by locking down, monitoring, and destroying weapons and weapons-related material, assists with plans and responses to WMD events, and develops and delivers cutting-edge technologies to assist with these endeavors.

    As a Department of Defense (DoD) agency, the DTRA/SCC-WMD does not own real property. Most agency actions typically occur on host military service installations or ranges, or other Federal agency properties. DTRA/SCC-WMD formerly relied upon host installation NEPA implementing procedures, including categorical exclusions to address potential environmental impacts of agency actions. With the issuance of CEQ guidance “Establishing, Applying, and Revising Categorical Exclusions under the National Environmental Policy Act” (Nov. 23, 2010) and after consulting with CEQ and other similar DoD components, DTRA/SCC-WMD determined the need to establish NEPA implementing procedures and categorical exclusions specific to DTRA/SCC-WMD projects and actions. The information assembled while developing categorical exclusions is described in the “DTRA/SCC-WMD Administrative Record for Supporting Categorical Exclusions” and is available on the DTRA/SCC-WMD Web site at: http://www.dtra.mil/Home/NEPA.aspx.

    The categorical exclusions describe the categories of actions that DTRA/SCC-WMD determined to normally not individually or cumulatively have significant impact on the environment. These and the other implementing procedures will serve as the agency's guide for complying with the requirements of NEPA for DTRA/SCC-WMD actions.

    The text of the complete DTRA/SCC-WMD NEPA implementing procedures can be found on the DTRA/SCC-WMD Web site at: http://www.dtra.mil/Home/NEPA.aspx and in this document.

    Dated: August 31, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. Table of Contents 1. Purpose 2. Applicability 3. Policy 4. Responsibilities 5. Environmental Planning & Analysis (a) Record of Environmental Review (b) Categorical Exclusion (CATEX) (c) Environmental Assessment (EA) (d) Finding of No Significant Impact (FONSI) (e) Environmental Impact Statement (EIS) (f) Record of Decision (ROD) 6. Mitigation and Monitoring 7. Subsequent Analyses (a) Tiering and Programmatic Review (b) Supplemental EAs/EISs (c) Adoption of EAs/EISs 8. Actions on Host Installations/Actions Abroad (a) Actions on Host Installations (b) Actions Occurring Abroad 9. Classified Actions 10. Administrative Record 11. Glossary (a) Abbreviations and Acronyms (b) Definitions Appendix A: The NEPA Process Appendix B: Categorical Exclusions (CATEXs) Appendix C: Record of Environmental Consideration (REC) Appendix D: Notice of Intent (NOI) Appendix E: Notice of Availability (NOA) Appendix F: Record of Decision (ROD) Defense Threat Reduction Agency/USSTRATCOM Center for Combating Weapons of Mass Destruction NEPA Implementing Procedures 1. Purpose

    Pursuant to DTRA/SCC-WMD Instruction 4715.5, “Environmental Compliance” (Aug. 22, 2014), this guide identifies requirements and provides procedures for implementing the provisions of the National Environmental Policy Act (NEPA) in accordance with Council on Environmental Quality Regulations for Implementing the Procedural Provisions of the National Environmental Policy Act, 40 CFR parts 1500-1508, and E.O. 12114, “Environmental Effects Abroad of Major Federal Actions” (Jan. 4, 1979). It supplements 40 CFR parts 1500-1508 and E.O. 12114 by establishing policy, responsibilities, and procedures for fully considering environmental consequences of proposed actions, preparing necessary documentation for actions with the potential for significant environmental impact, and demonstrating transparency in decision-making.

    DTRA/SCC-WMD does not own real property or undertake projects or programs where actions are planned or funded by private applicants or other non-Federal entities. Therefore, this guide does not include provisions to account for such actions.

    2. Applicability

    The requirements and procedures of this guide apply to all entities of DTRA/SCC-WMD and its executing agents.

    3. Policy

    It is DTRA/SCC-WMD policy to:

    (a) Integrate environmental consideration into all Agency/Center activities at the earliest possible planning stage, make decisions considering environmental consequences, assess a range of reasonable alternative actions, and take actions that protect, restore, and enhance the environment.

    (b) Prepare all necessary documentation required under NEPA and 40 CFR parts 1500-1508 whenever acting as the proponent or lead agency for a proposed action that has the potential for significant environmental impact.

    (c) Serve as a cooperating agency for activities in which DTRA/SCC-WMD participates but is not the proponent or lead agency and provide full cooperation and necessary technical expertise and documentation to the lead agency as requested.

    (d) Use programmatic and tiered analyses, when possible, to eliminate redundancies in future project/program analyses, effectively evaluate cumulative environmental effects, and reduce mission delays.

    (e) Periodically (at least every 7 years) review the effectiveness of its NEPA procedures including responsibilities, implementing procedures, and categorical exclusions (CATEXs), and when new information or circumstances warrant, review the currency of existing Programmatic Environmental Impact Statements (EISs) and Programmatic Environmental Assessments (EAs).

    (f) Involve the public in preparing and executing its NEPA procedures, and publish NEPA implementing procedures, CATEXs, and other relevant NEPA documentation as appropriate on the DTRA/SCC-WMD public Web site.

    (g) Prepare NEPA documentation and procedures that are written in plain language so that decision-makers and the public can readily understand them.

    (h) To the fullest extent possible, integrate NEPA requirements with other environmental review and consultation requirements including, but not limited to, Clean Water Act, Clean Air Act, Endangered Species Act, National Historic Preservation Act, Resource Conservation and Recovery Act, and Comprehensive Environmental Response, Compensation, and Liability Act.

    (i) Eliminate duplication with State and local procedures by providing for, as appropriate, joint planning processes and, where appropriate, joint preparation of NEPA reviews (analyses and documentation).

    (j) Eliminate duplication with other Federal procedures by jointly preparing NEPA reviews, or adopting other agencies' EAs and EISs, or incorporating by reference material into an EA or EIS where appropriate.

    (k) Comply with host installation NEPA requirements in addition to the requirements set forth in this guide. Equivalent host installation documentation may be used to satisfy DTRA/SCC-WMD documentation requirements.

    4. Responsibilities (a) Director, DTRA/SCC-WMD (J0)

    The J0 has final approval and signature authority of EIS Records of Decision (RODs) generated by DTRA/SCC-WMD or its contractors. This authority may be delegated as deemed appropriate by the J0.

    (b) Joint Director (JDIR), Acquisition, Finance, and Logistics (J4/8)

    The JDIR, J4/8 monitors the effective implementation of these procedures through the Director, Environment, Safety, and Occupational Health (ESOH) Department (J4E) and hereby appoints the Director, J4E as the principal Agency/Center advisor on NEPA-related requirements.

    (c) Director, J4E

    The Director, J4E as the principal Agency advisor on NEPA-related requirements:

    (1) Provides guidance to Project/Program Managers as necessary on the requirements in this guide and maintains direct oversight of the NEPA process.

    (2) Reviews project proposals to determine NEPA applicability and requirements, and provides qualified personnel to support Project/Program Managers with NEPA compliance.

    (3) Performs environmental compliance reviews of EISs/RODs, EAs/Findings of No Significant Impact (FONSIs), and Records of Environmental Consideration (RECs) generated by DTRA/SCC-WMD or its contractors and provides initial approval by signature as the compliance authority.

    (4) When DTRA/SCC-WMD serves as a cooperating agency for activities in which it participates but is not the proponent or lead, reviews and approves NEPA documents as requested by the lead agency.

    (5) Maintains an organized administrative record of all NEPA documents generated by DTRA/SCC-WMD or its contractors, including documentation supporting Agency/Center CATEXs.

    (6) Represents DTRA/SCC-WMD in NEPA-related matters with external organizations.

    (7) Ensures required NEPA mitigation measures are documented in the administrative record, performed, and monitored.

    (d) Office of the General Counsel (J0GC)

    The J0GC provides a legal review of EISs, RODs, EAs, and FONSIs generated by DTRA/SCC-WMD or its contractors.

    (e) Governmental and Public Affairs Office (J0XG)

    The J0XG:

    (1) Assists Project/Program Managers with engaging the public for scoping meetings, accepting comments, providing adjudications, outreach efforts, and other related interactions.

    (2) Coordinates the public release of DTRA/SCC-WMD NEPA documentation using various mediums including local newspapers, DTRA/SCC-WMD's public Web sites, and the Federal Register (FR).

    (3) Approves, signs, and publishes Notices of Intent (NOI) and Notices of Availability (NOA).

    (f) Directorate JDIRs/Staff Office Chiefs/SCC-WMD Divisions

    The Directorate JDIRS/Staff Office Chiefs/SCC-WMD Divisions:

    (1) Integrate environmental considerations early in the planning stages of all Directorate/Staff Office/SCC-WMD Division activities with adequate time to ensure NEPA requirements can be met.

    (2) Provide project proposals to the Director, J4E for any planned DTRA/SCC-WMD activity with potential for environmental impact.

    (3) Provide necessary funding to satisfy NEPA requirements for Directorate/Staff Office/SCC-WMD Division activities subject to compliance.

    5. Environmental Planning & Analysis (a) Record of Environmental Review

    (1) A flowchart outlining the general NEPA process can be found in Appendix A.

    (2) As early in the planning process as possible, the Project/Program Manager of a proposed action must provide to the J4E a project proposal by completing the top section of a REC (found in Appendix C) with information regarding the scope of the activity.

    (3) A REC is used to document the environmental analysis for an activity. The REC could indicate that a CATEX applies and there are no extraordinary circumstances requiring further analysis; that the activity is covered under a previous analysis (EA/EIS) and further analysis is not required, or that additional analysis is needed (EA/EIS).

    (4) Based on conclusions of the initial environmental analysis, additional analysis may be required. Project/Program Managers must also comply with other applicable statutory or regulatory requirements set out in DTRA/SCC-WMD Instruction 4715.5, including but not limited to environmental permits, consultations, and approvals such as those required for actions affecting federally-listed threatened or endangered species or their designated critical habitat, historic and cultural preservation, safe drinking water requirements, as well as other applicable state, DoD, or local regulatory requirements.

    (b) Categorical Exclusion (CATEX)

    (1) A CATEX is a category of Agency/Center actions which have been determined to normally not individually or cumulatively have significant impact on the environment and therefore neither an EA nor EIS is required. Project/Program Managers may use a CATEX for a proposed action with approval from the J4E when there are no extraordinary circumstances that warrant further analysis in an EA or EIS. (i) A list of approved CATEXs can be found in Appendix B. DTRA/SCC-WMD must not use a CATEX that is not listed in the appendix. Proposals for additional CATEXs must be submitted to and approved by the J4E and CEQ, be reviewed through a public comment period, and be supported by appropriate substantiating documentation such as an EA/FONSI, impact demonstration projects, or information from professional staff, expert opinions, and scientific analyses. (ii) Extraordinary circumstances are also listed in Appendix B following the list of CATEXs.

    (2) If a CATEX applies, the J4E will document use of the specific CATEX on the REC, and the action may proceed. The REC should document any determination and conclusion where the issue of whether an extraordinary circumstance requires further review has been resolved. This determination can be made using current information and expertise, if available and adequate, or can be derived through conversation, as long as the basis for the determination is included in the REC. Copies of appropriate interagency correspondence can be attached to the REC. Example conclusions regarding screening criteria are as follows: (i) “U.S. Fish and Wildlife Service concurred in informal coordination that endangered or threatened species will not be adversely affected.” (ii) “Corps of Engineers determined action is covered by nationwide general permit.” (iii) “State Historic Preservation Officer concurred with action.” (iv) “State Department of Natural Resources concurred that no adverse effects to state sensitive species are expected.”

    (3) If a CATEX does not apply, either by not including the proposed action or due to extraordinary circumstances, and the action is not covered under an existing document, then an EA or EIS must be prepared unless the proposed action is not further considered.

    (4) To use a CATEX, the proponent must satisfy the following three screening conditions: (i) The action has not been segmented. Determine that the proposed action has not been segmented to meet the definition of a CATEX and fits within the category of actions described in the CATEX. Segmentation can occur when an action is broken down into small parts in order to avoid the appearance of significance of the total action. An action can be too narrowly defined, minimizing potential impacts in an effort to avoid a higher level of NEPA documentation. The scope of an action must include the consideration of connected actions, and the effects when applying extraordinary circumstances must consider cumulative impacts. (ii) No exceptional circumstances exist. Determine if the action involves extraordinary circumstances that would preclude the use of a CATEX (see Appendix B). (iii) One CATEX encompasses the proposed action. Identify a CATEX that encompasses the proposed action (see Appendix B). If multiple CATEXs could be applicable, proceed when it is clear that the entire proposed action is covered by one CATEX. Any limitation in any potentially applicable CATEX should be considered when determining whether it is appropriate to proceed without further analysis in an EA or EIS.

    (c) Environmental Assessment (EA)

    (1) An EA is a concise public document used to provide sufficient evidence and analysis for determining whether to prepare an EIS or FONSI or to comply with NEPA when an EIS is not necessary.

    (2) The EA must include, at a minimum, the following: (i) Cover page, which identifies the proposed action and the geographic location. (ii) Purpose and need for the proposed action or activity. (iii) Description of the proposed action with sufficient detail in terms that are understandable to readers that are not familiar with DTRA/SCC-WMD activities. (iv) Discussion of alternative actions considered, including the preferred action and a “no action” alternative. There is no requirement for a specific number of alternatives or a specific range of alternatives to be included in an EA. An EA may limit the range of alternatives to the proposed action and no action when there are no unresolved conflicts concerning alternative uses of available resources. For alternatives considered but eliminated from further study, the EA should briefly explain why these were eliminated. (v) Description of the affected environment. (vi) Analysis of the potential environmental impacts of the proposed action and alternatives. The EA must discuss, in comparative form, the reasonably foreseeable environmental impacts of the proposed action, the no action alternative, and any other reasonable alternatives necessary to address unresolved conflicts concerning the alternative use of resources. The discussion of environmental impacts must focus on substantive issues and provide sufficient evidence and analysis to support a FONSI unless a determination to prepare an EIS is made. (vii) Identification of any permits, licenses, approvals, reviews, or applicable special purpose laws. Although the NEPA process does not preclude separate compliance with these other requirements, DTRA/SCC-WMD will integrate applicable environmental review, consultation, and public involvement requirements under special purpose laws and requirements into its NEPA planning and documentation to reduce paperwork and delay. (viii) List of preparers, agencies, and persons consulted. (ix) Signature of the preparer(s) and the Director, J4E. (x) References and appendices. The appendices may include: (A) References that support statements and conclusions in the body of the EA, including methodologies used. Proper citations and, when available, hyperlinks to reference materials should be provided; (B) Evidence of coordination or required consultation with affected Federal, state, tribal, and local officials and copies or a summary of their comments or recommendations and the responses to such comments and recommendations; and (C) A summary of public involvement, including a summary of issues raised at any public hearing or public meeting.

    (3) The analysis of potential environmental impacts (item (c)(2)(vi) above) will include an assessment of the direct, indirect, and cumulative impacts that can reasonably be expected from taking the proposed action or alternatives, and the analysis should address substantive comments raised by interested Federal agencies, non-Federal agencies, and private parties. (i) When direct or indirect impacts exist, the EA must consider cumulative impacts. Cumulative impacts are impacts on the environment resulting from the incremental impact of the action when added to other past, present, and reasonably foreseeable future actions. (ii) Actions by Federal agencies, non-Federal agencies, and private parties must be included when considering cumulative impacts.

    (4) DTRA/SCC-WMD must coordinate, as appropriate, preparation of the EA with other agencies (Federal, state, local, or tribal governments) when the action involves resources they manage or protect, and will invite agencies with jurisdiction by law or with special expertise to participate as cooperating agencies. (i) Agencies with jurisdiction by law are those with the authority to grant permits for implementing actions, approve or veto portions of the proposed action, or finance a portion of the proposed action. Federal agencies with jurisdiction by law must be a cooperating agency. Non-federal agencies may be invited. (ii) Agencies with special expertise are those that have the expertise needed to help meet a statutory responsibility, to carry out in part the DTRA/SCC-WMD mission, or in the proposed actions' relationship to the objectives of regional, state, or local land use plans, policies, and controls. Federal and non-federal agencies may be invited.

    (5) DTRA/SCC-WMD must involve the public, to the extent practicable, in preparing EAs. (i) The appropriate level of involvement will vary based on the proposed action. A public scoping meeting, as described in 40 CFR 1501.7, is not required for an EA but is optional. Scoping can be particularly useful when an EA deals with uncertainty or controversy regarding potential conflicts over the use of resources or the environmental impacts of the proposed actions. The scoping process can provide a transparent way to identify environmental issues, focusing the analysis on the most pertinent issues and impacts. (ii) A draft EA should be circulated for 30 days of public comment and, if applicable, with the unsigned proposed FONSI, per paragraph (d)(7) of the FONSI provisions below. The length of comment period may be adjusted based on mission requirements.

    (6) DTRA/SCC-WMD will use the conclusions of an EA to determine whether to issue a FONSI or an NOI to prepare an EIS (found in Appendix D).

    (d) Finding of No Significant Impact (FONSI)

    (1) A FONSI is a document that briefly presents the reasons why a proposed action will not have a significant effect on the human environment and for which an EIS therefore will not be prepared. It must include the EA or a summary of it and note any other environmental documents related to it.

    (2) Mitigated FONSIs are appropriate where the J4E and Project/Program Manager, or other decision-maker for the project/program determine that mitigation measures can reduce potentially significant adverse impacts below the level of significance. These mitigation measures may be used to support a FONSI, provided that: (i) The relevant areas of environmental concern are identified in the EA; (ii) The EA supports the Agency's determination that the potential impacts, including the impacts of any mitigation commitments, will be insignificant; and (iii) The Agency has identified mitigation measures that will be sufficient to reduce potential impacts below applicable significance thresholds and has ensured commitments to implement these measures.

    (3) Mitigation that is used to support a mitigated FONSI must be included as a condition of project approval. In these cases, if DTRA/SCC-WMD's decision to act is not otherwise evidenced by a final decision document such as a rule, license, or approval, the J4E and the Project Manager or other decision-maker for the project/program must document the decision in the conclusion of the FONSI. The decision must identify those mitigation measures DTRA/SCC-WMD is adopting and identify any monitoring and enforcement program applicable to such measures (see Section 6: Mitigation and Monitoring).

    (4) A FONSI or Mitigated FONSI must document, in plain writing, the reasons why an action, not otherwise categorically excluded, would not have a significant impact on the human environment. The FONSI documents the basis for the determination that the proposed action would not have significant environmental impacts and the decision to implement the proposed action. The FONSI may be attached to an EA, or the EA and FONSI may be combined into a single document. If the FONSI is attached or combined with the EA, it need not repeat the discussion in the EA. If the FONSI is not attached or combined with the EA, the FONSI must include a summary of the EA and note any other environmental documents related to it. The FONSI must: (i) Briefly describe the proposed action, the purpose and need, and the alternatives considered (including the no action alternative), and assess and document all relevant matters necessary to support the conclusion that the proposed action would not significantly affect the quality of the human environment; (ii) Determine the proposed action's consistency or inconsistency with community planning, and document the basis for the determination; (iii) Present any mitigation measures that are a condition of project approval. The FONSI should also reflect coordination of mitigation commitments (including any applicable monitoring program) with, and consent and commitment from, those entities with the authority to implement specific mitigation measures committed to in the FONSI; and (iv) Reflect compliance with all applicable environmental requirements, including interagency and intergovernmental coordination and consultation, public involvement, and documentation requirements. Findings and determinations required under special purpose laws and requirements, regulations, and orders, if not made in the EA, must be included in the FONSI. (v) If the FONSI is prepared following adoption of all or part of another agency's NEPA document, the FONSI must identify the part(s) of the document being adopted and include documentation of DTRA/SCC-WMD's independent evaluation of the document.

    (5) All FONSIs must include the following approval statement: After careful and thorough consideration of the facts contained herein, the undersigned finds that the proposed Federal action is consistent with existing national environmental policies and objectives as set forth in Section 101 of NEPA and other applicable environmental requirements and will not significantly affect the quality of the human environment.

    APPROVED: DATE:

    (6) Following preparation of the FONSI, the Project/Program Manager reviews and signs the FONSI. Issuance of a FONSI signifies that DTRA/SCC-WMD will not prepare an EIS and has completed the NEPA process for the proposed action. Following the approval of a FONSI, the Project/Program Manager may decide whether to take or approve the proposed action. Mitigation measures that were made as a condition of approval of the FONSI must be incorporated in the decision to implement the action.

    (7) The J0XG in coordination with the Project/Program Manager will publish an NOA (found in Appendix E) with local media to open a 30-day public comment period for the final draft EA and unsigned proposed FONSI. For actions with national interest, J0XG shall also publish the NOA in the FR. The length of comment period may be adjusted based on mission requirements.

    (8) After closure of the public comment period, the Project/Program Manager in coordination with the J4E will adjudicate the comments received and update the EA as necessary. The Project/Program Manager in coordination with the J4E will decide to prepare an EIS, or terminate the proposed action.

    (9) Upon completing the adjudication, the final FONSI will be signed by the J4E and Project/Program Manager or other decision-maker for the project/program, and the action may proceed.

    (10) The J0XG will make the final EA and signed FONSI available to the public and post on DTRA/SCC-WMD's public Web site. (i) A copy of the FONSI and EA should be sent to reviewing agencies and organizations or individuals who made substantive comments or specifically requested copies. (ii) When a project involves a resource protected under a special purpose law or requirement, or other directive, the J0XG will send a signed copy of the FONSI and the EA supporting it to the agency(ies) with whom DTRA/SCC-WMD consulted to comply with the applicable law or directive and to any party requesting copies of those documents.

    (e) Environmental Impact Statement (EIS)

    (1) When a proposed action has the potential for significant environmental impact or when an EA does not result in a FONSI, an EIS will be prepared to examine the potential impacts of the proposed action, reasonable alternatives, and measures to mitigate those effects.

    (2) Prior to preparing an EIS, the Project/Program Manager in coordination with J0XG will publish an NOI (Appendix D) in the FR to initiate preparation of the EIS. (i) The NOI includes an overview of the proposed action, any reasonable alternatives being considered (including no action), and known potential environmental impacts associated with the action. If the NOI is also used to satisfy public notice and comment requirements of other environmental requirements in addition to NEPA that are applicable to the proposed action, the NOI should include a statement to that effect with a reference to the applicable laws, regulations, or Executive Orders. (ii) The NOI will also identify a DTRA/SCC-WMD point of contact who can provide additional information about the action and to whom comments should be sent. (iii) There will be a public scoping period of 30 days from the date of publication of the NOI in the FR to allow other interested agencies and the public to provide input and comments. If a scoping meeting is planned and sufficient information is available at the time of the NOI, the NOI should also announce the meeting, including the meeting time and location, and other appropriate information such as availability of a scoping document.

    (3) The Project/Program Manager must host a public EIS scoping meeting to identify the range of actions, alternatives, and impacts to consider for analysis. Scoping is a required part of the EIS process. Scoping is an early and open process for determining the scope of issues to be addressed in the EIS and identifying the significant issues related to a proposed action. The Project/Program Manager shall tailor the scoping processes to match the complexity of the proposal. (i) DTRA/SCC-WMD representatives must include at a minimum the Project/Program Manager, the J4E, and program subject matter experts. The Project/Program Manager will also invite interested members of the public and representatives from cooperating organizations, and may include other participants as necessary. (ii) Scoping serves additional purposes such as identifying those issues that do not require detailed analysis or that have been covered by prior environmental review, setting the temporal and geographic boundaries of the EIS, determining reasonable alternatives, and identifying available technical information. (iii) The Project/Program Manager with assistance from the J4E must take the lead in the scoping process, inviting the participation of potentially affected Federal, state, and local agencies, any potentially affected tribes, and other interested persons (including those who might oppose the proposed action).

    (4) An EIS must include the following components presented in the standard EIS format in accordance with 40 CFR parts 1500-1508: (i) A cover page that includes: (A) A list of the responsible lead and cooperating agencies (identifying the lead agency); (B) The title of the proposed action together with the state(s) and county(ies) where the action is located; (C) The name, address, and telephone number of the responsible DTRA/SCC-WMD official; (D) The designation of the statement as draft, final, or supplement; (E) A one paragraph abstract of the EIS; and (F) For draft EISs, a statement that this EIS is submitted for review pursuant to applicable public law requirements. (ii) An executive summary that adequately and accurately summarizes the EIS. The summary describes the proposed action, stresses the major conclusions, areas of controversy (including issues raised by agencies and the public), and the issues to be resolved (including the choice among alternatives). It also discusses major environmental considerations and how these have been addressed, summarizes the analysis of alternatives, and identifies the agency preferred alternative. It discusses mitigation measures and any monitoring. (iii) A table of contents that lists the chapters and exhibits (including figures, maps, and tables) presented throughout the EIS. It will also list any appendices, acronym list, glossary, references, and index. (iv) A Purpose and Need section that briefly describes the underlying purpose and need for the Federal action. It presents the problem being addressed and describes what DTRA/SCC-WMD is trying to achieve with the proposed action. It provides the parameters for defining a reasonable range of alternatives to be considered. The purpose and need for the proposed action must be clearly explained and stated in terms that are understandable to individuals who are not familiar with DTRA/SCC-WMD activities. Where appropriate, the responsible DTRA/SCC-WMD official should initiate early coordination with cooperating agencies in developing purpose and need. (v) An Alternatives section that includes the proposed action. This section is the heart of the EIS. It presents a comparative analysis of the no action alternative, the proposed action, and other reasonable alternatives to fulfill the purpose and need for the action, to sharply define the issues, and provide a clear basis for choice among alternatives by the approving official. Whether a proposed alternative is reasonable depends, in large part, upon the extent to which it meets the purpose and need for the proposed action. Reasonable alternatives not within the jurisdiction of the lead agency should be considered. DTRA/SCC-WMD may include alternatives proposed by the public or another agency. However, they must meet the basic criteria for any alternative: It must be reasonable, feasible, and achieve the project's purpose. The extent of active participation in the NEPA process by the proponent of the alternative also bears on the extent to which a preferred alternative deserves consideration. Charts, graphs, and figures, if appropriate, may aid in understanding the alternatives. To provide a clear basis of choice among the alternatives, graphic or tabular presentation of the comparative impact is recommended. This section also presents a brief discussion of alternatives that were not considered for detailed analysis (e.g., because they do not meet the purpose and need for the proposed action). The draft EIS must identify the preferred alternative or alternatives, if one or more exists at the time the draft EIS is issued. The final EIS must specifically and individually identify the preferred alternative. Criteria other than those included in the affected environment and environmental consequences sections of the EIS may be applied to identify the preferred alternative. Although CEQ encourages Federal agencies to identify the environmentally-preferred alternatives in the EIS, the CEQ Regulations do not require that discussion until the ROD. (vi) An affected environment section that describes the environmental conditions of the potentially affected geographic area or areas. The discussion of the affected environment should be no longer than is necessary. It should include detailed discussion of only those environmental impact categories affected by the proposed action or any reasonable alternatives to demonstrate the likely impacts; data and analyses should be presented in detail commensurate with the importance of the impact. To ensure that this section emphasizes the important aspects of the impacts on the environment, the discussion should summarize and incorporate by reference information or analysis that is reasonably available to the public. This section may include the following, if appropriate: (A) Location map, vicinity map, project layout plan, and photographs; (B) Existing and planned land uses and zoning, including: industrial and commercial growth characteristics in the affected vicinity; affected residential areas, schools, places of outdoor assemblies of persons, churches, and hospitals; public parks, wildlife and waterfowl refuges; federally listed or proposed candidate, threatened, or endangered species or federally designated or proposed critical habitat; wetlands; national and state forests; floodplains; farmlands; coastal zones, coastal barriers, or coral reefs; recreation areas; wilderness areas; wild and scenic rivers; Native American cultural sites, and historic and archeological sites eligible for or listed on the National Register of Historic Places; (C) State or local jurisdictions affected by the proposed action or any reasonable alternatives; (D) Population estimates and other relevant demographic information for the affected environment, including a census map where appropriate; and (E) Past, present, and reasonably foreseeable future actions, whether Federal or non-Federal, including related or connected actions to show the cumulative effects of these actions on the affected environment. (vii) An environmental consequences section, which forms the scientific and analytical basis for comparing the proposed action, the no action alternative, and other alternatives retained for detailed analysis. (A) The discussion of environmental consequences will include the environmental impacts of the alternatives including the proposed action; any adverse environmental impacts that cannot be avoided should the proposed action or any of the reasonable alternatives be implemented; the relationship between short-term uses of man's environment and the maintenance and enhancement of long-term productivity; any irreversible or irretrievable commitments of resources that would be involved in the proposed action or any reasonable alternatives should they be implemented; and mitigation. It must include considerations of direct, indirect, and cumulative impacts and their significance and possible conflicts with the objectives of Federal, regional, state, tribal, and local land use plans, policies, and controls for the area concerned and other unresolved conflicts. To avoid excessive length, the environmental consequences section may incorporate by reference background data to support the impacts analysis. 40 CFR 1502.22 sets forth requirements for addressing situations in which information for assessing reasonably foreseeable significant adverse impacts is incomplete or unavailable. (B) Specific environmental impact categories must be discussed to the level of detail necessary to support the comparisons of impacts of each alternative retained for detailed analysis, including the no action alternative. The section should include the information required to demonstrate compliance with other applicable requirements and should identify any permits, licenses, other approvals, or reviews that apply to the proposed action or any reasonable alternatives, and indicate any known problems with obtaining them. This section should also provide the status of any interagency or intergovernmental consultation required, for example, under the National Historic Preservation Act, 16 U.S.C. 470-470x-6, the Endangered Species Act, 16 U.S.C. 1531-1544, the Coastal Zone Management Act, 16 U.S.C. 1451-1466, the American Indian Religious Freedom Act, 42 U.S.C. 1996, Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, 63 Federal Register 27655 (May 14, 1998), the Wild and Scenic Rivers Act, 16 U.S.C. 1271-1287, and the Fish and Wildlife Coordination Act, 16 U.S.C. 661-667d. (viii) An EIS must describe mitigation measures considered or planned to minimize harm from the proposed action and reasonable alternatives. The EIS must discuss mitigation in sufficient detail to disclose that the environmental consequences have been fairly evaluated. Mitigation incorporated into project design must be clearly described in the proposed action and any reasonable alternatives. Environmental impacts resulting from mitigation must be considered in the EIS, when applicable. (A) The following types of mitigation measures should be considered: design and construction actions to avoid or reduce impacts; management actions that reduce impacts during operation of the facility; and replacement, restoration (reuse, conservation, preservation, etc.), and compensation measures. (B) Electronic data collection, tracking, and analysis may be useful in the consideration of appropriate mitigation measures. The DTRA/SCC-WMD ESOH Management System may also be used for tracking and monitoring mitigation commitments. (C) Mitigation and other conditions established in the EIS, or during review of the EIS, and that are committed to in the ROD, must be implemented by DTRA/SCC-WMD or another appropriate entity with authority to implement the identified mitigation measures or other conditions. DTRA/SCC-WMD ensures implementation of such mitigation measures through special conditions, funding agreements, contract specifications, directives, other review or implementation procedures, and other appropriate follow-up actions in accordance with 40 CFR parts 1500-1508. (ix) The EIS must list the preparers of the NEPA document, including the names, and qualifications (e.g., expertise experience, professional disciplines) of DTRA/SCC-WMD staff that were primarily responsible for preparing the EIS or significant background material, and contractors who assisted in preparing the EIS or associated environmental studies. (x) The EIS must contain a list of agencies, organizations, and persons to whom copies of the EIS are sent. This list is included for reference and to demonstrate that the EIS is being circulated, and thus, that the public review process is being followed. (xi) An index that reflects the key terms used throughout the EIS for easy reference. The index must include page numbers for each reference. (xii) An EIS must include appendices, if necessary. This section consists of material that substantiates any analysis that is fundamental to the EIS, but would substantially contribute to the length of the EIS or detract from the document's readability, if included in the body of the EIS. This section should contain information about formal and informal consultation conducted and related agreement documents prepared, pursuant to other special purpose laws and requirements. (xiii) The Final EIS must assess and respond to comments received on the draft EIS. (xiv) If applicable, the EIS may include footnotes. Footnotes include the title, author, date of document, and page(s) relied upon for sources used.

    (5) An EIS may not include any final decisions regarding the Agency/Center's course of action.

    (6) The J4E must file the draft EIS with the United States Environmental Protection Agency (EPA) through the e-NEPA electronic filing system at: http://www.epa.gov/oecaerth/nepa/submiteis/index.html. As part of the draft EIS filing process, the EPA will issue an NOA in the FR to open a 45-day comment period for the public, federally recognized tribes, or other interested Federal, state, and local agencies. This starts the official comment period for the draft EIS. The J0XG shall also publish an NOA (Appendix E) in a local daily newspaper on the same day that EPA's NOA is published. DTRA/SCC-WMD should send a press release to local media and, if the EIS is national in scope, to national media outlets. DTRA/SCC-WMD must notify EPA if it approves an extension of the public comment period so that EPA may provide an update in its FR notice. (i) The draft EIS should be available at local libraries or similar public depositories. Material used in developing or referenced in the draft EIS must be available for review at the appropriate DTRA/SCC-WMD office(s) or at a designated location. Upon request, copies of the draft EIS must be made available to the public without charge to the extent practical or at a reduced charge, which is not more than the actual cost of reproducing copies. The draft EIS may also be placed on the Internet and/or copies may be made available in digital form. (ii) The J0XG should use the following standard language in press releases and notices announcing the draft EIS's availability for comment and any public meetings or hearing(s) associated with the proposed project: DTRA/SCC-WMD encourages all interested parties to provide comments concerning the scope and content of the draft EIS. Comments should be as specific as possible and address the analysis of potential environmental impacts and the adequacy of the proposed action or merits of alternatives and the mitigation being considered. Reviewers should organize their participation so that it is meaningful and makes the agency aware of the reviewer's interests and concerns using quotations and other specific references to the text of the draft EIS and related documents. Matters that could have been raised with specificity during the comment period on the draft EIS may not be considered if they are raised for the first time later in the decision process. This commenting procedure is intended to ensure that substantive comments and concerns are made available to DTRA/SCC-WMD in a timely manner so that DTRA/SCC-WMD has an opportunity to address them. Before including your address, phone number, email address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so.

    (7) DTRA/SCC-WMD should hold public meetings or hearings on the draft EIS, when appropriate. If DTRA/SCC-WMD conducts a public meeting or hearing for the purpose of obtaining public comment on a draft EIS, DTRA/SCC-WMD should ensure that the draft document is available for public review at least 15 days before the event occurs. (i) The Project/Program Manager must request comments on the draft EIS from appropriate Federal, state, and local agencies and from tribes when the impacts may be on a reservation or affect tribal interests. (ii) Draft EISs must be coordinated with the appropriate regional offices of other Federal agencies having jurisdiction by law or special expertise, appropriate state and local agencies including cooperating agencies, affected cities and counties, and others known to have an interest in the action, and appropriate tribal governments when the impacts may affect tribal interests.

    (8) After closure of the comment period, the Project/Program Manager and the J4E will adjudicate the comments received by considering the input or concern and documenting a response, update the EIS as necessary, and complete an ROD (found in Appendix F) or terminate the proposed action. (i) DTRA/SCC-WMD must take into consideration all comments received on the draft EIS and comments recorded during public meetings or hearings, and respond to the substantive comments in the final EIS. All substantive comments received on the draft EIS (or summaries where the comments are voluminous) must be attached to the final EIS. Comments must be responded to in one or more of the following ways: (A) Written into the text of the final EIS; (B) Stated in an errata sheet attached to the final EIS; or (C) Included or summarized and responded to in an attachment to the final EIS, and if voluminous, may be compiled in a separate supplemental volume for reference. (ii) DTRA/SCC-WMD may, subject to the conditions set forth below, attach errata sheets to the draft EIS. If the modifications to the draft EIS in response to comments are minor and are confined to factual corrections or explanations of why the comments do not warrant additional agency response, then only the comments, responses, and errata sheets need to be circulated and the draft EIS and errata sheets may be filed as the final EIS as set out in 40 CFR1503.4(c). Use of errata sheets is subject to the condition that the errata sheets: (A) Cite the sources, authorities, or reasons that support the position of DTRA/SCC-WMD; and (B) If appropriate, indicate the circumstances that would trigger agency reappraisal or further response.

    (9) The cover page or summary of the final EIS or a draft EIS with errata sheets in lieu of a final EIS must include the following declaration language below. After careful and thorough consideration of the information contained herein and following consideration of the views of those Federal agencies having jurisdiction by law or special expertise with respect to the environmental impacts described, the undersigned finds that the proposed Federal action is consistent with existing national environmental policies and objectives as set forth in Section 101(a) of the National Environmental Policy Act of 1969.

    (10) Other required environmental findings and conclusions must be included in the summary, if not included in the body or at the end of the EIS.

    (11) The final EIS must be reviewed and approved by the Project/Program Manager and the J4E prior to generating an ROD.

    (12) The J4E will file the final EIS with the EPA through the e-NEPA electronic filing system at: http://www.epa.gov/oecaerth/nepa/submiteis/index.html. The EPA will issue an NOA for the final EIS in the FR. The Project/Program Manager may request that the J0XG also publish a more detailed availability notice in the FR, but the DTRA/SCC-WMD notice cannot be substituted for the EPA FR notice. The final EIS must be sent to: (i) The appropriate regional office of EPA; (ii) Any relevant DoD officials; (iii) Each Federal, state, and local agency, tribe, and private organization that made substantive comments on the draft EIS and to individuals who requested a copy of the final EIS or who made substantive comments on the draft EIS (one copy each); (iv) DOE headquarters for projects having major energy-related consequences (one copy); and (v) The appropriate state-designated single point of contact (or specific agency contacts when states have not designated a single contact point), unless otherwise designated by the governor (adequate number of copies, which varies by state). (vi) Additional copies must be sent to accessible locations to be made available to the general public such as state, metropolitan, and local public libraries to facilitate accessibility. The final EIS, comments received, and supporting documents must be made available to the public without charge to the fullest extent practical or at a reduced charge, which is not more than the actual cost of reproducing copies, at appropriate agency office(s) or at a designated location.

    (13) DTRA/SCC-WMD must wait a minimum of 30 days after the EPA NOA of the final EIS is published in the FR (and at least 90 days after filing of the draft EIS) before making a decision on the proposed action and issuing an ROD. The 30-day period provides time for the decision-maker to consider the final EIS and other pertinent information and make a decision; it is not for receiving public comments unless DTRA/SCC-WMD requests comments on the final EIS. At the conclusion of the 30-day waiting period, the J0 may issue the final decision in an ROD and implementation of the selected action may begin. (i) When DTRA/SCC-WMD is the lead Federal agency, the EPA, upon a showing by another Federal agency of compelling reasons of national policy, may extend prescribed periods up to 30 days, but no longer than 30 days without the permission of DTRA/SCC-WMD. The Project/Program Manager may also extend the waiting period or request the EPA to reduce this period for compelling reasons of national policy. The 90-day waiting period after the NOA of the draft EIS cannot be altered by the EPA. (ii) If DTRA/SCC-WMD unilaterally approves an overall extension of a comment period, the EPA must be notified so that the EPA may provide an update in its FR notice.

    (14) Under certain circumstances, DTRA/SCC-WMD may choose to terminate an EIS. This could occur, for example, when a proponent has decided not to go forward with the action or it is determined to be no longer needed. DTRA/SCC-WMD may also terminate an EIS and revert to an EA if the environmental analysis shows that there would not be significant impacts from the project. DTRA/SCC-WMD will provide notice of the determination to no longer conduct an EIS that is issued in a manner comparable to the publication and distribution used for the NOI to prepare the EIS. The notice should cite the date of the original NOI to prepare an EIS and state the reasons why DTRA/SCC-WMD has chosen to terminate the EIS.

    (f) Record of Decision (ROD)

    (1) The ROD (Appendix F) will state DTRA/SCC-WMD's final decision on which action will be taken. The ROD may be prepared after the time periods outlined in the EIS section above. The Project/Program Manager and the J4E must provide concurrence on the ROD before submitting to the J0 for approval. Supplements to final EISs may be necessary (see Section (7)(b) Supplemental EAs/EISs) and must be reviewed and approved in the same manner as the original document, and a new draft ROD should be prepared, circulated, and approved. (i) DTRA/SCC-WMD may select any alternative within the range of alternatives analyzed in the final EIS. The selected alternative may be an alternative other than the agency's preferred alternative or the environmentally-preferred alternative. The selected action may not be implemented until the J0 has approved and signed the ROD. (ii) If DTRA/SCC-WMD selects an alternative other than the preferred alternative in the final EIS that involves special purpose laws and requirements, such as those related to Section 4(f) land, federally listed endangered species, wetlands, or historic sites, the Agency must first complete any required permit, evaluation, consultation, or other approval requirement prior to taking the action.

    (2) DTRA/SCC-WMD must provide public notice of availability of the ROD through appropriate means as required by 40 CFR 1506.6(b). Such means may include publication in the FR, other media, and on the Internet, although publication in the FR is only required for actions with effects of national concern.

    (3) The ROD must: (i) Present DTRA/SCC-WMD's decision on the proposed action, and identify and discuss all factors, including any essential considerations of national policy, that were balanced by the Agency in making its decision and state how those considerations entered into the decision; (ii) Identify all alternatives DTRA/SCC-WMD considered and which alternative(s) is/are considered to be environmentally-preferable. DTRA/SCC-WMD may discuss preferences among alternatives based on relevant factors including economic and technical considerations, and agency statutory missions; (iii) Identify any mitigation measure(s) committed to as part of the decision and summarize any applicable mitigation monitoring and enforcement program. This must include any mitigation measure that was committed to as a condition of the approval of the final EIS; (iv) State whether all practicable means to avoid or minimize environmental harm from the selected alternatives have been adopted, and if not, why; and (v) Include any findings required by Executive Order, regulation, or special purpose law or requirement (e.g., wetlands, Section 4(f), etc.).

    (4) As necessary, the ROD can be used to clarify and respond to issues raised on the final EIS when those issues do not require supplementation of the final EIS.

    (5) If the ROD is prepared following adoption of all or part of another agency's NEPA document (see Section (7)(c) Adoption of EAs/EISs), the ROD must incorporate by reference the part(s) of the document being adopted and include documentation of DTRA/SCC-WMD's independent evaluation of the document.

    (6) The ROD must be signed by the J0 or delegated authority and posted with the EIS on the DTRA/SCC-WMD public Web site by the J0XG.

    (7) The action must proceed no less than 30 days after the EPA has published the NOA for the final EIS (see paragraph (5)(e)(13)).

    6. Mitigation and Monitoring

    (a) DTRA/SCC-WMD must indicate whether mitigation measures will be implemented for the action selected in either a FONSI or ROD, the commitments the Agency/Center considered and selected, and who will be responsible for implementing, funding, and monitoring the mitigation measures.

    (b) If the J4E and the Project Manager or other decision-maker for the project/program determine that a mitigation measure stipulated in a FONSI has not been implemented or the implemented mitigation is failing to mitigate environmental impacts as predicted, and as a result a significant impact may occur, the J4E and the Project Manager or other decision-maker for the project/program must initiate the EIS process by issuing an NOI to prepare an EIS if there remains discretionary DTRA/SCC-WMD action to be taken related to the project.

    (c) When possible, the Project/Program Manager should include the cost of mitigation as a line item in the budget for a proposed project/program. DTRA/SCC-WMD ensures implementation of such mitigation measures through memorandums of agreement, funding agreements, contract specifications, directives, other review or implementation procedures, and other appropriate follow-up actions.

    (d) DTRA/SCC-WMD may “mitigate to insignificance” potentially significant environmental impacts found during preparation of an EA instead of preparing an EIS. The FONSI will include these mitigation measures, which must be implemented simultaneously with the project/program action (see Sections 5(d)(i)-(iii)).

    (e) Mitigation includes: (1) Avoiding the impact altogether by not taking a certain action or parts of an action. (2) Minimizing impacts by limiting the degree or magnitude of the action and its implementation. (3) Rectifying the impact by repairing, rehabilitating, or restoring the affected environment. (4) Reducing or eliminating the impact over time by preservation and maintenance operation during the life of the action. (5) Compensating for the impact by replacing or providing substitute resources or environments.

    7. Subsequent Analyses (a) Tiering and Programmatic Review

    (1) A programmatic review may assist decision-makers and the public in understanding the environmental impact from proposed broad federal actions and activities. A programmatic EIS or EA may be prepared to cover: (i) A broad group of related actions; or (ii) A program, policy, plan, system, or national level proposal that may later lead to individual actions, requiring subsequent NEPA analysis.

    (2) A programmatic document is useful in analyzing the cumulative impacts of a group of related actions and when the proposed actions are adequately analyzed can serve as the NEPA review for those actions. Programmatic documents may also be useful in providing the basis for subsequent project-level specific environmental review. A programmatic EIS or EA may contain a broader, less specific, analysis than is done for a specific proposed project. If a programmatic EIS or EA is prepared, DTRA/SCC-WMD will determine whether project-specific EISs or EAs are needed for individual actions. Broad Federal actions analyzed in a programmatic EIS or EA may be evaluated geographically, generically, or by stage of technological development.

    (3) The use of a programmatic EIS or EA, and subsequent preparation of a project-specific EIS or EA is referred to as “tiering” the environmental review. Tiering can also be used to sequence environmental documents from the early stage of a proposed action (e.g., need for the action and site selection) to a subsequent stage (e.g., proposed construction) to help focus on issues that are ripe for decision and exclude from consideration issues not yet ripe or already decided. When this approach is used, DTRA/SCC-WMD must ensure that the proposed action is not being segmented by describing the independent utility of each stage. Programmatic and tiered EISs and EAs are subject to the same preparation and processing requirements as other EISs and EAs.

    (4) When a programmatic EIS or EA has been prepared, any subsequent EIS or EA for proposed projects within the scope of the programmatic document only needs to incorporate it by reference by summarizing the issues discussed in the programmatic document, providing access to the programmatic EIS or EA, and concentrating the subsequent project-specific EIS or EA on site-specific impacts not covered by the programmatic document. The project-specific document must state how to obtain a copy of the earlier programmatic document (i.e., a Web page or contact person/office).

    (b) Supplemental EAs/EISs

    (1) Project/Program Managers must prepare a supplemental EA, draft EIS, or final EIS if either of the following occurs: (i) There are substantial changes to the proposed action that are relevant to environmental concerns; or (ii) There are significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts.

    (2) Significant information is information that paints a dramatically different picture of impacts compared to the description of impacts in the EA or EIS. DTRA/SCC-WMD may also prepare supplements when the purposes of NEPA will be furthered by doing so.

    (3) Supplemental documents must be prepared following the same general process as the original EA or EIS addressing the new circumstances, information, or actions and incorporating by reference and summary the original EA or EIS. No new scoping is required for a supplemental EIS, but may be conducted at the discretion of the Project/Program Manager or the Director, J4E.

    (4) When a supplemental EA or EIS is completed, a new FONSI or ROD must be issued and made available to the public.

    (c) Adoption of EAs/EISs

    (1) DTRA/SCC-WMD may adopt in whole or in part, another Federal agency's draft or final EA, the EA portion of another agency's EA/FONSI, or EIS in accordance with 40 CFR 1506.3 and CEQ Guidance, “Improving the Process for Preparing Efficient and Timely Environmental Reviews under the National Environmental Policy Act,” March 6, 2012, where DTRA/SCC-WMD's proposed action is substantially the same as the action described in the existing EA or EIS. When another agency's NEPA document does not adequately address DTRA/SCC-WMD's proposed action or meet the applicable standards in the CEQ Regulations and these implementing procedures, then DTRA/SCC-WMD cannot adopt the EA or EIS and should consider which portions of that EA or EIS can be incorporated by reference.

    (2) The Project/Program Manager and J4E will independently review the EA or EIS and determine whether it is current, satisfies the requirements of NEPA, and covers the proposed action. In adopting all or part of another agency's NEPA document, DTRA/SCC-WMD takes full responsibility for the scope and content that addresses the relevant DTRA/SCC-WMD action(s).

    (3) If the actions covered by the original NEPA analysis and the DTRA/SCC-WMD proposed action are substantially the same, DTRA/SCC-WMD may reissue the EA or EIS as a final document and prepare its own FONSI or ROD. The EA or EIS will be recirculated and a public comment period will be provided per Section 5(e) above. When DTRA/SCC-WMD adopts an EA or EIS where it has acted as a cooperating agency and its comments and suggestions have been satisfied by the lead agency in the original document, then coordination with the public is not required.

    8. Actions on Host Installations/Actions Abroad (a) Actions on Host Installations

    DTRA/SCC-WMD must comply with the host installation NEPA implementing regulations, procedures, and guidance in addition to those set forth in this guide, and all environmental compliance actions must be coordinated with the appropriate host installation point of contact. Equivalent host installation documentation may be used to satisfy DTRA/SCC-WMD documentation requirements when signed and approved by DTRA/SCC-WMD and maintained in its administrative record.

    (b) Actions Occurring Abroad

    (1) Executive Order 12114 is based on the authority vested in the President by the Constitution and the laws of the United States. The objective of the Executive Order is to further foreign policy and national security interests while at the same time taking into consideration important environmental concerns. DTRA/SCC-WMD acts with care in the global commons because the stewardship of these areas is shared by all the nations of the world. DTRA/SCC-WMD will take account of environmental considerations when it acts in the global commons in accordance with these procedures.

    (2) DTRA/SCC-WMD also acts with care within the jurisdiction of a foreign nation. Treaty obligations and the sovereignty of other nations must be respected, and restraint must be exercised in applying United States laws within foreign nations unless the Congress has expressly provided otherwise. DTRA/SCC-WMD will take account of environmental considerations in accordance with these procedures when it acts in a foreign nation.

    (3) Foreign policy considerations require coordination with the Department of State on communications with foreign governments concerning environmental agreements and other formal arrangements with foreign governments concerning environmental matters. Informal working-level communications and arrangements are not included in this coordination requirement. Consultation with the Department of State also is required in connection with the utilization of additional exemptions from these procedures.

    (4) Executive Order 12114, implemented by these procedures, prescribes the exclusive and complete procedural measures and other actions to be taken by DTRA/SCC-WMD to further the purpose of the National Environmental Policy Act with respect to the environment outside the United States. As such, actions with potential for significant environmental impact occurring abroad or in the global commons outside the jurisdiction of any nation (e.g., the ocean or Antarctica) are subject to the environmental analysis procedures set forth in this Guide with the exception of hosting public meetings. Project/Program Managers may choose to host public meetings in consideration of the following factors: (i) Foreign relations sensitivities. (ii) Whether the hearings would be an infringement or create the appearance of infringement on the sovereign responsibilities of another government. (iii) Requirements of domestic and foreign governmental confidentiality. (iv) Requirements of national security. (v) Whether meaningful information could be obtained through hearings; (vi) Time considerations. (vii) Requirements for commercial confidentiality.

    (5) Consideration will be given to whether any foreign government should be informed of the availability of environmental documents. Communications with foreign governments concerning environmental agreements and other formal arrangements with foreign governments concerning environmental matters must be coordinated by the J0XG with the Department of State through the Assistant Secretary of Defense (International Security Affairs).

    9. Classified Actions

    (a) Classification of an action for national security does not relieve DTRA/SCC-WMD from the requirements of NEPA. DTRA/SCC-WMD will prepare, safeguard, and disseminate NEPA documents in accordance with DoD requirements for classified information.

    (b) Classified information in NEPA documents will be written in a separate appendix from unclassified information so that the unclassified portions of the documents can be made available to the public.

    (c) When classified information is an integral part of the analysis so that a meaningful unclassified NEPA analysis cannot be produced, the Project/Program Manager in coordination with the J4E will form a team to review the classified NEPA analysis. This team will include environmental professionals and subject matter experts who will ensure the consideration of environmental effects is consistent with the intent of NEPA, including public participation requirements for unclassified portions.

    10. Administrative Record

    (a) The J4E will maintain an administrative record for each environmental analysis performed and an administrative record to support these implementing procedures.

    (b) The administrative record for a proposed action must be retained for 7 years after completing the action, unless the action involves controversy concerning environmental effects or is of a nature that warrants keeping it longer as determined by the J4E.

    (c) The administrative records maintained will include, but are not limited to: (1) All supporting documentation used to generate DTRA/SCC-WMD's NEPA implementing procedures and CATEXs. (2) All supporting documentation and information used to make a decision for Agency actions with potential for significant environmental impact. (3) Maps and other documents relevant to developing an EA or EIS. (4) Formal communication by a consulting, coordinating, or cooperating agency. (5) Studies and inventories of affected environmental resources. (6) Correspondence with regulatory agencies, private citizens, tribes, State or local governments, and other individuals and agencies contacted during public involvement.

    11. Glossary (a) Abbreviations and Acronyms CATEX Categorical Exclusion CEQ Council on Environmental Quality DoD Department of Defense DTRA/SCC-WMD Defense Threat Reduction Agency and United States Strategic Command Center for Combating Weapons of Mass Destruction EA Environmental Assessment EIS Environmental Impact Statement EPA Environmental Protection Agency ESOH Environment, Safety, and Occupational Health FIRS Federal Information Relay Service FONSI Finding of No Significant Impact FR Federal Register JO Director, DTRA/SCC-WMD JOGC Office of the General Counsel JOXG Governmental and Public Affairs Office J4/8 Acquisition, Finance, and Logistics Directorate J4E Environment, Safety, and Occupational Health Department JDIR Joint Director NEPA National Environmental Policy Act NOA Notice of Availability NOI Notice of Intent REC Record of Environmental Consideration ROD Record of Decision TDD telecommunication devices for the deaf (b) Definitions

    Unless otherwise noted, these terms and their definitions are for the purpose of this NEPA Procedures Guide. The definitions in 40 CFR parts 1500-1508 control in the event of any inconsistency or difference.

    CATEX. A CATEX is defined at 40 CFR 1508.4 as a category of actions which do not individually or cumulatively have a significant effect on the human environment and which have been found to have no such effect in Federal agency NEPA implementing procedures and, therefore, neither an EA nor an EIS is required. This Guide provides for extraordinary circumstances in which an action that is normally categorically excluded may have a significant effect and therefore merit further analysis in an EA or EIS.

    Cooperating agency. A cooperating agency, defined at 40 CFR 1508.5, is any Federal agency or State, tribal, or local governmental entity which has jurisdiction by law or special expertise with respect to any environmental impact involved in a proposed action or a reasonable alternative. The selection and responsibilities of a cooperating agency are described at 40 CFR 1501.6.

    EA. An EA, defined at 40 CFR 1508.9, is a concise public document for which a Federal agency is responsible that serves to: (1) Briefly provide sufficient evidence and analysis for determining whether to prepare an EIS or a FONSI; and (2) aid an agency's compliance with NEPA when no environmental impact is necessary. An EA includes an evaluation of whether a project's potential environmental impacts may be significant. Includes an evaluation of the No Action Alternative and other alternatives to the proposed project, and results in either a FONSI or an NOI.

    EIS. An EIS, defined at 40 CFR 1508.11, is a detailed written evaluation of the potential environmental impacts and socioeconomic impacts of a proposed action (project), including an evaluation of the No Action Alternative and other alternatives to the proposed project. The EIS identifies mitigation measures needed to address adverse environmental impacts.

    Environmental planning. The process of identifying and considering environmental factors that impact on, or are impacted by, planned DoD activities and operations.

    FONSI. A FONSI, defined at 40 CFR 1508.13, is a document briefly presenting the reasons why the proposed action, based on the EA findings, will not have a significant effect on the human environment and therefore an EIS is not required.

    Impact. Any change to the environment wholly or partially resulting from an organization's activities, products, or services. Impact is synonymous with effect as defined at 40 CFR 1508.7 and 8.

    NEPA. The National Environmental Policy Act (NEPA) [42 U.S.C. 4321 et seq.] establishes national environmental policy and goals for the protection, maintenance, and enhancement of the environment and provides a process for implementing these goals within Federal agencies. NEPA also established the Council on Environmental Quality.

    NOA. A notice of availability is a document notifying the public and other government agencies that an EA or an EIS is available for review.

    NOI. A notice of intent, as defined at 40 CFR 1508.22, is a notice that an EIS will be prepared and considered. This notice includes a description of the proposed action and possible alternatives, a description of the agency's proposed scoping process, and the name and address of an agency representative who can answer questions about the proposed action and the EIS.

    Proponent. The organization that exercises primary management responsibility for a proposed action or activity.

    REC. Document stating that the proposed action (project) does not require further NEPA documentation.

    Appendix A: The NEPA Process BILLING CODE 5001-06-P EN06SE16.008 BILLING CODE 5001-06-C Appendix B: Categorical Exclusions (CATEXS)

    This Appendix includes categorical exclusions (CATEXs) and extraordinary circumstances for DTRA/SCC-WMD activities.

    Actions categorically excluded in the absence of extraordinary circumstances are:

    1. Normal personnel, fiscal or budgeting, and administrative activities and decisions, including those involving military and civilian personnel (for example, recruiting, processing, data collection, conducting surveys, payroll, and record keeping).

    2. Preparing, revising, or adopting regulations, instructions, directives, or guidance documents, including those that implement without substantial change to the regulations, instructions, directives, or guidance documents from higher headquarters or other Federal agencies.

    3. Decreases, increases, relocation, and realignment of personnel into existing Federally-owned or commercially-leased space that does not involve a substantial change affecting the supporting infrastructure or use of space (e.g., no increase in traffic beyond the capacity of the supporting network to accommodate such an increase).

    4. Routine procurement of goods and services conducted in accordance with applicable procurement regulations and green purchasing requirements including office supplies, equipment, mobile assets, and utility services for routine administration, operation, and maintenance.

    5. Administrative study efforts involving no commitment of resources other than personnel and funding allocations. If any of these study efforts result in proposals for further action, those proposals must be considered separately by an appropriate CATEX or NEPA analysis. Examples include, but are not limited to: Studies and surveys conducted to further administrative, personnel-related, architectural, engineering, safety, security, siting, and facility audit activities.

    6. Studies, monitoring, data and sample collection, and information gathering that involve no permanent physical change to the environment. If any of these activities result in proposals for further action, those proposals must be considered by an appropriate CATEX or NEPA analysis. Examples include, but are not limited to: Surveys for threatened and endangered species, wildlife and wildlife habitat, historic properties, and archeological sites; wetland delineations; minimal water, air, waste; material and soil sampling (e.g., grab samples). Environmental Baseline Surveys or Environmental Condition of Property Surveys. Topographical surveying and mapping that does not require cutting and/or removal of trees.

    7. Sampling, borehole drilling, well drilling and installation, analytical testing, site preparation, and minimally intrusive physical testing. These activities could involve minor clearing, grubbing, or movement of heavy equipment such as drill rigs. If any of these actions result in proposals for further actions, those proposals must be considered by an appropriate CATEX or NEPA analysis. Examples include, but are not limited to: Sampling for asbestos-containing materials, polychlorinated biphenyls, and lead-based paint. Topographical surveys and surveys for unexploded ordnance. Minimally-intrusive (no more than 25 square feet of disturbed surface area) geological, geophysical surveys, geo-technical activities, and seismic studies. Minimally-intrusive sampling to determine if hazardous wastes, contaminants, pollutants, or special hazards are present. Ground water monitoring wells, subsurface soil sampling, and soil borings.

    8. Immediate responses to the release or discharge of oil or hazardous materials in accordance with an approved Spill Prevention, Control and Countermeasure Plan or Spill Contingency Plan, or that is otherwise consistent with the requirements of the EPA National Contingency Plan.

    9. Temporary use of transportable power generators or operational support equipment when located in a previously disturbed area and when operated in compliance with applicable regulatory requirements.

    10. Routine movement, handling, use, and distribution of materials, including hazardous materials or wastes that are moved, handled, or distributed in accordance with applicable regulations, such as Resource Conservation and Recovery Act, National Oil and Hazardous Substance Pollution Contingency Plan, Occupational Safety and Health Act, and Hazardous Materials Transportation Act.

    11. Routine movement of mobile test assets (such as instrument trailers, cameras, portable antennas, etc.) for routine test and evaluation, for repair, overhaul, or maintenance where no new support facilities are required.

    12. Activities and operations to be conducted in an existing non-historic structure which are within the scope of and are compatible with the present functional use of the building, will not result in a substantial increase in waste discharged to the environment, will not result in substantially different waste discharges from current or previous activities, and emissions will remain within established permit limits, if any.

    13. Acquisition, installation, modification, routine repair and replacement, and operation of utility (e.g., water, sewer, and electrical) and communication systems, mobile antennas, data processing cable, and similar electronic equipment that use existing rights-of-way, easements, distribution systems, facilities, or previously disturbed land.

    14. Acquisition, installation, or minor relocation, operation and maintenance or evaluation of physical security devices or controls to protect human or animal life and to enhance the physical security of existing critical assets in compliance with applicable Federal, tribal, state, and local requirements to protect the environment. Examples include, but are not limited to: Motion detection systems. Lighting. Remote video surveillance systems. Access controls. Physical barriers, fences, grating, on or adjacent to existing facilities.

    15. Installation and maintenance of archaeological, historical, and endangered or threatened species avoidance markers, fencing, and signs.

    16. Road or trail construction and repair on existing rights-of-ways or in previously disturbed areas which do not result in a change in functional use. Runoff, erosion, and sedimentation controlled through implementation of best management practices.

    17. Routine repair and maintenance of buildings, grounds, and other facilities and equipment which do not result in a change in functional use or a significant impact on a historically significant element or setting. Examples include, but are not limited to: Repair of roofs, doors, windows, or fixtures, localized pest management, and minor erosion control measures.

    18. New construction or equipment installation or alterations (interior and exterior) to or construction of an addition to an existing structure that is similar to existing land use if the area to be disturbed has no more than five cumulative acres of new surface disturbance.

    19. Demolition of non-historic buildings, structures, or other improvements and repairs that result in disposal of debris there-from, or removal of a part thereof for disposal, in accordance with applicable regulations, including those regulations applying to removal of asbestos containing materials, polychlorinated biphenyls, lead-based paint, and other special hazard items.

    20. Research, testing, and operations conducted at existing facilities (including contractor-operated laboratories and plants) and in compliance with all applicable safety, environmental, and natural conservation laws (because of these controls, these types of activities have little potential for significant environmental impacts). Examples include, but are not limited to: Nuclear weapons effects simulators, weapons performance measurement, wind tunnels, high energy lasers, remote sensing instruments, vacuum chambers, high altitude simulator facilities, and propellant testing facilities.

    21. Routine installation and use of radars, cameras, communications equipment, and other essentially similar facilities and equipment within a launch facility, mobile platform, military installation, training area, or previously disturbed area that conform to current American National Standards Institute/Institute of Electrical and Electronics Engineers guidelines, Federal Communications Commission Radio Frequency Exposure Limits 1.1310, and Electric and Magnetic Fields Exposure Directive 99/519/EC for maximum permissible exposure to electromagnetic fields.

    22. Routine law and order activities performed by military personnel, military police, or other security personnel, including physical plant protection and security.

    Extraordinary circumstances that preclude the use of a CATEX are:

    1. A reasonable likelihood of significant impact on public health or safety.

    2. A reasonable likelihood of significant environmental effects (direct, indirect, and cumulative).

    3. A reasonable likelihood of involving effects on the environment that involve risks that are highly uncertain, unique, or are scientifically controversial.

    4. A reasonable likelihood of violating any Executive Order, or Federal, state, or local law or requirements imposed for the protection of the environment.

    5. A reasonable likelihood of adversely affecting “environmentally sensitive” resources, unless the impact has been resolved through another environmental process (e.g., Coastal Zone Management Act, National Historic Preservation Act, Clean Water Act, etc.) a CATEX cannot be used. Environmentally sensitive resources include: a. Proposed federally listed, threatened, or endangered species or their designated critical habitats. b. Properties listed or eligible for listing on the National Register of Historic Places. c. Areas having special designation or recognition such as prime or unique agricultural lands; coastal zones; designated wilderness or wilderness study areas; wild and scenic rivers; National Historic Landmarks (designated by the Secretary of the Interior); floodplains; wetlands; sole source aquifers (potential sources of drinking water); National Wildlife Refuges; National Parks; areas of critical environmental concern; or other areas of high environmental sensitivity. d. Cultural, scientific or historic resources.

    6. A reasonable likelihood of dividing or disrupting an established community or planned development, or is inconsistent with existing community goals or plans.

    7. A reasonable likelihood of causing an increase in surface transportation congestion that will decrease the level of service below acceptable levels.

    8. A reasonable likelihood of adversely impacting air quality or violating federal, state, local or tribal air quality standards under the Clean Air Act Amendments of 1990.

    9. A reasonable likelihood of adversely impacting water quality, sole source aquifers, public water supply systems or state, local, or tribal water quality standards established under the Clean Water Act and the Safe Drinking Water Act.

    10. A reasonable likelihood of effects on the quality of the environment that are highly controversial on environmental grounds. The term “controversial” means a substantial dispute exists as to the size, nature, or effect of the proposed action rather than to the existence of opposition to a proposed action, the effect of which is relatively undisputed.

    11. A reasonable likelihood of a disproportionately high and adverse effect on low income or minority populations (see Executive Order 12898).

    12. Limit access to and ceremonial use of Indian sacred sites on Federal lands by Indian religious practitioners or significantly adversely affect the physical integrity of such sacred sites (see Executive Order 13007).

    13. Contribute to the introduction, continued existence, or spread of noxious weeds or non-native invasive species known to occur in the area or actions that may promote the introduction, growth, or expansion of the range of such species (Federal Noxious Weed Control Act and Executive Order 13112).

    14. A greater scope or size than is normal for this category of action.

    15. A reasonable likelihood of degrading already existing poor environmental conditions. Also, initiation of a degrading influence, activity, or effect in areas not already significantly modified from their natural condition.

    16. A precedent (or makes decisions in principle) for future or subsequent actions that have a reasonable likelihood of having a future significant effect.

    17. Introduction or employment of unproven technology.

    18. A reasonable likelihood of (i) releases of petroleum, oils, and lubricants (except from a properly functioning engine or vehicle) or reportable releases of hazardous or toxic substances as specified in 40 CFR part 302, Designation, Reportable Quantities, and Notification); (ii) application of pesticides and herbicides; (iii) or where the proposed action results in the requirement to develop or amend a Spill Prevention, Control, or Countermeasures Plan.

    Appendix C: Record of Environmental Consideration (REC) DEFENSE THREAT REDUCTION AGENCY/UNITED STATES STRATEGIC COMMAND CENTER FOR COMBATING WEAPONS OF MASS DESTRUCTION (DTRA/SCC-WMD) RECORD OF ENVIRONMENTAL CONSIDERATION DATE OF REQUEST: PROJECT/PROGRAM MANAGER: PHONE NUMBER: EMAIL: ORGANIZATION ADDRESS: PROJECT TITLE: PROPOSED PROJECT START DATE: END DATE: A. PURPOSE AND NEED FOR ACTION: B. PROJECT SPECIFIC DETAILS (PROPOSED LOCATION, etc.): C: LIST OF PREVIOUS NEPA DOCUMENTATION (EA/EIS) FOR THIS OR SIMILAR ACTIVITY PRINT NAME SIGNED [Name of Project/Program Manager] DATE J4E ENVIRONMENTAL REVIEW ACTION NOT SUBJECT TO NEPA REQUIREMENTS PROPOSED ACTION QUALIFIES FOR CATEGORICAL EXCLUSION (CATEX) # PROPOSED ACTION DOES NOT INVOLVE EXTRAORDINARY CIRCUMSTANCES THAT MERIT REVIEW IN AN EA OR EIS (IDENTIFY ANY ENVIRONMENTAL PROCESS THAT HAS RESOLVED AN IMPACT ARISING FROM AN EXTRAORDINARY CIRCUMSTANCE) PROPOSED ACTION IS COVERED UNDER EXISTING ENVIRONMENTAL DOCUMENTATION (SPECIFY DOCUMENT AND SECTIONS) FURTHER ANALYSIS IS REQUIRED REMARKS: PRINT NAME SIGNED DATE Director, Environment, Safety, and Occupational Health Department DTRA/SCC-WMD 8725 John J. Kingman Rd. Ft. Belvoir, VA 22060 Appendix D: Notice of Intent (NOI) DEFENSE THREAT REDUCTION AGENCY/UNITED STATES STRATEGIC COMMAND CENTER FOR COMBATING WEAPONS OF MASS DESTRUCTION (DTRA/SCC-WMD) [Name of Office; Location; Short Title or Subject of the Notice] ACTION: Notice of intent to prepare an environmental impact statement. SUMMARY: [Briefly describe the nature and scope of the proposed action. Do not put legal citations or background information in the SUMMARY section; these belong in the SUPPLEMENTARY INFORMATION section.] DATES: Comments concerning the scope of the analysis must be received by [insert date 30 days from date of publication in the Federal Register].

    The draft environmental impact statement is expected [insert estimated month and year] and the final environmental impact statement is expected [insert estimated month and year.]

    ADDRESSES: Send written comments to [insert address]. Comments may also be sent via email to [insert email address], or via facsimile to [insert fax number]. [In this section, you also may put additional addresses, locations of meetings, etc. Do not put more than four addresses in this section. If there are more than four pertinent addresses, create a heading for them under the SUPPLEMENTARY INFORMATION section of the notice.]

    It is important that reviewers provide their comments at such times and in such a way that they are useful to the Agency's preparation of the EIS. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.

    Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered.

    FOR FURTHER INFORMATION CONTACT: [insert name(s) and contact information you wish to use, such as telephone number and email address].

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION: Purpose and Need for Action

    [Describe why DTRA/SCC-WMD is proposing the action: Why here? Why now?]

    Proposed Action

    [Describe the proposed action. Consider who, what, how, where, and when.]

    Possible Alternatives

    [Include only if any have been identified (delete heading if not used or request input on any alternatives considered reasonable—including technically and economically feasible—that will meet the purpose and need).]

    Lead and Cooperating Agencies

    [Include only if there are other agencies to list as joint lead agencies and/or cooperating agencies (delete heading if not used).]

    Responsible Official

    [Provide the title and address of the official(s) responsible for the proposed action. Use of the responsible official's name is optional.]

    Nature of Decision To Be Made

    [Describe the framework or scope of the decision(s) to be made by the responsible official(s).]

    Preliminary Issues

    [Include only if any have been identified (delete heading if not used). To the extent practicable, resolve internal issues before proposing the action.]

    Permits or Licenses Required

    [Include only if any have been identified (delete heading if not used).]

    Addresses

    [Include only if all addresses could not be included in the SUMMARY (delete heading if not used).]

    Scoping Process

    This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. [Describe any other public comment opportunities, including whether, when, and where any scoping meetings will be held. Describe any additional information related to the scoping process and nature of comments being sought.]

    [Name] Date Chief, Governmental and Public Affairs Office DTRA/SCC-WMD
    Appendix E: Notice of Availability (NOA) DEFENSE THREAT REDUCTION AGENCY/UNITED STATES STRATEGIC COMMAND CENTER FOR COMBATING WEAPONS OF MASS DESTRUCTION (DTRA/SCC-WMD) AGENCY: [Office name], DTRA/SCC-WMD, Department of Defense ACTION: Notice of Availability of the [Draft EA, Final EA and FONSI, Draft EIS, Final EIS, or ROD] SUMMARY: DTRA/SCC-WMD announces the availability of the [insert type of NEPA document] for a proposed project in [insert location]. DATES: [As applicable, list dates of public scoping meetings, deadlines for comments, etc.] ADDRESSES: [As applicable, list addresses for public scoping meetings, availability of the document, etc.] The [insert Draft EIS, Final EIS, ROD as appropriate] is also available at [insert project Web site.] FOR FURTHER INFORMATION CONTACT: [insert name(s) and contact information you wish to use, such as telephone number and email address.] SUPPLEMENTARY INFORMATION: Effective [Date], the DTRA/SCC-WMD assumed environmental responsibilities for this project. DTRA/SCC-WMD as the agency responsible for the National Environmental Policy Act (NEPA) review has, in cooperation with [insert cooperating agencies], prepared a [insert type of NEPA document] on a proposal for [insert brief description of action] in [location]. [Provide additional details regarding the proposed action, description of the proposed alternatives, length of project, and any anticipated federal approvals, such as permits]. Issued on: [Date signed] [Name] Chief, Governmental and Public Affairs Office DTRA/SCC-WMD Appendix F: Record of Decision (ROD) RECORD OF DECISION [Project Name] DEFENSE THREAT REDUCTION AGENCY/UNITED STATES STRATEGIC COMMAND CENTER FOR COMBATING WEAPONS OF MASS DESTRUCTION (DTRA/SCC-WMD) [Project Location] [County, State] Decision

    Based on my review of the Environmental Impact Statement (EIS), I have decided to implement Alternative [X], which [insert description of selected alternative. Include any permits, licenses, grants, or authorizations needed to implement the decision. Also include any mitigation and monitoring actions related to the decision.]

    Background

    [Provide a brief description of the purpose and need for action.]

    Decision Rationale

    [Describe the reasons for the decision. Specifically, discuss the following:

    How the selected action/alternative best meets the purpose and need and why other alternatives were not selected.

    How significant issues and environmental impacts were considered and taken into account.

    Any factors other than environmental effects considered in making the decision.

    Discuss how the above factors influenced the decision (are some more important than others?)

    State whether all practical means to avoid or minimize environmental harm from the selected alternative have been adopted and if not, why not.]

    The [Project Name] EIS documents the analysis and conclusions upon which this decision is based.

    Public Involvement

    A notice of intent to prepare an EIS was published in the Federal Register on [date] ([Cite Federal Register volume and beginning page number (i.e. 73 FR 43084]). People were invited to review and comment on the proposal through [insert public notice methods and dates such as mailings, news releases, phone calls, etc.]. The EIS lists agencies, organizations, and people who received copies on page [X].

    The following issues were identified from scoping comments and were used to determine the scope of the analysis. [Briefly describe the significant issues used in the analysis]. A full description of issues significant to the proposed action appears in the EIS on page [X].

    A draft EIS was published for review and comment on [date of publication of EPA's notice of availability in the Federal Register].

    Alternatives Considered

    In addition to the selected alternative, I considered [X] other alternatives, which are discussed below. A more detailed comparison of these alternatives can be found in the EIS on pages [X-X].

    Alternative 1—[insert a brief description of the alternative; identify which is considered to be environmentally-preferable.]

    Alternative 2—[insert a brief description of the alternative]

    [Repeat for each alternative.]

    Mitigation

    [State (a) which mitigation measures have been adopted; (b) whether all practicable means to avoid or minimize have been adopted, and if not why they were not; and (c) whether monitoring and enforcement programs are adopted, and if so summarize them.]

    Implementation Date

    [Describe the expected date(s) of implementation].

    Contact

    For additional information concerning this decision, contact: [contact name, title, office, mailing address, phone number, and email]

    Concurrence: [Name] Project/Program Manager Date Director, J4E Date Approval: Director, DTRA/SCC-WMD Date
    [FR Doc. 2016-21294 Filed 9-2-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0096] Agency Information Collection Activities; Comment Request; Student Assistance General Provisions—Subpart K—Cash Management AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 7, 2016.

    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-2016-ICCD-0096. 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 2E-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    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: Student Assistance General Provisions—Subpart K—Cash Management.

    OMB Control Number: 1845-0038.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments; Individuals or Households; Private Sector.

    Total Estimated Number of Annual Responses: 26,266,031.

    Total Estimated Number of Annual Burden Hours: 1,194,318.

    Abstract: This request is for a revision to the current information collection 1845-0038 that is expiring. This collection pertains to the recordkeeping requirements contained in the regulations related to the administration of the Subpart K—Cash Management section of the Student Assistance General Provisions. The regulatory language has not changed. These program regulations are designed to provide benefits to title IV, HEA applicants, and protect the taxpayers' interest. The information collection requirements in these regulations are necessary to provide students with required information about their eligibility to receive funding under the federal student financial aid programs and to prevent fraud and abuse of program funds by allowing students to reduce or reject aid being offered as well as being made aware of when such funding can be expected to be available.

    Dated: August 31, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-21291 Filed 9-2-16; 8:45 am] BILLING CODE 4000-01-P
    ELECTION ASSISTANCE COMMISSION Sunshine Act Meeting Notice AGENCY:

    U.S. Election Assistance Commission.

    ACTION:

    Notice of Public Meeting Agenda.

    DATE & TIME:

    Thursday, September 8, 2016, (1:00-4:00 p.m.—EDT).

    PLACE:

    1335 East West Highway (First Floor Conference Room) Silver Spring, MD 20910.

    AGENDA:

    Commissioners will meet to announce the winners of a national competition for the top election worker best practices from around the country. Commissioners will hear from state and local election officials and other experts to discuss: (1) Successful practices on election administration and management of the voter registration process; (2) activities regarding National Voter Registration Day; and (3) election system security.

    STATUS:

    This meeting will be open to the public.

    PERSON TO CONTACT FOR INFORMATION:

    Bryan Whitener, Telephone: (301) 563-3961.

    Bryan Whitener, Director of Communications and Clearinghouse, U.S. Election Assistance Commission.
    [FR Doc. 2016-21441 Filed 9-1-16; 4:15 pm] BILLING CODE 6820-KF-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Northern New Mexico AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, September 28, 2016, 1:00 p.m.-5:15 p.m.

    ADDRESSES:

    New Mexico Highlands University, Student Union Building, 800 National Avenue, Las Vegas, New Mexico 87701.

    FOR FURTHER INFORMATION CONTACT:

    Menice Santistevan, Northern New Mexico Citizens' Advisory Board (NNMCAB), 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda:

    • Call to Order • Welcome and Introductions • Approval of Agenda and Meeting Minutes of July 27, 2016 • Old Business • New Business ○ Report From Nominating Committee on Election of Officers ○ Election of Chair and Vice Chair for Fiscal Year 2017 ○ Report From RADWASTE Summit ○ Report From DOE National Cleanup Workshop • Update From Co-Deputy Designated Federal Officers • Presentation: Follow-on Contract Scope • Presentation: Air Monitoring at Los Alamos National Laboratory • Presentation: Waste Isolation Pilot Plant (WIPP) Recovery • Public Comment Period • Updates From EM Los Alamos Field Office and New Mexico Environment Department • Wrap-Up Comments From NNMCAB Members • Adjourn

    Public Participation: The EM SSAB, Northern New Mexico, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Menice Santistevan at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Menice Santistevan at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Menice Santistevan at the address or phone number listed above. Minutes and other Board documents are on the Internet at: http://energy.gov/em/nnmcab/northern-new-mexico-citizens-advisory-board.

    Issued at Washington, DC, on August 30, 2016. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2016-21311 Filed 9-2-16; 8:45 am] BILLING CODE 6405-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Notice of Re-Opening Request for Information (RFI): Stakeholder Input on Out-Year Marine and Hydrokinetic Program Strategy AGENCY:

    Water Power Technologies Office, Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of reopening of public comment period.

    SUMMARY:

    On April 6, 2016, the Water Power Technologies Office within the U.S. Department of Energy (DOE), published a notice in the Federal Register announcing a stakeholder meeting to receive comments on its request for information (RFI) to receive input for DOE's Outyear Marine and Hydrokinetic Program Strategy. Based on requests from several stakeholder to extend the RFI comment period, DOE has decided to reopen the RFI comment period.

    DATES:

    DOE will accept comments no later than Friday, September 30, 2016 at 11:59 p.m. ET.

    ADDRESSES:

    Interested persons can submit comments to the email address: [email protected] Please include with the subject line “Comments for RFI1570.”

    FOR FURTHER INFORMATION CONTACT:

    Maggie Yancey, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Ave SW., Washington, DC 20585. Telephone: (202) 586-4536. For email, please include in the subject line “Further Information,” and in the body of the email: your name, organization, contact information, and your specific question or inquiry. [email protected]

    SUPPLEMENTARY INFORMATION:

    On April 6, 2016, the Water Power Technologies Office within the DOE published a notice in the Federal Register, (81 FR 19963), announcing a stakeholder meeting to receive comments on its request for information (RFI) to receive input for DOE's Outyear Marine and Hydrokinetic Program Strategy. The RFI, numbered RFI 1570, is available on DOE's EERE Exchange Web site at: https://eere-exchange.energy.gov/and/or at this link: http://bit.ly/2bTiyie. The RFI has not been changed or modified to include new information that DOE is requesting feedback on; DOE is re-opening RFI 1570 to allow an additional opportunity for comments to be submitted.

    Issued on August 30, 2016 in Washington, DC. James M. Ahlgrimm, Acting Director, Water Power Technologies Office, Office of Energy Efficiency and Renewable Energy.
    [FR Doc. 2016-21307 Filed 9-2-16; 8:45 am] BILLING CODE 6450-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10487—Sunrise Bank of Arizona, Phoenix, Arizona

    NOTICE IS HEREBY GIVEN that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Sunrise Bank of Arizona, Phoenix, Arizona (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Sunrise Bank of Arizona on August 23, 2013. 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: August 31, 2016.

    Federal Deposit Insurance Corporation.

    Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-21324 Filed 9-2-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL TRADE COMMISSION SES Performance Review Board AGENCY:

    Federal Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given of the appointment of members to the FTC Performance Review Board.

    FOR FURTHER INFORMATION CONTACT:

    Vicki Barber, Chief Human Capital Officer, 600 Pennsylvania Avenue NW., Washington, DC 20580, (202) 326-2700.

    SUPPLEMENTARY INFORMATION:

    Publication of the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314 (c)(4). The PRB reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor, and makes recommendations regarding performance ratings, performance awards, and pay-for-performance pay adjustments to the Chairwoman.

    The following individuals have been designated to serve on the Commission's Performance Review Board:

    David Robbins, Executive Director, Chairman David Shonka, Acting General Counsel Deborah Feinstein, Director, Bureau of Competition Jessica Rich, Director, Bureau of Consumer Protection Michael Vita, Deputy Director, Bureau of Economics

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2016-21402 Filed 9-2-16; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-0607; Docket No. CDC-2016-0087] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on The National Violent Death Reporting System (NVDRS) to continue collecting state-based surveillance data on violent deaths that will provide more detailed and timely information.

    DATES:

    Written comments must be received on or before November 7, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0087 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    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 of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    The National Violent Death Reporting System (NVDRS), (OMB Control No. 0920-0607, Expiration 10/31/2017)—Revision—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Violence is an important public health problem. In the United States, suicide and homicide are the second and third leading causes of death, respectively, in the 1-34 year old age group. Unfortunately, public health agencies do not know much more about the problem than the numbers and the sex, race, and age of the victims, or information obtainable from the standard death certificate. Death certificates, however, carry no information about key facts necessary for prevention such as the relationship of the victim and suspect and the circumstances of the deaths. Furthermore, death certificates are typically available 20 months after the completion of a single calendar year. Official publications of national violent death rates, e.g. those in Morbidity and Mortality Weekly Report, rarely use data that is less than two years old.

    Local and Federal criminal justice agencies such as the Federal Bureau of Investigation (FBI) provide slightly more information about homicides, but they do not routinely collect standardized data about suicides, which are in fact much more common than homicides. The FBI's Supplemental Homicide Report (SHRs) does collect basic information about the victim-suspect relationship and circumstances related to the homicide. SHRs, do not link violent deaths that are part of one incident such as homicide-suicides. It also is a voluntary system in which some 10-20 percent of police departments nationwide do not participate. The FBI's National Incident Based Reporting System (NIBRS) provides slightly more information than SHRs, but it covers less of the country than SHRs. NIBRS also only provides data regarding homicides. Also, the Bureau of Justice Statistics Reports do not use data that is less than two years old.

    CDC requests OMB approval in order to revise its state-based surveillance system for violent deaths that will provide more detailed and timely information. The surveillance system captures case record information held by medical examiners/coroners, vital statistics (i.e., death certificates), and law enforcement. Data is collected by each state in the system and entered into a web system administered by CDC. Information is collected from these records about the characteristics of the victims and suspects, the circumstances of the deaths, and the weapons involved. States use standardized data elements and software designed by CDC. Ultimately, this information will guide states in designing, targeting, and evaluating programs that reduce multiple forms of violence. Neither victim's families nor suspects are contacted to collect this information; it all comes from existing records and is collected by state health department staff or their subcontractors. The number of hours per death required for the public agencies working with NVDRS states to retrieve and then refile their records is estimated to be 0.5 hours per death. Moving forward, we will no longer include state abstractors' time spent abstracting data in our estimates of public burden for NVDRS because state abstractors are funded by CDC to do this work. This significantly reduces the estimated public burden associated with NVDRS.

    The president has submitted plans to fund the expansion of the state-based surveillance system to collect information in all 50 U.S. states, the District of Columbia, and U.S. territories. This revision will allow 10 new state health departments, and 7 territorial governments to be added to the currently funded 39 state health departments (Maine and Vermont are funded as one entity), the health department of the District of Columbia, and 1 territorial government, resulting in a total of 59 states and territories to be included in the state-based surveillance system. Violent deaths include all homicides, suicides, legal interventions, deaths from undetermined causes, and unintentional firearm deaths. The average state will experience approximately 1,000 such deaths each year.

    There are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden hours
  • (in hours)
  • Public Agencies NVDRS Web System 59 1,000 30/60 29,500
    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. 2016-21296 Filed 9-2-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-16XD] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Practice Patterns Related to Opioid Use during Pregnancy and Lactation—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Over the past decade, the prevalence of maternal opioid use during pregnancy has steadily increased. The use of opioids or other psychoactive substances, either by illicit abuse or by nonmedical abuse of prescription opioids, increases the risks for health and social problems for both mother and infant. For example, maternal substance abuse during pregnancy increases the risk of preterm birth, low birth weight, perinatal death, and neonatal abstinence syndrome (NAS). For many women, and some at-risk women in particular, prenatal visits may be the only time they routinely see a physician. Because obstetrician-gynecologists (OB/GYNs) are the principal health care providers for women, OB/GYNs are well situated to screen for substance use and to treat or encourage cessation of substance use during pregnancy. Thus, it is important to understand current provider knowledge, attitudes, and practices regarding maternal opioid use.

    CDC, in collaboration with the American College of Obstetricians and Gynecologists (ACOG), plans to conduct a survey to address this gap in knowledge. Survey respondents will be ACOG Fellows and Junior Fellows who have a current medical license and are in medical practice focused on women's health. ACOG is separated into 11 districts, one of which represents OB/GYN members who are in the U.S. military. The remaining 10 ACOG districts correspond to geographic regions that encompass the entire United States and Canada. Survey invitations will be sent to a quasi-random sample of ACOG members in each district.

    CDC and ACOG estimate that 1,500 individuals will be contacted in order to obtain a study target of 600 respondents. The initial invitation will be distributed by email with instructions on completing a web-based version of the questionnaire. Three to four months after the initial invitation, a paper version of the questionnaire will be distributed to individuals who have not completed the online version. The estimated number of respondents for the full web-based or paper questionnaire is 420 and the estimated burden per response is 15 minutes. Approximately 6 weeks after the second recruitment attempt, ACOG will distribute a short version of the questionnaire to any non-responders. The estimated number of responses for the short version of the questionnaire is 180 and the estimated burden per response is 5 minutes. An overall 40% response rate is expected.

    The survey will collect information about provider attitudes and beliefs regarding maternal opioid use, their screening and referral practices for pregnant or postpartum patients, barriers to screening and treating pregnant and postpartum patients for opioid use, and resources that are needed to improve treatment and referral. No information will be collected about individual patients. Survey administration and data management will be conducted by ACOG, and participation is voluntary. De-identified response data will be shared with CDC for analysis. Findings will be used to create recommendations for educational programs and patient care. The total estimated annualized burden hours are 120. There are no costs to participants other than their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • OB/GYNs caring for pregnant women Practice Patterns related to Opioid Use during Pregnancy and Lactation—Full survey 420 1 15/60 Practice Patterns related to Opioid Use during Pregnancy and Lactation—Short introduction and survey 180 1 5/60
    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. 2016-21273 Filed 9-2-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Ethnic Community Self-Help Program Data Indicators.

    OMB No.: 0970-NEW.

    Description: The ACF Office of Refugee Resettlement proposes to collect information from Ethnic Community-Based Organizations (ECBOs) awarded federal funds under HHS-2016-ACF-ORR-1129. The information, collected through a questionnaire, is expected to provide information on Program objectives semi-annually in order for program staff to gauge the Program's progress for reporting and evaluation purposes.

    Respondents: ECBOs awarded under HHS-2016-ACF-ORR-1129.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Total burden
  • hours
  • ECSH Data Indicators 10 2 1 20

    Estimated Total Annual Burden Hours: 20.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected]. Attn: Desk Officer for the Administration for Children and Families.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2016-21250 Filed 9-2-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2526] Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were 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 the drug products listed in this document were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

    FOR FURTHER INFORMATION CONTACT:

    Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]

    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 approved 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 generally known 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).

    Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

    FDA has become aware that the drug products listed in the table in this document are no longer being marketed.

    Application No. Drug name Active
  • ingredient(s)
  • Strength(s) Dosage form/route Applicant
    NDA 012223 AQUAMEPHYTON Phytonadione 10 milligram (mg)/milliliter (mL); 1 mg/0.5 mL Injectable; Injection Teligent Pharma Inc. NDA 016087 VALIUM Diazepam 5 mg/mL Injectable; Injection Roche. NDA 017090 TOFRANIL-PM Imipramine Pamoate Equivalent to (EQ) 75 mg HCl; EQ 100 mg HCl; EQ 125 mg HCl; EQ 150 mg HCl Capsule; Oral Mallinckrodt Pharmaceuticals. NDA 017558 ROBINUL Glycopyrrolate 0.2 mg/mL Injectable; Injection Eurohealth International Sarl. NDA 017911 CLINORIL Sulindac 200 mg Tablet; Oral Merck. NDA 017962 PARLODEL Bromocriptine Mesylate EQ 5 mg base Capsule; Oral US Pharmaceuticals Holdings I LLC. NDA 018579 FUROSEMIDE Furosemide 10 mg/mL Injectable; Injection Luitpold Pharmaceuticals, Inc. NDA 018687 NORMODYNE Labetalol Hydrochloride 100 mg; 200 mg; 300 mg; 400 mg Tablet; Oral Schering-Plough Corp. NDA 018731 BUSPAR Buspirone Hydrochloride 5 mg Tablet; Oral Bristol-Myers Squibb. NDA 018776 NORCURON Vecuronium Bromide 10 mg/vial; 20 mg/vial Injectable; for Injection Organon USA Inc. NDA 019773 VENTOLIN Albuterol Sulfate EQ 0.083% base Solution; Inhalation GlaxoSmithKline. NDA 019810 PRILOSEC Omeprazole 10 mg; 20 mg; 40 mg Capsule, Delayed-Release Pellets; Oral AstraZeneca Pharmaceuticals LP. NDA 020059 ADENOSCAN Adenosine 60 mg/20 mL (3 mg/mL); 90 mg/30 mL (3 mg/mL) Solution; I.V. Infusion Astellas Pharma US, Inc. NDA 020799 FLOXIN OTIC Ofloxacin 0.3% Solution/Drops; Otic Daiichi-Sankyo. NDA 021045 PLAN B Levonorgestrel 0.75 mg Tablet; Oral Teva Branded Pharm. NDA 021214 RESCULA Unoprostone Isopropyl 0.15% Solution/Drops; Ophthalmic Sucampo Pharmaceuticals, Inc. NDA 050459 AMOXIL Amoxicillin 250 mg; 500 mg Capsule; Oral GlaxoSmithKline. NDA 050460 AMOXIL Amoxicillin 125 mg/5mL; 50 mg/mL; 250 mg/5 mL for Suspension; Oral GlaxoSmithKline. NDA 050460 LAROTID Amoxicillin 50 mg/mL for Suspension; Oral GlaxoSmithKline. ANDA 072652 ALBUTEROL SULFATE Albuterol Sulfate EQ 0.083% base Solution; Inhalation Mylan Specialty L.P. ANDA 075117 ORAPRED Prednisolone Sodium Phosphate EQ 15 mg base/5 mL Solution; Oral Concordia Pharmaceuticals Inc. ANDA 075385 BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride 5 mg; 10 mg; 15 mg Tablet; Oral Teva Pharmaceuticals USA, Inc. ANDA 078665 LEVONORGESTREL Levonorgestrel 0.75 mg Tablet; Oral Watson Labs. ANDA 087811 PHRENILIN Acetaminophen; Butalbital 325 mg; 50 mg Tablet; Oral Valeant Pharmaceuticals International Inc. ANDA 088825 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Acetaminophen; Butalbital; Caffeine 325 mg; 50 mg; 40 mg Capsule; Oral Gilbert Labs.

    FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.

    Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

    Dated: August 30, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21227 Filed 9-2-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1064] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing an opportunity for public 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 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 application for participation in the Medical Device Fellowship Program.

    DATES:

    Submit either electronic or written comments on the collection of information by November 7, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. [FDA-2013-N-1064] for “Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program.”

    Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    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 of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Application for Participation in the Medical Device Fellowship Program—OMB Control Number 0910-0551—Extension

    Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of title 5 of the United States Code authorize Federal Agencies to rate applicants for Federal jobs. Collecting applications for the Medical Device Fellowship Program will allow FDA's Center for Devices and Radiological Health (CDRH) to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in CDRH activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with CDRH.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 FDA form Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    Application Form (FDA 3608) 250 1 250 1 250 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: August 30, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21229 Filed 9-2-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0380] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications 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 October 6, 2016.

    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 0910-0523. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [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.

    Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications—21 CFR Part 3—OMB Control Number 0910-0523—Extension

    This regulation relates to Agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of: (1) A drug and a device; (2) a device and a biological product; (3) a biological product and a drug; or (4) a drug, a device, and a biological product.

    The second purpose of this regulation is to enhance the efficiency of Agency management and operations by providing procedures for classifying and determining which Agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute.

    The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant's recommendation as to which Agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biological products, and combination products. The respondents will be businesses or other for-profit organizations.

    In the Federal Register of January 28, 2016 (81 FR4921), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR part Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    3 84 1 84 24 2,016 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    These burden estimates are based on the number of applications FDA received over the past fiscal year.

    Dated: August 30, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-21228 Filed 9-2-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Senior Executive Service Performance Review Board AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    In this notice, the Health Resources and Services Administration (HRSA) located within the Department of Health and Human Services (HHS) publishes a list of persons who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA.

    FOR FURTHER INFORMATION CONTACT:

    Dora Ober, Executive Resources, Office of Human Resources, 5600 Fishers Lane, Rm 12N06C, Rockville, Maryland 20857, Telephone (301) 443-0759.

    SUPPLEMENTARY INFORMATION:

    Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following persons may be named to serve on the HRSA Performance Review Board, which will oversee the evaluation of performance appraisals of Senior Executive Service members for the Fiscal Year 2016 review period:

    Leslie Atkinson, Tonya Bowers, Adriane Burton, Tina Cheatham, Laura Cheever, Cheryl Dammons, Elizabeth DeVoss, Diana Espinosa, Catherine Ganey, Alexandra Garcia, Richard Goodman, Heather Hauck, Avril Houston, Laura Kavanagh, Martin Kramer, Sarah Linde, Rimas Liogys, Michael Lu, Dennis Malcomson, James Macrae, Thomas Morris, Kerry Nesseler, William O'Rourke, Luis Padilla, Deborah Parham Hopson, Wendy Ponton, Patricia Stroup.

    Dated: August 30, 2016. James Macrae, Acting Administrator.
    [FR Doc. 2016-21320 Filed 9-2-16; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Request for Public Comment on Draft Health Center Program Compliance Manual AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Request for public comment on Draft Health Center Program Compliance Manual.

    SUMMARY:

    HRSA is inviting public comment on the Draft Health Center Program Compliance Manual, hereafter referred to as the Compliance Manual. The purpose of the Compliance Manual is to provide a consolidated web-based resource to assist current and prospective health centers in understanding and demonstrating compliance with requirements of the Health Center Program, a HRSA-administered program authorized under 42 U.S.C. 254b. The Compliance Manual identifies requirements found in the Health Center Program's authorizing legislation and implementing regulations, as well as certain applicable grant regulations. The Compliance Manual also addresses HRSA's approach to determining eligibility for and oversight of the Health Center Program. In addition, the Compliance Manual includes the requirements for obtaining deemed Public Health Service (PHS) employee status under the Federally Supported Health Centers Assistance Acts of 1992 and 1995, for purposes of Federal Tort Claims Act (FTCA) liability protections for the performance of medical, surgical, dental, and related functions within the scope of deemed PHS employment.

    DATES:

    Submit written comments no later than November 22, 2016.

    ADDRESSES:

    Written comments should be submitted through the HRSA/Bureau of Primary Health Care (BPHC) Web site at http://bphc.hrsa.gov/programrequirements/draftcompliancemanual/index.html.

    FOR FURTHER INFORMATION CONTACT:

    For questions regarding this notice, contact HRSA/BPHC/Office of Policy and Program Development at [email protected]

    SUPPLEMENTARY INFORMATION:

    HRSA provides grants to eligible applicants under section 330(e), (g), (h), and/or (i) of the PHS Act, as amended (42 U.S.C. 254b), to support the delivery of preventive and primary care services to medically underserved communities and vulnerable populations. Nearly 1,400 Health Center Program-funded health centers operate approximately 9,800 service delivery sites that provide care to over 24 million patients in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. HRSA also designates eligible applicants under the Health Center Look-Alike Program (see Sections 1861(aa)(4)(B) and 1905(l)(2)(B) of the Social Security Act). Look-Alikes do not receive Health Center Program funding but must meet the Health Center Program statutory and regulatory requirements. Note that for the purposes of the Compliance Manual, the term “health center” refers to entities that receive a federal award under section 330 of the PHS Act, as amended, subrecipients, and organizations designated as look-alikes, unless otherwise stated.

    HRSA also makes determinations of deemed PHS employment status for health centers funded under section 330 and their covered individuals for purposes of providing liability protections under the Health Center Federal Tort Claims Act (FTCA) Program. Section 224(g)-(n) of the PHS Act (42 U.S.C. 233(g)-(n)) authorizes the FTCA Program and affords eligibility for FTCA coverage as the exclusive civil remedy for acts or omissions arising from the performance of medical, surgical, dental, or related functions within the scope of such employment by deemed health centers and by any officers, governing board members, employees, and certain individual contractors of these entities. A favorable FTCA deeming determination requires submission of an application by the Health Center Program awardee in the form and manner specified by HRSA.

    The Compliance Manual includes sections identifying the requirements found in the Health Center Program's authorizing legislation and program implementing regulations (section 330 of the PHS Act, as amended, 42 CFR part 51c, and 42 CFR part 56); certain applicable HHS grant regulations (45 CFR part 75); and the Health Center FTCA Program's authorizing legislation and implementing regulations (section 224(g)-(n) of the PHS Act, and 42 CFR part 6). Organizations receiving Health Center Program federal awards, including subrecipients, are also subject to all requirements incorporated within documents such as Funding Opportunity Announcements and Notices of Award. The Compliance Manual specifies Health Center Program non-regulatory policy issuances that would be superseded, as well as those that would remain in effect.

    The first chapter of the Compliance Manual outlines HRSA's approach to determining organizational eligibility for the Health Center Program, including how to demonstrate non-profit or public agency status. The chapter also describes organizational eligibility requirements that apply only to look-alikes. The second chapter clarifies HRSA/BPHC's oversight process by providing information on how HRSA will address areas of noncompliance and impose enforcement actions, including those for serious violations that may lead to the suspension of grant activities or termination of grant funding by HRSA under 45 CFR part 75.

    The Compliance Manual contains 18 chapters on Health Center Program requirements, each of which: (a) Cites the applicable statutory and regulatory authorities; (b) lists statutory and regulatory requirements; (c) describes how health centers would demonstrate compliance to HRSA; and d) includes examples of areas in which health centers have discretion or that may be helpful for health centers to consider when implementing the requirements.

    The final chapter specifies the FTCA requirements for obtaining deemed PHS employment status, including how a health center would demonstrate compliance with the FTCA requirements in its annual deeming application. Please note that deemed employment status does not confer FTCA coverage in all cases, as health center providers also must comply with applicable legal eligibility requirements and covered actions must be undertaken within the scope of such deemed PHS employment (for more information, see the Federal Tort Claims Act Health Center Policy Manual at http://bphc.hrsa.gov/ftca/healthcenters/ftcahcpolicymanual.html). When FTCA matters become the subject of litigation, the U.S. Department of Justice and the federal courts may assume significant roles in certifying or determining whether or not a given activity falls within the scope of employment, for purposes of FTCA coverage.

    Dated: August 30, 2016. James Macrae, Acting Administrator.
    [FR Doc. 2016-21321 Filed 9-2-16; 8:45 am] BILLING CODE 4165-15-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 (5 U.S.C. App.), 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: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Skeletal Biology Development and Disease Study Section.

    Date: September 28-29, 2016.

    Time: 7:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Holiday Inn San Francisco Fisherman's Wharf, 1300 Columbus Avenue, San Francisco, CA 94133.

    Contact Person: Aruna K Behera, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301-435-6809, [email protected].

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section.

    Date: October 5, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Cambria Suites Rockville, 1 Helen Heneghan Way, Rockville, MD 20850.

    Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301-402-5671, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Alcohol and Motivated Behavior.

    Date: October 5-6, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD 20892, 301-435-1119, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Biophysics of Neural Systems Study Section.

    Date: October 5, 2016.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Monaco Baltimore, 2 North Charles Street, Baltimore, MD 212013.

    Contact Person: Geoffrey G Schofield, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040-A, MSC 7850, Bethesda, MD 20892, 301-435-1235, [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: August 30, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-21232 Filed 9-2-16; 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 Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 Heart, Lung, and Blood Institute Special Emphasis Panel; SBIR Direct Phase II, Bioreactors for Reparative Medicine.

    Date: September 28, 2016.

    Time: 1:00 p.m. to 1:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892-7924, 301-435-0725, [email protected].

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Phase I and Phase II, Bioreactors for Reparative Medicine (SBIR).

    Date: September 28, 2016.

    Time: 1:30 p.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: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892-7924, 301-435-0725, [email protected].

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Phase I and Phase II, Bioreactors for Reparative Medicine (STTR).

    Date: September 28, 2016.

    Time: 12:30 p.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892-7924, 301-435-0725, [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: August 30, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-21233 Filed 9-2-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 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 on Aging Special Emphasis Panel; Nathan Shock Center Coordinating Center.

    Date: October 3, 2016.

    Time: 12:00 p.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2c212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7701, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 30, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-21234 Filed 9-2-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; NIDDK Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases) AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register (Vol. 81, No. 93, page 29877) on May 13, 2016 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

    DATES:

    Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Winnie Martinez, Program Officer, OMHRC, NIDDK, NIH, 6707 Democracy Blvd., Room 9215, Bethesda, MD 20892 or call non-toll free number (301) 435-2988 or Email your request including your address to [email protected] Formal requests for additional plans and instruments must be requested in writing.

    SUPPLEMENTARY INFORMATION:

    The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

    Proposed collection: NIDDK Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications, 0925—New, Existing collection in use without OMB control number, National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) National Institutes of Health (NIH).

    Need and Use of Information Collection: The purpose of the proposed information collection activity is to assure that prospective trainees to OMHRC Research Training and Mentoring Programs meet basic eligibility requirements; to assess their potential as future scientists; to determine where mutual research interests exist; and to make decisions regarding which applicants will be proposed and approved for traineeship awards. In each case, completing the application is voluntary, but in order to receive due consideration, the prospective trainee must complete all required fields.

    OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2569.

    Estimated Annualized Burden Hours Form name Type of
  • respondents
  • Estimated
  • Number of
  • respondents
  • Estimated
  • Number of
  • responses
  • annually per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Est. total
  • annual
  • burden
  • hours
  • Attachment 1: Short-Term Research Experience for Underrepresented Persons (STEP-UP) Application Students 2,000 1 45/60 1,500 Attachment 2: STEP-UP Student Feedback Form Students 200 1 30/60 100 Attachment 3: Diversity Summer Research Training Program (DSRTP) Application Students 200 1 45/60 150 Attachment 4: DSRTP Feedback Form Students 40 1 30/60 20 Attachment 5: Network of Minority Research Investigators (NMRI) Enrollment Form Researchers 200 1 15/60 50 Attachment 6: NMRI Evaluation Form Researchers 100 1 15/60 25 Attachment 7: NMRI Survey Form Researchers 1,000 1 30/60 500 Attachment 8: NMRI Mentor/Mentee/Agreement Forms Researchers 100 1 30/60 50 Attachment 9: NIH/NMA Fellows Program on Careers in Academic Medicine Application Fellows 200 1 20/60 67 Attachment 10: NIH/NMA Feedback Form Fellows 40 1 30/60 20 Attachment 11: NIH/NHMA Fellows Program Application Form Fellows 200 1 20/60 67 Attachment 12: NIDDK/NHMA Feedback Form Fellows 40 1 30/60 20 Totals 4,320 4,320 2,569
    Dated: August 26, 2016. Priscilla Logan, NIDDK Project Clearance Liaison, Office of Management and Policy Analysis, NIDDK, NIH.
    [FR Doc. 2016-21329 Filed 9-2-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 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 on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA Fellowship Review.

    Date: November 3, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference Room 508/509, Rockville, MD 20892.

    Contact Person: Richard A. Rippe, Ph.D., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Room 2109, Rockville, MD 20852, 301-443-8599, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS)
    Dated: August 29, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-21235 Filed 9-2-16; 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 (5 U.S.C. App.), 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: Cardiovascular and Respiratory Sciences Integrated Review Group; Lung Cellular, Molecular, and Immunobiology Study Section.

    Date: September 28-29, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: George M. Barnas, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD 20892, 301-435-0696, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR16-044: Image Guided Drug Delivery.

    Date: September 30, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Serrano Hotel, 405 Taylor Street, San Francisco, CA 94102.

    Contact Person: Mehrdad Mohseni, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301-435-0484, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Molecular Neuropharmacology and Signaling Study Section.

    Date: October 3-4, 2016.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Lorien Hotel & Spa, 1600 King Street, Alexandria, VA 22314.

    Contact Person: Deborah L. Lewis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4183, MSC 7850, Bethesda, MD 20892, 301-408-9129, [email protected]

    Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; Social Psychology, Personality and Interpersonal Processes Study Section.

    Date: October 3-4, 2016.

    Time: 8:00 a.m. to 5:00 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: Marc Boulay, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, (301) 300-6541, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Bioengineering, Technology and Surgical Sciences.

    Date: October 3, 2016.

    Time: 11:30 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Guo Feng Xu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5122, MSC 7854 Bethesda, MD 20892, 301-237-9870, [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: August 30, 2016. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-21243 Filed 9-2-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-4277-DR; Docket ID FEMA-2016-0001] Louisiana; Amendment No. 1 to Notice of a Major Disaster Declaration AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-4277-DR), dated August 14, 2016, and related determinations.

    DATES:

    Effective Date: August 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    The notice of a major disaster declaration for the State of Louisiana is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of August 14, 2016.

    Acadia, Ascension, East Feliciana, Iberia, Lafayette, Pointe Coupee, St. Landry, and Vermilion Parishes for Individual Assistance and assistance for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
    W. Craig Fugate, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2016-21262 Filed 9-2-16; 8:45 am] BILLING CODE 9111-23-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-4278-DR; Docket ID FEMA-2016-0001] Kentucky; Major Disaster and Related Determinations AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Kentucky (FEMA-4278-DR), dated August 26, 2016, and related determinations.

    EFFECTIVE DATE:

    August 26, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that, in a letter dated August 26, 2016, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:

    I have determined that the damage in certain areas of the Commonwealth of Kentucky resulting from severe storms, tornadoes, flooding, landslides, and mudslides during the period of July 2-9, 2016, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”). Therefore, I declare that such a major disaster exists in the Commonwealth of Kentucky.

    In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.

    You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the Commonwealth. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.

    Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Warren J. Riley, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.

    The following areas of the Commonwealth of Kentucky have been designated as adversely affected by this major disaster:

    Adair, Butler, Caldwell, Calloway, Christian, Clay, Crittenden, Daviess, Edmonson, Hart, Hopkins, Livingston, Lyon, Marshall, Metcalfe, Ohio, Todd, Trigg, Union, and Webster Counties for Public Assistance.

    All areas within the Commonwealth of Kent