Federal Register Vol. 83, No.204,

Federal Register Volume 83, Issue 204 (October 22, 2018)

Page Range53159-53361
FR Document

83_FR_204
Current View
Page and SubjectPDF
83 FR 53248 - Sunshine Act MeetingPDF
83 FR 53295 - Government in the Sunshine Act Meeting NoticePDF
83 FR 53352 - Plexus Fund IV-B, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of InterestPDF
83 FR 53351 - Plexus Fund IV-C, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of InterestPDF
83 FR 53352 - Plexus Fund IV-A, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of InterestPDF
83 FR 53355 - Overseas Security Advisory Council (OSAC) RenewalPDF
83 FR 53294 - Request for Nominations for the Gateway National Recreation Area Fort Hancock 21st Century Advisory CommitteePDF
83 FR 53293 - Request for Nominations for the Made in America Outdoor Recreation Advisory CommitteePDF
83 FR 53355 - Overseas Security Advisory Council (Osac) Meeting Notice; Closed MeetingPDF
83 FR 53195 - Airline Transport Pilot and Type Rating for Airplane Airman Certification StandardsPDF
83 FR 53356 - Petition for Exemption; Summary of Petition Received; Latitude Engineering, LLCPDF
83 FR 53357 - Notice of Intent To Rule on Disposal of Aeronautical Property at Murfreesboro Municipal Airport, Murfreesboro, TNPDF
83 FR 53356 - Petition for Exemption; Summary of Petition Received; Sprayt RoboticsPDF
83 FR 53358 - Correction to Notice of Availability (NOA) for Consensus Standards, Light-Sport Aircraft, Notice No. NOA-18-01PDF
83 FR 53250 - General Services Administration Acquisition Regulation (GSAR); Submission for OMB Review; Environmental Conservation, Occupational Safety, and Drug-Free WorkplacePDF
83 FR 53290 - Agency Information Collection Activities; Homeliving Programs and School Closure and ConsolidationPDF
83 FR 53196 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; AvailabilityPDF
83 FR 53197 - Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; AvailabilityPDF
83 FR 53241 - Certain New Chemical Substances; Receipt and Status Information for July 2018PDF
83 FR 53241 - Meeting of the Mobile Sources Technical Review SubcommitteePDF
83 FR 53288 - 60-Day Notice of Proposed Information Collection: Revitalization Area Designation and ManagementPDF
83 FR 53282 - Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts for 2019PDF
83 FR 53183 - National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to OklahomaPDF
83 FR 53341 - Procure Active ETF Trust, et al.PDF
83 FR 53233 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Contract FinancingPDF
83 FR 53334 - Procure ETF Trust I, et al.PDF
83 FR 53216 - Gulf of Mexico Fishery Management Council; Public MeetingPDF
83 FR 53232 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public MeetingPDF
83 FR 53253 - Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation ProceduresPDF
83 FR 53231 - South Atlantic Fishery Management Council; Public MeetingsPDF
83 FR 53358 - Pipeline Safety: Information Collection Activities; Revision of the Hazardous Liquid Annual ReportPDF
83 FR 53256 - Mine Safety and Health Research Advisory Committee (MSHRAC)PDF
83 FR 53251 - Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)PDF
83 FR 53317 - Exelon Generation Company, LLC; Oyster Creek Nuclear Generating Station Request for Exemptions Regarding Emergency Planning RequirementsPDF
83 FR 53321 - Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Inspections, Tests, Analyses, and Acceptance CriteriaPDF
83 FR 53297 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability ActPDF
83 FR 53315 - Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Containment Sump Level InstrumentationPDF
83 FR 53351 - Presidential Declaration of a Major Disaster for Public Assistance Only for the Commonwealth of VirginiaPDF
83 FR 53351 - Presidential Declaration Amendment of a Major Disaster for the State of FloridaPDF
83 FR 53292 - Notice of Availability of the Draft Environmental Impact Statement for the Proposed Deep South Expansion Project, Lander and Eureka Counties, NevadaPDF
83 FR 53291 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Donor Certification FormPDF
83 FR 53264 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050PDF
83 FR 53204 - The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light TrucksPDF
83 FR 53355 - Release of Waybill DataPDF
83 FR 53212 - Export Trade Certificate of ReviewPDF
83 FR 53190 - Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions; Office of Engineering and Technology Releases and Seeks Comment on Updated OET-69 Software; Office of Engineering and Technology Seeks To Supplement the Incentive Auction Proceeding Record Regarding Potential Interference Between Broadcast Television and Wireless ServicesPDF
83 FR 53212 - University of California, Berkeley et al.; Notice of Decision on Application for Duty-Free Entry of Scientific InstrumentsPDF
83 FR 53212 - Foreign-Trade Zone 168-Dallas/Fort Worth, Texas, Area; Application for Subzone; Schumacher Electric Corporation; Fort Worth, TexasPDF
83 FR 53352 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
83 FR 53214 - Certain Activated Carbon From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 53289 - Endangered and Threatened Species; Receipt of Recovery Permit ApplicationsPDF
83 FR 53361 - Notice of Stakeholder Roundtable on Coin CirculationPDF
83 FR 53235 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Family Educational Loan Program-Servicemembers Civil Relief Act (SCRA)PDF
83 FR 53234 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Servicemembers Civil Relief Act (SCRA): Interest Rate Limitation RequestPDF
83 FR 53295 - Forged Steel Fittings From China and Italy; Scheduling of the Final Phase of Antidumping and Countervailing Duty InvestigationsPDF
83 FR 53257 - Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship ProgramsPDF
83 FR 53275 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing ResultsPDF
83 FR 53273 - Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSAPDF
83 FR 53259 - Determination of Regulatory Review Period for Purposes of Patent Extension; TECENTRIQPDF
83 FR 53260 - Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOSPDF
83 FR 53262 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act ProductsPDF
83 FR 53271 - Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food ImportersPDF
83 FR 53276 - National Committee on Vital and Health Statistics: HearingPDF
83 FR 53207 - Solicitation of Veterinary Shortage Situation Nominations for the Veterinary Medicine Loan Repayment Program (VMLRP)PDF
83 FR 53237 - Winter 2018-2019 Operations and Market Performance in Regional Transmission Organizations and Independent System Operators; Supplemental Notice of Technical ConferencePDF
83 FR 53240 - Combined Notice of FilingsPDF
83 FR 53355 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “The Jeweled Isle: Art From Sri Lanka” ExhibitionPDF
83 FR 53237 - Pacific Gas and Electric Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and ProtestsPDF
83 FR 53241 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Birdsboro Power LLCPDF
83 FR 53238 - Combined Notice of Filings #1PDF
83 FR 53239 - Records Governing Off-The-Record Communications Public NoticePDF
83 FR 53337 - Investor Advisory Committee MeetingPDF
83 FR 53257 - Allergenic Products Advisory Committee; CancellationPDF
83 FR 53361 - Enhanced-Use Lease (EUL) of U.S. Department of Veterans Affairs (VA) Real Property for the Development of a Permanent Supportive Housing Facility at the Lexington VA Health Care System, Franklin R. Sousley Campus in Lexington, KentuckyPDF
83 FR 53252 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
83 FR 53256 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
83 FR 53211 - Agenda and Notice of Public Meeting of the Rhode Island Advisory CommitteePDF
83 FR 53163 - Special Conditions: The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, With or Without Airbag Devices or 3-Point RestraintsPDF
83 FR 53358 - Petition for Exemption; Summary of Petition Received; Corvus Airlines dba Ravn AlaskaPDF
83 FR 53326 - Securities Exchange Act of 1934; Release No. 34-84440/October 16, 2018; Investment Company Act of 1940; Release No. IC-33272/October 16, 2018; Order Under Section 15b, Section 17a and Section 36 of the Securities Exchange Act of 1934 Granting Exemptions From Specified Provisions of the Exchange Act and Certain Rules Thereunder; Order Under Section 6(C) and Section 38(A) of the Investment Company Act of 1940 Granting Exemptions From Specified Provisions of the Investment Company Act and Certain Rules ThereunderPDF
83 FR 53168 - Special Conditions: Bombardier, Inc., BD-700-2A12 and BD-700-2A13 Airplanes; Multiple-Place Side-Facing Seats With Active Leg-Flail Restraint Device and Shoulder-Belt AirbagsPDF
83 FR 53193 - Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplanes; Airbag Systems on Multiple-Place and Single-Place Side-Facing SeatsPDF
83 FR 53356 - Petition for Exemption; Summary of Petition Received; Bombardier Inc.; CorrectionPDF
83 FR 53210 - Notice of Public Meeting of the Michigan Advisory CommitteePDF
83 FR 53297 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-National Fire Protection AssociationPDF
83 FR 53240 - City of Alexandria, Louisiana v. Cleco Power LLC; Notice of ComplaintPDF
83 FR 53217 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Mission Bay Ferry and Water Taxi Landing Project in San Francisco Bay, CaliforniaPDF
83 FR 53166 - Special Conditions: Mitsubishi Aircraft Corporation Model MRJ-200 Airplane; Passenger Seats With Non-Traditional, Large, Non-Metallic PanelsPDF
83 FR 53294 - Clad Steel Plate From Japan; Cancellation of Hearing for Full Five-Year ReviewPDF
83 FR 53296 - Certain Road Milling Machines and Components Thereof; Notice of Request for Statements on the Public InterestPDF
83 FR 53312 - Investigations Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
83 FR 53313 - Agency Information Collection Activities: Announcement of the Office of Management and Budget (OMB) Control Numbers Under the Paperwork Reduction ActPDF
83 FR 53297 - Notice of Determinations Regarding Eligibility To Apply for Trade Adjustment AssistancePDF
83 FR 53301 - Post-Initial Determinations Regarding Eligiblity To Apply for Trade Adjustment AssistancePDF
83 FR 53248 - Proposed Agency Information Collection Activities; Comment RequestPDF
83 FR 53191 - List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS®; Universal Storage System, Certificate of Compliance No. 1015, Amendment No. 6PDF
83 FR 53159 - List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS® Universal Storage System, Certificate of Compliance; No. 1015, Amendment No. 6PDF
83 FR 53199 - Safety Zone; Delaware River; Camden, NJ; Fireworks DisplayPDF
83 FR 53339 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To List and Trade Corporate Non-Convertible Bonds on NasdaqPDF
83 FR 53343 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To List and Trade Shares of the FormulaFolios Sector Rotation ETF, a Series of the Northern Lights Fund Trust IV, Under Rule 14.11(i), Managed Fund SharesPDF
83 FR 53336 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Order Approving a Proposed Rule Change To Amend Exchange Rule 6.49A, Transfer of PositionsPDF
83 FR 53337 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Order Approving a Proposed Rule Change To Amend Rule 6.2, Interpretation and Policy .01, Concerning Strategy OrdersPDF
83 FR 53339 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Allow CCIT Members To Elect To Pay Their Funds-Only Settlement Amount Debits Using a Different ProcessPDF
83 FR 53324 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change of Non-Substantive Amendments to Rules 1.1, 7.31, and 7.46PDF
83 FR 53349 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use on Cboe EDGX Exchange, Inc.PDF
83 FR 53347 - Self-Regulatory Organizations; NYSE National, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its Schedule of Fees To Adopt the Same Billing Dispute Practice as the Exchange's Affiliates and Other ExchangesPDF
83 FR 53277 - National Center for Complementary and Integrative Health; Notice of MeetingPDF
83 FR 53276 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingsPDF
83 FR 53279 - National Institute on Deafness and Other Communication Disorders; Notice of Closed MeetingPDF
83 FR 53278 - Center for Scientific Review; Notice of Closed MeetingPDF
83 FR 53277 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 53279 - National Library of Medicine; Notice of Closed MeetingsPDF
83 FR 53360 - Notice of OFAC Sanctions ActionPDF
83 FR 53315 - Notice of Information CollectionPDF
83 FR 53329 - Blackstone Real Estate Income Fund, et al.PDF
83 FR 53211 - Agenda and Notice of Public Meeting of the District of Columbia Advisory CommitteePDF
83 FR 53179 - Presumption of Herbicide Exposure and Presumption of Disability During Service for Reservists Presumed Exposed to HerbicidesPDF
83 FR 53351 - Presidential Declaration Amendment of a Major Disaster for the State of North CarolinaPDF
83 FR 53281 - Notice of Adjustment of Disaster Grant AmountsPDF
83 FR 53280 - Notice of Adjustment of Minimum Project Worksheet AmountPDF
83 FR 53279 - Notice of Adjustment of Statewide per Capita Impact IndicatorPDF
83 FR 53279 - Notice of Adjustment of Countywide per Capita Impact IndicatorPDF
83 FR 53282 - Florida; Emergency and Related DeterminationsPDF
83 FR 53281 - Notice of Maximum Amount of Assistance Under the Individuals and Households ProgramPDF
83 FR 53280 - National Advisory Council; MeetingPDF
83 FR 53359 - Notice of OFAC Sanctions ActionsPDF
83 FR 53236 - Environmental Management Site-Specific Advisory Board, Northern New MexicoPDF
83 FR 53206 - Submission for OMB Review; Comment RequestPDF
83 FR 53235 - State Energy Advisory BoardPDF
83 FR 53236 - Environmental Management Site-Specific Advisory Board, NevadaPDF
83 FR 53206 - Codex Alimentarius Commission: Meeting of the Codex Committee on Spices and Culinary HerbsPDF
83 FR 53233 - Multistakeholder Process on Promoting Software Component TransparencyPDF
83 FR 53322 - Excepted ServicePDF
83 FR 53171 - Airworthiness Directives; Bell Helicopter Textron Canada Limited HelicoptersPDF
83 FR 53201 - Air Plan Approval; ID, West Silver Valley PM2.5PDF
83 FR 53177 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous AmendmentsPDF
83 FR 53174 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous AmendmentsPDF

Issue

83 204 Monday, October 22, 2018 Contents Agriculture Agriculture Department See

National Institute of Food and Agriculture

See

The U.S. Codex Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53206 2018-22876
Antitrust Division Antitrust Division NOTICES Changes under the National Cooperative Research and Production Act: National Fire Protection Association, 53297 2018-22925 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53252-53253, 53256-53257 2018-22939 2018-22940 Assisted Reproductive Technology Success Rates Reporting and Data Validation Procedures, 53253-53256 2018-22991 Meetings: Board of Scientific Counselors, National Center for Health Statistics, 53251-53252 2018-22987 Mine Safety and Health Research Advisory Committee, 53256 2018-22988 Civil Rights Civil Rights Commission NOTICES Meetings: District of Columbia Advisory Committee, 53211 2018-22893 Michigan Advisory Committee, 53210-53211 2018-22926 Rhode Island Advisory Committee, 53211-53212 2018-22935 Coast Guard Coast Guard PROPOSED RULES Safety Zones: Delaware River, Camden, NJ, Fireworks Display, 53199-53201 2018-22911 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

Defense Acquisition Defense Acquisition Regulations System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Defense Federal Acquisition Regulation Supplement; Contract Financing, 53233-53234 2018-22995 Defense Department Defense Department See

Defense Acquisition Regulations System

Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Family Educational Loan Program—Servicemembers Civil Relief Act, 53235 2018-22965 Servicemembers Civil Relief Act; Interest Rate Limitation Request, 53234-53235 2018-22964 Employment and Training Employment and Training Administration NOTICES Trade Adjustment Assistance; Determinations, 53297-53312 2018-22915 2018-22916 Worker Adjustment Assistance; Investigations, 53312-53313 2018-22918 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Meetings: Environmental Management Site-Specific Advisory Board, Nevada, 53236 2018-22874 Environmental Management Site-Specific Advisory Board, Northern New Mexico, 53236-53237 2018-22877 State Energy Advisory Board, 53235-53236 2018-22875
Environmental Protection Environmental Protection Agency RULES National Emission Standards for Hazardous Air Pollutants: Delegation of Authority to Oklahoma, 53183-53189 2018-22999 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Idaho, West Silver Valley PM2.5 Clean Data Determination, 53201-53204 2018-22285 Safer Affordable Fuel-Efficient Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks; Correction, 53204-53205 2018-22976 NOTICES Certain New Chemical Substances: Receipt and Status Information for July 2018, 53241-53248 2018-23004 Meetings: Mobile Sources Technical Review Subcommittee, 53241 2018-23003 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Bell Helicopter Textron Canada Limited Helicopters, 53171-53174 2018-22414 Special Conditions: Bombardier, Inc., BD-700-2A12 and BD-700-2A13 Airplanes; Multiple-Place Side-Facing Seats with Active Leg-Flail Restraint Device and Shoulder-Belt Airbags, 53168-53171 2018-22929 Mitsubishi Aircraft Corporation Model MRJ-200 Airplane; Passenger Seats with Non-Traditional, Large, Non-Metallic Panels, 53166-53168 2018-22922 The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, With or Without Airbag Devices or 3-point Restraints, 53163-53166 2018-22933 Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures, 53174-53178 2018-22270 2018-22274 PROPOSED RULES Airline Transport Pilot and Type Rating for Airplane Airman Certification Standards, 53195-53196 2018-23013 Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplanes; Airbag Systems on Multiple-Place and Single-Place Side-Facing Seats, 53193-53195 2018-22928 NOTICES Consensus Standards, Light-Sport Aircraft; Correction, 53358 2018-23009 Disposal of Aeronautical Property at Murfreesboro Municipal Airport Murfreesboro, TN, 53357 2018-23011 Petitions for Exemptions; Summaries: Bombardier, Inc.; Correction, 53356 2018-22927 Corvus Airlines dba Ravn Alaska, 53358 2018-22932 Latitude Engineering, LLC, 53356-53357 2018-23012 Sprayt Robotics, 53356 2018-23010 Federal Communications Federal Communications Commission RULES Expanding Economic and Innovation Opportunities of Spectrum through Incentive Auctions, 53190 2018-22973 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 53248 2018-23152 Federal Emergency Federal Emergency Management Agency NOTICES Adjustment of Countywide Per Capita Impact Indicator, 53279-53280 2018-22886 Adjustment of Disaster Grant Amounts, 53281-53282 2018-22890 Adjustment of Minimum Project Worksheet Amount, 53280 2018-22889 Adjustment of Statewide Per Capita Impact Indicator, 53279 2018-22888 Emergency and Related Determinations: Florida, 53282 2018-22885 Maximum Amount of Assistance under the Individuals and Households Program, 53281 2018-22884 Meetings: National Advisory Council, 53280-53281 2018-22883 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Pacific Gas and Electric Co., 53237-53238 2018-22947 Combined Filings, 53238-53240 2018-22945 2018-22949 Complaints: City of Alexandria, LA v. Cleco Power, LLC, 53240-53241 2018-22924 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Birdsboro Power, LLC, 53241 2018-22946 Meetings: Winter 2018-2019 Operations and Market Performance in Regional Transmission Organizations and Independent System Operators; Technical Conference, 53237 2018-22950 Records Governing Off-the-Record Communications, 53239-53240 2018-22944 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53248-53250 2018-22914 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species: Receipt of Recovery Permit Applications, 53289-53290 2018-22967 Food and Drug Food and Drug Administration PROPOSED RULES Guidance: Guide to Minimize Food Safety Hazards of Fresh-cut Produce, 53197-53199 2018-23005 Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 53196-53197 2018-23006 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs, 53257-53259 2018-22960 Draft Guidance for Industry: Labeling of Red Blood Cell Units with Historical Antigen Typing Results, 53275-53276 2018-22959 Foreign Supplier Verification Programs for Food Importers, 53271-53273 2018-22953 Guidance for Industry on Formal Meetings with Sponsors and Applicants for Prescription Drug User Fee Act Products, 53262-53264 2018-22954 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: BESPONSA, 53273-53275 2018-22958 TECENTRIQ, 53259-53260 2018-22957 TYMLOS, 53260-53262 2018-22956 List of Recognized Standards, Recognition: List Number: 050; Modifications, 53264-53271 2018-22977 Meetings: Allergenic Products Advisory Committee; Cancellation, 53257 2018-22942 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 53359-53360 2018-22882 2018-22896 Foreign Trade Foreign-Trade Zones Board NOTICES Subzone Applications: Foreign-Trade Zone 168, Dallas/Fort Worth, TX, 53212 2018-22971 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Environmental Conservation, Occupational Safety, and Drug-Free Workplace, 53250-53251 2018-23008 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Hearings: National Committee on Vital and Health Statistics, 53276 2018-22952
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Revitalization Area Designation and Management, 53288-53289 2018-23001 Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts for 2019, 53282-53288 2018-23000 Indian Affairs Indian Affairs Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Homeliving Programs and School Closure and Consolidation, 53290-53291 2018-23007 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

See

National Park Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Donor Certification Form, 53291-53292 2018-22978
International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Activated Carbon from the People's Republic of China, 53214-53216 2018-22969 Duty-Free Entry of Scientific Instruments; Applications: University of California, Berkeley et al., 53212 2018-22972 Export Trade Certificate of Review, 53212-53214 2018-22974 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Road Milling Machines and Components Thereof, 53296-53297 2018-22920 Clad Steel Plate from Japan, 53294-53295 2018-22921 Forged Steel Fittings from China and Italy, 53295-53296 2018-22961 Meetings; Sunshine Act, 53295 2018-23041 Justice Department Justice Department See

Antitrust Division

NOTICES Proposed Consent Decrees: Comprehensive Environmental Response, Compensation, and Liability Act, 53297 2018-22984
Labor Department Labor Department See

Employment and Training Administration

See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Deep South Expansion Project, Lander and Eureka Counties, NV, 53292-53293 2018-22979 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53315 2018-22895 National Highway National Highway Traffic Safety Administration PROPOSED RULES Safer Affordable Fuel-Efficient Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks; Correction, 53204-53205 2018-22976 National Institute Food National Institute of Food and Agriculture NOTICES Requests for Nominations: Veterinary Shortage Situations; Veterinary Medicine Loan Repayment Program, 53207-53210 2018-22951 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 53277-53279 2018-22898 2018-22899 National Center for Complementary and Integrative Health, 53277 2018-22902 National Heart, Lung, and Blood Institute, 53276-53277 2018-22901 National Institute on Deafness and Other Communication Disorders, 53279 2018-22900 National Library of Medicine, 53279 2018-22897 National Oceanic National Oceanic and Atmospheric Administration NOTICES Meetings: Fisheries of South Atlantic; Southeast Data, Assessment, and Review, 53232-53233 2018-22992 Gulf of Mexico Fishery Management Council, 53216-53217 2018-22993 South Atlantic Fishery Management Council, 53231-53232 2018-22990 Takes of Marine Mammals Incidental to Specified Activities: Mission Bay Ferry and Water Taxi Landing Project in San Francisco Bay, CA, 53217-53231 2018-22923 National Park National Park Service NOTICES Requests for Nominations: Gateway National Recreation Area Fort Hancock 21st Century Advisory Committee, 53294 2018-23016 Made in America Outdoor Recreation Advisory Committee, 53293-53294 2018-23015 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings: Multistakeholder Process on Promoting Software Component Transparency, 53233 2018-22872 Nuclear Regulatory Nuclear Regulatory Commission RULES List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS Universal Storage System, Certificate of Compliance No. 1015, Amendment No. 6, 53159-53163 2018-22912 PROPOSED RULES List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS Universal Storage System, Certificate of Compliance No. 1015, Amendment No. 6, 53191-53193 2018-22913 NOTICES Exemptions and Combined Licenses; Amendments: Southern Nuclear Operating Co., Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Containment Sump Level Instrumentation, 53315-53317 2018-22983 Exemptions: Exelon Generation Co., LLC; Oyster Creek Nuclear Generating Station, 53317-53321 2018-22986 Inspections, Tests, Analyses, and Acceptance Criteria: Southern Nuclear Operating Co., Inc. Vogtle Electric Generating Plant, Units 3 and 4, 53321-53322 2018-22985 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53313-53315 2018-22917 Personnel Personnel Management Office NOTICES Excepted Service, 53322-53324 2018-22685 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Revision of the Hazardous Liquid Annual Report, 53358-53359 2018-22989 Securities Securities and Exchange Commission NOTICES Applications: Blackstone Real Estate Income Fund, et al., 53329-53334 2018-22894 Procure Active ETF Trust, et al., 53341-53343 2018-22996 Procure ETF Trust I, et al., 53334-53335 2018-22994 Meetings: Investor Advisory Committee, 53337 2018-22943 Securities Exchange Act and Investment Company Act: Hurricane Michael, 53326-53329 2018-22931 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 53343-53347 2018-22909 Cboe EDGX Exchange, Inc., 53349-53350 2018-22904 Cboe Exchange, Inc., 53336-53339 2018-22907 2018-22908 Fixed Income Clearing Corp., 53339-53341 2018-22906 Nasdaq Stock Market, LLC, 53339 2018-22910 New York Stock Exchange, LLC, 53324-53326 2018-22905 NYSE National, Inc., 53347-53349 2018-22903 Small Business Small Business Administration NOTICES Exemption under the Small Business Investment Act, Conflicts of Interest: Plexus Fund IV-A, LP, 53352 2018-23019 Plexus Fund IV-B, LP, 53352 2018-23021 Plexus Fund IV-C, LP, 53351 2018-23020 Major Disaster Declarations: Florida, 53351 2018-22981 North Carolina, 53351-53352 2018-22891 Virginia; Public Assistance Only, 53351 2018-22982 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53352-53355 2018-22970 State Department State Department NOTICES Charter Renewals: Overseas Security Advisory Council, 53355 2018-23017 Culturally Significant Objects Imported for Exhibition: The Jeweled Isle: Art from Sri Lanka, 53355 2018-22948 Meetings: Overseas Security Advisory Council, 53355 2018-23014 Surface Transportation Surface Transportation Board NOTICES Release of Waybill Data, 53355-53356 2018-22975 Codex The U.S. Codex Office NOTICES Meetings: Codex Alimentarius Commission; Committee on Spices and Culinary Herbs, 53206-53207 2018-22873 Transportation Department Transportation Department See

Federal Aviation Administration

See

National Highway Traffic Safety Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department See

Foreign Assets Control Office

See

United States Mint

U.S. Mint United States Mint NOTICES Meetings: Stakeholder Roundtable on Coin Circulation, 53361 2018-22966 Veteran Affairs Veterans Affairs Department RULES Presumption of Herbicide Exposure and Presumption of Disability During Service for Reservists Presumed Exposed to Herbicides, 53179-53182 2018-22892 NOTICES Enhanced-Use Leases of Real Property: Lexington VA Health Care System, Franklin R. Sousley Campus, Lexington, KY, 53361 2018-22941 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.

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83 204 Monday, October 22, 2018 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2018-0075] RIN 3150-AK12 List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS® Universal Storage System, Certificate of Compliance; No. 1015, Amendment No. 6 AGENCY:

Nuclear Regulatory Commission.

ACTION:

Direct final rule.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the NAC International NAC-UMS® listing within the “List of approved spent fuel storage casks” to include Amendment No. 6 to Certificate of Compliance (CoC) No. 1015. Amendment No. 6 revises the CoC's technical specifications (TSs) to: Remove a redundant requirement for inspection of the concrete cask and canister; revise a limiting condition of operation (LCO) for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; and clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the Final Safety Analysis Report (FSAR), “or within the time limit for a less than design-basis heat load case, as evaluated.” Amendment No. 6 also clarifies that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.

DATES:

This direct final rule is effective January 7, 2019, unless significant adverse comments are received by November 21, 2018. If this direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date. Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the Federal Register.

ADDRESSES:

You may submit comments by any of the following methods:

Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0075. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Bernard H. White, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-6577; email: [email protected] or Robert D. MacDougall, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-5175; email: [email protected] Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents I. Obtaining Information and Submitting Comments II. Rulemaking Procedure III. Background IV. Discussion of Changes V. Voluntary Consensus Standards VI. Agreement State Compatibility VII. Plain Writing VIII. Environmental Assessment and Finding of No Significant Environmental Impact IX. Paperwork Reduction Act Statement X. Regulatory Flexibility Certification XI. Regulatory Analysis XII. Backfitting and Issue Finality XIII. Congressional Review Act XIV. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2018-0075 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 Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0075.

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] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

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.

B. Submitting Comments

Please include Docket ID NRC-2018-0075 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Rulemaking Procedure

This direct final rule is limited to the changes contained in Amendment No. 6 to CoC No. 1015 and does not include other aspects of the NAC-UMS® Universal Storage System design. The NRC is using the “direct final rule procedure” to issue this amendment because it represents a limited and routine change to an existing CoC that is expected to be noncontroversial. Adequate protection of public health and safety continues to be ensured. The amendment to the rule will become effective on January 7, 2019. However, if the NRC receives significant adverse comments on this direct final rule by November 21, 2018, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC to make a change (other than editorial) to the rule, CoC, or TSs.

For detailed instructions on filing comments, please see the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register.

III. Background

Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule that added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on October 19, 2000 (65 FR 62581), that approved the NAC-UMS® Universal Storage System design and added it to the list of NRC-approved cask designs provided in § 72.214 as CoC No. 1015.

IV. Discussion of Changes

On May 23, 2017, NAC International submitted a request to the NRC to amend CoC No. 1015. NAC International supplemented its request on January 16, 2018. Amendment No. 6 revises the CoC's TSs to: (1) Remove a redundant requirement for inspection of the concrete cask and canister; (2) revise an LCO for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; (3) remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; (4) clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the FSAR, “or within the time limit for a less than design-basis heat load case, as evaluated”; and (5) clarify that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.

As documented in the preliminary safety evaluation report (PSER), the NRC performed a safety review of the proposed CoC amendment request. There are no significant changes to cask design requirements in the proposed CoC amendment. Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of containment, shielding, and criticality control in the event of an accident. This amendment does not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 6 would remain well within the 10 CFR part 20 limits. There will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for, or consequences from, radiological accidents.

This direct final rule revises the NAC-UMS® System listing in § 72.214 by adding Amendment No. 6 to CoC No. 1015. The amendment consists of the changes previously described, as set forth in the revised CoC and TSs. The revised TSs are identified and evaluated in the PSER.

The amended NAC-UMS® cask design, when used under the conditions specified in the CoC, the TSs, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under § 72.210 may, consistent with the license conditions under § 72.212, load spent nuclear fuel into those NAC-UMS® Universal Storage System casks that meet the criteria of Amendment No. 6 to CoC No. 1015.

V. Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the NAC-UMS® Universal Storage System design listed in § 72.214. This action does not constitute the establishment of a standard that contains generally applicable requirements.

VI. Agreement State Compatibility

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR. Although an Agreement State may not adopt program elements reserved to the NRC, and the Category “NRC” does not confer regulatory authority on the State, the State may wish to inform its licensees of certain requirements by means consistent with the particular State's administrative procedure laws.

VII. Plain Writing

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

VIII. Environmental Assessment and Finding of No Significant Environmental Impact A. The Action

The action is to amend § 72.214 to revise the NAC International NAC-UMS® Universal Storage System listing of casks that power reactor licensees can use for dry storage of spent fuel at reactor sites under a general license. This direct final rule amends the listing to add Amendment No. 6 to CoC No. 1015. Specifically, Amendment No. 6 revises the CoC's TSs to: (1) Remove a redundant requirement for inspection of the concrete cask and canister; (2) revise an LCO for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; (3) remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; (4) clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the FSAR, “or within the time limit for a less than design-basis heat load case, as evaluated”; and (5) clarify that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.

B. The Need for the Action

This direct final rule amends the CoC for the NAC-UMS® Universal Storage System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Amendment No. 6 clarifies and removes redundancies in requirements for the use of the NAC-UMS® Universal Storage System. The amendment facilitates the dry cask storage of spent fuel that might otherwise have to be stored in the affected power reactors' spent fuel storage pools.

C. Environmental Impacts of the Action

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the environmental assessment (EA) for the 1990 final rule. The EA for this Amendment No. 6 tiers off of the EA for the July 18, 1990, final rule. Tiering off past EAs is a standard process under the National Environmental Policy Act of 1969, as amended (NEPA).

NAC-UMS® Universal Storage Systems are designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other events.

Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of confinement, shielding, and criticality control in the event of an accident. If there is no loss of confinement, shielding, or criticality control, the environmental impacts resulting from an accident would be insignificant. This amendment does not reflect a significant change in design or fabrication of the cask. Because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 6 would remain well within 10 CFR part 20 limits. Therefore, the proposed CoC changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the EA supporting the July 18, 1990, final rule. There will be no significant change in the types or amounts of any effluent released, no significant increase in individual or cumulative radiation exposures, and no significant increase in the potential for or consequences of radiological accidents. The NRC documented its safety findings in a PSER.

D. Alternative to the Action

The alternative to this action is to deny approval of Amendment No. 6 and end the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into NAC International NAC-UMS® Universal Storage Systems in accordance with the changes described in proposed Amendment No. 6 would have to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. Therefore, the environmental impacts of the alternative action would be the same as, or more likely greater than, the preferred action.

E. Alternative Use of Resources

Approval of Amendment No. 6 to CoC No. 1015 would result in no irreversible commitment of resources.

F. Agencies and Persons Contacted

No agencies or persons outside the NRC were contacted in connection with the preparation of this EA.

G. Finding of No Significant Impact

The environmental impacts of the action have been reviewed under the requirements in NEPA, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” Based on the foregoing EA, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS® Universal Storage System, Certificate of Compliance No. 1015, Amendment No. 6” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

IX. Paperwork Reduction Act Statement

This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing collections of information were approved by the Office of Management and Budget (OMB), approval number 3150-0132.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to respond to a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

X. Regulatory Flexibility Certification

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and NAC International. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).

XI. Regulatory Analysis

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On October 19, 2000 (65 FR 62581), the NRC issued an amendment to 10 CFR part 72 that approved the NAC-UMS® Universal Storage System design by adding it to the list of NRC-approved cask designs in § 72.214.

On May 23, 2017, and as supplemented on January 16, 2018, NAC International submitted an application to amend the NAC-UMS® Universal Storage System as described in Section IV, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Amendment No. 6 and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into NAC International NAC-UMS® Universal Storage Systems under the changes described in Amendment No. 6 to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the PSER and EA, this direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.

XII. Backfitting and Issue Finality

The NRC has determined that the actions in this direct final rule do not require a backfit analysis because they either do not fall within the definition of backfitting under § 72.62 or § 50.109(a)(1), or they do not impact any general licensees currently using these systems. Additionally, the actions in this direct final rule do not impact issue finality provisions applicable to combined licenses under 10 CFR part 52.

This direct final rule revises CoC No. 1015 for the NAC International NAC-UMS® Universal Storage System, as currently listed in § 72.214. The revision consists of Amendment No. 6, which revises the CoC's TSs to: (1) Remove a redundant requirement for inspection of the concrete cask and canister; (2) revise an LCO for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; (3) remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; (4) clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the FSAR, “or within the time limit for a less than design-basis heat load case, as evaluated”; and (5) clarify that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.

Amendment No. 6 to CoC No. 1015 for the NAC International NAC-UMS® Universal Storage System was initiated by NAC International and was not submitted in response to new NRC requirements, or an NRC request for amendment. Amendment No. 6 applies only to new casks fabricated and used under Amendment No. 6. These changes do not affect existing users of the NAC International NAC-UMS® Universal Storage System, and the current Amendment No. 5 continues to be effective for existing users. While current CoC users may comply with the new requirements in Amendment No. 6, this would be a voluntary decision on the part of current users.

For these reasons, Amendment No. 6 to CoC No. 1015 does not constitute backfitting under § 72.62 or § 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis for this rulemaking.

XIII. Congressional Review Act

This direct final rule is not a rule as defined in the Congressional Review Act.

XIV. Availability of Documents

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

Document ADAMS accession
  • No./web link/
  • Federal Register
  • citation
  • Request to Amend Certificate of Compliance No. 1015 for the NAC-UMS® Cask System, dated May 23, 2017 ML17145A380 Revision of Request to Amend Certificate of Compliance No. 1015 for the NAC-UMS® Cask System, dated January 16, 2018 ML18018A893 Revision 11 to NAC-UMS® Final Safety Analysis Report for the UMS Universal Storage System ML16341B102 Proposed CoC No. 1015, Amendment No. 6 ML18088A174 Proposed Technical Specifications, Appendix A ML18088A176 Proposed Technical Specifications, Appendix B ML18088A178 Preliminary Safety Evaluation Report ML18088A181

    The NRC may post materials related to this document, including public comments, on the Federal Rulemaking website at http://www.regulations.gov under Docket ID NRC-2018-0075. The Federal Rulemaking website allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2018-0075); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:

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

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

    2. In § 72.214, Certificate of Compliance 1015 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1015.

    Initial Certificate Effective Date: November 20, 2000.

    Amendment Number 1 Effective Date: February 20, 2001.

    Amendment Number 2 Effective Date: December 31, 2001.

    Amendment Number 3 Effective Date: March 31, 2004.

    Amendment Number 4 Effective Date: October 11, 2005.

    Amendment Number 5 Effective Date: January 12, 2009.

    Amendment Number 6 Effective Date: January 7, 2019.

    SAR Submitted by: NAC International, Inc.

    SAR Title: Final Safety Analysis Report for the NAC-UMS Universal Storage System.

    Docket Number: 72-1015.

    Certificate Expiration Date: November 20, 2020.

    Model Number: NAC-UMS.

    Dated at Rockville, Maryland, this 9th day of October 2018.

    For the Nuclear Regulatory Commission.

    Margaret M. Doane, Executive Director for Operations.
    [FR Doc. 2018-22912 Filed 10-19-18; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2016-4136; Special Conditions No. 25-621B-SC] Special Conditions: The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, With or Without Airbag Devices or 3-Point Restraints AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Amended final special conditions; request for comments.

    SUMMARY:

    These amended special conditions are issued for the Boeing Model 777 series airplanes. These special conditions are for oblique (side-facing) seats, installed in Boeing Model 777 series airplanes, at an angle of 18 to 45 degrees to the airplane centerline and which may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This amendment adds a note and one special condition to the Special Conditions section. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant passenger seats equipped with or without airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    DATES:

    This action is effective on The Boeing Company on October 22, 2018. Send comments on or before December 6, 2018.

    ADDRESSES:

    Send comments identified by Docket No. FAA-2016-4136 using any of the following methods:

    Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

    Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    John Shelden, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3214; email [email protected]

    SUPPLEMENTARY INFORMATION:

    The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA therefore finds it unnecessary to delay the effective date and finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

    Comments Invited

    We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

    We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

    Background

    On November 22, 2017, Boeing applied for an amendment to Type Certificate No. T00001SE for the installation of oblique (side-facing) passenger seats with or without airbag devices or 3-point restraints in the Boeing Model 777 series airplanes. The Boeing Model 777 series airplanes are twin-engine, transport category airplanes with a maximum certified passenger capacity of up to 550 and a maximum takeoff weight of approximately 775,000 lbs.

    Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 777 series airplanes meet the applicable provisions of the regulations listed in Type Certificate No. T00001SE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

    If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 777 series airplanes because of novel or unusual design features, special conditions are prescribed under the provisions of § 21.16.

    Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

    In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

    The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

    Novel or Unusual Design Features

    The business-class seating configuration Boeing proposes is novel or unusual due to the seat installation at 30 degrees to the airplane centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration is also beyond the limits of current acceptable equivalent-level-of-safety findings. These oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection.

    The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785.

    The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.

    Discussion

    The FAA has been conducting and sponsoring research on appropriate injury criteria for oblique (side-facing) seat installations. However, the FAA research program is not complete and we may update these criteria as we obtain further research results. To reflect current research findings, the FAA issued policy statement PS-ANM-25-03-R1 to update injury criteria for fully side-facing seats, and policy statement PS-AIR-25-27, to define injury criteria for oblique (side-facing) seats.

    The proposed Boeing Model 777 series airplanes business-class seat installation is novel such that the current Boeing Model 777 series airplanes certification basis does not adequately address protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. The FAA issued special conditions No. 25-569-SC for Model 777-300ER airplanes on September 25, 2014, and special conditions No. 25-621-SC for certain Model 777-300ER airplanes on August 3rd, 2016. These special conditions contained injury criteria for oblique seats based on the best knowledge the FAA had at the time. These special conditions for oblique seat installations do not adequately address oblique seats, reflecting the current research results, with or without 3-point or airbag restraint systems. Therefore, Boeing's proposed configuration will require amended special conditions.

    The installation of passenger seats at angles of 18 to 45 degrees to the airplane centerline are unique due to the seat/occupant interface with the surrounding furniture that introduces occupant alignment/loading concerns with or without the installation of a 3-point or airbag restraint system, or both. On-going research has invalidated previously released special conditions for oblique (side-facing) seat installations. These updated special conditions further address potential injuries to the occupant's neck and spine. As a result, these special conditions replace special conditions 25-569-SC and 25-621-SC. This amendment adds a note to special condition number 7 and adds special condition number 8 to the Special Condition section. The note and special condition 8 were unintentionally omitted from the previous issuance of these special conditions. This additional text is standard, in all material respects, in previously issued special conditions of the same topic.

    FAA-sponsored research has found that an un-restrained flailing of the upper torso, even when the pelvis and torso are nearly aligned, can produce serious spinal and torso injuries. At lower impact severities, even with significant misalignment between the torso and pelvis, these injuries did not occur. Tests with an FAA H-III anthropomorphic test device (ATD) have identified a level of lumbar spinal tension corresponding to the no-injury impact severity. This level of tension is included as a limit in the special conditions. The spine tension limit selected is conservative with respect to other aviation injury criteria since it corresponds to a no-injury loading condition.

    As noted in the special conditions for each airbag restraint system, because an airbag restraint system is essentially a single use device, there is the potential that it could deploy under crash conditions that are not sufficiently severe as to require head injury protection from the airbag restraint system. Since an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the airbag restraint system useless if a larger impact follows the initial impact. This situation does not exist with energy absorbing pads or upper torso restraints, which tend to provide protection according to the severity of the impact. Therefore, the installation of the airbag restraint system should be such that the airbag restraint system will provide protection when it is required, and will not expend its protection when it is not needed.

    Because these airbag restraint systems may or may not activate during various crash conditions, the injury criteria listed in these special conditions and in § 25.562 must be met in an event that is slightly below the activation level of the airbag restraint system. If an airbag restraint system is included with the oblique seats, the system must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 777 series airplanes.

    These amended special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    Applicability

    As discussed above, these special conditions are applicable to the Boeing Model 777 series airplane. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

    Conclusion

    This action affects only certain novel or unusual design features on one model series of airplanes. It is not a rule of general applicability.

    List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping requirements.

    Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:

    49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

    The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Boeing Model 777 series airplanes.

    Side-Facing Seats Special Conditions

    In addition to the requirements of § 25.562:

    1. Head Injury Criteria (HIC)

    Compliance with § 25.562(c)(5) is required, except that, if the ATD has no apparent contact with the seat/structure but has contact with an airbag, a HIC unlimited score in excess of 1000 is acceptable, provided the HIC15 score for that contact (calculated in accordance with 49 CFR 571.208) is less than 700.

    2. Body-to-Wall/Furnishing Contact

    If a seat is installed aft of structure (e.g., interior wall or furnishings) that does not provide a homogenous contact surface for the expected range of occupants and yaw angles, then additional analysis and tests may be required to demonstrate that the injury criteria are met for the area which an occupant could contact. For example, different yaw angles could result in different airbag device performance, then additional analysis or separate tests may be necessary to evaluate performance.

    3. Neck Injury Criteria

    The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is a reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.

    a. The Nij, calculated in accordance with 49 CFR 571.208, must be below 1.0, where Nij = Fz/Fzc + My/Myc, and Nij critical values are:

    i. Fzc = 1,530 lbs for tension ii. Fzc = 1,385 lbs for compression iii. Myc = 229 lb-ft in flexion iv. Myc = 100 lb-ft in extension

    b. In addition, peak upper-neck Fz must be below 937 lbs. in tension and 899 lbs. in compression.

    c. Rotation of the head about its vertical axis, relative to the torso is limited to 105 degrees in either direction from forward-facing.

    d. The neck must not impact any surface that would produce concentrated loading on the neck.

    4. Spine and Torso Injury Criteria

    a. The lumbar spine tension (Fz) cannot exceed 1,200 lbs.

    b. Significant concentrated loading on the occupant's spine, in the area between the pelvis and shoulders during impact, including rebound, is not acceptable. During this type of contact, the interval for any rearward (X direction) acceleration exceeding 20g must be less than 3 milliseconds as measured by the thoracic instrumentation specified in 49 CFR part 572, subpart E, filtered in accordance with SAE recommended practice J211/1, “Instrumentation for Impact Test-Part 1-Electronic Instrumentation.”

    c. The occupant must not interact with the armrest or other seat components in any manner significantly different than would be expected for a forward-facing seat installation.

    5. Pelvis Criteria

    Any part of the load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of the seat bottom seat-cushion supporting structure.

    6. Femur Criteria

    Axial rotation of the upper leg (about the z-axis of the femur per SAE Recommended Practice J211/1) must be limited to 35 degrees from the nominal seated position. Evaluation during rebound does not need to be considered.

    7. ATD and Test Conditions

    Longitudinal tests conducted to measure the injury criteria above must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609, “A Lumbar Spine Modification to the Hybrid III ATD for Aircraft Seat Tests.” The tests must be conducted with an undeformed floor, at the most-critical yaw cases for injury, and with all lateral structural supports (e.g., armrests or walls) installed.

    Note:

    Boeing must demonstrate that the installation of seats via plinths or pallets meets all applicable requirements. Compliance with the guidance contained in policy memorandum PS-ANM-100-2000-00123, “Guidance for Demonstrating Compliance with Seat Dynamic Testing for Plinths and Pallets,” dated February 2, 2000, is acceptable to the FAA.

    8. Inflatable Airbag Restraint Systems Special Conditions

    If inflatable airbag restraint systems are installed, the airbag systems must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 777 series airplanes.

    Issued in Des Moines, Washington, on October 4, 2018. Victor Wicklund, Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-22933 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2018-0932; Special Conditions No. 25-733-SC] Special Conditions: Mitsubishi Aircraft Corporation Model MRJ-200 Airplane; Passenger Seats With Non-Traditional, Large, Non-Metallic Panels AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final special conditions; request for comments.

    SUMMARY:

    These special conditions are issued for the Mitsubishi Aircraft Corporation Model MRJ-200 airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features include passenger seats that incorporate non-traditional, large, non-metallic panels in lieu of the traditional metal frame covered by fabric. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    DATES:

    This action is effective on Mitsubishi Aircraft Corporation on October 22, 2018. Send comments on or before December 6, 2018.

    ADDRESSES:

    Send comments identified by Docket No. FAA-2018-0932 using any of the following methods:

    Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

    Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Nicholas Wilson, International Section, AIR-676, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3230; email [email protected]

    SUPPLEMENTARY INFORMATION:

    The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA, therefore, finds it unnecessary to delay the effective date and finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

    Comments Invited

    We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

    We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

    Background

    On August 19, 2009, Mitsubishi Aircraft Corporation applied for a type certificate for their new Model MRJ-200 airplane. The Mitsubishi Aircraft Corporation Model MRJ-200 airplane is a low-wing, conventional-tail design with two wing-mounted turbofan engines. The primary structure is metal with an aluminum wing and composite empennage. The airplane is equipped with an electronic flight control system. The airplane has seating for 96 passengers and a maximum takeoff weight of 98,800 lbs.

    Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.17, Mitsubishi Aircraft Corporation must show that the Model MRJ-200 airplane meets the applicable provisions of part 25, as amended by amendments 25-1 through 25-141; part 36, as amended by amendments 36-1 through 36-30; and part 34, as amended by amendments 34-1 through the amendment effective at the time of design approval.

    If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Mitsubishi Aircraft Corporation Model MRJ-200 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

    Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

    In addition to the applicable airworthiness regulations and special conditions, the Mitsubishi Aircraft Corporation Model MRJ-200 airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

    The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

    Novel or Unusual Design Features

    The Mitsubishi Aircraft Corporation Model MRJ-200 airplane will incorporate the following novel or unusual design features:

    Passenger seats that incorporate non-traditional, large, non-metallic panels in lieu of the traditional metal frame covered by fabric.

    Definition of “Non-Traditional, Large, Non-Metallic Panel”

    A non-traditional, large, non-metallic panel, in this case, is defined as a panel with exposed surface areas greater than 1.5 square feet installed per seat place. The panel may consist of either a single component or multiple components in a concentrated area. Examples of parts of the seat where these non-traditional panels are installed include, but are not limited to: seat backs, bottoms and leg/foot rests, kick panels, back shells, credenzas and associated furniture. Examples of traditional exempted parts of the seat include: arm caps, armrest close-outs such as end bays and armrest-styled center consoles, food trays, video monitors and shrouds.

    Clarification of “Exposed”

    “Exposed” includes those panels directly exposed to the passenger cabin in the traditional sense, plus those panels enveloped such as by a dress cover. Traditional fabrics or leathers currently used on seats are excluded from these special conditions. These materials must still comply with 14 CFR 25.853(a) and (c) if used as a covering for a seat cushion, or 14 CFR 25.853(a) if installed elsewhere on the seat. Non-traditional, large, non-metallic panels covered with traditional fabrics or leathers will be tested without their coverings or covering attachments.

    Discussion

    In the early 1980s, the FAA conducted extensive research on the effects of post-crash flammability in the passenger cabin. As a result of this research and service experience, the FAA adopted new standards for interior surfaces associated with large surface area parts. Specifically, the rules require measurement of heat release and smoke emission (part 25, appendix F, parts IV and V) for the affected parts. Heat release has been shown to have a direct correlation with post-crash fire survival time. Materials that comply with the standards (i.e., § 25.853, Compartment interiors, as amended by amendment 25-61 and amendment 25-66) extend survival time by approximately two minutes over materials that do not comply.

    At the time these standards were written, the potential application of the requirements of heat release and smoke emission to seats was explored. The seat frame itself was not a concern because it was primarily made of aluminum and there were only small amounts of non-metallic materials. It was determined that the overall effect on survivability was negligible, whether or not the food trays met the heat release and smoke requirements. The requirements, therefore, did not address seats. The preambles to both the Notice of Proposed Rulemaking, Notice No. 85-10, 50 FR 15038, April 16, 1985, and the Final Rule, amendment 25-61, 51 FR 26206, July 21, 1986, specifically note that seats were excluded because the recently-adopted standards for flammability of seat cushions will greatly inhibit involvement of the seats.

    Subsequently, the Final Rule, amendment 25-83, 60 FR 6615, March 6, 1995, clarified the definition of minimum panel size by stating that it is not possible to cite a specific size that will apply in all installations; however, as a general rule, components with exposed surface areas of one square foot or less may be considered small enough that they do not have to meet the new standards. Components with exposed surface areas greater than two square feet may be considered large enough that they do have to meet the new standards. Those with exposed surface areas greater than one square foot, but less than two square feet, must be considered in conjunction with the areas of the cabin in which they are installed before a determination could be made.

    The FAA issued Policy Statement PS-ANM100-97-112-39, Guidance for Flammability Testing of Seat/Console Installations, on October 17, 1997 (http://rgl.faa.gov). That document was issued when it became clear that seat designs were evolving to include large, non-metallic panels with surface areas that would impact survivability during a cabin fire event, comparable to partitions or galleys. The document noted that large surface area panels must comply with heat release and smoke emission requirements, even if they were attached to a seat. If the FAA had not issued such policy, seat designs could have been viewed as a loophole to the airworthiness standards that would result in an unacceptable decrease in survivability during a cabin fire event.

    In October of 2004, an issue was raised regarding the appropriate flammability standards for passenger seats that incorporated non-traditional, large, non-metallic panels in lieu of the traditional metal covered by fabric. The FAA determined that special conditions would be promulgated to apply the standards defined in 14 CFR 25.853(d) to seats with large, non-metallic panels in their design.

    These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    Applicability

    As discussed above, these special conditions are applicable to the Mitsubishi Aircraft Corporation Model MRJ-200 airplane. Should Mitsubishi Aircraft Corporation apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

    Conclusion

    This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability.

    List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping requirements.

    Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:

    49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

    The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Mitsubishi Aircraft Company Model MRJ-200 airplanes.

    1. Except as provided in paragraph 3 of these special conditions, compliance with 14 CFR part 25, appendix F, part IV, Heat Release and part V, Smoke Emission, is required for seats that incorporate non-traditional, large, non-metallic panels that may either be a single component or multiple components in a concentrated area in their design.

    2. The applicant may designate up to and including 0.139 square meter (1.5 square feet of non-traditional, non-metallic panel material per seat place that does not have to comply with paragraph 1 of these special conditions. A double seat assembly may have a total of 0.278 square meter (3.0 square feet) excluded on any portion of the assembly (e.g., outboard seat place 0.093 square meter [1 square foot] and inboard 0.185 square meter [2.0 square feet]).

    3. Seats do not have to meet the test requirements of 14 CFR part 25, appendix F, parts IV and V, when installed in compartments defined in 14 CFR 25.853(e).

    Issued in Des Moines, Washington, on October 16, 2018. Victor Wicklund, Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-22922 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2018-0714; Special Conditions No. 25-734-SC] Special Conditions: Bombardier, Inc., BD-700-2A12 and BD-700-2A13 Airplanes; Multiple-Place Side-Facing Seats With Active Leg-Flail Restraint Device and Shoulder-Belt Airbags AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final special conditions; request for comments.

    SUMMARY:

    These special conditions are issued for the Bombardier, Inc., (Bombardier) BD-700-2A12 and BD-700-2A13 airplanes, marketed respectively as Global 7000 and Global 8000. These airplanes, as modified by Bombardier, will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. These design features are multiple-place side-facing seats with active leg-flail restraint devices and shoulder-belt airbags. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    DATES:

    This action is effective on Bombardier on October 22, 2018. Send comments on or before December 6, 2018.

    ADDRESSES:

    Send comments identified by Docket No. FAA-2018-0714 using any of the following methods:

    Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

    Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Alan Sinclair, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3215; email [email protected]

    SUPPLEMENTARY INFORMATION:

    The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA therefore finds it unnecessary to delay the effective date and finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

    Comments Invited

    We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

    We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

    Background

    On June 10, 2015, Bombardier applied for a supplemental type certificate for multiple-place side-facing seats equipped with active leg-flail restraint devices and shoulder-belt airbags in the Model BD-700-2A12 and BD-700-2A13 airplanes.

    These airplanes are derivatives of the Model BD-700 series of airplanes and are marketed as the Bombardier Global 7000 (Model BD-700-2A12) and Global 8000 (Model BD-700-2A13). These airplanes are twin-engine, transport-category, executive-interior business jets. The maximum passenger capacity is 19 and the maximum takeoff weights are 106,250 lb. (Model BD-700-2A12) and 104,800 lb. (Model BD-700-2A13).

    Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-700-2A13 airplanes, as changed, continue to meet the applicable provisions of the regulations listed in type certificate no. T00003NY or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

    If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Bombardier BD-700-2A12 and BD-700-2A13 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

    Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

    In addition to the applicable airworthiness regulations and special conditions, the Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.

    The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

    Novel or Unusual Design Features

    The Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design features:

    Multiple-place side-facing seats with active leg-flail restraint devices and shoulder-belt airbags.

    Discussion

    Many proposed airplane interior configurations include multiple-place side-facing seats and single-place side-facing seats (hereafter referred to as side-facing seats). Some of these side-facing seat designs include an airbag system in the shoulder belt, and some may also include leg-flail protection. The FAA has determined that the existing regulations do not provide adequate or appropriate safety standards for occupants of side facing seats. In addition, the FAA has determined that the existing regulations do not provide adequate or appropriate safety standards for the addition of airbag systems in the shoulder belt on side-facing seats.

    Side-facing seats are considered a novel design for transport-category airplanes that include § 25.562 in their certification basis. The performance measures of § 25.562(c) only address forward- and aft-facing seats, and do not provide adequate or appropriate safety standards for occupants of side-facing seats because they do not consider the differences in the dynamic forces that apply to a side-facing occupant.

    The FAA issued Policy Statement PS-ANM-25-03-R1 to provide technical criteria for approving side-facing seats, to be issued as special conditions for the design approval of such seats. The technical criteria set forth in that policy are the result of FAA research findings and provide the level of safety envisioned in § 25.562. These technical criteria are applicable to all fully side-facing seats, both multiple-place and single-place.

    These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    Applicability

    As discussed above, these special conditions are applicable to the Bombardier BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

    Conclusion

    This action affects only certain novel or unusual design features on the Bombardier BD-700-2A12 and BD-700-2A13 airplanes. It is not a rule of general applicability.

    List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping requirements.

    Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:

    49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

    The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Bombardier BD-700-2A12 and BD-700-2A13 airplanes as modified by Bombardier.

    1. Additional requirements applicable to tests or rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

    a. The longitudinal test(s) conducted in accordance with § 25.562(b)(2) to show compliance with the seat-strength requirements of § 25.562(c)(7) and (8), and these special conditions must have an ES-2re anthropomorphic test dummy (ATD) (49 CFR part 572, subpart U) or equivalent, or a Hybrid-II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent, occupying each seat position and including all items contactable by the occupant (e.g., armrest, interior wall, or furnishing) if those items are necessary to restrain the occupant. If included, the floor representation and contactable items must be located such that their relative position, with respect to the center of the nearest seat place, is the same at the start of the test as before floor misalignment is applied. For example, if floor misalignment rotates the centerline of the seat place nearest the contactable item 8 degrees clockwise about the aircraft x-axis, then the item and floor representations must be rotated by 8 degrees clockwise also to maintain the same relative position to the seat place. Each ATD's relative position to the seat after application of floor misalignment must be the same as before misalignment is applied. To ensure proper loading of the seat by the occupants, the ATD pelvis must remain supported by the seat pan, and the restraint system must remain on the pelvis and shoulder of the ATD until rebound begins. No injury-criteria evaluation is necessary for tests conducted only to assess seat-strength requirements.

    b. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the injury assessments required by § 25.562(c) and these special conditions, may be conducted separately from the test(s) to show structural integrity. In this case, structural-assessment tests must be conducted as specified in paragraph 1a, above, and the injury-assessment test must be conducted without yaw or floor misalignment. Injury assessments may be accomplished by testing with ES-2re ATD (49 CFR part 572, subpart U) or equivalent at all places. Alternatively, these assessments may be accomplished by multiple tests that use an ES-2re at the seat place being evaluated, and a Hybrid-II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent used in all seat places forward of the one being assessed, to evaluate occupant interaction. In this case, seat places aft of the one being assessed may be unoccupied. If a seat installation includes adjacent items that are contactable by the occupant, the injury potential of that contact must be assessed. To make this assessment, tests may be conducted that include the actual item, located and attached in a representative fashion. Alternatively, the injury potential may be assessed by a combination of tests with items having the same geometry as the actual item, but having stiffness characteristics that would create the worst case for injury (injuries due to both contact with the item and lack of support from the item).

    c. If a seat is installed aft of structure (e.g., an interior wall or furnishing) that does not have a homogeneous surface contactable by the occupant, additional analysis and/or test(s) may be required to demonstrate that the injury criteria are met for the area which an occupant could contact. For example, different yaw angles could result in different injury considerations and may require additional analysis or separate test(s) to evaluate.

    d. To accommodate a range of occupant heights (5th percentile female to 95th percentile male), the surface of items contactable by the occupant must be homogenous 7.3 inches (185 mm) above and 7.9 inches (200 mm) below the point (center of area) that is contacted by the 50th percentile male size ATD's head during the longitudinal test(s) conducted in accordance with paragraphs a, b, and c, above. Otherwise, additional head-injury criteria (HIC) assessment tests may be necessary. Any surface (inflatable or otherwise) that provides support for the occupant of any seat place must provide that support in a consistent manner regardless of occupant stature. For example, if an inflatable shoulder belt is used to mitigate injury risk, then it must be demonstrated by inspection to bear against the range of occupants in a similar manner before and after inflation. Likewise, the means of limiting lower-leg flail must be demonstrated by inspection to provide protection for the range of occupants in a similar manner.

    e. For longitudinal test(s) conducted in accordance with § 25.562(b)(2) and these special conditions, the ATDs must be positioned, clothed, and have lateral instrumentation configured as follows:

    f. ATD positioning:

    i. Lower the ATD vertically into the seat while simultaneously:

    ii. Aligning the midsagittal plane (a vertical plane through the midline of the body; dividing the body into right and left halves) with approximately the middle of the seat place.

    iii. Applying a horizontal x-axis direction (in the ATD coordinate system) force of about 20 lb (89 N) to the torso at approximately the intersection of the midsagittal plane and the bottom rib of the ES-2re or lower sternum of the Hybrid-II at the midsagittal plane, to compress the seat back cushion.

    iv. Keeping the upper legs nearly horizontal by supporting them just behind the knees. Once all lifting devices have been removed from the ATD:

    1. Rock it slightly to settle it in the seat.

    2. Separate the knees by about 4 inches (100 mm).

    3. Set the ES-2re's head at approximately the midpoint of the available range of z-axis rotation (to align the head and torso midsagittal planes).

    4. Position the ES-2re's arms at the joint's mechanical detent that puts them at approximately a 40 degree angle with respect to the torso. Position the Hybrid-II ATD hands on top of its upper legs.

    5. Position the feet such that the centerlines of the lower legs are approximately parallel to a lateral vertical plane (in the aircraft coordinate system).

    g. ATD clothing: Clothe each ATD in form-fitting, mid-calf-length (minimum) pants and shoes (size 11E) weighing about 2.5 lb (1.1 Kg) total. The color of the clothing should be in contrast to the color of the restraint system. The ES-2re jacket is sufficient for torso clothing, although a form-fitting shirt may be used in addition if desired.

    h. ES-2re ATD lateral instrumentation: The rib-module linear slides are directional, i.e., deflection occurs in either a positive or negative ATD y-axis direction. The modules must be installed such that the moving end of the rib module is toward the front of the aircraft. The three abdominal-force sensors must be installed such that they are on the side of the ATD toward the front of the aircraft.

    2. The combined horizontal/vertical test, required by § 25.562(b)(1) and these special conditions, must be conducted with a Hybrid II ATD (49 CFR part 572, subpart B, as specified in § 25.562), or equivalent, occupying each seat position.

    3. Restraint systems:

    a. If inflatable restraint systems are used, they must be active during all dynamic tests conducted to show compliance with § 25.562.

    b. The design and installation of seat-belt buckles must prevent unbuckling due to applied inertial forces or impact of the hands/arms of the occupant during an emergency landing.

    4. Additional performance measures applicable to tests and rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

    a. Body-to-body contact: Contact between the head, pelvis, torso, or shoulder area of one ATD with the adjacent-seated ATD's head, pelvis, torso, or shoulder area is not allowed. Contact during rebound is allowed.

    b. Thoracic: The deflection of any of the ES-2re ATD upper, middle, and lower ribs must not exceed 1.73 inches (44 mm). Data must be processed as defined in Federal Motor Vehicle Safety Standards (FMVSS) 571.214.

    c. Abdominal: The sum of the measured ES-2re ATD front, middle, and rear abdominal forces must not exceed 562 lbs (2,500 N). Data must be processed as defined in FMVSS 571.214.

    d. Pelvic: The pubic symphysis force measured by the ES-2re ATD must not exceed 1,350 lbs (6,000 N). Data must be processed as defined in FMVSS 571.214.

    e. Leg: Axial rotation of the upper-leg (femur) must be limited to 35 degrees in either direction from the nominal seated position.

    f. Neck: As measured by the ES-2re ATD and filtered at CFC 600 as defined in SAE J211:

    i. The upper-neck tension force at the occipital condyle (O.C.) location must be less than 405 lb (1,800 N).

    ii. The upper-neck compression force at the O.C. location must be less than 405 lb (1,800 N).

    iii. The upper-neck bending torque about the ATD x-axis at the O.C. location must be less than 1,018 in-lb (115 Nm).

    iv. The upper-neck resultant shear force at the O.C. location must be less than 186 lb (825 N).

    g. Occupant (ES-2re ATD) retention: The pelvic restraint must remain on the ES-2re ATD's pelvis during the impact and rebound phases of the test. The upper-torso restraint straps (if present) must remain on the ATD's shoulder during the impact.

    h. Occupant (ES-2re ATD) support:

    i. Pelvis excursion: The load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of its seat's bottom seat-cushion supporting structure.

    ii. Upper-torso support: The lateral flexion of the ATD torso must not exceed 40 degrees from the normal upright position during the impact.

    5. For seats with an airbag system in the shoulder belts, show that the airbag system in the shoulder belt will deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th percentile male. The airbag system in the shoulder belt must provide a consistent approach to energy absorption throughout that range of occupants. When the seat system includes an airbag system, that system must be included in each of the certification tests as it would be installed in the airplane. In addition, the following situations must be considered:

    a. The seat occupant is holding an infant.

    b. The seat occupant is a pregnant woman.

    6. The airbag system in the shoulder belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the shoulder belt.

    7. The design must prevent the airbag system in the shoulder belt from being either incorrectly buckled or incorrectly installed, such that the airbag system in the shoulder belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required injury protection.

    8. It must be shown that the airbag system in the shoulder belt is not susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.

    9. Deployment of the airbag system in the shoulder belt must not introduce injury mechanisms to the seated occupant, or result in injuries that could impede rapid egress. This assessment should include an occupant whose belt is loosely fastened.

    10. It must be shown that inadvertent deployment of the airbag system in the shoulder belt, during the most critical part of the flight, will either meet the requirement of § 25.1309(b) or not cause a hazard to the airplane or its occupants.

    11. It must be shown that the airbag system in the shoulder belt will not impede rapid egress of occupants 10 seconds after airbag deployment.

    12. The airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection.

    13. The airbag system in the shoulder belt must function properly after loss of normal aircraft electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the airbag system in the shoulder belt does not have to be considered.

    14. It must be shown that the airbag system in the shoulder belt will not release hazardous quantities of gas or particulate matter into the cabin.

    15. The airbag system in the shoulder-belt installation must be protected from the effects of fire such that no hazard to occupants will result.

    16. A means must be available for a crewmember to verify the integrity of the airbag system in the shoulder-belt activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals. The FAA considers that the loss of the airbag-system deployment function alone (i.e., independent of the conditional event that requires airbag deployment) is a major-failure condition.

    17. The inflatable material may not have an average burn rate of greater than 2.5 inches/minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).

    18. The airbag system in the shoulder belt, once deployed, must not adversely affect the emergency-lighting system (i.e., block floor proximity lights to the extent that the lights no longer meet their intended function).

    Issued in Des Moines, Washington, on October 10, 2018. Victor Wicklund, Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-22929 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0834; Product Identifier 2018-SW-058-AD; Amendment 39-19421; AD 2018-16-51] RIN 2120-AA64 Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters AGENCY:

    Federal Aviation Administration (FAA), Department of Transportation (DOT).

    ACTION:

    Final rule; request for comments.

    SUMMARY:

    We are publishing a new airworthiness directive (AD) for Bell Helicopter Textron Canada Limited (Bell) Model 429 helicopters. This AD was sent previously to all known U.S. owners and operators of these helicopters as Emergency AD 2018-16-51, dated July 26, 2018, which superseded Emergency AD 2018-15-51, dated July 20, 2018. This AD requires inspecting the tail rotor (T/R) gearbox installation, inspecting the T/R gearbox retaining hardware and support attachment point areas, and replacing each nut. This AD is prompted by two reports of T/R gearbox assemblies loosely attached to the gearbox support. The actions of this AD are intended to address an unsafe condition on these products.

    DATES:

    This AD becomes effective November 6, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-16-51, issued on July 26, 2018, which contains the requirements of this AD.

    We must receive comments on this AD by December 21, 2018.

    ADDRESSES:

    You may send comments by any of the following methods:

    Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your comments electronically.

    Fax: 202-493-2251.

    Mail: Send comments to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.

    Hand Delivery: Deliver to the “Mail” address between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    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-2018-0834; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the Transport Canada AD, the economic evaluation, any comments received, and other information. The street address for Docket Operations (telephone 800- 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    For service information identified in this final rule, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at http://www.bellcustomer.com/files/. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

    FOR FURTHER INFORMATION CONTACT:

    Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

    Discussion

    Transport Canada, which is the aviation authority for Canada, issued Emergency AD No. CF-2018-18, dated July 11, 2018, to correct an unsafe condition for Bell Model 429 helicopters. Transport Canada advises of two reports of T/R gearbox assemblies loosely attached to the gearbox support. According to Transport Canada, this condition could lead to structural damage and possible loss of control of the helicopter.

    As a result, on July 20, 2018, we issued Emergency AD 2018-15-51 (Emergency AD 2018-15-51), which required inspecting the T/R gearbox installation for looseness, visually inspecting the T/R gearbox retaining hardware and support attachment point areas, and torque inspecting the gearbox retaining nuts. Depending on the inspection results, Emergency AD 2018-15-51 required replacing or repairing the affected parts in accordance with FAA-approved procedures. Emergency AD 2018-15-51 was sent previously to all known U.S. owners and operators of these helicopters. The actions in Emergency AD 2018-15-51 were intended to prevent detachment of the T/R gearbox, loss of T/R control, and loss of control of the helicopter.

    After we issued Emergency AD 2018-15-51, we discovered an error in the replacement nut P/N. The required replacement nut P/N is NAS9926-6L; not NAS9926-5L as incorrectly stated in Emergency AD 2018-15-51. Therefore, on July 26, 2018, we issued Emergency AD 2018-16-51 to supersede Emergency AD 2018-15-51 to correct the nut P/N. Emergency AD 2018-16-51 otherwise retains all of the requirements of Emergency AD 2018-15-51. Emergency AD 2018-16-51 was also sent previously to all known U.S. owners and operators of these helicopters.

    FAA's Determination

    These helicopters have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to our bilateral agreement with Canada, Transport Canada, its technical representative, has notified us of the unsafe condition described in the Transport Canada AD. We are issuing this AD because we evaluated all information provided by Transport Canada and determined the unsafe condition exists and is likely to exist or develop on other helicopters of the same type design.

    Related Service Information

    We reviewed Bell Alert Service Bulletin 429-18-40, dated July 6, 2018, which specifies a one-time inspection of the T/R gearbox installation and a one-time visual and torque inspection of the six installation attachment points. This service information also specifies contacting Bell Product Support Engineering with the results of the T/R gearbox installation inspection, any findings of the visual inspection, and the results of the torque inspection.

    AD Requirements

    This AD requires inspecting the T/R gearbox installation for looseness, visually inspecting the T/R gearbox retaining hardware and each support attachment point area, and torque inspecting each gearbox retaining nut. Depending on the inspection results, this AD requires replacing or repairing the affected parts in accordance with FAA-approved procedures.

    Differences Between This AD and the Transport Canada AD

    The Transport Canada AD applies to helicopters with specific serial numbers, whereas this AD applies to all Model 429 helicopters. The Transport Canada AD includes a calendar based compliance time, whereas this AD does not. The Transport Canada AD requires reporting certain information to Bell Product Support Engineering and this AD does not. If there is looseness, this AD requires performing the visual inspection and torque inspection before further flight, while the Transport Canada AD requires contacting Bell. Lastly, if the torque of a T/R gearbox retaining nut is below 160 in-lbs (19 Nm), this AD requires removing the T/R gearbox and inspecting the mounting surfaces and retaining hardware, while the Transport Canada AD requires contacting Bell.

    Interim Action

    We consider this AD to be an interim action. If final action is later identified, we might consider further rulemaking then.

    Costs of Compliance

    We estimate that this AD affects 90 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85.00 per work-hour.

    Inspecting the T/R gearbox installation takes about 0.25 work-hour for an estimated cost of $21 per helicopter and $1,890 for the U.S. fleet. Inspecting the T/R gearbox retaining hardware and the support attachment points takes about 0.5 work-hour for an estimated cost of $43 per helicopter and $3,870 for the U.S. fleet. Replacing the nuts takes about 1 work-hour and parts cost about $20 for an estimated cost of $105 per helicopter and $9,450 for the U.S. fleet.

    FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that required the immediate adoption of Emergency AD 2018-16-51, issued on July 26, 2018, to all known U.S. owners and operators of these helicopters. The FAA found that the risk to the flying public justified waiving notice and comment prior to adoption of this rule because there are required actions that must be completed before further flight and within 5 hours time-in-service. These conditions still exist and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, we find that good cause exists for making this amendment effective in less than 30 days.

    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, I certify that this AD:

    1. Is not a “significant regulatory action” under Executive Order 12866;

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

    3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

    We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-16-51 Bell Helicopter Textron Canada Limited: Amendment 39-19421; Docket No. FAA-2018-0834; Product Identifier 2018-SW-058-AD. (a) Applicability

    This AD applies to Model 429 helicopters, certificated in any category.

    (b) Unsafe Condition

    This AD defines the unsafe condition as a loose tail rotor (T/R) gearbox support attachment point. This condition could result in detachment of the T/R gearbox, loss of T/R control, and loss of control of the helicopter.

    (c) Related ADs

    This AD requires the same actions as Emergency AD 2018-16-51, dated July 26, 2018, which superseded Emergency AD 2018-15-51, dated July 20, 2018.

    (d) Effective Date

    This AD becomes effective November 6, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-16-51, issued on July 26, 2018, which contains the requirements of this AD.

    (e) Compliance

    You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

    (f) Required Actions

    (1) Before further flight, inspect for looseness of the T/R gearbox installation to the T/R gearbox structural support by moving the T/R gearbox output shaft in an upward and downward direction. If the T/R gearbox installation is loose, before further flight, complete the actions required by paragraphs (f)(2)(i) and (ii) of this AD.

    (2) Within 5 hours time-in-service, unless already completed as required by paragraph (f)(1) of this AD:

    (i) Visually inspect the T/R gearbox retaining hardware and each support attachment point area for evidence of fretting, a crack, and incorrect installation. If there is any evidence of fretting, a crack, or incorrect installation, before further flight, repair in accordance with FAA-approved procedures.

    (ii) Inspect each T/R gearbox retaining nut by applying 160 in-lbs (19 Nm) of torque. If the torque of a T/R gearbox retaining nut is below 160 in-lbs (19 Nm), before further flight:

    (A) Remove the T/R gearbox and inspect each stud for proper staking, each stud thread for uniformity, each mounting surface for evidence of fretting and cracking, and each mounting hole for elongation. If a stud is not properly staked, a stud thread is not uniform, a mounting surface has evidence of fretting or cracking, or a mount hole is elongated, before further flight, replace the affected parts or repair in accordance with FAA-approved procedures.

    (B) Replace each nut with nut part number NAS9926-6L and apply a torque of 160 in-lbs.

    (g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

    (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.

    (h) Additional Information

    (1) Bell Alert Service Bulletin 429-18-40, dated July 6, 2018, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at http://www.bellcustomer.com/files/. You may review a copy of the service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

    (2) The subject of this AD is addressed in Transport Canada AD No. CF-2018-18, dated July 11, 2018. You may view the Transport Canada AD on the internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2018-0834.

    (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor Gearbox.

    Issued in Fort Worth, Texas, on October 5, 2018. Lance T. Gant, Director, Compliance & Airworthiness Division, Aircraft Certification Service.
    [FR Doc. 2018-22414 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 31216; Amdt. No. 3820] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

    DATES:

    This rule is effective October 22, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.

    The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of October 22, 2018.

    ADDRESSES:

    Availability of matter incorporated by reference in the amendment is as follows:

    For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC, 20590-0001;

    2. The FAA Air Traffic Organization Service Area in which the affected airport is located;

    3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,

    4. 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/code_of_federal_regulations/ibr_locations.html.

    Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.

    FOR FURTHER INFORMATION CONTACT:

    Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420)Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK. 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK. 73125) telephone: (405) 954-4164.

    SUPPLEMENTARY INFORMATION:

    This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

    This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

    Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as listed in the ADDRESSES section.

    The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

    The Rule

    This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

    The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

    Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979) ; and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR part 97

    Air traffic control, Airports, Incorporation by reference, Navigation (air).

    Issued in Washington, DC on September 21, 2018. Rick Domingo, Executive Director, Flight Standards Service. Adoption Of The Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

    PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

    2. Part 97 is amended to read as follows:

    By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:

    * * * Effective Upon Publication AIRAC date State City Airport FDC No. FDC date Subject 8-Nov-18 MS Columbus Columbus-Lowndes County 8/0472 9/11/18 RNAV (GPS) Rwy 36, Amdt 1. 8-Nov-18 IL Flora Flora Muni 8/0929 9/11/18 LOC/DME Rwy 21, Orig-C. 8-Nov-18 IL Flora Flora Muni 8/0933 9/11/18 RNAV (GPS) Rwy 21, Amdt 2B. 8-Nov-18 IL Flora Flora Muni 8/0934 9/11/18 RNAV (GPS) Rwy 3, Amdt 2A. 8-Nov-18 TX Pearsall McKinley Field 8/1500 9/11/18 VOR/DME OR GPS-A, Amdt 2A. 8-Nov-18 TX Dallas Dallas Executive 8/1501 9/11/18 RNAV (GPS) Rwy 17, Orig. 8-Nov-18 NY Glens Falls Floyd Bennett Memorial 8/1703 9/13/18 RNAV (GPS) Rwy 19, Amdt 1B. 8-Nov-18 VA Charlottesville Charlottesville-Albemarle 8/1832 9/11/18 ILS OR LOC Rwy 3, Amdt 1. 8-Nov-18 WY Afton Afton Muni 8/2294 9/13/18 RNAV (GPS) Rwy 16, Amdt 2A. 8-Nov-18 OH Middletown Middletown Regional/Hook Field 8/2374 9/10/18 RNAV (GPS) Rwy 5, Orig-B. 8-Nov-18 OH Middletown Middletown Regional/Hook Field 8/2380 9/10/18 LOC Rwy 23, Amdt 7H. 8-Nov-18 NY Massena Massena Intl-Richards Field 8/2410 9/12/18 ILS OR LOC Rwy 5, Amdt 3A. 8-Nov-18 SD Sioux Falls Joe Foss Field 8/2495 9/11/18 RNAV (GPS) Rwy 27, Orig-D. 8-Nov-18 SD Sioux Falls Joe Foss Field 8/2497 9/11/18 RNAV (GPS) Rwy 9, Orig-D. 8-Nov-18 SD Sioux Falls Joe Foss Field 8/2498 9/11/18 RNAV (GPS) Rwy 3, Amdt 1B. 8-Nov-18 SD Sioux Falls Joe Foss Field 8/2499 9/11/18 VOR OR TACAN Rwy 15, Amdt 21D. 8-Nov-18 SD Sioux Falls Joe Foss Field 8/2500 9/11/18 VOR/DME OR TACAN Rwy 33, Amdt 12D. 8-Nov-18 FL Fort Myers Page Field 8/2504 9/12/18 ILS OR LOC Rwy 5, Amdt 7B. 8-Nov-18 FL Fort Myers Page Field 8/2506 9/12/18 RNAV (GPS) Rwy 5, Orig-B. 8-Nov-18 FL Fort Myers Page Field 8/2507 9/12/18 RNAV (GPS) Rwy 13, Amdt 1D. 8-Nov-18 FL Fort Myers Page Field 8/2508 9/12/18 RNAV (GPS) Rwy 23, Orig-B. 8-Nov-18 FL Fort Myers Page Field 8/2511 9/12/18 VOR Rwy 13, Orig-E. 8-Nov-18 GA Greensboro Greene County Rgnl 8/2542 9/10/18 LOC Rwy 25, Amdt 3D. 8-Nov-18 GA Atlanta Fulton County Airport-Brown Field 8/2669 9/10/18 ILS OR LOC Rwy 8, Amdt 17A. 8-Nov-18 GA Atlanta Fulton County Airport-Brown Field 8/2679 9/10/18 RNAV (GPS) Rwy 26, Amdt 1B. 8-Nov-18 GA Atlanta Fulton County Airport-Brown Field 8/2681 9/10/18 RNAV (GPS) Y Rwy 8, Amdt 1A. 8-Nov-18 GA Atlanta Fulton County Airport-Brown Field 8/2682 9/10/18 VOR-A, Amdt 1B. 8-Nov-18 TN Knoxville McGhee Tyson 8/2879 9/13/18 RADAR 1, Amdt 22. 8-Nov-18 VA Emporia Emporia-Greensville Rgnl 8/3212 9/11/18 RNAV (GPS) Rwy 16, Amdt 2A. 8-Nov-18 ME Belfast Belfast Muni 8/3307 9/13/18 RNAV (GPS) Rwy 33, Amdt 1. 8-Nov-18 FL Fort Myers Page Field 8/3326 9/12/18 RNAV (GPS) Rwy 31, Orig-C. 8-Nov-18 IN New Castle New Castle-Henry Co Muni 8/3484 9/12/18 NDB Rwy 10, Orig. 8-Nov-18 TX Crosbyton Crosbyton Muni 8/3665 9/11/18 RNAV (GPS) Rwy 17, Orig-A. 8-Nov-18 CT Bridgeport Igor I Sikorsky Memorial 8/3818 9/11/18 RNAV (GPS) Rwy 29, Amdt 1A. 8-Nov-18 CT Bridgeport Igor I Sikorsky Memorial 8/3821 9/11/18 RNAV (GPS) Rwy 6, Amdt 1. 8-Nov-18 CT Bridgeport Igor I Sikorsky Memorial 8/3825 9/11/18 RNAV (GPS) Rwy 24, Amdt 1. 8-Nov-18 CT Bridgeport Igor I Sikorsky Memorial 8/3826 9/11/18 VOR Rwy 24, Amdt 17. 8-Nov-18 CT Bridgeport Igor I Sikorsky Memorial 8/3828 9/11/18 ILS OR LOC Rwy 6, Amdt 10. 8-Nov-18 WI New Richmond New Richmond Rgnl 8/4055 9/13/18 RNAV (GPS) Rwy 32, Amdt 2B. 8-Nov-18 AR Little Rock Bill and Hillary Clinton National/Adams Field 8/4149 9/13/18 ILS OR LOC Rwy 22R, ILS Rwy 22R (SA CAT I), ILS Rwy 22R (CAT II-III), Amdt 3. 8-Nov-18 AK Noorvik Robert/Bob/Curtis Memorial 8/4205 9/10/18 RNAV (GPS) Rwy 6, Orig. 8-Nov-18 AK Noorvik Robert/Bob/Curtis Memorial 8/4206 9/10/18 RNAV (GPS) Rwy 24, Orig. 8-Nov-18 MN Little Falls Little Falls/Morrison County-Lindbergh Fld 8/4718 9/13/18 NDB Rwy 31, Amdt 6C. 8-Nov-18 MN Little Falls Little Falls/Morrison County-Lindbergh Fld 8/4720 9/13/18 RNAV (GPS) Rwy 31, Orig-A. 8-Nov-18 CO Del Norte Astronaut Kent Rominger 8/4915 9/13/18 RNAV (GPS) Rwy 24, Orig. 8-Nov-18 TX New Braunfels New Braunfels Rgnl 8/5257 9/11/18 RNAV (GPS) Rwy 35, Amdt 2. 8-Nov-18 TX New Braunfels New Braunfels Rgnl 8/5261 9/11/18 RNAV (GPS) Rwy 17, Orig. 8-Nov-18 TX New Braunfels New Braunfels Rgnl 8/5263 9/11/18 RNAV (GPS) Rwy 13, Amdt 1. 8-Nov-18 VA Charlottesville Charlottesville-Albemarle 8/5662 9/11/18 RNAV (GPS) Y Rwy 21, Amdt 2A. 8-Nov-18 TX Kountze/Silsbee Hawthorne Field 8/5684 9/11/18 NDB Rwy 13, Amdt 3. 8-Nov-18 DC Washington Ronald Reagan Washington National 8/5696 9/11/18 RNAV (GPS) Rwy 15, Orig-A. 8-Nov-18 AK South Naknek South Naknek NR 2 8/5893 9/13/18 RNAV (GPS) Rwy 31, Orig. 8-Nov-18 AK South Naknek South Naknek NR 2 8/5902 9/13/18 RNAV (GPS) Rwy 13, Orig. 8-Nov-18 NC Hickory Hickory Rgnl 8/6760 9/13/18 RNAV (GPS) Rwy 24, Amdt 1A. 8-Nov-18 NC Hickory Hickory Rgnl 8/6761 9/13/18 RNAV (GPS) Rwy 19, Amdt 1. 8-Nov-18 NC Hickory Hickory Rgnl 8/6762 9/13/18 ILS OR LOC Rwy 24, Amdt 8A. 8-Nov-18 OK Chandler Chandler Rgnl 8/6841 9/11/18 RNAV (GPS) Rwy 35, Orig. 8-Nov-18 MD Frederick Frederick Muni 8/6887 9/10/18 RNAV (GPS) Rwy 5, Orig-C. 8-Nov-18 MD Frederick Frederick Muni 8/6888 9/10/18 RNAV (GPS) Z Rwy 23, Orig-E. 8-Nov-18 MD Frederick Frederick Muni 8/6893 9/10/18 RNAV (GPS) Y Rwy 23, Amdt 1C. 8-Nov-18 OK Chandler Chandler Rgnl 8/7279 9/11/18 Takeoff Minimums and Obstacle DP, Amdt 1. 8-Nov-18 SC Summerville Summerville 8/7291 9/13/18 RNAV (GPS) Rwy 24, Orig-B. 8-Nov-18 SC Summerville Summerville 8/7292 9/13/18 NDB Rwy 6, Amdt 1A. 8-Nov-18 TX New Braunfels New Braunfels Rgnl 8/7527 9/11/18 VOR/DME-A, Orig. 8-Nov-18 NE Broken Bow Broken Bow Muni/Keith Glaze Fld 8/8087 9/10/18 RNAV (GPS) Rwy 14, Orig-A. 8-Nov-18 NE Broken Bow Broken Bow Muni/Keith Glaze Fld 8/8089 9/10/18 RNAV (GPS) Rwy 32, Amdt 1A. 8-Nov-18 NE Broken Bow Broken Bow Muni/Keith Glaze Fld 8/8090 9/10/18 VOR Rwy 14, Amdt 4C. 8-Nov-18 NE Broken Bow Broken Bow Muni/Keith Glaze Fld 8/8093 9/10/18 VOR/DME Rwy 32, Orig-C. 8-Nov-18 VT Burlington Burlington Intl 8/8214 9/12/18 ILS OR LOC/DME Rwy 15, Amdt 24A. 8-Nov-18 MN Hibbing Range Rgnl 8/8419 9/13/18 RNAV (GPS) Rwy 4, Orig. 8-Nov-18 OR Astoria Astoria Rgnl 8/8578 9/10/18 RNAV (GPS) Rwy 8, Amdt 1. 8-Nov-18 OR Astoria Astoria Rgnl 8/8590 9/10/18 RNAV (GPS) Rwy 26, Amdt 1. 8-Nov-18 NY New York John F Kennedy Intl 8/8694 9/13/18 ILS OR LOC Rwy 4L, Amdt 11B. 8-Nov-18 IA Jefferson Jefferson Muni 8/8986 9/10/18 RNAV (GPS) Rwy 14, Orig. 8-Nov-18 IA Jefferson Jefferson Muni 8/8988 9/10/18 RNAV (GPS) Rwy 32, Orig. 8-Nov-18 IA Jefferson Jefferson Muni 8/8990 9/10/18 NDB Rwy 32, Amdt 6. 8-Nov-18 OR Medford Rogue Valley Intl—Medford 8/9687 9/10/18 RNAV (GPS)-D, Amdt 1. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9712 9/10/18 LOC Rwy 4R, Amdt 1B. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9718 9/10/18 LOC Rwy 8L, Amdt 1. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9719 9/10/18 LDA Rwy 26L, Amdt 5B. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9720 9/10/18 RNAV (GPS) Rwy 4L, Orig-A. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9721 9/10/18 RNAV (GPS) Rwy 8R, Orig-A. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9726 9/10/18 RNAV (GPS) Y Rwy 4R, Amdt 2B. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9728 9/10/18 RNAV (GPS) Y Rwy 8L, Amdt 2. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9729 9/10/18 VOR OR TACAN Rwy 4R, Orig-C. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9730 9/10/18 VOR OR TACAN-A, Amdt 1B. 8-Nov-18 HI Honolulu Daniel K Inouye Intl 8/9736 9/10/18 VOR OR TACAN-B, Amdt 2B.
    [FR Doc. 2018-22270 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 31215; Amdt. No. 3819] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

    DATES:

    This rule is effective October 22, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.

    The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of October 22, 2018.

    ADDRESSES:

    Availability of matters incorporated by reference in the amendment is as follows:

    For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.

    2. The FAA Air Traffic Organization Service Area in which the affected airport is located;

    3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,

    4. 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/code_of_federal_regulations/ibr_locations.html.

    Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.

    FOR FURTHER INFORMATION CONTACT:

    Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK. 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.

    SUPPLEMENTARY INFORMATION:

    This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

    The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

    Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as listed in the ADDRESSES section.

    The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

    The Rule

    This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

    The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

    Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C 553(d), good cause exists for making some SIAPs effective in less than 30 days.

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979) ; and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR part 97

    Air traffic control, Airports, Incorporation by reference, Navigation (air).

    Issued in Washington, DC on September 21, 2018. Rick Domingo, Executive Director, Flight Standards Service. Adoption Of The Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

    PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

    2. Part 97 is amended to read as follows: Effective 8 November 2018 Fairbanks, AK, Fairbanks Intl, RNAV (GPS) RWY 2R, Amdt 1A Fairbanks, AK, Fairbanks Intl, RNAV (GPS) RWY 20L, Amdt 1A Fairbanks, AK, Fairbanks Intl, RNAV (GPS) Y RWY 2L, Amdt 1B Fairbanks, AK, Fairbanks Intl, RNAV (GPS) Y RWY 20R, Amdt 1C Tanana, AK, Ralph M Calhoun Memorial, Takeoff Minimums and Obstacle DP, Amdt 1A Wales, AK, Wales, RNAV (GPS) RWY 18, Amdt 1 Wales, AK, Wales, RNAV (GPS) RWY 36, Amdt 1 Wales, AK, Wales, Takeoff Minimums and Obstacle DP, Amdt 1 Bentonville, AR, Bentonville Muni/Louise M Thaden Field, Takeoff Minimums and Obstacle DP, Amdt 2 Pueblo, CO, Pueblo Memorial, ILS OR LOC RWY 8R, Amdt 1A Melbourne, FL, Melbourne Intl, VOR RWY 27L, Orig Pensacola, FL, Pensacola Intl, ILS OR LOC RWY 17, Amdt 14C Pensacola, FL, Pensacola Intl, LOC RWY 26, Amdt 1B Pensacola, FL, Pensacola Intl, NDB RWY 35, Orig Pensacola, FL, Pensacola Intl, RNAV (GPS) RWY 8, Amdt 2D Pensacola, FL, Pensacola Intl, RNAV (GPS) RWY 17, Amdt 2E Pensacola, FL, Pensacola Intl, RNAV (GPS) RWY 26, Amdt 2D Pensacola, FL, Pensacola Intl, RNAV (GPS) RWY 35, Amdt 2D St Petersburg, FL, Albert Whitted, RNAV (GPS) RWY 36, Amdt 1A St Petersburg, FL, Albert Whitted, VOR RWY 18, Amdt 9C Atlanta, GA, Atlanta Rgnl Falcon Field, RNAV (GPS) RWY 13, Amdt 3 Atlanta, GA, Atlanta Rgnl Falcon Field, RNAV (GPS) RWY 31, Amdt 3 Savannah, GA, Savannah/Hilton Head Intl, ILS OR LOC RWY 1, Amdt 8B Savannah, GA, Savannah/Hilton Head Intl, ILS OR LOC RWY 10, ILS RWY 10 SA CAT I, ILS RWY 10 SA CAT II, Amdt 29 Fairfield, IL, Fairfield Muni, RNAV (GPS) RWY 9, Amdt 1 Monticello, IL, Piatt County, Takeoff Minimums and Obstacle DP, Orig, CANCELED Monticello, IL, Piatt County, VOR OR GPS-A, Amdt 1A, CANCELED South Bend, IN, South Bend Intl, RNAV (GPS) RWY 9R, Amdt 1 Terre Haute, IN, Sky King, RNAV (GPS)-A, Amdt 1 Terre Haute, IN, Sky King, Takeoff Minimums and Obstacle DP, Amdt 5 Terre Haute, IN, Sky King, VOR-A, Amdt 7 Lawrence, MA, Lawrence Muni, VOR RWY 23, Amdt 12A Waterville, ME, Waterville Robert Lafleur, Takeoff Minimums and Obstacle DP, Amdt 1 Berrien Springs, MI, Andrews University Airpark, Takeoff Minimums and Obstacle DP, Amdt 1 Madison, MN, Lac Qui Parle County, NDB RWY 32, Amdt 4B, CANCELED Wheaton, MN, Wheaton Muni, Takeoff Minimums and Obstacle DP, Amdt 2 Sikeston, MO, Sikeston Memorial Muni, Takeoff Minimums and Obstacle DP, Amdt 1A Corinth, MS, Roscoe Turner, ILS OR LOC RWY 18, Amdt 3A Vicksburg, MS, Vicksburg Muni, Takeoff Minimums and Obstacle DP, Amdt 3 Kenansville, NC, Duplin Co, RNAV (GPS) RWY 5, Amdt 1 Kenansville, NC, Duplin Co, RNAV (GPS) RWY 23, Amdt 1 Kenansville, NC, Duplin Co, Takeoff Minimums and Obstacle DP, Amdt 1 Bismarck, ND, Bismarck Muni, ILS OR LOC RWY 13, Amdt 4 Bismarck, ND, Bismarck Muni, RNAV (GPS) RWY 21, Amdt 2 Alliance, NE, Alliance Muni, ILS OR LOC RWY 30, Orig-A Alliance, NE, Alliance Muni, RNAV (GPS) RWY 8, Orig-A Alliance, NE, Alliance Muni, RNAV (GPS) RWY 12, Orig-A Alliance, NE, Alliance Muni, RNAV (GPS) RWY 26, Orig-A Alliance, NE, Alliance Muni, RNAV (GPS) RWY 30, Amdt 1A Alliance, NE, Alliance Muni, VOR RWY 12, Amdt 3B Alliance, NE, Alliance Muni, VOR RWY 30, Amdt 3A Neligh, NE, Antelope County, Takeoff Minimums and Obstacle DP, Amdt 1 O'Neill, NE, The O'Neill Muni-John L Baker Field, Takeoff Minimums and Obstacle DP, Amdt 1 Caldwell, NJ, Essex County, RNAV (GPS) RWY 4, Orig-C Caldwell, NJ, Essex County, RNAV (GPS) RWY 10, Amdt 1 Caldwell, NJ, Essex County, Takeoff Minimums and Obstacle DP, Amdt 2A Mount Holly, NJ, South Jersey Rgnl, RNAV (GPS) RWY 26, Amdt 1C Newark, NJ, Newark Liberty Intl, GLS RWY 4L, Amdt 1A Newark, NJ, Newark Liberty Intl, GLS RWY 4R, Amdt 1A Newark, NJ, Newark Liberty Intl, GLS RWY 22R, Amdt 1A Newark, NJ, Newark Liberty Intl, VOR RWY 11, Amdt 2F New York, NY, John F Kennedy Intl, ILS OR LOC RWY 13L, ILS RWY 13L CAT II, Amdt 18B Skaneateles, NY, Skaneateles Aero Drome, Takeoff Minimums and Obstacle DP, Amdt 1 Freeport, PA, McVille, RNAV (GPS) RWY 14, Orig Freeport, PA, McVille, RNAV (GPS) RWY 32, Orig Freeport, PA, McVille, Takeoff Minimums and Obstacle DP, Orig Pageland, SC, Pageland, NDB RWY 24, Amdt 1, CANCELED Belle Fourche, SD, Belle Fourche Muni, RNAV (GPS) RWY 32, Amdt 2 Mitchell, SD, Mitchell Muni, ILS OR LOC RWY 31, Orig-C Spearfish, SD, Black Hills-Clyde Ice Field, Takeoff Minimums and Obstacle DP, Amdt 2 Jacksboro, TN, Colonel Tommy C Stiner Airfield, RNAV (GPS) RWY 23, Amdt 1C Jacksboro, TN, Colonel Tommy C Stiner Airfield, Takeoff Minimums and Obstacle DP, Amdt 2A Fort Worth, TX, Fort Worth Meacham Intl, Takeoff Minimums and Obstacle DP, Amdt 8 Killeen, TX, Skylark Field, VOR-A, Amdt 4A Washington Island, WI, Washington Island, COPTER RNAV (GPS) 029, Orig Washington Island, WI, Washington Island, Takeoff Minimums and Obstacle DP, Orig RESCINDED: On September 11, 2018 (83 FR 45822), the FAA published an Amendment in Docket No. 31211, Amdt No. 3815, to Part 97 of the Federal Aviation Regulations under section 97.25, 97.33, and 97.37. The following entries for Bay Minette, AL, Oneonta, AL, and for Minocqua-Woodruff, WI, effective November 8, 2018, are hereby rescinded in their entirety: Bay Minette, AL, Bay Minette Muni, RNAV (GPS) RWY 8, Amdt 1B Oneonta, AL, Robbins Field, RNAV (GPS) RWY 6, Orig-C Oneonta, AL, Robbins Field, RNAV (GPS) RWY 24, Orig-A Oneonta, AL, Robbins Field, Takeoff Minimums and Obstacle DP, Orig-B Minocqua-Woodruff, WI, Lakeland/Noble F. Lee Memorial Field, LOC RWY 36, Amdt 1A, CANCELED
    [FR Doc. 2018-22274 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900-AP43 Presumption of Herbicide Exposure and Presumption of Disability During Service for Reservists Presumed Exposed to Herbicides AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) is adopting as final an interim final rule published on June 19, 2015, to amend its adjudication regulation governing individuals presumed to have been exposed to certain herbicides. Specifically, VA expanded the regulation to include an additional group consisting of individuals who performed service in the Air Force or Air Force Reserve under circumstances in which they had regular and repeated contact with C-123 aircraft known to have been used to spray an herbicide agent (“Agent Orange”) during the Vietnam era. In addition, the regulation established a presumption that members of this group who later develop an Agent Orange presumptive condition were disabled during the relevant period of service, thus establishing that service as “active military, naval, or air service.” The effect of this action is to presume herbicide exposure for these individuals and to create a presumption that the individuals who are presumed exposed to herbicides during reserve service also meet the statutory definition of “veteran” (hereinafter, “veteran status”) for VA purposes and eligibility for some VA benefits.

    DATES:

    Effective Date: This rule is effective October 22, 2018.

    Applicability Date: This final rule is applicable to any claim for service connection for an Agent Orange presumptive condition filed by a covered individual that was pending on or after June 19, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Li, Chief, Regulations Staff (211D), Compensation Service, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.)

    SUPPLEMENTARY INFORMATION:

    In a document published in the Federal Register on June 19, 2015 (80 FR 35246), VA amended its regulation at 38 CFR 3.307 governing individuals presumed to have been exposed to certain herbicides. VA provided the public 60 days in which to comment on the amendment made by the interim final rule, with the comment period ending August 18, 2015. VA received 46 comments from various organizations and individuals. The issues raised by the commenters that concerned a similar topic have been grouped together and VA's discussion of the comments organized accordingly. For the reasons set forth in the interim final rule and for those reasons discussed below, we are adopting the interim final rule as final without changes.

    The majority of public comments asserted a need for retroactive application of the effective date assigned for the interim final rule. Retroactivity is generally not favored in the law and an agency will not generally be considered to have authority to provide retroactive effect unless an exception to this general rule is provided via an express statutory delegation of authority. See Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988). Further, 38 U.S.C. 5110(g) stipulates that the effective date of an award or increase based on a liberalizing law or VA issue will either be the “effective date of the Act or administrative issue,” or the date entitlement arose, whichever is later. This statute is implemented through regulation (38 CFR 3.114), which generally does not contemplate VA providing benefits effective prior to the effective date of the liberalizing regulation itself.

    Even to the extent VA's rulemaking authority under 38 U.S.C. 501 includes authority to issue retroactive regulations, and assuming such an understanding can be reconciled with section 5110(g), VA declines to do so in this matter. Even if VA's rulemaking authority extends to assigning a retroactive effective date in the abstract, doing so is nevertheless inconsistent with the intent of section 5110(g) and would certainly be inconsistent with VA's usual and longstanding practice to make substantive rules effective prospectively. Maintaining a general policy of applying new regulations prospectively helps ensure that all new liberalizing regulations are applied in a fair and consistent manner. The United States Court of Appeals for the Federal Circuit has reviewed this authority and held that VA did not act unreasonably in using a prospective effective date for a liberalizing regulation rather than a retroactive effective date in circumstance similar to this. McKinney v. McDonald, 796 F.3d 1377, 1384-85 (Fed. Cir. 2015). Additionally, we note that avoiding retroactivity serves the interests of orderly administration and clarity in the law. If new regulations apply only prospectively, then determining what law applied to a past claim as of a given point in time is a matter of looking up the regulation for the applicable year. When new regulations are given retroactive effect, agency personnel must navigate considerably more complexity (e.g., having to consult the law in 2018 in order to figure out what the law was in 1990). Retroactive application of a new regulation also entails significant complexity insofar as adjudicators may have to assess intervening changes to other relevant statutes and regulations and seek to develop evidence, years after the fact, regarding the existence and extent of disability during past periods. This would increase the potential for confusion, inconsistency, and delay in VA claim adjudications, in addition to the disparate treatment that would result from making some presumptions retroactive, but not others. Therefore, although it may be possible for VA to provide retroactive effect in some exceptional circumstance, this would be inappropriate as a routine matter. VA will make the provisions addressed herein effective prospectively from the date of enactment consistent with the approach both VA and Congress generally have followed in establishing liberalizing regulations and statutes benefitting other groups of veterans, and makes no change based on the comments suggesting a retroactive effective date for the amendments to 38 CFR 3.307.

    Multiple sub-categories were present within the broad category of requests for a retroactive effective date. Numerous commenters argued that this regulation is unnecessary as current VA policies and procedures already allow for establishing service-connected disability status based on exposure to residual dioxin aboard C-123 aircraft and the subsequent development of disabilities related thereto. Multiple commenters theorized that the regulation is unnecessary to establish presumption of exposure as an in-service injury during inactive duty training or active duty for training status. The comments referenced an opinion of VA's Office of General Counsel (OGC), VAOPGCPREC 4-2002, as a basis for establishing that the exposure to residual dioxin was an in-service “injury” sufficient to satisfy the criteria for service connection under 38 U.S.C. 101(24). Similarly, other comments received referenced another OGC opinion, VAOPGCPREC 08-2001, as a basis to establish occurrence of an “injury” for the purposes of establishing active service to satisfy section 101(24).

    The two cited opinions and the argument that reservists can meet the statutory definition of “veteran” simply on the basis of injury are all inapposite to this rulemaking. Current law, specifically 38 U.S.C. 101(2), defines “veteran” as “a person who served in the active military, naval, or air service, and who was discharged or released therefrom under conditions other than dishonorable.” Section 101(24) then clarifies that “active military, naval, or air service” includes active duty for training during which an injury or disease is incurred or aggravated in the line of duty, or inactive duty for training during which an injury was incurred or aggravated in the line or duty or during which an acute myocardial infarction, a cardiac arrest, or a cerebrovascular accident occurs. Further, in both scenarios, section 101(24) requires that, “during” the referenced duty period, the putative veteran “was disabled or died” from a covered injury or disease. Thus, two discrete elements are required before VA can conclude that active duty for training (ADT) or inactive duty training (IDT) are considered active service: Injury (or in the case of ADT, disease as well, or in the case of IDT, the events specified in section 101(24)(C)(ii)) incurred or aggravated in the line of duty, and incurrence of disability during such duty period from that same covered injury or disease. Although the commenters are correct in that VA stated in the interim final rule that exposure to Agent Orange constitutes injury for veteran status purposes, insofar as the commenters argue that injury alone is sufficient to establish veteran status they are incorrect. In both ADT and IDT cases, disability must be incurred during the period of service. See section 101(24) (B) and (C). In the absence of incurrence of disability or death during service, veteran status is still not established. The operation of the presumption at issue in this regulation is therefore necessary for the putative veterans in question to achieve service connection on a presumptive basis.

    Both of the OGC opinions cited by commenters addressed whether specific incidents during service were legally sufficient to satisfy the definition of injury in section 101(24). The opinions did not address whether the injuries at issue could or did cause a disability or death during the same period of service, much less create a presumption that the injuries at issue would do so. See VAOPGCPREC 08-2001, 04-2002. Nor did the opinions create a presumption that an entire class of servicemembers was, in fact, exposed to herbicide. Claimants who present evidence of both injury during ADT or IDT service and disability first manifest or aggravated during that same service—the situation addressed in both VAPGCPREC 08-2001 and 04-2002—could be entitled to service connection on a direct basis if the elements for service connection are otherwise established. This rule does not affect that basis of service connection for any individual. Rather, this rule creates presumptions for individuals who performed service in the Air Force or Air Force Reserve under circumstances in which they had regular and repeated contact with C-123 aircraft known to have been used to spray an herbicide agent regarding exposure to herbicides, injury, and onset of diseases specified in 38 CFR 3.309(e). Thus, we disagree that this rule is unnecessary and/or conflicts with VAPGCPREC 08-2001 and 04-2002. No changes are made in response to these comments.

    Multiple comments referenced a March 2013 correspondence from the Joint Services Records Research Center (JSRRC) to VA. JSRRC had cited the findings of a study by the Agency for Toxic Substances and Disease Registry (ATSDR) as relevant documentation establishing exposure to residual dioxin. The commenters requested that this memorandum be utilized as a basis for a retroactive effective date. Similarly, multiple comments referenced the 2015 findings of the Institute of Medicine (IOM) and requested that the date of these findings be utilized as a basis for the effective date of this regulation.

    VA finds no basis to utilize the JSRRC correspondence or the IOM findings to establish an earlier effective date for the regulation. For all regulations in which VA has established a presumption of exposure, there is a body of scientific evidence that must be considered and ultimately informs the decision to establish the presumption of exposure. This body of scientific evidence, by logical necessity, predates the effective date of the regulation. Exposure aboard contaminated C-123 aircraft is no different. As discussed above, to the extent VA has legal authority to establish a retroactive effective date, it is unquestionably the well-established practice of VA and Congress to establish liberalizing regulations and statutes benefitting other groups of veterans with prospective effective dates. Therefore, no change is warranted based on any of these multiple theories asserted in support of assigning a retroactive effective date for this regulation.

    Some comments referenced prior VA decisions to grant service-connected disability benefits based on exposure during inactive or active duty for training status aboard contaminated C-123 aircraft and utilized this as a basis for the argument to assign an earlier effective date for this regulation. Prior decisions granting benefits as described were made on the basis of the facts found in the individual case and the law that existed at the time, and are not a means for assigning an effective date for a regulation. As previously noted, under 38 U.S.C. 5110(g), effective dates “shall be fixed in accordance with the facts found but shall not be earlier than the effective date of the Act or administrative issue.” The prior cases referenced in the comments were all granted on the basis of individual facts found, and as already discussed above, the current regulation establishes entitlement on a presumptive basis. Thus, no change is warranted based on these comments.

    Some commenters objected to the regulation on the basis that the regulation imposes an additional challenge for cases already on appeal as veteran status must now be considered. Determining veteran status is always part of the claims process. Although veteran status may not be directly addressed and discussed in the adjudication of every claim or an appeal, it is one of many determinations that must be made along the path of considering entitlement to any VA benefit, and is frequently at issue in claims arising from periods of active duty for training or inactive duty training. See, e.g., Collaro v. West, 136 F.3d 1304, 1308 (Fed. Cir. 1998) (noting that “status as a veteran” is one of five elements to be resolved in an application for service-connected disability benefits). Thus, no change is made based upon these comments as veteran status is and has been a consideration always inherent in deciding claims for VA benefits.

    An additional category of comments objected to the effective date on the basis that failure to allow for retroactive benefits results in denial of due process for those individuals who had previously submitted claims. For a denial of due process to occur, there must be a property interest, such as entitlement to a benefit, and deprivation of the property interest flowing from the defective process. At the time any claim was received prior to the effective date of this regulation, presumptive entitlement to a benefit did not exist as a matter of law (38 U.S.C. 5110(g) and 38 CFR 3.114). Due process serves to protect property interests that are recognized or created by the law—it does not itself create property interests. Leis v. Flynt, 439 U.S. 438, 441 (1979); Town of Castle Rock v. Gonzalez, 545 U.S. 748, 771 (2005). The requirements of due process therefore cannot serve to create a presumption of entitlement to benefits prior to the time that presumption actually existed. Additionally, the creation of a presumption of exposure to dioxin effective June 19, 2015, does not prevent a claimant from introducing evidence in an earlier claim in order to establish service connection on a facts found basis. As noted earlier, VA granted entitlement to benefits on the basis of individual facts found before enactment of this rule. Consequently, there is no deprivation of due process, and no change is warranted based upon these comments.

    Multiple comments referenced what was viewed as unfavorable treatment of reserve service as compared to individuals who established status as a veteran after other types of service. As described in the explanation of responses to effective date comments, the term “veteran” is defined in existing statutes. This rule serves as a vehicle to help members of the Air Force Reserve establish that their herbicide-related disease was incurred during active service. VA is without authority to ignore the statutory definition of the term “veteran” regardless of whether that term treats reserve service differently than other types of service. Therefore, no change is warranted based on these comments.

    VA received comments requesting action in accordance with the effective date rules governed by the class action case of Nehmer v. United States Department of Veterans Affairs, No. CV-86-6160 TEH (N.D. Cal.). The Nehmer case established herbicide exposure claim procedures for veterans who served in Vietnam. Thus, reservists who served aboard C-123 aircraft outside Vietnam are not Nehmer class members, unless the individual in question separately deployed to Vietnam, in which case they have long been presumed exposed to herbicides without regard to the impact of this regulation. The stipulations that the parties entered into in Nehmer therefore do not apply to this rulemaking. Consequently, no changes are warranted based on these comments.

    VA received four comments in which the commenter objected to concession of exposure based on a lack of and/or faulty scientific evidence confirming actual exposure to residual dioxin. One of these comments also cited a 20-year Air Force Health Study that showed no correlation between exposure in crews participating in Operation Ranch Hand and those disabilities that VA presumes associated with herbicide exposure. VA has based its decision to add presumptions for C-123 veterans on the entire body of relevant evidence, including the findings of the February 24, 2015, IOM report “Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C-123 Aircraft.” The report found evidence of potentially harmful exposure to residual dioxin for those Air Force Reservists who worked aboard contaminated, former Operation Ranch Hand C-123 aircraft. VA considered the comments and evidence cited by the commenters, but determined that they are not sufficient to outweigh the IOM's finding that “[Air Force] Reservists working in [Operation Ranch Hand] C-123s were exposed (in the technical sense of the word of having bodily contact with the chemicals) to the components of Agent Orange to some extent.” Therefore, no change is warranted based on these comments.

    Further, with regard to the comment questioning the validity of the presumptive correlation between exposure to residual dioxin and the subsequent development of diseases, the IOM report clearly states and provides sufficient analysis to confirm that it is plausible that Air Force Reservists “would have experienced some exposure to chemicals from herbicide residue when working inside [Operation Ranch Hand] C-123s.” The IOM committee reported that “[n]o matter what” decontamination methods were used, “TCDD and phenoxy herbicide residues were still detected 30 years later in several of the C-123 aircraft at levels in excess of international guidelines.” TCDD refers to the dioxin, an unintended contaminant in Agent Orange, which was later determined to be a human carcinogen. The IOM was able to find sufficient sampling data to demonstrate that the C-123s experienced long-term contamination with Agent Orange and TCDD. The report further explains that the available data was sufficient to suggest that “the C-123s did contribute to some adverse health consequences among the [Air Force] Reservists who worked in [Operation Ranch Hand] C-123s.” It has been longstanding VA policy to presume service-connection for certain disabilities determined to have been related to exposure to Agent Orange or related herbicides during military service. See 38 CFR 3.309(e), Disease associated with exposure to certain herbicide agents. Consequently, no changes are made with regard to that comment.

    Two comments were received requesting Agent Orange Registry examinations. Entitlement to Agent Orange Registry examinations is not within the scope of this rule making. Agent Orange Registry examinations are made available to individuals who may have been exposed to herbicides during a military operation or as a result of testing, transporting, or spraying herbicides for military purposes. This rulemaking does not impact the availability of Agent Orange Registry examinations. Consequently, no change is made based upon these comments.

    Several comments were received pertaining to exposure aboard C-123 aircraft at specific locations. This regulation does not establish criteria based on specific locations, but rather based on the type of service (Air Force or Air Force Reserve) and circumstances of that service (regular and repeated contact with C-123 aircraft known to have been used to spray Agent Orange during the Vietnam era). Specifically, the amended regulation establishes that VA will presume exposure to herbicides and in-service injury and incurrence of disability for individuals who suffer from specified herbicide-related diseases and “regularly and repeatedly operated, maintained, or served onboard C-123 aircraft known to have been used to spray an herbicide agent during the Vietnam era.” It further clarifies that the individual had to have been assigned to an Air Force or Air Force Reserve squadron that was permanently assigned one of the affected aircraft, and that he/she had an Air Force specialty code indicating duties as a flight, ground maintenance, or medical crew member. VA procedures have been established based upon the interim final rule to set forth this criteria in order to determine whether an individual was exposed based on the circumstances of service. Therefore, no change is warranted in response to these comments.

    One commenter requested that breast cancer be designated as a disability presumptively related to exposure to residual dioxin on C-123 aircraft. This comment is outside the scope of this rulemaking. This rulemaking establishes means for presuming exposure to herbicides and establishing veteran status. The designation of a presumptive relationship between herbicide exposure and the subsequent development of any type of disease, such as breast cancer, is not within the scope of this rulemaking. Consequently, no change is warranted based upon this comment. However, VA will continue to monitor relevant scientific and medical reports for conditions associated with exposure to certain herbicide agents. If, at a later date, there is sufficient evidence to suggest a relationship between exposure and additional disabilities, VA will initiate additional rulemaking as appropriate.

    One comment was received requesting clarification of entitlement to survivor benefits within the rulemaking. Although clarification of entitlement to survivor benefits is not within the scope of this rulemaking in particular, we note that status to claim entitlement to survivor benefits is generally predicated on the basis of the survivor's relationship to a veteran, while the benefits that a survivor may claim can be dependent on the benefits to which that veteran was entitled. Whether a veteran's entitlement to benefits is established based in part on this liberalizing rule would not itself impact a suvivor's ability to claim benefits or the benefits to which the survivor would be entitled. No change is warranted based upon this comment.

    Executive Orders 12866, 13563, and 13771

    Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, 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 set forth in this Executive Order.”

    The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined and it has been determined to be a significant regulatory action under Executive Order 12866, because it rasises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm by following the link for VA Regulations Published from FY 2004 through FYTD. This rule is not subject to the requirements of E.O. 13771 because this rule results in no more than de minimis costs.

    Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This final rule will directly affect only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

    Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

    Paperwork Reduction Act

    This regulatory action contains provisions constituting a collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Specifically, this rule is associated with information collections related to the filing of disability benefits claims, VA Forms 21-526EZ and 21P-534EZ. The information collections are currently approved by the Office of Management and Budget (OMB) and have been assigned OMB control numbers 2900-0747 and 2900-0004. There are no changes to any of these collections and, thus, no incremental costs associated with this rulemaking.

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.

    List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jacquelyn Hayes-Byrd, Acting Chief of Staff, Department of Veterans Affairs, approved this document on June 12, 2018, for publication.

    Dated: October 11, 2018. Jeffrey M. Martin, Assistant Director, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. PART 3—ADJUDICATION Based on the rationale set forth in the interim final rule published in the Federal Register at 80 FR 35246 on June 19, 2015, and in this document, VA is adopting the provisions of the interim final rule amending 38 CFR part 3 as a final rule without change.
    [FR Doc. 2018-22892 Filed 10-19-18; 8:45 am] BILLING CODE 8320-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 61 and 63 [EPA-R06-OAR-2008-0063; FRL-9985-49-Region 6] National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to Oklahoma AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule; delegation of authority.

    SUMMARY:

    The Oklahoma Department of Environmental Quality (ODEQ) has submitted updated regulations for receiving delegation and approval of its program for the implementation and enforcement of certain National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both part 70 and non-part 70 sources), as provided for under previously approved delegation mechanisms. The updated state regulations incorporate by reference certain NESHAP promulgated by the EPA at parts 61 and 63, as they existed through September 1, 2016. The EPA is providing notice that it is taking final action to approve the delegation of certain NESHAP to ODEQ.

    DATES:

    This rule is effective on November 21, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2008-0063. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Rick Barrett (6MM-AP), (214) 665-7227; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.

    Table of Contents I. Background II. What does this action do? III. What is the authority for delegation? IV. What criteria must Oklahoma's program meet to be approved? V. How did ODEQ meet the NESHAP program approval criteria? VI. What is being delegated? VII. What is not being delegated? VIII. How will statutory and regulatory interpretations be made? IX. What authority does the EPA have? X. What information must ODEQ provide to the EPA? XI. What is the EPA's oversight role? XII. Should sources submit notices to the EPA or ODEQ? XIII. How will unchanged authorities be delegated to ODEQ in the future? XIV. Final Action XV. Statutory and Executive Order Reviews I. Background

    The background for this action is discussed in detail in our August 10, 2018, proposal (83 FR 39641). In that document we proposed to approve a request from the Oklahoma Department of Environmental Quality (ODEQ) to update its existing NESHAP regulations for receiving delegation and approval of its program for the implementation and enforcement of certain National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both part 70 and non-part 70 sources), as provided for under previously approved delegation mechanisms. We received five anonymous public comments on the proposed rulemaking action. The comments are posted to the docket (EPA-R06-OAR-2008-0063). None of the comments are relevant to our proposed rulemaking to approve ODEQ's request updating the delegation of certain NESHAP. Since these comments are not relevant to the specific action EPA proposed, the EPA will not be responding to these comments or making any changes to our proposed rulemaking because of these comments.

    II. What does this action do?

    EPA is providing notice that it is taking final action to approve ODEQ's request updating the delegation of certain NESHAP. With this delegation, ODEQ has the primary responsibility to implement and enforce the delegated standards. See sections VII and VIII, below, for a discussion of which standards are being delegated and which are not being delegated.

    III. What is the authority for delegation?

    Section 112(l) of the CAA and 40 CFR part 63, subpart E, authorize the EPA to delegate authority for the implementation and enforcement of emission standards for hazardous air pollutants to a State or local agency that satisfies the statutory and regulatory requirements in subpart E. The hazardous air pollutant standards are codified at 40 CFR parts 61 and 63.

    IV. What criteria must Oklahoma's program meet to be approved?

    Section 112(l)(5) of the CAA requires the EPA to disapprove any program submitted by a State for the delegation of NESHAP standards if the EPA determines that:

    (A) The authorities contained in the program are not adequate to assure compliance by the sources within the State with respect to each applicable standard, regulation, or requirement established under section 112;

    (B) adequate authority does not exist, or adequate resources are not available, to implement the program;

    (C) the schedule for implementing the program and assuring compliance by affected sources is not sufficiently expeditious; or

    (D) the program is otherwise not in compliance with the guidance issued by the EPA under section 112(l)(2) or is not likely to satisfy, in whole or in part, the objectives of the CAA.

    In carrying out its responsibilities under section 112(l), the EPA promulgated regulations at 40 CFR part 63, subpart E setting forth criteria for the approval of submitted programs. For example, in order to obtain approval of a program to implement and enforce Federal section 112 rules as promulgated without changes (straight delegation) for part 70 sources, a State must demonstrate that it meets the criteria of 40 CFR 63.91(d). 40 CFR 63.91(d)(3) provides that interim or final Title V program approval will satisfy the criteria of 40 CFR 63.91(d).1

    1 Some NESHAP standards do not require a source to obtain a title V permit (e.g., certain area sources that are exempt from the requirement to obtain a title V permit). For these non-title V sources, the EPA believes that the State must assure the EPA that it can implement and enforce the NESHAP for such sources. See 65 FR 55810, 55813 (Sept. 14, 2000). EPA has previously approved Oklahoma's program to implement and enforce the NESHAP as they apply to non-part 70 sources. See 66 FR 1584 (Jan. 9, 2001).

    The NESHAP delegation for Oklahoma, as it applies to both part 70 and non-part 70 sources, was most recently approved on December 13, 2005 (70 FR 73595).

    V. How did ODEQ meet the NESHAP program approval criteria?

    As to the NESHAP standards in 40 CFR parts 61 and 63, as part of its Title V submission ODEQ stated that it intended to use the mechanism of incorporation by reference to adopt unchanged Federal section 112 into its regulations. This commitment applied to both existing and future standards as they applied to part 70 sources. EPA's final interim approval of Oklahoma's Title V operating permits program delegated the authority to implement certain NESHAP, effective March 6, 1996 (61 FR 4220, February 5, 1996). On December 5, 2001, EPA promulgated final full approval of the State's operating permits program, effective November 30, 2001 (66 FR 63170). These interim and final Title V program approvals satisfy the up-front approval criteria of 40 CFR 63.91(d). Under 40 CFR 63.91(d)(2), once a State has satisfied up-front approval criteria, it needs only to reference the previous demonstration and reaffirm that it still meets the criteria for any subsequent submittals for delegation of the section 112 standards. ODEQ has affirmed that it still meets the up-front approval criteria. With respect to non-part 70 sources, the EPA has previously approved delegation of NESHAP authorities to ODEQ after finding adequate authorities to implement and enforce the NESHAP for such sources. See 66 FR 1584 (January 9, 2001).

    VI. What is being delegated?

    By letter dated June 25, 2018, the EPA received a request from ODEQ to update its existing NESHAP delegation.2 With certain exceptions noted in section VII below, Oklahoma's request included NESHAP in 40 CFR part 61 and 40 CFR part 63. ODEQ's request included newly incorporated NESHAP promulgated by the EPA and amendments to existing standards currently delegated, as they existed though September 1, 2016. This action is being taken in reponse to ODEQ's request noted above.

    2 ODEQ's June 25, 2018 letter rescinds its previous three letters, dated January 11, 2008; August 23, 2012; and October 16, 2017, requesting EPA approval to update Oklahoma's NESHAP delegation.. As such, the EPA's proposed rulemaking (80 FR 9678, February 24, 2015) associated with ODEQ's January 11, 2008 letter is hereby withdrawn.

    VII. What is not being delegated?

    All authorities not affirmatively and expressly delegated by this action are not delegated. These include the following part 61 and 63 authorities listed below:

    • 40 CFR part 61, subpart B (National Emission Standards for Radon Emissions from Underground Uranium Mines);

    • 40 CFR part 61, subpart H (National Emission Standards for Emissions of Radionuclides Other Than Radon From Department of Energy Facilities);

    • 40 CFR part 61, subpart I (National Emission Standards for Radionuclide Emissions from Federal Facilities Other Than Nuclear Regulatory Commission Licensees and Not Covered by Subpart H);

    • 40 CFR part 61, subpart K (National Emission Standards for Radionuclide Emissions from Elemental Phosphorus Plants);

    • 40 CFR part 61, subpart Q (National Emission Standards for Radon Emissions from Department of Energy facilities);

    • 40 CFR part 61, subpart R (National Emission Standards for Radon Emissions from Phosphogypsum Stacks);

    • 40 CFR part 61, subpart T (National Emission Standards for Radon Emissions from the Disposal of Uranium Mill Tailings);

    • 40 CFR part 61, subpart W (National Emission Standards for Radon Emissions from Operating Mill Tailings); and

    • 40 CFR part 63, subpart J (National Emission Standards for Polyvinyl Choride and Copolymers Production).

    In addition, the EPA regulations provide that we cannot delegate to a State any of the Category II Subpart A authorities set forth in 40 CFR 63.91(g)(2). These include the following provisions: § 63.6(g), Approval of Alternative Non-Opacity Standards; § 63.6(h)(9), Approval of Alternative Opacity Standards; § 63.7(e)(2)(ii) and (f), Approval of Major Alternatives to Test Methods; § 63.8(f), Approval of Major Alternatives to Monitoring; and § 63.10(f), Approval of Major Alternatives to Recordkeeping and Reporting. Also, some part 61 and part 63 standards have certain provisions that cannot be delegated to the States. Furthermore, no authorities are delegated that require rulemaking in the Federal Register to implement, or where Federal overview is the only way to ensure national consistency in the application of the standards or requirements of CAA section 112. Finally, this action does not delegate any authority under section 112(r), the accidental release program.

    All inquiries and requests concerning implementation and enforcement of the excluded standards in the State of Oklahoma should be directed to the EPA Region 6 Office.

    In addition, this delegation to ODEQ to implement and enforce certain NESHAP does not extend to sources or activities located in Indian country, as defined in 18 U.S.C. 1151. Oklahoma is not seeking delegation for such areas, and neither the EPA nor ODEQ is aware of any existing facilities in Indian country subject to the NESHAP being delegated. ODEQ may submit a request to expand this program to non-reservation areas of Indian country in the future, at which time the EPA would evaluate the request through the appropriate process.

    VIII. How will statutory and regulatory interpretations be made?

    In approving the NESHAP delegation, ODEQ will obtain concurrence from the EPA on any matter involving the interpretation of section 112 of the CAA or 40 CFR parts 61 and 63 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance.

    IX. What authority does the EPA have?

    We retain the right, as provided by CAA section 112(l)(7) and 40 CFR 63.90(d)(2), to enforce any applicable emission standard or requirement established under section 112. In addition, the EPA may enforce any federally approved State rule, requirement, or program under 40 CFR 63.90(e) and 63.91(c)(1)(i). The EPA also has the authority to make certain decisions under the General Provisions (subpart A) of parts 61 and 63. We are delegating to the ODEQ some of these authorities, and retaining others, as explained in sections VI and VII above. In addition, the EPA may review and disapprove State determinations and subsequently require corrections. See 40 CFR 63.91(g)(1)(ii). EPA also has the authority to review ODEQ's implementation and enforcement of approved rules or programs and to withdraw approval if we find inadequate implementation or enforcement. See 40 CFR 63.96.

    Furthermore, we retain any authority in an individual emission standard that may not be delegated according to provisions of the standard. Also, listed in footnote 2 of the part 63 delegation table at the end of this rule are the authorities that cannot be delegated to any State or local agency which we therefore retain.

    Finally, we retain the authorities stated in the original delegation agreement. See “Provisions for the Implementation and Enforcement of NSPS and NESHAP in Oklahoma,” effective March 25, 1982, a copy of which is included in the docket for this action.

    X. What information must ODEQ provide to the EPA?

    ODEQ must provide any additional compliance related information to EPA, Region 6, Office of Enforcement and Compliance Assurance within 45 days of a request under 40 CFR 63.96(a). In receiving delegation for specific General Provisions authorities, ODEQ must submit to EPA Region 6 on a semi-annual basis, copies of determinations issued under these authorities. See 40 CFR 63.91(g)(1)(ii). For part 63 standards, these determinations include: § 63.1, Applicability Determinations; § 63.6(e), Operation and Maintenance Requirements—Responsibility for Determining Compliance; § 63.6(f), Compliance with Non-Opacity Standards—Responsibility for Determining Compliance; § 63.6(h), Compliance with Opacity and Visible Emissions Standards—Responsibility for Determining Compliance; § 63.7(c)(2)(i) and (d), Approval of Site-Specific Test Plans; § 63.7(e)(2)(i), Approval of Minor Alternatives to Test Methods; § 63.7(e)(2)(ii) and (f), Approval of Intermediate Alternatives to Test Methods; § 63.7(e)(iii), Approval of Shorter Sampling Times and Volumes When Necessitated by Process Variables or Other Factors; § 63.7(e)(2)(iv), (h)(2) and (3), Waiver of Performance Testing; § 63.8(c)(1) and (e)(1), Approval of Site-Specific Performance Evaluation (Monitoring) Test Plans; § 63.8(f), Approval of Minor Alternatives to Monitoring; § 63.8(f), Approval of Intermediate Alternatives to Monitoring; §§ 63.9 and 63.10, Approval of Adjustments to Time Periods for Submitting Reports; § 63.10(f), Approval of Minor Alternatives to Recordkeeping and Reporting; and § 63.7(a)(4), Extension of Performance Test Deadline.

    XI. What is the EPA's oversight role?

    The EPA oversees ODEQ's decisions to ensure the delegated authorities are being adequately implemented and enforced. We will integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place. If, during oversight, we determine that ODEQ made decisions that decreased the stringency of the delegated standards, then ODEQ shall be required to take corrective actions and the source(s) affected by the decisions will be notified, as required by 40 CFR 63.91(g)(1)(ii) and (b). Our oversight authorities allow us to initiate withdrawal of the program or rule if the corrective actions taken are insufficient. See 51 FR 20648 (June 6, 1986).

    XII. Should sources submit notices to the EPA or ODEQ?

    For the delegated NESHAP standards and authorities covered by this action, sources would submit all of the information required pursuant to the general provisions and the relevant subpart(s) of the delegated NESHAP (40 CFR parts 61 and 63) directly to the ODEQ at the following address: State of Oklahoma, Department of Environmental Quality, Air Quality Division, P.O. Box 1677, Oklahoma City, Oklahoma 73101-1677. The ODEQ is the primary point of contact with respect to delegated NESHAP. Sources do not need to send a copy to the EPA. The EPA Region 6 waives the requirement that notifications and reports for delegated standards be submitted to EPA in addition to ODEQ in accordance with 40 CFR 63.9(a)(4)(ii) and 63.10(a)(4)(ii).3 For those standards and authorties not delegated as discussed above, sources must continue to submit all appropriate information to the EPA.

    3 This waiver only extends to the submission of copies of notifications and reports; the EPA does not waive the requirements in delegated standards that require notifications and reports be submitted to an electronic database (e.g., 40 CFR part 63, subpart HHHHHHH).

    XIII. How will unchanged authorities be delegated to ODEQ in the future?

    As stated in previous NESHAP delegation actions, the EPA has approved Oklahoma's mechanism of incorporation by reference of NESHAP standards into ODEQ regulations, as they apply to both part 70 and non-part 70 sources. See, e.g., 61 FR 4224 (February 5, 1996) and 66 FR 1584 (January 9, 2001). Consistent with the EPA regulations and guidance,4 ODEQ may request future updates to Oklahoma's NESHAP delegation by submitting a letter to the EPA that appropriately identifies the specific NESHAP which have been incorporated by reference into state regulations, reaffirms that it still meets up-front approval delegation criteria for part 70 sources, and demonstrates that ODEQ maintains adequate authorites and resources to implement and enforce the delegated NESHAP requirements for all sources. We will respond in writing to the request stating that the request for delegation is either granted or denied. A Federal Register action will be published to inform the public and affected sources of the updated delegation, indicate where source notifications and reports should be sent, and amend the relevant portions of the Code of Federal Regulations identifying which NESHAP standards have been delegated to the ODEQ. We have not been using this informational notice process but intend to from now on upon receipt of the next NESHAP delegation request from ODEQ.5

    4See Harardous Air Pollutants: Amendments to the Approval of State Programs and Delegation of Federal Authorities, Final Rule (65 FR 55810, September 14, 2000); and “Straight Delegation Issues Concerning Sections 111 and 112 Requirements and Title V,” by John S. Seitz, Director of Air Qualirty Planning and Standards, EPA, dated December 10, 1993.

    5 A request from ODEQ that raises an issue not previously subject to comment, presents new data, requires EPA to examine its interpretion of the applicable law, or where EPA wishes to re-examine its present position on a matter will be processed through notice and comment rulemaking in the Federal Register.

    XIV. Final Action

    EPA is taking final action to approve an update to the Oklahoma NESHAP delegation that would provide the ODEQ with the authority to implement and enforce certain newly incorporated NESHAP promulgated by the EPA, and amendments to existing standards currently delegated, as they existed though September 1, 2016. As requested in ODEQ's June 25, 2018 letter, this final delegation to ODEQ does not extend to sources or activities located in Indian country, as defined in 18 U.S.C. 1151.

    XV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator has the authority to approve section 112(l) submissions that comply with the provisions of the Act and applicable Federal regulations. In reviewing section 112(l) submissions, the EPA's role is to approve state choices, provided that they meet the criteria and objectives of the CAA and of the EPA's implementing regulations. Accordingly, this final action merely approves the State's request as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this final action:

    • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

    • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

    • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

    • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);

    • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

    • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

    • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

    • does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    List of Subjects 40 CFR Part 61

    Environmental protection, Administrative practice and procedure, Air pollution control, Arsenic, Benzene, Beryllium, Hazardous substances, Mercury, Intergovernmental relations, Reporting and recordkeeping requirements, Vinyl chloride.

    40 CFR Part 63

    Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.

    Authority:

    42 U.S.C. 7401 et seq

    Dated: October 16, 2018. Wren Stenger, Director, Multimedia Division, Region 6.

    For the reasons stated in the preamble, 40 CFR parts 61 and 63 are amended as follows:

    PART 61—NATIONAL EMISSON STANDARDS FOR HAZARDOUS AIR POLLUTANTS 1. The authority citation for part 61 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart A—General Provisions 2. Section 61.04 is amended by revising paragraphs (b)(38) and (c)(6)(iv) to read as follows:
    § 61.04 Address.

    (b) * * *

    (38) State of Oklahoma, Oklahoma Department of Environmental Quality, Air Quality Division, P.O. Box 1677, Oklahoma City, OK 73101-1677. For a list of delegated standards for Oklahoma see paragraph (c)(6) of this section.

    (c) * * *

    (6) * * *

    (iv) Oklahoma. The Oklahoma Department of Environmental Quality (ODED) has been delegated the following part 61 standards promulgated by EPA, as amended in the Federal Register through September 1, 2016. The (X) symbol is used to indicate each subpart that has been delegated.

    Delegation Status for National Emission Standards for Hazardous Air Pollutants (Part 61 Standards) for Oklahoma [Excluding Indian Country] Subpart Source category ODEQ 1 A General Provisions X B Radon Emissions From Underground Uranium Mines C Beryllium X D Beryllium Rocket Motor Firing X E Mercury X F Vinyl Chloride X G (Reserved) H Emissions of Radionuclides Other Than Radon From Department of Energy Facilities I Radionuclide Emissions From Federal Facilities Other Than Nuclear Regulatory Commission Licensees and Not Covered by Subpart H J Equipment Leaks (Fugitive Emission Sources) of Benzene X K Radionuclide Emissions From Elemental Phosphorus Plants L Benzene Emissions From Coke By-Product Recovery Plants X M Asbestos X N Inorganic Arsenic Emissions From Glass Manufacturing Plants X O Inorganic Arsenic Emissions From Primary Copper Smelters X P Inorganic Arsenic Emissions From Arsenic Trioxide and Metallic Arsenic Production Facilities X Q Radon Emissions From Department of Energy Facilities R Radon Emissions From Phosphogypsum Stacks S (Reserved) T Radon Emissions From the Disposal of Uranium Mill Tailings U (Reserved) V Equipment Leaks (Fugitives Emission Sources) X W Radon Emissions From Operating Mill Tailings X (Reserved) Y Benzene Emissions From Benzene Storage Vessels X Z-AA (Reserved) BB Benzene Emissions From Benzene Transfer Operations X CC-EE (Reserved) FF Benzene Waste Operations X 1 Program delegated to Oklahoma Department of Environmental Quality (ODEQ).
    PART 63—NATIONAL EMISSON STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES 3. The authority citation for part 63 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart E—Approval of State Programs and Delegation of Federal Authorities 4. Section 63.99 is amended by revising paragraph (a)(37)(i) to read as follows:
    § 63.99 Delegated Federal authorities.

    (a) * * *

    (37) * * *

    (i) The following table lists the specific part 63 standards that have been delegated unchanged to the Oklahoma Department of Environmental Quality for all sources. The “X” symbol is used to indicate each subpart that has been delegated. The delegations are subject to all of the conditions and limitations set forth in Federal law, regulations, policy, guidance, and determinations. Some authorities cannot be delegated and are retained by EPA. These include certain General Provisions authorities and specific parts of some standards. Any amendments made to these rules after September 1, 2016 are not delegated.

    Delegation Status for Part 63 Standards—State of Oklahoma [Excluding Indian Country] Subpart Source category ODEQ 1 2 A General Provisions X F Hazardous Organic NESHAP (HON)—Synthetic Organic Chemical Manufacturing Industry (SOCMI) X G HON—SOCMI Process Vents, Storage Vessels, Transfer Operations and Wastewater X H HON—Equipment Leaks X I HON—Certain Processes Negotiated Equipment Leak Regulation X J Polyvinyl Chloride and Copolymers Production 3 K (Reserved) L Coke Oven Batteries X M Perchloroethylene Dry Cleaning X N Chromium Electroplating and Chromium Anodizing Tanks X O Ethylene Oxide Sterilizers X P (Reserved) Q Industrial Process Cooling Towers X R Gasoline Distribution X S Pulp and Paper Industry X T Halogenated Solvent Cleaning X U Group I Polymers and Resins X V (Reserved) W Epoxy Resins Production and Non-Nylon Polyamides Production X X Secondary Lead Smelting X Y Marine Tank Vessel Loading X Z (Reserved) AA Phosphoric Acid Manufacturing Plants X BB Phosphate Fertilizers Production Plants X CC Petroleum Refineries X DD Off-Site Waste and Recovery Operations X EE Magnetic Tape Manufacturing X FF (Reserved) GG Aerospace Manufacturing and Rework Facilities X HH Oil and Natural Gas Production Facilities X II Shipbuilding and Ship Repair Facilities X JJ Wood Furniture Manufacturing Operations X KK Printing and Publishing Industry X LL Primary Aluminum Reduction Plants X MM Chemical Recovery Combustion Sources at Kraft, Soda, Sulfide, and Stand-Alone Semichemical Pulp Mills X NN Wool Fiberglass Manufacturing at Area Sources X OO Tanks-Level 1 X PP Containers X QQ Surface Impoundments X RR Individual Drain Systems X SS Closed Vent Systems, Control Devices, Recovery Devices and Routing to a Fuel Gas System or a Process X TT Equipment Leaks—Control Level 1 X UU Equipment Leaks—Control Level 2 Standards X VV Oil—Water Separators and Organic—Water Separators X WW Storage Vessels (Tanks)—Control Level 2 X XX Ethylene Manufacturing Process Units Heat Exchange Systems and Waste Operations X YY Generic Maximum Achievable Control Technology Standards X ZZ-BBB (Reserved) CCC Steel Pickling—HCI Process Facilities and Hydrochloric Acid Regeneration X DDD Mineral Wool Production X EEE Hazardous Waste Combustors X FFF (Reserved) GGG Pharmaceuticals Production X HHH Natural Gas Transmission and Storage Facilities X III Flexible Polyurethane Foam Production X JJJ Group IV Polymers and Resins X KKK (Reserved) LLL Portland Cement Manufacturing X MMM Pesticide Active Ingredient Production X NNN Wool Fiberglass Manufacturing X OOO Amino/Phenolic Resins X PPP Polyether Polyols Production X QQQ Primary Copper Smelting X RRR Secondary Aluminum Production X SSS (Reserved) TTT Primary Lead Smelting X UUU Petroleum Refineries—Catalytic Cracking Units, Catalytic Reforming Units and Sulfur Recovery Plants X VVV Publicly Owned Treatment Works (POTW) X WWW (Reserved) XXX Ferroalloys Production: Ferromanganese and Silicomanganese X AAAA Municipal Solid Waste Landfills X CCCC Nutritional Yeast Manufacturing X DDDD Plywood and Composite Wood Products 4 X EEEE Organic Liquids Distribution X FFFF Misc. Organic Chemical Production and Processes (MON) X GGGG Solvent Extraction for Vegetable Oil Production X HHHH Wet Formed Fiberglass Mat Production X IIII Auto & Light Duty Truck (Surface Coating) X JJJJ Paper and other Web (Surface Coating) X KKKK Metal Can (Surface Coating) X MMMM Misc. Metal Parts and Products (Surface Coating) X NNNN Surface Coating of Large Appliances X OOOO Fabric Printing Coating and Dyeing X PPPP Plastic Parts (Surface Coating) X QQQQ Surface Coating of Wood Building Products X RRRR Surface Coating of Metal Furniture X SSSS Surface Coating for Metal Coil X TTTT Leather Finishing Operations X UUUU Cellulose Production Manufacture X VVVV Boat Manufacturing X WWWW Reinforced Plastic Composites Production X XXXX Tire Manufacturing X YYYY Combustion Turbines X ZZZZ Reciprocating Internal Combustion Engines (RICE) X AAAAA Lime Manufacturing Plants X BBBBB Semiconductor Manufacturing X CCCCC Coke Ovens: Pushing, Quenching and Battery Stacks X DDDDD Industrial/Commercial/Institutional Boilers and Process Heaters Major Sources 5 X EEEEE Iron Foundries X FFFFF Integrated Iron and Steel X GGGGG Site Remediation X HHHHH Miscellaneous Coating Manufacturing X IIIII Mercury Cell Chlor-Alkali Plants X JJJJJ Brick and Structural Clay Products Manufacturing 6 X KKKKK Clay Ceramics Manufacturing 6 X LLLLL Asphalt Roofing and Processing X MMMMM Flexible Polyurethane Foam Fabrication Operation X NNNNN Hydrochloric Acid Production, Fumed Silica Production X OOOOO (Reserved) PPPPP Engine Test Facilities X QQQQQ Friction Products Manufacturing X RRRRR Taconite Iron Ore Processing X SSSSS Refractory Products Manufacture X TTTTT Primary Magnesium Refining X UUUUU Coal and Oil-Fired Electric Utility Steam Generating Units 7 X VVVVV (Reserved) WWWWW Hospital Ethylene Oxide Sterilizers X XXXXX (Reserved) YYYYY Electric Arc Furnace Steelmaking Area Sources X ZZZZZ Iron and Steel Foundries Area Sources X AAAAAA (Reserved) BBBBBB Gasoline Distribution Bulk Terminals, Bulk Plants, and Pipeline Facilities X CCCCCC Gasoline Dispensing Facilities X DDDDDD Polyvinyl Chloride and Copolymers Production Area Sources X EEEEEE Primary Copper Smelting Area Sources X FFFFFF Secondary Copper Smelting Area Sources X GGGGGG Primary Nonferrous Metals Area Source: Zinc, Cadmium, and Beryllium X HHHHHH Paint Stripping and Miscellaneous Surface Coating Operations at Area Sources X IIIIII (Reserved) JJJJJJ Industrial, Commercial, and Institutional Boilers Area Sources X KKKKKK (Reserved) LLLLLL Acrylic and Modacrylic Fibers Production Area Sources X MMMMMM Carbon Black Production Area Sources X NNNNNN Chemical Manufacturing Area Sources: Chromium Compounds X OOOOOO Flexible Polyurethane Foam Production and Fabrication Area Sources X PPPPPP Lead Acid Battery Manufacturing Area Sources X QQQQQQ Wood Preserving Area Sources X RRRRRR Clay Ceramics Manufacturing Area Sources X SSSSSS Glass Manufacturing Area Sources X TTTTTT Secondary Nonferrous Metals Processing Area Sources X UUUUUU (Reserved) VVVVVV Chemical Manufacturing Area Sources X WWWWWW Plating and Polishing Operations Area Sources X XXXXXX Metal Fabrication and Finishing Area Sources X YYYYYY Ferroalloys Production Facilities Area Sources X ZZZZZZ Aluminum, Copper, and Other Nonferrous Foundries Area Sources X AAAAAAA Asphalt Processing and Asphalt Roofing Manufacturing Area Sources X BBBBBBB Chemical Preparation Industry Area Sources X CCCCCCC Paints and Allied Products Manufacturing Area Sources X DDDDDDD Prepared Feeds Areas Sources X EEEEEEE Gold Mine Ore Processing and Production Area Sources X FFFFFFF-GGGGGGG (Reserved) HHHHHHH Polyvinyl Chloride and Copolymers Production Major Sources X 1 Program delegated to Oklahoma Department of Environmental Quality (ODEQ). 2 Authorities which may not be delegated include: § 63.6(g), Approval of Alternative Non-Opacity Emission Standards; § 63.6(h)(9), Approval of Alternative Opacity Standards; § 63.7(e)(2)(ii) and (f), Approval of Major Alternatives to Test Methods; § 63.8(f), Approval of Major Alternatives to Monitoring; § 63.10(f), Approval of Major Alternatives to Recordkeeping and Reporting; and all authorities identified in the subparts (e.g., under “Delegation of Authority”) that cannot be delegated. 3 The ODEQ has adopted this subpart unchanged and applied for delegation of the standard. The subpart was vacated and remanded to EPA by the United States Court of Appeals for the District of Columbia Circuit. See, Mossville Environmental Action Network v. EPA, 370 F. 3d 1232 (DC Cir. 2004). Because of the DC Court's holding, this subpart is not delegated to ODEQ at this time. 4 This subpart was issued a partial vacatur by the United States Court of Appeals for the District of Columbia Circuit. See 72 FR 61060 (October 29, 2007). 5 Final rule. See 76 FR 15608 (March 21, 2011), as amended at 78 FR 7138 (January 31, 2013); 80 FR 72807 (November 20, 2015). 6 Final promulgated rule adopted by the EPA. See 80 FR 65470 (October 26, 2015). Note that Part 63 Subpart KKKKK was amended to correct minor typographical errors at 80 FR 75817 (December 4, 2015). 7 Final Rule. See 77 FR 9304 (February 16, 2012), as amended 81 FR 20172 (April 6, 2016). Final Supplemental Finding that it is appropriate and necessary to regulate HAP emissions from Coal- and Oil-fired EUSGU Units. See 81 FR 24420 (April 25, 2016).
    [FR Doc. 2018-22999 Filed 10-19-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 27 [GN Docket No. 12-268, ET Docket No. 13-26 and ET Docket No. 14-14, FCC 15-141] Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions; Office of Engineering and Technology Releases and Seeks Comment on Updated OET-69 Software; Office of Engineering and Technology Seeks To Supplement the Incentive Auction Proceeding Record Regarding Potential Interference Between Broadcast Television and Wireless Services AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule; announcement of effective date.

    SUMMARY:

    In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions, Third Report and Order and First Order on Reconsideration (Order)'s no harmful interference rule. This document is consistent with the Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of the rule.

    DATES:

    The amendment to 47 CFR 27.1310 published at 80 FR 71731, November 17, 2015, are effective October 22, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Aspasia Paroutsas, Office of Engineering and Technology, at (202) 418-7285, or email: [email protected] For additional information concerning the Paperwork Reduction Act information collection requirements contact Nicole Ongele at (202) 418-2991 or via email at [email protected]

    SUPPLEMENTARY INFORMATION:

    This document announces that, on April 3, 2017, OMB approved, for a period of three years, the information collection requirements relating to the harmful interference rule contained in the Commission's Order, FCC 15-141, published at 80 FR 71731, November 17, 2015. The OMB Control Number is 3060-1229. The Commission publishes this document as an announcement of the effective date of the rule. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1-A620, 445 12th Street SW, Washington, DC 20554. Please include the OMB Control Number, 3060-1229, in your correspondence. The Commission will also accept your comments via email at [email protected]

    To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    Synopsis

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on April 3, 2017, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR part 27.

    Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

    No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1229.

    The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

    The total annual reporting burdens and costs for the respondents are as follows:

    OMB Control Number: 3060-1229.

    OMB Approval Date: April 3, 2017.

    OMB Expiration Date: April 30, 2020.

    Title: Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions.

    Form Number: N/A.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 832 respondents; 832 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: Wireless licensees who are required to conduct an interference study will be required to produce the study upon request and when an interference complaint occurs.

    Obligation to Respond: Mandatory. The statutory authority for this information collection is contained in 47 U.S.C. 151, 154, 301, 303, 307, 308, 309, 316, 319, 332, 403, 1452 and 1454.

    Total Annual Burden: 832 hours.

    Total Annual Cost: $10.

    Nature and Extent of Confidentiality: There is no need for confidentiality. However, applicants may request that any information supplied be withheld from public inspection, pursuant to 47 CFR 0.459 of the FCC's rules. This request must be justified pursuant to 47 CFR 0.457.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: The collection was submitted to the Office of Management and Budget (OMB) and approved for the information collection requirements relating to the harmful interference rule contained in the Commission's Order, FCC 15-141.

    On October 26, 2015, the Federal Communications Commission released a Third Report and Order and First Order on Reconsideration, FCC 15-141, published at 80 FR 71731, November 17, 2015, Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions, ET Docket Nos. 13-26, 14-14 and GN Docket No. 12-268, adopting a final rule—containing information requirements—which resolved the remaining technical issues affecting the operation of 600 MHz wireless licenses and broadcast television stations in areas where they operate on the same or adjacent channels in geographic proximity. Specifically, the Commission adopted a rule requiring wireless licensees to conduct an interference study prior to deploying or operating a wireless base station within a specified distance of a broadcast television station that is co-channel or adjacent channel to their spectrum. A wireless licensee is required to provide this interference study to the Commission upon request or to the broadcast television station when there is an interference complaint.

    Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-22973 Filed 10-19-18; 8:45 am] BILLING CODE 6712-01-P
    83 204 Monday, October 22, 2018 Proposed Rules NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2018-0075] RIN 3150-AK12 List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS®; Universal Storage System, Certificate of Compliance No. 1015, Amendment No. 6 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the NAC International NAC-UMS® listing within the “List of approved spent fuel storage casks” to include Amendment No. 6 to Certificate of Compliance (CoC) No. 1015. Amendment No. 6 revises the CoC's technical specifications (TSs) to: Remove a redundant requirement for inspection of the concrete cask and canister; revise a limiting condition of operation (LCO) for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; and clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the Final Safety Analysis Report (FSAR), “or within the time limit for a less than design-basis heat load case, as evaluated.” Amendment No. 6 also clarifies that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.

    DATES:

    Submit comments by November 21, 2018. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0075. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected]. For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected]. If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Bernard H. White, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-6577; email: [email protected] or Robert D. MacDougall, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-5175; email: [email protected]. Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Obtaining Information and Submitting Comments II. Rulemaking Procedure III. Background IV. Plain Writing V. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0075 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 Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0075.

    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]. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    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.

    B. Submitting Comments

    Please include Docket ID NRC-2018-0075 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Rulemaking Procedure

    Because the NRC considers this action to be non-controversial, the NRC is publishing this proposed rule concurrently with a direct final rule in the Rules and Regulations section of this issue of the Federal Register. The direct final rule will become effective on January 7, 2019. However, if the NRC receives significant adverse comments on this proposed rule by November 21, 2018, then the NRC will publish a document that withdraws the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to these proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

    A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

    (1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

    (a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

    (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

    (c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

    (2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

    (3) The comment causes the NRC staff to make a change (other than editorial) to the rule.

    For procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this issue of the Federal Register.

    III. Background

    Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

    To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on October 19, 2000 (65 FR 62581), that approved the NAC-UMS® Universal Storage System design and added it to the list of NRC-approved cask designs provided in § 72.214 as CoC No. 1015.

    IV. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on the proposed rule with respect to clarity and effectiveness of the language used.

    V. Availability of Documents

    The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

    Document ADAMS accession
  • No./web link/
  • Federal Register
  • citation
  • Request to Amend Certificate of Compliance No. 1015 for the NAC-UMS® Cask System, dated May 23, 2017 ML17145A380 Revision of Request to Amend Certificate of Compliance No. 1015 for the NAC-UMS® Cask System, dated January 16, 2018 ML18018A893 Revision 11 to NAC-UMS® Final Safety Analysis Report for the UMS Universal Storage System ML16341B102 Proposed CoC No. 1015, Amendment No. 6 ML18088A174 Proposed Technical Specifications ML18088A176 Appendix A—Proposed Technical Specifications ML18088A178 Appendix B—Preliminary Safety Evaluation Report ML18088A181

    The NRC may post materials related to this document, including public comments, on the Federal Rulemaking website at http://www.regulations.gov under Docket ID NRC-2018-0075. The Federal Rulemaking website allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: 1) navigate to the docket folder (NRC-2018-0075); 2) click the “Sign up for Email Alerts” link; and 3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is proposing to adopt the following amendments to 10 CFR part 72:

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

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

    2. In § 72.214, Certificate of Compliance 1015 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1015.

    Initial Certificate Effective Date: November 20, 2000.

    Amendment Number 1 Effective Date: February 20, 2001.

    Amendment Number 2 Effective Date: December 31, 2001.

    Amendment Number 3 Effective Date: March 31, 2004.

    Amendment Number 4 Effective Date: October 11, 2005.

    Amendment Number 5 Effective Date: January 12, 2009.

    Amendment Number 6 Effective Date: January 7, 2019.

    SAR Submitted by: NAC International, Inc.

    SAR Title: Final Safety Analysis Report for the NAC-UMS Universal Storage System.

    Docket Number: 72-1015.

    Certificate Expiration Date: November 20, 2020.

    Model Number: NAC-UMS.

    Dated at Rockville, Maryland, this 9th day of October, 2018.

    For the Nuclear Regulatory Commission.

    Margaret M. Doane, Executive Director for Operations.
    [FR Doc. 2018-22913 Filed 10-19-18; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2017-0240; Notice No. 25-18-04-SC] Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplanes; Airbag Systems on Multiple-Place and Single-Place Side-Facing Seats AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed amended special conditions.

    SUMMARY:

    This action proposes amended special conditions for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII-G500 airplane. This amendment changes an error in a reference to a special conditions number and adds one special condition. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature is airbag systems on multiple-place and single-place side-facing seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    DATES:

    Send comments on or before November 21, 2018.

    ADDRESSES:

    Send comments identified by Docket No. FAA-2017-0240 using any of the following methods:

    Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

    Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Alan Sinclair, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3215.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the proposed special conditions, explain the reason for any recommended change, and include supporting data.

    We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

    Background

    On March 29, 2012, Gulfstream Aerospace Corporation applied for a type certificate for their new Model GVII-G500 airplane. The Model GVII-G500 airplane will be a twin-engine, transport-category, business jet capable of accommodating up to 19 passengers. The Model GVII-G500 airplane will have a maximum takeoff weight of 76,850 lbs.

    The FAA issued “final special conditions, request for comments” for airbag systems on multiple-place and single-place side-facing seats installed in Gulfstream Model GVII-G500 airplanes, on June 8, 2017. The special conditions were published in the Federal Register on June 19, 2017 (82 FR 27771). This notice of proposed special conditions provides the public an opportunity to comment on the additional condition no. 14 amended into The Proposed Special Conditions section.

    Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.17, Gulfstream must show that the Model GVII-G500 airplane meets the applicable provisions of 14 CFR part 25, as amended by amendments 25-1 through 25-129.

    If the Administrator finds that the applicable airworthiness regulations (i.e., part 25) do not contain adequate or appropriate safety standards for the Model GVII-G500 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

    Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

    In addition to the applicable airworthiness regulations and special conditions, Model GVII-G500 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

    The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

    Novel or Unusual Design Features

    The Model GVII-G500 airplane will incorporate the following novel or unusual design feature:

    Airbag systems on multiple-place and single-place side-facing seats.

    Discussion

    Side facing seats are considered a novel design for transport-category airplanes that include 14 CFR part 25, amendment 25-64, in their certification bases because this feature was not anticipated when those airworthiness standards were issued. Therefore, the existing regulations do not provide adequate or appropriate safety standards for occupants of side-facing seats. For the Model GVII-G500 airplane, FAA Special Conditions No. 25-618-SC, “Technical Criteria for Approving Side-Facing Seats,” provide special conditions to address the certification of single- and multiple-place side-facing seats. Those special conditions include condition 2(e), which requires the axial rotation of the upper leg (femur) to be limited to 35 degrees in either direction from the nominal seat position. To accommodate that requirement, Gulfstream has developed a new airbag system that will be installed close to the floor, and which is designed to limit the axial rotation of the occupant's upper legs.

    This amendment changes, in the second paragraph of the Special Conditions section, an erroneous reference to Special Conditions No. 25-495-SC, which is here corrected to 25-618-SC, and adds special condition number 14 to the Special Conditions section. Special Condition 14 was unintentionally omitted from the previous issuance of these special conditions.

    These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    Applicability

    As discussed above, these special conditions are applicable to the Gulfstream Model GVII-G500 airplane. Should Gulfstream apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

    Conclusion

    This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability.

    List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping requirements.

    Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:

    49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

    The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Gulfstream Aerospace Corporation Model GVII-G500 airplanes.

    In addition to the requirements of §§ 25.562 and 25.785, and Special Conditions No. 25-618-SC, the following special conditions are part of the type certification basis for the Gulfstream Model GVII-G500 airplane with leg-flail airbags installed on side-facing seats.

    1. For seats with a leg-flail airbag system, the system must deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th-percentile male. At some buttock popliteal length and effective seat-bottom depth, the lower legs will not be able to form a 90-degree angle relative to the upper leg; at this point, the lower leg flail would not occur. The leg-flail airbag system must provide a consistent approach to prevention of leg flail throughout that range of occupants whose lower legs can form a 90-degree angle relative to the upper legs when seated upright in the seat. Items that need to be considered include, but are not limited to, the range of occupants' popliteal height, the range of occupants' buttock popliteal length, the design of the seat effective height above the floor, and the effective depth of the seat-bottom cushion.

    2. The leg-flail airbag system must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active leg-flail airbag system.

    3. The leg-flail airbag system must not be susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.

    4. Deployment of the leg-flail airbag system must not introduce injury mechanisms to the seated occupant, nor result in injuries that could impede rapid egress.

    5. Inadvertent deployment of the leg-flail airbag system, during the most critical part of the flight, must either meet the requirement of § 25.1309(b), or not cause a hazard to the airplane or its occupants.

    6. The leg-flail airbag system must not impede rapid egress of occupants from the airplane 10 seconds after airbag deployment.

    7. The leg-flail airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lightning (§ 25.1316) and HIRF (§ 25.1317) are incorporated by reference for the purpose of measuring lightning and HIRF protection.

    8. The leg-flail airbag system must function properly after loss of normal airplane electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the leg-flail airbag system does not have to be considered.

    9. The leg-flail airbag system must not release hazardous quantities of gas or particulate matter into the cabin.

    10. The leg-flail airbag system installation must be protected from the effects of fire such that no hazard to occupants will result.

    11. A means must be available to verify the integrity of the leg-flail airbag system's activation system prior to each flight, or the leg-flail airbag system's activation system must reliably operate between inspection intervals. The FAA considers that the loss of the leg-flail airbag system's deployment function alone (i.e., independent of the conditional event that requires the leg-flail airbag system's deployment) is a major-failure condition.

    12. The airbag inflatable material may not have an average burn rate of greater than 2.5 inches per minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).

    13. The leg-flail airbag system, once deployed, must not adversely affect the emergency-lighting system (i.e., must not block floor-proximity lights to the extent that the lights no longer meet their intended function).

    14. The leg flail system(s) must perform its intended function after impact from any other proximate assemblies (e.g., life raft) that may become detached under the loads specified in §§ 25.561 and 25.562.

    Issued in Des Moines, Washington, on October 15, 2018. Victor Wicklund, Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-22928 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 61 [Docket No.: FAA-2018-0811] Airline Transport Pilot and Type Rating for Airplane Airman Certification Standards AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of document availability and request for comments.

    SUMMARY:

    This document announces the availability of the Airline Transport Pilot (ATP) and Type Rating for Airplane Airman Certification Standards (FAA-S-ACS-11) for public comment.

    DATES:

    Send comments on or before December 21, 2018.

    ADDRESSES:

    Send comments identified by docket number FAA-2018-0811 using any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: We will post all 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 viewed at www.dot.gov/privacy.

    Docket: Background documents or comments received may be read at http://www.regulations.gov at any time. Follow the online instructions for accessing the docket or Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Larry West, Regulatory Support Division, Federal Aviation Administration, FAA Mike Monroney Aeronautical Center, P.O. Box 25082, Oklahoma City, OK 73125; telephone 405-954-4431; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Authority for This Action

    Under 49 U.S.C. 44703(a), the Administrator is required to issue an airman certificate when the Administrator finds, after investigation, that an individual is qualified for, and physically able to perform the duties related to the position authorized by the certificate. Consistent with this authority, the Administrator establishes testing standards to ensure that inspectors and designated examiners conducting practical tests under the Administrator's authority determine that an applicant is qualified for and physically able to perform the duties related to the position authorized by the certificate or rating sought.

    Background

    The FAA established the Aviation Rulemaking Advisory Committee (ARAC) to provide information, advice, and recommendations on aviation related issues that could result in rulemaking to the Administrator, through the Associate Administrator of Aviation Safety. On December 19, 2013, ARAC accepted the FAA's assignment of a new task to establish an Airman Certification Standards Working Group (ACS WG) to assist in the development of standards, training guidance, test management, and reference materials for airman certification testing. The FAA announced the ARAC's acceptance of this task through a Federal Register Notice published on January 29, 2014 (79 FR 4800). The original task focused on the Private Pilot, Commercial Pilot, ATP, and Authorized Instructor certificates and the Instrument Rating in the airplane category. The task was expanded in February 2016 (81 FR 6099) to include the Aircraft Mechanic certificate with Airframe and/or Powerplant ratings. The task was further expanded in September 2017 to add the Sport Pilot and Recreational Pilot certificates in all airplane categories, and the Private Pilot, Commercial Pilot, ATP, and Instructor certificates and the Instrument rating in the remaining aircraft categories to include rotorcraft, powered-lift, and glider.1

    1 The ARAC Task Notice is available at: https://www.faa.gov/regulations_policies/rulemaking/committees/documents/index.cfm/document/information/documentID/3282.

    On June 21, 2018, the ARAC met and approved the Interim Final Report of the ACS WG. The Interim Final Report contained a recommendation for the Airline Transport Pilot and Type Rating for Airplane (ATP/Type Rating) ACS. The FAA received that recommendation from ARAC on June 22, 2018. The FAA has reviewed the draft ATP/Type Rating ACS, made some changes based on internal feedback, and is now seeking comment from the public. A copy of the document has been placed in the docket for this action. The FAA will review and consider all comments received and make any necessary changes prior to issuing the final version of the ATP/Type Rating ACS. The final version of the ATP/Type Rating ACS will be published at https://www.faa.gov/training_testing/testing/acs/.

    Comments Invited

    The FAA invites interested persons to join in this notice and comment process by filing written comments, data, or views. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments or, if comments are filed electronically, commenters should submit only one time. More information on submitting comments can be found in the ADDRESSES section of this document.

    The FAA will review all comments it receives on or before the closing date for the comment period. The FAA will consider comments submitted after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may make changes based on the comments it receives.

    Issued in Washington, DC, on October 16, 2018. Lirio Liu, Executive Director, Office of Rulemaking, Federal Aviation Administration.
    [FR Doc. 2018-23013 Filed 10-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 112 [Docket No. FDA-2018-D-3631] Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of availability.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” The draft guidance, when finalized, will provide FDA's current thinking and recommendations to help covered farms comply with the final regulation entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (Produce Safety Rule), which established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption.

    DATES:

    Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2018-D-3631 for “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

    FOR FURTHER INFORMATION CONTACT:

    Samir Assar, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.

    SUPPLEMENTARY INFORMATION:

    I. Background

    We are announcing the availability of a draft guidance for industry entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    We intend to conduct four public meetings in diverse regions of the United States to discuss the draft guidance, and we will provide details about these public meetings in a notice published in the Federal Register.

    The Produce Safety Rule (80 FR 74353) established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. Requirements of the rule focus on major routes of contamination, including health and hygiene; biological soil amendments of animal origin; domesticated and wild animals; and equipment, tools, and buildings.

    This draft guidance provides recommendations, examples, and information related to compliance and implementation of the following subparts of the Produce Safety Rule:

    Subpart A—General Provisions

    Subpart C—Personnel Qualifications and Training

    Subpart D—Health and Hygiene

    Subpart F—Biological Soil Amendments of Animal Origin and Human Waste

    Subpart I—Domesticated and Wild Animals

    Subpart K—Growing, Harvesting, Packing, and Holding Activities

    Subpart L—Equipment, Tools, Buildings, and Sanitation

    Subpart O—Records

    Subpart P—Variances

    This draft guidance is based on FDA's current thinking and we believe that additional information would assist us in developing the final guidance. While we invite comments on all aspects of the draft guidance, we seek specific comments, information, and data on the following:

    For equipment and tools intended to or likely to contact covered produce:

    • When acquiring equipment and tools, how do you engage with equipment and tool suppliers about the size, design, and construction of your buildings so that they can accommodate the equipment and tools?

    • What information or data can you provide about cleaning, sanitizing, and maintenance practices and procedures for equipment and tools that have wood, foam, or other porous or absorbent materials?

    For domesticated and wild animals:

    • What data or information can you provide about factors or conditions that would affect the likelihood of contamination of covered produce by animals? Such factors include, for example, historical information and conditions on or near farms that influence animal habitats.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 112 have been approved under OMB control number 0910-0816.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

    Dated: October 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-23006 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA-2018-D-3583] Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of availability.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.” The draft guidance, when finalized, will supersede a previous guidance, entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,” that we issued in 2008. The draft guidance is intended to explain our current thinking on how to comply with recently modernized requirements for current good manufacturing practice (CGMP) and with new requirements for hazard analysis and risk-based preventive controls under our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” during the production of fresh-cut produce.

    DATES:

    Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2018-D-3583 for “Guide to Minimize Food Safety Hazards of Fresh-cut Produce: Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Office of Food Safety, Division of Produce Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

    FOR FURTHER INFORMATION CONTACT:

    Insook Son, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1648.

    SUPPLEMENTARY INFORMATION:

    I. Background

    We are announcing the availability of a draft guidance for industry entitled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d).

    In 2008, we issued a guidance for industry entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables.” Fresh-cut fruits and vegetables mean any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking). That guidance was intended for all fresh-cut produce processing firms to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. It explained our thinking on how to comply with CGMP requirements that then were established in a regulation entitled “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food” (21 CFR part 110).

    In the Federal Register of September 17, 2015 (80 FR 55908), we published a final rule that, among other things, modernized the CGMP requirements and established them in new 21 CFR part 117 (part 117), entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Part 117 also includes new requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities. The draft guidance that we are making available for public comment is intended to explain our current thinking on how all food establishments that produce fresh-cut produce can comply with the modernized CGMP requirements in part 117. The draft guidance also is intended to explain our current thinking on how fresh-cut produce food facilities that are subject to the new requirements for hazard analysis and risk-based preventive controls can comply with those requirements.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB control number 0910-0751.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

    Dated: October 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-23005 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0948] RIN 1625-AA00 Safety Zone; Delaware River; Camden, NJ; Fireworks Display AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a temporary safety zone on a portion of the Delaware River in Camden, NJ. This action is necessary to protect the surrounding public and vessels on these navigable waters adjacent to the Battleship New Jersey Museum and Memorial, Camden, NJ, during a fireworks display on November 14, 2018. This proposed rulemaking would prohibit persons and vessels from entering, transiting, or remaining within the safety zone unless authorized by the Captain of the Port Delaware Bay or a designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before November 6, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2018-0948 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email Petty Officer Thomas Welker, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division; telephone 215-271-4814, email [email protected].

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    On September 14, 2018, Rexel, Inc notified the Coast Guard that it will be conducting a fireworks display from 8:35 p.m. to 8:55 p.m. on November 14, 2018. The fireworks are to be launched from a barge in the Delaware River adjacent to the Battleship New Jersey Museum and Memorial, Camden, NJ. Hazards from fireworks displays include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The Captain of the Port Delaware Bay (COTP) has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within a 600-foot radius of the barge.

    The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within a 600-foot radius of the fireworks barge before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.

    III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from approximately 8:15 p.m. through 9:15 p.m. on November 14, 2018. The safety zone would cover all navigable waters within 600 feet of a fireworks barge in the Delaware River adjacent to the Battleship New Jersey Museum and Memorial, Camden, NJ. The barge will be anchored in approximate position 39°56′20″ N Latitude, 075°08′08″ W Longitude. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 8:35 p.m. to 8:55 p.m. fireworks display. No vessel or person would be permitted to enter, transit, or remain within the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which would impact a small designated area of the Delaware River for one hour during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

    B. Impact on Small Entities

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

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

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a safety zone lasting one hour that would prohibit entry within 600 feet of a fireworks barge. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

    Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T05-0948 to read as follows:
    § 165.T05-0948 Safety Zone; Delaware River; Camden, NJ; Fireworks Display.

    (a) Location. The following area is a safety zone: all waters of the Delaware River within a 600-foot radius of the fireworks barge, which will be anchored in approximate position 39°56′20″ N Latitude 075°08′08″ W Longitude. All coordinates are based on Datum NAD 1983.

    (b) Definitions. As used in this section, designated representative means a Coast Guard Patrol Commander, including a Coast Guard petty officer, warrant or commissioned officer on board a Coast Guard vessel or on board a federal, state, or local law enforcement vessel assisting the Captain of the Port, Delaware Bay in the enforcement of the safety zone.

    (c) Regulations. (1) Under the general safety zone regulations in subpart C of this part—

    (i) You may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative; and

    (ii) All persons and vessels in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

    (2) To request permission to enter the safety zone, contact the COTP or the COTP's representative on marine band radio VHF-FM channel 16 (156.8 MHz) or 215-271-4807.

    (3) No vessel may take on bunkers or conduct lightering operations within the safety zone during the enforcement period.

    (4) This section applies to all vessels except those engaged in law enforcement, aids to navigation servicing, and emergency response operations.

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

    (e) Enforcement period. This zone will be enforced from 8:15 p.m. through 9:15 p.m. on November 14, 2018.

    Dated: October 15, 2018. S.E. Anderson, Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
    [FR Doc. 2018-22911 Filed 10-19-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2017-0170; FRL-9985-39-Region 10] Air Plan Approval; ID, West Silver Valley PM2.5 Clean Data Determination AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) proposes to determine that the West Silver Valley, Idaho nonattainment area has clean data for the 2012 annual fine particulate matter (PM2.5) National Ambient Air Quality Standard (NAAQS). This proposed clean data determination (CDD) is based upon quality-assured, quality-controlled, and certified ambient air monitoring data showing the area has attained the 2012 PM2.5 NAAQS based on the 2015-2017 data available in the EPA's Air Quality System (AQS) database. The EPA also proposes to take final agency action on the September 2017 wildfire exceptional event at the Pinehurst monitoring station, pursuant to EPA regulations, as having affected PM2.5 and PM10 values. Based on the proposed clean data determination, the EPA is also proposing to determine that the obligation for Idaho to make submissions to meet certain Clean Air Act (CAA or the Act) requirements related to attainment of the NAAQS for this area are not applicable for as long as the area continues to attain the 2012 annual PM2.5 NAAQS.

    DATES:

    Written comments must be received on or before November 21, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R10-OAR-2017-0170, at https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Justin Spenillo, at 206-553-6125, or [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, wherever “we”, “us” or “our” are used, it is intended to refer to the EPA.

    Table of Contents I. Background II. Clean Data Determination for the West Silver Valley, Idaho Nonattainment Area III. The EPA's Proposed Action IV. Statutory and Executive Order Reviews I. Background

    On December 14, 2012, the Environmental Protection Agency (EPA) promulgated a revised primary annual PM2.5 NAAQS to provide increased protection of public health from fine particle pollution (“2012 annual PM2.5 NAAQS”).1 In that action, the EPA strengthened the primary annual PM2.5 standard, lowering the level from 15.0 micrograms per cubic meter (µg/m3) to 12.0 µg/m3. The 2012 annual PM2.5 NAAQS is attained when the 3-year average of the annual arithmetic means does not exceed 12.0 µg/m3. See 40 CFR 50.18 and 40 CFR part 50, appendix N. Effective April 15, 2015, the EPA made designation determinations, as required by section 107(d)(1) of the CAA, for the 2012 annual PM2.5 NAAQS.2 In that action, the EPA designated the West Silver Valley area in Shoshone County, Idaho (WSV NAA) as moderate nonattainment for the 2012 annual PM2.5 NAAQS. See 40 CFR 81.313.

    1 78 FR 3086, January 15, 2013.

    2 80 FR 2206.

    On March 26, 2018, the EPA issued a finding of failure to submit under section 110(k) of the CAA finding that several states, including Idaho, failed to submit specific moderate area SIP elements for the 2012 annual PM2.5 NAAQS required under subpart 4 of part D of Title I of the CAA.3 In particular, Idaho failed to submit the following specific moderate area SIP elements for the WSV NAA: An attainment demonstration; control strategies, including reasonably available control measures (“RACM”) and reasonably available control technologies (“RACT”); a reasonable further progress (RFP) plan; quantitative milestones; and contingency measures. This finding triggered the sanctions clock under Section 179 of the CAA, as well as an obligation under Section 110(c) of the CAA for EPA to promulgate a FIP no later than 2 years from the effective date of the finding, if Idaho does not submit, and the EPA has not approved, the required SIP submission.

    3 83 FR 14759.

    On August 24, 2016, the EPA issued the Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements (“PM2.5 SIP Requirements Rule”).4 The PM2.5 SIP Requirements Rule is codified at 40 CFR part 51, subpart Z and provides rules for the implementation of current and future PM2.5 NAAQS.

    4 81 FR 58010, effective October 24, 2016.

    Over the past 2 decades, the EPA has consistently applied its “Clean Data Policy” interpretation to attainment related provisions of subparts 1, 2, and 4 of the CAA. The EPA codified the approach in the Clean Data Policy in the PM2.5 SIP Requirements Rule (40 CFR 51.1015(a)) for the implementation of current and future PM2.5 NAAQS. See 81 FR 58010, 58161 (August 24, 2016). In accordance with 40 CFR 51.1015, the EPA may issue a clean data determination for a specific area if the EPA determines the area has attained the relevant NAAQS based on 3 years of quality-assured, certified air quality monitoring data. For a complete discussion of the Clean Data Policy's history and the EPA's longstanding interpretation under the CAA, please refer to the August 24, 2016 PM2.5 SIP Requirements Rule (81 FR 58010).

    As provided in 40 CFR 51.1015, so long as an area continues to meet the standard, finalization of a CDD suspends the requirements for a nonattainment area to submit an attainment demonstration, associated RACM and RACT, an RFP plan, quantitative milestones, contingency measures, and any other SIP requirements related to the attainment of the 2012 annual PM2.5 NAAQS. The requirement to submit a projected attainment inventory as part of an attainment demonstration or RFP plan is also suspended by this determination. As discussed in the 2016 PM2.5 SIP Requirements Rule, the nonattainment base emissions inventory required by section 172(c)(3) of the CAA is not suspended by this determination because the base inventory is a requirement independent of planning for an area's attainment. See 81 FR 58009 at 58028 and 58127-8 and 80 FR 15340 at 15441-2. Additionally, as discussed in the PM2.5 SIP Requirements Rule, and required by sections 110(a)(2)(C); 172(c)(5); 173; 189(a), and 189(e) of the CAA, nonattainment New Source Review (NNSR) requirements are not suspended by a CDD because this requirement is independent of the area's attainment planning. See 81 FR 58010 at 58107 and 58127.

    By extension, the requirement to submit a motor vehicle emissions budget (MVEB) for the attainment year for the purposes of transportation conformity is also suspended. A MVEB is that portion of the total allowable emissions defined in the submitted or approved control strategy implementation plan revision or maintenance plan for a certain date for the purpose of meeting RFP milestones or demonstrating attainment or maintenance of the NAAQS, for any criteria pollutant or its precursors, allocated to highway and transit vehicle use and emissions. For the purposes of the transportation conformity regulations, the control strategy implementation plan revision is the implementation plan which contains specific strategies for controlling the emissions of and reducing ambient levels of pollutants in order to satisfy CAA requirements for demonstrations of RFP and attainment. Given that MVEBs are required to support the RFP and attainment demonstration requirements in the attainment plan, suspension of the RFP and attainment demonstration requirements through a CDD, also suspends the requirement to submit MVEBs for the attainment and RFP years. The suspension of planning requirements pursuant to 40 CFR 51.1015, does not preclude the state from submitting suspended elements of its moderate area attainment plan for EPA approval for the purposes of strengthening the state's SIP.

    The suspension of the obligation to submit such requirements applies regardless of when the plan submissions are due. A clean data determination is not equivalent to a redesignation, and the state must still meet the statutory requirements for redesignation in order to be redesignated to attainment.

    In accordance with 40 CFR 51.1015(a)(1) and (2), the CDD suspends the aforementioned SIP obligations until such time as the area is redesignated to attainment, after which such requirements are permanently discharged; or the EPA determines that the area has re-violated the PM2.5 NAAQS, at which time the state shall submit such attainment plan elements for the moderate nonattainment area by a future date to be determined by the EPA and announced through publication in the Federal Register at the time the EPA determines the area is violating the 2012 annual PM2.5 NAAQS.

    II. Clean Data Determination for the West Silver Valley, Idaho Nonattainment Area Air Quality Data

    Under the EPA regulations at 40 CFR 50.18 and part 50, appendix N, the 2012 annual PM2.5 NAAQS is met when the 3-year average of PM2.5 annual mean mass concentrations for each eligible monitoring site is less than or equal to 12.0 μg/m3. Three years of valid, annual means are required to produce a valid annual PM2.5 NAAQS design value. A year of data meets data completeness requirements when quarterly data capture rates for all four quarters are at least 75 percent from eligible monitoring sites. See 40 CFR part 50, appendix N. There is one PM2.5 eligible monitoring site in the WSV NAA, located in Pinehurst, Idaho. Table 1 shows the WSV NAA design value for the 2012 annual PM2.5 NAAQS for the years 2015-2017 at that Pinehurst, Idaho monitoring site.

    Table 1—2015-2017 Annual PM2.5 Values for West Silver Valley, Shoshone, Idaho Monitor ID Weighted mean
  • (μg/m3)
  • 2015 2016 2017 Complete
  • quarters
  • 2015 2016 2017 Certified
  • annual design
  • value
  • 2015-2017
  • (μg/m3)
  • 160790017 13.6 9.3 12.3 4 4 4 11.7

    Consistent with the requirements contained in 40 CFR part 58, the EPA has reviewed the PM2.5 ambient air quality monitoring data for the monitoring period from 2015 through 2017 for the WSV NAA, as recorded in the AQS database, and has determined the data meet the quality assurance requirements set forth in part 58. In this respect, the data have been deemed usable by the EPA for regulatory compliance purposes. As shown in Table 1, each quarter from 2015 through 2017 is complete with all four quarters reporting data capture rates of at least 75 percent. The certified annual design value for 2015-2017 is 11.7 μg/m3, which is below the 2012 annual PM2.5 standard of 12.0 μg/m3. Therefore, the WSV NAA has attained the 2012 annual PM2.5 NAAQS in accordance with the requirements in 40 CFR part 50, section 50.18 and appendix N.

    Exceptional Event

    The CAA allows for the exclusion of air quality monitoring data from design value calculations when there are exceedances caused by events, such as wildfires or high wind events, that meet the criteria for an exceptional event identified in the EPA's implementing regulations, the Exceptional Events Rule at 40 CFR 50.1, 50.14 and 51.930. In 2017, emissions from multiple wildfires in the Pacific Northwest impacted PM2.5 and PM10 concentrations recorded at the Pinehurst monitor within the WSV NAA. For purposes of this proposed action, on August 10, 2018, the Idaho Department of Environmental Quality (IDEQ) submitted an exceptional event demonstration to request exclusion of the 2017 data impacted by wildfires. The EPA evaluated the IDEQ's exceptional event demonstration for the flagged values of the 24-hour PM2.5 and PM10 listed in Table 2, at the monitor in Pinehurst, Idaho, with respect to the requirements of the EPA's Exceptional Events Rule (40 CFR 50.1, 50.14, and 50.930). The EPA determined the event and the IDEQ's demonstration met the exceptional event rule requirements.

    Table 2—24-hr PM2.5 and PM10 Values at the Pinehurst Monitoring Station, Concurred on by the EPA as Meeting the Exceptional Event Criteria Date 24-hr PM2.5
  • concentration
  • (µg/m3)
  • 16-079-0017 POC1
  • 24-hr PM10
  • concentration
  • (µg/m3)
  • 16-079-0017 POC3
  • 9/4/2017 144.9 9/5/2017 222.2 9/6/2017 147.1 169.6 9/7/2017 123.8 149.8 9/8/2017 116.7 143.7

    On August 24, 2018, the EPA concurred with the IDEQ's request to exclude event-influenced data listed in Table 2. As such, the event-influenced data have been removed from the data set used for regulatory purposes. For this proposed action, the EPA relies on the calculated values that exclude the event-influenced data (see Table 1, above). The EPA now proposes to take final regulatory action on the IDEQ's request to exclude PM10 and PM2.5 data listed in Table 2, in regulatory decisions. For further information, refer to the IDEQ's Exceptional Event demonstration package and the EPA's concurrence and analysis located in the docket for this proposed action.

    III. The EPA's Proposed Action

    Pursuant to the Clean Data Policy codified at 40 CFR 51.1015(a), the EPA proposes to determine that based on 3-years of certified, valid monitoring data between 2015 and 2017, the WSV NAA has attained the 2012 annual PM2.5 NAAQS. The EPA also proposes to take final agency action on the wildfire exceptional event that affected the Pinehurst monitor as listed in Table 2 for both PM2.5 and PM10. Pursuant to 40 CFR 51.1015(a), and based upon our proposed determination that the WSV NAA has attained the standard, the EPA proposes to determine that the obligation to submit any attainment-related SIP revisions arising from classification of the WSV NAA as a moderate nonattainment area under subpart 4 of part D, of title I of the Act for the 2012 annual PM2.5 NAAQS is not applicable for so long as the area continues to attain the 2012 annual PM2.5 NAAQS. In particular, if the EPA finalizes this determination, it will suspend the requirements for the area to submit an attainment demonstration, RACM and RACT, RFP plan, quantitative milestones, contingency measures, and any other SIP requirements related to the attainment of the 2012 annual PM2.5 NAAQS, so long as the area continues to meet the standard. If today's action is finalized as proposed, the sanctions and FIP clocks triggered by the EPA's March 26, 2018, finding of failure to submit will be suspended. See 83 FR 14759.

    This proposed determination of attainment does not constitute a redesignation to attainment. The WSV NAA will remain designated nonattainment for the 2012 annual PM2.5 NAAQS until the EPA determines the WSV NAA meets the CAA requirements for redesignation to attainment, including an approved maintenance plan, pursuant to sections 107 and 175A of the CAA. The EPA is soliciting public comments on EPA's proposed action. These comments will be considered before taking final action.

    IV. Statutory and Executive Order Reviews

    This action proposes to exclude certain air quality monitoring data from design value calculations and suspend certain federal requirements, and thus would not impose additional requirements beyond those imposed by state law. For these reasons, this proposed action:

    • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

    • is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

    • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

    • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

    • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

    • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

    • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

    • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and

    • does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this proposed action does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP obligations discussed herein do not apply to Indian tribes and, thus, this proposed action will not impose substantial direct costs on tribal governments or preempt tribal law.

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Particulate matter, Reporting and recordkeeping requirements.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: October 3, 2018. Chris Hladick, Regional Administrator, Region 10.
    [FR Doc. 2018-22285 Filed 10-19-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 85 and 86 DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Parts 523, 531, 533, 536, and 537 [NHTSA-2018-0067; EPA-HQ-OAR-2018-0283; FRL-9984-62-OAR; NHTSA-2017-0069] RIN 2127-AL76; 2060-AU09 The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks AGENCY:

    Environmental Protection Agency and National Highway Traffic Safety Administration.

    ACTION:

    Proposed rule; correction.

    SUMMARY:

    This document corrects information in the proposed rule published in the August 24, 2018 issue of the Federal Register entitled The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks. Specifically, a table in the Paperwork Reduction Act section is corrected; two minor changes are made to one amendatory instruction in NHTSA's regulatory text, and the coefficients specifying the proposed carbon dioxide standards in EPA's regulatory text have been corrected to reflect EPA's proposal to exclude credits for direct A/C emissions for purposes of compliance with carbon dioxide standards after model year 2020, as explained in Section III of the proposed rule. This document contains only clerical corrections and makes no updates to either the proposal or to the analysis underlying the proposal. For the reader's information, an updated Preliminary Regulatory Impact Assessment (PRIA) will also be made available concurrent with this notice; that document will include descriptions starting on the second page detailing the corrections to various tables and figures therein.

    DATES:

    Comments for the proposed rule must be received on or before October 26, 2018.

    FOR FURTHER INFORMATION CONTACT:

    EPA: Christopher Lieske, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: (734) 214-4584; fax number: (734) 214-4816; email address: [email protected], or contact the Assessment and Standards Division, email address: [email protected] NHTSA: James Tamm, Office of Rulemaking, Fuel Economy Division, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone number: (202) 493-0515.

    SUPPLEMENTARY INFORMATION:

    In the proposed rule beginning at 83 FR 42986, in the issue of August 24, 2018, make the following corrections:

    On page 43480, replace the existing Table XII-2 with the following table:

    Table XII-2—Estimated Burden for Reporting Requirements Manufacturers Hours Cost Government Hours Cost Prior Collection 3,189.00 $24,573.50 975.00 $31,529.00 Current Collection 3,774.5 187,530.82 3,038.00 141,246.78 Difference 585.50 162,957.32 2,063.00 109,717.78

    On page 43489, third column, remove the first instance of instruction 16 and in the second, in paragraph (a)(4)(ii) correct “8,877” to read “8,887.”

    On page 43494, replace existing Table 1 to Paragraph (c)(2)(i)(A) with the following table:

    Model year CO2
  • target value
  • (grams/mile)
  • 2012 244.0 2013 237.0 2014 228.0 2015 217.0 2016 206.0 2017 195.0 2018 185.0 2019 175.0 2020 166.0 2021 and later 182.0

    On Page 43495 replace Table 1 to Paragraph (c)(2)(i)(B) with the following table:

    Model year CO2
  • target value
  • (grams/mile)
  • 2012 315.0 2013 307.0 2014 299.0 2015 288.0 2016 277.0 2017 263.0 2018 250.0 2019 238.0 2020 226.0 2021 and later 244.0

    On Page 43496 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(2)(i)(C)” with the following table header and table:

    Table 1 to Paragraph (c)(2)(i)(C) Model year a b 2012 4.72 50.5 2013 4.72 43.3 2014 4.72 34.8 2015 4.72 23.4 2016 4.72 12.7 2017 4.53 8.9 2018 4.35 6.5 2019 4.17 4.2 2020 4.01 1.9 2021 and later 4.09 14.6

    On Page 43497 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(3)(i)(A)” with the following table header and table:

    Table 1 to Paragraph (c)(3)(i)(A) Model year CO2
  • target value
  • (grams/mile)
  • 2012 294.0 2013 284.0 2014 275.0 2015 261.0 2016 247.0 2017 238.0 2018 227.0 2019 220.0 2020 212.0 2021 and later 227.0

    On Page 43498 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(3)(i)(B)” with the following table header and table:

    Table 1 to Paragraph (c)(3)(i)(B) Model year Maximum footprint a b 2012 66.0 4.04 128.6 2013 66.0 4.04 118.7 2014 66.0 4.04 109.4 2015 66.0 4.04 95.1 2016 66.0 4.04 81.1 2017 50.7 4.87 38.3 2018 60.2 4.76 31.6 2019 66.4 4.68 27.7 2020 68.3 4.57 24.6 2021 and later 68.3 4.57 39.9

    On Page 43499 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(3)(i)(D)” with the following table header and table:

    Table 1 to Paragraph (c)(3)(i)(D) Model year Minimum
  • footprint
  • CO2
  • target value
  • (grams/mile)
  • 2012 66.0 395.0 2013 66.0 385.0 2014 66.0 376.0 2015 66.0 362.0 2016 66.0 348.0 2017 66.0 347.0 2018 66.0 342.0 2019 66.4 339.0 2020 68.3 337.0 2021 and later 68.3 352.0
    Issued on October 16, 2018 in Washington, DC, under authority delegated in 49 CFR 1.95 and 501.5. Heidi R. King, Deputy Administrator, National Highway Traffic Safety Administration. Dated: October 16, 2018. William L. Wehrum, Assistant Administrator for Air and Radiation, Environmental Protection Agency.
    [FR Doc. 2018-22976 Filed 10-19-18; 8:45 am] BILLING CODE 4910-59-P
    83 204 Monday, October 22, 2018 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request October 16, 2018.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by November 21, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Agricultural Research Service

    Title: Patent License Application.

    OMB Control Number: 0518-0003.

    Summary of Collection: Public Law 96-517, HR 209 (Technology Transfer Commercialization Act of 2000), and 37 CFR part 404 requires Federal agencies to use the patent system to promote the utilization of inventions arising from federally supported research and provide the authority to grant patent licenses. 37 CFR 404.8 specifies the information which must be submitted by a patent license applicant to the Federal agency having custody of a patent. Form ADS-761 collects the information specified under 37 CFR 404.8.

    Need and Use of the Information: The Agricultural Research Service (ARS) will collect identifying information on the applicant, identifying information for the business, and a detailed description for development and/or marketing of the invention using form AD-761. The information collected is used to determine whether the applicant has both a complete and sufficient plan for developing and marketing the invention and the necessary manufacturing, marketing, technical, and financial resources to carry out the submitted plan.

    Description of Respondents: Business or other for profit; Not-for-profit institutions; Individuals or households.

    Number of Respondents: 75.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 225.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-22876 Filed 10-19-18; 8:45 am] BILLING CODE 3410-03-P
    DEPARTMENT OF AGRICULTURE U.S. Codex Office Codex Alimentarius Commission: Meeting of the Codex Committee on Spices and Culinary Herbs AGENCY:

    U.S. Codex Office, USDA.

    ACTION:

    Notice of public meeting and request for comments.

    SUMMARY:

    The U.S Codex Office is sponsoring a public meeting on December 5, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 4th Session of the Codex Committee on Spices and Culinary Herbs (CCSCH) of the Codex Alimentarius Commission, in Thiruvananthapuram, India, January 21-25, 2019. The U.S. Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs, recognize the importance of providing interested parties the opportunity to obtain background information on the 4th Session of the CCSCH and to address items on the agenda.

    DATES:

    The public meeting is scheduled for Wednesday, December 5, 2018 from 2 p.m. to 4 p.m.

    ADDRESSES:

    The public meeting will take place at the United States Department of Agriculture (USDA), Jamie L. Whitten Building, 1400 Independence Avenue SW, Room 107-A, Washington, DC 20250. Documents related to the 4th Session of the CCSCH will be accessible via the internet at the following address: http://www.codexalimentarius.org/meetings-reports/en.

    Dorian LaFond, U.S. Delegate to the 4th Session of the CCSCH invites U.S. interested parties to submit their comments electronically to the following email address: [email protected]

    Call-In-Number: If you wish to participate in the public meeting for the 4th Session of the CCSCH by conference call, please use the call-in-number: 1-888-844-9904.

    The participant code will be posted on the following web page: http://www.usda.gov/codex.

    Registration: Attendees may register to attend the public meeting by emailing [email protected] by November 20th, 2018. Early registration is encouraged because it will expedite entry into the building. The meeting will take place in a Federal building. Attendees should bring photo identification and plan for adequate time to pass through the security screening systems. Attendees who are not able to attend the meeting in person, but who wish to participate, may do so by phone, as discussed above.

    For Further Information about the 4th Session of the CCSCH Contact: Dorian LaFond, International Standards Coordinator, Fruit and Vegetables Program, Specialty Crop Inspection Division, Agricultural Marketing Service, 1400 Independence Avenue SW, Mail Stop 0247, Washington DC 20250-0247. Phone: +1 (202) 690-4944. Email: [email protected]

    For Further Information about the Public Meeting Contact: Marie Maratos, U.S. Codex Office, 1400 Independence Avenue SW, Room 4861, South Agriculture Building, Washington, DC 20250. Phone: (202) 690-4795, Fax: (202) 720-3157, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization. Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.

    The CCSCH is responsible for elaborating worldwide standards for spices and culinary herbs in their dried and dehydrated state in whole, ground, and cracked or crushed form and consulting, as necessary, with other international organizations in the standards development process to avoid duplication.

    The CCSCH is hosted by India. The U.S. attends CCSCH as a member country of Codex.

    Issues To Be Discussed at the Public Meeting

    The following items on the Agenda for the 4th Session of the CCSCH will be discussed during the public meeting:

    • Matters referred by the Codex Alimentarius Commission and its subsidiary bodies • Oregano—Proposed Draft Standard for Dried Oregano • Dried Roots, Rhizomes and Bulbs—Proposed draft Standard for Dried Dehydrated Ginger • Proposed Draft Standard for Dried Garlic • Dried Fruits and Berries—Proposed Draft Standard for Dried Chilli Peppers and Paprika • Dried Herbs—Proposed Draft Standard for Dried Basil • Dried Seeds—Proposed Draft Standard for Dried Nutmeg • Dried Floral Parts—Proposed Draft Standard for Dried Cloves • Proposed Draft Standard for Dried Saffron • Proposals for new work • Other business • Date and place of the next session Public Meeting

    At the December 6, 2018, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Dorian LaFond, U.S. Delegate for the 4th Session of the CCSCH (see ADDRESSES). Written comments should state that they relate to activities of the 4th Session of the CCSCH.

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this Federal Register publication on-line through the USDA web page located at: http://www.usda.gov/codex/, a link that also offers an email subscription service providing access to information related to Codex. Customers can add or delete their subscription themselves, and have the option to password protect their accounts.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email.

    Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.

    Fax: (202) 690-7442, Email: [email protected]

    Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington DC on October 16, 2018. Mary Lowe, U.S. Manager for Codex Alimentarius.
    [FR Doc. 2018-22873 Filed 10-19-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF AGRICULTURE National Institute of Food and Agriculture Solicitation of Veterinary Shortage Situation Nominations for the Veterinary Medicine Loan Repayment Program (VMLRP) AGENCY:

    National Institute of Food and Agriculture, USDA.

    ACTION:

    Notice and solicitation for nominations.

    SUMMARY:

    The National Institute of Food and Agriculture (NIFA) is soliciting nominations of veterinary service shortage situations for the Veterinary Medicine Loan Repayment Program (VMLRP) for fiscal year (FY) 2019, as authorized under the National Veterinary Medical Services Act (NVMSA). This notice initiates the nomination period and prescribes the procedures and criteria to be used by eligible nominating officials (State, Insular Area, DC and Federal Lands) to nominate veterinary shortage situations. Each year all eligible nominating officials may submit nominations, up to the maximum indicated for each entity in this notice. NIFA is conducting this solicitation of veterinary shortage situation nominations under an approved information collection (OMB Control Number 0524-0050).

    DATES:

    Shortage situation nominations must be submitted not later than 30 days after the publication of this notice.

    ADDRESSES:

    Submissions must be made by clicking the submit button on the Veterinarian Shortage Situation nomination form provided in the VMLRP Shortage Situations section of the NIFA website at www.nifa.usda.gov/vmlrp.

    This form is sent as a data file directly to the Veterinary Medicine Loan Repayment Program; National Institute of Food and Agriculture; U.S. Department of Agriculture.

    FOR FURTHER INFORMATION CONTACT:

    Michelle Colby; National Program Leader; National Institute of Food and Agriculture; U.S. Department of Agriculture; STOP 2240 1400 Independence Avenue SW, Washington, DC 20250-2220; Voice: 202-401-4202; Fax: 833-208-8205; Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Background and Purpose

    Food supply veterinary medicine embraces a broad array of veterinary professional activities, specialties and responsibilities, and is defined as all aspects of veterinary medicine's involvement in food supply systems, from traditional agricultural production to consumption. A series of studies and reports 1 2 3 4 5 6 have drawn attention to maldistributions in the veterinary workforce leaving some communities, especially rural areas, with insufficient access to food supply veterinary services.

    1 Government Accountability Office, Veterinary Workforce: Actions Are Needed to Ensure Sufficient Capacity for Protecting Public and Animal Health, GAO-09-178: Feb. 18, 2009;

    2 National Academies of Science, Workforce Needs in Veterinary Medicine, 2013.

    3 Andrus DM, Gwinner KP, Prince, JB. Food Supplyn Veterinary Medicine Coaltion Report: Estimating FSM Demand and Maintaining the Availability of Veterinarians in Food Supply Related Disciplines in the United States and Canada, 2016. https://www.avma.org/KB/Resources/References/Pages/Food-Supply-Veterinary-Medicine-Coalition-Report.aspx.

    4 Andrus DM, Gwinner KP, Prince, JB. Future demand, probable shortgages and strategies for creating a better future in food supply veterinary medicine, 2006, JAVMA 229(1) :57-69.

    5 Andrus DM, Gwinner KP, Prince, JB. Attracting students to careers in food supply veterinary medicine. 2006, JAVMA 228(1) :16931704.

    6 Andrus DM, Gwinner KP, Prince, JB. Job satisfaction, changes in occupational area and commitment to a career in food supply veterinary medicine. 2006, JAVMA 228(12) :1884-1893.

    Two programs, born out of this concern, aim to mitigate the maldistribution of the veterinary workforce: The Veterinary Medicine Loan Repayment Program (VMLRP) and Veterinary Services Grant Program (VSGP), both administered by USDA-NIFA. VMLRP addresses increasing veterinary school debt by offering veterinary school debt payments in exchange for service in shortage situations, while VSGP addresses other factors contributing to the maldistribution of veterinarians serving the agricultural sector.

    Specifically, the VSGP promotes availability and access to (1) specialized education and training which will enable veterinarians and veterinary technicians to provide services in designated veterinarian shortage situations, and (2) practice-enhancing equipment and personnel resources to enable veterinary practices to expand or improve access to veterinary services.

    Paperwork Reduction Act

    In accordance with the Office of Management and Budget (OMB) regulations (5 CFR part 1320) that implement the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements imposed by the implementation of these guidelines have been approved by OMB Control Number 0524-0050.

    Table of Contents in Guidelines for Veterinary Shortage Situation Nominations I. Preface and Authority II. Nomination of Veterinary Shortage Situations A. General 1. Eligible Shortage Situations 2. Authorized Respondents and Use of Consultation 3. State Allocation of Nominations 4. FY 2019 Shortage Situation Nomination Process 5. Submission and Due Date 6. Period Covered 7. Definitions B. Nomination Form C. NIFA Review of Shortage Situation Nominations 1. Review Panel Composition and Process 2. Review Criteria Guidelines for Veterinary Shortage Situation Nominations I. Preface and Authority

    In January 2003, the National Veterinary Medical Service Act (NVMSA) was passed into law adding section 1415A to the National Agricultural Research, Extension, and Teaching Policy Act of 1997 (NARETPA). This law established a new Veterinary Medicine Loan Repayment Program (7 U.S.C. 3151a) authorizing the Secretary of Agriculture to carry out a program of entering into agreements with veterinarians under which they agree to provide veterinary services in veterinarian shortage situations in return for repayment of qualified educational loans. In FY 2010, NIFA announced the first funding opportunity for the VMLRP.

    Section 7104 of the 2014 Farm Bill (Pub. L. 113-79) added section 1415B to NARETPA, as amended, (7 U.S.C. 3151b) to establish the Veterinary Services Grant Program (VSGP). This amendment authorizes the Secretary of Agriculture to make competitive grants to qualified entities and individual veterinarians that carry out programs in veterinarian shortage situations and for the purpose of developing, implementing, and sustaining veterinary services. Funding for the VSGP was first appropriated in FY 2016 through the Consolidated Appropriations Act, 2016 (Pub. L. 114-113).

    Pursuant to the requirements enacted in the NVMSA of 2004 (as revised), and the implementing regulation for this Act, Part 3431 Subpart A of the VMLRP Final Rule [75 FR 20239-20248], NIFA hereby implements guidelines for eligible nominating officials to nominate veterinary shortage situations for the FY 2018 program cycle.

    II. Nomination of Veterinary Shortage Situations A. General 1. Eligible Shortage Situations

    Section 1415A of NARETPA, as amended and revised by Section 7105 of the Food, Conservation and Energy Act, directs determination of veterinarian shortage situations for the VMLRP to consider (1) geographical areas that the Secretary determines have a shortage of veterinarians; and (2) areas of veterinary practice that the Secretary determines have a shortage of veterinarians, such as food animal medicine, public health, epidemiology, and food safety. This section also added that priority should be given to agreements with veterinarians for the practice of food animal medicine in veterinarian shortage situations.

    While the NVMSA (as amended) specifies priority be given to food animal medicine shortage situations, and that consideration also be given to specialty areas such as public health, epidemiology and food safety, the Act does not identify any areas of veterinary practice as ineligible. Accordingly, all nominated veterinary shortage situations will be considered eligible for submission.

    A subset of the shortages designated for VMLRP applicants is also available to satisfy requirements, as applicable, for VSGP applicants. In addition, a shortage situation under the VSGP must also be designated rural as defined in section 343(a) of the Consolidated Farm and Rural Development Act (7 U.S.C. 1991(a)).

    Nominations describing either public or private practice veterinary shortage situations are eligible for submission.

    2. Authorized Respondents and Use of Consultation

    The only authorized respondent on behalf of each State is the chief State Animal Health Official (SAHO), as duly authorized by the Governor or the Governor's designee in each State. The only authorized respondent on behalf of the Federal Government is the Chief Federal Animal Health Officer (Deputy Administrator of Veterinary Services, the Animal and Plant Health Inspection Service or designee), as duly authorized by the Secretary of Agriculture. The eligible nominating official must submit nominations using the instructions provided in section A.4, FY 2018 Shortage Situation Nomination Process. NIFA strongly encourages the nominating officials to involve leading health animal experts in the State in the identification and prioritization of shortage situation nominations.

    3. State Allocation of Nominations

    NIFA will accept the number of nominations equivalent to the maximum number of designated shortage areas for each State. For historical background and more information on the rationale for capping nominations and State allocation method, visit https://nifa.usda.gov/vmlrp-nomination-and-designation-veterinary-shortage-situations.

    The maximum number of nominations (and potential designations) is based on data from the 2012 Agricultural Census conducted by the USDA National Agricultural Statistics Service (NASS). Awards from previous years have no bearing on a State's maximum number of allowable shortage nomination submissions or designations in any given year, or number of nominations or designations allowed for subsequent years. NIFA reserves the right in the future to proportionally adjust the maximum number of designated shortage situations per State to ensure a balance between available funds and the requirement to ensure that priority is given to mitigating veterinary shortages corresponding to situations of greatest need. Nomination Allocation tables for FY 2019 are available under the VMLRP Shortage Situations section of the VMLRP website at https://nifa.usda.gov/resource/vmlrp-shortage-allocations.

    Table I lists the maximum nomination allocations by State. Table II lists “Special Consideration Areas” which include any State or Insular Area not reporting data to NASS, reporting less than $1,000,000 in annual Livestock and Livestock Products Total Sales ($), and/or possessing less than 500,000 acres. One nomination is allocated to any State or Insular Area classified as a Special Consideration Area.

    Table III shows the values and quartile ranks of States for two variables broadly correlated with demand for food supply veterinary services: “Livestock and Livestock Products Total Sales ($)” (LPTS) and “Land Area (acres)” (LA). The maximum number of NIFA-designated shortage situations per State is based on the sum of quartile rankings for LPTS and LA for each State and can be found in Table IV.

    While Federal Lands are widely dispersed within States and Insular Areas across the country, they constitute a composite total land area over twice the size of Alaska. If the 200-mile limit for U.S. coastal waters and associated fishery areas are included, Federal Land total acreage would exceed 1 billion. Both State and Federal Animal Health officials have responsibilities for matters relating to terrestrial and aquatic food animal health on Federal Lands. Interaction between wildlife and domestic livestock, such as sheep and cattle, is particularly common in the plains States where significant portions of Federal lands are leased for grazing. Therefore, both SAHOs and the Chief Federal Animal Health Officer (Deputy Administrator of Veterinary Services, the Animal and Plant Health Inspection Service or designee) may submit nominations to address shortage situations on or related to Federal Lands. Nominations related to Federal Lands submitted by SAHOs will count towards the maximum number of nominations for that individual state.

    NIFA emphasizes that the shortage nomination allocation is set to broadly balance the number of designated shortage situations across States prior to the nomination and award phases of the VMLRP and VSGP. Awards will be made based strictly on the peer review panel's assessment according to each program's review criteria; thus no State will be given a preference for placement of awardees. Additionally, each designated shortage situation will be limited to one award per program.

    4. FY 2019 Shortage Situation Nomination Process

    For the FY 2019 program cycle, all eligible nominating officials submitting may: (1) Request to retain designated status for any shortage situation successfully designated in FY 2018 and/or (2) submit new nominations. Any shortage from FY 2018 not retained or submitted as a new nomination will not be considered a shortage situation in FY 2019. The total number of new nominations plus designated nominations retained (carried over) may not exceed the maximum number of nominations each eligible nominating official is permitted.

    The following process is the mechanism for retaining a designated nomination: Each nominating official should review the map of VMLRP designated shortage situations for FY 2018 (https://go.usa.gov/xUhqW) and download a PDF copy of the nomination form for each designated area that remains open (not awarded) in FY 2018. If the nominating official wishes to retain (carry over) one or more designated nomination(s), the nominating official shall copy and paste the prior year information into the current year's nomination form and select “SUBMIT”.

    Both new and retained nominations must be submitted on the Veterinary Shortage Situation Nomination form provided in the VMLRP Shortage Situations section at https://nifa.usda.gov/vmlrp-shortage-situations.

    Nominations retained (carried over) will be designated without review unless major changes in content are identified during administrative processing or the shortage has been retained for three years. Major changes in content or shortages already retained for three consecutive years will be treated as new submissions and undergo merit review.

    5. Submission and Due Date

    Submissions must be made by clicking the submit button on the Veterinarian Shortage Situation nomination form provided in the VMLRP Shortage Situations section at https://nifa.usda.gov/vmlrp-shortage-situations. This form is sent as a data file directly to the Veterinary Medicine Loan Repayment Program; National Institute of Food and Agriculture; U.S. Department of Agriculture; Shortage situation nominations. Both new and retained (carry-over) nominations must be submitted not later than 30 days after the publication of this notice.

    7. Period Covered

    Each shortage situation is approved for one program year cycle only. However, any previously approved shortage situation not filled in a given program year may be resubmitted as a retained (carry-over) nomination. Retained (carry-over) shortage nominations (without any revisions) will be automatically approved for up to three years before requiring another merit review. By resubmitting a carry-over nomination, the nominating official is affirming that in his or her professional judgment the original case made for shortage status, and the original description of needs, remain current and accurate.

    8. Definitions

    For the purpose of implementing the solicitation for veterinary shortage situations, the definitions provided in 7 CFR part 3431 are applicable.

    B. Nomination Form

    The VMLRP Shortage Nomination Form must be used to nominate veterinarian shortage situations. Once designated as a shortage situation, VMLRP applicants will use the information to select shortage situations they are willing and qualified to fill, and to guide the preparation of their applications. NIFA will use the information to assess contractual compliance of awardees. The form is available in the VMLRP Shortage Situations section at https://nifa.usda.gov/vmlrp-shortage-situations. See Part II A. 5. for submission information. Detailed directions for each field can be found at https://nifa.usda.gov/resource/vmlrp-veterinarian-shortage-situation-nomination-form-form-nifa-2009-0001.

    C. NIFA Review of Shortage Situation Nominations 1. Review Panel Composition and Process

    NIFA will convene a panel of food supply veterinary medicine experts from Federal and/or State agencies, and an institution receiving Animal Health and Disease Research Program funds under section 1433 of NARETPA, to review the nominations and make recommendations to the NIFA Program Manager. NIFA will review the panel's recommendations and designate the VMLRP shortage situations. The list of approved shortage situations will be made available on the VMLRP website at www.nifa.usda.gov/vmlrp.

    2. Review Criteria

    Criteria used by the shortage situation nomination review panel and NIFA for certifying a veterinary shortage situation will be consistent with the information requested in the shortage situations nomination form. NIFA understands the process for defining the risk landscape associated veterinary service shortages within a State may require consideration of many qualitative and quantitative factors. In addition, each shortage situation will be characterized by a different array of subjective and objective supportive information that must be developed into a cogent case identifying, characterizing, and justifying a given geographic or disciplinary area as deficient in certain types of veterinary capacity or service. To accommodate the uniqueness of each shortage situation, the nomination form provides opportunities to present a case using both supportive metrics and narrative explanations to define and explain the proposed need.

    While NIFA anticipates some arguments made in support of a given shortage situation will be qualitative, respondents are encouraged to present verifiable quantitative and qualitative evidentiary information wherever possible. Absence of quantitative data such as animal and veterinarian census data for the proposed shortage area(s) may lead the panel to recommend disapproval of the shortage nomination.

    The maximum point value that panelists may award for each element is as follows:

    20 points: Describe the objectives of a veterinarian to meet the needs of the shortage situation in the community, area, State/insular area, or position requested above.

    20 points: Describe the activities required of a veterinarian to meet the needs of the shortage situation located in the community, area, State/insular area, or position requested above.

    5 points: Describe any past efforts to recruit and retain a veterinarian to achieve the objectives and activities in the shortage situation identified above.

    35 points: Describe the risk of this veterinarian position not being filled or retained. Include the risk(s) to the production of a safe and wholesome food supply and/or to animal, human, and environmental health not only in the community but in the region, State/insular area, nation, and/or international community. Type III shortages should comment on the need for and indicators of retention for individual shortage situations, as Type III shortages are unique and traditional retention indicators do not necessarily apply.

    An additional 20 points will be used to evaluate overall merit/quality of the case made for each nomination.

    Robert Holland, Associate Director for Operations, National Institute of Food and Agriculture.
    [FR Doc. 2018-22951 Filed 10-19-18; 8:45 am] BILLING CODE 3410-22-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Michigan Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Michigan Advisory Committee (Committee) will hold a meeting on Wednesday November 14, 2018, at 12 p.m. EST for the purpose discussing next steps in their study of voting rights in the state.

    DATES:

    The meeting will be held on Wednesday November 14, 2018, at 12 p.m. EST

    PUBLIC CALL INFORMATION:

    Dial: 877-260-1479, Conference ID: 2679533.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski, DFO, at [email protected] or 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public can listen to the discussion. This meeting is available to the public through the above toll-free call-in number. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit Office, U.S. Commission on Civil Rights, 230 S. Dearborn St., Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected] Persons who desire additional information may contact the Regional Programs Office at (312) 353-8311.

    Records generated from this meeting may be inspected and reproduced at the Regional Programs Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Michigan Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Office at the above email or street address.

    Agenda Welcome and Introductions Discussion: Civil Rights in Michigan: Voting Rights Public Comment Future Plans and Actions Adjournment Dated: October 16, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-22926 Filed 10-19-18; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the District of Columbia Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of monthly planning meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the District of Columbia Advisory Committee to the Commission will convene by conference call, at 12:00 p.m. (EST) Thursday, November 1, 2018. The purpose of the planning meeting is to continue project planning for a future briefing meeting on the Committee's civil rights project, which will examine the treatment of homeless persons that get swept up in the DC criminal justice system, including a review of the DC Mental Health Court.

    DATES:

    Thursday, November 1, 2018 at 12:00 p.m. (EST).

    Public Call-In Information: Conference call number: 1-855-719-5012 and conference call ID: 3606878.

    FOR FURTHER INFORMATION CONTACT:

    Ivy L. Davis, at [email protected] or by phone at 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-855-719-5012 and conference call ID: 3606878. Please be advised that before placing them into the conference call, the conference call operator may ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number herein.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number: 1-855-719-5012 and conference call ID: 3606878.

    Members of the public are entitled to submit written comments. The comments must be received in the regional office by Monday, December 3, 2018. Comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425 or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Eastern Regional Office at 202-376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://gsageo.force.com/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzlKAAQ. Please click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

    Agenda Thursday, November 1, 2018, at 12:00 p.m. (EST) I. Rollcall II. Welcome and Introductions III. Discuss Project Planning IV. Other Business V. Adjourn Dated: October 16, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-22893 Filed 10-19-18; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the Rhode Island Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meetings.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Rhode Island State Advisory Committee to the Commission will convene by conference call, on Tuesday, November 13, 2018 at 11 a.m. (EST). The purpose of the meeting is to vote on the voting rights report and continue planning.

    DATES:

    Tuesday, November 13, 2018, at 11 a.m. (EST).

    Public Call-In Information: Conference call number: 1-877-260-1479 and conference call ID: 2287314.

    FOR FURTHER INFORMATION CONTACT:

    Evelyn Bohor, at [email protected] or by phone at 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-877-260-1479 and conference call ID: 2287314. Please be advised that before placing them into the conference call, the conference call operator may ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number herein.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number:1-877-260-1479 and conference call ID: 2287314.

    Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://gsageo.force.com/FACA/apex/FACAPublicCommittee?id=a10t0000001gzm4AAA; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

    Agenda: Tuesday, November 13, 2018 at 11:00 a.m. (EST) I. Rollcall II. Discussion and Vote on Voting Rights Report III. Project Planning IV. Open Comment V. Adjournment Dated: October 16, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-22935 Filed 10-19-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-167-2018] Foreign-Trade Zone 168—Dallas/Fort Worth, Texas, Area; Application for Subzone; Schumacher Electric Corporation; Fort Worth, Texas

    An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Metroplex International Trade Development Corporation, grantee of FTZ 168, requesting subzone status for the facility of Schumacher Electric Corporation located in Fort Worth, Texas. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on October 17, 2018.

    The proposed subzone (24.41 acres) is located at 14200 FAA Boulevard in Fort Worth. No authorization for production activity has been requested at this time. The proposed subzone would be subject to the existing activation limit of FTZ 168.

    In accordance with the Board's regulations, Camille Evans of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is December 3, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to December 17, 2018.

    A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via www.trade.gov/ftz.

    For further information, contact Camille Evans at [email protected] or (202) 482-2350.

    Dated: October 17, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-22971 Filed 10-19-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration University of California, Berkeley et al.; Notice of Decision on Application for Duty-Free Entry of Scientific Instruments

    This is a decision pursuant to Section 6(c) of the Educational, Scientific, and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301). Related records can be viewed between 8:30 a.m. and 5:00 p.m. in Room 3720, U.S. Department of Commerce, 14th and Constitution Ave. NW, Washington, DC.

    Docket Number: 17-019. Applicant: University of California, Berkeley, Berkeley, CA 94720. Instrument: High Field Cryogen-Free Measurement System (CFMS) for Precision Measurement of Physical Properties. Manufacturer: Cryogenic US, LLC., United Kingdom. Intended Use: See notice at 83 FR 45104, September 5, 2018. Comments: None received. Decision: Approved. We know of no instruments of equivalent scientific value to the foreign instruments described below, for such purposes as this is intended to be used, that was being manufactured in the United States at the time of order. Reasons: The instrument will be used to study thin films of metal-oxides for advanced oxide-based electronic devices, magnetic and electrical properties of oxide materials and devices at low temperatures and/or high magnetic fields. Angle dependent magnetoelectric properties of the devices will be explored on multiple axes. The investigations done with this instrument will lead to advancement of understanding of the properties of metal-oxide thin films and their interfaces for new generation of oxide-based microelectronic devices.

    Dated: October 15, 2018. Gregory Campbell, Director, Subsidies Enforcement, Enforcement and Compliance.
    [FR Doc. 2018-22972 Filed 10-19-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [Application No. 84-29A12] Export Trade Certificate of Review ACTION:

    Notice of Issuance of an amended Export Trade Certificate of Review to Northwest Fruit Exporters (“NFE”), Application No. 84-29A12.

    SUMMARY:

    The Secretary of Commerce, through the Office of Trade and Economic Analysis (“OTEA”), issued an amended Export Trade Certificate of Review to NFE on October 9, 2018. A previous amended Export Trade Certificate of Review was issued to NFE on October 24, 2016, and a notice of its issuance was published in the Federal Register on November 7, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Joseph Flynn, Director, OTEA, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2018). OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the Federal Register. Under Section 305(a) of the Act and 15 CFR 325.11(a), any person aggrieved by the Secretary's determination may, within 30 days of the date of this notice, bring an action in any appropriate district court of the United States to set aside the determination on the ground that the determination is erroneous.

    Description of Certified Content

    NFE's Export Trade Certificate of Review has been amended as follows:

    (a) Added the following companies as new Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):

    (1) Pine Canyon Growers LLC, Orondo, WA (2) WP Packing LLC, Wapato, WA

    (b) Deleted the following companies as Members of the Certificate:

    (1) Columbia Fruit Packers/Airport Division, Wenatchee, WA (2) Phillippi Fruit Company, Inc., E. Wenatchee, WA (3) Western Traders LLC, Wenatchee, WA

    (c) Changed the name of the following Members of the Certificate:

    (1) Columbia Marketing International Corp., Wenatchee, WA, is now named CMI Orchards LLC, Wenatchee, WA (2) Pride Packing Company, Wapato, WA, is now named Pride Packing Company LLC, Wapato, WA

    (d) Corrected the name of the following Members of the Certificate:

    (1) Diamond Fruit Growers, Odell, OR, is corrected to Diamond Fruit Growers, Inc., Odell, OR (2) HoneyBear Growers, Inc., Brewster, WA, is corrected to HoneyBear Growers LLC, Brewster, WA (3) Honey Bear Tree Fruit Co., LLC, Wenatchee, WA, is corrected to Honey Bear Tree Fruit Co LLC, Wenatchee, WA (4) L&M Companies, Union Gap, WA, is corrected to L & M Companies, Union Gap, WA (5) Polehn Farm's Inc., The Dalles, OR, is corrected to Polehn Farms, Inc., The Dalles, OR (6) Valicoff Fruit Co., Inc., Wapato, WA, is corrected to Valicoff Fruit Company Inc., Wapato, WA

    NFE's Export Trade Certificate of Review Membership, as amended, is below:

    1. Allan Bros., Naches, WA 2. AltaFresh L.L.C. dba Chelan Fresh Marketing, Chelan, WA 3. Apple House Warehouse & Storage, Inc., Brewster, WA 4. Apple King, L.L.C., Yakima, WA 5. Auvil Fruit Co., Inc., Orondo, WA 6. Baker Produce, Inc., Kennewick, WA 7. Blue Bird, Inc., Peshastin, WA 8. Blue Star Growers, Inc., Cashmere, WA 9. Borton & Sons, Inc., Yakima, WA 10. Brewster Heights Packing & Orchards, LP, Brewster, WA 11. Broetje Orchards LLC, Prescott, WA 12. C.M. Holtzinger Fruit Co., Inc., Yakima, WA 13. Chelan Fruit Cooperative, Chelan, WA 14. Chiawana, Inc. dba Columbia Reach Pack, Yakima, WA 15. CMI Orchards LLC, Wenatchee, WA 16. Columbia Fruit Packers, Inc., Wenatchee, WA 17. Columbia Valley Fruit, L.L.C., Yakima, WA 18. Congdon Packing Co. L.L.C., Yakima, WA 19. Conrad & Adams Fruit L.L.C., Grandview, WA 20. Cowiche Growers, Inc., Cowiche, WA 21. CPC International Apple Company, Tieton, WA 22. Crane & Crane, Inc., Brewster, WA 23. Custom Apple Packers, Inc., Quincy, and Wenatchee, WA 24. Diamond Fruit Growers, Inc., Odell, OR 25. Domex Superfresh Growers LLC, Yakima, WA 26. Douglas Fruit Company, Inc., Pasco, WA 27. Dovex Export Company, Wenatchee, WA 28. Duckwall Fruit, Odell, OR 29. E. Brown & Sons, Inc., Milton-Freewater, OR 30. Evans Fruit Co., Inc., Yakima, WA 31. E.W. Brandt & Sons, Inc., Parker, WA 32. Frosty Packing Co., LLC, Yakima, WA 33. G&G Orchards, Inc., Yakima, WA 34. Gilbert Orchards, Inc., Yakima, WA 35. Hansen Fruit & Cold Storage Co., Inc., Yakima, WA 36. Henggeler Packing Co., Inc., Fruitland, ID 37. Highland Fruit Growers, Inc., Yakima, WA 38. HoneyBear Growers LLC, Brewster, WA 39. Honey Bear Tree Fruit Co LLC, Wenatchee, WA 40. Hood River Cherry Company, Hood River, OR 41. Ice Lakes LLC, East Wenatchee, WA 42. JackAss Mt. Ranch, Pasco, WA 43. Jenks Bros Cold Storage & Packing, Royal City, WA 44. Kershaw Fruit & Cold Storage, Co., Yakima, WA 45. L & M Companies, Union Gap, WA 46. Larson Fruit Co., Selah, WA 47. Legacy Fruit Packers LLC, Wapato, WA 48. Manson Growers Cooperative, Manson, WA 49. Matson Fruit Company, Selah, WA 50. McDougall & Sons, Inc., Wenatchee, WA 51. Monson Fruit Co., Selah, WA 52. Morgan's of Washington dba Double Diamond Fruit, Quincy, WA 53. Naumes, Inc., Medford, OR 54. Northern Fruit Company, Inc., Wenatchee, WA 55. Olympic Fruit Co., Moxee, WA 56. Oneonta Trading Corp., Wenatchee, WA 57. Orchard View Farms, Inc., The Dalles, OR 58. Pacific Coast Cherry Packers, LLC, Yakima, WA 59. Peshastin Hi-Up Growers, Peshastin, WA 60. Piepel Premium Fruit Packing LLC, East Wenatchee, WA 61. Pine Canyon Growers LLC, Orondo, WA 62. Polehn Farms, Inc., The Dalles, OR 63. Price Cold Storage & Packing Co., Inc., Yakima, WA 64. Pride Packing Company LLC, Wapato, WA 65. Quincy Fresh Fruit Co., Quincy, WA 66. Rainier Fruit Company, Selah, WA 67. Roche Fruit, Ltd., Yakima, WA 68. Sage Fruit Company, L.L.C., Yakima, WA 69. Smith & Nelson, Inc., Tonasket, WA 70. Stadelman Fruit, L.L.C., Milton-Freewater, OR, and Zillah, WA 71. Stemilt Growers, LLC, Wenatchee, WA 72. Strand Apples, Inc., Cowiche, WA 73. Symms Fruit Ranch, Inc., Caldwell, ID 74. The Dalles Fruit Company, LLC, Dallesport, WA 75. Underwood Fruit & Warehouse Co., Bingen, WA 76. Valicoff Fruit Company Inc., Wapato, WA 77. Washington Cherry Growers, Peshastin, WA 78. Washington Fruit & Produce Co., Yakima, WA 79. Western Sweet Cherry Group, LLC, Yakima, WA 80. Whitby Farms, Inc. dba: Farm Boy Fruit Snacks LLC, Mesa, WA 81. WP Packing LLC, Wapato, WA 82. Yakima Fresh, Yakima, WA 83. Yakima Fruit & Cold Storage Co., Yakima, WA 84. Zirkle Fruit Company, Selah, WA

    The effective date of the amendment is July 10, 2018, the date on which NFE's application to amend was deemed submitted.

    Dated: October 17, 2018. Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, U.S. Department of Commerce.
    [FR Doc. 2018-22974 Filed 10-19-18; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-904] Certain Activated Carbon From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) determines that Datong Juqiang Activated Carbon Co. Ltd. (Datong Juqiang) and Carbon Activated Tianjin Co., Ltd. (Carbon Activated) sold activated carbon from the People's Republic of China at less than normal value (NV) during the period of review (POR) April 1, 2016, through March 31, 2017.

    DATES:

    Applicable October 22, 2018.

    FOR FURTHER INFORMATION CONTACT:

    John Anwesen or Jinny Ahn, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0131, or (202) 482-0339, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    Commerce published the Preliminary Results1 on May 18, 2018. For events subsequent to the Preliminary Results, see Commerce's Issues and Decision Memorandum.2 On August 2, 2018,3 in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), Commerce extended the deadline for issuing the final results until October 17, 2018.

    1See Certain Activated Carbon from the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2016-2017, 83 FR 23254 (May 18, 2018) (Preliminary Results), and accompanying Preliminary Decision Memorandum (PDM).

    2See Memorandum, “Certain Activated Carbon from the People's Republic of China: Issues and Decision Memorandum for the Final Results of the Tenth Antidumping Duty Administrative Review,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).

    3See Memorandum, “Activated Carbon from the People's Republic of China: Extension of Deadline for Final Results of 2016-2017 Antidumping Duty Administrative Review,” dated August 2, 2018.

    Scope of the Order

    The merchandise subject to the Order4 is certain activated carbon. The products are currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheading 3802.1000. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of the order remains dispositive.5

    4See Notice of Antidumping Duty Order: Certain Activated Carbon from the People's Republic of China, 72 FR 20988 (April 27, 2007) (Order).

    5See Issues and Decision Memorandum for a complete description of the scope of the Order.

    Analysis of Comments Received

    In the Issues and Decision Memorandum, we addressed all issues raised in parties' case and rebuttal briefs. In Appendix I to this notice, we provided a list of the issues raised by parties. The Issues and Decision Memorandum is a public document and is on file in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building, as well as electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and it is available to all parties in the CRU. In addition, parties can directly access a complete version of the Issues and Decision Memorandum on the internet at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic version of the Issues and Decision Memorandum are identical in content.

    Changes Since the Preliminary Results

    Based on our review of the record and comments received from interested parties regarding our Preliminary Results, we made certain revisions to the margin calculations for Carbon Activated and Datong Juqiang,6 and to the rate assigned to the non-examined, separate rate respondents. Further, the Issues and Decision Memorandum contains descriptions of these revisions.7

    6See Memoranda, “Antidumping Duty Administrative Review of Certain Activated Carbon from the People's Republic of China: Final Results Calculation Memorandum for Carbon Activated” (Carbon Activated's Final Calculation Memorandum) and “Antidumping Duty Administrative Review of Certain Activated Carbon the People's Republic of China: Final Results Calculation Memorandum for Datong Juqiang Activated Carbon Co., Ltd. ” (Datong Juqiang's Final Calculation Memorandum) dated concurrently with this memorandum; see also Memorandum, “Tenth Administrative Review of Certain Activated Carbon from the People's Republic of China: Surrogate Values for the Final Results,” dated concurrently with this memorandum.

    7See Issues and Decisions Memorandum at 3-4 for a summary of these revisions.

    Final Determination of No Shipments

    In the Preliminary Results, we preliminarily determined that Calgon Carbon (Tianjin) Co., Ltd., (Calgon Tianjin), Datong Municipal Yunguang Activated Carbon Co., Ltd. (Datong Yunguang), Jilin Bright Future Chemicals Co., Ltd. (Jilin Bright Future), Shanxi Dapu International Trade Co., Ltd. (Shanxi Dapu), Shanxi Industry Technology Trading Co., Ltd. (Shanxi Industry), Shanxi Tianxi Purification Filter Co., Ltd. (Shanxi Tianxi), and Tianjin Channel Filters Co., Ltd. (Tianjin Channel) had no shipments of subject merchandise to the United States during the POR.8 We received no information to contradict this determination. Therefore, we continue to find that Calgon Tianjin, Datong Yunguang, Jilin Bright Future, Shanxi Dapu, Shanxi Industry, Shanxi Tianxi, and Tianjin Channel had no shipments of subject merchandise during the POR and will issue appropriate liquidation instructions that are consistent with our “automatic assessment” clarification for these final results.9

    8See Preliminary Results, 83 FR at 23255.

    9See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 4, 2011) (Assessment Practice Refinement).

    Separate Rate Respondents

    In our Preliminary Results, we determined that Carbon Activated, Datong Juqiang, and six other companies demonstrated their eligibility for separate rates.10 We received no comments or argument since the issuance of the Preliminary Results that provide a basis for reconsideration of these determinations. Therefore, for these final results, we continue to find that the six companies listed in the table in the “Final Results” section of this notice are eligible for a separate rate.

    10See Preliminary Results, and accompanying PDM at 5-9.

    Rate for Non-Examined Separate Rate Respondents

    The statute and our regulations do not address the establishment of a rate to be assigned to respondents not selected for individual examination when we limit our examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, we look to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Section 735(c)(5)(A) of the Act articulates a preference for not calculating an all-others rate using rates which are zero, de minimis, or based entirely on facts available.11 Accordingly, we generally will determine the dumping margin for companies not individually examined by averaging the weighted-average dumping margins for the individually examined respondents, excluding rates that are zero, de minimis, or based entirely on facts available.12

    11See Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Final Results of Antidumping Duty Administrative Reviews and Rescission of Reviews in Part, 73 FR 52823, 52824 (September 11, 2008), and accompanying Issues and Decision Memorandum (IDM) at Comment 16.

    12See, e.g., Preliminary Determination of Sales at Less Than Fair Value and Partial Affirmative Determination of Critical Circumstances: Certain Polyester Staple Fiber from the People's Republic of China, 71 FR 77373, 77377 (December 26, 2006), unchanged in Final Determination of Sales at Less Than Fair Value and Partial Affirmative Determination of Critical Circumstances: Certain Polyester Staple Fiber from the People's Republic of China, 72 FR 19690 (April 19, 2007).

    For the final results, we calculated a rate only for Carbon Activated that was not zero, de minimis, or based entirely on facts available.13 Therefore, for these final results, following the practice described above, we have assigned to the companies that have not been individually examined, but have demonstrated their eligibility for a separate rate, the weighted-average rate calculated for Carbon Activated.

    13See Carbon Activated's Final Calculation Memorandum and Datong Juqiang's Final Calculation Memorandum.

    Final Results of the Review

    For companies subject to this review, which established their eligibility for a separate rate, Commerce determines that the following weighted-average dumping margins exist for the POR from April 1, 2016, through March 31, 2017:

    14 In the second administrative review of the Order, Commerce determined that it would calculate per-unit weighted-average dumping margins and assessment rates for all future reviews. See Certain Activated Carbon from the People's Republic of China: Final Results and Partial Rescission of Second Antidumping Duty Administrative Review, 75 FR 70208, 70211 (November 17, 2010) (AR2 Carbon), and accompanying IDM at Comment 3.

    15 In the third administrative review of the Order, Commerce found that Jacobi Carbons AB, Tianjin Jacobi International Trading Co. Ltd., and Jacobi Carbons Industry (Tianjin) are a single entity and, because there were no facts presented on the record of this review which would call into question our prior finding, we continue to treat these companies as part of a single entity for this administrative review, pursuant to sections 771(33)(E), (F), and (G) of the Act and 19 CFR 351.401(f). See Certain Activated Carbon from the People's Republic of China: Final Results and Partial Rescission of Third Antidumping Duty Administrative Review, 76 FR 67142, 67145 n.25 (October 31, 2011); see also Preliminary Results, and accompanying PDM at n.26.

    Exporter Weighted-
  • average dumping
  • margin
  • (USD/kg) 14
  • Beijing Pacific Activated Carbon Products Co., Ltd 0.45 Carbon Activated Tianjin Co., Ltd 0.45 Datong Juqiang Activated Carbon Co., Ltd 0.00 Jacobi Carbons AB 15 0.45 Ningxia Guanghua Cherishmet Activated Carbon Co., Ltd 0.45 Ningxia Huahui Activated Carbon Co., Ltd 0.45 Ningxia Mineral & Chemical Limited 0.45 Shanxi Sincere Industrial Co., Ltd 0.45

    In the Preliminary Results, Commerce found that 16 companies for which a review was requested did not establish eligibility for a separate rate because they did not file a separate rate application or a separate rate certification, as appropriate. No interested party commented on Commerce's preliminary determination with respect to these 16 companies. Therefore, for these final results we determine these companies, listed in Appendix II of this notice, to be part of the China-wide entity. Because no party requested a review of the China-wide entity, and Commerce no longer considers the China-wide entity as an exporter conditionally subject to administrative reviews,16 we did not conduct a review of the China-wide entity. Thus, the weighted-average dumping margin for the China-wide entity (i.e., 2.42 USD/kg) 17 is not subject to change as a result of this review.

    16See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963, 65969-70 (November 4, 2013).

    17See, e.g., Certain Activated Carbon from the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2012-2013, 79 FR 70163, 70165 (November 25, 2014).

    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. We intend to issue assessment instructions to CBP 15 days after the publication date of these final results of review.

    For each individually-examined respondent in this review which has a final weighted-average dumping margin that is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer- (or customer-) specific per-unit duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's (or customer's) examined sales to the total sales quantity associated with those sales, in accordance with 19 CFR 351.212(b)(1).18 We will also calculate (estimated) ad valorem importer-specific assessment rates with which to determine whether the per-unit assessment rates are de minimis. 19 Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer- (or customer-) specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.20

    18See AR2 Carbon, and accompanying IDM at Comment 3.

    19 For calculated (estimated) ad valorem importer-specific assessment rates used in determining whether the per-unit assessment rate is de minimis, see Carbon Activated's Final Calculation Memorandum and Datong Juqiang's Calculation Memorandum and attached Margin Calculation Program Logs and Outputs.

    20See 19 CFR 351.106(c)(2).

    For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the rate assigned to them for the final results (i.e., 0.45 USD/kg).

    For the companies identified in Appendix II as part of the China-wide entity, we will instruct CBP to apply a per-unit assessment rate of 2.42 USD/kg to all entries of subject merchandise during the POR which were produced or exported by those companies.

    Pursuant to a refinement in our non-market economy practice, for sales that were not reported in the U.S. sales data submitted by companies individually examined during this review, we will instruct CBP to liquidate entries associated with those sales at the rate for the China-wide entity. Furthermore, where we found that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's cash deposit rate) will be liquidated at the rate for the China-wide entity.21

    21 For a full discussion of this practice, see Assessment Practice Refinement, 76 FR at 65694.

    Cash Deposit Requirements

    The following per-unit cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For Carbon Activated, Datong Juqiang, and the non-examined, separate rate respondents, the cash deposit rate will be equal to their weighted-average dumping margins established in the final results of this review; (2) for previously investigated or reviewed Chinese and non-Chinese exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be equal to the weighted-average dumping margin for the China-wide entity (i.e., 2.42 USD/kg); and (4) for all non-Chinese exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the Chinese exporter(s) that supplied that non-Chinese exporter. These per-unit cash deposit requirements, when imposed, shall remain in effect until further notice.

    Disclosure

    We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Notification to Importers Regarding the Reimbursement of Duties

    This notice also serves as a final 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 POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of double antidumping duties.

    Notification Regarding Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction 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 the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    We are issuing and publishing these final results of administrative review and notice in accordance with sections 751(a)(1) and 777(i) of the Act.

    Date: October 16, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations. Appendix I Issues and Decision Memorandum Summary Background Scope of the Order Changes Since the Preliminary Results Discussion of the Issues Comment 1: Use of Import Statistics In lieu of Highest Calculated Normal Value as Adverse Facts Available Comment 2: Coal Tar Surrogate Value Comment 3: Carbonized Material Surrogate Value Comment 4: Hydrochloric Acid Surrogate Value Comment 5: Labor Surrogate Value Comment 6: Whether to Continue to Use the Thai Financial Statements Comment 7: Value-Added Tax Adjustments Comment 8: Ministerial Errors Recommendation Appendix II Companies Not Eligible for a Separate Rate and To Be Treated as Part of China-Wide Entity Company 1. Beijing Embrace Technology Co., Ltd. 2. Datong Municipal Yunguang Activated Carbon Co., Ltd. 3. Jilin Bright Future Chemicals Co., Ltd. 4. Meadwestvaco (China) Holding Co., Ltd. 5. Ningxia Guanghua A/C Co., Ltd. 6. Ningxia Guanghua Activated Carbon Co., Ltd. 7. Ningxia Guanghua Chemical Activated Carbon Co., Ltd. 8. Ningxia Jirui Activated Carbon 9. Shanxi Dapu International Trade Co., Ltd. 10. Shanxi DMD Corporation 11. Shanxi Industry Technology Trading Co., Ltd. 12. Tancarb Activated Carbon Co., Ltd. 13. Tangshan Solid Carbon Co., Ltd. 14. Tianjin Channel Filters Co., Ltd. 15. Tianjin Jacobi International Trading Co., Ltd. 16. Tianjin Maijin Industries Co., Ltd.
    [FR Doc. 2018-22969 Filed 10-19-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG564 Gulf of Mexico Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council (Council) will hold a meeting of its Ad Hoc Red Snapper and Grouper-Tilefish Individual Fishing Quota (IFQ) Advisory Panel.

    DATES:

    The meeting will convene on Wednesday, November 7, 2018; starting 8:30 a.m. and will adjourn at 5 p.m.

    ADDRESSES:

    The meeting will be held at the Gulf Council's office, 4107 W Spruce Street, Suite 200, Tampa, FL 33607; telephone: (813) 348-1630.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Ava Lasseter, Anthropologist, Gulf of Mexico Fishery Management Council; [email protected], telephone: (813) 348-1630.

    SUPPLEMENTARY INFORMATION:

    The items of discussion on the agenda are as follows:

    Agenda Wednesday, November 7, 2018, 8:30 a.m. until 5 p.m. 1. Introductions and Adoption of Agenda 2. Approval of April 10, 2018 meeting summary 3. Scope of Work 4. Presentations on National Quota Banks 5. Reef Fish Amendment 36B: Modifications to Commercial IFQ Programs 6. Other Business —Meeting Adjourns

    The Agenda is subject to change, and the latest version along with other meeting materials will be posted on www.gulfcouncil.org as they become available.

    Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see ADDRESSES), at least 5 working days prior to the meeting.

    Dated: October 17, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-22993 Filed 10-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG105 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Mission Bay Ferry and Water Taxi Landing Project in San Francisco Bay, California AGENCY:

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

    ACTION:

    Notice; issuance of incidental harassment authorization.

    SUMMARY:

    In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Port of San Francisco to incidentally harass, by Level B harassment only, marine mammals during construction activities associated with the pile driving, pile removal, and drilling on the Mission Bay Ferry Landing (MBFL) and Water Taxi Landing (WTL) Project in San Francisco Bay, California.

    DATES:

    This Authorization is effective from June 1, 2019, to May 31, 2020.

    FOR FURTHER INFORMATION CONTACT:

    Gray Redding, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION:

    Background

    The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of an incidental take authorization may be provided to the public for review.

    Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.

    Summary of Request

    On November 2, 2017, NMFS received a request from the Port of San Francisco for an IHA to take marine mammals incidental to pile driving and drilling in San Francisco Bay. NMFS determined that a revised version of the Port's application was adequate and complete on June 22, 2018. The Port of San Francisco's request was for take of seven species of marine mammals by Level B harassment only. This authorization is valid from June 1, 2019, to May 31, 2020. Neither the Port of San Francisco nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

    Description of Proposed Activity Overview

    The Port of San Francisco plans to construct the MBFL and WTL on San Francisco Bay, within the Port of San Francisco's Southern Waterfront in the Mission Bay/Central Waterfront area. The project will create two, two-berth, floating landings to add ferry and water taxi access to the area. The project's activities that have the potential to take marine mammals include vibratory and impact pile driving, vibratory pile removal, and down the hole drilling. In total, 28 permanent piles ranging from 16-inch to 36-inch in diameter will be installed, but only 24 will require in water installation. Twelve older piles will be removed, and four 14-inch H-piles and one 30-inch steel pile will be driven temporally to act as the caisson and supports during down the hole drilling at 10 locations. In addition, the project will include dredging, however authorization of take from this activity is neither requested nor proposed for authorization. All piles will be driven between June 1, 2019 and November 20, 2019.

    A detailed description of the planned Port of San Francisco MBFL and WTL project is provided in the Federal Register notice for the proposed IHA (83 FR 42465; August 22, 2018). Since that time, no changes have been made to the planned Port of San Francisco activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

    While there were not changes to the planned activity, some errors were corrected and other minor changes occurred following publication of the proposed IHA. These changes are outlined in each section of this notice In this section, the rate of pile installation for 36-inch steel piles was corrected from 5 piles per day to 4, to address an inconsistency in the application and more accurately reflect the applicant's expected schedule.

    Table 1—Summary of In Water Pile Installation Locations Project
  • element
  • Pile
  • diameter
  • (inch)
  • Pile type Number of
  • piles
  • Method Piles/day Construction
  • days
  • Debris Removal 12 Steel 12 If necessary, a vibratory hammer will be used to remove up to 12 piles 60‐120 seconds/pile while pulling the pile up to loosen it from the sediment 12 1 MBFL Pier 14
  • 30
  • 24
  • H-pile steel
  • Steel Caisson
  • Octagonal Concrete
  • 4
  • 1
  • 10
  • Four 14-inch steel H beams will be driven with Vibratory Driver 600 seconds/pile to support 30‐inch steel caisson sleeve driven with Vibratory Driver (900 sec/pile) to refusal, drill out hole removing soils, place and position concrete pile, grout pile in place while simultaneously pulling the caisson 4
  • 1
  • 1
  • 10
    Float Guide Piles 36 Steel 6 Vibratory Driver 1,200 sec/pile then Impact Hammer last 15 ft (150 strikes/pile ~20 minutes); bubble curtain will be used during impact duration 4 2 Donut Fender Piles 36 Steel 2 Vibratory Driver 1200 sec/pile then Impact Hammer last 15 ft (150 strikes/pile ~20 minutes); bubble curtain will be used during impact duration 4 WTL Platform 16 Steel 2 Vibratory Driver 600 sec/pile then Impact Hammer last 15 ft (500 strikes/pile ~20 minutes); bubble curtain will be used during impact duration 2 1 Guide Piles 20 Square Concrete 4 Impact Hammer 500 strikes/pile (max 20 minutes); a bubble curtain will be used during impact duration 4 1
    Comments and Responses

    A notice of NMFS's proposal to issue an IHA to the Port of San Francisco was published in the Federal Register on August 22, 2018 (83 FR 42465). That notice described, in detail, the Port of San Francisco's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission. The Marine Mammal Commission recommended that NMFS issue the IHA, subject to inclusion of the proposed mitigation, monitoring, and reporting measures.

    Comment 1: The Commission recommended NMFS authorize take by Level A harassment for harbor seals, noting the estimated number that could occur in the Level A harassment zone, the potential for take, and the possible limited effectiveness of mitigation.

    Response 1: NMFS recognizes the potential for Level A harassment associated with the Port of San Francisco's MBFL and WTL project, but notes that this anticipated take by Level A harassment of two harbor seals is avoidable given the required mitigation and monitoring. Additionally, this calculation is highly conservative because it uses the project's largest Level A harassment zone for the entire duration, despite this zone being in effect for a short time and other Level A harassment zones being smaller. While NMFS could authorize take by Level A harassment associated with this activity as a precaution, we do not agree that such authorization is warranted and the applicant did not request such authorization. Additionally, the observation of an animal within the Level A harassment zone does not necessarily equate to an incident of Level A harassment, as the calculation of that zone assumes that the animal is present at that distance from the driven pile for a given duration necessary to accumulate sufficient sound energy to actually incur injury. The largest Level A harassment zone for harbor seals, of 130 meters (m), assumes an activity duration of 40 minutes. Given that, it is unlikely that briefly occupying the Level A harassment zone would expose an animal to sound energy sufficient to cause take by Level A harassment.

    Comment 2: The Commission recommended that NMFS refrain from using a source level reduction factor for sound attenuation device implementation during impact pile driving for all relevant incidental take authorizations due to the different noise level reduction at different received ranges.

    Response 2: While it is true that noise level reduction measured at different received ranges does vary, given that both Level A and Level B harassment estimation using geometric modeling is based on noise levels measured at near-source distances (~10 m), NMFS believes it reasonable to use a source level reduction factor for sound attenuation device implementation during impact pile driving. In the case of the SF-OBB impact driving isopleth estimates using an air bubble curtain for source level reduction, NMFS reviewed Caltrans' bubble curtain “on and off” studies conducted in San Francisco Bay in 2003 and 2004. The equipment used for bubble curtains has likely improved since 2004 but due to concerns for fish species, Caltrans has not been able to conduct “on and off” tests recently. Based on 74 measurements (37 with the bubble curtain on and 37 with the bubble curtain off) at both near (<100 m) and far (>100 m) distances, the linear averaged received level reduction is 6 decibels (dB). If limiting the data points (a total of 28 measurements, with 14 during bubble curtain on and 14 during bubble curtain off) to only near distance measurements, the linear averaged noise level reduction is 7 dB. Since impact zone analysis using geometric spreading model is typically based on measurements at near-source distance, we consider it appropriate to use a reduction of 7 dB as a noise level reduction factor for impact pile driving using an air bubble curtain system.

    Bubble curtains are effective at attenuating sound originating within the water column. Pile driving does generate sound within the seafloor as well. This sound travels within the seafloor and emerges back to the water column, but its intensity is reduced within the sediment due to absorption by the sediment and reflection at the sediment/water interface.

    NMFS will evaluate the appropriateness of using a certain source level reduction factor for sound attenuation device implementation during impact pile driving for all relevant incidental take authorizations when more data become available.

    Comment 3: The Commission recommended that NMFS require the applicant to conduct sound source measurements of its drilling activities in conjunction with the required sound measurements of ambient conditions.

    Response 3: NMFS agrees that sound source measurements of the drilling activities would be valuable, but has determined that this would be an overly burdensome requirement relative to the expected impacts of the specified activity (refer to negligible impact section). The project's permitted activity is short. Additionally, the process to record sound data sufficiently rigorous enough to provide new source information can be complex and costly. If the Port of San Francisco chooses to conduct sound source measurements, NMFS will work with the Port to help ensure these measurements are properly taken to best ensure their usefulness.

    Comment 4: The Commission recommends that NMFS require applicants to provide proposed hydroacoustic monitoring plans with their applications to allow for public comment, or provide them to the Commission for review prior to final authorization.

    Response 4: NMFS disagrees that the MMPA or NMFS's implementing regulations require that detailed hydroacoustic monitoring plans be made available for public review. Additionally, NMFS has the necessary technical expertise to properly evaluate and make recommendations to hydroacoustic monitoring plans that are received. That said, NMFS encourages applicants to prepare as detailed a monitoring plan as possible, as early in the process as possible, and shares these plans with the public if they are available at the time the proposed authorization is published.

    Comment 5: The Commission recommends that NMFS refrain from implementing its proposed renewal process and instead use abbreviated Federal Register notices and reference existing documents to streamline the incidental harassment authorization process. The Commission suggested that the MMPA states that public comment on proposed authorizations must be concurrent with publication in the Federal Register. The Commission further recommends that if NMFS did not pursue a more general route, NMFS provide the Commission and the public with a legal analysis supporting its conclusion that the process is consistent with the requirements under section 101(a)(5)(D) of the MMPA.

    Response 5: The notice of the proposed IHA expressly notifies the public that under certain, limited conditions an applicant could seek a renewal IHA for an additional year. The notice describes the conditions under which such a renewal request could be considered and expressly seeks public comment in the event such a renewal is sought. Additional reference to this solicitation of public comment has recently been added at the beginning of FR notices that consider renewals. NMFS appreciates the streamlining achieved by the use of abbreviated Federal Register notices and intends to continue using them for proposed IHAs that include minor changes from previously issued IHAs, but which do not satisfy the renewal requirements. However, we believe our proposed method for issuing renewals meets statutory requirements and maximizes efficiency. Importantly, such renewals would be limited to where the activities are identical or nearly identical to those analyzed in the proposed IHA, monitoring does not indicate impacts that were not previously analyzed and authorized, and the mitigation and monitoring requirements remain the same, all of which allow the public to comment on the appropriateness and effects of a renewal at the same time the public provides comments on the initial IHA. NMFS has, however, modified the language for future proposed IHAs to clarify that all IHAs, including renewal IHAs, are valid for no more than one year and that the agency would consider only one renewal for a project at this time. In addition, notice of issuance or denial of a renewal IHA would be published in the Federal Register, as are all IHAs. Last, NMFS will publish on our website a description of the renewal process before any renewal is issued utilizing the new process.

    Description of Marine Mammals in the Area of Specified Activities

    A detailed description of the species likely to be affected by the Port of San Francisco's MBFL and WTL project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (83 FR 42465; August 22, 2018); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website (https://www.fisheries.noaa.gov/find-species) for generalized species accounts.

    Table 2 lists all species with expected potential for occurrence in the Mission Bay/Central Waterfront area of San Francisco Bay and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow the Committee on Taxonomy (2017). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's Stock Assessment Report (SAR)). While NMFS neither anticipates nor proposes to authorize mortality here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.

    Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. 2017 SAR (Carretta et al., 2017). All values presented in Table 2 are the most recent available at the time of publication and are available in the 2017 SAR (Carretta et al., 2017).

    Table 2—Marine Mammals in the Project Area Common name Scientific name Stock ESA/
  • MMPA status;
  • strategic
  • (Y/N) 1
  • Stock abundance
  • (CV, Nmin, most recent
  • abundance survey) 2
  • PBR Annual
  • M/SI 3
  • Order Cetartiodactyla—Cetacea—Superfamily Mysticeti (baleen whales) Family Eschrichtiidae: Gray whale Eschrichtius robustus Eastern North Pacific -/-; N 20,990 (0.05, 20,125, 2011) 624 132 Family Balaenopteridae (rorquals): Humpback whale Megaptera novaeangliae California/Oregon/Washington E/D; Y 1,918 (0.03, 1,876, 2014) 11 >6.5 Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family Delphinidae: Bottlenose dolphin Tursiops truncatus California Coastal -/-; N 453 (0.06, 346, 2011) 2.7 >2 Family Phocoenidae (porpoises): Harbor porpoise Phocoena phocoena San Francisco-Russian River -/-; N 9,886 (0.51, 6,625, 2011) 66 0 Order Carnivora—Superfamily Pinnipedia Family Otariidae (eared seals and sea lions): California sea lion Zalophus californianus U.S. -/-; N 296,750 (n/a, 153,337, 2011) 9,200 389 Northern fur seal Callorhinus ursinus California -/-; N 14,050 (n/a, 7,524, 2013) 451 1.8 Eastern North Pacific -/-; N 626,734 (n.a., 530,474, 2014) 11,405 1.1 Guadalupe fur seal Arctocephalus townsendi Mexico to California T/D; Y 20,000 (n/a, 15,830, 2010) 542 >3.2 Family Phocidae (earless seals): Pacific harbor seal Phoca vitulina richardii California -/-; N 30,968 (n/a, 27,348, 2012) 1,641 43 Northern elephant seal Mirounga angustirostris California Breeding -/-; N 179,000 (n/a, 81,368, 2010) 4,882 8.8 1 Endangered Species Act (ESA) status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock. 2 NMFS marine mammal stock assessment reports online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments. CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases, CV is not applicable 3 These values, found in NMFS's SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined (e.g., commercial fisheries, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value or range. A CV associated with estimated mortality due to commercial fisheries is presented in some cases. Note: Italicized species are not expected to be taken or proposed for authorization.

    All species that could potentially occur in the Port's proposed project area in San Francisco Bay are included in Table 2. However, the temporal and/or spatial occurrence of humpback whale and Guadalupe fur seal is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here. Humpback whales are rare visitors to the interior of San Francisco Bay. A recent, seasonal influx of humpback whales inside San Francisco Bay near the Golden Gate was recorded from April to November in 2016 and 2017 (Keener 2017). The Golden Gate is outside of this project's action area and humpback whales are not expected to be present during the project. Guadalupe fur seals occasionally range into the waters of northern California and the Pacific Northwest. The Farallon Islands (off central California) and Channel Islands (off southern California) are used as haulouts during these movements (Simon 2016). Juvenile Guadalupe fur seals occasionally strand in the vicinity of San Francisco, especially during El Niño events. Most strandings along the California coast are animals younger than two years old, with evidence of malnutrition (NMFS 2017a). Because Guadalupe fur seals are rare in the area, and sightings are associated with abnormal weather conditions, such as El Niño events, NMFS has determined that no Guadalupe fur seals are likely to occur in the project vicinity and, therefore, no take is expected to occur.

    Potential Effects of Specified Activities on Marine Mammals and Their Habitat

    The effects of underwater noise from pile driving, pile removal, and drilling activities for the MBFL and WTL Project in San Francisco Bay, California have the potential to result in behavioral harassment of marine mammals in the vicinity of the action area. The Federal Register notice for the proposed IHA (83 FR 42465; August 22, 2018) included a discussion of the effects of anthropogenic noise on marine mammals, therefore that information is not repeated here; please refer to the Federal Register notice (83 FR 42465; August 22, 2018) for that information.

    Anticipated Effects on Habitat

    The main impact associated with the Port of San Francisco's MBFL and WTL project would be temporarily elevated sound levels and the associated direct effects on marine mammals. The project would not result in permanent impacts to habitats used directly by marine mammals, such as haulout sites, but may have potential short-term impacts to food sources such as forage fish, and minor impacts to the immediate substrate during installation/removal of piles and drilling during the MBFL and WTL project. These potential effects are discussed in detail in the Federal Register notice for the proposed IHA (83 FR 42465; August 22, 2018), therefore that information is not repeated here; please refer to that Federal Register notice for that information.

    Estimated Take

    This section provides an estimate of the number of incidental takes for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.

    After public comment and review of the proposed authorization, the following items have changed in the final authorization.

    (1) The Level B harassment zone for drilling activities has decreased from 21,544 m to 15,849 m to account for an error that was present in the proposed IHA. During the drafting of the proposed IHA, the source level for drilling activities was reduced from 170 dB to 168 dB based on proxy data from the Alaska Department of Transportation (2016). The resulting Level B harassment zone was not updated from 21,544 m to 15,849 m until this error was noticed during public comment (Table 5).

    (2) The Level B harassment zone for impact driving of 16-inch steel piles changed from 215 m to 136 m to account for an error that was present in the proposed IHA. This change resulted in a corresponding correction the ensonified area (Table 5).

    (3) The Level B harassment zone for vibratory installation of 16-inch steel pipe piles was reduced from 21,544 m to 3,415 m. This change was to correct a misstatement in the proposed IHA. The original Level B harassment zone was stated as 21,544 m, when 3,415 m was the correct value for the given source level (158 dB SPL). This source level remains at 158 dB as presented in the proposed IHA, and the Level B harassment zone has been updated to match this source level with a corresponding correction to the ensonified area (Table 5).

    (4) To correct errors present in the proposed IHA, duration estimates for some activities were updated. Updated activity durations included vibratory pile removal, vibratory pile installation of 36-inch steel piles, vibratory pile installation of 14-inch steel H piles, and down the hole drilling (Table 6). These changes were accompanied by corresponding but minor changes in Level A harassment zones (Table 7).

    (5) Errors in calculation of takes by Level B harassment for harbor seal, California sea lion, and harbor porpoise were corrected, resulting in decreased take estimates. Take estimates for northern elephant seal and northern fur seal were increased from 1 to 3 individuals to account for the large Level B harassment zones for certain activities (Table 9).

    Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to acoustic sources. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (i.e., use of a bubble curtain, wood cushion, and shutdown—discussed in detail below in the Mitigation Measures section), Level A harassment is neither anticipated nor authorized.

    As described previously, no mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.

    Generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (e.g., previous monitoring results or average group size). Below, we describe these components in more detail and present the take estimate.

    Acoustic Thresholds

    Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

    Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (e.g., frequency, predictability, duty cycle), the environment (e.g., bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall et al., 2007, Ellison et al., 2012). Based on what the available science indicates and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 dB re 1 micro pascal (μPa) root mean square (rms) for continuous (e.g., vibratory pile-driving, drilling) and above 160 dB re 1 μPa (rms) for non-explosive impulsive (e.g., impact pile driving) sources.

    The Port of San Francisco's activity includes the use of continuous (vibratory pile driving, down the hole drilling) and impulsive (impact pile driving) sources, and therefore the 120 and 160 dB re 1 μPa (rms) thresholds are applicable.

    Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (NMFS, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The Port of San Francisco's activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources.

    These thresholds are provided in Table 3 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS's 2018 Technical Guidance, which may be accessed at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.

    Table 3—Thresholds Identifying the Onset of Permanent Threshold Shift Hearing group PTS onset acoustic thresholds *
  • (received level)
  • Impulsive Non-impulsive
    Low-Frequency (LF) Cetaceans Cell 1: L pk,flat: 219 dB; L E,LF,24h: 183 dB Cell 2: L E,LF,24h: 199 dB. Mid-Frequency (MF) Cetaceans Cell 3: L pk,flat: 230 dB; L E,MF,24h: 185 dB Cell 4: L E,MF,24h: 198 dB. High-Frequency (HF) Cetaceans Cell 5: L pk,flat: 202 dB; L E,HF,24h: 155 dB Cell 6: L E,HF,24h: 173 dB. Phocid Pinnipeds (PW) (Underwater) Cell 7: L pk,flat: 218 dB; L E,PW,24h: 185 dB Cell 8: L E,PW,24h: 201 dB. Otariid Pinnipeds (OW) (Underwater) Cell 9: L pk,flat: 232 dB; L E,OW,24h: 203 dB Cell 10: L E,OW,24h: 219 dB. * Dual metric acoustic thresholds for impulsive sounds: Use whichever results in the largest isopleth for calculating PTS onset. If a non-impulsive sound has the potential of exceeding the peak sound pressure level thresholds associated with impulsive sounds, these thresholds should also be considered. Note: Peak sound pressure (L pk) has a reference value of 1 μPa, and cumulative sound exposure level (L E) has a reference value of 1 μPa2s. In this Table, thresholds are abbreviated to reflect American National Standards Institute standards (ANSI 2013). However, peak sound pressure is defined by ANSI as incorporating frequency weighting, which is not the intent for this Technical Guidance. Hence, the subscript “flat” is being included to indicate peak sound pressure should be flat weighted or unweighted within the generalized hearing range. The subscript associated with cumulative sound exposure level thresholds indicates the designated marine mammal auditory weighting function (LF, MF, and HF cetaceans, and PW and OW pinnipeds) and that the recommended accumulation period is 24 hours. The cumulative sound exposure level thresholds could be exceeded in a multitude of ways (i.e., varying exposure levels and durations, duty cycle). When possible, it is valuable for action proponents to indicate the conditions under which these acoustic thresholds will be exceeded.
    Ensonified Area

    Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficients.

    Reference sound source levels used by the Port of San Francisco for all vibratory and impact piling/removal and drilling activities were derived from source level data from construction projects within Caltrans (2015) except for two cases noted below where Navy and Alaska Department of Transportation sources were used. To determine the ensonified areas for both the Level A and Level B harassment zones for vibratory piling of the 36-inch, 30-inch, and 16-inch steel piles and 14-inch steel H piles, the Port of San Francisco used sound pressure levels (SPL) of 170 dB re 1 μPa rms, 170 dB re 1 μPa rms, 158 dB re 1 μPa rms, and 158 dB re 1 μPa rms, respectively. These were derived from vibratory pile driving data of 36-inch (for 36-inch and 30-inch steel piles), 18-inch (for 16-inch steel piles) and 14-inch (for 14-inch steel H-pile) steel piles reported in the values listed in Table 1.2-2 and Table 1.2.3 of Caltrans (2015), and Table 6-1 of Navy (2017). For vibratory pile removal, the Port of San Francisco used an SPL of 155 dB re 1 μPa rms. This proxy source level was derived from vibratory pile driving data of 12-inch steel pipe piles in Caltrans (2015; Table 1.2-2). In addition, for down the hole drilling activities used to place 24-inch octagonal concrete piles, an SPL of 168 dB was used, corresponding to the mean SPL reported in Table 72 of the Alaska Department of Transportation (2016) hydroacoustic report.

    For impact pile driving, the Port of San Francisco used both SPLs and sound exposure levels (SEL) derived from summary source level values reported in Caltrans (2015). These source levels were then reduced by 7 dB due to the Port of San Francisco's use of a bubble curtain. NMFS used a reduction value of 7 dB as it was roughly the average sound reduction value derived from sound measurements of piles that used bubble curtains within Caltrans (2015). For piling of 36-inch steel piles, a source level of 183 dB SEL was chosen as a proxy value for modeling Level A harassment zones (Caltrans 2015, Table 1.2-1). This source level was reduced to 176 dB SEL with the 7 dB reduction. For piling of 20-inch concrete piles, a source level of 167 dB SEL was chosen as a proxy value for modeling Level A harassment zones (Caltrans 2015, Table 1.5-4, reported from 24-inch concrete pile measurements at a project in the Port of Oakland). This source level was selected as a proxy because of the proximity of the Port of Oakland project to the proposed work and it is more conservative than Caltrans (2015) summary value reported in Table 1.2-1. This source level was reduced to 160 dB SEL with the 7 dB reduction. In addition, for impact piling of 16-inch steel piles, a source level of 158 dB SEL was chosen as a proxy value for modeling Level A harassment zones (Caltrans 2015, Table I.2-1). This source level was reduced to 151 dB SEL with the 7 dB reduction. The stated source levels and their corresponding activity are presented in Table 4 below.

    Table 4—Project Source Levels Activity Source level
  • at 10 meters
  • (dB)
  • Vibratory Pile Driving/Removal: 36-inch steel pile installation 170 SPL 30-inch steel pile installation (Caisson) 170 SPL 14-inch steel H pile installation 158 SPL Removal of pre-existing piles 155 SPL 16-inch steel pile installation 158 SPL Impact Pile Driving: * 36-inch steel pile installation 176 SEL/186 SPL 20-inch concrete pile installation 160 SEL/172 SPL 16-inch steel pile installation 151 SEL/177 SPL Down the Hole Drilling: 24-inch Octagonal Concrete (drilling of 30-inch hole) 168 SPL * The values in the cells reflect a 7dB reduction due to the Port of San Francisco's use of a bubble curtain.
    Level B Harassment Zones

    The practical spreading model was used by the Port of San Francisco to generate the Level B harassment zones for all piling/removal activities. Practical spreading is described in full detail below.

    Pile driving and drilling generates underwater noise that can potentially result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

    TL = B * log10 (R1/R2), Where R1 = the distance of the modeled SPL from the driven pile, and R2 = the distance from the driven pile of the initial measurement. This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20 * log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10 * log[range]). A practical spreading value of 15 is often used under conditions where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions.

    Utilizing the practical spreading loss model, the Port of San Francisco determined underwater noise will fall below the behavioral effects threshold of 120 dB rms for marine mammals at a maximum radial distance of 21,544 m for vibratory piling (36 and 30-inch steel piles) and 15,849 m for drilling ((24-inch octagonal concrete pile). The maximum Level B harassment zone for this activity will therefore be set at 21,544 m. However, previous sound monitoring for other projects in San Francisco Bay (i.e. Caltrans 2015; 2016) have shown background sound levels in the active portions of the Bay, near the project area, to range from 110 to 140 dB rms, with typical background levels in the range of 110 to 120 dB rms. This ambient noise may affect the ability to distinguish sound from vibratory pile driving in the region (Rodkin, 2009), but direct applicability of that finding to the Port's work is unknown, and therefore no reduction in Level B harassment zone is applied. The maximum radial distance of the Level B harassment zone for impact pile driving equaled 541.2 m (impact driving 36-inch steel piles). At this radial distance, the entire Level B harassment zone for impact piling equaled 0.3699 square kilometers (km2). This ensonified area is based on a GIS map of the area accounting for structures and landmasses which would block sound spreading (Please see Figure 9 of the Application). Table 5 below provides all Level B radial distances and their corresponding areas for each activity during the Port of San Francisco's project. Level B harassment zone areas are calculated using a GIS map (See Figure 9 of the Application).

    Table 5—Level B Harassment Zones Calculated Using the Practical Spreading Model Source Calculated
  • distance to
  • Level B
  • threshold
  • (meters)
  • Level B
  • harassment zone
  • (square kilometers
  • km2)
  • Vibratory Pile Driving 36-inch steel pile installation 21,544 47.1608 30-inch steel pile installation 21,544 47.1608 16-inch steel pile installation 3,415 7.6431 14-inch steel H pile installation 3,415 7.6431 Removal of pre-existing concrete and wood piles 2,154 3.1511 Impact Pile Driving 36-inch steel pile installation 541.2 0.36993 20-inch concrete pile installation 63.1 0.006650 16-inch steel pile installation 136 0.0291 Down the Hole Drilling 15,849 47.1608
    Level A Harassment Zones

    When the NMFS Technical Guidance (2016) was published, in recognition of the fact that the ensonified area could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which will result in some overestimate of Level A harassment. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For stationary sources (i.e. pile driving), NMFS's User Spreadsheet predicts the closest distance at which, if a marine mammal remained at that distance the whole duration of the activity, it would not incur PTS. Inputs used in the User Spreadsheet, and the resulting isopleths are reported below. Daily ensonified areas for Level A harassment are approximated as a semi-circle because the pile driving and drilling are occurring close to shore and the coastline is approximately linear.

    Table 6—Parameters of Pile Driving and Drilling Activity Equipment type Vibratory pile driver
  • (removal of
  • concrete and
  • wood piles)
  • Vibratory pile driver
  • (installation of 36-inch steel piles)
  • Vibratory pile driver
  • (installation of 30-inch steel piles)
  • Vibratory pile driver
  • (installation of 16-inch steel piles)
  • Vibratory pile driver
  • (installation of 14-inch steel H piles)
  • Impact pile
  • driver
  • (36-inch steel piles)
  • Impact pile
  • driver
  • (20-inch concrete piles)
  • Impact pile
  • driver
  • (16-inch steel piles)
  • Drilling
  • (24-inch
  • octagonal concrete pile)
  • Spreadsheet Tab Used Non-impulsive, continuous Non-impulsive, continuous Non-impulsive, continuous Non-impulsive, continuous Non-impulsive, continuous Impulsive, Non-continuous Impulsive, Non-continuous Impulsive, Non-continuous Non-impulsive, continuous. Source Level 155 SPL 170 SPL 170 SPL 158 SPL 158 SPL 176 SEL * 160 SEL * 151 SEL * 168 SPL. Weighting Factor Adjustment (kHz) 2.5 2.5 2.5 2.5 2.5 2 2 2 2. (a) Activity duration (hours) within 24 hours, (b) Number of strikes per pile, (c) Number of piles per day (a) 0.66 (a) 1.33 (a) 0.25 (a) 0.33 (a) 0.66 (b) 150, (c) 4 (b) 500, (c) 4 (b) 500, (c) 2 (a) 5.5. Propagation (xLogR) 15 15 15 15 15 15 15 15 15. Distance of source level measurement (meters) + 10 10 10 10 10 10 10 10 10. * Displayed source values include the 7 dB reduction for use of a bubble curtain.
    Table 7—Level A Harassment Zone Isopleth and Ensonified Area for Pile Driving and Drilling Source type PTS isopleth (meters) Low-
  • frequency cetaceans
  • Mid-
  • frequency cetaceans
  • High-
  • frequency cetaceans
  • Phocid
  • pinnipeds
  • Otariid
  • pinnipeds
  • Vibratory Pile Driver (Removal of concrete and wood piles) 1.5 0.1 2.2 0.9 0.1 Vibratory Pile Driver (Installation of 36-inch steel piles) 32.9 2.9 48.7 20.0 1.4 Vibratory Pile Driver (Installation of 30-inch steel piles) 10.8 1.0 16.0 6.6 0.5 Vibratory Pile Driver (Installation of 14-inch steel H piles) 3.3 0.3 4.9 2.0 0.1 Vibratory Pile Driver (Installation of 16-inch steel H piles) 2.1 0.2 3.0 1.3 0.1 Impact Pile Driver (36-inch steel piles) 242.6 8.6 288.9 129.8 9.5 Impact Pile Driver (20-inch concrete piles) 46.4 1.7 55.3 24.8 1.8 Impact Pile Driver (16-inch steel piles) 7.3 0.3 8.8 3.9 0.3 Drilling(24-inch octagonal concrete pile) 62.7 3.5 54.9 33.5 2.4 Daily ensonified area (m2) Vibratory Pile Driver (Removal of concrete and wood piles) 3.5 0.02 7.6 1.3 0.02 Vibratory Pile Driver (Installation of 36-inch steel piles) 1,700 13 3,730 628 3.1 Vibratory Pile Driver (Installation of 30-inch steel piles) 183 1.6 402 68 0.4 Vibratory Pile Driver (Installation of 14-inch steel H piles) 17 0.14 37 6.3 0.02 Vibratory Pile Driver (Installation of 16-inch steel H piles) 6.9 0.06 14 2.7 0.02 Impact Pile Driver (36-inch steel piles) 92,450 120 131,100 26,460 140 Impact Pile Driver (20-inch concrete piles) 3,380 4.5 4,800 966 5.1 Impact Pile Driver (16-inch steel piles) 84 0.1 120 24 0.1 Drilling(24-inch octagonal concrete pile) 6,180 19 4,730 1,760 9.0
    Marine Mammal Occurrence

    In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.

    No systematic line transect surveys of marine mammals have been performed in San Francisco Bay. Therefore, the in-water densities of harbor seals, California sea lions, and harbor porpoises were calculated based on 17 years of observations during monitoring for the San Francisco Bay-Oakland Bay Bridge (SFOBB) construction and demolition project (Caltrans 2018). Care was taken to eliminate multiple observations of the same animal, although this can be difficult and is likely that the same individual may have been counted multiple times on the same day. The amount of monitoring performed per year varied, depending on the frequency and duration of construction activities with the potential to affect marine mammals. During the 257 days of monitoring from 2000 through 2017 (including 15 days of baseline monitoring in 2003), 1,029 harbor seals, 83 California sea lions, and 24 harbor porpoises were observed in waters in the project vicinity in total. In 2015, 2016, and 2017, the number of harbor seals in the project area increased significantly. In 2017, the number of harbor porpoise in the project area also increased significantly. Therefore, a harbor seal density estimate was calculated using the 2015-2017 data, and a harbor porpoise density estimate was calculated using the 2017 data, which may better reflect the current use of the project area by these animals. These observations included data from baseline, pre-, during, and post-pile driving, mechanical dismantling, on-shore blasting, and off-shore implosion activities.

    Insufficient sighting data exist to estimate the density of bottlenose dolphins. However, a single bottlenose dolphin has been observed regularly near the project site. One individual was documented regularly, through photo ID, over several months off the coast of the former Alameda Air Station (Perlman 2017).

    Insufficient sighting data exist to estimate elephant seal densities in the Bay. Generally, only juvenile elephant seals enter the Bay and do not remain long. The most recent sighting near the project area was in 2012, on the beach at Clipper Cove on Treasure Island, when a healthy yearling elephant seal hauled out for approximately 1 day. Approximately 100 juvenile northern elephant seals strand in or near the Bay each year, including individual strandings at Yerba Buena Island and Treasure Island (less than 10 strandings per year).

    In addition, insufficient sighting data exist to estimate northern fur seal and gray whale densities in the Bay. Only two to four northern fur seals strand in the Bay each year, and they are unlikely to occur in the project area. Also, during the Caltrans Richmond-San Rafael Bridge project, monitors recorded 12 living and two dead gray whales in the surveys performed in 2012. All sightings were in either the Central or North Bay, and all but two sightings occurred during the months of April and May. One gray whale was sighted in June and one in October. The Oceanic Society has tracked gray whale sightings since they began returning to San Francisco Bay regularly in the late 1990s. Most sightings occurred just a mile or two inside of the Golden Gate, with some traveling into San Pablo Bay in the northern part of the San Francisco Bay (Self 2012). The Oceanic Society data show that all age classes of gray whales enter San Francisco Bay and they enter as singles or in groups of up to five individuals (Winning 2008). It is estimated that two to six gray whales enter San Francisco Bay in any given year.

    Numbers used for density calculations are shown in Table 8. These numbers were calculated from observations in nearby waters of the San Francisco Bay during San Francisco-Oakland Bay Bridge construction conducted by Caltrans (Caltrans 2018). These observations occurred from 2000 to 2017 in a 2 km2 monitoring zone for California sea lions, from 2015-2017 in a 2 km2 monitoring zone for harbor seals, and in 2017 in a 15 km2 zone for harbor porpoise. In the cases where densities were refined to capture a narrower range of years to be conservative, bold densities were used for take calculations.

    Table 8—Estimated In-Water Density of Marine Mammal Species in San Francisco Bay Area [Caltrans 2017] Species observed Area of
  • monitoring zone
  • (km2)
  • Days of
  • monitoring
  • Number of
  • animals
  • observed
  • Density
  • animals/km2
  • Harbor seals 2000-2017 2 257 1,029 2.002. Harbor Seals 2015-2017 2 47 372 3.957. California Sea Lions 2000-2017 2 257 83 0.161. Bottlenose Dolphins 2017 2 6 2 Insufficient sighting data exists to estimate density. Harbor Porpoise 2000-2017 3 257 24 0.031. Harbor Porpoise 2017 15 6 15 0.167. Elephant Seal 2000-2017 2 257 0 Insufficient sighting data exists to estimate density. Northern Fur Seal 2000-2017 2 257 0 Insufficient sighting data exists to estimate density. Gray Whale 2000-2017 2 257 0 Insufficient sighting data exists to estimate density. Notes: Densities for Pacific harbor seals, California sea lions, and harbor porpoises are based on monitoring for the east span of the SFOBB from 2000 to 2017. A second set of Pacific harbor seal densities were calculated from the increase in sightings recorded from 2015 to 2017. A second set of harbor porpoise densities were calculated for the increase in sightings that were recorded in 2017. Bold densities were used for take calculations. Sources: CalTrans 2001, 2004b, 2013b, 2013c, 2014, 2015b, 2016, 2017; Perlman 2017.

    For species without enough sightings to construct a density estimate, we used information based on group size and frequency of sightings from previous years of work to inform the number of animals estimated to be taken, which is detailed in the Take Estimation section below.

    Take Calculation and Estimation

    Here we describe how the information provided above is brought together to produce a quantitative take estimate.

    When density data was available, Level B take for the project was calculated by multiplying the density times the largest Level B harassment zone (km2) times the number of construction days. Since density data was only available for harbor seals, harbor porpoises, and California sea lions, these were the only species whose take was calculated used this methodology. Table 9 shows the number of take calculated for species with density and without density estimates. For species without density information, information on average group size of the species was used. This is discussed below Table 9.

    Table 9—Take Estimates as a Percentage of Stock Abundance Species Density
  • animals/km2
  • Level B
  • harassment
  • zone
  • (km2) 1
  • Construction
  • days 2
  • Proposed
  • Level B
  • take
  • Percentage
  • of stock
  • Harbor Seal 3.957 47.1608 15 2,799 9.0 California Sea Lions 0.161 47.1608 15 114 0.038 Harbor Porpoise 0.167 47.1608 15 118 1.2 Northern Elephant Seal Insufficient sighting data exists to estimate density 47.1608 15 3 0.0034 Northern Fur Seal Insufficient sighting data exists to estimate density 47.1608 15 3 0.0005 Gray Whale Insufficient sighting data exists to estimate density 47.1608 15 3 0.014 Bottlenose Dolphin Insufficient sighting data exists to estimate density 47.1608 15 15 3.3 1 Represents area of largest Level B harassment zone during pile driving/removal and drilling activities. 2 Total construction days for pile driving/removal and drilling.
    Gray Whale

    Gray whales occasionally enter San Francisco Bay during their northward migration period of February and March. Pile driving and drilling are not proposed to occur during this time and gray whales are not likely to be present at other times of the year. It is estimated that two to six gray whales enter the Bay in any given year, but they are unlikely to be present during the work period (June 1 through November 30). However, individual gray whales have occasionally been observed in San Francisco Bay during the work period, and therefore it is conservatively estimated that, at most, 3 gray whales, or one average sized group, may be exposed to Level B harassment during the 15 days of pile driving/drilling.

    Bottlenose Dolphin

    When bottlenose dolphins are present in San Francisco Bay, they are more typically found close to the Golden Gate. Recently, beginning in 2015, two individuals have been observed frequently in the vicinity of Oyster Point (GGCR 2016, 2017; Perlman 2017) and one individual has been observed near Alameda (GGCR 2016). Observations of bottlenose dolphins are primarily west of Treasure Island and concentrated along the nearshore areas of San Francisco south to Redwood City (Caltrans 2018). Bottlenose dolphins rarely occur in San Francisco Bay, but given the size of the Level B harassment zone NMFS authorizes take of 15 bottlenose dolphins by level B harassment.

    Northern Fur Seal

    Observations of northern fur seals are too few to establish a density for this species in San Francisco Bay. The Marine Mammal Center (TMMC) reported only two to four northern fur seal strandings in the Bay in 2015 and 2016 (in Marin, San Francisco, and Santa Clara counties) (TMMC 2017). To account for the possible rare presence of the species in the action area, NMFS authorizes three takes by Level B harassment of northern fur seal.

    Northern Elephant Seal

    Elephant seals breed between December and March and have been rarely cited in San Francisco Bay. It is anticipated that if an elephant seal is encountered at all during pile driving or drilling it would be a juvenile. To account for the possible rare presence of the species in the action area, NMFS authorizes three takes by Level B harassment of elephant seal.

    Level A Harassment

    High frequency cetaceans (including harbor porpoise) have the largest Level A harassment zone resulting from this project as shown in Table 7. Estimated take by Level A harassment for harbor porpoise, based on density reported in Table 8 and the Level A harassment zone, is less than one individual (Density * Days * Ensonified Area). Given the required mitigation measures, including shutdown zones which exceed the Level A harassment zone, NMFS authorizes no Level A harassment for harbor porpoise or any marine mammal.

    Mitigation Measures

    The only change to mitigation measures were updates to the minimum shutdown zones to reflect the changes in Level A harassment zones discussed in the previous section.

    In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).

    In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:

    (1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned); and

    (2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations.

    In addition to the specific measures described later in this section, the Port must conduct briefings for construction supervisors and crews, the monitoring team, and Port staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, the marine mammal monitoring protocol, and operational procedures.

    Timing Restrictions

    All work will be conducted during daylight hours. If poor environmental conditions restrict full visibility of the shutdown zone, pile installation would be delayed.

    Sound Attenuation

    Sound attenuation methods, including a bubble curtain, will be implemented for the duration of impact pile driving to install 36-inch and 16-inch steel and 20-inch concrete piles. Additionally, a caisson sleeve will be used during down the whole drilling. The Port shall implement the following bubble curtain performance standards:

    • The bubble curtain must distribute air bubbles around 100 percent of the piling perimeter for the full depth of the water column;

    • The lowest bubble ring shall be in contact with the mudline for the full circumference of the ring, and the weights attached to the bottom ring shall ensure 100 percent mudline contact. No parts of the ring or other objects shall prevent full mudline contact;

    • The selected contractor will ensure that personnel are trained in the proper balancing of air flow to the bubblers and shall require that construction contractors submit an inspection/performance report for approval by the Port of San Francisco within 72 hours following the performance test. Corrections to the attenuation device to meet the performance standards shall occur prior to impact driving.

    Shutdown Zone For In-Water Heavy Machinery Work

    For in-water heavy machinery work (using, e.g., standard barges, tug boats, barge-mounted excavators, or clamshell equipment used to place or remove material), a minimum 10 meter shutdown zone shall be implemented. If a marine mammal comes within 10 m of such operations, operations shall cease and vessels shall reduce speed to the minimum level required to maintain steerage and safe working conditions. This type of work could include (but is not limited to) the following activities: (1) Vibratory pile driving; (2) movement of the barge to the pile location; (3) positioning of the pile on the substrate via a crane (i.e., stabbing the pile); or (4) removal of the pile from the water column/substrate via a crane (i.e., deadpull).

    Additional Shutdown Zones

    For all pile driving/removal and drilling activities, The Port of San Francisco will establish a shutdown zone for a marine mammal species that is greater than its corresponding Level A harassment zone. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). The shutdown zones for each of the pile driving and drilling activities are listed below in Table 10.

    Table 10—Shutdown Zones Source Shutdown zones (meters) Low-frequency cetaceans (humpback whale, minke whale) Mid-frequency cetaceans (Pacific-white sided dolphin) High-
  • frequency cetaceans (Dall's
  • porpoise, harbor porpoise)
  • Phocid
  • (harbor seal)
  • Otariid
  • (sea lion)
  • In-Water Construction Activities * In Water Heavy Construction (i.e., Barge movements, pile positioning, deadpulling, and sound attenuation) 10 10 10 10 10 Vibratory Pile Driving Vibratory Pile Driver (Removal of concrete and wood piles) 10 10 10 10 10 Vibratory Pile Driver (Installation of 14-inch steel H piles) 10 10 10 10 10 Vibratory Pile Driver (Installation of 16-inch steel H piles) 10 10 10 10 10 Vibratory Pile Driver (Installation of 30-inch steel piles) 25 10 25 10 10 Vibratory Pile Driver (Installation of 36-inch steel piles) 50 10 75 25 10 Impact Pile Driving Impact Pile Driver (16-inch steel piles) 10 10 10 10 10 Impact Pile Driver (20-inch concrete piles) 75 10 75 30 10 Impact Pile Driver (36-inch steel piles) 300 25 300 150 25 Drilling 24-inch concrete pile (1 pile) (5.5 hours per day) 75 10 50 20 10
    Monitoring Zones

    The Port of San Francisco will establish and observe a monitoring zone. The monitoring zones for this project will differ based on activity. For vibratory pile driving and down the hole drilling, it may not be possible to observe the entire Level B harassment zones (areas where SPLs are equal to or exceed 120 dB rms) due to their size. The Port is expected to monitor and record observations in the largest reasonable portion of this Level B harassment zone based on the number of observers and visibility, but conditions may require efforts to be focused in a smaller monitoring zone. For impact pile driving, the monitoring zones are areas where SPLs are equal to or exceed 160 dB rms. For vibratory pile driving/drilling and impact pile driving the Level B Harassment zones are presented in Table 11 below. For the vibratory pile driving and drilling activities, it is noted that Level B harassment zone radius and area will not necessarily equal the monitoring zone. These zones provide utility for monitoring conducted for mitigation purposes (i.e., shutdown zone monitoring) by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring of disturbance zones enables observers to be aware of and communicate the presence of marine mammals in the project area, but outside the shutdown zone, and thus prepare for potential shutdowns of activity. However, the primary purpose of disturbance zone monitoring is for documenting instances of Level B harassment; disturbance zone monitoring is discussed in detail later (see Monitoring and Reporting).

    Table 11—Monitoring Zones Source Radial
  • Distance to
  • Level B
  • threshold
  • (meters)
  • Level B
  • Harassment
  • Zone
  • (km2)
  • Vibratory Pile Driving 36-inch steel pile installation * 21,544 * 47.1608 30-inch steel pile installation * 21,544 * 47.1608 16-inch steel pile installation * 3,415 * 7.6431 14-inch steel H pile installation * 3,415 * 7.6431 Removal of pre-existing concrete and wood piles * 2,154 * 3.1511 Impact Pile Driving 36-inch steel pile installation 541.2 0.3699 20-inch concrete pile installation 63.1 0.006650 16-inch steel pile installation 136 0.0291 Down the Hole Drilling * 15,849 * 47.1608 * The monitored radius and area of the Level B harassment zone may vary based on visibility.
    Non-Authorized Take Prohibited

    If a species enters or approaches the Level B harassment zone and that species is either not authorized for take or its authorized takes are met, pile driving, pile removal, and drilling activities must shut down immediately using delay and shut-down procedures. Activities must not resume until the animal has been confirmed to have left the area or an observation time period of 15 minutes has elapsed.

    Soft Start

    The use of a soft-start procedure is believed to provide additional protection to marine mammals by providing warning and/or giving marine mammals a chance to leave the area prior to the impact hammer operating at full capacity. For impact pile driving, contractors will be required to provide an initial set of strikes from the hammer at 40 percent energy, each strike followed by no less than a 30-second waiting period. This procedure will be conducted a total of three times before impact pile driving begins. This soft start procedure must be implemented at the start of a day's impact pile driving and at any time following cessation of impact driving of 30 minutes or greater. Soft start is not required during vibratory pile driving/removal or drilling activities.

    Pre-Activity Monitoring

    Prior to the start of daily in-water construction activity, or whenever a break in pile driving or drilling of 30 minutes or longer occurs, the observer will observe the shutdown and monitoring zones for a period of 30 minutes. The shutdown zone will be cleared when a marine mammal has not been observed within the zone for that 30-minute period. A determination that the shutdown zone is clear must be made during a period of good visibility (i.e., the entire shutdown zone and surrounding waters must be visible to the naked eye). If a marine mammal is observed within the shutdown zone, a soft-start cannot proceed until the animal has left the zone or has not been observed for 15 minutes. If the monitoring zone has been observed for 30 minutes and non-permitted species are not present within the zone, soft start procedures can commence and work can continue even if visibility becomes impaired within the monitoring zone. When a marine mammal permitted for take by Level B harassment is present in the monitoring zone, pile driving, pile removal, and drilling activities may begin and take by Level B harassment will be recorded. As stated above, if the entire Level B harassment zone is not visible at the start of construction, piling or drilling activities can begin. If work ceases for more than 30 minutes, the pre-activity monitoring of both the monitoring zone and shutdown zone will commence.

    Based on our evaluation of the applicant's mitigation measures, as well as other measures considered by NMFS, NMFS has determined that the mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Monitoring and Reporting

    Between the proposed IHA and final IHA, the only change to monitoring and reporting protocols were a decrease in the required minimum number of protected species observers (PSOs) from two to one. To minimize the burden of monitoring on the applicant, two PSOs will be used for the first week of the project. Later portions of the project will utilize one PSO if monitoring results up to that point have not shown unexpectedly high numbers of marine mammals. NMFS determined that one PSO is sufficient to effectively observe the shutdown zones and a portion of the monitoring zone. This level of observation minimized burden on the applicant while still ensuring effective monitoring. Additionally, the use of two PSOs for a portion of the project will increase understanding of the impacts of this and similar projects on marine mammals in San Francisco Bay, while not placing an excessive burden on the Port of San Francisco.

    In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.

    Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

    • Occurrence of marine mammal species or stocks in the area in which take is anticipated (e.g., presence, abundance, distribution, density);

    • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) affected species (e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (e.g., age, calving or feeding areas);

    • Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

    • How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

    • Effects on marine mammal habitat (e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

    • Mitigation and monitoring effectiveness.

    Hydroacoustic Monitoring

    The Port recognizes in their application the need to implement a sound monitoring plan (SMP) as required by the Regional NMFS and U.S. Army Corps of Engineers programmatic review for pile driving activities in San Francisco Bay. The Port indicates that this SMP will recommend sound monitoring stations at 10 m, 100 m, and 300 m to monitor ambient noise conditions in the area. NMFS feels that ambient noise measurements are highly specific to the time and place they were taken, and therefore might have limited use to future projects. However, there are few source level measurements for down the hole drilling activities, as shown by the use of Alaska DOT proxy data in this IHA. NMFS feels that rigorous hydroacoustic monitoring of source level for the down the hole drilling activity will be more beneficial for future projects in this region and others. While NMFS is not requiring these source level measurements, if the Port were already planning to conduct measurements, we recommend focusing on source level verification and could offer guidance on its implementation.

    Visual Monitoring

    Monitoring would be conducted 30 minutes before, during, and 30 minutes after all pile driving/removal and drilling activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven, removed, or pile holes being drilled. Pile driving and drilling activities include the time to install, remove, or drill a hole for a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes.

    Monitoring will be conducted by NMFS approved PSOs. There will be a minimum of one PSO during all pile driving/removal and drilling activities. Two PSOs will be required to observe the shutdown and disturbance zones for the first five (5) days of combined pile driving, pile removal, and drilling.

    PSOs shall scan the waters using binoculars, and/or spotting scopes, and shall use a handheld GPS or range-finder device to verify the distance to each sighting from the project site. All PSOs shall be trained in marine mammal identification and behaviors and are required to have no other project-related tasks while conducting monitoring. In addition, monitoring shall be conducted by qualified observers, who shall be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained and/or experienced professionals, with the following minimum qualifications:

    i. At least one PSO must have prior experience working as a marine mammal observer during construction activities;

    • Independent observers (i.e., not construction personnel);

    ii. Other PSOs may substitute education (degree in biological science or related field) or training for experience;

    iii. Where a team of three or more PSOs are required, a lead observer or monitoring coordinator shall be designated. The lead observer must have prior experience working as a marine mammal observer during construction;

    iv. The Port of San Francisco shall submit PSO CVs for approval by NMFS;

    The Port of San Francisco shall ensure that observers have the following additional qualifications:

    • Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;

    • Ability to conduct field observations and collect data according to assigned protocols;

    • Experience or training in the field identification of marine mammals, including the identification of behaviors;

    • Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior;

    • Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary; and

    • Sufficient training, orientation, or experience with the construction operations to provide for personal safety during observations.

    The Port of San Francisco shall submit a draft report to NMFS not later than 90 days following the end of construction activities. The Port of San Francisco shall provide a final report within 30 days following resolution of NMFS' comments on the draft report. Reports shall contain, at minimum, the following:

    • Date and time that monitored activity begins and ends for each day conducted (monitoring period);

    • Construction activities occurring during each daily observation period, including how many and what type of piles driven;

    • Deviation from initial proposal in pile numbers, pile types, average driving times, etc.;

    • Weather parameters in each monitoring period (e.g., wind speed, percent cloud cover, visibility);

    • Water conditions in each monitoring period (e.g., sea state, tide state);

    • Extrapolated estimates of the total observed Level B harassment takes based on the percentage of the Level B harassment zone that was not visible or was not monitored.

    • For each marine mammal sighting:

    ○ Species, numbers, and, if possible, sex and age class of marine mammals;

    ○ Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;

    ○ Location and distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

    ○ Estimated amount of time that the animals remained in the Level B harassment zone;

    ○ Description of implementation of mitigation measures within each monitoring period (e.g., shutdown or delay);

    ○ Other human activity in the area within each monitoring period; and

    ○ A summary of the following:

    Total number of individuals of each species detected within the monitoring zone, and estimated as taken if correction factor appropriate;

    Total number of individuals of each species detected within the Level A harassment zone and the average amount of time that they remained in that zone; and

    Daily average number of individuals of each species (differentiated by month as appropriate) detected within the monitoring zone, and estimated as taken, if appropriate.

    Negligible Impact Analysis and Determination

    NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any responses (e.g., critical reproductive time or location, migration), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

    As stated in the mitigation section, bubble curtains will be used and shutdown zones that encompass the area in which Level A harassment might be expected to occur will be implemented. As a result, no take by Level A harassment is expected nor authorized for this activity. Exposures to elevated sound levels produced during pile driving activities may cause behavioral responses by an animal, but they are expected to be mild and temporary. Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (e.g., Thorson and Reyff, 2006; Lerma, 2014). Most likely, individuals will simply move away from the sound source and be temporarily displaced from the areas of pile driving, although even this reaction has been observed primarily only in association with impact pile driving. These reactions and behavioral changes are expected to subside quickly when the exposures cease. Within the project area, there are no critical habitats or other biologically important areas (Calambokidis et al., 2015). The area is an active commercial port, and while harbor seals, California sea lions, and other marine mammals may be present, the area is not an established rookery or breeding ground for local populations.

    During all impact driving, implementation of soft start procedures, the use of a bubble curtain, and monitoring of established shutdown zones will be required. Given sufficient notice through use of soft start (for impact driving), marine mammals are expected to move away from an irritating sound source prior to it becoming potentially injurious. In addition, PSOs will be stationed within the action area whenever pile driving/removal and drilling operations are underway. Depending on the activity, The Port of San Francisco will employ the use of at least one PSO to monitor shutdown and monitoring zones.

    Although the MBFL and WTL Project would have some permanent removal of habitat available to marine mammals, the area lost would be negligible. Construction of the MBFL and WTL structures and dredging for the project will result in the disturbance of up to approximately 8.4 acres of predominantly fine‐grained sediment and the associated benthic infaunal community. Total habitat disturbed from the project activities is estimated at 0.000071 percent of the total South San Francisco Bay subtidal habitat available (NOAA 2007). This is a relatively small fraction of area relative to the total available habitat for foraging and transit for marine mammals. In addition, to minimize impacts, in‐water construction will be limited to locally established environmental work windows between June and November.

    Overall, impacts to marine mammals and prey species due to the Mission Bay Ferry and Water Taxi Landing Project are expected to be minor and temporary. The area impacted by the project is very small compared to the available habitat around San Francisco Bay. The most likely impact to prey will be temporary behavioral avoidance of the immediate area. During pile driving and drilling, it is expected that fish and marine mammals would temporarily move to nearby locations and return to the area following cessation of in-water construction activities. Therefore, indirect effects on marine mammal prey during the construction are not expected to be substantial.

    In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:

    • Mortality is not anticipated or authorized;

    • Minimal impacts to marine mammal habitat are expected;

    • Bubble curtain and other sound attenuating devices are used during impact pile driving will lessen the amount of behavioral disturbance and contribute to the alleviation of the likelihood of injury;

    • Impacts are not occurring in rookeries, or known areas or features of special significance for foraging or reproduction in the project area;

    • Anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior; and

    • Required mitigation measures (i.e., shutdown zones) are expected to be effective in reducing the effects of the specified activity.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the activity will have a negligible impact on all affected marine mammal species or stocks.

    Small Numbers

    As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

    Take for all species authorized except harbor seal is less than five percent of their respective stock abundance. For harbor seal, the authorized take is less than 10 percent of the stock abundance. Based on this and the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.

    Unmitigable Adverse Impact Analysis and Determination

    There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    National Environmental Policy Act

    To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our action (i.e., the issuance of an incidental harassment authorization) with respect to potential impacts on the human environment.

    This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.

    Endangered Species Act (ESA)

    No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.

    Dated: October 16, 2018. Catherine Marzin, Acting Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-22923 Filed 10-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG575 South Atlantic Fishery Management Council; Public Meetings AGENCY:

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

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The South Atlantic Fishery Management Council (Council) will hold a meeting of its Habitat Protection and Ecosystem-Based Management Advisory Panel (AP).

    DATES:

    The Habitat Protection and Ecosystem-Based Management AP meeting will take place November 6, 2018, from 9 a.m. to 4:30 p.m., November 7, 2018, from 9 a.m. until 4:30 p.m., and November 8, 2018, from 9 a.m. until 12 p.m.

    ADDRESSES:

    Meeting address: The meetings will be held at the Sirata Beach Resort and Conference Center, 5300 Gulf Boulevard, St. Petersburg, FL 33706; phone: (727) 363-5100.

    Council address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N Charleston, SC 29405.

    FOR FURTHER INFORMATION CONTACT:

    Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free (866) SAFMC-10; fax: (843) 769-4520; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Habitat Protection and Ecosystem-Based Management AP meeting is open to the public and will be available via webinar as it occurs. Registration is required. Webinar registration information and other meeting materials will be posted to the Council's website at: http://safmc.net/safmc-meetings/current-advisory-panel-meetings/ as it becomes available.

    The Habitat Protection and Ecosystem-Based Management AP meeting agenda will include the following: An update on the Final Environmental Impact Statement for the Navy Fleet Training and Testing Area cooperatively developed by the Navy and NOAA Fisheries; be provided an update and provide comments on Bureau of Ocean Energy Management (BOEM) energy development activities with a focus on Renewable Energy development and industry planning in North Carolina and developing plans for other South Atlantic States; review and provide input on Council Web Services refinements developed for the Fishery Ecosystem II Dashboard; receive an overview of frigate and bullet mackerel as prey supporting the dolphin wahoo fisheries; receive an update on fishery independent research programs supporting stock and habitat assessment and ecosystem modelling including the Southeast Area Monitoring and Assessment Program (SEAMAP-SA), Marine Resources Monitoring, Assessment, and Prediction (MARMAP) and Southeast Fishery-Independent Survey (SEFIS); and receive a presentation on the ongoing mapping and characterization of South Atlantic deepwater by NOAA Office of Ocean Exploration and the NOAA research vessel Okeanus Explorer ecosystems which serve as Essential Fish Habitat (EFH)—Habitat Areas of Particular Concern (HAPC). The AP meeting will also include a discussion/breakout session to provide input on refining EFH information and online access for regional partner development of Environmental Impact Statements and supporting information for permit review addressing non-fishing threats in the region. AP members will also receive an update on NOAA Fisheries Ecosystem Based Fishery Management activities including a Climate Vulnerability Analysis, Ecosystem Status Report, Community Vulnerability and Ecosystem modelling. The AP will develop recommendations as necessary for consideration by the Council's Habitat Protection and Ecosystem-Based Management Committee.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES) 3 days prior to the meeting.

    Note:

    The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 17, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-22990 Filed 10-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG531 Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting AGENCY:

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

    ACTION:

    Notice of SEDAR 63 Review Workshop for Gulf of Mexico Menhaden.

    SUMMARY:

    The SEDAR 63 assessment of the Gulf of Mexico stock of Menhaden will be reviewed by an independent Panel at the Review Workshop. See SUPPLEMENTARY INFORMATION.

    DATES:

    The SEDAR 63 Review Workshop will be held on November 6, 2018, from 8:30 a.m. until 6 p.m.; and November 7, 2018, from 8:30 a.m. until 3:30 p.m. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the assessment process. Such adjustments may result in the meeting being extended from, or completed prior to the time established by this notice.

    ADDRESSES:

    Meeting address: The SEDAR 63 Review Workshop will be held at the Four Points by Sheraton French Quarter Hotel, 541 Bourbon Street, New Orleans, LA 70130; phone: (504) 648-2322.

    SEDAR address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N Charleston, SC 29405; www.sedarweb.org.

    FOR FURTHER INFORMATION CONTACT:

    Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing a workshop and webinars; and (3) Review Workshop. The product of the Data Workshop is a data report, which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report, which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

    The items of discussion in the Review Workshop are as follows:

    Independent peer review of the assessment developed during the Data Workshop and Assessment Process. Panelists will review the assessment and document their comments and recommendations in a Summary Report.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see ADDRESSES) at least 10 business days prior to the meeting.

    Note:

    The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 17, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-22992 Filed 10-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Multistakeholder Process on Promoting Software Component Transparency AGENCY:

    National Telecommunications and Information Administration, U.S. Department of Commerce.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    The National Telecommunications and Information Administration (NTIA) will convene a meeting of a multistakeholder process on promoting software component transparency on November 6, 2018.

    DATES:

    The meeting will be held on November 6, 2018, from 10 a.m. to 4 p.m., Eastern Standard Time.

    ADDRESSES:

    The meeting will be held at the American Institute of Architects, 1735 New York Ave. NW, Washington, DC 20006.

    FOR FURTHER INFORMATION CONTACT:

    Allan Friedman, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Room 4725, Washington, DC 20230; telephone: (202) 482-4281; email: [email protected] Please direct media inquiries to NTIA's Office of Public Affairs: (202) 482-7002; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    This National Telecommunications and Information Administration cybersecurity multistakeholder process focuses on promoting software component transparency. Most modern software is not written completely from scratch, but includes existing components, modules, and libraries from the open source and commercial software world. Modern development practices, such as code reuse, and a dynamic IT marketplace with acquisitions and mergers, make it challenging to track the use of software components. The Internet of Things compounds this phenomenon, as new organizations, enterprises, and innovators take on the role of software developer to add “smart” features or connectivity to their products. Although the majority of libraries and components do not have known vulnerabilities, the sheer quantity of software means that some software products ship with vulnerable or out-of-date components.

    Under the multistakeholder process, NTIA acts as the convener, but stakeholders drive the outcomes, determine how to scope and organize the work through subgroups or other means, and evaluate success of the process based on the extent to which the group's findings on software component transparency are implemented across the ecosystem. The first meeting of this multistakeholder process was held on July 19, 2018, in Washington, DC.1 Stakeholders presented multiple perspectives, and identified four inter-related work streams: Understanding the Problem, Use Cases and State of Practice, Standards and Formats, and Healthcare Proof of Concept.

    1 Notes, presentations, and a video recording of the July 19, 2018, kickoff meeting are available at: https://www.ntia.doc.gov/SoftwareTransparency.

    The main objectives of the November 6, 2018, meeting are to share progress from the working groups and hear feedback from the broader stakeholder community. Stakeholders will also discuss how the outputs of the different work streams can complement each other, and identify issues for further study. More information about stakeholders' work is available at: https://www.ntia.doc.gov/SoftwareTransparency.

    Time and Date: NTIA will convene the next meeting of the multistakeholder process on software component transparency on November 6, 2018, from 10 a.m. to 4 p.m. Eastern Standard Time. Please refer to NTIA's website, https://www.ntia.doc.gov/SoftwareTransparency, for the most current information.

    Place: The meeting will be held at the American Institute of Architects, 1735 New York Ave. NW, Washington, DC 20006. The location of the meeting is subject to change. Please refer to NTIA's website, https://www.ntia.doc.gov/SoftwareTransparency, for the most current information.

    Other Information: The meeting is open to the public and the press on a first-come, first-served basis. Space is limited.

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Allan Friedman at (202) 482-4281 or [email protected] at least seven (7) business days prior to each meeting. The meetings will also be webcast. Requests for real-time captioning of the webcast or other auxiliary aids should be directed to Allan Friedman at (202) 482-4281 or [email protected] at least seven (7) business days prior to each meeting. There will be an opportunity for stakeholders viewing the webcast to participate remotely in the meetings through a moderated conference bridge, including polling functionality. Access details for the meetings are subject to change. Please refer to NTIA's website, https://www.ntia.doc.gov/SoftwareTransparency, for the most current information.

    Dated: October 16, 2018. Kathy Smith, Chief Counsel, National Telecommunications and Information Administration.
    [FR Doc. 2018-22872 Filed 10-19-18; 8:45 am] BILLING CODE 3510-60-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System [Docket Number DARS-2018-0047; OMB Control Number 0704-0321] Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Contract Financing AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Notice and request for comments regarding a proposed extension of an approved information collection requirement.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through January 31, 2019. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.

    DATES:

    DoD will consider all comments received by December 21, 2018.

    ADDRESSES:

    You may submit comments, identified by OMB Control Number 0704-0321, using any of the following methods:

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

    Email: [email protected] Include OMB Control Number 0704-0321 in the subject line of the message.

    Fax: 571-372-6094.

    Mail: Defense Acquisition Regulations System, Attn: Mr. Mark Gomersall, OUSD(A&S)DPC(DARS), 3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060.

    Comments received generally will be posted without change to http://www.regulations.gov, including any personal information provided.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Mark Gomersall, at 571-372-6099.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Part 232, Contract Financing, and the Clause at 252.232-7002, Progress Payments for Foreign Military Sales Acquisitions; OMB Control Number 0704-0321.

    Needs and Uses: Section 22 of the Arms Export Control Act (22 U.S.C. 2762) requires the U.S. Government to use foreign funds, rather than U.S. appropriated funds, to purchase military equipment for foreign governments. To comply with this requirement, the Government needs to know how much to charge each country. The clause at 252.232-7002, Progress Payments for Foreign Military Sales Acquisitions, requires each contractor whose contract includes foreign military sales (FMS) requirements to submit a separate progress payment request for each progress payment rate, and to submit a supporting schedule that clearly distinguishes the contract's FMS requirements from U.S. requirements. The Government uses this information to determine how much of each country's funds to disburse to the contractor.

    Affected Public: Businesses or other for-profit and not-for-profit institutions.

    Respondent's Obligation: Required to obtain or retain benefits.

    Number of Respondents: 144.

    Responses per Respondent: Approximately 30.

    Annual Responses: 4,320.

    Average Burden per Response: 1.5 hours.

    Annual Burden Hours: 6,480 (includes 2,160 response hours plus 4,320 recordkeeping hours).

    Frequency: On occasion.

    Summary of Information Collection

    This information collection includes requirements relating to DFARS part 232, Contract Financing, and the related clause at DFARS 252.232-7002, Progress Payments for Foreign Military Sales Acquisitions. DFARS 232.502-4-70(a) prescribes use of the clause at DFARS 252.232-7002 in any contract that provides for progress payments and contains FMS requirements. The clause at 252.232-7002 requires each contractor whose contract includes FMS requirements to submit a separate progress payment request for each progress payment rate and to submit a supporting schedule that distinguishes the contract's FMS requirements from U.S. requirements.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.
    [FR Doc. 2018-22995 Filed 10-19-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0085] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Servicemembers Civil Relief Act (SCRA): Interest Rate Limitation Request AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 21, 2018.

    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-2018-ICCD-0085. 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, 550 12th Street SW, PCP, Room 9086, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Ian Foss, 202-377-3681.

    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: Servicemembers Civil Relief Act (SCRA): Interest Rate Limitation Request

    OMB Control Number: 1845-0135.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 200.

    Total Estimated Number of Annual Burden Hours: 67.

    Abstract: The Servicemembers Civil Relief Act (SCRA) provides that those on active duty military service are entitled to have an interest rate in excess of 6% be capped at 6% for the duration of their qualifying military service. The Department is requesting an extension of the currently approved information collection. These Federal Family Education Loan (FFEL) Program and Direct Loan Program regulations have not changed. The regulations require a loan holder to match its database against the Department of Defense's Defense Manpower Data Center (DMDC) and automatically apply the interest rate limitation, as appropriate, to borrowers under the Servicemembers Civil Relief Act. The form in this collection would only be used in limited cases where the borrower is not found in the Defense Manpower Data Center, or does not have a copy of military orders, but still wishes to receive benefits under the SCRA.

    Dated: October 17, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-22964 Filed 10-19-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0086] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Family Educational Loan Program—Servicemembers Civil Relief Act (SCRA) AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 21, 2018.

    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-2018-ICCD-0086. 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, 550 12th Street SW, PCP, Room 9086, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Ian Foss, 202-377-3681.

    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: Federal Family Educational Loan Program—Servicemembers Civil Relief Act (SCRA).

    OMB Control Number: 1845-0093.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Private Sector; State, Local, or Tribal Governments.

    Total Estimated Number of Annual Responses: 16,731.

    Total Estimated Number of Annual Burden Hours: 50,115.

    Abstract: The Department is requesting a revision of the current information collection. These Federal Family Education Loan (FFEL) Program regulations require a loan holder to match its database against the Defense Manpower Data Center (DMDC) and automatically apply the interest rate limitation, as appropriate, to borrowers under the Servicemembers Civil Relief Act (SCRA). There has been no change in the statute or in the regulations. The Department is revising downward the overall collection burden due to the decreasing number of FFEL loan holders and affected loans. Additionally, the Department is removing the minimal burden previously assessed individuals as a separate form was created subsequent to the initial information collection and the burden on individuals is more appropriate linked to that information collection.

    Dated: October 17, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-22965 Filed 10-19-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY State Energy Advisory Board AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    November 27, 2018 9 a.m. to 5:30 p.m. ET November 28, 2018 9 a.m. to 3:30 p.m. ET ADDRESSES:

    The meeting will be held at the National Renewable Energy Laboratory, 15013 Denver West Parkway, Golden, CO 80401.

    FOR FURTHER INFORMATION CONTACT:

    Michael Li, Senior Policy Advisor, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585. Phone number 202-287-5189, and email [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: To make recommendations to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy regarding goals and objectives, programmatic and administrative policies, and to otherwise carry out the Board's responsibilities as designated in the State Energy Efficiency Programs Improvement Act of 1990 (Pub. L. 101-440).

    Tentative Agenda: Meet with and hear from lab staff that support the work of the Office of Energy Efficiency and Renewable Energy. The meeting is also expected to examine the work of the Grid Modernization Initiative, Building Technologies Office and the Weatherization and Intergovernmental Programs Office. The Board is expected to develop recommendations for the Assistant Secretary of the Office of Energy Efficiency and Renewable Energy.

    Public Participation: The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Members of the public who wish to make oral statements pertaining to agenda items should contact Michael Li at the address or telephone number listed above. Requests to make oral comments must be received five days prior to the meeting; reasonable provision will be made to include requested topic(s) on the agenda. The Chair of the Board is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

    Minutes: The minutes of the meeting will be available for public review and copying within 90 days on the STEAB website: http://www.energy.gov/eere/steab/state-energy-advisory-board.

    Signed in Washington, DC, on October 16, 2018. Latanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-22875 Filed 10-19-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Nevada AGENCY:

    Office of Environmental Management, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, November 7, 2018 4 p.m.

    ADDRESSES:

    Frank H. Rogers Science and Technology Building, 755 East Flamingo, Las Vegas, Nevada 89119.

    FOR FURTHER INFORMATION CONTACT:

    Barbara Ulmer, Board Administrator, 232 Energy Way, M/S 167, North Las Vegas, Nevada 89030. Phone: (702) 523-0894; Fax (702) 295-2025 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:

    1. Briefing for Offsite Groundwater Contamination Communication Plan—Work Plan Item #6 2. Briefing on the Emergency Preparedness Working Group

    Public Participation: The EM SSAB, Nevada, 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 Barbara Ulmer at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral presentations pertaining to agenda items should contact Barbara Ulmer at the telephone number listed above. The request 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 can do so during the 15 minutes allotted for public comments.

    Minutes: Minutes will be available by writing to Barbara Ulmer at the address listed above or at the following website: http://www.nnss.gov/NSSAB/pages/MM_FY19.html.

    Signed in Washington, DC, on October 16, 2018. Latanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-22874 Filed 10-19-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Northern New Mexico AGENCY:

    Office of Environmental Management, 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 requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, November 7, 2018, 1 p.m.-5:15 p.m.

    ADDRESSES:

    The Lodge at Santa Fe, Kachina Ballroom, 750 North St. Francis Drive, Santa Fe, New Mexico 87501.

    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 September 26, 2018 • Old Business ○ Consideration and Action on Recommendation from the EM SSAB Chairs Regarding Site-Specific Advisory Board Involvement in Enhancing Stakeholder/Public Engagement ○ Other Items • New Business • Presentation on Epidemiological Data for Cancer and Autoimmune Diseases Downstream of the Los Alamos National Laboratory • Break • Public Comment Period • Fiscal Year 2018 Accomplishments • Update from EM-Los Alamos Field Office • Update from New Mexico Environment Department • Update from NNMCAB Deputy Designated Federal Officer and Executive Director • 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: https://energy.gov/em/nnmcab/meeting-materials.

    Signed in Washington, DC, on October 16, 2018. Latanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-22877 Filed 10-19-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD16-24-000] Winter 2018-2019 Operations and Market Performance in Regional Transmission Organizations and Independent System Operators; Supplemental Notice of Technical Conference

    As announced in a Notice of Technical Conference issued on September 10, 2018, Federal Energy Regulatory Commission (Commission) staff will hold a technical conference, after the October 2018 Commission public meeting, to hear from the Regional Transmission Organizations (RTOs) and Independent System Operators (ISOs) 1 on their efforts for ensuring reliable and economic system performance during the 2018-2019 winter season. The technical conference will take place on October 18, 2018 at the Commission's offices at 888 First Street NE, Washington, DC beginning at 2:00 p.m. and ending at 3:30 p.m. (Eastern Time). Commission staff will lead the technical conference, and the Chairman and Commissioners may attend.

    1 The technical conference will include representatives from California Independent System Operator Corporation, ISO New England Inc., Midcontinent Independent System Operator, Inc., New York Independent System Operator, Inc., PJM Interconnection, L.L.C., and Southwest Power Pool, Inc.

    The agenda for this technical conference is attached.

    All interested persons may attend the conference, and registration is not required. However, in-person attendees are encouraged to register on-line at: https://www.ferc.gov/whats-new/registration/10-18-18-form.asp. In-person attendees should allow time to pass through building security procedures before the 2:00 p.m. start time of the technical conference.

    This technical conference will be transcribed and webcast. Transcripts will be available immediately for a fee from Ace Reporting (202-347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at www.ferc.gov. The Capitol Connection provides technical support for the webcasts and offers the option of listening to the conference via phone-bridge for a fee. For additional information, visit www.CapitolConnection.org or call 703-993-3100.

    While this conference is not for the purpose of discussing specific cases, it may address matters at issue in the following Commission proceedings that are pending:

    ISO New England Inc.: ISO New England Inc., Docket No. ER17-795-000 and ER17-795-001; ISO New England Inc., Docket No. ER18-1509-000; ISO New England Inc., Docket No. EL18-182-000; ISO New England Inc., Docket No. ER18-1639-000; ISO New England Inc., Docket No. ER18-1639-001; ISO New England Inc., Docket No. ER18-2364-000; ISO New England Inc., Docket No. ER18-619-000; ISO New England Inc., Docket No. ER18-619-001; ISO New England Inc., Docket No. ER13-2266-000, et al.

    New York Independent System Operator, Inc.: N.Y. Indep. Sys. Operator, Inc., Docket No. ER16-120-007.

    PJM Interconnection, L.L.C.: Energy Storage Association v. PJM Interconnection, L.L.C., Docket No. EL17-64-000; Renewable Energy Systems Americas v. PJM Interconnection, L.L.C., Docket No. EL17-65-000; PJM Interconnection, L.L.C., Docket No. ER16-372-000, et al.; Independent Market Monitor for PJM v. American Electric Power Corp., Docket No. EL17-22-000, et al.; PJM Interconnection, L.L.C., Docket No. ER18-87-000, et al.; PJM Interconnection, L.L.C., Docket No. EL18-34-000; ER18-1314-000, et al.; Calpine Corporation et. al. v. PJM Interconnection, L.L.C., Docket No. EL16-49-000, et. al.; PJM Interconnection, L.L.C., Docket No. EL18-178-000, et al.; CPV Power Holdings, L.P., et. al. v. PJM Interconnection, L.L.C., Docket No. EL18-169-000; PJM Interconnection, L.L.C., Docket No. ER18-988-000, et. al.; PJM Interconnection, L.L.C., Docket No. EL14-48-000, et. al.

    California Independent System Operator Corp.: CXA La Paloma, LLC v. Cal. Indep. Sys. Operator Corp., Docket No. EL18-177-000; Cal. Indep. Sys. Operator Corp., Docket No. ER18-2369-000; Cal. Indep. Sys. Operator Corp., Docket No. ER18-2520-000.

    Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to [email protected] or call toll free (866) 208-3372 (voice) or (202) 502-8659 (TTY), or send a fax to (202) 208-2106 with the requested accommodations.

    For more information about this technical conference, please contact David Rosner at 202-502-8479, [email protected], or Samin Peirovi at 202-502-8080, [email protected] For information related to logistics, please contact Sarah McKinley at 202-502-8368, [email protected]

    Dated: October 16, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22950 Filed 10-19-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 1121-127] Pacific Gas and Electric Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Type of Application: Recreation Plan Amendment.

    b. Project No: 1121-127.

    c. Date Filed: September 14, 2018.

    d. Applicant: Pacific Gas and Electric Company.

    e. Name of Project: Battle Creek Hydroelectric Project.

    f. Location: The project is located on the mainstem Battle Creek, North Fork Battle Creek, and South Fork Battle Creek, in Shasta and Tehama counties, California.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Ms. Elisabeth Rossi, License Coordinator, Pacific Gas and Electric Company, Mail Code N13E, P.O. Box 770000, San Francisco, CA 94177, (415) 973-2032.

    i. FERC Contact: Mr. Jon Cofrancesco, (202) 502-8951, [email protected]

    j. Deadline for filing comments, motions to intervene, and protests: November 15, 2018.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-1121-127. Comments emailed to Commission staff are not considered part of the Commission record.

    The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. Description of Request: Pacific Gas and Electric Company (licensee) filed a revised recreation plan proposing to delete a new fishing access area on the Cross Country Canal required under the project's current recreation plan. While beginning construction of the new site, the licensee discovered historical artifacts and immediately stopped work. After further assessment, it has been determined that construction of the new fishing access site cannot proceed without impacting cultural resources. After finding no suitable alternatives for the new site and given the current low recreation use of existing informal canal fishing access sites in the area, the licensee proposes to remove the required new site from the project's recreation plan. The proposed revised recreation plan reflects the deletion of this fishing access site, as well as the deletion of extraneous or outdated information. All other aspects of the current recreation plan would remain the same.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE, Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's website at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above. Agencies may obtain copies of the application directly from the applicant.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.

    Dated: October 16, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22947 Filed 10-19-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC19-12-000.

    Applicants: Meadowlark Wind I LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act, et al. of Meadowlark Wind I LLC.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5103.

    Comments Due: 5 p.m. ET 11/6/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER11-4338-004.

    Applicants: New York Independent System Operator, Inc.

    Description: Compliance filing: Compliance to set effective date—Order No. 745 Demand Response to be effective 10/31/2018.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5091.

    Comments Due: 5 p.m. ET 11/6/18.

    Docket Numbers: ER18-2312-000.

    Applicants: Enel Green Power Diamond Vista Wind Project, LLC.

    Description: Supplement to August 31, 2018 Supplement to Enel Green Power Diamond Vista Wind Project, LLC tariff filing. Also on October 12, 2018 filed a supplement to the October 11, 2018 filing.

    Filed Date: 10/11/18; 10/12/18.

    Accession Number: 20181011-5200; 20181012-5213.

    Comments Due: 5 p.m. ET 10/26/18.

    Docket Numbers: ER18-2330-000.

    Applicants: Enel Green Power Rattlesnake Creek Wind Project, LLC.

    Description: Supplement to August 28, 2018 Enel Green Power Rattlesnake Creek Wind Project, LLC tariff filing.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5216.

    Comments Due: 5 p.m. ET 10/26/18.

    Docket Numbers: ER18-2361-000.

    Applicants: Enel Green Power Hilltopper Wind, LLC.

    Description: Supplement to August 30, 2018 Enel Green Power Hilltopper Wind, LLC tariff filing.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5218.

    Comments Due: 5 p.m. ET 10/26/18.

    Docket Numbers: ER19-66-000.

    Applicants: Conemaugh Power Pass-Through Holders LLC.

    Description: Amendment to October 9, 2018 Conemaugh Power Pass-Through Holders LLC tariff filing.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5159.

    Comments Due: 5 p.m. ET 10/29/18.

    Docket Numbers: ER19-70-000.

    Applicants: Keystone Power Pass-Through Holders LLC.

    Description: Amendment to October 9, 2018 Keystone Power Pass-Through Holders LLC tariff filing.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5161.

    Comments Due: 5 p.m. ET 10/29/18.

    Docket Numbers: ER19-111-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: Balancing Accounts Update 2019 (TRBAA, RSBAA, ECRBAA) to be effective 1/1/2019.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5115.

    Comments Due: 5 p.m. ET 11/5/18.

    Docket Numbers: ER19-112-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-10-16_SA 2395 MidAmerican-ITC Midwest 4th Rev GIA (H021 J041) to be effective 9/28/2018.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5035.

    Comments Due: 5 p.m. ET 11/6/18.

    Docket Numbers: ER19-113-000.

    Applicants: ISO New England Inc.

    Description: ISO New England Inc. submits Third Quarter 2018 Capital Budget Report.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5158.

    Comments Due: 5 p.m. ET 11/5/18.

    Docket Numbers: ER19-114-000.

    Applicants: Midcontinent Independent System Operator, Inc., ALLETE, Inc.

    Description: § 205(d) Rate Filing: 2018-10-16_SA 3183 MP-GRE T-L IA (Bellevue) to be effective 10/17/2018.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5094.

    Comments Due: 5 p.m. ET 11/6/18.

    Docket Numbers: ER19-115-000.

    Applicants: FL Solar 5, LLC.

    Description: Baseline eTariff Filing: FL Solar 5, LLC MBR Application to be effective 11/15/2018.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5107.

    Comments Due: 5 p.m. ET 11/6/18.

    Docket Numbers: ER19-116-000.

    Applicants: Midcontinent Independent System Operator, Inc., ALLETE, Inc.

    Description: § 205(d) Rate Filing: 2018-10-16_SA 3187 MP-GRE T-L IA (St. Stephens) to be effective 10/17/2018.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5123.

    Comments Due: 5 p.m. ET 11/6/18.

    Docket Numbers: ER19-117-000.

    Applicants: Innovative Solar 54, LLC.

    Description: Baseline eTariff Filing: Baseline new to be effective 12/9/2018.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5132.

    Comments Due: 5 p.m. ET 11/6/18.

    Docket Numbers: ER19-118-000.

    Applicants: Innovative Solar 67, LLC.

    Description: Baseline eTariff Filing: Baseline new to be effective 12/6/2018.

    Filed Date: 10/16/18.

    Accession Number: 20181016-5134.

    Comments Due: 5 p.m. ET 11/6/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 16, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22945 Filed 10-19-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98-1-000] Records Governing Off-The-Record Communications Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.

    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.

    Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.

    Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).7

    The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659.

    Docket No. File date Presenter or Requester Prohibited: 1. P-405-106 10-3-2018 Alex Balboa Exempt: 1. CP17-495-000 10-1-2018 FERC Staff 1 2. CP17-101-000 10-5-2018 FERC Staff 2 3. CP18-46-000 10-12-2018 FERC Staff 3 1 Memorandum dated October 1, 2018 forwarding letter from the Oregon State Historic Preservation Office. 2 Addendum to meeting minutes for interagency teleconference on August 13, 2018 with the U.S. Environmental Protection Agency, the New York State Department of Environmental Conservation, and the New Jersey Department of Environmental Protection. 3 Memorandum for project conference call on October 10, 2018 with Adelphia. Dated: October 16, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22944 Filed 10-19-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP10-930-001.

    Applicants: Kinder Morgan Louisiana Pipeline LLC.

    Description: Compliance filing Electronic Original Volume No. 2 to be effective 11/12/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5156.

    Comments Due: 5 p.m. ET 10/24/18.

    Docket Numbers: RP19-80-000.

    Applicants: ETC Tiger Pipeline, LLC.

    Description: eTariff filing per 1430: FERC Form No. 501-G Report.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5000.

    Comments Due: 5 p.m. ET 10/24/18.

    Docket Numbers: RP19-81-000.

    Applicants: Iroquois Gas Transmission System, L.P.

    Description: eTariff filing per 1430: 101218 Petition for Waiver of Form 501-G Filing.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5020.

    Comments Due: 5 p.m. ET 10/24/18.

    Docket Numbers: RP19-82-000.

    Applicants: High Point Gas Transmission, LLC.

    Description: eTariff filing per 1430: Form No 501-G Filing.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5120.

    Comments Due: 5 p.m. ET 10/24/18.

    Docket Numbers: RP19-83-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Negotiated Rate Agreement-Castleton Commodities—TempCapRelease to be effective 10/13/2018.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5060.

    Comments Due: 5 p.m. ET 10/29/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 16, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22949 Filed 10-19-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL19-6-000] City of Alexandria, Louisiana v. Cleco Power LLC; Notice of Complaint

    Take notice that on October 12, 2018, pursuant to sections 206, 306, and 309 of the Federal Power Act, 16 U.S.C. 824e, 825e, and 825h and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, the City of Alexandria, Louisiana (Complainant) filed a formal complaint against Cleco Power LLC (Respondent), alleging that the Respondent is violating its Attachment O formula rate in the Midcontinent Independent System Operator, Inc. Tariff. Complainant also argues that the Respondent is violating Commission orders, regulations, and generally applicable ratemaking policies, all as more fully explained in the complaint.

    The Complainant certifies that copies of the complaint were served on the contacts for Respondent and the Louisiana Public Service Commission as listed on the Commission's list of Corporate Officials.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on November 1, 2018.

    Dated: October 15, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-22924 Filed 10-19-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER19-106-000] Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Birdsboro Power LLC

    This is a supplemental notice in the above-referenced proceeding of Birdsboro Power LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 5, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 16, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22946 Filed 10-19-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL 9985-65-OAR] Meeting of the Mobile Sources Technical Review Subcommittee AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of meeting.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, the Environmental Protection Agency's (EPA's), Mobile Sources Technical Review Subcommittee (MSTRS) will meet on January 10, 2019. The MSTRS is a subcommittee under the Clean Air Act Advisory Committee. This is an open meeting. The meeting will include discussion of current topics and presentations about activities being conducted by EPA's Office of Transportation and Air Quality. The preliminary agenda for the meeting and any notices about change in venue will be posted on the subcommittee's website: http://www2.epa.gov/caaac/mobile-sources-technical-review-subcommittee-mstrs-caaac. MSTRS listserv subscribers will receive notification when the agenda is available on the subcommittee website. To subscribe to the MSTRS listserv, send an email to [email protected]

    DATES:

    The meeting will be held on Thursday, January 10, 2019, from 9 a.m. to 4:30 p.m.. Registration begins at 8:30 a.m.

    ADDRESSES:

    The meeting is currently scheduled to be held at Dupont Circle Hotel, 1500 New Hampshire Ave. NW, Washington DC 20036. However, this date and location are subject to change and interested parties should monitor the subcommittee website (above) for the latest logistical information.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Courtney McCubbin, Designated Federal Officer, Transportation and Climate Division, Mailcode 6406A, U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-2436; email: [email protected]

    Background on the work of the subcommittee is available at: https://www.epa.gov/caaac/mobile-sources-technical-review-subcommittee-mstrs-caaac.

    Individuals or organizations wishing to provide comments to the subcommittee should submit them to Ms. McCubbin at the address above by December 27, 2018. The subcommittee expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements.

    SUPPLEMENTARY INFORMATION:

    During the meeting, the subcommittee may also hear progress reports from some of its workgroups as well as updates and announcements on activities of general interest to attendees.

    For Individuals with disabilities: For information on access or services for individuals with disabilities, please contact Ms. McCubbin (see above). To request accommodation of a disability, please contact Ms. McCubbin, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

    Dated: October 16, 2018. Christopher Grundler, Director, Office of Transportation and Air Quality.
    [FR Doc. 2018-23003 Filed 10-19-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2018-0406; FRL-9985-20] Certain New Chemical Substances; Receipt and Status Information for July 2018 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA section 5, including notice of receipt of a Premanufacture Notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a Test Marketing Exemption (TME), both pending and/or concluded; a Notice of Commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from July 1, 2018 to July 31, 2018.

    DATES:

    Comments identified by the specific case number provided in this document must be received on or before November 21, 2018.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0406, and the specific case number for the chemical substance related to your comment, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Jim Rahai, Information Management Division (MC 7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8593; email address: [email protected]

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

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary A. What action is the Agency taking?

    This document provides the receipt and status reports for the period from July 1, 2018 to July 31, 2018. The Agency is providing notice of receipt of PMNs, SNUNs and MCANs (including amended notices and test information); an exemption application under 40 CFR part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.

    EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis.

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

    Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., a chemical substance may be either an “existing” chemical substance or a “new” chemical substance. Any chemical substance that is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is classified as a “new chemical substance,” while a chemical substance that is listed on the TSCA Inventory is classified as an “existing chemical substance.” (See TSCA section 3(11).) For more information about the TSCA Inventory go to: https://www.epa.gov/tsca-inventory.

    Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).

    TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to: http://www.epa.gov/oppt/newchems.

    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the Federal Register certain information, including notice of receipt of a PMN/SNUN/MCAN (including amended notices and test information); an exemption application under 40 CFR part 725 (biotech exemption); an application for a TME, both pending and concluded; NOCs to manufacture a new chemical substance; and a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review.

    C. Does this action apply to me?

    This action provides information that is directed to the public in general.

    D. Does this action have any incremental economic impacts or paperwork burdens?

    No.

    E. What should I consider as I prepare my comments for EPA?

    1. Submitting confidential business information (CBI). Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. Status Reports

    In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the Federal Register after providing notice of such changes to the public and an opportunity to comment (See the Federal Register of May 12, 1995, (60 FR 25798) (FRL-4942-7). Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5 cases under EPA review and, in particular, the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis.

    III. Receipt Reports

    For the PMN/SNUN/MCANs received by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices received by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer (i.e., domestic producer or importer), the potential uses identified by the manufacturer in the notice, and the chemical substance identity.

    As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter “A” (e.g., P-18-1234A). The version column designates submissions in sequence as “1”, “2”, “3”, etc. Note that in some cases, an initial submission is not numbered as version 1; this is because earlier version(s) were rejected as incomplete or invalid submissions. Note also that future versions of the following tables may adjust slightly as the Agency works to automate population of the data in the tables.

    Table I—PMN/SNUN/MCANs Received From 7/1/2018 to 7/31/2018 Case No. Version Received date Manufacturer Use Chemical substance J-18-0028 1 7/3/2018 DSM BioProducts & Services (G) Ethanol production from the fermentation of C-6 sugars (G) Saccharomyces cerevisiae modified. J-18-0029 1 7/3/2018 DSM BioProducts & Services (G) Ethanol production from the fermentation of C-6 sugars (G) Saccharomyces cerevisiae modified. J-18-0030 1 7/3/2018 DSM BioProducts & Services (G) Ethanol production from the fermentation of C-6 sugars (G) Saccharomyces cerevisiae modified. J-18-0038A 2 7/2/2018 CBI (G) Biopolymer Production (G) Biopolymer producing modified microorganism(s) with chromosomally-borne modifications. J-18-0039A 2 7/2/2018 CBI (G) Biopolymer Production (G) Biopolymer producing modified microorganism(s) with chromosomally-borne modifications. P-16-0180A 3 6/25/2018 CBI (S) Component of industrial and maintenance coatings (G) Isocyanic acid, polymethylenepolyphenylene ester, polymer with a-hydro-w-hydroxypoly[oxy(methyl-1,2-ethanediyl)] and alkylene oxide polymer, alkylamine initiated. P-16-0275A 2 7/12/2018 CBI (G) Surfactant, (G) None (G) Rhamnolipid salt, (G) Rhamnolipids. P-16-0275A 3 7/21/2018 CBI (G) Surfactant, (G) None (G) Rhamnolipid salt, (G) Rhamnolipids. P-16-0276A 2 7/12/2018 CBI (G) Surfactant, (G) None (G) Rhamnolipid salt, (G) Rhamnolipids. P-16-0276A 3 7/21/2018 CBI (G) Surfactant, (G) None (G) Rhamnolipid salt, (G) Rhamnolipids. P-17-0347A 3 7/17/2018 Sasol Chemicals (USA) LLC (G) Oilfield Surfactant (S) Oxirane, 2-methyl-, polymer with oxirane, mono(2-butyloctyl) ether. P-17-0348A 3 7/17/2018 Sasol Chemicals (USA) LLC (G) Oilfield Surfactant (S) Oxirane, 2-methyl-, polymer with oxirane, mono(2-hexyldecyl) ether. P-17-0349A 3 7/17/2018 Sasol Chemicals (USA) LLC (G) Oilfield Surfactant (S) Oxirane, 2-methyl-, polymer with oxirane, mono(2-octyldodecyl) ether. P-17-0350A 3 7/17/2018 Sasol Chemicals (USA) LLC (G) Oilfield Surfactant (S) Oxirane, 2-methyl-, polymer with oxirane, mono(2-decyltetradecyl) ether. P-17-0351A 3 7/17/2018 Sasol Chemicals (USA) LLC (G) Oilfield Surfactant (S) Oxirane, 2-methyl-, polymer with oxirane, mono(2-dodecylhexadecyl) ether. P-17-0352A 3 7/17/2018 Sasol Chemicals (USA) LLC (G) Oilfield Surfactant (S) Oxirane, 2-methyl-, polymer with oxirane, mono(2-tetradecyloctadecyl) ether. P-17-0398A 8 7/20/2018 Nexus Fuels (G) Stock use, (G) Wax-Component of complex formulations for blending (G) Branched cyclic and linear hydrocarbons from plastic depolymerization. P-17-0399A 8 7/20/2018 Nexus Fuels (G) Stock use, (G) Wax-Component of complex formulations for blending (G) Alkane, alkene, styrenic compounds derived from plastic depolymerization. P-18-0028A 4 7/20/2018 Nexus Fuels (G) Blending stock (G) Branched cyclic and linear hydrocarbons from plastic depolymerization. P-18-0031A 5 7/10/2018 CBI (G) Ingredient for industrial coating (G) Substituted dicarboxylic acid, polymer with various alkanediols. P-18-0036A 4 7/19/2018 Bluestar Silicones USA Corp (G) Water repellant (S) Siloxanes and silicones, di-me, 3-[3-carboxy-2(or 3)-(octenyl)-1-oxopropoxy]propyl group-terminated. P-18-0042A 6 7/16/2018 Myriant Corporation (G) Industrial Coating (S) 2,5-furandione, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1h-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, 2-hydroxyethyl acrylate- and 2-hydroxyethyl methacrylate-blocked. P-18-0049A 4 6/28/2018 CBI (G) Coating component/processing aid (G) Mixed metal halide. P-18-0050A 3 6/21/2018 CBI (G) Raw material in industrial coatings (G) Alkane, diisocyanato-, homopolymer, alkyl dihydrogen phosphate- and polyalkylene glycol mono-alkyl ether-. P-18-0057A 7 7/5/2018 CBI (S) A drier accelerator that is used for superior drying performance in solvent-borne and waterborne air dried paints, inks and coatings (S) Vanadium, tris(2-ethylhexanoato-ko)tri-μ-oxotri-, cyclo. P-18-0104A 4 6/21/2018 CBI (S) Halogen free flame retardant in thermoplastic polymers (G) Acrylic acid, reaction products with pentaerythritol, polymerized. P-18-0129A 3 7/23/2018 CBI (G) Intermediate used for chemical production (S) Benzenepropanal, alpha, alpha, 3-trimethyl-. P-18-0152A 4 7/5/2018 CBI (G) Intermediate for use in manufacturing (G) Hydrolyzed functionalized di-amino silanol polymer. P-18-0155A 3 6/25/2018 CBI (G) Component in cement (G) Crosslinked polymer of alkyl acrylamides, acrylate esters, and alkyl acrylamide sulfonate salt. P-18-0156A 3 6/25/2018 CBI (G) Component in cement (G) Crosslinked polymer of alkyl acrylamides, acrylate esters, and alkyl acrylamide sulfonic acid. P-18-0162A 4 7/19/2018 CBI (G) Adhesive component (G) Cashew nutshell liquid, polymer with diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol. P-18-0170A 4 7/10/2018 CBI (G) Textile treatment (S) 1-propanaminium, n,n′-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-n,n-dimethyl-, dichloride. P-18-0175A 3 7/12/2018 Hexion Inc (S) Non-food contact can coating, (S) Food can coating (S) Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol and phenol, bu ether. P-18-0184A 2 7/13/2018 CBI (G) Component in printing plates, (G) Coating component (G) Halide, bis alkylaromatic, polyaromatic non-metal salt. P-18-0210A 4 7/11/2018 CBI (G) Intermediate (G) Phosphonomethylated ether diamine. P-18-0212A 2 6/26/2018 Allnex USA Inc (S) Coating resin for improved appearance and adhesion (G) Substituted carbomonocycle, polymer with alkyl alkenoate, alkenyl substituted carbomonocycle, substituted alkanediol, heteropolycycle, alkylene glycol and alkenoic acid, compd. with alkylamino alkanol. P-18-0217A 3 6/26/2018 Galata Chemicals LLC (S) Stabilizer for PVC compound (G) Alkyltin dodecylthioester. P-18-0218A 3 6/26/2018 Galata Chemicals LLC (S) Stabilizer for PVC compound (G) Alkyltin tetradecylthioester. P-18-0219A 4 7/2/2018 CBI (G) Intermediate for topcoat (G) Polythioether, short chain diol polymer terminated with aliphatic diisocyanate. P-18-0223 1 6/26/2018 Clariant Corporation (S) Selectivity improver for catalysts used in the production of polyolefins (G) Alkane, bis(alkoxymethyl)-dimethyl-. P-18-0224A 3 6/27/2018 CBI (G) Component of ink (G) Alkenoic acid, polymer with alkenylcarbomonocycle, [alkanediylbis(substitutedalkylene)] bis[heteromonocycle] and (alkylalkenyl) aromatic, salt. P-18-0225A 3 6/27/2018 CBI (G) Component of ink (G) Alkenoic acid, polymer with substituted alkyloxirane, alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and (alkylalkenyl) aromatic salt. P-18-0226A 3 7/10/2018 CBI (G) Anti-agglomerate (G) Tri alkyl, mono alkoxy, fatty acid ester, ammonium salt. P-18-0227 1 6/29/2018 CBI (G) Corrosion inhibitor, (G) Chemical intermediate (S) D-glucaric acid. P-18-0230 1 6/29/2018 Clariant Plastics & Coatings USA Inc (S) Lubricant and surface protection agent (S) Waxes and waxy substances, rice bran, oxidized, calcium salts. P-18-0231 1 6/29/2018 Allnex USA Inc (S) Waterborne UV curable coating resin binder for inkjet, ink or overprint varnish (G) Alkanoic acid, substituted alkyl-, polymer with isocyanatoalkane, alkyl carbonate, alkanediol and polyalkylene glycol ether with alkyl(substituted alkyl) alkanediol alkenoate, glycerol monoacrylate alkanoate-blocked. P-18-0232 1 7/5/2018 Clariant Corporation (S) Hydrogen sulfide scavenger in oil and gas applications (G) Polyol, reaction products with formaldehyde and methanol. P-18-0233 1 7/6/2018 CBI (G) Coating agent (G) Alkyl alkenoic acid, alkyl ester, telomer with alkylthiol, substituted carbomonocycle, substituted alkyl alkyl alkenoate and hydroxyalkyl alkenoate, tert-butyl alkyl peroxoate-initiated. P-18-0234 1 7/6/2018 Eastman Kodak Company (G) Coating component (G) Alkenoic acid, reaction products with bis substituted alkane and ether polyol. P-18-0234A 2 7/11/2018 CBI (G) Coating component (G) Alkenoic acid, reaction products with bis substituted alkane and ether polyol. P-18-0234A 4 7/24/2018 CBI (G) Coating component (G) Alkenoic acid, reaction products with bis substituted alkane and ether polyol. P-18-0235A 2 7/23/2018 CBI (S) Component in automotive gasoline/transportation fuel for consumer use (G) Naphtha oils. P-18-0236 1 7/11/2018 The Sherwin Williams Company (G) Paint additive (G) Metal, alkenoic acid, alkyl substituted alkenoate polymer carbopolycycle complexes. P-18-0237A 3 7/19/2018 CBI (G) Use in print resins (G) Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-, and dialkylheteromonocycle-blocked. P-18-0238 1 7/16/2018 Georgia-Pacific Chemicals LLC (S) Binder for wood panels (G) Saccharide reaction products with acid anhydride, etherified. P-18-0239 1 7/16/2018 CBI (G) Reactant in coating (G) N-alkyl propanamide. P-18-0240 1 7/16/2018 CBI (G) Reactant in coating (G) N-alkyl acetamide. P-18-0241 1 7/16/2018 CBI (G) Necessary precursor for automotive coating (G) 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, substituted-alkyl-2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, formats (salts). P-18-0242 1 7/16/2018 CBI (G) Necessary precursor for automotive coating (G) 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate substituted-alkyl-2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, acetates (salts). P-18-0243 1 7/16/2018 CBI (G) Necessary precursor for automotive coating (G) 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, substituted-alkyl-2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, sulfamates (salts). P-18-0244 1 7/16/2018 CBI (G) Necessary precursor for automotive coating (G) 2-propenoic acid, substituted-alkyl-2-propenoate, polymer with ethenylbenzene, ethyl 2-propenoate, methyl 2-methyl-2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, formats (salts). P-18-0245 1 7/16/2018 CBI (G) Necessary precursor for automotive coating (G) 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate, 1,2-propanediol mono(2-methyl-2-propenoate) and substituted-alkyl-2-propenoate, reaction products with diethanolamine, formats (salts). P-18-0246 1 7/16/2018 CBI (G) Necessary precursor for automotive coating (G) 2-propenoic acid, substituted-alkyl-2-propenoate, polymer with ethenylbenzene, ethyl 2-propenoate, methyl 2-methyl-2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, acetates (salts). P-18-0247 1 7/18/2018 CBI (S) Crosslinker for automotive electrocoat (G) Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, alpha, alpha′-[(1-methylethylidene)di-4,1-phenylene]bis[omega-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and et alc.- and methanol- and 1-methoxy-2-propanol-blocked. P-18-0248 1 7/18/2018 CBI (S) Crosslinker for automotive electrocoat (G) Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol-blocked. P-18-0249 1 7/18/2018 CBI (S) Crosslinker for automotive electrocoat (G) Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked. P-18-0250 1 7/18/2018 CBI (S) Crosslinker for automotive electrocoat (G) Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and 1(or2)-(2-methoxymethylethoxy)propanol-blocked. P-18-0251 1 7/18/2018 CBI (S) Crosslinker for automotive electrocoat (S) Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1(or2)-(2-methoxymethylethoxy)propanol-blocked. P-18-0252 1 7/18/2018 CBI (S) Crosslinker for automotive electrocoat (S) Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked. P-18-0253 1 7/20/2018 UBE America Inc (G) Extrusion and Injection Molding Polymer (S) Dodecanoic acid, 12-amino-, homopolymer. P-18-0254 1 7/20/2018 UBE America Inc (G) Extrusion and Injection Molding Polymer (G) Hexanedioic acid, polymer with 12-aminododecanoic acid and a polyetheramine. P-18-0255 1 7/20/2018 UBE America Inc (G) Recreational equipment (S) Dodecanoic acid, 12-amino-, polymer with hexahydro-2h-azepin-2-one. P-18-0256 1 7/20/2018 CBI (G) Chemical Intermediate, (G) Solvent (S) Undecanol, branched. P-18-0257 1 7/23/2018 Everris NA Inc (S) Inorganic Fertilizer (S) Phosphoric acid, potassium salt (2:3). P-18-0258 1 7/23/2018 CBI (G) Copolyamide for Monofilament, (G) Copolyamide for Packaging Films, (G) Copolyamide for Molding Parts (G) Dioic acids, polymers with caprolactam and alkyldiamines. P-18-0259 1 7/23/2018 CBI (G) Copolyamide for Monofilament, (G) Copolyamide for Packaging Films, (G) Copolyamide for Molding Parts (G) Fatty acids, dimers, hydrogenated, polymers with caprolactam and alkyl diamine. P-18-0260 1 7/26/2018 Allnex USA Inc (S) Binder for wood stains (G) Fatty acids, polymers with alkanoic acid and substituted carbomonocycle, peroxide-initiated, polymers with alkanoic acid esters and substituted carbomonocycle, ammonium salts. P-18-0261 1 7/26/2018 CBI (G) Polymer composite additive (G) Metal, alkylcarboxylate oxo complexes. P-18-0263 1 7/27/2018 CBI (G) Solution additive (G) Mixed alkyl esters-, polymer with n1-(2-aminoethyl)- 1,2-ethanediamine, aziridine, n-acetyl derivs., acetates (salts). P-18-0264 1 7/27/2018 CBI (G) Intermediate (G) Phosphonomethylated ether diamine. SN-18-0004A 3 7/5/2018 CBI (S) This SNUN is a request to incorporate PMN substance P-12-0044 as an anti-corrosion additive and/or strengthening additive for use in epoxy compounds for coatings, paints and composites (S) Functionalized multiwall carbon nanotubes. SN-18-0004A 3 7/5/2018 CBI (S) This SNUN is a request to incorporate PMN substance P-12-0044 as an anti-corrosion additive and/or strengthening additive for use in epoxy compounds for coatings, paints and composites (S) Functionalized multiwall carbon nanotubes.

    In Table II. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the TMEs received by EPA during this period: The EPA case number assigned to the TME, the date the TME was received by EPA, the projected end date for EPA's review of the TME, the submitting manufacturer/importer, the potential uses identified by the manufacturer/importer in the TME, and the chemical identity.

    Table II—TMEs Received From 7/1/2018 to 7/31/2018 Case No. Submission type Version Received date Manufacturer Use Chemical substance T-18-0003A SS78 2 07/16/2018 CBI (G) Additive (G) Alkylated diphenylamines, homopolymers.

    In Table III. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs received by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, a notation of the type of amendment (e.g., amendment to generic name, specific name, technical contact information, etc.) and chemical substance identity.

    Table III—NOCs Received From 7/1/2018 to 7/31/2018 Case No. Received date Commencement date If
  • amendment, type of
  • amendment
  • Chemical substance
    P-11-0182 7/20/2018 10/23/2017 N (S) Poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-hydroxy-, polymers with hydroxy-terminated polybutadiene and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, 4-methoxyphenol-blocked. P-13-0253A 7/20/2018 5/18/2018 Y (G) Alkoxy substituted carbopolycyclemethyl. P-13-0253A 7/11/2018 5/18/2018 Y (G) 3,4-bis(alkoxy)-4-(carbopolycyclemethyl)-. P-13-0289 6/27/2018 6/13/2018 N (G) Alkanoic acid, tetramethylheteromonocycle ester. P-13-0878A 7/19/2018 5/9/2018 Y (G) 2-propenoic acid, reaction products with tris (2-hydroxyethyl) isocyanurate. P-14-0125 7/25/2018 4/26/2018 N (S) 1-octadecanaminium, n-(3-chloro-2-hydroxypropyl)-n,n-dimethyl-, chloride (1:1). P-14-0314A 7/13/2018 4/6/2018 Y (G) Poly oxy aliphatic halogenated phosphate. P-14-0471A 7/19/2018 5/9/2018 Y (G) Hexanedioic acid, polymer with 2-(chloromethyl) oxirane polymer with isocyanato acrylate blocked, cmpds with triethylamine. P-14-0472 7/9/2018 6/14/2018 N (G) Polyphosphoric acids, [(alkyl-oxo-2-propen-1-yl)oxy]ethyl esters, compds. with n-(aminoiminomethyl)urea. P-15-0368 7/11/2018 5/13/2016 N (S) Starch, acid-hydrolyzed, 3-(trimethylammonio)propyl ether, bromide. P-15-0652 7/3/2018 6/12/2018 N (G) Dicarboxylic acids, polymers with alkyl prop-2-enoate, alkanediol, 2-substituted alkyl 2-methylprop-2-enoate, 3-substituted-2-(substituted alkyl)-2-alkylpropanoic acid, 5-isocyanato-1-(isocyanatoalkyl)-1,3,3-trialkylcycloalkane, alkanedioic acid, methyl 2-methylprop-2-enoate and vinyl carbomonocycle compds. with trialkyl amine. P-16-0588A 7/17/2018 5/13/2018 Y (G) Alkyl methacrylate, polymer with alkyl acrylate and polyesters. P-17-0343A 7/19/2018 4/9/2018 Y (G) Heteropolycyclic-alkanol, carbomonocycle-alkanesulfonate. P-18-0017 6/29/2018 6/29/2018 N (G) Substituted carbomonocycle, polymer with substituted heteromonocycle and substituted polyalkylene glycol. P-18-0044 7/11/2018 6/13/2018 N (G) Fatty acids. P-18-0045 7/18/2018 7/17/2018 N (G) Fatty acids, alkyl esters. P-18-0046 7/2/2018 6/29/2018 N (G) Substituted carbomonocycle, polymer with diisocyanatoalkane, substituted alkylacrylate-blocked. P-18-0071 7/26/2018 7/23/2018 N (G) Aromatic dicarboxylic acid, compound with alkane diamines, polymer with alkane diamine and dicarboxylic acid. P-18-0079 7/26/2018 7/23/2018 N (G) Aromatic dicarboxylic acid, compound with alkyl diamines, homopolymer.

    In Table IV. of this unit, EPA provides the following information (to the extent such information is not subject to a CBI claim) on the test information received by EPA during this time period: The EPA case number assigned to the test information; the date the test information was received by EPA, the type of test information submitted, and chemical substance identity.

    Table IV—Test Information Received From 7/1/2018 to 7/31/2018 Case No. Received date Type of test information Chemical substance P-16-0404 7/3/2018 Color Fastness Local Lymph Node Assay (OECD 442b) Bacterial Mutation Assay (OECD 471) (G)- Alkyl ester, 2-({4-[2-(trisubstituted phenyl)azo]-5-acetamido-2-substitutedphenyl}(substituted alkoxy)amino). P-17-0200 7/3/2018 Fresh Water Algal Growth Inhibition Test with [CBI] (OECD 201) (G) 1,3-bis(substitutedbenzoyl)benzene. P-18-0052 7/9/2018 Surface Tension Testing (G) Perfluoroalkylethyl- and vinyl-modified Organopolysiloxane. P-18-0053 7/9/2018 Surface Tension Testing (G) Perfluoroalkylethyl- and vinyl-modified Organopolysiloxane. P-15-0121 7/9/2018 Algae Growth Inhibition Test (OPPTS 850.1000) (S) Formaldehyde, polymer with 2-aminocyclopentanemethanamine, 1,4-butanediamine, 1,2-cyclohexanediamine, 1,6-hexanediamine, hexahydro-1H-azepine and 2-methyl-1,5,-pentanediamine. P-15-0583 7/9/2018 Sediment-Water Life-Cycle Toxicity Test using Spiked Sediment (OECD 233) (G) Butanedioic acid, alkyl amine, dimethylbutyl ester. P-16-0438 7/10/2018 Acrolein Cyanohydrin-O-Acetate (ACA) TSCA Workplace Exposure Task and Personnel Protective Equipment Testing, Task Monitoring, PPE sampling, Testing to determine the Effective Organic Vapor Analyzer Response Factor and Detection Limit for ACA (S) 3-Butenenitrile, 2-(acetyloxy). P-17-0187 7/13/2018 Primary Skin Irritation Test (G) Polymer with benzoic acid tetra halogen hydroxy tetrahalogen oxo H xanthenyl alkenylaryl alkyl ester alkalai metal salt, butyl-2-propenoate, ethenyl neodecanoate, methyl-2-methyl-2- propenoate and 2-methyl-2-propenoic acid. SN-18-0003 7/13/2018 Metals Removal Testing (S) Lithium nickel oxide (LiNiO2). P-17-0257 7/18/2018 Dustiness Testing using the Vortex Shaker (S) Single Walled Carbon Nanotubes. P-18-0230 7/18/2018 Water Solubility Test (OECD 105) Bovine Corneal Opacity and Permeability Test (OECD 437) (S) Waxes and Waxy substances, rice bran, oxidized, calcium salts. P-15-0583 7/19/2018 Anaerobic and Aerobic Aquatic Metabolism Toxicity data (OECD 308) (G) Butanedioic acid, alkyl amine, dimethylbutyl ester. P-18-0036 7/19/2018 Skin Sensitization Study (OECD 406) (G) Siloxanes and Silicones, di-Me, 3-[3-carboxy-2(or 3)-(octenyl)-1-oxopropoxy]propyl group-terminated.

    If you are interested in information that is not included in these tables, you may contact EPA's technical information contact or general information contact as described under FOR FURTHER INFORMATION CONTACT to access additional non-CBI information that may be available.

    Authority:

    15 U.S.C. 2601 et seq.

    Dated: October 11, 2018. Pamela Myrick, Director, Information Management Division, Office of Pollution Prevention and Toxics.
    [FR Doc. 2018-23004 Filed 10-19-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting TIME AND DATE:

    Thursday, October 25, 2018 at 10:00 a.m.

    PLACE:

    1050 First Street NE, Washington, DC (12th Floor).

    STATUS:

    This meeting will be open to the public.

    MATTERS TO BE CONSIDERED:

    Correction and Approval of Minutes for October 11, 2018 Draft Advisory Opinion 2018-12: Defending Digital Campaigns, Inc. Management and Administrative Matters CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.

    Dayna C. Brown, Secretary and Clerk of the Commission.
    [FR Doc. 2018-23152 Filed 10-18-18; 4:15 pm] BILLING CODE 6715-01-P
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    ACTION:

    Notice, request for comment.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Basel II Interagency Pillar 2 Supervisory Guidance (Pillar 2 Guidance) (FR 4199; OMB No. 7100-0320).

    DATES:

    Comments must be submitted on or before December 21, 2018.

    ADDRESSES:

    You may submit comments, identified by FR 4199, by any of the following methods:

    Agency Website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx.

    Email: [email protected] Include OMB number in the subject line of the message.

    Fax: (202) 452-3819 or (202) 452-3102.

    Mail: Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments are available from the Board's website at http://www.federalreserve.gov/apps/foia/proposedregs.aspx as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street NW (between 18th and 19th Streets NW), Washington, DC 20006 between 9 a.m. and 5 p.m. on weekdays. For security reasons, the Board requires that visitors make an appointment to inspect comments. You may do so by calling (202) 452-3684. Upon arrival, visitors will be required to present valid government-issued photo identification and to submit to security screening in order to inspect and photocopy comments.

    Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503, or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, if approved. These documents will also be made available on the Board's public website at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    Request for Comment on Information Collection Proposal

    The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;

    b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    c. Ways to enhance the quality, utility, and clarity of the information to be collected;

    d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

    At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal. Proposal Under OMB Delegated Authority To Extend for Three Years, Without Revision, the Following Information Collection

    Report title: Basel II Interagency Pillar 2 Supervisory Guidance (Pillar 2 Guidance).

    Agency form number: FR 4199.

    OMB control number: 7100-0320.

    Frequency: As needed.

    Respondents: Banking institutions.

    Estimated number of respondents: 13.

    Estimated average hours per response: 420.

    Estimated annual burden hours: 5,460.

    General description of report: The advanced approaches framework requires certain banks and bank holding companies (BHCs) to use an internal ratings-based approach to calculate regulatory credit risk capital requirements and advance measurement approaches to calculate regulatory operational risk capital requirements.

    A bank is required to comply with the advanced approaches framework if it meets either of two independent threshold criteria: (1) Consolidated total assets of $250 billion or more, as reported on the most recent year-end regulatory reports; or (2) consolidated total on-balance sheet foreign exposure of $10 billion or more at the most recent year-end.

    A BHC is required to comply with the advanced approaches framework if the BHC has (1) consolidated total assets (excluding assets held by an insurance underwriting subsidiary) of $250 billion or more, as reported on the most recent year-end regulatory reports; (2) consolidated total on-balance sheet foreign exposure of $10 billion or more at the most recent year-end; or (3) a subsidiary depository institution (DI) that meets the criteria to be subject to the advanced approaches rule or elects to adopt the advanced approaches. As of year-end 2017, 13 BHCs meet the above criteria and are therefore subject to the advanced approaches rule.1

    1 Regulation YY permits a bank holding company that is a subsidiary of a foreign banking institution to elect not to comply with the advanced approaches rule prior to formation of an intermediate holding companies (IHCs) with the prior approval of the Board. 12 CFR 252.153(e)(2)(C). Currently, no savings and loan holding companies are subject to the advanced approaches rule.

    Also, some banks or BHCs may voluntarily decide to adopt the advanced approaches framework. Both mandatory and voluntary respondents are required to meet certain qualification requirements before they can use the advanced approaches framework for risk-based capital purposes.

    The Pillar 2 Guidance sets the expectation that respondents maintain certain documentation as described in paragraphs 37, 41, 43, and 46 of this portion of the guidance. Details of the expectations for each section are provided below.

    Setting and Assessing Capital Adequacy Goals That Relate to Risk

    Paragraph 37. In analyzing capital adequacy, a banking organization should evaluate the capacity of its capital to absorb losses. Because various definitions of capital are used within the banking industry, each banking organization should state clearly the definition of capital used in any aspect of its internal capital adequacy assessment process (ICAAP).2 Since components of capital are not necessarily alike and have varying capacities to absorb losses, a banking organization should be able to demonstrate the relationship between its internal capital definition and its assessment of capital adequacy. If a banking organization's definition of capital differs from the regulatory definition, the banking organization should reconcile such differences and provide an analysis to support the inclusion of any capital instruments that are not recognized under the regulatory definition. Although common equity is generally the predominant component of a banking organization's capital structure, a banking organization may be able to support the inclusion of other capital instruments in its internal definition of capital if it can demonstrate a similar capacity to absorb losses. The banking organization should document any changes in its internal definition of capital and the reason for those changes.

    2 Under the Board's capital plan rule (12 CFR 225.8), a bank holding company with total consolidated assets of $50 billion or more is required to develop and maintain a capital plan; however, on July 6, 2018, the Board issued a public statement regarding the impact of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA) (Pub. L. No. 115-174, 132 Stat. 1296 (2018)). The Board stated, consistent with EGRRCPA, that it will not action to require bank holding companies with total consolidated assets greater than or equal to $50 billion but less than $100 billion to comply with the Board's capital plan rule (https://www.federalreserve.gov/newsevents/pressreleases/files/bcreg20180706b1.pdf). Bank holding companies subject to the capital plan rule must have a capital policy that sets forth a capital adequacy process. ICAAP would constitute an internal capital adequacy process for purposes of the capital plan rule, and bank holding companies that have a satisfactory ICAAP generally would be considered to have a satisfactory internal capital adequacy process for purposes of the capital plan rule.

    Ensuring Integrity of Internal Capital Adequacy Assessments

    Paragraph 41. A banking organization should maintain thorough documentation of its ICAAP to ensure transparency. At a minimum, this should include a description of the banking organization's overall capital-management process, including the committees and individuals responsible for the ICAAP; the frequency and distribution of ICAAP-related reporting; and the procedures for the periodic evaluation of the appropriateness and adequacy of the ICAAP. In addition, where applicable, ICAAP documentation should demonstrate the banking organization's sound use of quantitative methods (including model selection and limitations) and data-selection techniques, as well as appropriate maintenance, controls, and validation. A banking organization should document and explain the role of third-party and vendor products, services and information—including methodologies, model inputs, systems, data, and ratings—and the extent to which they are used within the ICAAP. A banking organization should have a process to regularly evaluate the performance of third-party and vendor products, services and information. As part of the ICAAP documentation, a banking organization should document the assumptions, methods, data, information, and judgment used in its quantitative and qualitative approaches.

    Paragraph 43. The board of directors and senior management have certain responsibilities in developing, implementing, and overseeing the ICAAP. The board should approve the ICAAP and its components. The board or its appropriately delegated agent should review the ICAAP and its components on a regular basis and approve any revisions. That review should encompass the effectiveness of the ICAAP, the appropriateness of risk tolerance levels and capital planning, and the strength of control infrastructures. Senior management should continually ensure that the ICAAP is functioning effectively and as intended, under a formal review policy that is explicit and well documented. Additionally, a banking organization's internal audit function should play a key role in reviewing the controls and governance surrounding the ICAAP on an ongoing basis.

    Paragraph 46. As part of the ICAAP, the board or its delegated agent, as well as appropriate senior management, should periodically review the resulting assessment of overall capital adequacy. This review, which should occur at least annually, should include an analysis of how measures of internal capital adequacy compare with other capital measures (such as regulatory, accounting-based or market-determined). Upon completion of this review, the board or its delegated agent should determine that, consistent with safety and soundness, the banking organization's capital takes into account all material risks and is appropriate for its risk profile. However, in the event a capital deficiency is uncovered (that is, if capital is not consistent with the banking organization's risk profile or risk tolerance) management should consult and adhere to formal procedures to correct the capital deficiency.

    Legal authorization and confidentiality: The collection of information is authorized pursuant to the International Lending Supervision Act (12 U.S.C. 3907(a)(1) and (b)(3)), section 1831o of the Federal Deposit Insurance Act (12 U.S.C. 1831o), section 5 of the Bank Holding Company Act of 1956 (12 U.S.C. 1844), section 10(b)(2) of the Homeowners' Loan Act (12 U.S.C. 1467a(b)), and section 171 of the Dodd-Frank Act (12 U.S.C. 5371). The FR 4199 is voluntary.

    Because the collections of information associated with the FR 4199 do not involve the submission of information to the Board, no issues of confidentiality would normally arise. To the extent that the Board collects information kept by a banking organization as a record during an examination of the banking organization, confidential treatment may be afforded to the records under exemption 8 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(8)), which protects information collected as part of the Board's supervisory process. Additionally, individual respondents may request that certain information be afforded confidential treatment pursuant to exemption 4 of FOIA (5 U.S.C. 552(b)(4)) if the information has not previously been publically disclosed and the release of the data would likely cause substantial harm to the competitive position of the respondent.

    Board of Governors of the Federal Reserve System, October 16, 2018. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2018-22914 Filed 10-19-18; 8:45 am] BILLING CODE 6210-01-P
    GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-0205; Docket No. 2018-0001; Sequence No. 12] General Services Administration Acquisition Regulation (GSAR); Submission for OMB Review; Environmental Conservation, Occupational Safety, and Drug-Free Workplace AGENCY:

    Office of Acquisition Policy, General Services Administration (GSA).

    ACTION:

    Notice of request for comments regarding the extension of a previously existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding Environmental Conservation, Occupational Safety, and Drug-Free Workplace.

    DATES:

    Submit comments on or before: November 21, 2018.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Comment Now” that corresponds with “Information Collection 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace”. Follow the instructions provided on the screen. Please include your name, company name (if any), and “Information Collection 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace.

    Instructions: Please submit comments only and cite Information Collection 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace, in all correspondence related to this collection. Comments received generally will be posted without change to regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check regulations.gov, approximately two-to-three business days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Johnnie McDowell, Procurement Analyst, General Services Acquisition Policy Division, GSA, at telephone 202-718-6112, or via email to [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    The Federal Hazardous Substance Act and Hazardous Material Transportation Act prescribe standards for packaging of hazardous substances. To meet the requirements of the Acts, the General Services Administration Regulation prescribes provision 552.223-72, Hazardous Material Information, to be inserted in solicitations and contracts that provides for delivery of hazardous materials on a Free On Board (FOB) origin basis.

    This information collection will be accomplished by means of the provision which requires the contractor to identify for each National Stock Number (NSN), the DOT Shipping Name, Department of Transportation (DOT) Hazards Class, and whether the item requires a DOT label. Contracting Officers and technical personnel use the information to monitor and ensure contract requirements based on law and regulation.

    Properly identified and labeled items of hazardous material allows for appropriate handling of such items throughout GSA's supply chain system. The information is used by GSA, stored in an NSN database and provided to GSA customers. Non-Collection and/or a less frequently conducted collection of the information resulting from GSAR provision 552.223-72 would prevent the Government from being properly notified. Government activities may be hindered from apprising their employees of; (1) All hazards to which they may be exposed; (2) Relative symptoms and appropriate emergency treatment; and (3) Proper conditions and precautions for safe use and exposure.

    B. Annual Reporting Burden

    Respondents: 563.

    Responses per Respondent: 3.

    Total Responses: 1,689.

    Hours per Response: .67.

    Total Burden Hours: 1111.

    C. Public Comments

    A 60-day notice published in the Federal Register at 83 FR 32296 on July 12, 2018. No comments were received. Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division, 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace, in all correspondence.

    Dated: October 15, 2018. Jeffrey A. Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy.
    [FR Doc. 2018-23008 Filed 10-19-18; 8:45 am] BILLING CODE 6820-61-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS) AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, [email protected], or Sayeedha Uddin, 301-458-4303, [email protected] at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulation, Subpart 101-20.301, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.

    DATES:

    The meeting will be held on December 4, 2018, 11:00 a.m.-5:30 p.m., EDT, and December 5, 2018, 8:30 a.m.-1:00 p.m., EDT.

    ADDRESSES:

    NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 20782.

    FOR FURTHER INFORMATION CONTACT:

    Sayeedha Uddin, M.D., M.P.H., Executive Secretary, NCHS/CDC, Board of Scientific Counselors, 3311 Toledo Road, Room 2627, Hyattsville, Maryland 20782, telephone (301)458-4303, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose: This committee is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the scientific and technical program goals and objectives, strategies, and priorities of NCHS.

    Matters to be Considered: Day 1 meeting agenda includes welcome remarks by NCHS leadership; update on the National Health Interview Statistics Redesign Bridge Sample; update on National Study of Long-Term Care Providers; update on the Comparability Study for Opioid Questions; update from the Patient-Centered Outcomes Research Trust Fund Drug Workgroup; Day 2 meeting agenda includes update on Indicator Selection for Healthy People 2030; update on Evaluation of Birth Outcomes Associated with Drug Use; and an update on the Utilization of Electronic Health Records (EHR) Data in NCHS Data Systems. Requests to make oral presentations should be submitted in writing to the contact person listed above. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by November 19, 2018. Agenda items are subject to change as priorities dictate.

    The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention.
    [FR Doc. 2018-22987 Filed 10-19-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-19-1014; Docket No. CDC-2018-0096] 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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled CDC Worksite Health Scorecard, an updated organizational assessment and planning tool designed to help employers identify gaps in their health promotion programs and prioritize high-impact strategies for health promotion at their worksites.

    DATES:

    CDC must receive written comments on or before December 21, 2018.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0096 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments to Regulations.gov.

    Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    The OMB is particularly interested in comments that will help:

    1. 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;

    2. 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;

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

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    5. Assess information collection costs.

    Proposed Project

    CDC Worksite Health ScoreCard—Revision—(OMB# 0920-1014 Exp. 02/28/2019) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    In the United States, chronic diseases such as heart disease, obesity and diabetes are among the leading causes of death and disability. Although chronic diseases are among the most common and costly health problems, they are also among the most preventable. Adopting healthy behaviors—such as eating nutritious foods, being physically active and avoiding tobacco use—can prevent the devastating effects and reduce the rates of these diseases.

    Employers are recognizing the role they can play in creating healthy work environments and providing employees with opportunities to make healthy lifestyle choices. To support these efforts, the Centers for Disease Control and Prevention (CDC) developed an online organizational assessment tool called the CDC Worksite Health Scorecard (“Scorecard”).

    The Scorecard is a tool designed to help employers assess whether they have implemented evidence-based health promotion interventions or strategies in their worksites to prevent heart disease, stroke, and related conditions such as hypertension, diabetes, and obesity. The updated, validated, and pilot tested instrument contains 154 core health topic yes/no questions, eight core worksite demographic questions, with an additional eight optional worksite demographic questions divided into 19 modules (risk factors/conditions/demographics) that assess how evidence-based health promotion strategies are implemented at a worksite. These strategies include health promoting counseling services, environmental supports, policies, health plan benefits, and other worksite programs shown to be effective in preventing heart disease, stroke, and related health conditions. Employers can use this tool to assess how a comprehensive health promotion and disease prevention program is offered to their employees, to help identify program gaps, and to prioritize high impact strategies for health promotion at the worksite.

    This is a revised Information Collection Request (ICR) supporting a broader group of employers to access the updated and pilot tested Scorecard, a web-based worksite organizational assessment, to regularly assess their workplace health programs and practices. Scorecard users will create a user account, complete the online assessment and receive an immediate feedback report that summarizes the current status of their worksite health program; identifies gaps in current programming; benchmarks individual employer results against other users of the system; and provides access to worksite health tools and resources to address employer gaps and priority program areas.

    The updated Scorecard is based on a 2017 pilot test to determine the validity and reliability involving 89 employers (each represented by two knowledgeable employees) who completed the survey and follow-up telephone interviews to gather general impressions of the Scorecard—particularly the new modules—and also to discuss items where there were discrepancies (and items that were left blank) to understand the respondent's interpretation and perspective of their answers to these questions. The revised instrument includes some reorganization of the instrument and minor revisions, particularly to the new modules/questions, to better explain and define the context, concepts, or administration of the strategies and interventions contained in the questions has been completed. This will streamline future information collection and minimize additional response time.

    CDC will continue to provide outreach to, and register approximately 800 employers per year to use the online Scorecard survey in their workplace health program assessment, planning, and implementation efforts, which is open to employers of all sizes, industry sectors, and geographic locations across the country. OMB approval is requested for three years. Participation is voluntary and 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 hrs)
  • Total burden
  • (in hrs)
  • Employers CDC Worksite Health ScoreCard Registration 800 1 5/60 67 CDC Worksite Health Scorecard 800 1 45/60 600 Total 667
    Jeffrey M. Zirger, Acting 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. 2018-22940 Filed 10-19-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2018-0054] Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures AGENCY:

    Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC).

    ACTION:

    Notice of availability.

    SUMMARY:

    On May 31, 2018, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) requested comments on a plan to (1) revise the definition and characterization of Assisted Reproductive Technology (ART) success rates and (2) introduce clinic validation footnotes for the annual ART Fertility Clinic Success Rates Report. In the plan, CDC proposed to include the footnotes to identify clinics selected by CDC to participate in the validation process of the National ART Surveillance System (NASS) data and: (a) Do participate, (b) do participate and have major data discrepancies identified through this process, or (c) decline to participate in the data validation process. This notice responds to the comments received in response to the notice published on May 31, 2018 and announces the availability of the revised process for ART Success Rates Reporting and plans for revising Data Validation Procedures.

    FOR FURTHER INFORMATION CONTACT:

    Jeani Chang, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop F-74, Atlanta, Georgia 30341. Telephone: (770) 488-5200; email: [email protected]

    Public Comment Summary and Responses

    CDC received three public comments to the docket. One comment was considered nonsubstantive because it was outside the scope of the docket. A second comment was supportive of CDC's planned approach for revising the definition of success rates and introducing clinic validation footnotes. The third comment contained concerns about CDC's planned clinic validation footnotes and the approach to clinic validation, and requested a clarification of the reporting requirements of embryo banking cycles. These suggestions, as well as CDC's responses, are included below:

    1. ART success rates reporting: One commenter asked that CDC provide more details about reporting requirements of embryo banking cycles.

    Response: CDC thanks the commenter for this request. Egg/embryo banking cycles intended for pregnancy in the short term include cycles initiated with the intent of cryopreserving all eggs/embryos for subsequent transfers within 12 months. Egg/embryo banking cycles intended for pregnancy in the long term (often referred to as fertility preservation) include cycles where the patient did not start any transfer cycles within the 12 month period following the date on which the intended retrieval cycle started and one of the following: (1) The cycle intent was long term (>12 months) banking for fertility preservation prior to gonadotoxic medical treatments; or (2) The cycle intent was long term (>12 months) banking for other reasons and (a) at least one egg was retrieved, and (b) at least one egg or embryo was frozen. Specifics about the reporting process and requirements are described in “Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs” (80 FR 51811).

    2. Clinic data validation and footnotes: A commenter expressed concern that discrepancies identified during on-site data validation would not be corrected prior to publication of the ART Fertility Clinic Success Rates Report. The commenter suggested that instead of including a footnote, identification of erroneous data (such as an incorrect number of reported cycles or pregnancy outcomes) should result in removing clinic success rates from ART Fertility Clinic Success Rates Report, and that erroneous data should not be included with data from other clinics. The commenter was also concerned that random selection of clinics under the current CDC validation system does not identify systematic reporting errors. The commenter suggested that targeted selection of clinics based on reporting characteristics that predict erroneously inflated ART success rates is a better approach to identify systematic reporting errors. Finally, the commenter was concerned that validation footnotes and the appendix may not be easily understood by the patients.

    Response: CDC thanks the commenter for expressing these concerns and for providing suggestions to improve reporting. CDC is considering these concerns and reviewing options for future years' data validation. CDC is withdrawing its pending proposal for data validation footnotes (83 FR 25009). If CDC determines that changes in data validation selection processes and/or footnotes are advisable, proposed changes will be published in the Federal Register for public comment.

    Appendix—Notice for Assisted Reproductive Technology (ART) Success Rates Reporting: A. Background

    Section 2(a) of Public Law 102-493 (42 U.S.C. 263a-1(a)), the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), requires that each assisted reproductive technology (ART) program report annually to the Secretary of the Department of Health and Human Services through the Centers for Disease Control and Prevention (CDC) pregnancy success rates achieved through assisted reproductive technology. The FCSRCA also requires CDC to annually publish and distribute to the public reported pregnancy success rates for each ART clinic. According to the FCSRCA, the definitions of pregnancy success rates should be developed in consultation with appropriate consumer and professional organizations, should take into account the effect on success rates of age, diagnosis, and other significant factors, and should include the live birth rate per attempted ovarian stimulation procedure and the live birth rate per successful oocyte retrieval.

    Specifics about the reporting process and requirements are described in “Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs” (August 26, 2015; 80 FR (51811-51819)). Specifics about the definition and characterization of ART success rates were last described in “Reporting of Pregnancy Success Rates from Assisted Reproductive Technology Programs” (February 5, 2004; 69 FR (5548-5550)). Success rates for fresh, nondonor cycles were defined as: 1. The rate of pregnancy after completion of ART according to the number of all ovarian stimulation or monitoring procedures; 2. the rate of live birth after completion of ART according to the number of all ovarian stimulation or monitoring procedures, the number of oocyte retrieval processes, and the number of embryo (or zygote or oocyte) transfer procedures; 3. the rate of singleton live birth after completion of ART according to the number of all ovarian stimulation or monitoring procedures and the number of embryo (or zygote or oocyte) transfer procedures. Success rates for cycles using thawed embryos and cycles using donor oocytes or embryos were defined as: 4. the rate of live birth after completion of ART according to the number of embryo (or zygote or oocyte) transfer procedures; 5. the rate of singleton live birth after completion of ART according to the number of embryo (or zygote or oocyte) transfer procedures.

    Effective for reporting year 2017, CDC is implementing substantial changes to the definition and characterization of ART success rates due to changes in clinical practice and more variation in treatment options, including improvements in cryopreservation resulting in more segmentation of typical treatment cycles. The field of ART is moving toward the calculation and reporting of cumulative success rates where data collection systems can collect successes over all embryo transfers from a single oocyte retrieval or across several oocyte retrievals and embryo transfers. After consultation with consumer and professional organizations with expertise in ART, CDC will begin cumulative ART success rates reporting in reporting year 2017. The ART success rates described in this Federal Register notice shall replace those previously described in 2004.

    B. ART Procedures Among Patients Using Their Own Oocytes

    ART success rates for ART procedures among all patients using their own eggs are defined as:

    1. The rate of live birth or singleton live birth resulting from the transfer of oocytes retrieved from the patient in the year prior to the reporting year or from the transfer of embryos created from oocytes retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, transfer procedures must have started within 12 months of the start of the retrieval procedure. Oocytes must have been retrieved in the year prior to the reporting year in order to allow a full year to perform transfers of the retrieved oocytes (either in the prior reporting year or in the current reporting year). The live birth rate and singleton live birth rate will be presented according to the number of:

    a. All ovarian stimulation or monitoring procedures started from the year prior to the reporting year with the intent to retrieve oocytes from the patient.

    b. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient in which at least one oocyte was retrieved.

    c. All transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.

    2. The number of ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient presented according to the number of:

    a. Live births resulting from all transfers of at least one oocyte retrieved from the patient in the year prior to the reporting year, or transfers of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.

    Other rates for ART procedures among all patients using their own eggs are defined as follows (and may be provided publically at the ART program's discretion)—

    3. The rate of cancellation, implantation, pregnancy, live birth, singleton live birth, multiple live birth, twin live birth, triplet or higher order live birth, preterm live birth, low birthweight live birth or term, normal birthweight and singleton live birth resulting from the transfer of oocytes retrieved from the patient in the year prior to the reporting year or the transfer of embryos created from oocytes retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, transfer procedures must have started within 12 months of the start of the retrieval procedure. These other rates may be presented according to the number of:

    a. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient.

    b. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient in which at least one oocyte was retrieved.

    c. All transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.

    d. All first, second, third, or more transfer procedures after retrieval of at least one oocyte from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.

    Rates for ART procedures among new ART patients (i.e. patients that have never had a prior ART cycle ever) using their own oocytes are defined as—

    4. The rate of live birth resulting from the transfer of oocytes or embryos from all first intended oocyte retrievals presented according to the number of:

    a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year.

    5. The rate of live birth resulting from the transfer of oocytes or embryos from all first or second intended oocyte retrievals presented according to the number of:

    a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year.

    6. The rate of live birth resulting from the transfer of oocytes or embryos from all intended oocyte retrievals presented according to the number of:

    a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year.

    7. The number of ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient presented according to the number of:

    a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures.

    8. The number of transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year presented according to the number of:

    a. Ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure. Also, ART patients must have reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures.

    C. ART Procedures Among Patients Using Oocytes or Embryos From a Donor

    Success rates for ART procedures among patients using oocytes or embryos from a donor are defined as—

    9. The rate of live birth or singleton live birth presented according to the number of:

    a. Transfer procedures of at least one donor egg, embryo created from a donor egg, or donated embryo started in the current reporting year.

    Other rates for ART procedures among patients using oocytes or embryos from a donor are defined as follows (and may be provided publically at the ART program's discretion):

    10. The rate of cancellation, implantation, pregnancy, live birth, singleton live birth, multiple live birth, twin live birth, triplet or higher order live birth, preterm live birth, low birthweight live birth, or term, normal birthweight and singleton live birth presented according to the number of:

    a. ART procedures to prepare a patient (recipient) for the transfer of at least one donor egg, embryo created from a donor egg, or donated embryo, started in the current reporting year.

    b. Transfer procedures of at least one donor egg, embryo created from a donor egg, or donated embryo started in the current reporting year.

    D. ART Procedures Among All Patients and All Cycle Types

    At the discretion of the ART program, ART reporting also may include:

    11. The number, average number or percentage of ART procedures or ART patients with certain characteristics, such as:

    a. Patient characteristics (e.g. patient age or reason for ART).

    b. ART procedure characteristics (e.g. type of treatment (fertility preservation, short term banking, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer), stimulation protocol, source of the oocytes or embryos (patient or donor), the state of the oocytes or embryos (fresh or frozen), the intent of the procedure, the use of prenatal genetic diagnosis or screening, the use of intracytoplasmic sperm injection, the use of assisted hatching, the use of a gestational carrier, the stage of the embryo at transfer, or the number of embryos transferred).

    All ART patient and procedure characteristics, ART success rates, and other rates for patients using their own oocytes as well as for patients using oocytes or embryos from a donor may be stratified by CDC by factors thought to influence the outcome of an ART procedure.

    12. Factors for stratification may include:

    a. Characteristics of the ART patient such as patient age or reason for ART.

    b. Characteristics of the ART procedure such as type of treatment (fertility preservation, short term banking, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer), stimulation protocol, the source of the oocytes or embryos (patient or donor), the state of the oocytes or embryos (fresh or frozen), the intent of the procedure, the use of prenatal genetic diagnosis or screening, the use of intracytoplasmic sperm injection, the use of assisted hatching, the use of a gestational carrier, the stage of the embryo at transfer, or the number of embryos transferred.

    Dated: October 17, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2018-22991 Filed 10-19-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee (MSHRAC) AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 38 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at [email protected] or by phone at 412-386-5302 at least 5 business days in advance of the meeting.

    DATES:

    The meeting will be held on November 29, 2018, 8 a.m.-4 p.m., MST and on November 30, 2018, 8 a.m.-12 p.m. MST.

    ADDRESSES:

    University of Arizona, ENR2 Building, Room S215, 1064 E. Lowell Street, Tucson, AZ 85721 United States.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey H. Welsh, Designated Federal Officer, MSHRAC, NIOSH, CDC, 626 Cochrans Mill Road, Pittsburgh, PA 15236, telephone 412-386-4040; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose: This committee is charged with providing advice to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C. 812(b)(2), Section 102(b)(2).

    Matters to be Considered: The agenda will include discussions on mining safety and health research projects and outcomes, including real-time DPM monitor; industrial minerals sector research priorities; MSHRAC metal mine automation workgroup report; cemented backfill research; recent research in coal mine explosion and fire prevention; engaging in the miner health program; stability evaluation of active gas wells in longwall abutment pillars; and durable support for western US underground metal mines. The meeting will also include updates from the NIOSH Associate Director for Mining, the Spokane Mining Research Division, and the Pittsburgh Mining Research Division. Agenda items are subject to change as priorities dictate.

    The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention.
    [FR Doc. 2018-22988 Filed 10-19-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-19-18UF] Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Assessment of Evidence to Inform Standards that Ensure Turnout Gear Remains Protective Throughout Its Lifecycle to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 12, 2018 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

    CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

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

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

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

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

    (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

    Proposed Project

    Evidence to Inform Standards that Ensure Turnout Gear Remains Protective Throughout Its Lifecycle—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Turnout gear is a type of personal protective equipment used by the 1.1 million U.S. fire fighters to shield the body from carcinogens, flames, heat, and chemical/biological agents. It serves as a barrier to external hazards while simultaneously allowing for the escape of metabolic heat to prevent elevated core body temperatures. To provide the necessary performance characteristics, turnout gear design is complex, consisting of three major layers that work as a composite—a thermal liner, a moisture barrier, and an outer shell.

    Consensus standards provide performance requirements and retirement criteria for turnout gear. The retirement criteria is based on visual inspections and a 10-year age cap with visual inspection being less effective for the moisture barrier and thermal liner layers. Recent data of turnout gear donated from fire departments demonstrates that turnout gear from 2 to 10 years old was unable to meet all performance requirements. Thus, under the current retirement criteria, turnout gear that may not be protective against all hazards is being used by fire fighters.

    Intuitively, the use conditions to which turnout gear would be exposed to when used by a large or medium metropolitan fire department would be very different than those of a smaller department. However, the absence of scientific data to link performance to use conditions (e.g., number and type of washings, number of fire-related calls) provides a barrier to transitioning to an alternative approach to retirement.

    This study will obtain a statistically meaningful sample of turnout gear from three fire departments. The use conditions for the sampled turnout gear will be determined, and the gear will be subjected to established performance requirements. For each set of gear, its performance will be directly linked to its use condition history. This combined lab and field data will help determine if there is a relationship between turnout gear use conditions and the ability for turnout gear to effectively protect the user.

    The use conditions for each set of sampled gear will be determined by:

    (1) Reviewing fire department records, practices, and policies;

    (2) surveying the fire fighters assigned to each set of sampled gear to obtain one-month of retrospective information about the use conditions to which it was likely exposed; and

    (3) a 6-month prospective data collection where the fire fighters assigned to each set of sampled gear provide information about their shift-specific exposures.

    The estimated annualized Burden Hours for this information collection is 1,050. There is no cost to respondents 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)
  • Individual Fire Fighter Turnout Gear Safety Survey—Retrospective Exposures for past month 100 1 30/60 Turnout Gear Safety Survey—Prospective Exposures for six months 100 60 10/60
    Jeffrey M. Zirger, Acting 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. 2018-22939 Filed 10-19-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3305] Allergenic Products Advisory Committee; Cancellation AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The meeting of the Allergenic Products Advisory Committee scheduled for November 7, 2018, is cancelled. This meeting was announced in the Federal Register of September 26, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 240-402-5771, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22942 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3728] Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 “Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.”

    DATES:

    Submit either electronic or written comments on the collection of information by December 21, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2018]. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2018-N-3728 for “Collection of Conflict of Interest Information for Participation in FDA Fellowship and Traineeship Programs.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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.

    Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs; OMB Control Number 0910—NEW

    In compliance with 44 U.S.C. 3507, FDA will submit to the Office of Management and Budget a request to review and approve a new collection of information: “Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” Section 742 (b) of the Food, Drug and Cosmetic Act (21 U.S.C. 379l) allows FDA to conduct and support intramural training programs through fellowship and traineeship programs. These new forms provide the FDA with information about financial investments and relationships from non-employee scientists who participate in FDA fellowship and traineeship programs. Participants in FDA fellowship and traineeship programs will be asked for certain information about financial interests and current relationships: (1) Description of the financial interest; (2) the type of financial interest (e.g. stocks, bonds, stock options); (3) if the financial interest is an employee benefit from prior employment; (4) value of financial interest; (5) who owns the financial interest (e.g. self, spouse minor children); (6) employment relationship with an FDA significantly regulated organization (SRO); (7) and service as a consultant to an FDA SRO, and/or proprietary interest(s) in one of more product(s) regulated by FDA, including patent, trademark, copyright, or licensing agreement. The purpose of the financial information is for FDA to determine if there is a conflict of interest between the Fellow's or Trainee's financial and relationship interests and their activities at FDA. The collection of information is mandatory to participate in FDA's fellowship and traineeship programs.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Collection Form—Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA Oak Ridge Institute for Science and Education Fellowship 500 1 500 1 500 Traineeship Program 500 1 500 1 500 Reagan-Udall Fellowship at FDA 50 1 50 1 50 Total 1,050 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22960 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-3916] Determination of Regulatory Review Period for Purposes of Patent Extension; TECENTRIQ AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECENTRIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 21, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 22, 2019. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-E-3916 for “Determination of Regulatory Review Period for Purposes of Patent Extension; TECENTRIQ.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION: I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product TECENTRIQ (atezolizumab). TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received a patent term restoration application for TECENTRIQ (U.S. Patent No. 8,217,149) from Genentech, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 20, 2017, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of TECENTRIQ represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for TECENTRIQ is 1,836 days. Of this time, 1,708 days occurred during the testing phase of the regulatory review period, while 128 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 11, 2011. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on May 11, 2011.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C.262): January 12, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for TECENTRIQ (BLA 761034) was initially submitted on January 12, 2016.

    3. The date the application was approved: May 18, 2016. FDA has verified the applicant's claim that BLA 761034 was approved on May 18, 2016.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 769 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22957 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-E-6715, FDA-2017-E-6721, and FDA-2017-E-6726] Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TYMLOS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 21, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 22, 2019. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket Nos. FDA-2017-E-6715, FDA-2017-E-6721, and FDA-2017-E-6726 for “Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION: I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product TYMLOS (abaloparatide). TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the USPTO received patent term restoration applications for TYMLOS (U.S. Patent Nos. 7,803,770; 8,148,333; and 8,748,382) from Radius Health, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated February 8, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TYMLOS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for TYMLOS is 4,130 days. Of this time, 3,735 days occurred during the testing phase of the regulatory review period, while 395 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: January 8, 2006. FDA has verified the applicant's claim that the date the investigational new drug application became effective was January 8, 2006.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 30, 2016. FDA has verified the applicant's claim that the new drug application (NDA) for TYMLOS (NDA 208743) was initially submitted on March 30, 2016.

    3. The date the application was approved: April 28, 2017. FDA has verified the applicant's claim that NDA 208743 was approved on April 28, 2017.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 724 days, 1,123 days, or 1,128 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22956 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2434] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by November 21, 2018.

    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 0910-0429. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [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.

    Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products OMB Control Number 0910-0429—Extension

    This information collection supports the above captioned Agency guidance document. The guidance document was issued to help individuals with procedures on formal meetings between FDA and sponsors or applicants regarding the development and review of Prescription Drug User Fee Act (PDUFA) products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how FDA interprets and applies section 119(a) of the Food and Drug Administration Modernization Act of 2007 (Pub. L. 105-115), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 12.47 and 312.82 (21 CFR 312.47 and 312.82)). The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests and background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an “end-of-phase 2 meeting” (§§  312.47(b)(1)(ii) and (iv)) and a “pre-NDA meeting” (§  312.47(b)(2)). While the information collection provisions of §  312.47 are currently approved under OMB control number 0910-0014, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. The guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf.

    Request for a Meeting—Consistent with recommendations found in the guidance, a sponsor or applicant interested in meeting with the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) should submit a meeting request to the appropriate FDA component as an amendment to the application for the underlying product in accordance with our regulations (§§  312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)). Information provided to the Agency as part of an investigational new drug application (IND), new drug application (NDA), or biological license application (BLA) must be submitted with an appropriate cover form. Form FDA 1571 must accompany IND submissions, and Form FDA 356h must accompany NDA and BLA submissions. These Agency forms are approved under OMB control numbers 0910-0014 and 0910-0338, respectively.

    We recommend that a request be submitted in this manner to ensure that each request is kept in the administrative file with the complete application, and to ensure that pertinent information about the request is entered into appropriate tracking databases. Using information from our tracking databases enables us to monitor progress on activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner.

    The guidance recommends that meeting requests include the following information:

    • Information identifying and describing the product • the type of meeting being requested • a brief statement of the purpose of the meeting • a list of objectives and expected outcomes from the meeting • a preliminary proposed agenda • a draft list of questions to be raised at the meeting • a list of individuals who will represent the sponsor or applicant at the meeting • a list of Agency staff requested to be in attendance • the approximate date that the information package will be sent to the Agency • suggested dates and times for the meeting

    We use the information to determine the purpose of the meeting, the necessary participants, the proposed agenda, and to schedule the meeting.

    Information Package—The guidance also recommends that a sponsor or applicant submitting an information package provide summary information relevant to the product and supplementary information pertaining to any issue raised by the sponsor, applicant, or FDA. Information packages should generally include:

    • Identifying information about the underlying product • a brief statement of the purpose of the meeting • a list of objectives and expected outcomes of the meeting • a proposed agenda for the meeting • a list of specific questions to be addressed at the meeting • a summary of clinical data that will be discussed (as appropriate) • a summary of preclinical data that will be discussed (as appropriate) • chemistry, manufacturing, and controls information that may be discussed (as appropriate)

    The information package enables Agency staff to prepare for the meeting and allows appropriate time for reviewing relevant product data. Although FDA reviews similar information in the meeting request, the information package should provide updated data reflecting the most current and accurate information available to the sponsor or applicant.

    In the Federal Register of July 11, 2018 (83 FR 32130), 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 Guidance recommendations Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Meeting Requests: CDER 1,319 2.31 3,058 10 30,580 CBER 301 1.21 363 10 3,630 Subtotal 34,210 Information Packages: CDER 1,149 2.19 2,522 18 45,396 CBER 187 1.12 210 18 3,780 Subtotal 49,176 Total 83,386 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an overall increase since the previous OMB approval. We attribute this adjustment to an increase in the number of meeting requests and information packages received over the last few years.

    Based on Agency data, we estimate 1,319 sponsors and applicants (respondents) request 3,058 formal meetings with CDER annually, and 301 respondents request 363 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent spends preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be 10 hours. We expect it takes this amount of time to gather and copy brief statements about the product as well as a description of the purpose and details of the meeting.

    Also consistent with Agency data, we estimate 1,149 respondents submitted 2,522 information packages to CDER annually, and 187 respondents submitted 210 information packages to CBER annually, prior to a formal meeting regarding the development and review of a PDUFA product. We estimate 18 hours is needed to prepare the information package in accordance with the guidance.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22954 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050 AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 050” (Recognition List Number: 050), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

    DATES:

    Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective October 22, 2018.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2004-N-0451 for “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 050.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    An electronic copy of Recognition List Number: 050 is available on the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 050 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 050” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144.

    FOR FURTHER INFORMATION CONTACT:

    Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

    In the Federal Register notice of September 13, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate use of Voluntary Consensus Standards in Premarket Submission for Medical Devices.” The guidance describes how FDA has implemented its standard recognition program and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

    These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

    II. Modifications to the List of Recognized Standards, Recognition List Number: 050

    FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 050” to identify the current modifications.

    In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

    In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.

    Table 1—Modifications to the List of Recognized Standards Old
  • recognition
  • No.
  • Replacement recognition No. Title of standard 1 Change 2
    A. Anesthesiology 1-85 1-139 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment—Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Withdrawn and replaced with newer version. 1-96 1-140 ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors Withdrawn and replaced with newer version. B. Biocompatibility 2-176 2-255 ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity Withdrawn and replaced with newer version. 2-204 2-256 ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test Withdrawn and replaced with newer version. 2-233 2-257 ASTM F2382-17e1 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) Withdrawn and replaced with newer version. C. Cardiovascular 3-110 AAMI TIR41:2011/(R)2017 Technical Information Report Active implantable medical devices—Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators Reaffirmation. 3-123 3-152 IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Withdrawn and replaced with newer version. D. Dental/Ear, Nose, and Throat (ENT) 4-214 4-242 ISO 10139-1 Third edition 2018-03 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Withdrawn and replaced with newer version. E. General I (Quality Systems/Risk Management) (QS/RM) 5-42 ASTM D903-98 (Reapproved 2017) Standard Test Method for Peel or Stripping Strength of Adhesive Bonds Reaffirmation. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19-8 IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests Extent of recognition. 19-19 IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment—Part 4-2: Guidance and interpretation—Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems Extent of recognition. 19-21 19-30 AIM Standard 7351731 Rev. 2.00 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers—An AIM Standard Withdrawn and replaced with newer version. G. General Hospital/General Plastic Surgery (GH/GPS) 6-123 ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury‐in‐Glass, Maximum Self‐Registering Clinical Thermometers Reaffirmation. 6-254 ASTM F2100-11 (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks Reaffirmation. 6-301 6-408 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters—Sterile and single-use catheters—Part 1: General requirements [Including AMENDMENT 1 (2017)] Withdrawn and replaced with newer version including amendment. 6-352 6-409 ASTM F703-18 Standard Specification for Implantable Breast Prostheses Withdrawn and replaced with newer version. H. In Vitro Diagnostics (IVD) 7-127 7-275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry Withdrawn and replaced with newer version. 7-171 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi Withdrawn and replaced with newer version. 7-201 7-277 CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens Withdrawn and replaced with newer version. 7-204 7-278 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts Withdrawn and replaced with newer version. 7-217 CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts Title change. 7-240 CLSI M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement Withdrawn. See 7-217. 7-245 CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition Withdrawn. 7-254 7-279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically Withdrawn and replaced with newer version. 7-258 7-280 CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests Withdrawn and replaced with newer version. 7-271 7-281 CLSI M100 28th Edition Performance Standards for Antimicrobial Susceptibility Testing Withdrawn and replaced with newer version. I. Materials 8-57 8-465 ISO 5832-2 Fourth edition 2018-03 Implants for surgery—Metallic materials—Part 2: Unalloyed titanium Withdrawn and replaced with newer version. 8-112 ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Reaffirmation. 8-128 8-466 ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment Withdrawn and replaced with newer version. 8-330 8-467 ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser Withdrawn and replaced with newer version. 8-334 8-468 ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis Withdrawn and replaced with newer version. 8-372 8-469 ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Withdrawn and replaced with newer version. 8-380 ASTM F1160-14 (Reapproved 2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Reaffirmation. 8-382 8-470 ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants Withdrawn and replaced with newer version. 8-390 8-471 ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants Withdrawn and replaced with newer version. 8-412 ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion Reaffirmation. 8-414 8-472 ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments Withdrawn and replaced with newer version. 8-419 8-473 ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications Withdrawn and replaced with newer version. Extent of recognition. 8-420 8-474 ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications Withdrawn and replaced with newer version. 8-436 8-475 ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications Withdrawn and replaced with newer version. 8-448 8-476 ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis Withdrawn and replaced with newer version. 8-454 8-477 ASTM F2129-17b Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices Withdrawn and replaced with newer version. J. Nanotechnology No new entries at this time. K. Neurology No new entries at this time. L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) 9-43 9-117 ISO 16038 Second edition 2017-11 Male condoms—Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms Withdrawn and replaced with newer version. 9-67 ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms Reaffirmation. 9-92 9-118 ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Withdrawn and replaced with newer version. 9-95 9-119 IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment—Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy Withdrawn and replaced with new recognition number. 9-112 9-120 ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms) Withdrawn and replaced with newer version. M. Ophthalmic 10-56 ANSI Z80.12-2007 (R2017) American National Standard for Ophthalmics—Multifocal Intraocular Lenses Reaffirmation. 10-57 ANSI Z80.13-2007 (R2017) American National Standard for Ophthalmics—Phakic Intraocular Lenses Reaffirmation. 10-60 10-111 ISO 11981 Third edition 2017-11 Ophthalmic optics—Contact lenses and contact lens care products—Determination of physical compatibility of contact lens care products with contact lenses Withdrawn and replaced with newer version. 10-67 10-112 ISO 11986 Third edition 2017-11 Ophthalmic optics—Contact lenses and contact lens care products—Determination of preservative uptake and release Withdrawn and replaced with newer version. 10-84 ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics—Laser Systems for Corneal Reshaping Reaffirmation. N. Orthopedic 11-185 ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression Reaffirmation. 11-197 ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components Reaffirmation. 11-199 ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments Reaffirmation. 11-203 11-322 ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices Withdrawn and replaced with newer version. 11-224 11-323 ASTM F2706-17 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model Withdrawn and replaced with newer version. 11-226 8-478 ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments Withdrawn and replaced with newer version. Transferred. 11-227 11-324 ASTM F366-17 Standard Specification for Fixation Pins and Wires Withdrawn and replaced with newer version. 11-228 11-325 ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples Withdrawn and replaced with newer version. 11-245 11-326 ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices Withdrawn and replaced with newer version. 11-257 11-327 ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws Withdrawn and replaced with newer version. 11-261 11-328 ASTM F1378-17 Standard Specification for Shoulder Prostheses Withdrawn and replaced with newer version. 11-271 11-329 ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables Withdrawn and replaced with newer version. 11-284 11-330 ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation Withdrawn and replaced with newer version. 11-288 11-331 ASTM F2077-17 Test Methods for Intervertebral Body Fusion Devices Withdrawn and replaced with newer version. 11-296 11-332 ASTM F2193-18 Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System Withdrawn and replaced with newer version. 11-297 11-333 ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates Withdrawn and replaced with newer version. 11-310 ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers Reaffirmation. 11-315 11-334 ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear Withdrawn and replaced with newer version. 11-318 11-335 ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles Withdrawn and replaced with newer version. O. Physical Medicine 16-159 16-202 ISO 7176-2 Third edition 2017-10 Wheelchairs—Part 2: Determination of dynamic stability of electric wheelchairs Withdrawn and replaced with newer version. 16-185 ANSI RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters Extent of recognition. 16-193 16-203 ASME A18.1-2017 Safety Standard for Platform Lifts and Stairway Chairlifts Withdrawn and replaced with newer version. P. Radiology 12-202 IEC 60601-2-43 Edition 2.0 2010-03 Medical electrical equipment—Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures Recognition restored with transition period. 12-204 IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis Recognition restored with transition period. 12-296 12-317 IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including: Amendment 2 (2018)] Withdrawn and replaced with newer version including amendment. Q. Software/Informatics No new entries at this time. R. Sterility 14-138 14-512 ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products—Part 2: Sterilizing filtration Withdrawn and replaced with newer version. 14-275 ANSI/AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness Reaffirmation. 14-293 ANSI/AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers Reaffirmation. 14-294 ANSI/AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities Reaffirmation. 14-295 ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices Withdrawn. See 14-515. 14-344 14-513 ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery Withdrawn and replaced with newer version. 14-407 14-514 ISO 11737-1 Third edition 2018-01 Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products Withdrawn and replaced with newer version. S. Tissue Engineering No new entries at this time. 1 All standard titles in this table conform to the style requirements of the respective organizations. 2 Standards that are “Withdrawn” or “Withdrawn and replaced with newer version” will have a transition period with an expiration date as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
    III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 050.

    Table 2—New Entries to the List of Recognized Standards Recognition No. Title of standard 1 Reference No. and date A. Anesthesiology No new entries at this time. B. Biocompatibility No new entries at this time. C. Cardiovascular 3-153 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems ASTM F2743-11. 3-154 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices ASTM F3211-17. 3-155 Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC 60601-2-47 Edition 2.0 2012-02. 3-156 Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer ISO 14708-1 Second edition 2014-08-15. D. Dental/Ear, Nose, and Throat (ENT) 4-243 Corrosion Test Methods ANSI/ADA Standard No. 97:2002/ISO 10271:2001 Reaffirmed by ANSI: May 29, 2013. 4-244 Dentistry—Test methods for rotary instruments ISO 8325 Second edition 2004-09-15. 4-245 Dentistry—Corrosion test methods for metallic materials ISO 10271 Second edition 2011-08-01. 4-246 Dentistry—Pre-capsulated dental amalgam ISO 20749 First edition 2017-03. 4-247 Dentistry—Laser welding and filler materials ISO 28319 Second edition 2018-04. E. General I (Quality Systems/Risk Management) (QS/RM) 5-118 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms AAMI TIR66:2017. 5-119 Medical devices—Connectors for reservoir delivery systems for healthcare applications—Part 3: Enteral application ISO 18250-3 First edition 2018-06. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19-31 American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment ANSI C63.15-2017 (Revision of ANSI C63.15-2016). G. General Hospital/General Plastic Surgery (GH/GPS) No new entries at this time. H. In Vitro Diagnostics (IVD) 7-282 Performance Standards for Antifungal Susceptibility Testing of Yeasts CLSI M60 1st Edition. 7-283 Essential Tools for Implementation and Management of a Point-of-Care Testing Program CLSI POCT04 3rd Edition. 7-284 Supplemental Tables for Interference Testing in Clinical Chemistry CLSI EP37 1st Edition. I. Materials 8-479 Implants for surgery—Homopolymers, copolymers and blends on poly(lactide)—In vitro degradation testing ISO 13781 Second edition 2017-07. J. Nanotechnology No new entries at this time. K. Neurology No new entries at this time. L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) No new entries at this time. M. Ophthalmic 10-113 American National Standard for Ophthalmics—Toric Intraocular Lenses ANSI Z80.30-2018. N. Orthopedic 11-336 Wear of implant materials—Polymer and metal wear articles—Isolation and characterization ISO 17853 Third edition 2011-03-01. 11-337 Implants for surgery—Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants ISO 16087 First edition 2013-10-01. 11-338 Implants for surgery—Determination of impact resistance of ceramic femoral heads for hip joint prostheses ISO 11491 First edition 2017-07. 11-339 Implants for surgery—Partial and total hip joint prostheses—Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016)] ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15. 11-340 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices ASTM F3018-17. 11-341 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements ASTM F3140-17. O. Physical Medicine No new entries at this time. P. Radiology 12-318 Medical electrical equipment—Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment IEC 60601-2-64 Edition 1.0 2014-09. 12-319 Medical electrical equipment—Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment IEC 60601-2-68 Edition 1.0 2014-09. 12-320 Medical electrical equipment—Medical light ion beam equipment—Performance characteristics IEC 62667 Edition 1.0 2017-08. Q. Software/Informatics No new entries at this time. R. Sterility 14-515 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices ISO 17664 Second edition 2017-10. 14-516 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration ASTM F3039-15. 14-517 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices ASTM F3293-18. S. Tissue Engineering 15-55 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds ASTM F3259-17. 1 All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet appeared in the Federal Register). FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary.

    V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to [email protected] To be considered, such recommendations should contain, at a minimum, the following information available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22977 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0143] Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 information collection requirements associated with our Foreign Supplier Verification Programs (FSVP) for Food Importers.

    DATES:

    Submit either electronic or written comments on the collection of information by December 21, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2011-N-0143 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [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.

    Foreign Supplier Verification Programs (FSVP) for Food Importers OMB Control Number 0910-0752—Extension

    This information collection supports FDA regulations at 21 CFR part 1, subpart L—Foreign Supplier Verification Programs for Food Importers, as well as associated guidance. As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply. The regulations are intended to help ensure that food imported into the United States is produced in compliance with specific processes and procedures, including reasonably appropriate risk-based preventive controls. The regulations establish that importers of foods must develop, maintain, and follow an FSVP that provides adequate assurances that a foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 of the FD&C Act (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (21 U.S.C. 350h) (regarding standards for produce safety), if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 (21 U.S.C. 342) (regarding adulteration) and 403(w) (21 U.S.C. 343(w)) (if applicable) (regarding misbranding with respect to labeling for the presence of major food allergens) of the FD&C Act. The regulations also provide for certain exemptions.

    To assist respondents with the requirements we have developed Agency guidance, which is available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.

    We estimate the burden of the information collection is as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual
  • responses
  • Average burden per response Total hours
    Exemption for food for research 1.501(c) 36,360 40 1,454,400 0.083 (5 minutes) 120,715 DUNS number for filing with U.S. Customs and Border Protection 1.509(c), 1.511(c), 1.512(b)(2) 56,800 157 8,917,600 0.02 (1.2 minutes) 178,352 Total 299,067 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 Information collection activity; 21 CFR section Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual records Average
  • burden per
  • recordkeeping
  • Total hours
    Controls for low-acid canned foods; 1.502(b) 2,443 4 9,772 1 9,772 FSVP Recordkeeping, including hazard determination, written procedures, reevaluation; audits; and corrective actions: Determine and document hazards; 1.504(a) 11,701 1 11,701 3.5 40,954 Review hazard analysis; 1.504(d) 11,701 7 81,907 0.33 (20 minutes) 27,029 Evaluation of food and foreign supplier; 1.505(a)(2), 1.511(c)(1) 11,701 1 11,701 4 46,804 Approval of suppliers; 1.505(b), 1.512(c)(1)(iii) 8,191 1 8,191 12 98,292 Reevaluation of food and foreign supplier; 1.505(c), 1.512(c)(1)(ii)(A) 11,701 365 4,270,865 0.25 (15 minutes) 1,067,716 Confirm or change requirements of foreign supplier verification activity; 1.505(c), 1.512(c)(1)(ii)(A) 2,340 1 2,340 2 4,680 Review of other entities assessments; 1.505(d), 1.512(c)(1)(iii) 3,510 1 3,510 1.2 4,212 Written procedures for use of approved foreign suppliers; 1.506(a)(1), 1.511(c)(2), 1.512(c)(3)(i) 11,701 1 11,701 8 93,608 Review of written procedures; 1.506(a)(2), 1.511(c)(2)(ii), 1.512(c)(3)(ii) 11,701 1 11,701 1 11,701 Written procedures for conducting verification activities; 1.506(b), 1.511(c)(3) 11,701 1 11,701 2 23,402 Determination and documentation of appropriate supplier verification activities; 1.506(d)(1)-(2), 1.511(c)(5)(i) 11,701 4 46,804 3.25 152,113 Review of appropriate supplier verification activities determined by another entity; 1.506(d)(3), 1.511(c)(5)(iii) 11,701 2 23,402 0.33 (20 minutes) 7,723 Conduct/review audits; 1.506(e)(1)(i), 1.511(c)(4)(ii)(A) 11,701 2 23,402 3 70,206 Conduct periodic sampling/testing; 1.506(e)(1)(ii), 1.511(c)(4)(ii)(B) 11,701 2 23,402 1 23,402 Review records; 1.506(e)(1)(iii), 1.511(c)(4)(ii)(C) 11,701 2 23,402 1.6 37,443 Document your review of supplier verification activity records; 1.506(e)(3), 1.511(c)(4)(iii) 11,701 6 70,206 0.25 (15 minutes) 17,552 1.507(a)(1) 11,701 3.17 37,092 1.25 46,365 Written assurances; 1.507(a)(2), 1.507(a)(3), and 1.507(a)(4) 11,701 8.72 102,038 0.50 (30 minutes) 51,019 Disclosures that accompany assurances; 1.507(a)(2), 1.507(a)(3), and 1.507(a)(4) 102,038 1 102,038 0.50 (30 minutes) 51,019 Document assurances from customers; 1.507(c) 36,522 2.8 102,262 0.25 (15 minutes) 25,566 Document corrective actions; 1.508(a) and 1.512(b)(4) 2,340 1 2,340 2 4,680 Investigate and determine FSVP adequacy; 1.508(b), 1.511(c)(1) 2,340 1 2,340 5 11,700 Subtotal for FSVP Recordkeeping Itemized Above 4,984,046 1,917,186 Written assurances for food produced under dietary supplement current good manufacturing practices; 1.511(b) 11,701 2.88 33,699 2.25 75,823 Document very small importer/certain small foreign supplier status; 1.512(b)(1) 50,450 1 50,450 1 50,450 Written assurances associated with very small importer/certain small foreign supplier 1.512(b)(3) 50,450 2.8 141,260 2.25 317,835 Total 2,361,294 1 There are no capital costs or operating and maintenance costs associated with the information collection.

    We are retaining the currently approved burden estimates. The FSVP requirements became effective May 30, 2017, and we continue to evaluate associated burden.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22953 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2018-E-0675, FDA-2018-E-0678, and FDA-2018-E-0689] Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSA AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BESPONSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 21, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 22, 2019. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket Nos. FDA-2018-E-0675, FDA-2018-E-0678, and FDA-2018-E-0689 for “Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSA.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product BESPONSA (inotuzumab ozogamicin). BESPONSA is indicated for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Subsequent to this approval, the USPTO received patent term restoration applications for BESPONSA (U.S. Patent Nos. 8,153,768; 8,835,611; and 8,747,857) from Wyeth Holdings LLC, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated April 4, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of BESPONSA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for BESPONSA is 5,298 days. Of this time, 5,057 days occurred during the testing phase of the regulatory review period, while 241 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: February 16, 2003. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on February 16, 2003.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): December 20, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for BESPONSA (BLA 761040) was initially submitted on December 20, 2016.

    3. The date the application was approved: August 17, 2017. FDA has verified the applicant's claim that BLA 761040 was approved on August 17, 2017.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 654 days, 703 days, or 1,099 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22958 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-4308] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing Results AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA, or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by November 21, 2018.

    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-NEW and title “Draft Guidance for Industry: Labeling of Red Blood Cell Units with Historical Antigen Typing Results.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [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.

    Labeling of Red Blood Cell Units With Historical Antigen Typing Results, OMB Control Number 0910-NEW

    The draft guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling RBC units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The draft guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under 21 CFR 601.12.

    Description of Respondents: Establishments that collect blood and blood components intended for transfusion.

    Burden Estimate: We believe that the information collection provisions in the draft guidance do not create a new burden for respondents and are part of usual and customary business practices. According to the 30th edition of the AABB Standards for Blood Banks and Transfusion Services, RBC units may be labeled as RBC antigen negative without testing the current donation if two previous separate donations were tested by the collection facility and results of RBC typing were found to be concordant. The standards indicate that facilities have the option to put the non-ABO/Rh(D) historical antigen typing results on a tie-tag or directly on the container label.

    The guidance also recommends establishments that collect blood and blood components for transfusion should convey to transfusion services the practices for repeating historical RBC typing results on current donations and for labeling RBC units with historical RBC antigen typing results.

    We believe that collection establishments have already developed standard operating procedures for including the non-ABO/Rh(D) historical antigen typing results on a tie-tag or directly on the container label, and for conveying any change in their antigen typing or labeling practices to their consignees, including practices for repeating historical RBC typing results on current donations and for labeling RBC units with historical RBC antigen typing results.

    In the Federal Register of January 3, 2017 (82 FR 130), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received six comments on the guidance; however, no comments were related to the collection of information.

    The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR part 606 have been approved under OMB control number 0910-116.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22959 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Hearing

    Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee hearing.

    Name: National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards.

    Date and Times: Wednesday, December 12, 2018: 9 a.m.-5 p.m. (EST); Thursday, December 13, 2018: 9 a.m.-1 p.m. (EST).

    Place: Omni Shoreham Hotel, 2500 Calvert Street NW, Washington, DC 20008.

    Status: Open. There will be a public comment period during the final 15 minutes of both days of the meeting.

    Purpose: Health Insurance Portability and Accountability Act (HIPAA) legislation from 1996, as amended,1 directed the Secretary of Health and Human Services (HHS) to publish regulations adopting standards, code sets and identifiers to support the exchange of electronic health information between covered entities. The standards are for retail pharmacy and medical transactions.

    1 Along with Section 1104(c) of the Patient Protection and Affordable Care Act (ACA) of 2010.

    In its capacity to advise the HHS Secretary on health data, statistics, privacy, national health information policy, and HIPAA, NCVHS is in the final stages of the development of a standards update and adoption roadmap, referred to as the Predictability Roadmap. The development of the Predictability Roadmap has been a year and a half long process, achieved in collaboration with industry stakeholders and the standards development organizations (SDOs). The overall vision for the Predictability Roadmap is that:

    • HIPAA covered entities and their business associates use the adopted standards and operating rules in a consistent way to exchange health information and conduct business; and

    • Standards are reliably updated and adopted so that covered entities know when they will need to, and/or be able to update systems and business processes.

    To accomplish this goal, NCVHS conducted several information gathering activities and stakeholder engagement meetings and workshops: In June 2017 the Subcommittee on Standards met with each of the standards development organizations (SDOs) to learn about their individual maintenance processes; in August 2017 the Subcommittee held a visioning exercise with the SDOs and Designated Standards Maintenance Organization (DSMO); and in May 2018, the Subcommittee conducted a CIO Forum with 21 health care technology experts and senior corporate officers representing a cross-section of organizations that were end-users of the HIPAA and ACA administrative standards. The goal of this Forum was to elicit input for improving the standards development, update and adoption process, and address barriers to use of those standards. Based on this work, the Subcommittee on Standards developed a draft Predictability Roadmap comprised of 23 recommendations organized under three major focus areas. The draft recommendations were presented at the September 13-14 NCVHS meeting and are posted on the website at: https://ncvhs.hhs.gov/wp-content/uploads/2018/09/Presentation-NCVHS-Draft-Predictability-Roadmap-Recs-Coussoule-and-Goss.pdf.

    The purpose of this Subcommittee hearing is to obtain input from stakeholders on the draft recommendations designed to improve the processes for updating, adopting and using standards and operating rules, and developing a formal Predictability Roadmap. The Subcommittee will use the feedback received at this hearing to finalize recommendations to the Secretary of HHS.

    Individuals and representatives of organizations interested in submitting written testimony are invited to respond to the following questions:

    In general,

    1. Would these recommendations as a whole improve the predictability of the adoption of administrative standards and operating rules?

    2. What additional recommendations are critical to achieve predictability?

    And specifically,

    3. What is the value proposition of each recommendation and what improvements to the current state do you believe will arise from each recommendation/group of similar recommendations?

    4. Are there potential unintended consequences? What are those and how can they be mitigated with modifications to the recommendations?

    The questions outlined above can be used to guide written submissions to the Subcommittee. Written submissions should be sent electronically to [email protected] with “Predictability Roadmap” in the subject line no later than November 20, 2018.

    The times and topics for this meeting are subject to change. Please refer to the posted agenda at www.ncvhs.hhs.gov for any updates.

    Contact Persons for More Information: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone (301) 458-4715. Information pertaining to meeting content may be obtained from Lorraine Doo, MSW, MPH, (410) 786-6597; and/or Geanelle G. Herring, MSW, (410) 786-4466; Centers for Medicare & Medicaid Services, Office of Information Technology, Division of National Standards, 7500 Security Boulevard, Baltimore, Maryland, 21244. Summaries of meetings and a roster of Committee members are available on the NCVHS website: www.ncvhs.hhs.gov where further information including an agenda and instructions to access the live audio broadcast of the meeting will be posted.

    Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488-3210 as soon as possible.

    Sharon Arnold, Associate Deputy Assistant Secretary for Planning and Evaluation, Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation.
    [FR Doc. 2018-22952 Filed 10-19-18; 8:45 am] BILLING CODE 4151-05-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, 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; Review of NHLBI Cardiac Surgery Network Clinical Centers.

    Date: November 14, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton BWI (Baltimore), 1100 Old Elkridge Landing Road, Baltimore, MD 21090.

    Contact Person: Shelley S. Sehnert, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7206, Bethesda, MD 20892-7924, 301-435-0303, [email protected]

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Clinical Ancillary Studies (R01).

    Date: November 16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 20892-7924, 301-827-7942, [email protected]

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Early Phase Clinical Trials (R61/R33).

    Date: November 16, 2018.

    Time: 1:30 p.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Tony L. Creazzo, Ph.D. Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892-7924, 301-827-7913, [email protected]

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Early Phase Clinical Trials (R33).

    Date: November 16, 2018.

    Time: 2:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892-7924, 301-827-7913, [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: October 16, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22901 Filed 10-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary and Integrative Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended notice is hereby given of a meeting of the Special Emphasis Panel.

    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 Center for Complementary and Integrative Health Special Emphasis Panel, Early Phase Clinical Trials of Natural Products (NP).

    Date: November 29, 2018.

    Time: 12:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Martina Schmidt, Ph.D., Chief, Office of Scientific Review, National Center for Complementary and Integrative Health, NIH, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892, 301-594-3456, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Integrative Health, National Institutes of Health, HHS)
    Dated: October 16, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22902 Filed 10-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Physiology and Pathobiology of Cardiovascular and Respiratory Systems.

    Date: November 6-7, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Richard D. Schneiderman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, Bethesda, MD 20817, 301-402-3995, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Biological Chemistry, Biophysics and Assay Development.

    Date: November 8-9, 2018.

    Time: 8:30 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: JW Marriott New Orleans, 614 Canal Street, New Orleans, LA 70130.

    Contact Person: Vonda K. Smith, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6188, MSC 7892, Bethesda, MD 20892, 301-435-1789, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Developmental Brian Disorders and Alzheimer's Disease Applications.

    Date: November 8, 2018.

    Time: 1:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892, (301) 237-9838, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Cardiovascular and Respiratory Sciences.

    Date: November 14, 2018.

    Time: 12:00 p.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: Sara Ahlgren, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, RM 4136, Bethesda, MD 20892, 301-435-0904, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Biochemistry and Biophysics of Biological Macromolecules Fellowship Applications.

    Date: November 15, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Monaco Baltimore, 2 North Charles Street, Baltimore, MD 21201.

    Contact Person: Raymond Jacobson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5858, MSC 7849, Bethesda, MD 20892, 301-996-7702, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Biochemistry and Biophysics of Biological Macromolecules Fellowship Applications.

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Monaco Baltimore, 2 North Charles Street, Baltimore, MD 21201.

    Contact Person: Sudha Veeraraghavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1504, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 16-121: Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK.

    Date: November 15, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Raul Rojas, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6185, Bethesda, MD 20892, (301)451-6319, [email protected].

    Name of Committee: AIDS and Related Research Integrated Review Group; HIV Coinfections and HIV Associated Cancers Study Section.

    Date: November 19, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Washington Marriott at Metro Center, 775 12th Street NW, Washington, DC 20005.

    Contact Person: Eduardo A. Montalvo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7852, Bethesda, MD 20892, (301) 435-1168, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Disease Prevention and Management, Risk Reduction and Health Behavior Change.

    Date: November 19-20, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Fairmont Washington, DC, 2401 M Street NW, Washington, DC 20037.

    Contact Person: Michael John McQuestion, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3114, Bethesda, MD 20892, 301-480-1276, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Drug Discovery and Development.

    Date: November 19-20, 2018.

    Time: 8:30 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Sergei Ruvinov, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4158, MSC 7806, Bethesda, MD 20892, 301-435-1180, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Orthopedic, Skeletal Muscle and Oral Sciences.

    Date: November 19-20, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: Aftab A. Ansari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4108, MSC 7814, Bethesda, MD 20892, 301-237-9931, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Drug Discovery and Clinical Field Studies.

    Date: November 19, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD 20892, 301-996-5819, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Arthritis, Connective Tissue, and Skin Sciences.

    Date: November 19, 2018.

    Time: 1:00 p.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: Yi-Hsin Liu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-435-1781, [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: October 16, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22898 Filed 10-19-18; 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 Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The 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: Center for Scientific Review Special Emphasis Panel; Opioids in the CNS: Markers and Mechanisms.

    Date: October 23, 2018.

    Time: 2:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Julius Cinque, MS, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5186, MSC 7846, Bethesda, MD 20892, (301) 435-1252, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (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: October 16, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22899 Filed 10-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, 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 Library of Medicine Special Emphasis Panel COI/Career Award.

    Date: December 6, 2018.

    Time: 11 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Library of Medicine/Center for Scientific Review, 6701 Rockledge Drive, Room 3181, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Yanli Wang, Ph.D., Health Data Scientist, Division of Extramural Programs, National Library of Medicine, NIH, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892-7968, 301-594-4933, [email protected]

    (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS)
    Dated: October 16, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22897 Filed 10-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The 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 Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Chemical Senses Fellowship Review.

    Date: October 24, 2018.

    Time: 11:00 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Bethesda, MD (Virtual Meeting).

    Contact Person: Sheo Singh, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301-496-8683, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS)
    Dated: October 16, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22900 Filed 10-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2018-0001] Notice of Adjustment of Statewide per Capita Impact Indicator AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    FEMA gives notice that the statewide per capita impact indicator under the Public Assistance program for disasters declared on or after October 1, 2018, will be increased.

    DATES:

    This adjustment applies to major disasters declared on or after October 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.

    SUPPLEMENTARY INFORMATION:

    44 CFR 206.48 provides that FEMA will adjust the statewide per capita impact indicator under the Public Assistance program to reflect changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.

    FEMA gives notice that the statewide per capita impact indicator will be increased to $1.50 for all disasters declared on or after October 1, 2018.

    FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. The Bureau of Labor Statistics of the U.S. Department of Labor released the information on September 13, 2018.

    (Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters)) Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-22888 Filed 10-19-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2018-0001] Notice of Adjustment of Countywide per Capita Impact Indicator AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    FEMA gives notice that the countywide per capita impact indicator under the Public Assistance program for disasters declared on or after October 1, 2018, will be increased.

    DATES:

    This adjustment applies to major disasters declared on or after October 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.

    SUPPLEMENTARY INFORMATION:

    In assessing damages for area designations under 44 CFR 206.40(b), FEMA uses a countywide per capita indicator to evaluate the impact of the disaster at the county level. FEMA will adjust the countywide per capita impact indicator under the Public Assistance program to reflect annual changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.

    FEMA gives notice of an increase in the countywide per capita impact indicator to $3.78 for all disasters declared on or after October 1, 2018.

    FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. The Bureau of Labor Statistics of the U.S. Department of Labor released the information on September 13, 2018.

    Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters) Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-22886 Filed 10-19-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2018-0001] Notice of Adjustment of Minimum Project Worksheet Amount AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    FEMA gives notice that the minimum Project Worksheet Amount under the Public Assistance program for disasters and emergencies declared on or after October 1, 2018, will be increased.

    DATES:

    This adjustment applies to major disasters and emergencies declared on or after October 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.

    SUPPLEMENTARY INFORMATION:

    The Robert T. Stafford Disaster Relief and Emergency Assistance Act 42 U.S.C. 5121-5207 and 44 CFR 206.202(d)(2) provide that FEMA will annually adjust the minimum Project Worksheet amount under the Public Assistance program to reflect changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.

    FEMA gives notice of an increase to $3,200 for the minimum amount that will be approved for any Project Worksheet under the Public Assistance program for all major disasters and emergencies declared on or after October 1, 2018.

    FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. This is based on information released by the Bureau of Labor Statistics at the U.S. Department of Labor on September 13, 2018.

    (Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters) Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-22889 Filed 10-19-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2007-0008] National Advisory Council; Meeting AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Committee management; Notice of open Federal Advisory Committee meeting.

    SUMMARY:

    The Federal Emergency Management Agency (FEMA) National Advisory Council (NAC) will meet in person on November 6-8, 2018, in Washington, DC. The meeting will be open to the public.

    DATES:

    The NAC will meet Tuesday, November 6, 2018, from 8:00 a.m. to 5:00 p.m., Wednesday, November 7, 2018, from 8:30 a.m. to 5:00 p.m., and Thursday, November 8, 2018, from 8:30 a.m. to 1:00 p.m. Eastern Time (ET). Please note that the meeting may close early if the NAC has completed its business.

    ADDRESSES:

    The meeting will be held at The National Association of Counties, located at 660 North Capitol Street NW, Washington, DC 20001. It is recommended that attendees register with FEMA by October 26, 2018, by providing their name, telephone number, email address, title, and organization to the person listed in the FOR FURTHER INFORMATION CONTACT below.

    For information on facilities or services for people with disabilities and others with access and functional needs (including people who use mobility aids, require medication or portable medical equipment, use service animals, need information in alternate formats, or rely on personal assistance services), or to request assistance at the meeting, contact the person listed in the FOR FURTHER INFORMATION CONTACT below as soon as possible.

    To facilitate public participation, members of the public are invited to provide written comments on the issues to be considered by the NAC. The “Agenda” section below outlines these issues. The full agenda and any related documents for this meeting will be posted by Friday, November 2, 2018, on the NAC website at http://www.fema.gov/national-advisory-council. Written comments must be submitted and received by 5:00 p.m. ET on November 2, 2018, identified by Docket ID FEMA-2007-0008, and submitted by one of the following methods:

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

    Fax: (540) 504-2331. Please include a cover sheet addressing the fax to ATTN: Deana Platt.

    Mail: Regulatory Affairs Division, Office of Chief Counsel, FEMA, 500 C Street SW, Room 8NE, Washington, DC 20472-3100.

    Instructions: All submissions must include the words “Federal Emergency Management Agency” and the docket number for this action. Comments received, including any personal information provided, will be posted without alteration at http://www.regulations.gov.

    Docket: For access to the docket to read comments received by the NAC, go to http://www.regulations.gov, and search for Docket ID FEMA-2007-0008.

    A public comment period will be held on Wednesday, November 7, 2018, from 1:00 p.m. to 1:15 p.m. ET. All speakers must limit their comments to 5 minutes. Comments should be addressed to the NAC. Any comments not related to the agenda topics will not be considered by the NAC. To register to make remarks during the public comment period, contact the individual listed in the FOR FURTHER INFORMATION CONTACT by November 2, 2018. Please note that the public comment period may end before the time indicated, following the last call for comments.

    FOR FURTHER INFORMATION CONTACT:

    Deana Platt, Designated Federal Officer, Office of the National Advisory Council, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472-3184, telephone (202) 646-2700, Fax (540) 504-2331, and email [email protected] The NAC website is: www.fema.gov/national-advisory-council.

    SUPPLEMENTARY INFORMATION:

    Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix.

    The NAC advises the FEMA Administrator on all aspects of emergency management. The NAC incorporates input from state, local, tribal and territorial governments, and the private sector in the development and revision of FEMA plans and strategies. The NAC includes a cross-section of officials, emergency managers, and emergency response providers from state, local, tribal, and territorial governments, the private sector, and nongovernmental organizations.

    Agenda: On Tuesday, November 6, 2018, the NAC will be briefed on progress made on previous recommendations from the relevant FEMA program leadership and will also hear about strategic priorities from the FEMA Administrator.

    On Wednesday, November 7, 2018, the Integrated Public Alert and Warning System Subcommittee will present its recommendations to the full NAC for consideration and, based on group discussion, the NAC will vote to make recommendations as appropriate to the FEMA Administrator. Following this, the three permanent and one ad-hoc NAC subcommittees (Federal Insurance and Mitigation Subcommittee, Preparedness and Protection Subcommittee, Response and Recovery Subcommittee, and Tribal Subcommittee) will discuss and deliberate on their potential recommendations and again, based on group discussion, the NAC will vote to make recommendations as appropriate to the FEMA Administrator. Potential recommendation topics include (1) leveraging communities to build a culture of preparedness, (2) engaging the whole community in planning and response, and (3) closing the insurance gap.

    On Thursday, November 8, 2018, the NAC will review potential topics for research before the next in-person meeting, discuss recent disasters, review agreed upon recommendations, and confirm charges for the subcommittees.

    The full agenda and any related documents for this meeting will be posted by Friday, November 2, 2018, on the NAC website at http://www.fema.gov/national-advisory-council.

    Dated: October 10, 2018. William B. “Brock” Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-22883 Filed 10-19-18; 8:45 am] BILLING CODE 9111-48-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2018-0001] Notice of Maximum Amount of Assistance Under the Individuals and Households Program AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    FEMA gives notice of the maximum amount for assistance under the Individuals and Households Program for emergencies and major disasters declared on or after October 1, 2018.

    DATES:

    This adjustment applies to emergencies and major disasters declared on or after October 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Christopher B. Smith, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 212-1000.

    SUPPLEMENTARY INFORMATION:

    Section 408 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act), 42 U.S.C. 5174, prescribes that FEMA must annually adjust the maximum amount for assistance provided under the Individuals and Households Program (IHP). FEMA gives notice that the maximum amount of IHP financial assistance provided to an individual or household under section 408 of the Stafford Act with respect to any single emergency or major disaster is $34,900. The increase in award amount as stated above is for any single emergency or major disaster declared on or after October 1, 2018. In addition, in accordance with 44 CFR 61.17(c), this adjustment includes the maximum amount of available coverage under any Group Flood Insurance Policy (GFIP) issued.

    FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period, which ended in August 2018. The Bureau of Labor Statistics of the U.S. Department of Labor released the information on September 13, 2018.

    (Catalog of Federal Domestic Assistance No. 97.048, Federal Disaster 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). Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-22884 Filed 10-19-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2018-0001] Notice of Adjustment of Disaster Grant Amounts AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    FEMA gives notice of an adjustment to the threshold for Small Project subgrants made to state, tribal, and local governments and private nonprofit facilities for disasters declared on or after October 1, 2018.

    DATES:

    This adjustment applies to major disasters and emergencies declared on or after October 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.

    SUPPLEMENTARY INFORMATION:

    The Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207, as amended by the Sandy Recovery Improvement Act, Public Law 113-2, provides that FEMA will annually adjust the threshold for assistance provided under section 422, Simplified Procedures, relating to the Public Assistance program, to reflect changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.

    FEMA gives notice that $128,900 is the threshold for any Small Project subgrant made to state, tribal, and local governments or to the owner or operator of an eligible private nonprofit facility under section 422 of the Stafford Act for all major disasters or emergencies declared on or after October 1, 2018.

    FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. This is based on information released by the Bureau of Labor Statistics at the U.S. Department of Labor on September 13, 2018.

    (Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants-Public Assistance (Presidentially Declared Disasters) Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-22890 Filed 10-19-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-3405-EM; Docket ID FEMA-2018-0001] Florida; Emergency and Related Determinations AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This is a notice of the Presidential declaration of an emergency for the State of Florida (FEMA-3405-EM), dated October 9, 2018, and related determinations.

    DATES:

    The declaration was issued October 9, 2018.

    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 October 9, 2018, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the emergency conditions in certain areas of the State of Florida resulting from Hurricane Michael beginning on October 7, 2018, and continuing, are of sufficient severity and magnitude to warrant an emergency 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 an emergency exists in the State of Florida.

    You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for debris removal and emergency protective measures (Categories A and B), including direct Federal assistance, under the Public Assistance program in selected areas and emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program in selected areas.

    Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. 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 emergency assistance and administrative expenses.

    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, Department of Homeland Security, under Executive Order 12148, as amended, Thomas J. McCool, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.

    The following areas of the State of Florida have been designated as adversely affected by this declared emergency:

    Debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program for Bay, Calhoun, Franklin, Gadsden, Gulf, Hamilton, Jackson, Jefferson, Leon, Liberty, Madison, Suwannee, Taylor, and Wakulla Counties.

    Emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program for Alachua, Baker, Bradford, Citrus, Columbia, Dixie, Escambia, Gilchrist, Hernando, Hillsborough, Holmes, Lafayette, Levy, Manatee, Okaloosa, Pasco, Pinellas, Santa Rosa, Union, Walton, and Washington Counties.

    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.
    Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-22885 Filed 10-19-18; 8:45 am] BILLING CODE 9111-11-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6129-N-01] Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts for 2019 AGENCY:

    Office of the Assistant Secretary for Policy Development and Research, HUD.

    ACTION:

    Notice.

    SUMMARY:

    This document designates “Difficult Development Areas” (DDAs) and “Qualified Census Tracts” (QCTs) for purposes of the Low-Income Housing Tax Credit (LIHTC) under Internal Revenue Code (IRC) Section 42, as enacted by the Tax Reform Act of 1986. The United States Department of Housing and Urban Development (HUD) makes new DDA and QCT designations annually.

    FOR FURTHER INFORMATION CONTACT:

    For questions on how areas are designated and on geographic definitions, contact Michael K. Hollar, Senior Economist, Economic Development and Public Finance Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 Seventh Street SW, Room 8216, Washington, DC 20410-6000; telephone number 202-402-5878, or send an email to [email protected] For specific legal questions pertaining to Section 42, contact Branch 5, Office of the Associate Chief Counsel, Passthroughs and Special Industries, Internal Revenue Service, 1111 Constitution Avenue NW, Washington, DC 20224; telephone number 202-317-4137, fax number 202-317-6731. For questions about the “HUBZone” program, contact Mariana Pardo, Director, HUBZone Program, Office of Government Contracting and Business Development, U.S. Small Business Administration, 409 Third Street, SW, Suite 8800, Washington, DC 20416; telephone number 202-205-2985, fax number 202-481-6443, or send an email to [email protected] (These are not toll-free telephone numbers.) A text telephone is available for persons with hearing or speech impairments at 800-877-8339. Additional copies of this notice are available through HUD User at 800-245-2691 for a small fee to cover duplication and mailing costs.

    Copies Available Electronically: This notice and additional information about DDAs and QCTs are available electronically on the internet at http://www.huduser.org/datasets/qct.html.

    SUPPLEMENTARY INFORMATION:

    I. This Notice

    Under 26 U.S.C. 42(d)(5)(B)(iii), for purposes of the LIHTC, the Secretary of HUD must designate DDAs, which are areas with high construction, land, and utility costs relative to area median gross income. This notice designates DDAs for each of the 50 states, the District of Columbia, Puerto Rico, American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands. The designations of DDAs in this notice are based on modified Fiscal Year (FY) 2018 Small Area Fair Market Rents (Small Area FMRs), FY2018 nonmetropolitan county FMRs, FY2018 income limits, and 2010 Census population counts, as explained below.

    Similarly, under 26 U.S.C. 42(d)(5)(B)(ii), the Secretary of HUD must designate QCTs, which are areas where either 50 percent or more of the households have an income less than 60 percent of the area median gross income for such year or have a poverty rate of at least 25 percent. This notice designates QCTs based on new income and poverty data released in the American Community Survey (ACS). Specifically, HUD relies on the most recent three sets of ACS data to ensure that anomalous estimates, due to sampling, do not affect the QCT status of tracts.

    II. Data Used To Designate DDAs

    Data from the 2010 Census on total population of metropolitan areas, metropolitan Zip Code Tabulation Areas (ZCTAs), and nonmetropolitan areas are used in the designation of DDAs. The Office of Management and Budget (OMB) first published new metropolitan area definitions incorporating 2010 Census data in OMB Bulletin No. 15-01 on July 15, 2015. FY2018 FMRs and FY2018 income limits used to designate DDAs are based on these metropolitan statistical area (MSA) definitions, with modifications to account for substantial differences in rental housing markets (and, in some cases, median income levels) within MSAs. Small Area FMRs are calculated for the ZCTAs, or portions of ZCTAs within the metropolitan areas defined by OMB Bulletin No. 15-01.

    III. Data Used To Designate QCTs

    Data from the 2010 Census on total population of census tracts, metropolitan areas, and the nonmetropolitan parts of states are used in the designation of QCTs. The FY2018 income limits used to designate QCTs are based on these MSA definitions with modifications to account for substantial differences in rental housing markets (and in some cases median income levels) within MSAs. This QCT designation uses the OMB metropolitan area definitions published in OMB Bulletin No. 15-01 on July 15, 2015, without modification for purposes of evaluating how many census tracts can be designated under the population cap, but uses the HUD-modified definitions and their associated area median incomes for determining QCT eligibility.

    Because the 2010 Decennial Census did not include questions on respondent household income, HUD uses ACS data to designate QCTs. The ACS tabulates data collected over 5 years to provide estimates of socioeconomic variables for small areas containing fewer than 65,000 persons, such as census tracts. Due to sample-related anomalies in estimates from year to year, HUD utilizes three sets of ACS tabulations to ensure that anomalous estimates do not affect QCT status.

    IV. Background

    The U.S. Department of the Treasury (Treasury) and its Internal Revenue Service (IRS) are authorized to interpret and enforce the provisions of the LIHTC found at IRC Section 42. In order to assist in understanding HUD's mandated designation of DDAs and QCTs for use in administering IRC Section 42, a summary of the section is provided below. The following summary does not purport to bind Treasury or the IRS in any way, nor does it purport to bind HUD, since HUD has authority to interpret or administer the IRC only in instances where it receives explicit statutory delegation.

    V. Summary of the Low-Income Housing Tax Credit A. Determining Eligibility

    The LIHTC is a tax incentive intended to increase the availability of low-income rental housing. IRC Section 42 provides an income tax credit to certain owners of newly constructed or substantially rehabilitated low-income rental housing projects. The dollar amount of the LIHTC available for allocation by each state (credit ceiling) is limited by population. Each state is allowed a credit ceiling based on a statutory formula indicated at IRC Section 42(h)(3). States may carry forward unallocated credits derived from the credit ceiling for one year; however, to the extent such unallocated credits are not used by then, the credits go into a national pool to be redistributed to states as additional credit. State and local housing agencies allocate the state's credit ceiling among low-income housing buildings whose owners have applied for the credit. Besides IRC Section 42 credits derived from the credit ceiling, states may also provide IRC Section 42 credits to owners of buildings based on the percentage of certain building costs financed by tax-exempt bond proceeds. Credits provided under the tax-exempt bond “volume cap” do not reduce the credits available from the credit ceiling.

    The credits allocated to a building are based on the cost of units placed in service as low-income units under particular minimum occupancy and maximum rent criteria. Prior to the enactment of the Consolidated Appropriations Act of 2018 (Act), under IRC Section 42(h), a building was required to meet one of two tests to be eligible for the LIHTC; either: (1) 20 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 50 percent of the Area Median Gross Income (AMGI), or (2) 40 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 60 percent of AMGI. A unit is “rent-restricted” if the gross rent, including an allowance for tenant-paid utilities, does not exceed 30 percent of the imputed income limitation (i.e., 50 percent or 60 percent of AMGI) applicable to that unit. The rent and occupancy thresholds remain in effect for at least 15 years, and building owners are required to enter into agreements to maintain the low-income character of the building for at least an additional 15 years.

    The Act added a third test, the average income test. See § 42(g)(1), as amended by section 103(a)(1), Division T, of the Act. A building meets the minimum requirements of the average income test if 40 percent or more (25 percent or more in the case of a project located in a high cost housing area as described in IRS Section 142(d)(6)) of the residential units in such project are both rent-restricted and occupied by individuals whose income does not exceed the imputed income limitation designated by the taxpayer with respect to the respective unit. The taxpayer designates the imputed income limitation for each unit. The designated imputed income limitation of any unit is determined in 10-percentage-point increments, and may be designated as 20, 30, 40, 50, 60, 70, or 80 percent of area median gross income. The average of the imputed income limitations designated must not exceed 60 percent of area median gross income. See § 42(g)(1)(C), as amended by section 103(a)(2), Division T, of the Act.

    B. Calculating the LIHTC

    The LIHTC reduces income tax liability dollar-for-dollar. It is taken annually for a term of 10 years and is intended to yield a present value of either: (1) 70 percent of the “qualified basis” for new construction or substantial rehabilitation expenditures that are not federally subsidized (as defined in IRC Section 42(i)(2)), or (2) 30 percent of the qualified basis for the cost of acquiring certain existing buildings or projects that are federally subsidized. The tax credit rates are determined monthly under procedures specified in IRC Section 42 and cannot be less than 9 percent for new buildings that are not federally subsidized. Individuals can use the credits up to a deduction equivalent of $25,000 (the actual maximum amount of credit that an individual can claim depends on the individual's marginal tax rate). For buildings placed in service after December 31, 2007, individuals can use the credits against the alternative minimum tax. Corporations, other than S or personal service corporations, can use the credits against ordinary income tax, and, for buildings placed in service after December 31, 2007, against the alternative minimum tax. These corporations also can deduct losses from the project.

    The qualified basis represents the product of the building's “applicable fraction” and its “eligible basis.” The applicable fraction is based on the number of low-income units in the building as a percentage of the total number of units, or based on the floor space of low-income units as a percentage of the total floor space of residential units in the building. The eligible basis is the adjusted basis attributable to acquisition, rehabilitation, or new construction costs (depending on the type of LIHTC involved). These costs include amounts chargeable to a capital account that are incurred prior to the end of the first taxable year in which the qualified low-income building is placed in service or, at the election of the taxpayer, the end of the succeeding taxable year. In the case of buildings located in designated DDAs or designated QCTs, or buildings designated by the state agency, eligible basis can be increased up to 130 percent from what it would otherwise be. This means that the available credits also can be increased by up to 30 percent. For example, if a 70 percent credit is available, it effectively could be increased to as much as 91 percent (70 percent × 130 percent).

    C. Defining Difficult Development Areas (DDAs) and Qualified Census Tracts (QCTs)

    As stated above, IRC Section 42 defines a DDA as an area designated by the Secretary of HUD that has high construction, land, and utility costs relative to the AMGI. All designated DDAs in metropolitan areas (taken together) may not contain more than 20 percent of the aggregate population of all metropolitan areas, and all designated areas not in metropolitan areas may not contain more than 20 percent of the aggregate population of all nonmetropolitan areas. See 26 U.S.C. 42(d)(5)(B)(iii).

    Similarly, IRC Section 42 defines a QCT as an area designated by the Secretary of HUD where, for the most recent year for which census data are available on household income in such tract, either 50 percent or more of the households in the tract have an income which is less than 60 percent of the area median gross income or the tract's poverty rate is at least 25 percent. All designated QCTs in a single metropolitan area or nonmetropolitan area (taken together) may not contain more than 20 percent of the population of that metropolitan or nonmetropolitan area. Thus, unlike the restriction on DDA designations, QCTs are restricted by the total population of each individual area as opposed to the aggregate population across all metropolitan areas and nonmetropolitan areas. See 26 U.S.C. 42(d)(5)(B)(ii).

    IRC Section 42(d)(5)(B)(v) allows states to award an increase in basis up to 30 percent to buildings located outside of federally designated DDAs and QCTs if the increase is necessary to make the building financially feasible. This state discretion applies only to buildings allocated credits under the state housing credit ceiling and is not permitted for buildings receiving credits in connection with tax-exempt bonds. Rules for such designations shall be set forth in the LIHTC-allocating agencies' qualified allocation plans (QAPs). See 26 U.S.C. 42(m).

    VI. Explanation of HUD Designation Method A. 2019 Difficult Development Areas

    In developing the 2019 list of DDAs, as required by 26 U.S.C. 42(d)(5)(B)(iii), HUD compared housing costs with incomes. HUD used 2010 Census population for ZCTAs, and nonmetropolitan areas, and the MSA definitions, as published in OMB Bulletin 15-01 on July 15, 2015, with modifications, as described below. In keeping with past practice of basing the coming year's DDA designations on data from the preceding year, the basis for these comparisons is the FY2018 HUD income limits for very low-income households (very low-income limits, or VLILs), which are based on 50 percent of AMGI, and modified FMRs based on the FY2018 FMRs used for the Housing Choice Voucher (HCV) program. For metropolitan DDAs, HUD used Small Area FMRs based on three annual releases of ACS data, to compensate for statistical anomalies which affect estimates for some ZCTAs. For non-metropolitan DDAs, HUD used the FY2018 FMRs published on October 2, 2017 (83 FR 7205) as updated through February 20, 2018 (83 FR 7205).

    In formulating the FY2018 FMRs and VLILs, HUD modified the current OMB definitions of MSAs to account for differences in rents among areas within each current MSA that were in different FMR areas under definitions used in prior years. HUD formed these “HUD Metro FMR Areas” (HMFAs) in cases where one or more of the parts of newly defined MSAs were previously in separate FMR areas. All counties added to metropolitan areas are treated as HMFAs with rents and incomes based on their own county data, where available. HUD no longer requires recent-mover rents to differ by five percent or more in order to form a new HMFA. All HMFAs are contained entirely within MSAs. All nonmetropolitan counties are outside of MSAs and are not broken up by HUD for purposes of setting FMRs and VLILs. (Complete details on HUD's process for determining FY2018 FMR areas and FMRs are available at https://www.huduser.gov/portal/datasets/fmr.html#2018. Complete details on HUD's process for determining FY2018 income limits are available at https://www.huduser.gov/portal/datasets/il.html#2018.)

    HUD's unit of analysis for designating metropolitan DDAs consists of ZCTAs, whose Small Area FMRs are compared to metropolitan VLILs. For purposes of computing VLILs in metropolitan areas, HUD considers entire MSAs in cases where these were not broken up into HMFAs for purposes of computing VLILs; and HMFAs within the MSAs that were broken up for such purposes. Hereafter in this notice, the unit of analysis for designating metropolitan DDAs will be called the ZCTA, and the unit of analysis for nonmetropolitan DDAs will be the nonmetropolitan county or county equivalent area. The procedure used in making the DDA designations follows:

    1. Calculate FMR-to-Income Ratios. For each metropolitan ZCTA and each nonmetropolitan county, HUD calculated a ratio of housing costs to income. HUD used a modified FY2018 two-bedroom Small Area FMR for ZCTAs, the FY2018 two-bedroom FMR as published for non-metropolitan counties, and the FY2018 four-person VLIL for this calculation.

    The modified FY2018 two-bedroom Small Area FMRs for ZCTAs differ from the FY2018 Small Area FMRs in four ways. First, HUD did not limit the Small Area FMR to 150 percent of its metropolitan area FMR. Second, HUD did not limit annual decreases in Small Area FMRs to ten percent, which was first applied in the FY2018 FMR calculations. Third, HUD adjusted the Small Area FMRs in New York City using the New York City Housing and Vacancy Survey, which is conducted by the U.S. Census Bureau, to adjust for the effect of local rent control and stabilization regulations. No other jurisdictions have provided HUD with data that could be used to adjust Small Area FMRs for rent control or stabilization regulations.1 Finally, the Small Area FMRs are not limited to the State non-metropolitan minimum FMR.

    1 HUD encourages other jurisdictions with rent control laws that affect rents paid by recent movers into existing units to contact HUD about what data might be provided or collected to adjust Small Area FMRs in those jurisdictions.

    The numerator of the ratio, representing the development cost of housing, was the area's FY2018 FMR, or Small Area FMR in metropolitan areas. In general, the FMR is based on the 40th-percentile gross rent paid by recent movers to live in a two-bedroom rental unit.

    The denominator of the ratio, representing the maximum income of eligible tenants, was the monthly LIHTC income-based rent limit, which was calculated as 1/12 of 30 percent of 120 percent of the area's VLIL (where the VLIL was rounded to the nearest $50 and not allowed to exceed 80 percent of the AMGI in areas where the VLIL is adjusted upward from its 50 percent-of-AMGI base).

    2. Sort Areas by Ratio and Exclude Unsuitable Areas. The ratios of the FMR, or Small Area FMR, to the LIHTC income-based rent limit were arrayed in descending order, separately, for ZCTAs and for nonmetropolitan counties. ZCTAs with populations less than 100 were excluded in order to avoid designating areas unsuitable for residential development, such as ZCTAs containing airports.

    3. Select Areas with Highest Ratios and Exclude QCTs. The DDAs are those areas with the highest ratios that cumulatively comprise 20 percent of the 2010 population of all metropolitan areas and all nonmetropolitan areas. For purposes of applying this population cap, HUD excluded the population in areas designated as 2019 QCTs. Thus, an area can be designated as a QCT or DDA, but not both.

    B. Application of Population Caps to DDA Determinations

    In identifying DDAs, HUD applied caps, or limitations, as noted above. The cumulative population of metropolitan DDAs cannot exceed 20 percent of the cumulative population of all metropolitan areas, and the cumulative population of nonmetropolitan DDAs cannot exceed 20 percent of the cumulative population of all nonmetropolitan areas.

    In applying these caps, HUD established procedures to deal with how to treat small overruns of the caps. The remainder of this section explains those procedures. In general, HUD stops selecting areas when it is impossible to choose another area without exceeding the applicable cap. The only exceptions to this policy are when the next eligible excluded area contains either a large absolute population or a large percentage of the total population, or the next excluded area's ranking ratio, as described above, was identical (to four decimal places) to the last area selected, and its inclusion resulted in only a minor overrun of the cap. Thus, for both the designated metropolitan and nonmetropolitan DDAs, there may be minimal overruns of the cap. HUD believes the designation of additional areas in the above examples of minimal overruns is consistent with the intent of the IRC. As long as the apparent excess is small due to measurement errors, some latitude is justifiable, because it is impossible to determine whether the 20 percent cap has been exceeded. Despite the care and effort involved in a Decennial Census, the Census Bureau and all users of the data recognize that the population counts for a given area and for the entire country are not precise. Therefore, the extent of the measurement error is unknown. There can be errors in both the numerator and denominator of the ratio of populations used in applying a 20 percent cap. In circumstances where a strict application of a 20 percent cap results in an anomalous situation, recognition of the unavoidable imprecision in the census data justifies accepting small variances above the 20 percent limit.

    C. Qualified Census Tracts

    In developing the list of QCTs, HUD used 2010 Census 100-percent count data on total population, total households, and population in households; the median household income and poverty rate as estimated in the 2010-2014, 2011-2015 and 2012-2016, ACS tabulations; the FY2018 Very Low-Income Limits (VLILs) computed at the HUD Metropolitan FMR Area (HMFA) level to determine tract eligibility; and the MSA definitions published in OMB Bulletin No. 15-01 on July 15, 2015, for determining how many eligible tracts can be designated under the statutory 20 percent population cap.

    HUD uses the HMFA-level AMGIs to determine QCT eligibility because the statute, specifically IRC Section 42(d)(5)(B)(iv)(II), refers to the same section of the IRC that defines income for purposes of tenant eligibility and unit maximum rent, specifically IRC Section 42(g)(4). By rule, the IRS sets these income limits according to HUD's VLILs, which, starting in FY2006 and thereafter, are established at the HMFA level. HUD uses the entire MSA to determine how many eligible tracts can be designated under the 20 percent population cap as required by the statute (IRC Section 42(d)(5)(B)(ii)(III)), which states that MSAs should be treated as singular areas.

    The QCTs were determined as follows:

    1. Calculate 60 percent AMGI. To be eligible to be designated a QCT, a census tract must have 50 percent of its households with incomes below 60 percent of the AMGI or have a poverty rate of 25 percent or more. Due to potential statistical anomalies in the ACS 5-year estimates, one of these conditions must be met in at least 2 of the 3 ACS 5-year tabulations for a tract to be considered eligible for QCT designation. HUD calculates 60 percent of AMGI by multiplying by a factor of 1.2 the HMFA or nonmetropolitan county FY2017 VLIL adjusted for inflation to match the ACS estimates, which are adjusted to the value of the dollar in the last year of the 5-year group.

    2. Determine Whether Census Tracts Have Less than 50 percent of Households Below 60 percent AMGI. For each census tract, whether or not 50 percent of households have incomes below the 60 percent income standard (income criterion) was determined by: (a) Calculating the average household size of the census tract, (b) adjusting the income standard to match the average household size, and (c) comparing the average-household-size-adjusted income standard to the median household income for the tract reported in each of the three years of ACS tabulations (2010-2014, 2011-2015 and 2012-2016). HUD did not consider estimates of median household income to be statistically reliable unless the margin of error was less than half of the estimate (or a Margin of Error Ratio, MoER, of 50 percent or less). If at least two of the three estimates were not statistically reliable by this measure, HUD determined the tract to be ineligible under the income criterion due to lack of consistently reliable median income statistics across the three ACS tabulations. Since 50 percent of households in a tract have incomes above and below the tract median household income, if the tract median household income is less than the average-household-size-adjusted income standard for the tract, then more than 50 percent of households have incomes below the standard.

    3. Estimate Poverty Rate. For each census tract, the poverty rate was determined in each of the three releases of ACS tabulations (2010-2014, 2011-2015 and 2012-2016) by dividing the population with incomes below the poverty line by the population for whom poverty status has been determined. As with the evaluation of tracts under the income criterion, HUD applies a data quality standard for evaluating ACS poverty rate data in designating the 2019 QCTs. HUD did not consider estimates of the poverty rate to be statistically reliable unless both the population for whom poverty status has been determined and the number of persons below poverty had MoERs of less than 50 percent of the respective estimates. If at least two of the three poverty rate estimates were not statistically reliable, HUD determined the tract to be ineligible under the poverty rate criterion due to lack of reliable poverty statistics across the ACS tabulations.

    4. Designate QCTs Where 20 percent or Less of Population Resides in Eligible Census Tracts. QCTs are those census tracts in which 50 percent or more of the households meet the income criterion in at least two of the three years evaluated, or 25 percent or more of the population is in poverty in at least two of the three years evaluated, such that the population of all census tracts that satisfy either one or both of these criteria does not exceed 20 percent of the total population of the respective area.

    5. Designate QCTs Where More than 20 percent of Population Resides in Eligible Census Tracts. In areas where more than 20 percent of the population resides in eligible census tracts, census tracts are designated as QCTs in accordance with the following procedure:

    a. The statistically reliable income and poverty criteria are each averaged over the three ACS tabulations (2010-2014, 2011-2015 and 2012-2016). Statistically reliable values that did not exceed the income and poverty rate thresholds were included in the average.

    b. Eligible tracts are placed in one of two groups based on the averaged values of the income and poverty criteria. The first group includes tracts that satisfy both the income and poverty criteria for QCTs for at least two of the three evaluation years; a different pair of years may be used to meet each criterion. The second group includes tracts that satisfy either the income criterion in at least two of the three years, or the poverty criterion in at least two of three years, but not both. A tract must qualify by at least one of the criteria in at least two of the three evaluation years to be eligible.

    c. Tracts in the first group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the first group are ranked from highest to lowest by the average of the poverty rates. The two ranks are averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.

    d. Tracts in the second group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the second group are ranked from highest to lowest by the average of the poverty rates. The two ranks are then averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.

    e. The ranked first group is stacked on top of the ranked second group to yield a single, concatenated, ranked list of eligible census tracts.

    f. Working down the single, concatenated, ranked list of eligible tracts, census tracts are identified as designated until the designation of an additional tract would cause the 20 percent limit to be exceeded. If a census tract is not designated because doing so would raise the percentage above 20 percent, subsequent eligible census tracts are then considered to determine if one or more eligible census tract(s) with smaller population(s) could be designated without exceeding the 20 percent limit.

    D. Exceptions to OMB Definitions of MSAs and Other Geographic Matters

    As stated in OMB Bulletin 15-01, defining metropolitan areas:

    “OMB establishes and maintains the delineations of Metropolitan Statistical Areas, . . . solely for statistical purposes. . . . OMB does not take into account or attempt to anticipate any non-statistical uses that may be made of the delineations, [.] In cases where . . . an agency elects to use the Metropolitan . . . Area definitions in nonstatistical programs, it is the sponsoring agency's responsibility to ensure that the delineations are appropriate for such use. An agency using the statistical delineations in a nonstatistical program may modify the delineations, but only for the purposes of that program. In such cases, any modifications should be clearly identified as delineations from the OMB statistical area delineations in order to avoid confusion with OMB's official definitions of Metropolitan . . . Statistical Areas.”

    Following OMB guidance, the estimation procedure for the FMRs and income limits incorporates the current OMB definitions of metropolitan areas based on the CBSA standards, as implemented with 2010 Census data, but makes adjustments to the definitions, in order to separate subparts of these areas in cases where counties were added to an existing or newly defined metropolitan area. In CBSAs where subareas are established, it is HUD's view that the geographic extent of the housing markets are not the same as the geographic extent of the CBSAs.

    In the New England states (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont), HMFAs are defined according to county subdivisions or minor civil divisions (MCDs), rather than county boundaries. However, since no part of an HMFA is outside an OMB-defined, county-based MSA, all New England nonmetropolitan counties are kept intact for purposes of designating Nonmetropolitan DDAs.

    Future Designations

    DDAs are designated annually as updated income and FMR data are made public. QCTs are designated annually as new income and poverty rate data are released.

    Effective Date

    The 2019 lists of QCTs and DDAs are effective:

    (1) for allocations of credit after December 31, 2018; or

    (2) for purposes of IRC Section 42(h)(4), if the bonds are issued and the building is placed in service after December 31, 2018.

    If an area is not on a subsequent list of QCTs or DDAs, the 2019 lists are effective for the area if:

    (1) the allocation of credit to an applicant is made no later than the end of the 730-day period after the applicant submits a complete application to the LIHTC-allocating agency, and the submission is made before the effective date of the subsequent lists; or

    (2) for purposes of IRC Section 42(h)(4), if:

    (a) The bonds are issued or the building is placed in service no later than the end of the 730-day period after the applicant submits a complete application to the bond-issuing agency, and

    (b) the submission is made before the effective date of the subsequent lists, provided that both the issuance of the bonds and the placement in service of the building occur after the application is submitted.

    An application is deemed to be submitted on the date it is filed if the application is determined to be complete by the credit-allocating or bond-issuing agency. A “complete application” means that no more than de minimis clarification of the application is required for the agency to make a decision about the allocation of tax credits or issuance of bonds requested in the application.

    In the case of a “multiphase project,” the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the project received its first allocation of LIHTC. For purposes of IRC Section 42(h)(4), the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the first of the following occurred: (a) The building(s) in the first phase were placed in service, or (b) the bonds were issued.

    For purposes of this notice, a “multiphase project” is defined as a set of buildings to be constructed or rehabilitated under the rules of the LIHTC and meeting the following criteria:

    (1) The multiphase composition of the project (i.e., total number of buildings and phases in project, with a description of how many buildings are to be built in each phase and when each phase is to be completed, and any other information required by the agency) is made known by the applicant in the first application of credit for any building in the project, and that applicant identifies the buildings in the project for which credit is (or will be) sought;

    (2) the aggregate amount of LIHTC applied for on behalf of, or that would eventually be allocated to, the buildings on the site exceeds the one-year limitation on credits per applicant, as defined in the Qualified Allocation Plan (QAP) of the LIHTC-allocating agency, or the annual per-capita credit authority of the LIHTC allocating agency, and is the reason the applicant must request multiple allocations over 2 or more years; and

    (3) all applications for LIHTC for buildings on the site are made in immediately consecutive years.

    Members of the public are hereby reminded that the Secretary of Housing and Urban Development, or the Secretary's designee, has legal authority to designate DDAs and QCTs, by publishing lists of geographic entities as defined by, in the case of DDAs, the Census Bureau, the several states and the governments of the insular areas of the United States and, in the case of QCTs, by the Census Bureau; and to establish the effective dates of such lists. The Secretary of the Treasury, through the IRS thereof, has sole legal authority to interpret, and to determine and enforce compliance with the IRC and associated regulations, including Federal Register notices published by HUD for purposes of designating DDAs and QCTs. Representations made by any other entity as to the content of HUD notices designating DDAs and QCTs that do not precisely match the language published by HUD should not be relied upon by taxpayers in determining what actions are necessary to comply with HUD notices.

    Interpretive Examples of Effective Date

    For the convenience of readers of this notice, interpretive examples are provided below to illustrate the consequences of the effective date in areas that gain or lose QCT or DDA status. The examples covering DDAs are equally applicable to QCT designations.

    (Case A) Project A is located in a 2019 DDA that is NOT a designated DDA in 2020 or 2021. A complete application for tax credits for Project A is filed with the allocating agency on November 15, 2019. Credits are allocated to Project A on October 30, 2021. Project A is eligible for the increase in basis accorded a project in a 2019 DDA because the application was filed BEFORE January 1, 2020 (the assumed effective date for the 2020 DDA lists), and because tax credits were allocated no later than the end of the 730-day period after the filing of the complete application for an allocation of tax credits.

    (Case B) Project B is located in a 2019 DDA that is NOT a designated DDA in 2020 or 2021. A complete application for tax credits for Project B is filed with the allocating agency on December 1, 2019. Credits are allocated to Project B on March 30, 2022. Project B is NOT eligible for the increase in basis accorded a project in a 2019 DDA because, although the application for an allocation of tax credits was filed BEFORE January 1, 2020 (the assumed effective date of the 2020 DDA lists), the tax credits were allocated later than the end of the 730-day period after the filing of the complete application.

    (Case C) Project C is located in a 2019 DDA that was not a DDA in 2018. Project C was placed in service on November 15, 2018. A complete application for tax-exempt bond financing for Project C is filed with the bond-issuing agency on January 15, 2019. The bonds that will support the permanent financing of Project C are issued on September 30, 2019. Project C is NOT eligible for the increase in basis otherwise accorded a project in a 2019 DDA, because the project was placed in service BEFORE January 1, 2019.

    (Case D) Project D is located in an area that is a DDA in 2019 but is NOT a DDA in 2020 or 2021. A complete application for tax-exempt bond financing for Project D is filed with the bond-issuing agency on October 30, 2019. Bonds are issued for Project D on April 30, 2021, but Project D is not placed in service until January 30, 2022. Project D is eligible for the increase in basis available to projects located in 2019 DDAs because: (1) one of the two events necessary for triggering the effective date for buildings described in Section 42(h)(4)(B) of the IRC (the two events being bonds issued and buildings placed in service) took place on April 30, 2021, within the 730-day period after a complete application for tax-exempt bond financing was filed, (2) the application was filed during a time when the location of Project D was in a DDA, and (3) both the issuance of the bonds and placement in service of Project D occurred after the application was submitted.

    (Case E) Project E is a multiphase project located in a 2019 DDA that is NOT a designated DDA or QCT in 2020. The first phase of Project E received an allocation of credits in 2019, pursuant to an application filed March 15, 2019, which describes the multiphase composition of the project. An application for tax credits for the second phase of Project E is filed with the allocating agency by the same entity on March 15, 2020. The second phase of Project E is located on a contiguous site. Credits are allocated to the second phase of Project E on October 30, 2020. The aggregate amount of credits allocated to the two phases of Project E exceeds the amount of credits that may be allocated to an applicant in one year under the allocating agency's QAP and is the reason that applications were made in multiple phases. The second phase of Project E is, therefore, eligible for the increase in basis accorded a project in a 2019 DDA, because it meets all of the conditions to be a part of a multiphase project.

    (Case F) Project F is a multiphase project located in a 2019 DDA that is NOT a designated DDA in 2020 or 2021. The first phase of Project F received an allocation of credits in 2019, pursuant to an application filed March 15, 2019, which does not describe the multiphase composition of the project. An application for tax credits for the second phase of Project F is filed with the allocating agency by the same entity on March 15, 2021. Credits are allocated to the second phase of Project F on October 30, 2021. The aggregate amount of credits allocated to the two phases of Project F exceeds the amount of credits that may be allocated to an applicant in one year under the allocating agency's QAP. The second phase of Project F is, therefore, NOT eligible for the increase in basis accorded a project in a 2019 DDA, since it does not meet all of the conditions for a multiphase project, as defined in this notice. The original application for credits for the first phase did not describe the multiphase composition of the project. Also, the application for credits for the second phase of Project F was not made in the year immediately following the first phase application year.

    Findings and Certifications Environmental Impact

    This notice involves the establishment of fiscal requirements or procedures that are related to rate and cost determinations and do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 40 CFR 1508.4 of the regulations of the Council on Environmental Quality and 24 CFR 50.19(c)(6) of HUD's regulations, this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

    Federalism Impact

    Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any policy document that has federalism implications if the document either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the document preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the executive order. This notice merely designates DDAs and QCTs as required under IRC Section 42, as amended, for the use by political subdivisions of the states in allocating the LIHTC. This notice also details the technical methods used in making such designations. As a result, this notice is not subject to review under the order.

    Dated: September 26, 2018. Todd M. Richardson, General Deputy Assistant Secretary for Policy Development and Research.
    [FR Doc. 2018-23000 Filed 10-19-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-7005-N-22] 60-Day Notice of Proposed Information Collection: Revitalization Area Designation and Management AGENCY:

    Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

    DATES:

    Comments Due Date: December 21, 2018.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at [email protected] for a copy of the proposed forms or other available information. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    FOR FURTHER INFORMATION CONTACT:

    Ivery Himes, Director, Office of Single Family Asset Management, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410, telephone 202-708-1672, extension 5628 (this is not a toll-free number) or email Colette Pollard at [email protected] Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    A. Overview of Information Collection